Approved For Release 2000/08/08 CIA-RDP96-00789ROO3300220001 -1 Now, vow, Tuesday June 18 1991 Part I I Federal Policy for the Protection of Human Subjects; Notices and Rules Office of Science and Technology Policy Department of Agriculture Department of Energy National Aeronautics and Space Administration Department of Commerce Consumer Product Safety Commission International Development Cooperation Agency Agency for International Development Department of Housing and Urban Development Department of Justice Department of Defense Department of Education Department of Veterans Affairs Environmental Protection Agency Department of Health and Human Services Office of the Secretary Food and Drug Administration National Science Foundation Department of Transportation Approved For Release 2000/08/08 CIA-RDP96-00789ROO3300220001 -1 Approved For Release 2000/08/08 - CIA-RDF96-007 OP00220001 -1 19~?~qp 2,11" 2 Federal Register Vol. 56, No. 117 fl Tuesday.- ]LIre 18. ces by the DePartment of f Icalth and OFFICE OF SCIENCE AND TECHNOLOGY POLICY Federai Policy for the Protection of Human Subjects AGENCY: Office of Science and Technology Policy, Executive Office of the President. ACTION: Notice of Federal Policy for Protection of Human Subjects. - SUMMARY: The Office of Science and Technology Policy has accepted the Final Federal Policy for the Protection of Human Subjects in the form of the common rule promulgated in this issue of the Federal Register. The common rule was developed by the Interagency Human Subjects Coordinating Committee of the Federal Coordinating Council for Science, Engineeriniz and Technology, in respinse to pubfic d comment on the notice of propose policy for Department and Agency Implementation published in the Federal Register on November 10. 1988 (53 FR 45660). Note that the Central Intelligence Agency is required by Executive Order 1" .333 to conform to the guidelines issued Human Services (HIHS). ADDRESSES: Requests for additional information should be addressed to Dr. loan P. Porter, Interagency Human Subjects Coordinating Committee, Building 31. room 5B59. Bethesda. Maryland 20892. Telephone: (301) 496- 7005. D. Allan Bromley. Dlpector, Office qf Science and 1echnology Policy. Executive Office o,f the President. [FR Doc. 91-14257 Filed 6-17-91: 8:45 aml BILLWG CODE 317"1-M A"!% Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 1'('91 / 4es and Re2uiations 28003 9 1 A qF1 -40 -11 C-17PARTMENT OF AGRICULTURE 1`11CPARTMENT OF HEALTH AND approved by and on file inthe Office fec HUMAN SERVICES Frotectlon irom Rosearch Risks (OPR-R) 7 CFR Part Ic in the Department of Health and Human 45 CFR Part 46 Services may ccntinue to do so in DEPARTMENT OF ENERGY accord with the terms and conditions of NATIONAL SCIENCE FOUN'DATiON their MPAg, See Supplementary 10 CFR Part 745 Information for further details. 45 CFR Part 690 NOW" NATIONAL AERONAUTICS AND SPACE ADMINISTRATION 14 CFR Part 1230 DEPARTMENT OF COMMERCE 15 CFR Part 27 CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1028 INTERNATIONAL DEVELOPMENT COOPERATION AGENCY Agency fer International Development 22 CFR Part 225 DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 60 DEPARTMENT OF JUSTICE 26 crR Part 46 DEPARTMENT OF DEFENSE 32 CFR Pnrt 219 DEPARTMENT OF EDUCATION 34 CFR Part 97 DEPA,rlTk-*ENT OF VETERANS AFFAIRS 33 CFR Part 16 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 26 DEPARTMENT OF TRANSPORTATION 49 CFR Part 11 Federai Policy for the Protection of Human Subjects AGENCIES. United States Department of Agriculture; Department of Energy: National Aeronautics and Space Administration: Department of Commerce; Consumer Product Safety Commission: International Deveiopment Cooperation Agency, Agency for International Development: Department of Housing and Urban Development-, Department of justice; Department of Defense; Department of Education. Department of Veterans Affairs: Environmental Protection Agemn Department of Health and Human Services; National Science Foundation: Department of Transportation. ACTION: Final rule. SUMMARY: This document sets forth a common Federal Policy for the Protection of Human Subjects (NIodel Policy) accepted by the 6ffice of Science and Technology Policy and promulgated in regulation by each of the listed Departments and Agencies. A Proposed Federal Policy for the Protection of Human Subjects published November 10. 1(338 (53 FR 45661) has been revised in response to public comments. The Policv as revised is now set forth as a common final rule. For related documents, see other sections of this Federal, Register part. EFFECTIVE DATE: These regolations shall become effective on August 19, 1291. The Department of Education regulations (34 CFR part 97) take effcct either August 19, 1991, or later if Congress takes certain adjoumments. If you want to know the effective date of the Department of Education regulations in 34 Cr-R part 97, call or write Mr. Edward Glassman, Office of Planning, Budget and Evaluation, U.S. Dei)artment of Education. room 3127, 400 Maryland Avenue SW.. Washington, DC 20202- 4132. A document announcing the effective date of the Department of Education regulations will be published in the Federal Register. Institutions currently conducting or supporting research in accord with Multiple Project Assurances of Compliance (MPAs) FOR FURTHER INFORMATION CONTACT: Dr. Joan P. Porter. (301) 496-7005, Office for Protection from Research Risks, National Institutes of Health. Building 31, room 51339, Bethesda. NID 20392. SUPPLEMENTARY INFORMATION: Paperwork Reduction Act Raquirements, Sections -.103(a): .103(b): -,iw(b)(4)(i),, -.103(b)!-1)(1iii): -.103(b)~5): -.103(0: .109(d): -113; A 15(a); -.116: and -.117 contain information collection requirements subject to approval by the Office of Management and Budget (ON113) under the Paperwork Reduction Act. HHS has submitted the request for approval to OMB on behalf of ail Departments and Agencies governed by this final rule and has published elsewhere in this issue of the Federal Register a request for OMB expedited review arid approval of the information collection requirements. OMB has assigned OMB control number 9999-0020; however. the information collection requirements will not become effective untii OMB has approved them. Unless a notice is published to the contrary, the public may assume that OLNIB has approved the information collection requirements during the 60- 'ay period before the final rule becomes r-Ifective. For further information regarding CIMB anproval. of the information coilection. contact Ms. Shannah Koss- McCallum, OMD, (202) 395-7316. ComDliance Dates: institutions that hold NIPAs are permitted and 0 s of encouraged to apply all provision this final ru!e as soon as it is feasible to do so. They are urged not to wait for the negotiation and approval of a revised MPA to begin to function in accord with this rule. The OPRR, acting on behalf of the Secretary, Department of Health and Human Services (HHS), will continue to renegotiate and approve MPAs in the normal periodic cycle of renewal. Institutions that are not operating under an MPA approved by OPRR will be required to negotiate an Assurance of Compliance with the supporting Department or Agency, prior to initiating research involving human subjects. Institutions with MPAs approved by and on file with HHS will be allowed a "grace period" of sixty days after the Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001-1 ep CIA-RDP96-?V ~,20 e~ F ws too,, P c, u?9RnOPJ3 fflp~IuO cgr, g v1F olep rtp 28004 0. iv. une 18. 1991 a tZO001 es eg?? ns__ submission date for an application sepkinR HHS Support, to provide CL-Itification of institutional Review Board (IRB) review and approval. F-xceptions may occur for reasons of Congressional mandate or special program or revi Iew requirements. In such cases. institutions will be advised that certification must be sent at an earlier time. B ackground This notice sets forth as a common rule requirements for the protection of lwriian subjects involved in research conducted or funded by the following Federal Departments and Agencies: United States Department of Aericuiture: Department of Flnergy: National Aeronautics and Space Administration; Oeportrnnn: of Commerce: Consumer Product Safety Commission; International DeVelODMent Cooperation Agency Agency for I International Deveiopment: Department of Housing and Urba n Deveiaoment: Department of justice. Department uf Defense: Department of Education: Depanment of Voter ns Affairs: 4 Frvironxnentai Protection Agency; National Science F0 u1ndat4on: Department of I lealth and Human Services and the Department ot Tiansportation. Each of these Departments and Agencies have adouted the commoii rule as reguletiens to b' e codified as listed above. The Food and Drug Administration (FDA1 Final Rule to modify current iegultitions to conferin to 6e Federal Po!icv are presented elsewherp in. th . 13 issue of the Federal Register. E-Nistir, FDA regulations governing the protection of humari subjects share a common core with the Federal Polic V and implement the fundamental principles embodied in that policy. rh e aolencv is committed to being as consis Itent with the final Federal Pobcv us it can be, given the unique requirements of the Federai Food, Drug. and Cosmetic Act under which FDA operates; and the fact that FDA is a regulatory agency that rarely supports or conducts research under its regulations. Adoption of the common Policy by Fk~derai Departments and Agencies in ri-guiatory form WR implement a recommendation of'rhe President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research which was established on November 9,1978. by Public Law 95--622. One of the charges to the President's Commission was to* report biennially to the President. the Congress, and appropriate Federal Departments and Agencies on the protection oi human subjects of biomedical and behavioral research. In carrying out that charge. the President's Commission was directed to conduct a review of the adequacy and uniformity (1) of the rules, policies. guidelines, and regulat tions of all Federal Departments and Agencies regarding the protection of human subjects of biomedical or behavioral research which such Departments and Agencies conduct or support, and (2) of the 41nplementation of such rules, policies, guidelines, and regulations by such Departments and Agancies, such review to include appropriate recommendations for legislation and administrative action. In December 1981 the President's Commission issued its First Biennial Report on the Adequacy and Uniformity of Federal Rules a;id Policies. and their Impiementation. for the Protection of I luman Subjects in Biomedical and Behavioral Research. Protecting Human Subjects. In accord with Public Law 95--62Z. each Federal Department or Agency which rf.,ceives recommendations from the President's Commission with respect to its rules. policies, guidelines or regulations. must publish the recommendations in the Federal Register and provide an opportunity for interested persons to submit written data. views and arguments with respect lo adoption of the recommendations. On March 29, 1982 (47 FR 13262-13305). the Secretary, HHS. published the recommendation on behalf of all affected Departments and Agencies. ln.1vIay 1982 the Chairman of the Federal Coordinating Council for Science. Engineering, and Technology I kFCCSET) appointed an Ad Hoc Committee for the Protection of Human Research Subjects under the auspices of the FCCSET. The Committee. chaired by Dr. Edward N. Brandt. jr.. Assistant Secretary for Health, Health and Human Services (HHS). was composed of representatives and ex-officio members oi the affected Departments and Agencies. In consultation with the Office of Science and Technology Policy (CISTP) and the Office of Management and Budget. the Ad Hoc Committee. after considering all public comments, developed responses to the recommendations of the President's Commission. After further review and r,!finerient, OSTP responded on behalf of all the affected Department and Agency Heads to the recommendations of the ilresident's Commission. including the recommendation that: The President should. through at)propriate action. require that al) federal departments and agencies adopt as a common core the regulations governing research with human subjects issued by the Department of Health and Human Services (codified at 45 CFR Pan 46), as periodically amended or revised, while Permitting additions needed by any department or agencV that are not inconsistent with these core provisions. The Ad Hoc Committee agreed that uniformity is desirable among Departments and Agencies to eliminate unnecessary regulation and to promote increased understanding and ease of compliance by institutions that conduct federally supported or regulated research involving human subjects. Therefore, the Ad Hoc Committee developed a Model Federal Policy. which applies to research involving human subjects conducted. supp,?rted or regulated by Fedcrai Departments and Agencies. In accordance with the Commission's recommendation. the Model Federal Policv is based on subpart A of the regulations of IIHS for the protection of human research subipco (45 CFR part 46). The Proposed 'Mociel federal Poiicv deveior)ed by the Ad Hn- Committee was mociffled by OSTP to enhance uniformitv of implementation among the affected Federal Departments and Agencies and to provide consistency with other related policies. The revised Model Federal Policy was concurred in by all affected Federal Departments and Agencies in March 1985. An Interagency Human Subjects Coordinating Committee was chartered in October 1983 under the auspices of FCCSET to provide continued interagency cooperation in human subject research once the Ad Hoc Committee had completed its assignment. It is chaired bv the Director of & Office for Protection'from Research Risks, HHS. and composed of representatives of all Federal Departments and Agencies that conduct. support or regulate research involving human subjects. The Committee is advisory to Department and Agency Heads and. among other responsibilities. will evaluate the implementation of the Federal Policy and recommend modification as necessary. On June 3. 1986. OSTP published for public comment in the Fadoral Register (51 FR 20204) a Proposed Model Federal Policy for Protection of Human Subjects and Response to the First Biannial Report of the President's Commission. Over 200 written comments were received concerning the publication. Th Interagency Human Subjects Coordinating Committee considered these comments in the revision of a common Federal Policy proposed as a common rule on November 10. 198& for Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 AW7jj~W_%nc~R ations 28005 A pdMVAff *9RLd I JJ64-69hanMh in gul Nwool' 1%wol~ adoption bv each of the Denartments and Agencies listed. Response to the more tnan 60 public comm!mts. discussion of revisions made to unat publication and the, final common rule follow. Summary of Public Coiriments Received in Response to theNovember 10. 1988, ftdaral Register publioation (53 FR 45661) of the Notice of PrODosed Common Rulemaking, Ferlerai Policy for the Protection of Human Subjects for 16 Federal Departments and Agencies. In response to the November 10, 19S8. publication, 66 commentators responded mthin the comment period. which was extended to February 8, 1959. The source of conunerts included I institutional offices of sponsored research, departmental deans and chairs and other staff of academic institutions. institutional review board members and staff, principal investigators. and drug company representatives. Although there were 66 separate commentators. several responses were prepared by organizations each representing a consortium of institutions which had been poiled concerning the notice of proposed common rulemaking. For exanipie, the Council on Governmental Relations. the Association of An, erican Medical Colleges, Public Responsibility forMedicine and Research. Association of Amencan Universities. the American Medical Association and tl~e Consortium of Social Science Associations offered comment on behalf of tbeir member institutions. I In general, commentators endorsed 'he efforts of t~e Office oi Science and Technology Policy arid t"a Feuerai Departments and Agencies to develop a Common Rule for the protection of human subjects. T'he majority of the comments dealt with 'three points in the proposci common rule, as follows: Saction -103(b)(5)' concerns those vrccedures set forth in Assurances of Cori Diiance for research conducted or supported by a federeJ Deoartment or Agency. As proposed. this'section required that an Assurance should include: Written procedures for ensuring proinpt reporting to the IRB. appropriate institutional officials, and the department or agency head (i) env unanticipated problems or scientific misconduct involving riEks to human subjects or others (ii) any instance of serious or continuous noncompliance with this policy or the requirements of determinations of the IRB and (iii) any suspension or termination If 11"13 approval. Some commentators indicated that they believed the proposed policy would inappropriately require IRBs to notify Department and Agency heads of scientific misconduct involving nsks to human subjects and others and that the sc;entific fraud and misconduct regulations I September 19. 1988. R~!sponsibilities of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science (53 FR 36344)] create duplicate and potentially conflicting requirements. Several suggested that the proposed rules on misconduct should leave undisturbed other existing regulatory schemes such as human subjects regulations of the Department of Health and Human Services at 45 CIFR part 46. Other commentators indicated that the IRB should not have a "nolice" -ole and that its members are potentially legaily liable if they did or did not report certain misconduct activities.'Concern was also noted about aLt;onai responsibility arid work placed on the IRB. Several commentaton! requested clarification of § _.!03fb)(5!(i) in the terms - mi a conduct" and "unanticipated" problems. Respondents suggested that scientific miscond.uct implies falsification of data, plagiarism, abuse of confidentialiiv, dishonesty n presentirg publications. legal vio!at;ons and a cange uf other act'vities which should be addressed in a separate policy involving broader institutional ccrisiderations than those appropriate for an 111,B. In addition. some respondents suggested that actual "harm" rather than "possible risk" to human subjects be reported to Departments and Agencies. Concerning § _.103~b)[5)(41H' J two commentators sngqe_~te6 that irBs "'Ouid be reluctant to suspend IRB.- approved research for adminisirative infractions (such as tardiness of response to an IRB) if such suspension must be reported to an Agency. One comm ontator requested that revisions be rrade so that only suspensions or terminations for serious or continuing r,.onccmDiiance with the policy or daterm~naticn of the IRB need be reported to the Department or A-cencv head. In that way, IRBs would se u suspension or termination as a adminii1rative tool and continue to keep Depar~Qnts and Agencies informed of serious problems. One specific set of comments addressed all aspects of this secEion by suggesting deletion of reporting requirements to Department and Agency Heads altogether. iiather. reports to IRBs and institutional officials would be required concerning unanticipated problems involving risks to human subjects which are substantial: proven scientific fraud, instances of substantial or continuing noncompliance with the policy or the requirements or determination of the IRB: or any suspension or termination whi ch is more inore than minor or temporarv. Response In view of the comments and the policy concerning fraud and misconduct thatis row under deliberation. the Interagency Human Subjects Coordinating Committee revised § as follows: Written procedures for ensuring prompt re 3orting to the IRB, appropriate institutional officialls, and the department or aFency head of (i) env unanticipated problems involving nsks to 'subiects or oilliers or env serious or continuing noncompliance with this poiicy or the requirements or determinations of the IR13 and (ii) env suspension or termination of IRB approval. * The President's Commission recommended in its 1981 First Biennial Report that institutional assurances LhoUld specify how "misconduct" should be reported and investigated (pp. 77-RZ. Recommendations 7 and 6). Since the tl;ne of the publication of the 1981 report. however. the issue o, identification and recortine of misconduct has been d3libe'rated in many other contexts and has included consideration of more than -rnisconduct involving risks to human subjects." In August 1969 the Department of Health and Human Services published a final rule announcing responsibilities of awardce and applicant institutions for dealing with and reporting possible miscol'iduct in scien're [53 CFR 3244ral. The Committee agrees that in the curren' context the inclusion of the term .raisconduct" ir. the Federal Policy is confusing and misleading because other poiicv development efforts giving sl3ecLf;c meaning to scientilic re misconduct are ongoing. Thcreiw . the term is deleted from fts document. L, The revised language is closer to that of the or~Rinal provision in the a r tm, e a t o fHpaith and Human Dep Ser~,-,ccs reguiations. The Interagency committee ~vishes to clarilry that it was never the intention of the Policv to require IRBs to report directly to Department and Agency Heads. Assu nce are rarices of Complia negotiated between Departments or Agenciv!s and awardpe institutions. Assurances allow institutions to specify how reporting to Department and Agency Heads will take place. Reporting is the responsibility of the institutional official identified in each Assurance, Further, the Committee wishes to clarify that "unanticipated problems" in this context includes serious and unexpected reactions to biologicals, Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001-1 R~06800 0001.1 28031 Fxecutive Order 12291 These regulations have been reviewed in accordance with Executive Order. 2291. They are not classified as major iiiqlawbecause they do not meet the criteria for major regulations established under the Order. Regulatory Flexibility Act Certification The Secretary certifies that these interim final regulations will not have a significant economic impact on a substantial number of small entities. The small entities that are affected by these interim final regulations are small institutions receiving research grants or contracts under the programs of the National Institute on Disability and Rehabilitation Research. However. the regulations do not have a significant economic impact on these entities because the regulations do not impose excessive regulatory burdens. These regulations impose minimal requirements that are necessary to ensure the proper treatment of handicapped children and mentally disabled persons under the programs of the National Institute on Disability and Rehabilitation Research. Invitation To Continent Interested persons are invited to submit comments and recommendations Nswoo" regarding these interim final regulations. Comments are specifically invited on whether other research programs of the Department should have added protections for handicapped children and mentallv disabled persons. All comments submitted in response to these regulations will be available for public inspection, during and after the comment period, in room 3127. 400 Maryland Avenue, SW., Washington, DC between the hours of 9 a.m. and 4:30 p.m.. Monday through Friday of each week except Federal holidays. To assist the Department in coinplying with the specific requirements of Executive Order 12291 and the Paperwork Reduction Act of 1980 and their overall requirement of reducrig regulatory burden. the Secretary invites comment on whether there may be further opportunities to reduce any regulatory burdens found in these interim final regulations. Assessment of Educational In,.pcct The Secretary has determined that the regulations in this document do not require transmission of information that is being gathered by or is available from any other agency or authority of the N%WWI United States. List of Subjects 34 CFR Part 350 Education. Education of the handicapped. Educational research. Grant programs education. 34 CFR Part 356 Education. Education research, Fellowships. (Catalog of Federal Domestic Assistance Number does not apply.) Dated: June 6. 1991. Lamar Alexander. Secretary of Education. The Secretary amends tide 34 of the Code of Federal Regulations by amending parts 350 and 356 as follows: PART 350-DISABILITY AND REHABILITATION RESEARCH: GENERAL PROVISIONS 3. The authority citation for part 350 continues to read as follows: Authority: 29 U.S.C. 7GO-762. uniess rtherwise noted. 4. Section 350.3 is amended by rr-vising paragraph (d) and the authority citation at the- end of the section to read fts follows: 1250.3 What regulations apply to these progmms? (d)(1) The regulations in 34 CPR part 97. PROTECTION OF HUMAN SUBJECTS, except § 97.107(a). (2) Each Institutional Review Board !IRB) established under part 97 must nave at least five members. with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB must be sufficiendy qualified through the experience and expertise of its members. and the diversity of the members, including consideration of race. gender. and cultural backgrounds, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB must be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB must therefore include persons knowledgeable in these areas. When an IRE reviews research that purposefullv requires inclusion of handicapped children or mentally disabled persons as research subjects. the IRD must include at least one persen primarily con . cerned with the welfare of these research subjects. if an IRB rec gu!ariy reviews another vulnerable category of subjects. such an non-handicapped children. prisoners. pregnant women. or handicapped adults. consideration must also be given to the inclusion of one or more individuals who are knowledgeable about the expene"ce ir. working with these subjects. (Authority, 21) U.S.C. 761a. 762, 42 U.S.C. 3oov-i(b)) PART 3s6-01SABILITY AND REHABILITATION RESEARCK RESEARCH FELLOWSHIPS 1. The authority citation for part 156 continues to read as follows: Authority: 29 U.S.C. 761a(d), unless otherwigo noted. 2. Section 356.3 is amended b revising paragraph (r) and the autnority citation at the end of the section to read as follows: 356.3 what regulations apply to this program? (c)(1) The regulations in 34 CFR part 97, PROTECTION OF HUMAN SUBJECTS. except § 97.1077(a). (2) Each Institutional Review Board (IRB) established under part 97 must have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institutiom The IRB must be sufficiently qualified through the experience and expertise of its members. and the diversity of the members. including consideration of race, gender. and cultural backgrounds. and sensitivity to such issues Eis community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In-addition to possessing the professional competence necessary to review specific research activities. the IRB must be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB must therefore include persons knowledgeable in these areas. When an IRB reviews research that purposefully requires inclusion of handicapped children or mentally disabled persons a~ research subjects, Uie IRB must include at least one person primarily concerned with the welfare of these research subjects. If an IRB regularly reviews another vulnerable cateszory of subjects. such as non-handicapped childrP-'-'- Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 28006 .9 -R.Dp -1 A 9A6rWA9RQQWA&?PO01 drugs, or medical devices. Institutions have flexibility to establish channels of reporting to meet reporting requirements of Departments and Agencies. In addition. the Committee believes it is ~rnportant that suspension or termination. for whatever reason, be reported to the Department and Agency Heads. The Sixty Day "Grace" Period Com. m en t The section of the proposed Policy and Final Rule eliciting the most comments was 103(f) regarding submission of certification. That section is as follows: C,~rtification is required when the research is supported by a federal department or avency and net othenvise exempted or waived wider i § .1,91 (b) or ii). An ins!itil"rin with an approved assurance shall curtify research covered bv the assurance and bV § -.103 of &tt pohr% has been ieviewed anti approved by L~e iRB. Such cprifficat:on mlist be suLmitted wi(h the appli.-,ation or proposal or by such laier clate as mav be prescribed bv the deparurient or agencv to which ihe apt)IiCiltlon or propoqRi isaubmitted. Under no condition shall rese,trch covered by J ___103 of the policy be supported prior to receipt of the 10 cerniication that the res arch has been reviewed and aoprovedb.y tide LRB. Institutions without an approveill assurance covering the research shall certify within 30 days after receipt of a request for such a certification from the dcpartUrnen! or agency. ropn9al has been that the application or p approved by the IRB. If the certification is not submitted witnin these tivie liniiis. Ute application or pronosal mav be ri~turred to institution. Most of the commentaturs tiO) addressed the need for a gra(:,, period between the time of submission of an application for support to a D,!part-reiit and Agency and 311binission of certitication bv the IRB of review and appr-3val of the proposal. A &J~-dav ograce period was allowed in the previukis Departmcnt of Health and Human S:3r,vicps Reoulations for the PI-Wection ef Human Subjects. Under this provision. institutions with Niultiple Project Assurances on file with HIHS had sixty days to complete IRB review and approval and to notify HHS. This period of time roughly corresponded to the time between receipt of the appbcation and initial scientific merit review. 'The groups evaluating the application for scientific merit need certification of the fact that an appropriate IRB has determined that hLunan subject protections are adequate "he commentators cited many reasons why a grace period is important for orderly institutional review and for protection of human subjects. Many of the comments on this section requested that the grace period be reinstated in the regulations. In brief. respondents noted that if the grace period is not allowed. 4nvestigators would be required to submit proposals to IRBs about two months earlier than at present. IRBs would be convened into emergency sessions or required to meet more fi~aequentlv. Pressure to grant approval would inc'rease. Sorue commentators noted that institutions that have no Multiple Project Assurance on file with HHS are given 30 days to review and certify upon HHS request. If Multiple Proiect Assurance hoiders have no grace period. they maybe kit a disadvantage in time permitted for preparation and institutional review of their applications as compared to the time permitted institutions without a Multiple Project Assurance. Also, data for competitive renewals is often added just before ubmission to HHS so that the most current urogress under the originai ~,.warcl can be reported. If a grace period ~s not offered, applications may not contain information viral for appropriate peer review. Another concern raised was that some --search.ers are required to modify their several times before proposals submission. The current SG-day period allows the IRB to review the final subrniS3ion carefully. One commentator indicated that the ac proposed provision was ceptable to the institution. Response Miariv Federal DeDartments and cies do not have application review schedules that correspond L) those of L I iHS. A bo day grace period is without reievance to their review systems. At I time of publication of the proposed common rule. the !nterag.,.ncy Committee noted that Hf IS intended to retain a "grace period" for institutions that have Multiple Project Assurances and announce the period through advisories that are routinely received by institutions. MIS has carefully considered the public comments and will ordinarily retain the 60-day grace period in its administrative procedures. In some programs. such astUDS-related research, I MS has modified the receipt and review schedules in accordance with a Congressional mandate. The Departments and Agencies. other than HHS, adopting the common rule are aware of the concerns of the institutions and will provide as much flexibility to IRBs as possible in the orderly processing of appiications for support. To require a 60-day grace period or any standard grace period for all Departments and Agencies would require far-reaching changes in the re%iew and processing systems of these organizations. Institutions will be advised of Department and Agency procedures through routine publications. Consequently, the language in the final rule remains unchanged. Composition of the IRB Comments Section 107 of the Policy deals with composition of the LRB. Several points made by commentators are as follows: In § _107(a) there is the requirement that if an iRB reguiarly reviews research that involves a vulnerable category of subjects, such as children. prisoners pregnant women or mentally disabled persons. consideration shail be given to the inclusion of one or more individuals who are knowledgeable about and exDerienced in working with these su6jects. The H_HS regulations at 45 CFR part 46 promulgated in 1981 utilized a different standard. i.e., "if an IRB regularly reviews research that involves a vulnerable category of subjects. including but not hinited to subjects covered by other subparts of [45 CFR part 461. the IRB shail include one or more individuals who are primarily concerned with the welfare of these subjects." The commentator indicated that his institution would retain previous standards, because advocates for special populations have been of great benefit in tile IRB's decision-making proce's. Another commentator wrote that in her institution, full committee review is required when a vulnerable population is involved; all committee members are advocutes for subjects whether or not they themselves are involved in a vulnerable population. Adding new members would make the committee too large to be workable, she wrote. The majority of the comments on this section were directed to the departure proposed by the Department of Education at 34 CFIR part 97.107(a). The proposed departure was based on a concern for protection of mentally disabled persons and handicapped children. The departure would have provided that. for research conducted 0- supported by the Department of Education." when an IRB reviews research that deals with handicapped children or mentally disabled persons, the IRB shall include at least one person primarily concerned with the welfare of the research subject." The remainder of the departure reiterated the common Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 1%ow, NNW, 13007 rule's wovision which required institutions to consider retiresentation on the IRE of persons who are knowiedpeable about and experienced in workino v.,th certain vulnerable subjects 11 the IRB regularly reviews research involving those vulnerable subjects. Tw-enty-one institutions commenled on t'hi3 Droposed depart-re. The majoritv of these comments were opposed to the proposed departure. Some comme-ntaitors. while supporting. the proposed language in § -107. stated thcir behef that the departure was not necessarv because the policy in -.107 already addresses representation of the special concerns of vulnera'b'e subjects on the IRB. Thus, the rights of handicapped children and mentally di~abied t)erscns shnuid be representWon any' 1RB that*,"cgularly reviews nroposais invoiving those individuals. and there is no constructive advantage to emphasizing these two catei;!ohas of subjects. Such an emphasis was seen as a precedent with tile potentiai for discrimination against other catc2ories of vulnerable subiects. When special expertise is required, IRB9 already have the option and the obligaiion to seek informed consultants. respondents noted. One commentator stated. however, "If in future staffing of our IRB. someone with exDertise in this area is available and willing to serve. we would be happy to encourage such participation." Some commentators objected to the lack of consistency among Federal Departments and Agencies and cited the Department of Education's proposed departure as being inconsistent with the purpose of the common rule. bne commentator suggested that only when the IRE re_Tjia-lv reviews research that deals with handicapped children or rnental;v ri-sabied Dersons should ti-.-c IRE :nc!-.ii-:e at least one person primaniv concerned with the welfare of the research -subjects. Otherwise. consultation should take place when appropnilte. Another suggestion was that handicapped children and mentally disabled persons-be added to the list oi examples of vulnerable subjects for which an iRB that regularly reviews research might wan', to consider inclusion of oiie or more members who are knowiedgeable about and experienced in working with these subjects. Response The Decartment of Education has considered these comments carefully and has decided to withdraw the departure to the common rule and to adopt the common rule as promulgated in this document. The Secretary, however. continues to believe that there is a special need to protect handicapped children and mentally disabled persons. Thus. the Secretary strongly urges institutions to inciuded at least one person who is primarily concerned -~% ith the welfare of the research subjects wheriever the research involved handicapped children or mentally disab^led persons. "Illile tile Secreta"I agrees to t1-.,- common ruie provision regaruing lRB representation as a general matter, the Secretary hes decided to address the concerns u riderlined by the proposed departure on a programmatic basis under the Department of Education's programs of the National Institute on Disability and Rehabilitation Research (34 CFR parts 350 and 356). Accordingly. the Secretary amends the program regulations for these programs in a documant published in another section of this Federal Register part. In light of the concern of the Department of Education that these -rouT)s were not clearly identified as vulne'rable populations, -handicapped" has been added to the illustrative list in -107. Comments on Other Sections Section -101 explains the appiication of the Policy. Section -.101fb) describes categories of research that are exempt from the Policy. CorrIment Several commentators indicated that the language and intent of this section was helpful. One commentator indicated that he believes the section was written primarily for medical and lizaith rosearc~ and shouid not applv to involvement of human subjec'ts for general business interviews or surveys. The commentators recommended the exemption of information gathetiniz related to business. Further comment suggested that ail minimal risk research be exempt from the regulations. Response The Committee believes that the exemptions are sufficiently clear so that all types of research, not just biomedical or health research. may be reviewed using the specified criteria. In qddition. the Committee has indicated that the exemptions of § -.101(b) of the Policy provides for the exemption of certain research including much of the research used by business (e.g., survey research) in which there is little or no risk. Sactioa -10VO(2) Comment Section -.101(b)(21) is ail exemption for research involving the use Of educational tests, survey procedures or cbsel-vation of public behavior. To paraphrase. this type of research is exempt unless infirmation is recorded in a manner such that subjects can be identified and disclosure of the responses outside the reeearch could place the subjects at risk ot criminal or civil liability or be damaging to the subjects' financial standing. empiovabUity, or reputation. Three commentators extiressed concern that the additional subparts B. C. and D of the HHS regulations for the protection of human subjects are not part of the Federal policy, They noted that institutions with assurances with HHS will be reouired to appiy provisions of those subparts in research they support or conduct. while other Federally- gupported research would not be subject to the snbpart reouirements. Others commer .i!ing on -.101(b)(2) indicated that research that couid ilivolve sensitive data could place the subjects at risk, even if information is not recorded in such a manner that human subjects can be identified and should not be exenint from provisions of the Policy. One ' respondent noted that one IRB reviews this type of research even if an exemption is permitted by the regulations. Another indicated that this section will exclude from normally exe-mot educational. survey. interview or observational research any instances w,herein disclosure of subjects responses couid be damaging to the subject's reputation. Because reputation is a subjective term that is difficult to dofine operationady. the commentator sliggested that flie wording be changed to limit exceptions to specific risks of ..professional and sociololpical damage." Response The Interagency Committee may at a later date wi-sh to'ccrisider incorporation or orovisions of the other subparts of the HHS regulations into federal policy. However, such considerations should not delay publication of basic protections for all human subjects. At this time. institutions sponsoring research under HHS-approved assurances will adhere to provisions of all the subparts of 45 CFR part 46. A footnote has been added to § -.101(b) indicating that Institutions with HHS-approved assurances on file will abide by provisions Gf 45 CF.11 46 subparts A-D. Some of the other Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 28008 DePartment3 and Agencies have IIncorporated allpros-isio-7s of 45 CTR 46. i0i(b) into their polic. es and procedures as well. However, the exemptions at 45 CFR 46. iol(b) do not apply to research involving prisoners, fetuses. prrgnant women. or human in vitro fertilization. subparts B and C The exemption at 45 CFR 46. 101tbJ(2) for research involving survey or interview procedures or observation of public hehovzor, dces not apply to research with children. subpart D. except for research involving observation of public behavior when the ir? vestigator(s) do not participate in the activities being observed A Notice to amend subpart D, 45 CFR 40.401(a)(2)(b) to renumber exemptions to permitted and not permitted to conform the subpart D reference to the renumbered exemptions in the Common Rule is published elsewhere in this issue of the Federal Register. Under this footnote, for research involving children. institutions that have multiple project assurances on file with OPRR will not be able to use all provisions in the exemption in § --101(b)(2)~ However. the educational tests basis for the exemption contained in § -101(b)(2) will still be available to institutions conducting research involving children. in developing the common rule. a number of HHS exemptionsWere consolidated, including the HHS educational tests exemption. The educational tests exemption has been available for use under subpart D of the HHS regulations., Additional Protections Involving Children. Thus, the footnote to the common rule continues the provision that existed under the previous regulations. Some institutions do not choose to permit exemptions even if they are permitted by the policy. This is their prerogative, and assurances of compliance incorporate provisions for utiEzing exemptions. Section -101(b)(3) Cornment Section -.101(b)(3) described an exemption for research involving the use of educational tests, survey procedures. interview procedures. or observation of public behavior that is not exempt under the exemption in § -101(b)(2) if human subjects are elected or appointed public off icia 19 or candidates for public office or if Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. Two commentators recommended deletion of this exemption because confidentiality considerations are not the only purpose of IRB review, Other human sublects protections issues might need to be 'considered in research that is not exempt by the criteria described in § -101(b)(2). Furthermore, the commentators explained that IRBs and institutions will not know that Federal statutes afford . these protections, and inconsistency and confusion is likely. Response At present the only statutes that meet the criteria in. § -101(b)(3)(ii) of which the Committee is aware are those for research conducted or supported by the Department of Justice under 42 U.S.C. 3789g. and certain research conducted or supported by the National Center for Education Statistics of the Department of Education under 20 U.S.C. 122ne-1. The Department of justice's Office of justice Programs (OJP) has several constituent offices that conduct research that would fall und Ier § -101(b)(3). The law governing OJP research activities, 42 U.S.C. 3789g(a). provides that Except as provided by Federal law other than this chapter. no officer or employee of the Federal Government. and no recipient of assistance under the provisions of this chapter shall use or reveal any research or statistical information furnished under this chapter by any person and identifiable to any specific private person for any purpose other than the purpose for which it was obtained in accordance with this chapter. Such information and copies thereof shall be immune from legal process. and shall not. without the consent of the person furnishing such information. be admitted as evidence or used for any purpose in any action. stut. or other judicial, legislative. or administrative proceedings. The law governing research conducted by the National Center for Education Statistics under 20 U.S,C. 1ZZle-4 provides that data collected by the National Center for Education Statistics may not be used for any purpose other than the statistical purpose for which the data were collected and establishes further protections regarding that data, including a provision that they shall be immune from legal process, and shall not without the consent of the individual concerned. be admitted as evidence or used for any purpose in it~y action. suit. or other judicial or administrative proceeding. 20 U.S.C. 122"le-l(d)(4)(B). It Is the responsibility of a Federal Department or Agency to assist the institutions proposing to conduct a research project which it supports in determining if the research is subject to the provisions of the Federal statutes meeting the criteria in § -101(b)(31(ii). Section -101(h) AM~ Comment Section -101(h) discusses research that takes place in foreign countries covered by the policy. One respondent endorsed this section. Another found the provision somewhat ambiguous and suggested that it be made clear that a researcher may either comply with the policy provision or may substitute the foreign procedure in lieu of the policy only following a determination by the Department or Agency Head that the foreign procedures are at least equivalent to those required in the policy. Another comment reflected that it may be difficult at the time of submitting a research proposal to a supporting Department or Agency to know it a foreign country's guidelines provide protections which are at least equivalent to the policy; the Interagency Committee or Department or Agency Heads should publish regulations or advisories indicating which are considered equivalenL" Response The Interagency Committee concurs that evaluation of other country~q protection requirements in comparison Affl%~ with the policy will be an important Committee initiative and it will consider publication of notices that re&~t the decisions of Department and Agency Heads. Also in § -101(h). reference to Helsinki as amended in 1983 is now changed to Helsinki as amended in 1989. Section _1o2 Definitions Comment Section -102 includes the definition section in the Federal Policy. In this section. one commentator asked for a definition of "principal investigator," since that individual bears responsibility for human subject protection. Another commentator suggested adding a definition of .,scientific fraud." Another suggestion was to take into account First Amendment concerns involving freedom of speech in: situations where social scientists Interview foreign and domestic government and private individuals to obtain information. Another commentator suggested that the definition of human subject in I -io2(f) should make clear that with, respect to interview research. a AM%k distinction should be made between Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 APPr&*0F]&vqftldatd.2G0W0=8 TOWRI1109690089IT893300220W*4 28009 information provided by a person which relates to past or present events or the actions of others, as opposed to the attitudes or actions of the intervicwees themselves: ordv in the iatter case should the interviewee constitute a human subiect. Also. another letter explained t hat in some cuitures, ancestral research would not come under the definition of "human subject" because individuals were deceased, However, this type of research might be distressing to living family members. Section -102(bi includes the definition of "institution." One commentator proposed that the definition of "private entity" should also be included. Section 102(h) includes the definition of "IRB approval." Three commentators suggested that the term at the institution" was not appropriate in the de;inition oi approval as 11. . * determin'atic-n of the I.RB that the research has been reviewed and may be conducted at an institution within the constraints set fort1i b~' , the IRB and by other institutional and federal requirements." Much of the research of an institution is off-site and thus seemed to be in technical violation under the proposed language. Response The Interagency Committee agrees that the principal investigator is a key person for protection of human subjects and bears a broad responsibility for implementation of the requiremerts. The term "investigator" is used in the policy, but not "principal investigator" and no definition is provided because the responsibility for protecting human subjects is shared by the entire research team. No definition of scientific fraud has been included, and the term has been deleted from § -103(b)(5), as described previously. The Committee believes that the comment on i _1102(f), definition of "human subject," about interview content is addressed through application of exemption criteria in § -101(b)(2) as well as in the precise wording of the definition itself. In response to the comments about the phrase "at the institution" in the definition of IRB approval in § -102(h), the Interagency Committee responds that there are instances in which the IRB has approval authority where the research is not conducted at the institutional site. The policy at J -114, Cooperative Research, is an important cross- reference. Establishment and approval of other off-site IRBs may be required in some circumstances in which another institution is involved in research. The Departm crit or Agency Heads reserve the authority to approve cooperative arrangements. Th~e phrase "at the institution" in the definition of 1RB approval should be interpreted to mean field sites and other off-site facilities over which an institution has jurisdiction. Section - 203 Assurances Comment Section -103 explains how compliance is assured under this Policy in research conducted or supported by a federal Department or Agency. Most of tha comments on this section concerned reporting and misconduct issues in § -103(b)(5) or the "grace period" or timing of certification in 103(f). discussed previously. Several other comments are as follows: Three respondents asked for clarification of the rationale for r, -,portirip, requirements in J -103(a). This section reauires that when the existence of an HHS- approved assurance is accepted in lieu Of requiring submission of a new assurance, reports required by the Policy are to be made to the Department and Agency Heads. Reports (with the exception of certification) are also to be made to OPRR. Another comment was prompted by review of J -103(b)(1) which requires inclusion in the assurance of principles governing the institution in protection of human subjects, such as a statement of ethical principles or existing codes. The commentator suggested that a statement as to the purpose of having regulations which create an IRB structure should be expiicitly included in the regulations. A comment concerning § _103(f) requests clarification on what type of certification documentation will be acceptable. Response In consideration of these comments, the Interagency Committee offers the following information. In § _103(a) the only reports required to be made to both the head of the Department or Agency supporting the research and the OPRR when the HHS assurance is utilized are those required under § -103(b)(5). The head of the Department or Agency supporting a research project must have information concerning conduct of that research including instances of unanticipated problems or serious or continuing noncompliance with the Policy or the requirements or determinations of the IRB and any SUSDension or termination of IRB approval. OPRR requires this information to ensure that human subjects protections under the Policy and under the HHS-approved Assurance are being properly implemented and that institutions have fulfilled their requirements in an appropriate and timely manner. With regard to the comment 0 concerning certification requirements in _103(f), standardized language for the certification will be developed. Certification now used by HHS has been suggested as a basis for development of the language. Section -107 IRE Alembership Comment Most of the commentators on _-,w address the proposed departure on IRB membership for the Department of Education that has been d;s-.ussed above [§ -107(a)]. Other commentG received were as fillows: Reference is made in the Po!icv in several places to vulnerable subject populations. One commentator indicated that all subject populations are vulnerable and that the term "exceptionally vulnerable" would be better phraseology 'or those instances fotr which additional safeguards are urged or required. Section _107(b) requires that every reasonable nondiscriminatory effort be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes. One respondent indicated that the HHS standard in the regulations published in 1981 requiring that no IRB shall be constituted entirely of men or entirely of women should be retained. A further requirement of § -.107(b) is that no M may consist entirely of members of one profession. Another respondent suggested that the word "discipline" be substituted for '.profession." Response The Committee did not believe that the suggested language changes would significantly improve the understanding or implementation of the sections. It expects that institutions will use good judgment and diligence in selecting persons as IRB members who can fulfill the requirements of § -107 (a) and (b) so that persons of both genders and persons with varying backgrounds will promote responsible review of the research activities. in approving Assurances, the Federal Departments and Acencies that conduct. support or regulate research wfll review IRB Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 ,pr or P. 8 - CWeR2fA9 0 jM 01-1 ,12 91Pq1P eq er , Ptp ~V era~V 20010 0.0p, esdav. composition to ensure that the membership is appropriate for the research. and may request that membership be supplemented if complete and adequate review of the research does not appear possible. As regards the gender consideration in IRB composition the Committee notes that in seeking diverse membership on the IRB. the institution must consider both men and women who can contribute to the role of the IRB. Section -110 KxPedited Review "rocedures Comment This section sets forth expedited review procedures for certain kinds of research involving no more than minimal risk and for minor changes in approved research. Section --110(b) indicates that an Um may use the expedited review procedure under certain specified circumstances ' with the approval of Department or Agency heads. Four'regpondents noted that confusion may result in institutions if Departments or Agencies have different requirements. Furthermore, it may be burdensome to IRBs and institutions to seek Department and Agency approval for use of expedited review. One respondent recommended that the phrase "with the approval of department or agency heads" in § _110(b) be deleted because it will result in bureaucratic delays in approval to use the authority. Furthermore. the authority to restrict use of expedited review is fotuid in I __110(d) whereby the Department or Agency head may restrict. suspend, terminate or choose not to authorize the, use of the expedited review procedure. flesponse The Committee agreed that the phrase in § _110(b) "with the approval of department or agency heads." should be deleted because i _110(d) accomplished the intention of the Committee. As an example of Department and APricv use of this authority, note that HI-fS does not permit expedited review for institutions that do not hold Multiple Project Assurances of Compliance. Note also that some institutions which have authority to use expedited procedures choose to use Ul IRB review instead. Note that parentheses have been added to the word "reviewer(s)" In § -110(b)(1) to clarify that one or more reviewers may carry out the expedited review rocedures in accordance with -- -110(b). S"ction -ill Criteria for IRE Approval of Research Comment Three commentators requested deletion of the term "economically or educationally disadvantaged" in the examples of those who are vulnerable subjects because of lack of clarity of the term, difficulty in determining if some subjects were in this category and possible exclusion from beneficial research protocols of those deemed to be included in this category. Response The Contmittee believes that the criteria for participation and the potential vulnerability of some research subjects are still a very important consideration far JRBs. In exercising their responsibilities, IRBs are charged with evaluating the benefits and the burdens of the research so that unjust social patterns do not appear in the overall distribution of the burdens and benefits of research. The 1979 Belmont Report outlining ethical principles and guidelines for the protection of human subjects of research written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research makes special note that some populations are burdened in many ways by their social circumstances and environments. when research is proposed that involves risks and does not include a therapeutic component, other less burdened classes of persons should be called on first to accept these risks of research. except where research is directly related to the specific conditions of the class involved. . . . certain groups, such as racial minorities, the economically disadvantaged. the very sick. and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted. Given their dependent status and their frequently compromised capacity for free consent. they should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their Illness or socioeconomic condition. The Committee expects that in its review of equitable treatment and review of benefits and burdens, the educationally or economically disadvantaged will not be excluded from potentially beneficial research to individuals or to those persons as a class. Section -113 Suspension or Termination of IRE Approval of Research Comment One comment was offered suggesting that institutions, not IRBs. should report to Department and Agency Heads. mended that Another response recorn OPRR be designated as the central coordinating office to which such notification should be sent. Designation of OPRR as the single reporting channel would ensure prompt requisite reportinst to the Government, the commentator noted. Responss This section does not require that the IRB report to the Department or Agency head. The responsibility for reporting is specified in the institution's assurance. OPRR will receive reports if institutions have an assurance on file with the HHS which covers the research in question and will be notified in accordance with 1-103(b)(3). OPRR cannot act as a central information office for other Dep".ents and Agencies in receiving reports of this nature because of insufficient resnurce3 and regulatory jurisdictional considerations. Section -114 Cooperative Research Comment Confusion may result for institutions if Departments and Agencies eve differing requirements, Response The Committee will attempt to advise Departments and Agencies so that procedural requirements will be consistent. Section _1i5 IRE Records Comment Modified language for this section was suggested to assure that confidentiality will be maintained to the greatest extent possible. Response The Committee agreed that confidentiality considerations are most important for IRB records. While it rejected the detailed language uggested by the commentator. it acknowledged the importance of maintaining ~ confidentiality. it believes that the proposed language is adequate~ 00% Am%~ Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 28011 Section -116 C'eneral Requiremen ts for In.farmed Consent, mnd Section -117 Documentation of Informed Consent Comment One respondent wrote that the differences between 4-in (c) and (d) and §_-117(c) were confusing. Response Section -lis(c) specifies that an [RD may approve a consent procedure which alters some or ail of the required elements of informed consent or waives the requirement to obtain informed consent in research or demonstration projects which are subject to approval of state and local authorities and which meet certain other reouirements. Section -.116(d) specifies that an IR13 mav, under limited circumstances (other tha' n those of approve a consent procedure which alters some or aii of the elements of info ", , ed consent or waive the requirements to obtain informed consent for certain ty es of .p research. Section _1 17(c) specifies conditions under which an IRB may waive the requirement for the investigator to obtain a signed consent document for some or all subjects in the research. Section -123 EarIv Termination of Research Comment Two commentators expressed concern 07e establishment of this section imDiies ti~at a "blacklist" composed of individuals and institutions that, in the judgment of Department and Agency Heads, have failed to discharge properly their responsibilities for the protection of human subjects. Serious breaches of confidentiality and due process could be implied. The inclusion of the parenthetical phrase "(whether or not the research was subject to federal regulations)" was also of concern because it implies that information ,gathering may lead to violations of confidentiality. Response The Committee is aware of concerns about the need for confidentiality and due process considerations. The Committee notes that other federal regulations deal with the suspension and termination of funding. These -egulations provide the requisite due process. Sources of information and criteria to be used by Department and A.-ency Heads for making decisions are addrPssed with more specificity in those regulations, The federal governnnent does maintain information that is pertinent to t1he exercise of the discretionarv authority to award funding. Appropriate confidentiality protections apply to that information. Section -124 Conditions Comment A suggestion was made that additional considerations of the Department or Agency head noted in this section should be lim;+ed to those required by statute. Response The Committee, in its ongoing deliberations, will attempt to maintain consistencv and minimize burdens to institutions. Department and Agency-Specific Comments Department of Education The 34 CFR 97.107(a) departure on composition of the iRB was uJiscussed earlier in th4s pr3amble. The Department of Education proposed to amend §_101(b)[3), To what does this policy apply, by revising paragraph (b)(3)(h) to exempt educational tests and surveys, interviews, or certain observations from coverage of the regulations if the research is conducted under a program subject to the protections of the General Education Provisions Act (GEPA). This departure would have expanded upon an exception contained in the common rule that exempted research conducted under a statute that requires that the confidentiality of the personally identifiable information be maintained, without exception, d4roughout the research and thereafter. Much of the research that would have been covered by the GEPA exception is conducted bv the National Center for Education Siatistics (NCES). Since publication of the NPRIA for the common rule, the Department has developed procedures implementing new authority under GEPA that establish absolute confidentiality for Individuals who are the subjects of the NCES research which is subject to the confidentiality requirements of section 406(d)(4) of CEPA. Thus. NCES research covered by the GEPA confidentiality requirements now falls within the exception in the common rule that excludes from coverage of the regulations research under a statute that provides for absolute confidentiality [§_101(b)(3)(ii)] and an expanded exception for that research is unnecessany. The Secretary has decided to withdraw the GEPA departure as being inconsistent w,.th the Department's overall objective of ensuring that research conducted or sponsored by the Department contain the greatest possible protections consistent with the common rule. Research of the Department other than that conducted under the NCES statute will be covered by the common mle. Comment Four comments were received regarding the exception from the common rule requirements for prouams covered by CEPA. Three of the commentators were concerned that the proposed departure removed safeguards or did not provide additional safeguards for the protection of research subipcts, While possibly increasing administrative burdrn on !RBs. One of these three commentators %vas concerned that the re might prohibit proposed departu cencin research procedures as applied to educational practices or programs. One commentator indicated that the proposed departure would not pose any problems. RpsDonse Thie departure to §-.101(b)(3,1(ii) was based on statutes applicable to the Department that provide protection for subjects of the Deoartment's education-related tests and surveys, interview procedures, and observation of public be' havior. The protp-cuions are found in the CEPA at section 400A (control of paperwork) (20 U.S.C. 1221-3); section 456(d)(4) (confidentiality of National Center for Education Statistics data) (20 U.S.C. 12ZIe-1); section 438 (Fain'ily Educational Rights and rrIvacy Act) (20 U,S,C. 1232g),; and section 439 (Protection of Pupil Rights Amendment) (20 U.S,C. 1232h). The departure was not intended to crea'te additional burdens fur IR.Bs but to eliminate the need for IRB approval of research in those cases where the research was subject to the GEPA. The Secretary has withdrawn the proposed departure because it is inconsistent with ensuring the greatest protection under the programs administered by the Department. Because the departure is being withdrawn, there is no need to explain how the proposed departure would have affected research practices. Department of Veterans Affairs (VA) Concern was expressed that -.111(a)(4) and § -.116 of Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 "8= JpATR Xgg&g r, W.W g02 q pp//Of fflpl, vC 9M gg"Mol-1 the Federal Policy would supersede the Vi3terans Administration Department of x,!ed &S) icine and Surgery [VA D.M Circuiar 10-88-50 which allows next of kin to grant consent for incompetent relatives under specific conditions. The VA responded. however. that Federal Policy mandates informed consent by the subject. or the subject's "legally authorized representative." "Legally authorized representative" is defined to include "individual(s) * authorized under applicable law . . . In consent on behalf of it prospective subject Thus, 'L~e proposed consent does not preclude next of kin consent so long as such consent is ,.authorized under applicabie law." 18 U.S C. 4131. and VA policies promulgated thereunder, do authorize next of kin consent. AccordinRl'y. the Common Federal Policy and current VA poficies are consistent. Dep3rtment of Justice T'he Department of !ustice inlends to retain special protections for prison popuiations in research it supports or conducts in accordance with 28 CFR parts 22 and 512. Department of Defense Cornment One response requested clarification of how the Federal Policy will extend to DOD research. Numerous questions concerning applicability to militarv and non-militlary personnel. voluntary versus mandated participation situations. identifiable data and the broad range of DOD-sponsored research were posrold. The respondent indicated that formulating guideli el nes for informed (,onsii-nt is particularly important in the militarv context, ResconS6 Questions raised regarding ,ulatiom ;ipplication of the proposed reg to DOD-supported research are reasonable and appropriate but are regarded as agency specific. DOD plans to address these particular issues throuzh revision of DOD Directive 321- 16.2. Protection of I'luman Subjects in UOD-supported Research. The text of the common rule is adopted by the following Department and Agencies as sot forth below: Text of the Common Rule The text of the Common Rule as adopted by the Department and Agencies in this doctiment appears below-. _CFR Part --Protection of Human Subjects Sec. I -.101 To what does this policy appiy? -102 Definitions. _103 Assuring compliance with this policy-research conducted or supported by any federal department or agency. -1G4---106 (Reserved] _107 IRB membership. -108 IRB functions and operbitions. _109 IRB review of research. -.110 Expedited review procedures for certain kinds of research bivolving no more than minimal risk. and for minor changes in approved research. -.111 Criteria for IRB approval of research. _112 Review by institution, _113 Suspension or termination of IRB approval of research. _____114 Cooperative research. __115 IRB records. _115 General requirements for irfurmpd consent. __117 Documentation of informed consent. ---lid Applications and proposais 4ickin2 definite plans for involvement of human subjeuts. -.1"19 Research undertaken without the ;ntention of involving human subjects. -.120 Evaluation and dlSDOS~tion of applications and proposals for researrh to be conducted or supported by a federal department or agenev. -121 [Reserved) -122 Use of federal funds. _123 Early termination of research support: evaluation of applications and proposals. -124 Conditions. §_101 To what does this policy apply? (a) Except as provided in paragra L Piz 1,13) of this section. this policy applies to all research involving human subjects conducted. supported or otherwise subject to regulation by any Werai department or agency which takes appropriate adminisLrative action to make the policy applicable to such research. This includes research conducted by federal civilian employees or military personnel, except that each department or agency head may adopt SUc'h procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted. supported. or otherwise subject to regulation by the federal gauvernment outside the United States. (1) Research that is conducted or supported by a federal department or agency, whether or not it is regulated as definid in I -102(e), must comply with all sections of this policy. (2) Research that is neither conducted nor supported by a federal department or agency but is subject to regulation as defined in J -102(e) must be reviewed and approved, in compliance with I _lgl. § -102. and -107 through J -1!7 of this policy, by an institutional review board (IRBI that operates in accordance with the pertinent requirements of this policy. (b) Unless otherwise required by department or agency heads. research activities in which die only involvement of human subjects will be in one or more of the following categories are exempt from this policy: (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (H) research on the effectiveness of or the comparison among instructional techniques. curricula. or classroom management methods. (2) Research involving the use~of educational tests (cognitive, diagnostic. aptitude. achievement), survey procedures, interview procedures or observation of public behavior, uniess: (i) Information obtained is recorded in such a manner that human subjects can tie identified. directly or through identifiers linked to the subjects~ and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing. employability. or reputation. (3) Research involving the use of educational tests (cognitive. diagnostic. aptitude, achievement). survey Drocedures, interview Drocedures. or observation of public 6ehavior that is not exempt under paragraph (b)(2) of th is secti - if: on' (i) The human subjects are elected or appointed public officiais or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be ghout the research and maintained throw thereafter. (4) Research. involving &,a collection or study of existing data, documents. records. pathological specimens. or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. (5) Research and demonstration projects which are conducted by or subject to the approval of department of agency heads. and which are designed to study, evaluate. or otherwise examine: -40MA Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 Nup", (0 Public benefit or service programs; (1i) procedures for obtaining benefits or services under those programs: (iii) possible changes in or aierrativQc to those Drograms or proceaures: or (iv) possible changes in methods or leveis of payment for benefits or services under those programs. (6) Taste and food qualizy evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or L '-e!ow the level and for a use found to be safe, or agnicultural chemical or environmenial contaminant at or below 1~a found to be safe, by the Food and Dru- Administration or approved by the Environmental Protection Agency or thie Food Safety and Inspection Service of the U.S. Department of Agriculture. (c) Det3art-rent or agency heads retain Enal judgment as to whether a particular activitv is covered by this policy M Department or acen'cy heacis may require that specific research activilies or classes of research activities conducted. supported. or otherwige subject to regulation by the department or agencv but not otherwise covered by ihis poiic .y. ccmpiy with some or all of th'e requirements of this policy. (e) Compliance with tfiis policy requires compliance with pertinent lederal laws or regulations which rrov'de additional protections f, or human subjects. (i) This policy does not affect any 3t3te or local laws or re'"ilations v6hich may otherwise be applicable and which provide additional protections for human sull-iects. (C-) This policy does not affect any foreig -n laws or roguiptions which Mav ctherwi se be appiicable and which provide auditional protections to human subjects of research. (h) ~Vhen research covered by this policy takes piace in foreign cou'ritries, procedure3 nor-naily followed in the fore4gn countries to-protect b uman subjects may differ from those set forth in this poiic Y. [An example is a foreign institution which comriies with guidelines consistent with the Worid Medical Assembly Declaration (Declaration of He~lEinki amended ne.9) issued either by sovereign states or by an organization whose function for the protection of human research subjects is internationally recognized.] In these circumstances, if a department or agency head determines that the procedures prescr"bed by the institution afford protections that are at least equivalent to those provided in this policy, the department or agency head may approve the substitution ci~the foreign procedures in lieu of the pocedural requirements provided in ~~,as policy. Except when otherwise i-cquired by statute. Executive Order. or ,he departrent or agency head. notices th-me actions as t6y occur will be L L r~ublished in the Federal Register or v. ii be otherwise published as provided in department or agency procedures. (i) Unloss otherwise required by law. department or agency heads may waive the applicability of some or ail of the provisions of this policy to specific research activities or classes of research activities other-wise covered by thIS olicy. Except when oiherwise required p by statute or Executive Order. the department or agency head shall :7 iorward advance notices of these actions to the Office for Protection from Researcii Risks, Department of Health and Human Services (HHS), and shall also publish them in the Federal Register or in such' cther mariner as provided in department or agency procedures., §_102 Defiritions. (,i) Dopartment or coency head M,-dnS t!-e head of any federal department or 4,;Ency and any other officer or emi3lovee of any department or a=,cy ga n whom authority has been dele' ted. N Institution means any public or private entity or agency (including federal, state, and other agencies). (c) Le ally authorized reoresentative means an individual or judicial or other body authorized under applicable law tc consent on behalf of a prospective s~abfect to the subject's participation in tl'~e procedure(s) involved ir. the research. (d) Research rricans a systemati,; ;nv 'iealion, including research esL devetopment, testing and evaluation. designed to develop or contributo to g,enerahzable knowledge. Activities %-.,hich meet this definition constitute research for purposes of this policy, whethLr or not they are condicted or supported under a program whicn is ronside red rewarch for other purposes. For example. some dernonstration and service programs may include reEearch activities. Institutions with HHS-arproved assurances on wili abide bv provisions ot title 45 CFR part 46 subparts A-D. Some of the other Depai-Lments and Agencies have incorporated all provisions of title 45 CFR nart 46 into their policies and procedures as weil.'However. the exemptions at 45 CFR part 46-10iib) do not apply to research involving prisoners, fouses. prognant women. orniuman in vitro fertilization, subparts B and C. The examption tit 45 CFR pa~ 40.10riib)(2), for rese3rch involving survey or interview proccaures or observation of public behavior, does not apply to research with Oildren. subpart D. except to.- research involving observations of public behavior when the investigator(s) do not participate in the activities being observeci. (e) Rusearch subject to reguiation, and similar WrMs are irtended to encompass fficise research activities tor which a federal department or alencv has specific responsibility for reauiatinp 6 as a research activity, (for example. Investigational New Drug requirements administered by the Food and Drug Admiriistrat~on). It does not include research activities which are incidentaily r'e'~uiated by a federal department or agency soieiv as part of ~he department's or agency' broader responsibility to regulate certain types of activities whether research or non- research in nature (for example. Wage and Hour reallirements admi' istered by in the Departme'nt of Labor). Human subject means a hving individual about whom an investig"ator (whether professional or student) conducting research obtai' ns (1) dalla through intervention or interaction with the individual, or (2) ideatifiable private information. iwarvenz I;on includes both i3hvsicai procedures by which data ~re'gathered 0 (for example. venipurict Iure) and marnDuiallons of the subject or the subje.ct's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. "Private information" includes information about behavior that occurs in a context in wh~-_h an individual can reasonably expect that no observation or recording s taking piece, and infor-mation ,A;hich has 'U~!en provi4ed for Specific Durposes by art individual and wh4ch the individual can reasonabiv expect %vill rot be made public (for example, a medical r9cord). Private information M ' 'i;able (i.e., ust be in-dividually i~enti the identity oiflhe subject is or -.av ea_-'i;,., be as-cei-tained by the invebL;Rator or associated with the i-._rniation) in order for obtaining the Liformation to constitute research Involving human subjects. (g) IRE means an institutional review board established in accord with and for the purposes expressed in this policy. (h) IP3 c~oproval means the determination of the IRB that the research has been reviewed and may be criducied at an institution within the c constraints set forth by the 1RB and by other institutional and federal requirements. M Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are rot greater in and of themselves than those ordinarily encountered in daily life or during the performance of Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 28014 .routine physical or DSVCh010RiCai examinations or tests. (j) Certification means the official notificatio'n by the institution to the supporting department or agency. in accordance with the requirements of this policy, that a research project or activity invnivinR human subjects has been reviewed arid approved by an IRB in accordance with an approved assurance. (2) Designation of one or more iRBs established in accordance with the rcaquirements of this policy. and for which provisions are made for meeting space and sufficient staff to support the IRB's review Q rerordkeeping duties. (3) A list of IRB members identified by name: earned degrees: representative capacity: indications of experience such as board certifications, licenses, etc., sufflcient to describe each member's chief anticipated contributions to IRB deliberation's; and any employment or other relationship between each member and the institution-. for example: full-time employee, part-time employee. member of governing panel or board. stockholder, paid or unpaid consultant. Changes in IRB membership shall be reported to the department or agency head. unless in accord with § -.103(a) of this policy, the existence of an HHS- ccepted. In this approved assurance is a case, change in IRB membership shall be reoorted to the Office for Protection From Research Risks. lif !S. (4) Written procedures wifich the 1R8 %vill follow it) for conducting its initial and continuing review of research aid for reporting its findings and actions to the investigator and the institutioa; (i 'i) for determining which projects rvquire review more often than annually and which projects need verificatlon front sources other than the investigators that no material changes have occiirred s:nce previous IRB mview: and fiii) for ensuring prompt reporting to the IR13 cf "i proposecl changes in a rp. search -- ctivi; and for ensunnP that such clian.-es in approve-.1 research. during the pc,-;,,,d f,)r hich IRB approva I has ati eady bi~eri ~iiven. may not be initiated witCiout IRB review arid approval except vvh2n nacessar; to eliminate doparent irnmeiiate hazards to the subject. 5) kNritten procedures for ensuring p7ompt reporting va the IRB. approp-Hule ;nstitutiorial officials, and the department or agency head of (i) any unanticipated problems involviri~z r;,8"%3 to subjects or others or anv serious or continuing noncompliance wich this policy or the requirements or determinations of the !RD arid f;i) any SUSPen3ion or termination of IRB approval. (c) The assurance shall be executed by an individual authorized to act for the institution and to assume on behail of the institution the obligations imposed by this policy and shall be filed in such form and manner as the department or agency head prescribes. (d) The department or agency head will evaluate all assurances submitted in accordance with this policy through such officers and employees of the liepartment or agency and such experts )or consultants enogage'd for this purpose as the department or agency head determines to be appro"priatie. The department or agency hea&s evaluation will take into consideration the adequacy of the proposed IRB in light of the anticipated scope of the institution's research activities and the types of subject populations likely to be . involved, the appropriateness of the proposed initial and continuing review procedures in light of the probable risks, and the size and complexity of the institution. fe) On the basis of this evalluat~on. the de'partment or agency head may approve or disapprove the asstir4nce. or enter into negotiations to deveicp an approvable one. The department or agency head may hrrit the period during which any particular approved assurance' or class of approved tissuranres shall remain' effective or r-rierwise condition or restrict approval. f 1 i Cet tificLtior, is required when the -esearch is supponad by a federal deDartment or agency and not otherwise exe,mpted or waived under § .101 (b) or it). iln. mstitution with an approved assurance shall certify that each application or proposal 1'Jr research covered by the assurapce and by 13t _03 of this Policy has been reviewed and anproved by tije 11RB. Such cortifiraticn. must be submitted with the Pi)olication or proposal or by such later date tis may be prescribed bv t'rin department or aQ.ency to which the applicvtion or proposal is submitted. Under no condition shvil research Covered by -*~, _m of the Polit~.y be ~,upported prior to receipt o" the ' i; fi c a*. o' cer. , n that !he re3pairc6 has been c;~vjevved and approved bv the 1AB. i,-,stitutions without an approved assurance covering the research shall certifv within 30 days after receipt of a recue.st for such a certification from the department or agency, that the application or proposal has been approved by the IRB. If the certification is not submitted within these tirne limits. the application or proposa! may be rpturned to the institution. (Approved by the Office of Management and Budget under Control Number 9999-0020.) __103 Assuring compliance with this poficy-research conducted or supported by(any federal dapartmern or agency. ~a) Each institution engaged in research which is covered by this policy and which is conducted or supported by A iederai department or a.-ency shall Provide written assurance satisfactory lo tne department or agency head that it wfil comply with the reouirerrents set forth ;ii 'his colicv. In l4au oireouiring sIuhmission of an assurance. indiv;duzil or acencv beads shall ,ocept the eXISTence of :2 7-;1:rent ,tssurance, appropri~i!-i for the research ;n qLiestion. on file v%,th thr, Office f.,,r Protection from Research Risks, HHS, 2iid acoroved for federalwide use by teat o,';ice. When the existence uf an HHS-approved assurance is accepted in iieu of requiring submilssion of an assurance. reDOrt3 fovcrpt ceetflicationl required by th:s policy to be made to depEirtment and age6cv heads shail also be macle to the Off~ice for Prorerqion from Research Rlsks. H-HS. (b) Departments end acenci-m wJi conduct or s-urport -L,-.sea Ch Covered t"I .his policy oniv if tbe insti:ution has n ao nrovi,4ed4 in assurance app. 1. 1 section, and or# Jf L~e inc,,~:u'in_n nas ,:L,rt;flcd to the deDartm2m, or a2cT-,rv bead that the rese3rch has ueen -Pviewed and app-o~veti L~v cr, ip'13 provide~4 For 4r, U-'a alssu:anne, arid %v;ll lie sul bj,~ct to coritinuin" review by tiie ~RB. Assurances ap~~);;Icahle to tederal!v s-,~coorted or conducted researc'-, shah at a mininnum incliAe: (1) A statement of principles governing the instit tion in the discharge 14 of its responsibili ties lor protecting tLe -il , -hts and weifare of human subjects of researc'n conducted at or sponsored by the institution. regardless of whether the research is subjert to federal regulation. This may incluae an appropriate existing code, declaration, or slaternerit of ethical princiules. or a statement formulated bv the institution itself. T!'is requirement aloes not preempt provisions of this p-)Iicy applicable to department- or agency- supported or regulated research and need not be applicable to any research exempted oi waived under § -.101 (b) or (i) -.104 (Reserved] -105 [Reserved] § -106 [Peservedi § -107 IRS membership. AO=k -i (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review JO~ of research activities commoniv Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 A 123 0 15 Vfto", i'1111111110le conducted by the institution. The IRB shall be sufficiently qualified through experience and expertise of its ers. and memb the diversity of the mem .Ders, including consideration oi r3ce. gerider, and cultural backgrounds and sensitivitv to such issues as communitv attitudes, to promote respect for its advice and counsel in safeguarding ue rights and welfare of human subjects. In addition to Possessirg. the professional competence necessary to review specific research activit;cs. the IRB shall be able to ascertain the acceptability of proposed research in terms of institutionai commitments and regulations, applicable law, and standards of professionai conduct and practice. The IRB shall therefore include persons knowlea,-abie in these areas. If an lRB reguiarly reviews research that involves a vulnerable category of subjects, such as children. pr4soners, pregnant women. or handicapped or mentally d;3abled persons. consideration shall be vr.,en to the inclusion of one or more individuals who are k-nowledgeable about and experienced in working with these subjects. (b) Every nondiscriminatory eHort will I be made to ensure that no IRB con5ists entirely of men or entirely of women. ircluding the institution's consideration of qualified persons of both sexes, so 1; 'ong as no selection is made to the lRB on the basis of gender. No IRB may -sofone consist entirely of membe, profession. (c) Each IRB shall include at least one membnr whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. (d) Each IRB shall include at least one memoer who is not othervi-,se affiliated with the institution and who is not part of the immediate family of a person who is all"ihated with the institution. ,e) No IRB may have a member particiriate in the lRB's initial or continuing review of any project in which the member has a conflicting interest. except to provide information requested by the IRB. An IRB mav, in its discretion. invite Individuals with~ competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the iRB. These individuals may not vote with the IRB. i - 108 IRS functions and operations. In order to fulfill the requirements of this policy each IRB shall: (a) Follow written procedures in the same detail as described in _103(b)(4) and, to the extent roquil-cd by, § _.!03(b)(51. (b) Except when an expedited review Proceclure is used (see § review proposod research at convened niceting's at wifth a majority of the nembers or the IRB are present. Including at least one member whose primary concerns are in nonscientific areas. in order for the research to be approved, it shall receive the approval o~ a najority of those members present at the meeting. §_109 IRS Review of Research. (a) An IRB shall review and have authority to approve, require modificat tions in (to secure approval), or disapprove all research activities covered by this policy. (b) An IhB shall require that - information given to subjects as part or inforrined consent. is in accordance with § -.113. The I1kB may require that information, in addition to that specificail,; nientioned in § - n6. be given to zhe subjects when in the IRB's jiidgment the inforrnation would mealling-"Llffly add to the protection ol the rl,ghts and weifare of subjects. fcJ An IRB shall require locumeritation of informed consent or may waive documentation in accordance with § -117. (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the of pvoposad research activity, or modifications required to secure IRB aDprovai of the research activiiv. 11, the 1qB decides to disapprove a research activity. it shall include in its written notification a statement of the reasons for its decision and give the invesduator an opportun4ty to respond in person or in writirR. ,f~) An !RE- sliaH conduct continuing reviow or. rcsearch covered ~)Y this poiicv at intervals appropriate to the degree of risk. but not less than once p e r year, and shall have authority to observe or have a third party obsen,e the consent process and the research. (Approved by the Office of Management and Budget Linder Control Number 9999-M20.) §_110 Expedited review procedures for certain kinds of research Involving no more than minimal risk, and for minor changes In approved research. (a) The Secretary, HHS. has established, and published as a Notice in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list will be amended. as appropriate after consultation with other departments and agencies, through periodic republication 1-1, the Secretary, HIIS. in the Federal R~qlister. A copy of the list is available Ir .0m file Office lor Protection from Research Risk% National Institutes of lia-aith, HIHS. Bethesda, Marytand 20892. (b) An 1RB may use the expedited I re to review either or reviw.v procedu both of the (1) Some or ail of the research appearing on the list and found by the re'viewer(s) to involve no more than nl:nimai risk. (2) Minor changes in previously approved research duning the period (of 0 one year or less) for which approval is authorized. Under an exDedited review procedure. the review may be carried out by the IRB chaim erson or b- one or more experienced revielVers designated by 'c!,2 chairoerson from among members of the IRB. IIn reviewing the research. the reviewers mav exercise all of the ailihorities of the !F.B except that the reviewers may not disaoorove tht research. A research activity may be disapproved only after review in ccordance with the non-expedited procedure set forth in § -.108(b). (c) Each IR13 which uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals which have been approved under the procedure. (d) The departunent or agency hoad may restrict, suspend, terminate. or choose not to authorize an institution's or IRB's nse of the expedited review proccdure. ~f_411 Criteria for IRS 3pprova! of research. (a) In order to anprove researc 11 !:overed by this vo licv the IRB shall defermipe that all of the foliowing r2quirements are satisfied: (1) Risks to subjects are rilintinized: (i) By usin.- procedures which are Consistent with sound research desi-n and which do not unnecessarily expose ) whenever subjects to risk, and (i; appropriate, by using procedures already being performed on the subjects for diagnostic cr treatment purposes. (2) Risks to subjects are reasorabie in reiation to anticipated benefits. if any, to subjects, and the inivortance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not Dartilcipating in the research). The IRB should not consider possible long- range effects of applying knowledge -ained in the research (for example. the Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 For,F~e p1p 1. qOR9/9~%§, PlAn-ff 28016 'Wkerroall4ster 0 d'a , possible effects of the research on public; policy) as among those research risks that fall within the purview of its responsibility. (3) Selection of subjects is equitable. In making this assessment the iRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations. such as children. prisoners. pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. (4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative. in accordance with. and to the extent required by § _.im (5) Informed consent will be appropriately documented. in accordance with. and to the extent required by § -117. [6) When appropitiate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When approp 'ate, there are rl adequate provisions to protect the privacy of subjecta'and to maintain the confidentiality of data. (b) When some or all of the subjects are likely to be vulnerable to coercion ar undue influence, such as children. prisoners. pregnant women. mentally disabled persons, or economically or educationally disadvantaged persons. additional safegua ds have been included in the stu r to protect the IV rights and welfare C~f these subjects. §-112 Review byinstitution. Research covered by this policy that has been approved by an IRD may be subject to further appropriate review and approval or di I approval by officials of the institution. however, those officials may not approve the research if it has not been approved by an IRB. §__113 Suspension or termination of IRS approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension of termination of approval shall include a statement of the reasons for the IRP's action and shall be reported promptly to the investigator, appropriate institutional officials. and the department or,agency head. (Approved by the Office of NLinagement tuid .r W99-0020.1 Budget under Contrt)l Numbe §_114 Cooperative research. Cooperative research projects are those projects covered by this policy which involve more than'one institution, In the conduct of cooperative research projects. each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. With the approval of the department or agency head. an institution participating in a cooperative project may enter into a joint review arrangement. rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort. §_115 IRSrecords. (a) An institution. or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities. including the following. (1) Copies of all research proposals reviewed, scientific evaluations, if any. that accompany the proposals. approved sample consent documents. progress reports submitted by investigators. and reports of injuries to subjects. (2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining, the basis for requiring changes in or disapproving research: and a written summary of the discussion of controverted Issues and their resolution. (3) Records of continuing review activities. (4) Copies of all correspondence between the IRB and the investigators. (5) A list of IRB members in the same detail as described is § _103(b)(3), (6) Written procedures for the IRD in the same detail as described in 103(b)(4) and § -.103(b)(5). (7) -Statements of significant new findings provided to subjects. as required by § -116(b)(5). (b) The records required by this policy shall be retained for at least 3 years. and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the department or agency at reasonable times and in reasonable manner. (Approved by L Office of Management and Budget under Control Number 9999--0020.) §_116 General requirements for Informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall beinlanguage understandable to the subject or the representative. No informed consent. whether oral or written. may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights. or releases or appears to release the investigator. thp sponsor. the institution or its agents from liability for negligence. (a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section. in seeking informed consent the following information shall be proi, ided to each subject: (1) A statement that the study involves research. an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental: (2) A description of any reasonably foreseeable risks or discomforts to the subject: (3) A description of any benefits to the subject or to others which may reasonably be expected from the research: (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject: (5) A statement describing the extent. if any, to which confidentiality of records identifying the subject will be maintained: .(6.) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so. what they consis of, or where further information may be obtained: (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject: and (8) A statement that participation is voluntary. refusal to participate will _Adftk Approved For Release 2000/08/08: CIA-RDP96-00789ROO3300220001-1 AggrovWq'116F lfttiY,20GO/08/09:/ClAsROPWOOT89ROO33002200*iwtrs 28017 N"501 .nvoivp no penaitv or loss of beiiefits -o which the subject is otherwise entitled. ..'lid the subject may discontinue participation at any time without oenalty or loss of benefits to which the gubject is otherwise entitled. (b) Additional elements of informed consent. VVhen appropriate, one or more of the following elements of information -ball also be provided to each subject: (1) A statement that the particular ireatment or procedure may involve risks to the subject (or to the embryo or fetus. if the subject is or may become pregrant) which are currentiv unforeseeable: (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent: (3) Any additional costs to the subject that mav result from participation in the tescarc~: (4)The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject: (5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and (6) The approximate number of subjects involved in the study. (c) An IRB may approve a consent procedure which does not include. or which aiters, some or all of the elements of informed consent set forth above. or waive the requirement to obtain informed consent provided the IRB fin' is and documents that: (1) The research or demonstration project is to be conducted by or subject to the approval of state or local oovernment officials and is designed to 0 study, evaluate, or otherwise examine: (i) Public benefit of service programs: (ii) procedures for obtaining benefits or services under those programs: (iii) possible changes in or alternatives to those programs or procedures: or (iv) possible changes in methods or ievels of payment for benefits or services under those programs: and (2) The research could not practicably be carried out without the waiver or alteration. (d) An IRB may approve a consent procedure which does not include, or which aiters, some or all of the element8 of informed consent set forth in this section. or waive the requirements to obtain informed consent provided the IRB finds and documents that: (1) The research involves no more that, minimal risk to the subjects: (a) The waiver or alteration wiil not adversely affect the rights anzi welfare of the subjects: (3) The research could not practicably he carried out without the waiver or alteration: and (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation. (e) The informed consent requirements in this policy are not intended to preempt any applicable federal. state. or local laws which require additional information to be disclosed in order for infopmed consent to be legally effective. 0 (Q Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care. to the extent the physician is permitted to do so under applicable federal. state, or local law. (Approved by the Office of Management and Budmet under Control Number 9999-W20.) §_117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section. informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form. (b) Except as provided in paragraph (c) of this section. the consent form may be either of the following: (1) A written consent document that embodies the elements of informed consent required by § -116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is s4gned: or (2) A short form written consent document stating that the elements of informed consent required by § -.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used. there shall be a witness to the oral presentation. Also, the IRD shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by tl~e subject or the representative. However. the witness shall sign both the short form. and a copy of the summary, and the penion actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the. representative. in addition to a copy of the short form. I'c) An IRB may waive the ruouirempnt for the investigator to obtain a s'ianed consent form for some or all subjects 'If it finds either: (1) That the only record linkinv the subiect and the research would 6e the can .sent document and the principal risk, would be ootentiai harm resulting from a breach of confidentiality. Each subject will be asked whether the' subject wants documentation linking the subject with the research. and the subject's'wishes will govern: or (2) That the research presents no more than minimal risk of harm to subjects and involves no Drocedures for which W ritten consent is normally required outside of the research context. in cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research. (Approved by the Office of Management and Budget under Control Number 9999-W20.) §-118 Applications and proposals lacking definite plans for Involvement of human subjects. Certain types of applications for -rants, cooperative agreements. or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of support, but defirute plans would not normally be set forth in the application or proposal. These include activities such as institutional type =ants when selection of specific 0 projects is the institution's responsibility; research training grants in which the activities involving . subjects remain to be selected: and projects in which human subject's involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. These applications need not be reviewed by an IRB before an award may be made. However. except for research exempted or waived under § -101 (b) or (i), no hunian subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB. as provided in this policy. and certification submitted, by the institution, to the department or agency. §_i19 Research undertaken without the Intention of Involving human subjects. In the event research is undertaken without the intention of involving human subjects. but it is later proposed to involve human subjects in the reseirch. the research shall first be reviewed and approved by an IRB. as provided in this policy. a certification submitted. by the institution. to the department or rqnencv, Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 28018 FederAPP00Ved1Fb.r5Rd49M6 W00ft/08ne. and final approval given to the proposed change by the department or agency. §_120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a federal department or agency. The department or agency~head will evaluate all applications and proposals involving human subjects submitted to the department or agency through such officers and employees of the department or agency and such experts and consultants as the department or agency head, determines to be appropriate. This evaluation will take into consideration the risks to the subjects. the adequacy of protection against these risks. the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. (b) On the basis of this evaluation. the department or agency head may approve or disapprove the application or proposal. or enter into negotiations to develop an approvable one, §_121 [Reserved) §_1122 Use of federal funds. Federal funds administered by a department or agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied. §_1123 Early termination of research support; evaluation of applications and proposals. (a) The department or agency head may require that department or agency support for any project be terminated or suspended in the manner prescribed in applicable program requirements, when the department or agency head finds an institution has materially failed to comply with the terms of this policy. (b) In making decis.ions about supporting or approving applications or proposals covered by this policy the department or agency head may take into account. in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or suspension under paragarph (a) of this section and whether the applicant or the person or persons who would direct or has have directed the scientific and technical aspects of an activity has have, in the judgment of the department or agency head, materially failed to' discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to federal regulation). § -.124 Conditions. With respect to any research project or any class of research projects the department or agency head may impose additional conditions prior to or at the time of approval when in the judgment oi the department or agency head additional conditions are necessary for the protection of human subjects. DEPARTMENT OF AGRICULTURE 7 CFR Part Ic RIN 0518-AAOO list of Subjects in 7 CFR Part Ic Human subjects. Research, Reporting and record keeping requirements. Title 7 of the Code of Federal Regulations is amended by adding part lc as set forth at the end of this document. PART Ic PROTECTION OF HUMAN SUBJECTS Sec. 1c.201 To what does this policy apply? 1c.102 Definitions. 1c.103 Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency. 1c.104 (Reservedl Ic.1,05 [Reserved] 1c.100 [Reserved] 1c.107 IRB Membership. Ic-IGS IRB functions and operations. 1c.109 IRB review of research. 1c.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for mirior changes in approved research. ic-111 Criteria for IRB approval of research. 1c.112 Review by institution. 1c.113 Suspension or termination of LRB approval of research. 1c.114 Cooperative research. 1c.115 IRB records. 1c.116 General requirements for informed consent. IC-117 Documentation of informed consent. 1c.118 Applications and proposals lacking definite plans for involvement of human subjects. 1c.119 Research undertaken without the intention of involving human subjects. IC-120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency. 1(;.121 lReservedl 1c.122 Use of Federal funds. 1c.123 Early termination of research support: Evaluation of applications and proposals. 1C.124 Conditions. AuA%ority: 5 U.S.C. 301: 42 U.S.C. 3M-1 (b) Dated: December 13. 1990. Charles E. Hess. Assistant Secretary, Science &Education. DEPARTMENT OF ENERGY 10 CFR Part 745 RIN 1901-AA13 List of Subjects in 10 CFR Part 745 Human subjects, Research, reporting, and Record-keeping requirements. Title 10 of the Code of Federal Regulations is amended by revising part 745 as set forth at the end of this document PART 745 PROTECTION OF HUMAN SUBJECTS Sac. 745.101 To what does this policy apply? 745.102 Definitions. 745.103 Assuring compliance with this pollcy---research conducted or supportel by any Federal Department or Agency. 745,104 [Reserved] 745.105 [Reserved) 745.106 [Reserved] 745.107 IRB Membership. 745.108 IRB functions and operations. 745.109 IRB review of research. 745.110 Expedited review procedures for certain kinds of research involving no more than minimal risk. and for minor changes in approved research. 745.111 Criteria for IRB approval of research. 745.112 Review by institution. 745.113 Suspension or termination of IRB approval of research. 745.114 Cooperating research. 745.115 IRB records. 745,116 General requirements for informed consent. 745.117 Documentation of informed consent. 745.118 Applications and proposals lacking definite plans for involvement of human subjects. 745.119 Research undertaken without the intention of involving human subjects. 745.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency. 745.121 [Reserved) 745.122 Use of Federal funds. 745.123 Early termination of research support: Evaluation of applications and proposals. 745.124 Conditions. Authority: 5 U.S.C. 301; 42 U.S.C. 72,54.4Z U.S.C. 30ov-l(b). Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001-1 2301 A=-.,,,'--- -,teu: DecemDer -11. 1990. James 0. Watkins. t-'relary qf Ejwry,3. NATIONAL AERONAUTICS AND SPACE ADMINISTRATION 14 CFR Part 1230 RIN 2700-AA76 List of Subjects in 14 CFR Part 1230 I 1 itiman subjects. Research. Reportinq -ind Record-keeping requirements. Tiile 14 of the Code of Fe- deral Reguiationsis amanded by adding part 1230 its set f~,,rth at the end cf ihis document, PART 1230 PROTECTION OF HUMAN SUBJECTS 0-ited: lantiary 21. 1991. Richard 11. Truiv Administrator. DEPARTMENT OF COMMERCE 15 CFR Part 27 RIN 0690-AA17 List of Subjects in IS CFR Part 27 Human subjects, Research, Rep orting q~.rld recordkeeping requir" ments. Title 5 of the Code of Federal Reaulatiors is c-menc Iled by addin2 part 27 ds set forth at the end of this document. ~.:f-. 1'-30.1,01 To what does th',, o,;,uv 1231-102 C'efinitions, !-'30-103 Assuring compliance with th!j ,~)oucy-reseaarcri conducted or sunportad v any Federal D,nartrnpnt a," ~',-,-nrv. 1(A fReservedi 1230-105 iReservecil -eal 1230-106 [Reser% IRB Mciribersihip. IRB functions and operations. L'j!)-109 IRB rcview of research. 12-30-110 Expedited n3view procedures for cartairt kinds of research involviiii! no more than minimal risk, and for mi-nor ~'harices in approved re;iearch. 12"30-111 Q iteria for ERB approval of ^Psearch. 1L=.112 Review bv institution. 0.113 Su:~,p(,~nsionorterri-.,,-iozio(IRB appro%al of research. 114 Cooperaz',ve -esearc;h. IR13rezord- 11G General rP,--u:.~ernvnt:, fZ:r _'~;J-117 Coctunpn-,miun r,,. ;rifc. mmi .sent. '.118 Ai'plica-'!ons and P.---JP0SdfS di,finite plans for involventent tf;i;iman subjects. 1-L.41119 mtendon of involving human subjects. Evaluation and cl;sposii~,)n of lippiications and proposals for research !o be conducted or supported by a Federal Department or Agency. 1-'30.121 JReservedl 12,10.'22 Use of Federai funds. 1210.123 Furly termination of research support: Evaluation of app~Jcations and proposals. 1-'30.124 Conditions. Authority: 5 'j.S.C. 301: 41. U-S.C- i0ft-l(l)). Now, PART 27 PROTECTION OF HUMAN SUBJECTS 27-101 To what does !h~s poiicv oppiv? -'7.'02 Definitions, ~711(1,3 , Assuring commiance with this policy-research conducted or su,,)jiorted by aay Feclerai L)oparti-nent or Ac:pncv, [Rpservedi -17.105 lReserved) 27-106 [r\f2servedi 27.107 111B Membership. 27.108 IRB furctions and operations. 27,1051 IRB review of research. -'7.110 Expeditpd review procedures ft)r Certain k,~nds of iesearch involving no more thai minimal risk. and fur minor (;hanges in approved research. 17.111 Criteria f'c,'rlRBapprt)vtd ofreg-surch. -7-112 Pa view by institut ion. ;,ispens;on or termina lion of IR' 3 ap-,,oval of research. '7 1~4 - Cooperative re--;Larch. -'7. 115 11',13 racords. -5 Generid requ:rements for in,ormett ConScrIt. -117 L)ocumentwion nf infornied consent, '1118 APPILcations and proposals lackin-1 definite plans for involvement of human subjects. -'7.119 ROM-drch untiLrtaken wnhOLt the n1ention of invotving human subjects. 27.10 E~Auabon and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agencv. -"7.121 [Reservedl Z7.122' Use of Federal funds. ~7.123 E-.iTly termirialion of rpse;arch support: Evaitianon of applications and proposaiti. 2-.124 Conditions. Authoritv: 5 U.S.C. JO 1: 42 U.S.C. 3tX)v-1 (h). Dated: Dec~--mbcr :11, 19M. Robert Mosbach-ar. ~'-Crctarl'- o~ co"'Irnerre. CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1028 RIN 3041-AA95 Ust of Subipets ir 16 CFP%. Part 1028 Human subjects. Research, ReportinF Lindrecordkeeping requirements. Title 16 of the Code of Fe(lerai Regulationq 4 imetided b%, revising part 1023 as set [orth at the end of this docLurient. PART 1028 PROTECT,'ONOF H'JMA( SUBJECTS ~'?C. ~Vh3t dcj~'s ooh(yappiv? 'On-1112 1023-103 nolim-rqearrn conclucied or moppor:r. any Jemirtmrnt orAi-(-1t7.. ~f~-"8-144 '!RQsPrvPdJ . !Reservedl IP oserve~j 10-8-107 1l".9 Murnbe!ship. 1028,106 IRB functions and operations. 1026-IOU TT review of i-asearch. Expedited review proccdurcs for certain kinds ofresearch involving no -.norz~ i~nn min;msi risk. and for mincr hanges in LIMproved research. 1028.111 Cc:~PriaforlRBapprovalof research. ;0-13-112 i)v institution. 103.113 Susnersion or termination of !RD ppprovr~ I I;f 'Psearr'h. Coon-?rativeresc..,rch. lt'123.i-15 IR"~l records, Gwieral TFITmremcnif: ior ri~cc cons~:nt conrlel`!t. .028.1iii A-p(icatiuns and ornvc8 -Rts liwki n definite pians for involvement of htiman subivc: 's. WZ8.119 Research undertaker. without the intennon of invoiving h-,:man subiecis, !023.120 Evaiuation and disPositionof applications and proposals for resear-h to be conducted or supported by a redLral Department or Agenrv 1028.121 lResarvedl 1,0111.122 Use of Federal funds. 1028.123 Enrlyierminationofresearch support: Evpiuation of applicatinns ~inci proposals. 10L8.124 Ccridilions. Aulhoritv: 5 U S C. MI: 42 U.S.C. 300v-1 ~hj. Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 28020 ]AfttkAodtOctrftl(Mft.2000(/aStOSay,GWRDF!96,0071WROMOMMOO1 -1 Dated: January 11. 1991. Sheldon D. Butts, Acting Secretary, INTERNATIONAL DEVELOPMENT COOPERATION AGENCY, AGENCY FOR INTERNATIONAL DEVELOPMENT 22 CFR Part 225 RIN 0412-AA17 List of Subjects in 2a, CFR Part 223 Human subjects. Research, Reporting and record -keeping requirements. Title 22 of ffie Code of Federal Regulations is amended by adding part 2Z5 at set forth at the end of this document. PART 225 PROTECTION OF HUMAN SUBJECTS Sec. '15.101 Z. To what does t4is policy apply? 225.102 Definitions. 225.103 Assuring compliance with this policy-research conducted or supported by any Federal Department or Agency. 2Z5.104 [Reserved] 2Z5.105 [Reserved] 225.106 [Reserved] 225.107 IRB Membership- 225.108 IRB functions and operations. M.109 IRB review of research. 225.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for m pinor changes in approved research. 225.111 Criteria for IRB approval of research. 225.112 Review by institution. =5.113 Suspension or termination of IRB approval of research. 225.114 Cooperative research. 225.115 IRB records. 225.116 General requirements for informed consent. 225.117 Documentation of informed consent. .25.118 Applications and proposals lacking definite plans for involvement of human subjects. 225.119 Research undertaken without the intention of involving human subjects. 225.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency. 225.121 [Reservedl 225.122 Use of Federal funds. 225.123 Eariv termination of research support: Evaluation of applications and proposals. 225.124 Conditions. Authority: 5 U.S.C. 101; 42 U.S.C. 300v-1(b). Dated: December 13, 1990. Richard E. B-9sell, Assistant Administrator for Science and Technology. Department of Housing and Urban Development 24 CFR Part 60 RIN 2601-AAIS List of Subjects in 24 CFR Part 60 Human subjects, Research, Reporting and record-keeping requirements. Title 24 of the Code of Federal Regulations is amended by adding part 60 as set forth at the end of this document. PART 60 PROTECTION OF HUMAN SUBJECTS Sec, 60.101 To what does this policy apply? 60.102 Definitions. 60.103 Assuring compliance with this policy-research conducted or supported by any Federal Department or Agency. 60.104 [Reserved] 60.105 [Reserved) 60.108 [Reserved] 60.107 IRB Membership. 60.108 IRB functions and operations. 60.109 IRS review of research. 60.110 Expedited review procedures for certain kinds of research involving no more than minimal risk. and for minor changes in approved research. 60.111 Criteria for IRB approval of research. 60.112 Review by institution. 60.113 Suspension or termination of IRB approval of research. 60.114 Cooperative research. 60.115 IRB records. 00.116 General requirements for informed consent. 60.117 Documentation of informed consent. 60.118 Applications and proposals lacking definite plans for involvement of human subjects. 60.119 Research undertaken without the intention of involving human subjects. 60.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency. 60.121 [Reserved] 60.122 Use of Federal funds. 60.123 Early termination of research support: Evaluation of applications and proposals. 60.124 Conditions. Authoritr. s U.S.C. 301: 42 U.S.C. 3oov-1 (b). Dated: January 16.1991. Jack Kemp, Secretary. US. Department of Housing and D' Urban eveloPment. DEPARTMENT OF JUSTICE 28 CFR Part 46 RIN 1105-AA13 Ust of Subjects in 28 CFR Part 46 Human subjects, Research. Reporting and record-keeping requirements. Title 28 of the Code of Federal Regulations is amended by adding part 46 as set forth at the end of this document. PART 46-PROTECTION OF HUMAN SUBJECTS Sea. 46.101 To what does this policy apply? 46.102 Definitions. 48.103 Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency. 46,104 (Reserved] 46,10 [Reservedl 46.106 [Reserved) 40,107 IRB Membership. 40.108 IRB functions and operations. 46.109 03 review of research. 46.1io Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. 46.111 Criteria for IRB approval of research. 46.112 Review by institution. 46.113 Suspension or termination of IARB approval of research. 46.114 Cooperative research. 40.115 IPB records. 40.110 General requirements for informed consent. 46.117 Documentation of informed consent. 46.118 Applications and proposals lacking definite plans for involvement of human subjects. 46.119 Research undertaken without the intention of involving human subjects. 46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency. 46.121 [Reserved] 46.122 Use of Federal funds. 46.123 Early termination of research support: Evaluation of applications and proposals. 48.124 Conditions. Authority: 5 U.S.C. 301. 28 U.S.C. 509-510'. 42 U.S.C. 300v-1(b). AORNk Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 Approve;6f" IRgMpq ?9P940R'i0"':7C/ I~ZRR 6_00789ROD3300220001-1 es lune 18, 1991 / Rules and Re4ulations 28021 T= -NNW" Dated: Dec-ember 24. 1RW), Dated: )anuary 9, iw_n. Dick Thornburgh, Linda M. Hyrium, .4 Itornoy General. Ahzrrrole ()SD FedP,-1R",;swr Liaison 0~,rh^er, Dupartment of Deferrp, DEPARTMENT OF DEFE14SE 32 CFR Part 2119 DEPARTMENT OF EDUCATION RIN 0790-AC80 34 CFR Part 97 Ust of Subiects in 32 CFR Part 2ig Human subjects, Research, Reparting and record-keeping requirements. Title 32 of the Code of Federal Regulations is amended by revising part 219 as set forth at the end of this document. RIN 1875-AA07 Ust of Subjects in 34 CFR Part 97 Human subjects, Research, Reporting and record-keeping requirements, Title 34 of the Code of Fedeml Regulations is amended by adding part 97 as set forth at the end of this document. PART 21S--PROTECTION OF HUMAN SUBJECTS SeQ 219-101 To what does this pojjcy apply? "19,102 Definitions. L119.101 Assuring compliance with this poiicy--research condUCted or supported by any Federal DepRrtmr,.-,t or Agency. 239.104 [Reservedl '19.105 [Reservedl 219-100 lRoservedl 219.107 IRB Membprship. 219-108 LRB function,; and Liperalions. 219-109 IRB review of research, 219-110 Expedited review proceduret; for certain kinds of research involving no more than minimal risk, and foe minor rhanges in approved research, 219.111 Criteria for IRB approval of reearch 219.112 Review by institutic,ri. 419.113 Suspension ortermination of[RB approval of research, Z19.114 Cooperafiveresearch, 21q.li5 11113recwds. 21qllt3 General roquiremeni% for ink)-med consent. 219.117 Documentaic)nofiiifcirmedconsttnt. 219.118 Applications arid propus,,is lacking definite plans for involvement of human subjects. "19.119 Research undertaken without the intention of involving human subjects. Z!9.1120 Evaluation and disposition of applications and proposals for reseamb to be conducted or supp,irted by a Federal Department or Agency, 219.121 tReservedl 219.1221 Use offedvral funds. 219.123 Early termination of research support: Evaluetion Of applications arid proposals. '19.124 Conditions. Authority: 5 U.S.(- 301: 4:11 U.S.G. 300v. PART 97-PROTECTION OF HUMAN SUBJECTS Sec. 97.101 Fo what does this p(;iicv appiv? 97.102 Dvfinition3. 97,103 Assuring compliance with this policy-resestrch conducted or supporipci by any Federal Department or Aswricy. P7.104 [Reserved) 97.103 iYteserved) 97.106 IlInservedl 97-107 IRB Membership. '117.108 IRD functions and onerwions, W-109 IRB review ot'research. W.110 Expedited review procedures for rertain kinds of research involving no rpore than minima I risk. ana for minor changes in approvpd msaarch. 9-1.1111 C.-iteria for IRD approval afresearch. 97-112 Rc;view b% institution. (37.113 Suspension or termination of IN R approval of research, 97.114 Cooperatilm. research. M records. General requirements for 'wornied consent. 97-117 Doctimentatiotiol'iiiformedcurisent 97.118 Applications and proposals lac~-ing defini'to plans for involvement of hurrian 3ubjec-.9. 4*7.119 Research undertaken without the intention of invoiving human subiects. 97.120 Fvril(uidon and disposition of applications and proposals for research to be conducted car supported by a Fedora! Department or Agency. 97.121 [Reservedl 97.122 Use of Federal funds. 57.12-3 Farly termination of research support: Evaluation of apphrs rions and proposals. 97.124 Conditions. Authority- 5 11A.C. ',,01: 42 U.S.C. ~Wfv-ljbj. Dated- Itine 6, lm. Laninr Alexander. L~S. SPGr,-trrY OfFducazion. DEPARTMENT OF VETERANS AFFAIRS 36 CPR Part ils RIN 2900-AE29 List o' Subjects in 38 CFR Part 16 Human subjects, Research. Reporting and record-keeping requirements. Title 38 of the Code of Federai Reguiations is amended by adding part I 16 as set forth at the end of this document PART 4.6-PROTECTION OF HUMAN SUBJECTS 116-101 1'o what does this policy appiv? 16.102 Definitions. 10.103 Assuring compliance with this policy- research conducted or supported by any Federal Department or Agency. 16.104 iReserved) 16.105 JReservedl 18-106 tReserved) 15.107 IRB Membership. 16-IOB IRB functions and operations. 16,109 IRB review of research. JG.110 F--pedited review procedures for certain kinds of research invoiving ra more than minimal risk. and for minor changes in approved research. 16.111 Criteria for IRB approval of research. 16-112 Review by institution. 16-113 Susnension or termination of IRD approva. I of research. iti.11.1 Cooperative resparch. :6.115 M.13 records. 16.11b Generst ipquiremert% for lnformLd consent. 1,3.117 nocurnewution of mformed conspnt. 16.118 Applications and uroposals lac~irg definite plans for involveirient ofhuman subjects. 1.6.119 Research undertaken without tl~e intention oi involving human subiects. 16.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Deoartment or Agency 16-121 (Reservedl 16.122 Use oi Federal funds. 16.123 Eariv tormination of research support:-Evaluation of applications and Proposals. '.6.124 Conditions. Approved For Release 2oom=8 : CIA-RDP96-00789ROO3300220001 -1 A or Release 2000/08/08 : FIA-RRr9~15rRO -1 oved F 1 . u7 2 3 0 221 FedMIrRegister J Vol. 56, No. 117 / Tuec une 18, e~%URQqq&g0001 Authority: 5 U.S.C. 301; 38 U.S.C. 210k'c0), 4131. 4134; 42 U.S.C. 300v-l(b). Dated: February 19, 1991. Edward I. Derwinski Secretary of Veterans A ffairs. ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 26 RIN 2080-AA04 Ust of Subjects in 40 CFR Part 26 Human subjects, Research. Reporting and record-keeping requirements. Title 40 of the Code of Federal Regulations is amended by adding part 26 as set forth at the en~ d of this document. PART 26-FROTECTION OF HUMAN SUBJECTS Sec. 26-101 To what does this policy apply? 26-102 Definitions. 26-103 Assuring compliance with this poLicy-research conducted or suDported by any Federal Department or Agency. 26-104 (Reserved] 26.105 [Reserved] 26-106 [Reservedl 26-107 IRB Membership. 26-108 LRB functions and operations. 26-109 IRB review of research. 26.110 Expedited review procedures for certain kinds of research involving no more than minimal Fisk, and for minor changes in approved research. 26.111 Criteria for IRB approval of research. 26.112 Review by institution. 26.113 Suspension or termination of IRB approval of research. 26.114 Cooperative research. 26-115 IRB records. 26.116 General requirements for informed consent. 213.117 Documentation'of informed consent. 20.118 Applications and proposals lacking definite pians for involvement of human subjects. 20.119 Research undertaken without the intention of involving human subjects. 26.120 Evaluation an4 disposition of applications and proposals for research to be conducted or*pported by a Federal Department or Agency. 20.121 (Reserved] 26AZ2 Use of Federal funds. 28-12.3 Early terminadon of research support: Evaluation of applications and proposals. 26.124 Conditions. Authority: 5 U.S.C. 301: 42 U.S.C. 3OOv-1 (b). Dated: January 28,1931 William K. Reilly, Administrator. DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 46 RIN 0991-AA71 List of Subjects in 45 CFR Part 46 Human subjects, Research, Reporting and record-keeping requirements. Title 45 of the Code of Federal Regulations part 46 is amended, as follows: 1. An authority citation for subpart A is added to read as follows: Authority- 5 U.S.C. 301: 42 U.S.C. 289. 42 U.S.C. 3100v-i(b), 2. Subpart A is re0sed to read as set forth at the end of this document. PART 46-PROTECTION OF HUMAN SUBJECTS Subpart A-Basic HHS Policy for Protection of Human Research Subjects Set- 46.101 To what does this policy apply? 46.102 Definitions. 46.103 Assuring compliance with this policy-research conducted or supported by any Federal Department or Agency. 46.104 [Reserved) 46.105 [Reservedi 46.106 [Reservedi 46.107 IRB Membership. 46.108 IRB functions and operations. 46.109 IRB review of research. 46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. 46.111 Criteria for LRB approval of research. 46.112 Review by institution. 46.113 Suspension or termination of IRB approval of research. 46.114 Cooperative research. 46.115 IRB records. M4.116 General requirements for informed consent. 46.117 Documentation of informed consent. 46.118 Applications and proposals lacking definite plans for involvement of human subjects. 46.119 Research undertaken without the intention of involving human subjects. 46.120 Evaluation and disposition of applications and proposals for research to be.conducted or supported by a Federal Department or Agency. 46AZI (Reservedi 46.122 Use of Federal funds. 46.1Z3 Early termination of research Pupport: Evaiuatior of apphrations and propcsals, 46-124 Conditions. Dated: M -arch 29. 1991. Louis W. Sullivan, Secretat3,, of flealth and Ifunion Services. NATIONAL SCIENCE FOUNDATION 45 CFR Part 690 RIN 3145-AAIS List of Subjects in 45 CFR Part 690 Human subjects, Research, Reporting and record-keeping requirements. Title 45 of the Code of Federal Regulations is amended by adding part 690 as set forth at the end of this document. PART 690-PROTECT:ON OF HUMAN SUBJECTS See. 690.101 To what does this policy apply? 890.102 Deftnitions. 690.103 Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency. 690.104 [Reserved] 6M.105 [Reserved] 690.106 [Reserved) 690.107 IRB Membership. 690.108 IRB functions and operations. 690.109 IRB review of research. 69omo Expedited review procedures for certain kinds of research involving no more than minimal risk. and for minor changes in approved research. 690.111 Criteria for IRB approval of research. 690.112 Review by institution. 690.113 Suspension or termination of IRB approval of research. 690.114 Cooperative research. 690.115 IRB records. 690.110 General requirements for informed consent. 090.117 Documentation of informed consent 690.118 Applications and proposals lacking definite piano for involvement of'human subjects. 690.119 Research undertaken without the intention of involving human subjects. 690.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency. 6M.121 (Reserved] 090-122 Use of Federal funds. of research 690.123 Early termination support: Evaluation of applications and proposals. 690.124 Conditions. Dated: December 17, IM. A'aft, Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 Approv Release 2000/08/08 : CIA-RDP96-00789ROO3300220001-1 scoar R4ster / V01. F;6, INo. 117 / Tuesday, June 18. 1991 Rules and RegwlatiCE13 d28023 Authority: 5 U.S.C. 3WI: 42 U.S.C, 300i.-I(b). Frederick M. Bernthal. elctir~-Director, DEPARTMENT OF TRANSPORTATION 49 CFR Part 11 RIN 2105-A874 List of Subjects in 49 CFR part 11 Human subjects, Research. Reporting and record-keeping requirements, Title 49 of the Code of Federal Regulations is amended by adding part 11 as set forth at the need of this document. PART I 1-PROTECTION OF HUMAN SUBJECTS Sec.. 11.101 To what doeb this policy apply? JI.102 Definitions. 11.103 Assuring compliance IVith this policy-Fesearch conducted or supported by any Federal Department or Agency. 11-104 [Reserved] 11.105 (Reserved] 11.108 (Reservedl II.IC7 IRB Membership. 11-108 M functions and operations. 11.109 IRB review of research. 11.110 Expedited review procedures for certain kinds of research involving no move than minimal risk. and for minor changes in approved research. 11.111 Criteria for IRB approval of research. 11.112 Review by institution. 11.111. Suspension or termination of IRB approval of research. 11.114 Cooperative research. 11.115 IRB records. ',ec. 11.116 Gvneral requirements for informed consent. 11.117 Documentation of informed consent. 11.118 Applications and proposals lacking definite plans for involvement of human subjects. 11.119 Research undo-taken without the intention of involving human subjects. 11.12 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency. 11.121 [Reserved] 11.122 Use of Federal funds. 11-123 Eariv termination of research support:'Evaluation of applications and proposals. 11.124 Conditions. Authority: 5 U.S.C. 301: 42 U.S.C. 300v-1lbL Dated: February 4, 1991. Samuel K. Skinner, Secretarl of Transportation. tFR Doc. 91-14258 Filed 6-17-91: 8-45 am SUM CODE 4140-ot-M Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 28024 Federal Register / Vol. 56, No. 117 1 Tuesday, June 18, 1991 / Notices DEPARTMENT OF HEALTH AND established an interagency Human common rule will apply, and they are HUMAN SERVICES Subjects Coordinating Committee under seeking the most expeditious time frame Public Health Service Agency Forms Submitted to the Office of Management and Rudget for Clearance The following request has been submitted to the Office of Management and Budget (OMB) for clearance in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). Expedited review by OMB has been requested as described below, (Call PHS Reports Clearance Officer on 202-245-2100 for copies of submission) Federal Policy for the Protection of Human Subjects-New-Thii submission is for approval of the information requirements associated with the common rule for the protection of human subjects of research conducted. supported or regulated by the following Federal departments and agcncies: Department of Agriculture, Department of Energy, National Aeronautics and Space Administration, Department of Commerce, Consumer Product Safety Commission, Agency for International Development, Department of Housing and Urban Develepment, Department of Justice, Department of Defense, Department of Education, Department of Veterans' Affairs, Environmental Protection Agency, Department of Transportation, Central Intelligence Agency,~ and Department of ervices. Health and Human ~ Adoption of the common Federal policy by these departments and ;ies will implement a agenc recommendation of t .he President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. The Office of Science and Technology Policy the Federal Coordinating Council for Science Engineering and Technology. This group prepared a proposed Model Federal Policy for the Protection of Human Subjects that was published as a proposed policy in 1986 and again as a proposed common rule on November 10, 1988. After revision of the proposed common rule in response to public comments, the final common rule is being published elsewhere in this issue of the Federal Register. The common rule is based on Department of Health and Human Services (DHHS) regulations (45 CFR part 46, subpart A), the basic HHS Policy for the Protection of Human Subjects. Respondents. Individuals or households, State or local govemments, businesses or other for-profit. Federal agencies or employees. non-profit institutions, small businesses or organizations. The total number of respondents affected by these information requirements is estimated at 3,831. The total annual response burden for these requirements including all Federal departments and agencies subject to the common rule. is estimated at 187,408 hours divided as follows: 22.982 hours for recordkeeping requirements and 164.426 hours for reporting and disclosure requirements. Additional Information: DHHS has submitted this request for approval to OMB on behalf of all Departments and Agencies governed by this final rule. It is critical to receive OMB review and approval for the information requirements so that the common rule for the Protection of Human Subjects may be effective 60 days after publication. Federal Departments and Agencies have ongoing research programs to which the in which to begin protection of human subject policies and procedures. In addition, institutions supported or regulated by the involved Departments and Agencies have requested implementation of the final rule as soon as possible to lessen burden of compliance with numerous, sornetimas inconsistent, procedures for the protection of human subjects required by the various Federal Departments and Agencies, OMB has been requested to review and approve the information requirements in the common rule on an expedited basis no later than August 2, 1901. In keeping with the requirements for expedited review, we are publishing this announcement in the same issue as the proposed final rule. The information requirements are separately identified in the preamble to the rule. printed elsewhere in this issue. There are no separate forms or instructions for which approval is being sought.' OlUB Desk Qfflcen- Shannah Koss- McCallum. Because of the time frame in which OMM has been asked to act on this request. any comments and recommendations for the proposed information collection should be provided directly to the OMB Desk Officer designated above by telephone at (202) 395--7316 or by express mail at the following address- Human Resources and Housing Branch, New Executive Office Building, room 3GO2. Washington, DC 20503. Dated: May 31. 1991. Sandra K. Mahkorn, IDeputy Assistant Secretai~v for Public Health Policy. 11711 Doe. 91-14259 Filed 6-17 -91. 8:45 am] BILUNG CODE 4140-01-M AMA A9ftN Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 A ppr&kFdl ftf'Atl"Se 2080108IQ8T-UGIATRQPO%§:-QPX8/9RPLQ3AAOA M-POt-s' 2802r *ftvoi OEPARTMENT OF HEALTH AND HWAN SERVICES Food and Drug Administration 21 CFR Parts 50 and 56 Docket No. 87N--00321 SIN 0905-AC5.1 I.rotection of Hurnan Subjects; Ilif ormed Consent-, Stnnaards for Institutionai Review Boards for CHnIcal Investigations AGENCY: Food and Drug Administration. I His. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending its regulations on institutional review boards (IRB's) and on informed consent to conform them to the "Federal Policy for the Protection of Human Research Subjects" (Federal Policy) published elsewhere in this issue of the Federal Register. Existing FDA regulations cloverning the protection of human subjects share a common core with the Federal Policy and implement the fundamental principles embodied in that policy. EFFECTIVE DATE: August 19, 19M. FOR FURTHER INFORMATION CONTACT: Richard M. Klein. Office of Health Affairs (FIFY-20). Food and Drug Administration, 56M Fishers Lane. Rockville, MD 20357,3M-443-1382. SUPPLEMENTARY INFORMATION: 1. Background FDA is charged by statute with ensuring the protection of the ris4hts, safety, and welfare of human subjects who participate in clinical investigations Involving articles subject to section 5051i), 507(d), or 520(g) of the Federal Food. Drug. and Cosmetic Act I the act) (21 U.S.C. 3551i), 357(d). or 360jfg)). as Well as clinical investigations that support applications for research or marketing permits for products regulated by FDA, including food and color additives. drugs f ,or human use, medical devices for human use, biological products for human use. arid electronic Droducts. In the Federal Register of January 27. 1981, FDA adopted regulations ,ooveming informed consent of humin subjects (21 CFR part 51); 46 FR 8942) and regulations establishing standards for the composition. operation. and responsibilities of IRB's that review clinical investigations involving human subjerts (21 CFR part 56; 46 FR 8958). At the same time. the Department of Health and I luman Services (IIHS) adopted regulations on the protection of human research subjects (45 CFR part 46: 48 FR 8366). The FDA and HHS re-lulations share a common framework, !n December 1981. the President's Ccrriniission for the study of Fthtcal Problems in Medicine and Biomedical and Behavioral Research (the commission) issued its "First Biennial Report on the Adequacy and Uniformity of Federal Rules and Policies, and their Implementation, for the Protection of Human Subjects in Biomedical and Behavioral Research, Protecting Human Subjects." The commission recommended that all Federal departments and agencies adopt the HHS regulations (45 CFR part 46). In May 1982. the President's Science Advisor, Office of Science and Technology Policy (OSTP), appointed an ad hoe Committee for the Protection of Human Research Subjects (the committee), under the auspices of the Federal Coordinating Council for Science, Engineering, and Technology (FCCSE'n, to respond to the recommendations of the commission. The committee, composed of representatives and ex officio members from departments and agencies that conduct, support, or regulate research involving human subjects. developed responses to the commission in consultation with OSTP and the Office of Management and Budget (OMB). The committee agreed that uniformity of Federal regulations on human subject protection is desirable to eliminate unnecessary regulations and to promote increased understanding by-institutions that conduct federally-supported or regulated research. The committee developed a model policy which OSTP later modified and. with the concurrence 'of all affected Federal departments and a"encies, published as a proposal in the o Federal Register of June 3. 1986 (51 FR Z0204). More than 200 comments were submitted in response to the proposal. Published elsewhere in this issue of the Federal Register is the final rule on the Federal Policy. FDA conctIirs in that firial rule. In the Federal Register of November 10, 1988 (53 FR 45678), the agency proposed to amend its regniations in' 21 CFR parts 5U and 56 to conform them to the Federal Policy to the extent permitted by the act. The agency is committed to being as consistent with the final Federal Policv as it can be, given the unique requirements of the act and the fact that FDA is a regulatory agency that rarely supports or conducts research under its regulations. However. as explained in the proposed rule. FDA must diverge from § § -101(h) and -116(d) of the Federal Policy. FD11 received 22 comments on the oroposed rule from sponsom of regulated research, institutional review board members and staff. academic ;nstitutions, medical societies. and lawvers. Several commorts were prepared by or.-aniza0zons, each representing a consortia of institutions that had been polled ccncerning the proposed rule. A. General Comments 1. The majority of comments supported the agency's efforts to conform to the Federal Policy. 21, The majority of comments received concerned the proposal to amend § 56.108(b) to require that IRB's follow written guidelines for ensuring the reporting of scientific misconduct and of unanticipated problems to the IRB. institutional officials, and FDA. Two comments noted that this provision would make the IRB the institutional body that investigates Hlleged frauC severely damaging the IRB /investigator nd possibly diminishing relationship a~ the effectiveness of the iRB in protecting human subjects. Several comments rioted that the proposed additional reporting requirements would d.,plica e investigator and sponsor reporting requirements and would be difficult for the IRB to enforce. One comment said that this section may adversely affect the IR13/institution relationship and asked how FDA intended to ensure that reporting occurred. One comment interpreted the provision as applicable to animal studies and wondered whether IRB's would be responsible ior contacting sponsors. One comment expressed concern that the workload of the IRB would increase and adversely affect the recruitment of new members. One comment sought to exclude Adverse Drug Reaction reports. One comment argued that the reporting requirement was unauthorized by law. Two comments from sponsors requested that sponsor notification be added under proposed I 56-108(b), noting that an investigator engaged in misconduct is unlikely to report that misconduct to the IRB, and that the sponsor is the entity that frequently detects misconduct through its extensive monitoring practices. 1r addition. these comments requested clarification of the office in FDA to which scientific misconduct should be reported. Several comments requested that FDA define or riarify "scientific misconduct" and .,unanticipated problems." Since the proposed model policy was published, the Public Health Service published a final rule concerning fraud and misconduct in science (54 FR 32446. Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 Approved For Release 2000/08/08: CIA-RDP96-00789ROO3300220001-1 26026 Federal .Register / Vol. 56 No. 117 / Tues-day, June 18, 1991 Rules and kxegulations August 8, 1989). Because that rule directs institutions to establish provisions fc:- the investigation of alleged scientific fraud and misconduct, the mention of scientific misccnduct" has been deleted. as unnecessary, from the model policy. Because FDA only proposed to requi,re that IRB's report scientific misconduct to be consistent with the model policy, it has deleted this requirement from its final rule, This action should allay many of the concerns expressed in the comments. Moreover. FDA believes that the comments misconstrued the intent of 56 -108(b). This section requires simply that an IJRB have procedures by which it checks to ensure in reviewing each study presented. that provision has been made in the siudy to notify the IRB. appropriate institutional officials, and FDA in the specified circumstances. Section 56.108(b) does not require that the IRB itself provide the notification to eithicr the instituion or to FDA, unless such reporting WOLId riot otherwise occur. Altriough FDA's regulations include reportinR requirements for certain types of investigational articles (sce.' e.g.*. 21 CFR parts 312 (investigational drugs) and 812 (investigational devices)), there are no such provisions for other articles that may be the subject of an investigation (e.g'. food additives). Because all regulated research to be conducted at an institution will come before the IRB. FDA finds that the IRR is thc voprODriate entity to charge with the resvonsibility for ensuring that reporting of the specifiIed problIems to the L63. the institution, and the agerm, will occur. 3. One comment urged FDA to move toward the adoption of an assurance s,vstem. as established for the other Rpencies within HHS to guarantee compliance with re~lulations for the orotEction of human subjects. .FDA continues to beheve that it would be inappropriate for it to adopt this mechanism, As stated in the final rule in the Federal Register of January Z 27.19,31 (46 FR 8959. comment 2). the benefits of assurance from IRB's that are !:ubiect to FDA jurisdiction, but not otherwise to HHS jurisdiction. do not justify the increased administrative burdens that would result from an assurance system. FDA relies on its Dioresearch NIonitoring Program. along with its educational efforts. to assure COMDljance with these regulations. 4. bne comment expressed concern ovei FDA's proposed divergences from sections 101(h) and 116(d) of the Federal Policy. The comment contended that it is scmetimes impossible to obtain informed consent. as defined by FDA's regulations. in foreign clinical trials. As stated in the proposed rule (53 FR 4567/9), FDA does not have the authority to accept the procedures followed in a foreign country in lieu of informed consent as required by the act for studies that are conducted under a research permit that it grants. The comment did not provide any information that would compel a different conclusion. R Commer. ts on Definit ions 5. One comment suggested that the word "discomfort" used in proposed § 50.3(i) and .53.102(i) is difficult to define and is subjective. FDA believes that the meaning of "discomfort" is sufficiently ciear. FDA interprets this term to have its ordinary meaning: that is, to mean the extent to 0 which a subject may be made uncomfortable by the article that is the subject of the research. 6. One comment asserted that proposed § 56.102(m), the definition of "IRB approval," suggests an intent to change the procedural requirements of IRB approval. FDA proposed to add this definition to make the regulations conform to the Federal Policy and to clarify the meaning of die phrase "Ii~ approval" under this rule. The addition of this definition is not intended to effect a substantive change in part 56. In the preamble to its August 8,1978 proposal of the IRB regulation (43 FR 35186 at 35197), FDA presented a thorough discussion of its authority to require IRB review. 7. One comment stated that the reference to "other institutional and Federal requirements" in Droposed § 56-102(m) goes beyond FDA's ability to determine other institutional requirements and may be counterproductive where there is conflict between the institutional requirements and FDA or HHS requirements. The suggestion is made to delete "and other institutional requirements." This definition is intended to make clear that IRB approval is to be based on a determination that the proposed research is acceptable under any applicable institutional requirements, applicable law, and standards of professional conduct and practice. If there are conflicts between the institutional requirements and Federal law, those conflicts obviously must be resolved in favor of the Federal law. However, institutional requirements often address matters not addressed by Federal law. Therefore, FDA finds it appropriate to mention both institutional and Federal requirements in this definition. 8. One comment suggested substituting "clinical investigation" for the word "research" in § 56.102(m). FDA rejects the suggestion. FD.~ has defined "clinical investigation" in § 56.102(c) to be synonymous with ..research" (46 FR 8976). Because FDA deFires to conform to the Federal Polic% and in the absence of a compelling argument to diverge from it, FDAis using the word used in the Federal Policy. 9. Several comments sun ested deleting "at an institution" from § 56.102(m), contending that this phrase mav confuse the original intent o~ the meaning of IRB approval. Another comment noted that much research today is conducted outside the irstitutional setting. FDA reiects the comments. In 1181, when FDA adopted the IRB recul~;ions. FDA intentionally defined "instittiti=" broadly to include "any public or privatc entity or agency" (§ 56.1C2(f); 40 FRI 8903'comment 27). 1huq, J 56.102(m) is cons'istent with the onginal iilt,~nt of the IRB regulations. gested rev' i - 10. One ccmment sug ising 56.1G2(m) to read "IRB approval means * * that the research has been reviewed for undue risk to the subject and may be conducted * * *." ; FDA rejects the sugeestion-The suggested change does not adequately describe the role of the 111B. The IRB's review of studies and informed consent documents includes numerous considerations in addition to whether the study presents undue risks to the human subjects involved. C. Cammor;ts or., Exemprions From IRE Reouire;:-enis ii. One comment requesied that no exemptions from 1RB requirements be granted for those populations almady identified as vulnerable. FDA did not propose that studies involving vulnerabie populations be exempt irom IRB review. The only exemptions from the IRB review requirements were established in the 1981 final rule (46 FR 8"4 2. 21 CFR 56.10-4). The use of an investigationol article is exempt from IRB review if the investigation started before July 27. 1931, before the requirement of 11,113 review was in effect. or if it involves an emergency use of the test article, in which case there is not time for IRB review before the article is used. The agency found that in these circumstances, the considerations that support granting an exemption outweigh those that would support denying it (46 FR 8965. comment 41d). The comment did not provide any basis for reconsidering Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 Federal Register / Vol. 56 No. 117 Tuesday, June 18, 1991 / Rules and Regulations 2802 or revising this judgment. The agency M P,oints out that the latter consideration I .emergency use), which is the only basis on which a new study would be exempt. appii2s only to particuidr uses of an and would not provide the basis COr an exemption for the use of an artirle in a particular population. Therefore. FDA finds that this comment provides D basis for modifying its regulations. 12. One comment suggested that FDA completely exempt "minimal risk" 5tudies from IRB review. FDA rejects the comment. The determination of m-n:mal risk can be .-nada only by mem~e'rs of tile MB. riot ,_~e investisai-or or the soonsor.The burden OL an expedited review of a ;irot.ccol to determine if it presents T.Mimal risk is not so great as to justify the requested exemption. 0. Comments on IRE Membership 13. T11-ree comment:; sug,,ested that FDA -, __r :10 in § 036.107 the 0spocific mernbers to be inciuied on an IRB. Several comments suszoeste d that FDA lefine- in new § 56.1107tc). "nori- scientific." Two and ~;ornments suggested that the IRB ~iciulu "one member who has an 'MMUrstanding of the medical risks involved." Another comment suggested that I 56.107(c) be clarified to include a Statement requiring that at least one meniber of the MR have an understanding of the scientifir method. FDA rejects. those co.,nments. FDA li'm chosen not to prescribe profersional inembership requircments for IRB bars. T1,e rem_,lations sitlow for F;oxibility in the rrakoup of r-e IRP r 3 FRA P966, cOrrimr.1n, 0 315).ThLy require, however. that therc. be 9t least one member whose concerns are in nonscience areas and one Triemberwho ~_is t~e professional compc!3ncv to 'eview tile proD1,32d ~Osearch. 's LIL:.11 Lis a 1 : ~vsiciun. FDA interprets 'cornnetency' 1~ L ;ri this context to include the abitity to understand the sciertific method. The il ~21ercV believes that the membership ~2qllireinenL3 t1int it -has adopted a-e adequate to ensure that an 1~13 will be abie to fully consider the issues presented by a study. 14. One comment suggested that the proposed change in I 56.1.07(a), si:jowing 1RB's that regularly review studies that :nvoive vulnerable categories of subjects ,o consider including as a member an iridividual knowledgeable about. and Lxperienced in, working with vulnerable populations. will afford less human ,subject protection than the current regulation. The current regulation states that an IRB that regularly reviews research ;rivolving vulnerable populations should include as niembt~rs individuais who are primarily concerned w1th the weifare of vuinerable subjects. Revised § 56.1071(a) !;--ts categories ot subiects who are considered vulnerable and reouiros that 'he institution, or other author .! tv. consider including indNiduals ' knowledgeable and exppr~encvd in working with these types of subjects as votinR members on the IRB. This revist'On is not intended to le3sen in arly ,-;av the protections for vulnerable populations un4er FDA's re-u.1ations, As explained in the proposal (53 FR 45679). FDA is makdm,: this change only to conform to the language of Lhe Federal Pol:cv. FD'A cn -its own initikitive is adding parenthvsi's to zhe word "reviewers" in § 56.i'K1fb1;.i) to permit a continuance of exisurg _!~S review procedures. E. Comments on IRE Func!~onL! ond Operatio!7,,; 15. Several comr-wnts soupht ',rifi-ation of new b)~I) --vith 7eard to the definition and ~." 1(11 rp retation of "any unanticipated P'loblems involvinr, risks to human I . . si;bieuts and othm" and the level of risk to be reported. FDA interprets this phrase to mein an Unexpected adverse experience that is not listed in the libeling for the test article. Such experience includes an event that may be symptomatically and "'o-thophysiologicatily related to an event .,stgd in the labielirg but that differs fi-oin the eve-it because of greater s-~er4licily or severitv. Tt, ..e .vo,ct has pre%,ic,_n:!y been diefln~d as who Eire pmarti,~477,-, n2 in clin;Cal ~2rsons ials u,ider thg same or S!mdlar proiccols o.-,A,ho rnay be aff,~ct~~,j bv producTs or procedures aieveioped ir. those tritts (see 53 FR 45~,,65: OVe al,'_!C1 10, F. Comnmn ts on E~xpedi-,._! ~v Prccadurf.-!; 16. "'no comment repd ;hu ci arii U ge in § %A1 unce year or loE:s," ds affecftg a charige f:0M the CUITel-Itrapiatiors. FDA &,-,agrees with the comment. Under C'Urrent regulations. the IRD may approve a study that wili continue beyond 1 year. such as a longitudinal followup study. The IRB is obligated. however, under § 56.109(p) (21 CFR 58.109(e)), to conduct continuing review Gf the research at intervals appropriate to the degree of risk that it presents but not less than once a year. 17. One comment stated that expedited review procedures should rover be used in research that involves vulnerable populations. 17DA disacroes with the comment. - Expedited review procedures may only be used to review research that invoivc minimal risk as defined in § 56-102(i) 01 to review minor changes in previously approved research 56.11011b)). The determination that such conditions apply must be made by the chairpersoi of the IRB, or Dy one or more experienced members of the IRB designated by the chairperson. Thus. research involving vulnerable populations will not be -;ubject to expedited review unless a member of the IRB has affirmatively determined that the subjects will nct be exposed ti any --,eater risk of harm than t~- encounter in daily life or during routint physical or psychological examiration oriests. or that a change in research that has been reviewed by the whole IRB is minor. Obviously, in making the determinations, the IRR member MLISt consider the nature of the cub4~ct popidation. N."irvover. if expedited revipw is undertaken. the reviewer nin Pxercise Lill the authoritv of tho IRB. authoritv including under io ensure that any speci, problems 'of vulnerable pepulations h-wo Leen addressed. Thus. FDA ~,~lieves chat vulnerable populations will not be involved in research that h. been subject to expedited review procedures without full consideration .vhether such -.osearch should be skibit to expedited review at all and. if so, o, their irterevs. Therefore, FDA does n( the comment. agree wi, G. Cu.-Pments va Cr!,'Pria for MR 113. Onz comment Su'2ReS*Md dels~t4ni: economically o~ educationally f-om nt disaL!-.,'antw~ed persons 3 statirig that it wculd be ole iDr tho L%9 or tive ci4nical ;IlveFti-ator to make that duterminatic PDA disagrees with tile comment. P stated in § 5-3.111(b), FDA PxrL;cts the 1RB to make sure tl,.all adequa'te protections are included in those clini investigations in which vulnerable subjec;s wid be participating.There i6 no requirem-crit for the IRB to make a determina"on that individual subjectE aVe disadvantaged. However, the IRB required to determine whether it is likely that vulnerable individuals will involved in the study, and. if so. whet! adequate safeguards have been incluc: to protect the study subjects or wheth additional safeguards are necessary. 11. Environmental Impact The agency has determined under CFR 25.24(a)(8) that this action is of a type that does not individually or Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 A"$04 . Q1PP"A7A9FNRaJQQ920001-1 23028 Fe f cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. III. Economic and Regulatory Assessments FDA has examined the economic consequences of the final amendments to its regulations pertaining to IRB's and to informed consent in accordance with the criteria in section 1(b) of Executive Order 12291 and found that these amend.ments would not be a major rule under the Executive Order. ThL, agency also has considered the e;fect that thq final r,.!- would have on small entities including small businesses in accordance with the Regulatcry Flexibility Act (Pub. L. 96-354). The agency certifies that there wili not be a siRnificant economic impact on a substanti,ii nuniber of small entities, FDA eXDiairied the basis fc;r these conclusions in the prGPCSUi (53 FR 45681). Tr!e a~,f!ncy did not receive any comment.n. that suggest contrary conclusionE. This filial rule contains i-mormati'on collections subject to the Paperv..-ork Rsciuc~ion Act of 1930. These informE tirn collections ha,. a been approved under ONM contrel number 0910-0130. list of Subjects in 21 CFR Part 50 Prisoners, Reporting and recordkeepirg requirements. Research, Safety. f I CFR Purt 56 Report,n-, and R eccrdk;--e ping requirem-,nts, Research. Safety. Thereiore. under the Federal Food, Drug. and Gusmetic Act and the Pubhic Health Serv)ce Act. 21 CFR parts 50 and 56 are amended as follows: PART 50-PROTECTION OF HU44AN SUBJECTS 1. The authority citation for 21 CFR "~ as follows part 50 continues to rea Authority; Secs. 201. 401-1, 406, 409, 50.1. 503, 505. 508. 507. 510. 513-516, 51 P-5520, 701. 706. W1 of the Fe6eral Focd. Drug, and Cosmpt'~. Act 121 U.S.C. 321,34fl. 346a. 343.3-52.333, 355.356.3,57,350.3GOc-ML 360h-3601.371, 376, 381); secs. 215. 301. 351, 354--36OF of the Public Health Service Ad (42 U.S.C. 216.241. 202- 263b-263M. 2. Section bO.3 is amended by revisirg paragraph (1) to read as follow's; § 50.3 Definitions. [1) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. PART 56-IUSTITUTIONAL REVIEW BOARDS 3. The authority citation for 21 CFR part 56 continues to read as follows: Authority: Seca. 201. 406, 408. 409, 501. 502. 503,505.506.507.510, 513-51.6.51E~-520.701, 706. 801 of the Federal Food. Drug. and Cosmetic Act (21 U3.C. 321.346. 346a. 34f%, 351. 352, 333. 355, 356. 357, 360, 360h~Mi, 371, 3M 3ail: secs. 215, 301. 351. 334--36OF of the Public Health Service Act (42 U.S.C. 216.241, 26-2 ZG313-261i). 4. Section 56.102 is amended by revising paragraph (i) and by adding new paragraph (m.) to read as follo'A's. §56AG2 Definitions. (i) Minimalrisk means that the probability and magnitude of harnt or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in diily life or during the performance of routine physical or psychologicitl examinations or tests. (in) IRB approval means the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set fGrth by the IRB and by other institutional and Federal mquirements. 5. Section 56.104 is amended by adding new paragraph (d) to read as follows: § 'G6.104 Exemption% trom IRS requirement. (d) Taste and food qnallity evaluations and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or belo%v the level and for a use found to be safc. or agricultural. chernicaL or environmental contaminant at or below the level found to be safe. by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Irspection Service of the U.S. Department of Agriculture. 6. Section 56.107 is amended by revising paragraph& (a), (b). and (c) to read as follows: § 56.107 IRS membership. (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members. and the diversity of the members, including consideration of race, gender, cultural backgrourds. and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding &a rights and welfare of human subjects. In addition to possessing the professional competence necessary to review the specific research activities. the IRB shall be able to ascertain the acceotabilitv cf proposed research in terms of institutional commitments and regulations, applicable low, and standards or professional conduct and practice, The IRB shall therefore inciude persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable catgory c;' subjects, such as children. prisoners, pregnant women. or handicapped o: mentally disabled persons, consideration shall be given to the inclusion of one or more ind4viduals who are knowledgeable about t1ie exy3erienced in working with Lhose su~jactB. (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the instituton's consideration of qualified persons of both sexes, so long as no selection is made to the M11 on the basis of gender. No IRE may consist entirely of members of one profession. (c) Lach IRB shall inclu"'a at least one member whose primary concerns are in the scientific area and at least one rizember whose primary concerns are in nonscientific areas. 7. Section 56.108 is amended by tevising parauaob (a), bv removint: paragraph (c), by redesignating paragraph (b) as paragraph (c), by adding a new paragraph (b). and by adding a parertheticai statement to' the end of the section to read as fo'lows: § 56.10S IRS functions and operations. (a) Follow written procedures: (i) For conaucting its initial and continuing review of research and for reporfing its findings and actions to the investmator and the institution; (2) for determinin2 which projects require review more often than annually and which projects need verification from sources other than the investigator that no material changes have occurred since previ .ous IRB review, (3) for ensuring prompt reporting to the in of changes in Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 Approve&iiiaraMqtase/2,000/QW,0.81~ C.]A;,RQRO~,-,007d89.RD0360220QOlnlttions 23029 .-,!search activitv: and 1.4) for ensuring ~~at changes in approved research. -jurinp the period for which IRB approval has already been given, may ot be initiated without IRB review and ~jpproval except where necessarv to eliminate apparent immediate hazards to(the human subjects. ,b) rollow written procedures for ensuring prompt reporting to the IRB. appropriate institutional olficials. and the Food and Drug Adn-dnistration of: (1) Any unanticipated uroblems involving risks to human subjects or others: (2) any instance of serious or continuing with these regulations or the requirements or determinations of the IRB; or (3) any suspension or tetinination of IPjB approval. iinformation collection requirements in this section were approved by the Office of %tanaqement and Budcet (OMB) and assigned OMB control number u910--0-i30) Section 58.110 is amended bv revising paragraph (b) to read as follows: § 56.110 Expedited review procedures for certain kinds of research Involving no more than minimal risk, and for minor changes in approved research. N An IRB may use the expedited review procedure to review either or f both of the following: (1) Some or ail o the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk. (2) minor changes in previously approved research during the verj'od (of I year or tess) for which approval is authorized. Under an expedited review procedure. the review may bc carried out by the (RI3 chairperson or by one or more s~xperienced reviewers designated by d die IRB chairperson from aniong the rnembers of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove t, he research. A research activity may be disapproved only after review in dccordance with the nonexpedited -E:view procedure set forth in § 56.108(c). 9. Section 56,111 is amended by revising paragraphs (a)(31 and (b) to read as follows: §56.111 Criteria for IRS approval of research. (a) * . . (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should I)e particularly cognizant of the special problems. of resuarch involving "'u-inerable populations. suc_~ as c;1iildren. prisoners, pregnant women. handicapped, or mentaliv disabled porsons, or economically cr educaticnaily disadvant aqed persons. I (b) When some or all of the subjects. such as children, prisoners. pregnant women. handicapped, or mentaily disabled persons, or economicaily or educationally disadvantaged pers-ons. are likely to .be vuinerabie to coercion or undue influence additionai safeguards hilVe 6Pnn in(.iuded in the szudv-to of these protect the rights and weifare ' subjects. 10. Section .56.115 is amended by revising paragraph (a)(6) and by adding a parenthetical statement to the end of the section to read as follows: § 56.115 IRB records. (,I) I '51 Wriitpn procedures tor the IRB as r,,"~quired by ~ 56,108 (a) and (b). (intoematiun coilection requi-Lincals in this section w-re approved by the Offire of ianagenjent and Budget (OME) and assigned OM.B control ritinber 0910-411301 I)Ltedi March 29. 1M. David A. Kessler, CommissionerofFood undDrugy. Louis IV. Sullivan. S,;~vrem ry of.Heollh and Human Survices. [FR Doe. 91-14ZW Filed 6-17-91: 8:15 aml BILLING CODE 416"1-M DEPARTMENT OF EDUCATION 34 CFR Parts 350 and 356 Protection Of Human Subjects- Disability and Rchabifitation PesearO: General Provisions, Disability and Rehaoilitation Research: Research Fellowships AGENCY: Department of Educ,,nnn. ACTION: interim final re-ulations with an 0 opportunity to comment. SUMMARY: Nip Secretary amends program repulations for the NationA Institute on Disability and Rehabilitation Research to add certain protections for handicapped children and mentally disabled persons who are the subjects of research conducted or sponsored by those programs. Specificaliv. the program regulations would require that when an institutional review board (IRD) reviews research involving these research subjects. the IfZB must include at least one person who is primarily concerned with the welfare of the research subjects. The epulaticris are ncccssery as the rpsult of the Department of Education's (Department) withdrawal of a departure from the common re-tilatiuns for the Protection of hurnan reseprch subjects. DATES: Comments niust be received or, or before August 2. 1991. These regulations take effect either Atioust 19. L991. or later if 'the C0flgr*eS3 takles certain adjournments. if you want W know 0-le effective date of these regulations. cail or write the Department of Education contact person. A dk;current announcing the effective date will be p-=)hshed in the Federal Register. ADDRESSES: All comments concerninp these interim final re-,ulations shoult:i~be addressed to Ivir. Edward Glassman; Office of Planning. Budget and Fvaluation; U.S. Department of Education. Federal Building ;;u, roorn 3127. 4001%laryland Avenue STvV.. %Vishington, DC Z0202-413.2. FOR FURTHER INFCR?AATION CONTACT: Edward 13. Glassman. Telephone: (2021 401-3132. Deaf and hearing impaired individuals may call the Federal Dual Party Relay Seniue at 1-800-877--B339 (In t6 Washington DC area, 2102708- 93001 between 6 a.m. and 7 p.m. Eastern Time. SUPPLEMENTARY INFORMATION: The office of Science and Technology Policy. Executive Office of the President (OSTP), published a "Proposed Model Poliiy for the Protection of Human Subjects" in the Federal Register on Junt 3,1986 (51 FR 20-204). OSTP adopted a final policy for the protection of human research subjects on November 10. 1988 (51 FR 45660), The Final Policy tdoptcd by OSTP was included Lnproposed common reguiations published in the Federal Register on November 10, 1938 (53 CFR 45601) by sixteen departments and agencies in ihe Executive Branch of ',he Federal Government. including the he final Depa, tment of Education. T common regulations are published in another section of this Federal Register part. The notice of proposed ruiemaking (NPR.M11 for the common regulations spec1ic,"lly asked for comments addressing what effect promulgation of the Model Policv would have on each of the agencies involved in the proposed rulemaking. The Secretary proposed a departure from the common rmiations that would require representation on an Institutional Review Board (IRB) of at least one person Dri-rarily concerned with the welfare -of the research subirct., whenever the research involves handicapped children or montally disabled Persons. As discussed below, Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1 the Secretary has decided to withdraw this across-the-board deDarture in favor of program-specific regulations under those programs of t~e Department that are likely to support covered research that involves these research subjects. Comn-osition of the IRB Comment The Departmcnt proposed a departure to § -.107(a) of the common regulations that would have required that, for all programs of the Department, "when an.11113 rcviews research that deals with handicapped cliildnon or mentally disabled persons. the IRB shall include at least cne person primarily concerned with the welfare of the research subjects." The remainder of the departure reiterated the common rule's provision. which required institutions to consider rerresentation on the IRB of persons who are knowledgeable about and experienced in working with certain vulnerable subjects if the J_RB regularly reviews research involving those vulnerable subjects. Twenty-one institutions focused on this proposed departure in the4r ccramerits. The majoritv of these conurients were opposed to the proposed departure. Some commenters, while supporting the proposed general language in 1 -107, stated their belief that the departure was not necessary because the policy in § -107 already addresses representation of the special concerns of vulnerable subjects on the IRB. Thus, the rights of haadicapped children and mentally disabled persons should be represented on any IRB that regularly reviews proposals involving those individuals and there is nothing to be gained by emphasizing these two categories of subjects. Such an emphasis was seen as a precedent with the potential for discrimination against other categories ofvulnerable subjects. When special expertise is required. IRBs already have the option. and. they believed. the obligation to seek informed consultants. However, one commenter stated "if in future staffing of our IRB, someone with exvertise in this area is available and willing to serve, we would be happy to encourage such participation." One commenter suggested that only when an IRB regularly reviews research that deals with handicapped children or mentally disabled persons should the IRB include at least one person primarily concerned with the welfare of the research subjects. Otherwise, consultation should take place when appropriate. Another suggestion was that handicapped children be added to the list of examples of vulnerable subjects for which an IRB that regularly reviews research might want to consider inclusion of one or more members who are knowledgeable about and experienced in working with these subjects. Some commenters objected to the lack of consistency among Federal agencies and cited the Department of Education's proposed departure as inconsistent with the plurpose of the common rule. One commenter indicated that the departure would not pose any problem. Response The language of the proposed departure was rooted in the Secretery's concern that the welfare of research subjects who are handicapped children or mentally dusabled persoins be adequately protected because of the diminished capacity of such persons to protect thcir own interests and their corresponding greater potential for harm. It should be noted that, while the common rule does. in general, protect the interests of vulnerable populations. it does not specifically command representation of their interests in all cases. For example. the common rule only requires that'when an IRB regularly reviews research involving vulnerable subjects. consideration should be given to including on the IRB a researcher experienced in working with such subjects. Thus, the Department believes it is appropriate to offer special protection for handicappe& children and mentally disabled p6raons, and the protection proposed in the departure would have satisfied that need. The comments also appear to misunderstand the intent of the Department's proposed departure. Some commienters believed that the deDarture would require that an IRB include a permanent member to represent the special populations covered by the departure. Others appeared to believe that the departure would apply to all research of the institution that involved the special populations covered by the departure. The proposed deDarture would have produced neither of these results. Instead, the proposed departure would have required the addition of one member on an ad hoc basis only when the research is sponsored or funded by the Department of Education and purposefully requires the inclusion of handicapped children or mentally disabled persons. As explained above, the Secretary believes that there is a special need to protect handicapped children and mentally disablad persons. However. given the broad policy objective of providing consistent treatment through common regulations, the Secretary has representation requirements containe6 in the proposed departure are not necessary for most of the programs of the Department. because most programs of the Department do not support research likely to involve those Demons. Thus, the Secretary has decided'to withdraw the departure. However, the Secretary believes that the concerns addressed by the proposed departure have a particular urgency in those programs of the Department that support a significant amount of research involving handicapped ch-Ildren and mentally disabled persons. Therefore, the Secretary is amending the regulations for the programs of the National Institute on Disability and Rehabill'ation Research (34 CFR parts 350 and'3'56) to ensure that the protections that would have been afforded under the departure are implemented in those specific programs. Although the Secretary has decided to publish this regulation in final form. due to the strong pu blic interest created by the proposed departure, and because a number of commenters appeared to misunderstand the effect of the proposed rule. the Secretary has also decided to offer the public an additional opportunity to comment on the final rule. The address to which commenters should send their comments and the date by which those comments must 00 received is stated at the beginning of this preamble. Changes In the notice of proposed rulemaking, the proposed departure was stated as folloi-va: "When an IRB reviews research that deals with handicapped children or mentally disabled Dersons, the IRB must include at least one person primarily concerned with the welfare of the research subjects." The Secretary has decided to change this language in the program-specific regulations adopted in this document to make clear that the regulation specifically protects handicapped children and mentally disabled persons when those persons' are purposefully included in a research protocol. rather than incidentally. Therefore, the language has been changed to state: "When an IRB reviews research that purposefully requires inclusion of handicapped children or mentally disabled persons in the research sample, the IRB must include at least one person primarily concerned with the welfare of the Yesearch subjects." Approved For Release 2000/08/08 : CIA-RDP96-00789ROO3300220001 -1