Approved ~or Release 2000/08/08 CIA-RDP96-00788 ROO 1500140006-6 HUMAN USE REQUIREMENTS 1. Use of human subjects a. The following definitions are used: (1) At risk means that the human subject may be exposed to the possibility of harm r. physical, biological, psychological, sociological, or other as a consequence of an act or omission that goes beyond the application of those established and accepted methods or procedures which are in his best interests, or that increases ordinary risks of daily life, occupation or field of service. (2) Human Subject means any human being who, knowingly or unknowingly, is subjected to an act or omission, whether at task or not, the object of which is to contribute to knowledge to'be gaine,d as a part of work to be performied under the scope of this con,tract. b. The contractoy, before undertaking to perform any study involving human subjects, whether at risk or not, shall insure that the following minimum conditions are complied with- (1) The proposed s1--udy has been reviewed and approved by a committee meeting the requirements set forth in Chapter 46 of Title 45 of the Code of Federal Regulations.. (2) The number of human subjects used will be kept to the minimum number that will reasonably achieve the required results. (3) The study must be such as to contribute significantly to scientific knowledge and have reasonable prospects of yielding important results essential to an Army research program. (4) The study will be conducted only by persons possessing the requisite scientific qualifications. ~ The highest degree of skill and care will be required during all. stages of study of persons who conduct-or assist in the study. (5) The Subject will be informed that at any time during the course of his participation 'he'has the right to revoke his consent and withdraw from participation v;ithout prejudice to himself. (6) Participation by subjects will be immediately terminated if it subsequently appears that the risk to the subjects is significantly greater than anticipated at the time review and approval was granted. (7) There shall be no greater intrusi6n into the privacy of the human subject than is absolutely necessary for the conduct of the study involved. Except for the submission of reports and other Approved For Release 2000/08/08 : CIA-RDP96-00788 ROO 1500140006-6 " 1- MAI, Approved For Release 2000108/08 : CIA-RDP96-00788 ROO 1500140006-6 data required by this contract, any information obtained about human subjects as a result of participation shall be held as confidential as the law allow. (8) The study will be conducted so as to avoid all unnecessary physical or mental suffering or injury. (9) No study will be conducted if there is any inherent reason to believe that death or disabling injury is likely to occur. Sufficient animal or labo'ratory experiments, or other e~ialuations,' must have been completed to give.assurance of acceptable risks prior to the use of human subjects. - (10) The degree of risk to be taken will never exceed that which is justified by. the benefit to the subject and/or the' humanitarian importance of the knowledge to be gained. (11) A physician will. be responsible for the medical care of subjects. Even if not the project leader, the physician will have authority to terminate the study at any time that lie believes death, injury or harm is likely to result. (12) 11roper preparations will be made, and adequate [acilities provided to protect the subject against all foreseeable possibilities if injury, disability or death. This- includes but is not limited to hospitalization and medical treatment as may be required. In addition, all apparatus a~.d instruments necessary to deal with likely emergency situations will be available. (13) Human subjects will have no physical or mental. conditions which will make participation more hazardous for them than it would be for normal healthy persons, unless such' condition is a necessary prerequis-ite for the particular study involved. In any such case, the use of human subjects with such pre-existing conditions must have been specifically described and justified in the scope 'of the work to be performed under this contract. (14) The scientifically. qualified person conducting the study, and each member of his research team, will be prepared to terminate the' subject's participation at any stage if he has reasoir to believe, in the exercise of the good faith, superior -;kill, and careful judgment required of him, that continuation is likely to result in injury, disability, or death to the human subject. C. The contractor, before permitting any person to participate as a hum-an subject, whether at risk or not, shall irISUre that the following minimum conditions are complied with: (1) Legally effective informed consent will be obtained by adequate and appropriate *methods in accordance with the provisions of this clause. Approved For Release 2000/08/08 : CIA-RDP96-00788 ROO 1500140006-6 2 -Appiroved For Release 2000/08/08 : CIA-RDP96-00788 ROO 1500140006-6 (2) All consent must be voluntary. It must be the knowing consent of the individual o~(.- his legally authorized representative, so situated as to 'be able to exercise free power of choice without there having been any use of force, fraud, deceit, duress, constraint, coercion, or lawful or improper inducement. The elements of information necessary to such consent include: (i) A fair explana-tion of the procedures to be followed, and Lheir purposes, including identification of any procedures which are e x pe r imen t & 1 . (ii) A description of any attendant discomforts or risks reasonably to be anticipated. (iii) A description of any benefits reasonably to be anticipated. (iv) A disclosure of any appropriate alternative procedures that might be advantageous to the subject. (v) An offer to answer any questions concerning the procedure. (vi) An instruction that the subject is free to revoke his consent and to discontinue participation at any time without prejudice to himself. d. Exculpatory language through which the subject is made to waive, or appea-z to waive, any of his legal rights, including any release from liability for negligence, is prohibited. e. Prior consent by a subject or his legally authorized representative shall be obtained in all cases. Such consent shall be in writing whenever it is reasonably possible to do so. The'consent form may be read to the subject or his legally authorized representative, but in any event he or' his legally authorized representative must be given adequate opportunity to read it and to ask questions they might have. This- consent form should then be signed by the Subject or his legally authorized representative and by, a witness not directly involved in the study. Oral consent may be used only when it has been specifically described and justified in the scope of the Work to be performed under this contract or approved in writing by *the contracting officer. When so authorized and used, oral consent is subject to all the same standards as apply to written consent, except that the signature of the subject or his legally authorized representative is not required. f. Prior to conduct of the study, the contractor shall submit for approval to the contracting officer's representative a detailed description of the means by which informed consent will be Approved For Release 2000/0.8/08 : CIA-RDP96-00788 ROO 1500140006-6 7 Approved For Release 2000108/08 : CIA-RDP96-00788 ROO 1500140006-6 obtained, to include any forms to be used. Upon completion of the study, the contractor will submit to the contracting officer's representative a detailed report demonstrating compliance with paragraph (c), to include copies of the written consent if such was obtained. 9. The contractor shall not undertake to conduct: either the clinical pharmacology or. clinical trails of an investigational drug unless this contract cont~3'ins the clause entitled "Clinical Study 6f Investigational. Drugs." h. Prisoners of war will not be used under any circumstances. 2. DoD Directive 5240..1-R governing experimentation on human subjects will be followed by the contactor. Informed consent of all subjects will be obtained in writing in accordance with the guidelines issued by the Department of Health, Education and Welfare. All persons participating as human subjects, as defined in paragraph 6.1 above shall be known to possess the abilities and qualities which will be observed and analyzed during the conduct of this contract. or- Approved For Release 2000/08/08 :, CIA-RD096-00788RO01 500140006-6 4 Approved For Release 2000/08/08 Cl.~k-RDP9q.-OO788 ROO 1500140006-6 PROCEDURE 13. EXPERIMENTATION ON HU14AN SUBJECTS FOR INTELLIGENCE PURPOSES A. APPLICABILITY This procedure applies to experimentation on human'sub- jects if such experimentatton is conducted by or on behalf of a DoD intelligence component. This procedure does not apply to experimentation on animal subjects. B. EXPLANATION OF UNDEFINED TERMS 1. ExRt~~iinentation in this context means any research or testing activity involving hixnan subjects that may expose such subjects to the possibility of permanent or temporary injury (including physical or psychological damage and damage to the reputation of.such persons) beyond the risks of injury to which such subjects are ordinarily exposed in their daily lives. 2. Experimentation is conducted on behalf of a DoD intelligence component if it is conducted under contract to that component or to another DoD component for the benefit of the intelligence component or at the request of such a com- ponent regardless of the existence of a contractual rela- tionship. Approved For Release 2000/08/08 : CygqW96-00788 ROO 1500140006-6 2- Approved For Release 2000/08/08 CIA-RDP96-00788RO(11500140006-6 3. Human sub-ects in this context includes any person whether or not such person is. a United States person. C. PROCEDURES 1. Experimentation on human subjects conducted by or on behalf of a DoD intelligence component may be undertaken only with the informed consent. of the! subject, and in accordance with guidelines Issued by, the Department of Health and Human Services, setting out conditions that safeguard the welfare of such subjects. 2. DoD intelligence components may not engage in or contract for experimentation on himnan subjects without appro- val of the Secretary or Deputy Secretary of Defense, or the Secretary or Under Secretary of a Military Department, as appropriate. [Requests for such approval submitted by Army intelligence components will be addressed through command channels to HQDA (DAMI-CIC), WASH DC 20310.] Approved For Release 2000/08/08 : ~WRQP96-00788 ROO 1500140006-6