Al5proved For Release 2001/03/07 CIA-RDP96-00788ROO1500160010-9 CODE OF FEDERAL REGULATIONS 7,'TLE 45 PUBLIC WELFAAE it -n PA8T 416 -PROT E C'TION OF HUMAN SUBJECTS REVISE,,:) AS ()F Wnl_%tj 8, 1983 Approved For Release 2001/03/07 : CIA-RDP96-00788ROO1500160010-9 %proved For Release 2001103107 CIA-RDP96-00788RO01 500160010-9 45 CFR 46 ,4 46@-PROTECTN.ON OF HUMAN SUBJECT3 Subpart A-Basic IRIS Pt4j4,y 1t;,r- Protection of Hurnmu Rt.-.@tmrch Sillbjects 101 To *hat do their, (cpz@f o, s ljj@pj@ 102 1) 10.1 A slur inces. 4 f) i Q4 Section ie%erve,l 4o 1 ()@@ Scown rc,;ervcJ. -;ti I 0(i irction rc,,ervcj 46 107 IRE Mclni@cr,,hip. -1 1 0A IF13 luncitom and klotuhuln, 104 IRO review Ill rescarii, I It) E%Pcdilcd revirw prlxrjuers im Certain kind, at rcse.irch irty'alvilIg "(1 mOtc than Minimal ra%k, ard tor min%bv allpru%ed II I Cracria. f,)t IRB apptvv,,@ 14 fru:,ach. ;0 1J@ RCVICW kh@ 1niJlJUt,t)Ij 13 susvcn@1011 Of W1111"I'l Ion ol IRIN 'Appoval of re"Clill'ti, Ck-Avri.tuve lRb locords. Gr-wirtAi tequirefittll" 10: cvnNt! fiC 1 ? Docutrient4tort of COnWit 16 Applicati,)II@ ilij J011ttle pl,to% lor tif @Iufl:jll iutljCCL@ 4co I I q Rescirch undcriAltra w;@Nota i@c .r,CJ,tn 'If 4fk@k)tVkfig hutil"11 %k,jj@CL, t% E"Alwalkon and di%posowal of 4t) I.,0 applWalloni And Plovoials- @1@ 1.11 lavemigallonal new drtg lit dekt,:C 30-tW, d0j) reltutrrmeni. 40 121 Uic of federal tunds At, 123 Fatly ternmination of sc,,rat4h fult'jill? rvaluallort 01 'wb,;C-ql.,CnT And J)VOP13SAII. ,t, iN Conditions. @`lubpart 8-Additional Prritectiotiv Pvrtaining to Research, )),:vtlopment, and Rclai,,@d Actitilits ItIvolving Fcaosrs, llrvgnant Wonien, and Iluman in Vitro f'ertilizatioit 4r, Appitclihility, 7()l 4f) pugpo@e .102 46 Definitions .10) 4@,,Ethical Advisory @04 Board%, 4q@ AlAditlklnid dUtIC!, -@IUSOf the Rcuiciolo Boards in 4;tifincown lith ii. ton human in vtir,l fc(liblAt,toitt, 'it) tql r Wild ImIllationt 46, 10,; difetic, Inward Prf'rn'Ant %Vonlvr@ Is 40 108 Xomil.:4 directed friules In ultro , %U(I@Ccl% 46 ;!(N k';""It '; d1re"rd fVtuSC`1 CK uvro, im@luillng nonytame 1ctu%qr.I, a, subjcrl@, 46 .,to k@ljilllj:; involving the dead fe(u, (CIAI T,J!Mal. or the plawenia, 4i@ rVi-t,iining tot Biolnediep) anj arch Iny0ving Rrhatiotal Rese. P6,oncri as v oubjects SCC 116 Nit A &.30., 46, 303 C,rt 46 AN wi.,pos.4lon Il4%,%VJ% 11cie p@isoncs% ate itmilvo, 4 h 11, 5 Allilnoaal dalpes of the In'lklullon'd KI:Vicl %-,11cre p(oonrf% 'tte 0ed invoiling Subv, Protections for Ilivoly(A ILI, SubJecia in RciegIC11 4t-.C) I I wilai thf,,C rcgt4lulionj, I%pllly7 46.40 Z p, riviiii,N11t 46,403 1 K 1) (Ili Iles, ri- involving steater thAn 411 @Wll 8.0!-@Mch Involving gre,,iter thAll ullwXa3i v1A r1kripco-1 Of lk:111,11t let the Imlividual suhjcas. 4-104 Involving greater than MnI1111111 11@@ dijkl no prIlipeei twor,61 1,) indmdual subjecta, but likely to Yivlk! llnowleid@.c about silo., ilubj." ,J:('$ Y or condition. 46.407 Re.-xvis,t-il no( tittlerwiW which Lill opporlunily 11) undervAnd, prevelit, or slle@. title a -wriolim ft(,Ibl@!nt alfr%-.king the h4mlih or welfare of chl@dvcyl. 46.4GS VIcL1tjglcIrw@ Is for pCnli@,&IoFj by IWC SH cr guAl4utill And for wkwnt by chtldto@. 4-h 409 Authority: U S C 101, %ci 174(a). MR Siht@ 1@2 !A2 C -SubPArt A-13asic 1111S Policy for PT01"118111 of flumun Research -Subjects S@rlzc: 46 f7P, I JA6, j&nuary 26, 1911, 43 FR 9269, 110atcl, 4, 198j. 046-101 To Whail do these rexulations apply? I 00 Lxcept as wovided in paragraph (b) of Ili, section. this %Ubp'll't applies 10 211 research ifivOlving hurnan subjects conducted by 'Ile I)CWtIrIC"t Of Health and Ifurnan Services or funded in whole or in part by a Departynen, grant, contract, cooperative agreement or fellowship, (1) This inclLAcs research conducted t)y Department employees, CAcept Cach Principal ()Perating Cornpcment head may adopt such nonSuktantive, procedural 'nodificMions as MAY ble'apprupriste f'.-orn art adininktrative standpoint. (2) It also includes research coriductcd or funded by the Dcpartincrit of Health 'and fluman Services outside the United States. t3tlt '" aPPrt)Pfi:ltc circull'slances. the Sccrelary may. Under Paragraph (C) of this section %waive (he applicability of '-'ne or all of the requiiements of these regulations for research of this type. (b) Research activities in whicl, be Only involvettlent of human subjects will be in one or more of the fol lowi rig lategories are exemipt fr()M' this'e"iegula ., tions upless the research i:, covffed by other subparts of this part, 1) Research conducted in esiablished or commonly accepted cdacat.ional settings, involving noilrial educational practices, such as (1) research oil regular and sp:Cial educ-ation instructional strategies, or (it) re"arch om the effectiveness of or the comparison afriong in-itruction.4 IctAiniques, curricula. or classroorn mamigement Picitlixis. (2) Research involving ihc use of educational Icsti (cognitive, dui@@ ,nw;tic. apfiwdc, achievernent), if Approved For Release 2001/03107 CIA-RDP96-00788ROO1500160010-9 A01b"ed For Release 2001/03107 CIA-RDP96-00788 ROO 1500160010-9 Page SOWCo.s laturmation taken from 111cs'. ii e4vvirded in such a friarille:;, I sUbjects cannot be idelillfi,@d. direcox or through identifiers lij,,ke,j (() [Ile @-Ibjccfs. (3) Research invoiving sttr%ey or Wlef'vlew procedures. except where -ill of Iiw folitwing conditions cjj: ii) responses are recorded in sw:h @j li,anner that the hunian subjects cjn Ile Acivified, directly (it tbroti@h ic@'coullrrs linked to the sub I jectN ilik, ,UhjVct'S response", if th'.-Y bo.jrne ktiown outside th- i-esearch, c,,tokl reasonably place thc subju-CI '11 I 114 Of "in' Wil or civil liability or be C!.j@llaglrlg to the subject's finaricial st;lnding or employability, ,irid (iii) ,h.,- rescarch deals with sensitive 3@pv.cts of the subject *s, own behavior, ,,j,h 3s illegal conduct. drug use, ."Ittial behavior, or uFe of alcohol, A .11 re, ,earch involving wrvvy or rj@occdklrcs Is cxelllpt, A, hout exception. when IN w"Oolidents are Clecied or @4:vowled polific offi,:ials or candida(ei for 1111111@k: olfice@ 4@ Kcsearcll lnvolvilw dw (inclading o'i, DWI @ '111M) ip,ints) of public heh@k% or , where all of the folloM1111 CONJIllons exisl: 6) observiltion" irk@ ick,@,ded in -suo:h t nijimcr that dic ,uhjocis can be identirle(t, 16ii.-C(I or throuy,,h identilwr., lo&:ti to !')e mb ,jects, 111) (he obser%anons ubout thc individL1111, it' thev known outside the rewl4r,h. olu of ,dfly place the sub"10cl JI ri,,k if @-iln-jinal or ci% if lwhih,@ (:r fwc Ing to the S11h)CCI *N hn 1114:_41 s(XiJuile or eniplt)yahiliry, anu uil) th@, xwarOi deals @kith serisiti%e ot ihe SLAbject's oNkrit beh, vior 'al conduct. Jrug UNC. @!S Ill,q. Iwha@ior. or use of ulcohol. t@) Rc@,:@Jrch ino,olvine the k011"CliOll or sililly of ex)NIin" dat:1. Z11 0@1,@okflieats, rccord%, pathological or diagnoitic spccinwiis, it Iour,:cs are publicly ayadthlc Iq it Mformition is recorkl,M lt@ III,- 111\eNtigalor ill %Uch a 1111.0111cr lh..11 "Uh trfwt be idctillitW@j, Lj,!CCIj, siv,-ijin@v_ :,IW4.'J1j:ajjY teqUlfed by I'Litute, (Pmd MTN it) the extent pal-73graph ki) Mleftf L"ll proicvt wi,ch Cotiductf@;j ttN @ or so)jecj to the approval ()I* h,,, 'Ir,, pat tirient oi* 11califli saci iiijir,in seri,,, af,(j Which All-C. to StakfV, cvalux'," 'll WiSC exattline: (i) PrOVA31"W, uTio,"Ir the So3cial ScCuTily ACt, -jr (4lWr 1@vHic benvjit or sv"vi" (ii) 1)rocc-durt,% for obtaxiiiii, b,@alA'its or service!; under JhoW Pjrl-jtjjjjjjS; (iii) posSitile ehangtS it, Or to) those programi ar tir 6%) possible chL%ngy@; 4j, or levels ()f pa@lrleill f6v hic'-'efils or s4rr% iics '1wJvr Orl,@v prof,,,rains. @ c I 11, c ,, @, rc @ I I N, h a s I*i na I @!Ilihoril,e lo th-lermlile whelhei a parti"I'11,11' at, 111"ItV is coveteu I)v these rt: v 11 1;111k (di Thi 111-1@ ri@ijvlirc thal I;Pe 'Ifw icw. 1lics w :1asseI, ot rescalk:1) 1:001LILICII'd or 'LAIIJ(d t-,,k @he DeparlIMIM, bt,( liit olhvrookz omply 4ith "olnc ol @111 )I 01""Ie krI Th,: ill.ty if, I .(I Waive 01(@sv L!1!uIauon% to @pccillc &@Aiviiies or 0@isses Of r,.Lwxj@h otherv@lse L:,)% ci k@d 1- r -,@Wjiions Notice.; I) iwbl P'hcd In AN IN-V OCCL)r. t fl No mdi du.0 W-iv r@.*Cel@e I l't for reseiifkh @:(Y',Oyvd t'. lep@ulatiorls wife"'; Oil, Inlit,, !dti.d Ix J1`1_)IiUt0d With OV @,po,)wreo r-, in institution which I'm thc undr- al @;.Sjrlncc imi Jyinv ih@- r@:t1mr,w,-or.% if if);,, Virl, .)r the @Id!%IdLja@ luak, ." ,,her i1r.111pellicrit'. oWn VIL, ti"ptim,,ent. [hex lederal, N Or lok.A %,I rcvifl@@Iion" N Each stIbPa" of these feg-ollarions coniainq A Separate to what the subpart IVOW", Research which is COvered by niore thdri one liuhP:;ri Shall COMIPly with all applicable subpatts, 6) If fuflowinF, review of rOPO", p ed research activities that are exempt frorn tl`!@',C fe9tilations uridcr paragraph (b)(6), the Stxrctary delermine-s t1j,11 a riescarch or dernewillatinn project presents a d,injer to the Physical, Fricnial, or clMliOnal wF,,l1.b,_-ing of a Participant (If Rubi!ct ()( th(! rescacch or demoivaration project, then federal fund% nMY not tw- experided for such a Projoit wilholli the written, infOrtn0' consent of cach participant or Subject, Deffijjt,i@f)ns. (J) "SeCret;iry " nicans [lie @etrei:ti) of Heahl, and Jjujj)3n Service@, arid any other officer or cinvloyce of the Ppartment of fleilth Kimavi Servives to whorn jitthowy ha,, been delegaiefi@ I-0 "Depirtment - or -Hif S nicasi@ the Denaoci,@nt 01' Ifeid(h Arid Ilunrin iervice!i. itl "NstaAtiorl, . ineans any public or entity kh ug(,ncy (including feLictal, state. and wher ugencies), W) -Ugally autholized roprescPtative'' ni,,ias an individual or'itidicial or othcr nody atitherized illider *Plicatile )1c.-i to conient on heludt (it :1 prw;pectivc sub)cct to fit,! mlhject'@ parli,:ip@iiion in thc prm, C dill ... (S) il'YON"d in the rewarch. (e) "RetrearA - itnearis a sysicilialic designed to develop or contribuit: to gcricralizabli: knowledec, Acrivioci which ineet this definition constitute "reseirch" for puipo-,cs of' thz-sc regulitions, whe(her or not aicy 3re supporled or 1tjadLJ tinder a progtarn which is cunv,wcred rescarth for other purpo,cs. Vor cxample. some -&P-ionsiration" and -service" propyrzvns amy inclAdc research Approved For Release 2001/03107 : CIA-RDP96-00788ROO1500160010-9 r:fgt 6 A715-P~FO-V'ad-F6TIMezse~-20'OttO3tO7 :,CtA-RDP,96-00-7-&SRGO-1-6004UD-U4--- 45 CVR 1(0 "Human iubject',' U, It 'A Afa,irances. unp:A consult"'ll. Changes nicam if in lkB ving inJividual about (a), Fach in titation rociriber%hip shall %1knin in crigage4l in be reported to the b , rvs,:.ti,.Ii tN) rcgulatlon,,@St:-erclary, I (wheiher PrOfessional of st@dirno conducting researchO)AI prk-itic -Arilten (4) Wri,tcn procedures obwiw; as%tifance which the 1) data through intervention )r (11:kl it IRB will follow 6) for SeCtet'll) conducting its Ifi-CructiOn With tll(e 'Aill @:t'wllrk I-CLluircim-nisinitial ind continuing i4di% IdUil, or @ 2) wt review of ii.!emifiable inforin@ti;oif,fotih io t'- se wgulations I C re"ClIrch and for reporting its findings "Intervention Y includeb.i h i TI DePart Men( atid actiorks to 1he lbolh if colkducif oc investigator and the physical procedure,-@ tund fel,_,.ircli @:ovctedinsmution-, iiii) for hN which @jia irer by the-;C determining which J!Jilicref.) (for exampic,icgtiiatiot,,@ ordv )f pzoptcis require review veniptincllirc@ the insittimon has more often irat Inan i Pula Lions an assitraitce tpptoved than annually and which of' the @,J)JC-C( or as providcd in projects tit(.- sUbject's envirorimi.-ni:(his only if' khe instirtitionneed verification from hat ar, sourccl Othe- Pert .ormed for researchhis cooiftcd I , ihe than file itivesugitors St-crmaY that the that no materijl ofmcractioll", includes resi!ai,ti has @ecn n:vlcv,,-d-Jianges havc occurred ind since Preytoois Coninlunication or interperhonjiapprosc@kl h@v .)!I jRB 1101 review; (iii) for provided for 111 insuring prompt f:ol@uwt between o1VC%tlgit0f(he atid will hu, ,ubjectreporting to file IKH alld to of' propoked isuhj@,,ct. '.*Privati: review by (he M, This Jlangvs ill a rcsi:-Arch infermation" activity, and for I61,Juiles infornwion 3"Ur.:MCC shall at a iw,,iring that clianges about beNvior mininwin inchide: in approved Iha[ occurs in it con(ext(D A stJ[eIll,:rII of research. durin; the ill which aii principles period for which iodividual can rcasonablyLoveiviiig the institutionIRR jpprov;il ha,@ already vtpect Jim in ilie been given. tio observation or recordingI! L@;L@ (it Irv ce spoilminjy not hr initiated is tAin'- hi I i tics (i Ir wi(hout 1119 plice, and information @)WIO.'IIIW IfiC I'MICS ieview and appioval %killch fias 1111.1 WellaFe @.)f except wherd bet-n pr(.wided l'or hwmm hu`iircts of' resear(Lilnecessary to claninate !qwcific purpose% kAMIIJWL'tt@d apparent t", all Indif,ldual and At Of 1,kI,4lWrCLf 1-,y ininicoiate hAzards vtihicl; tile tile llv@ntwufllk, to the subject. and @Cdtvldu-il cill rea"oflaI11%(it, WUICC of ((md@ng, ov) for iiisuria@t prompt cxpek.( %kkil Tlil@ reporting to i-lot lie made pubilic ll)LhIk-'0 .11-1 'Apy)[01ITIMethi: IRB aod it) the (fklf C'_Illlpic, a CXlhfing Secretary I of @M:11 L:jt ccord). PrMiti:,:o0c, tit iaratwn, or Ill' nfi,:ipited problerns inf@)riv@mkm sufivirwnz of involving jivi-,i hL- individualk :JJlJCJ! jrqI;I,,.@JpJC%.it) stittjecis or others, IdeminAbIc or a sio(i,incut identify ill' the mmjectM th,: institou@,o (c) 'rhc iissurance 0, 4 shall be executed I I e. ,(he I nla@ fV,JJAv he ascortilneJI'lliN f"M Pleellipt 1.)y ;ill individvill h% OIL. authorized to act for :11 @ Q@4XOT ot JNSociatcdpro% t'_-VU1,ttJ0I1% Inc 111stitutluri iind v, m thc cc) assurric on wiorminow in ori.Jor for %Jizzainini! of tlw@ it),,Iltutiori the i@@ Ewt apph"O"Ic to obii.g,;mon% unposed -'ay by these iw,ol% Ing hunian w excmpl Jj,,td ani@ shall be filed in such 10 "Millimal risk" Ih;II'61 lol Iorm and mannt-r- as I 1, the Secretary ii@,ks ol harm anticip:ited4 one or more p.-escribe, in i1he ed tese.if0i are n,it in :wcol,dallcc iififh Of The SCcrefaly will f!ro@oer, evaluate all cow,idering probabdity Ow @il Ail-, stifp@irt, a5surariccs stibirnitfed m.1 and in accordance than those ili&narily @ot .%i%@k@k @lre ma(h: with Wese regulations for through such Oil@:Ol.lfltercd in Jaily@Utficwfl( ouff to officeri and empioyces fil,C of (;llrini, tit,- of the iwil,orniancc of rowine ph:,,,ical ,U))LkOj@ I6,@- @vylcw Depatirnent and sucli tuld experts or examinattow, or lests. f;ow-ulzarlI5 :ngiized for this purpose (h) -CCqif1c2tIOn1" nlc;tl@s"t, 11,14 Ili @1-c IRB is the Secrriarv d Ih,: Illenibers determines to be ii I d notification iffeniilj,@d name. earnedappropriate. 'rhe Secretary's by the izisfitution Jog rec . IqdIL'Jti(,ns of evaluatiorl.will ILAc @,@ aic Dicpartniccit into in accorkarice stih ilic requircracrits of o, ho!ird con%ldcration thc adequacy thi% par. umi @i of the r,-search pr;iject or ccjlhi.:-@iioris, lic,,,wws,propoied IRB in figlit acrivi-y ;MviAt ing erc of the lr,,roan subjects has 1,titllCl,@[Jf t 'L J"I'CrIbeanticipiled scopc of been rvviewi-d CJCh the institution's aoml @.,pprckvcd by the !J Contrihwwns to IRB k,cscark@n activities Institutionai and the types of krvics& Board ORD) in loN, :ifill ;iny empio@wcni,utjtcl populilioms accordinct: or likely to be % iih the approved assuranott @,Clwterl elch ori I tic at IMS. (Certification is III;-Inhrl ml,i Ili.- Relloffs %@,nJIJ tie requircd Y@h,,-n lrlslitufloll@ for filed wittli the Offict "hc fesearch is funded exalnpll@: ull-lillie for Ptimei.ilurk from hy C:nplofce, parl- Research Risks. NatiomIlil I)q-ariment and not othcrwise l-,olules of Hcalin. txcrripi I"110 t%"@ If( l!"llernlITDev4nmeni of licalih It ;Aild tit accordince with urtiqn Scrvwcs, Rethe%da, 46 klarylaf)d 101 (IN)) . panci or flom,l, St"I 20205 UIOILIC-, J)JlJ Or Approved For Release 2001103107 : CIA-RDP96-00788ROO1500160010-9 Approved For Release 2001103107 CIA-RDP96-00788RO01 500160010-9 4S ("'Fit 46 Page 7 itivolved, the 3ppropriatcncsi of lhe pftI()L;%ed illlti3l and continuing fe@lcw pfoccdures in light of the probable ri-As, and the silo 'wd ccmplexity of the insthtut4ofl. (e) On tile of this evalualwrl, i, - ScI:rctiry may app@-ove (it JI'lapprove the assurance, or cmer to;@o ncgotiations to dt@,velop an dl)prw@ahlc one. Tlic Sccr@-ijr)@ rna@ I i!nkii dir period ditring %hich ;lily approved assurolwo 'of Ckti, o" apploved assurances Q-@all fewall) citectivc or otherwise :ondinon I; wsliicl arpfoval. W; ',Vithin 60 days aficr tile. d.itc .4 s,tilinni%slon to HHS of 311 al"Pik%xi2l)n or Proposal. an ifl%titutlon % ith jil ippro-,ed a%surance coverii-%,%z thi: ,)ioposcd rcticarch shall cc-lay thal ,it,- application or proposal li@,,s been 1@*%Idwcd arid approved hY hv 14H. ("Jlcr ill%litutiolls sliall t:CT111), lli.li the application or proposal !)a.,, ;,,Cco bv the 11W withl.) I0 il! let 'C':eTt oi MJ) it I'll icallon lrorll the, t:l .Ck-flificinon is not stibri it -d @%IOIIII Ifics,@ linit: 111111o@, d"'.. .1rillic.looli Or PrOVosai ru.i, bl., I,1;UMCJ (I) the insiaution. .'(?@ @ 104 1 Re:@Vrvecj .16.105 ReservtA 46. 106 Rewir-t td '46. J1 07 IRU Inealtmr.,hip. I ; I I F. ac h111,13 sh-411 hatz It leist 6%c. "le"IticrS, wilt) I,,Irvins! to Pronli'le corlp@,@Ie a n d I -Vlekv of I-, a,-! moli k'011,1110,11Y conducwd hy tht; ,:I,,IrIft:11011. T@e IRB ShA b,z @,J: I i c; e:,lily qualified thrwi,-, t and CXpettlat Of its and the divcrsity of the uk: -@@btzrs, b3c.Lgrouni% intludipe of the mciA Nzn-d Cil-tiral 'backgrounds of rr-@m@-@ers JiiJ I ) @uch issues lis I :;,1T]UAJ1V alluades, to l1rOMOIC ,L,3;,CCl fO; Its Advice mid Cewlsel III ,:I!CI!.)arJing the rights and o vlfme 01' "Uhiccis, In 3ddition to Pos,'-vNirv thr Professioll:11 t@0111 n%:vciat-N. 14) r(lVi4W @Pcc tic ( -Scitich activill N. the MH Shall lvc :&I, to jscilia@n tile Prop"Ised fest-@Ilch in Tcfnl@l ol '11--ttlutional commitinerits alld applicatlic Ind sLmdillis ill" ProfesNional o.)rid,,kci and praviscz. 'llie. 114B lihall thIcrefore Inclk,Ac knowledteawe in ihesc It ill IRB rcgi0;ldY ft.N i,L .',* 1741VXCh lkat itill-olves a covvicLI bl,' cu'lc., subptrls of !he WIft s;W1 Ylcludc one or inoz indl,"I'lijis viill are prinalfily 4:MILVIWJ v-tib the velfare of dic-se h@j C, " t,;. 01) r" I ti@. 0 @YAY consjA cI)tITI,:l,i Of men or troir.-h or enlitcly of ffici-O'Cel ol C,;lz profcs'iioil@ (0 VIM @dlail Int:l(ldc At lvj.@l One MCIIA,Nj %ilosc prinl@lr`v ('011k,k1ris W @krc in nreas, foi It the 0111 1: V-h N' "J"Wil 11101K.-C. JC ]CJ!lo, or@(- is not affOl.tteJ %4-Ith 04C instilutioll alld Wht'; i,, not 1) irl of fl-le (ITInw-JIi1c fallilly ot :% whk) I-, ;11111kmed %,oLh tile w N@) 0,Ji may have a member p II) tile 11"13 'S Initi'Ji t.Ir C'MilkIM:t@, ;C% 11"V of AU@ I)IOIC(A !11 %hich 'k,. . @ticwocv h@i3 a conflicting )rovtdc hv thc IR15. k i", ifivitc k h rctlil".. I) I., ri v, I,@, c A@ .0 1_1@ %otl, @;,Ilh the N Except when in expedited mvisw pmccdure is used (see 46. 110). review proposed research at Co"Velled unrctings at which a majoriLy of the rnemtIers of the IRB ari, present, inctilding at least one nicinbcr whose primary concerns are in nonscientific areas, in order foi the 7c@eaitvh to I)c approved, it sliall t@%(:ive tht approval of a majority of those inernbcirs present at the filer. tifl@!. (k:) fie responsible for reporlirig to ole appropriate illslitutional (.)fri4:iaJj anct I)v Secretary I any serious or Conlinuing noncompliallec by ifives(igaturs with the requirements 30-d deterfinirlations of tile IRB. V;It01Oll% at"Ild In 010 1,@, fl@'11 ill IN. 's. 1 ol@ th:@- :27100@ Z@.t,.h IRD "11:111: ptl)@t,led !I 4f" 46. 119 JRB review orresearch. (a) An HZIB shall review and have _@jtho.6(y tit approve, require, roldificutiont in (to sectire approval), ig (Jit,lf vc all re%carch activities ppf 0 covereJ by these regultions. An 11,11 ihall rcqt;ire t1lal givto to tubjuts as pitirt' ot informed con5cilt is i c rd nc a ;JC 0 3 C with k@ 46.116, T@c JR111 may require Otiat ir ifonn@itiun, in add:tion to that Npccifically Mentioned in § 46.116, be to tile subjects when in the 111h*s Ju,ignient the information would ineaningfully add to the ;IitI1I:ci'Wn tit' the rights and welfare of sklhjvcl@. it-) An IRB shill require do'curn'-wation of informed consent or Inay W.,live llocuricritation in 1d) A.-i IRB siliall notify invcsligator@ anJ the institution in i 4 its decision it) approve or di,,,iriprovi: t1u. prolvscd research ot cf modifications required to IRH approval of the f---Jrcl' ;,,Ctivity- if tile IRU decides (0 @,hilil include m-itl; writien notification Oould lw tOW wmh ihc Officc 109 @'O 'C';km Uora itf..'CATCh NatIOTIA11 hi@wutci of I'leprimcni HcAth Hwua,) Scr@ ices, fletheidi, SNrylind Approved For Release 2001/03/07 CIA-RDP96-00788ROO1500160010-9 Aoo@@Zox-@Iease-2 QjA@-@QF96.00788 ROO 1500160010.9 45 CFR 46 O_M/0.3107 it stair-mcnt of the re3saw t"W it" de@ipi,pn *n'd give the invc5ul;4tor ;m opponunity to respond in person or M %4riting. (c) An IRB shall ccmdui.1 coal@nwins rcvicw of rcscar.@h cov@!red hy these regulations at ist-.r@'.ds @lpjlropriatc to the degree of rls@, but my. lesf. than once per yemur, aad ,hali hxic amhority to observe or hwet t tntid party obscrvc the cimssent tlitwass and the msearch. Profloi,lk -hich have been appowed (5) Infomed c,,mscs@ will be ujitler ptoccdtirc. Up Y u lrj. i n (d) 111C SCCICIATY may restrict, ptomiliel -dl@' 6'@" accordance wio,. and to ihe extent %nswrid. ttr teimmate an itmotljimn's required by § 46.117. or MY% uw of the expeditefi Fevic%v (6) %Vherc aPPI'Offfialc, tile resc3rch pioctkjwL vow-n nece."ary to protect Plan r1kilkes adc(lualc provision for tile )r wrllj@. of Subject'i. monitoring tile data Collected to insure the "fety o( gub*ts. §46.11 ?, Crilerin for HIM (7) Where appropriate, twe an approval 4 rrsearch. Adequate provisicms to protext the 0) In o0l@:r @,o appro@,: -.--st-aich Privacy of 1,Ubjects'and to maintain .1- -A - --.- .. ... @ .1- ff)Ul the confidentiality of dats. sliall &w-monc mat all ot' the %up -liciv 3ontc or iss or mc p6.11() Expedited revit,w aw %aw,fik-& subjecis are likely io be vulnerable to f:r-@Kcdurts for certain kinds of to "ut'jVVIS atf coercion (it undue influence, such as rcstearch involving no more than @'j U pcrsons with acute or severe physical minintal risk d f . ' U ROG4151004610191069Persons who ate ,' e 200143107 ' '? APHr(WimisfoUrd" ko H'p P 13, L Im gT,-m c t. Z`Vsctlfcb- dcsign and which do not lically (if cducafiovally ."0 The Secretary has esmMished, vaneces, di.-iadvantaged, spVolDriate additional, 45 CFk 46 'A-Opmedf-of-ReteasG-M-V-G3dO7.,: -C 1A:!-RQF!1a6@-P07 88 ROO 1500160010-9 Fare (4 all At 47 46.114 C(wperative ri.-szarCh, C90peragive research projects, .@re [ho Se projects, nonitally suppoiied through grants, contracts, or @siniil,vr w-rangemcnts. which involk,c tristifulions in addition it) t1w @rawce Of prune contrictor isuch its a 4:onl.ractor with the gfilliec, or A ,,"I%owractor Wigh the Prime oontractor). III Such instances, flic grantec or prime contractor remaili, tt:Nporisible to the Departmzzit for @.iileguurding the rights and Aclf;lr@ k3l 1wriwo subjects. Also, when cooperating institutioms cordtict soine Of 311 oI the research involyiiig sorric oi all of these subjects. each "00perating Institution shilli comply wizh the%c rcgulations its ihou@,h it rc@civcd funds for its participation in the project directly fron) Out lit that in ._--omp Dvilartmont, exce lying %@Ith these regulations in,-titutions M.i@ Use joint irview, reharcc 11poll 1:1V lcview of --inother quakfied IR11, W IMlilaf 317'rallgerneno, aimed at AVOlklarice of dupilcallon of effort. op 46. 115 IRB rn'Orils. ii) Ali insittutR311, or whefe apl,ropriate an IRB, shall pr:parc and 111.11111,1in a6e4uaxe docurnentation of I-W.11 activities, it 1cludifle, (tie lollowiny'.. I @ Copies of all rcsearch pfoposak i@ ved, scientific evaluations, if anv, that accompany the proposals, ilfffovi:J sample consent documents, prk)@.ress reports submitted by MV acid report@ of injuries 1 21) Minuies of IRD rcwctin:@s which .11:0 bc in sufficient dcwil it', ,hwx -11 the rnectings. 3@:Iions takcri by the IRB; the vote ort (ticst: 102011@s including (lie number of n.t.111hers @oting for. against. and the basis tor requrAng Jb@laining; cjl@.Ingci in or disapproving rc@,ear@:h, ,jili it Aritten summary of the ,I,N,:u%@ion of controverted is,%aes and the@ r Icsolution. (_i) Records of continuirte nvlew Ifics, (4) C-i)le, correliondetice bckvecl? ilit, UP11 and t5e rs (5) A lkt ccquir,,u h@ to 1!(;.1(1))(A) (6) J)1-0ccdurc% for tile A% tc+111"d by § 40. ('71 of siioltw@int new findiiij-, 11t,)Nidt!d to lq required by 46 116(b)(3). fee0rds rcquirud by this rcglflalktl@ 11;111 hc retaillrd fii`1 @11 1,13S( 3 YCkFS A-Lei' "(JMJJJCJi()(J Jf Ilie rewaich, and the rc,:ords shall @x- tm- 1jis" I ving Pection allo Coll, . h) alstholtiicd reple'sentitive% of the Dcliartroem at rr@tsonable times ;Ind in a rcz@.sctnable mannet, for Inforinvii ciMseAC, Excelit as provided elsewhere this or other suhparts, no investigaror 111,1N M.,olve a huniart N-ing iiii a SLIhje@_,I I'll WSC1.101i Covewd by 111csi, CU@!AIIM10111@ flic iJ1VCi;6Fatot has ob@ainud rtic lCgilly effective biformcd consent ol ilic sub ,icc t or the subject's legally authorized Aii inve%upttir %hall seek such coriNciii voly urKicr C1rcU111A;W.C,.S that jnoOdr 111C P1"0SP(!L'U-.- &jcct or the :,u!1w1cm vpI_,oriuniiy to COW,idcc kldlclh@.t or not to p-Articipalc axid that nimintize the possibiliq ot Cocivioll Or Uni'lic ifilluelic". 11c information thot is gi%en to :he. subicct of the represeld 1((V(@ @hall be in, lany'Ung ge to 0c @ubjc represcri@at:vc. Nt.) )-rilormed cowerij. Wheliltr @@F:fl Or @Ilitlell. mily inoludc any citculpmoly litnguage through Which the subject or (fie . . i% nwde to wilnr or aPPeitr ti- %@iovr Ans' of tile %ulticict's (eval ri@'tjj-L ot telt-itsQs or appear-, it) release the 'ryestigator, the ilic insim:mj() Or I'S drellis 11011) li"0111ty 1')f r,'Plipence. @31 of InfornAcd Coasel'.t. F@%:cpt ;I:, Vrovided in 01 "if thIS S,:,.1101k, ill secking Inforvied conwnt the following inforniation shall he Pyovid,:d to each subject: '1.@ (1) A %I31cmClIt that the study involve@ research. art explanation of fhe PWPOscs of the research and the 0 !@xpcctvd doran(in of the subjtct,q a %lescOption uf the. 4procedures to bc, 1,0110%ved. and identification of any piocc:durc, Which Are experimental. (2) A description of any re3sonably foteSeeable discomforts to the r subject, 1 (3) A dc-@cripfion of any benefits to the @u'bjcct or to others which may reasonably be expected from the @raseat(.h, (4) A disclosure of appropriate, Wternahvi: procedures or C()Urscl a .f ticatincrit, f any, that might be 3fivarciageous (o ,ht Su1JCC(.. (5) A Staterntal describing the evc-ni, if arty, to which tit tl:@Curds identifyitig the %uhiect will be maintained; ,6) 1,cr research invoNing more than rnirirnal ri-,k, an explanation as to whether any compensation and an D A c@p,:Anatioli M to Whether any midical treatment,, are available if injury occurs and, if so, what they consist of, or Wilgre furillef in!'orm;otion may be obtaincd. (7) An explan-Ation of whom to contact for ari%wers to pcni@lcnt (Jutstions iboul thc research and rcscarch subjects' rights. and whom it) contact in the event of a research- rcktcd injury to the subject. and M A !i(atertient that participration is voluntary, refusal to participate will irivolve no penally or loss of benefits Iu which the subject is otherwise entitled, aad the subjrct may i Jdiscontinue participation at arty time without penally or Jos$ of benefits to J,whic)i the %ublecl is otherwise entitled. 1(h) Additionat.;lements of 44011TICd 'Clonsent. When appropriatc, one Or 11113re Of the following elements of in;ormatiori shall alsk) be provided ill f!1_',Ch StibJeCt: Approved For Release 2001103/07 : CIA-RDP96-00788ROO1500160010-9 10 -90788ROO1500160010-9 45 CFR 9 C]A- ~ RD R O3W 2WV @Wrev@ Re4ease- .--. - - - - . - (1) A statesnent that the which iik%-4 wait ot adequate opportunity po-ticular all of die to ricid it before cregment oT procedure may elerments of igiformed it is signed-, or involve Coosent stt @i%lk@ to the subject Wr forth nticlvjr, or waive(2) A "shun forla- "I" to thir crikii-yo the tcfr fetus, if the subjectrcl1uir;!mGrts io ohullincon@ent document stating is or ma) informed tit&, the ;'.1-fecorric pregitzint) conse@-t pikivtdcd the elements of inforrned which arc curTenth, IRB finds and consent JV@:Unnrflm Chac 1@, [Ifore seeable: required by 146,116 have been - (2) Anticipated c-ircunkstaticcs1) Vir 1 exarch involve%presented orally to the no more subject or the C-Ildev which the subject'sthatl nwirtimal 11si SUbject's legally authorized to the -,uh 'jects, r.irlicipaiion may be tevininatcd(21) 111C wal,es or alictitiOnrepresentative. VAen by Will this mcthod is used. there shall be cic investigilitor wi0out riot -adycl-Sely affeci & wiuwss to the rl!gard "o the tile tight.,. wid @suhjec(,s consent. WC11317C ill (hc subitcts.Oral Prescritatiorl. Also. the IRD shall 1 (3) Any additionAl costs(3) 'Fit,.- @.-xzirvh approve a written summary To the could not of whsl is 0W illay resuit froill bc ()U( wahoti( tile to he said to (he Subject or the ouci-pation in the Tcsca%.h@W"i@el 01 and rePresentVive. Only the short f(xm j (4) The comcquenccs oi appropliwi:', thc it,,elf Is to be signed a by the Nubject or Suh)VCCS deciSioll to Wifildrawsubl"ts bc provided withthe representative, However, I'lool the @ akWitiviiiii peitirient witness shall sign both @ihe research and priveduresinformation after the shon form for i".0rderly (el-mination Patticipatien 101d 3 cOPY Of thr vflmmuy. of parlicipation and the @h@, the subject, (e) T'lie aiforined consentperson actwilly ofouitining consent I in thCSC NF@UlAti(IfIS shall sk!o a copy (if IS) A statenirrit thm sigitificalt;irrr the summary. A now findings developed no, inttndt:@ to Pirpt-Millcolly c4the surinnary during tile ally shall be given to coiirsc of the research appilLal'A". fcdctifl, tt@c subject or Ill.- whic.h may stale, or Jocal laws representative, in rclme to the subjr.-i't's 9.41itch jc@qvirc ?dditi(Jindladdition to 3 copy of willingnt:sN to illf0ftnation the -short :. @ to N., it) ordcr foT fUrn) ' ' 1.ontirluc p.Atticipao infouned .on will hV. it) (it,- 5ubjc,:I@ arlul ('010,L'Of L't) Ilk J0.V.3JJY(4:) An IRB may Wsive 0,f`(CCTiVV. the (Ik Ihc approximate ClurilhC(in thc-@e r(,-v ol, ulations is ii-quirettlent for tile investigator to .-IJUbjects Involved ill illIelldell 14) hill ol-4ain @i signed consent thc S1116y. I tilt allihOrily 01 (onn foc some a i c @ An IRB A144 applllvz: a C0421111CAIL 111'sit:_111 or all subjects if it finds either, pmceAu-113 "f d1c. or ..Ire, Iii tile Ckterl, 1) That the only recoird Ile linking the I @,lihject ind the research let would be the _d nsntt se r LoMN't do@@urncrit and ( he principal C';--h A-e,)V, or Wai"C risA would bc potential the harm resulting @o tiblain inforilled %:onsent44.117 LDN-omentation fiarn a breech of confidentiality. pio@id,:j of Each r@x iRB finds and ducumnits V th-j: ,hiect wilt be askcd WhCther the (1) Tle rnicarch or dcal'orlsilqtt .@S provided in sill!'ject wants documenlasion "a ion linking project Is to be .@otiducxcdPilralj;;ph lk:) of [Illsthe SUbJCC1 With 1hC by, ()r sectif"n, rCSC3rCh. atid the !-UbJ-@!Clt IC) the approvalirkG'kif4D1:d COWCIIJ su@jccl's wiihes will of stite or Si`)all Ile goveril: or I, wal govct-nincia offictilsloctow-111cd h) tile (2) That the Fcwarch C@@ tlw of 't written presents no altoac, or cowwri( I'mil approved 6rS16llV,J 10 Study, cv@ by the IR B morc than niini wal risk of harm to sobjecti and involves no procedures ol"Ierwise exarnipc: (1) :111 . U for which written consent pro.,@ ra ills d sili'lle tile @ubjcct is normally or dl@! Wider the Social Sec-ur' @olthorlzcd re(juired outside of' ity or .1 the research ocaer public beriefli Of rep i e @@e i w I.ive CLIPICXI@ scrVict A L:opy shill )@e 1-.ivCn1n caqes where the documentation !lrogf&tivs; (ii) procedur,,s10 tile 1!,!rson %i.,,ning1 @of Ole form. cincrit is %i)ivcd reoii , Me 1118 may ot)(Aining ktiefits or (h) require the invesir 'gator @ezvioe% u:iL!_,r .1 _&% prk)vijcd in to provide programs; (iii) possiuc pataprz:111h (i:) 4,@' subjec's with a wr men thZS %ectik)ll, dhe staLcment ;it or alternatives to COWXSti. iorm ivtaN tie fvfl:'Tdill@ tilt: rc:;i:arch. tho, eittler, k)t ttlc or pr(wedurcs, or (iv) posh.IlAc 0@jjigc.@ in methods or ro@tn COVISLA11 dol.,umcill46.118 Apphcations and 1cvifl.-, (if paymcut for bLilefits or that 01C Clernerm, of scrViLe.-% UildCr pr,)pasals lackdog, dellnile plans for lilose programs; and kilormed I-cliscra Irquired11M)lvement of human hv subjects. kD The cestairch cottid 46. 116, 1 forlik may Ccrtain typei of applicatiotis riolt he r@@oAd tip for practicably '-,e CarTicd tile stibl"cl (.I LLC out ,@mhouj the suhjcct's leg grallits, cmlprrative gaily agrevinirnis, or , I waii,cr or alteration, !i:prt wnfttlvc, but corltracts are Submitted 11) :11)y to the Gl) An IRB may approve 1 vent, lise w-,cligatorDepartment with tile a con"m shail t@ivk, knowledtiz that 11rocedurt which docs ilotcithel tile Alhieci or whjcI:t!i ritay be jlvolvc@l iaOud,t, or Ine ritpiewiliative wi(Ilin tile Approved For Release 2001103107 : CIA-RDP96-00788ROO1500160010-9 Approved For Release 2001/03/07 : CIA-RDP96-00788ROO1500160010-9 45 CYR 46 Page I pcriod of funding, but definite plans woold not normally be set forth in ifie application ot proposal. The!ic mclude activities stich as insmutional ants (including bltx@ grants) iype gr. kh-here @-.Iec(ion of specific proicrt% is ill, institution's responsibi lily; rV@:C,JrCh training grants wl@erv the layolving subjects remain to lo: sciectcd. and projects ir vdiich i, ,@Lllllin Subjects' involveincrit will 60pend upon completion of' lil!'Yruillents, Priur animal suldles, kit 1-ttrifit:jiion of cornpotinds. Thcsv J;)p!lCallolls Ileed not be rc,viewcd by ar. IRB lwforc all award may he However, oxcept for research de@.@ribcd in 4 46, 101 (b), no humarl s0b)CCIS Inny be involvej in any project supported by these aw3rds tintil (he project has tic-Cri reviewed 3o@l apl@joved by the. IRB. a@- 1)ro%ided ic O'c@e anti cert,fic'moll ,A@v)iitcd it) tile Departriwili., § .101. 119 Research undertaken " lthlout the intention of iwvolviog hufliall x4li-ijects. In dw Ctocat rcscalch (,,:orJtsiAed oi 111C @Oholit tile intcll@1011 Of in@,Avi;ii! human subjeos, but it is Loci- pi0posed to use hurrian @uhji.-cts M ow fewarch, tile reseat-A shdl firsi INt: re@ iewcd and approved by .in IIN'11, X. pi_%idcJ in these reg guljtio@t%, 1 ,,J!r"ili@ation @,uhnittted to the .111d 1HU approvIll @,IIVCJI t,, me propwxd change by ih@@ 4ti.120 Evaluation as)d w-'spo"'ition of applicalioll% aild Pt,)POSals. 1@:@ Vw S,:@.rc-iary will ci@ikfi;.te A and propo@als invoi%lfle @UMCCIS suhntith:d to [lie J through such officer,, alld eli,lpioveci, of tile Deparmient an,] "i-:l CAperts and consuitanis is tile S,Mclariif determines to he JJJJS eVaiUJ1l0n 'Alit [:Ike ai@o co n%ide ration (tic eisks to the the Jde(4113CY of PTOtecit',)n al'illist ilie-se ri%ks, tile poiensiai txm:kk %A the proposed re"Catch to tht NUI)JtCli and 411"ItfS, ADd thC impot:iwkx A)( ihe knowledge to b,: 83inCO'. (h) On 11kc hasis of 1his evaluatioll. the sc@,Irclafy lmq approve (it disapprok,c the ipplication or propwiA. or cniet into negotiationi. to develop .111 ;Arlrlfov;ihl,- oile. # 46.1.11 Mvestigational new drilig - ar devi(re NIAay delay .r -quir .ement. When au is recluircd (o vieparv Ail- to swwna a certit'ication With all applicalion or propo'.11 lillkl(!, the-se and tile allpilc;itioil or propcs..'d involve% an investiyational new drug (within the ineining of 21 U.S.C@ 3550) or 357(j)) or a significant risk device (as defined 11 2 1 Cl`,R.@ 12,300), the iwititnums @hall idimill'y the tivue or devicc 111 'tic, The ills"itution `k@1311 @Jso' State "heiher c@c 30-dav lk.,itlifej j'or n s I, 31-1. lial .1,1A (kit, ilpillficant r1sk kl,,-V iccs I L'I It :112.30 has ClJJ)Sk:d J:o(@,J alld i-au-st 11' tile. io J,ly @iltk@ "N.d explic,' 'Ale llrillwtioll S11JI, (at.: whinhe: t'le, I (kod :Ind D,@Jg 1@11kdtninislr,ioon has rckluo%ted that tht- vowmuc 1%) withhold oi "Cstrik:l tile ll',C Oi tile drug 1), @lcvice 11 hunian It' the 30 Lty lnror%ai Ila% ')t@l and @l %Naiver has 'lot b4,c-1 cvcknVcd, thc inoff"Itioll shatl Nerld 'l "i'Itc1liela to Ille DCpaltillclit :,11, .@l @!.@pmlliojl of Ilic lnter@ al Ple Ocp trrlm@flt will not 011111 lhl.@ ia,@Ofulioi@ 11;i,@ suhrliatcd I "ta"'Mellt lhal the 10 d,tN. Mter," Ahas %@13PW-d. Xl,i ktl,@ FO;,d 311d Drug d 11@ i@IIIMVIAIIM, La, r1of lequeswd it to hOW tho u@:-- of ',tl(- Ww,,, or J!.,vice, or illat the FoM @10 Dill" Adritim'(1- mon 11,I) m_li@ Ca (tic -1i I day 40 - I Z 1 t llfflkl'@ Ill D'*P@Wflh,lli in;i\ r!i.l tic 'XPNWl1d hir ulllc@,, Ot" M,I h C, t: r,7.gul-aiion3, inclucting all subparts o( llicse regulations, have bccn aatisfied. § 46,12.3 Early termination of reseurch fundinIt, evaluation or SuMe4iuent @itpplicafions and Proposals. (a) The SccretEiry Mity require that Depliornew funding for any project be terminated or suspended in the inamier prescribed in applicable piogram requirentents, when the itecretarv finds an institution has maierially tailed to comply with the tettn% ot these rz-J!Ula(iOflS, N In inaking decisions 3bout funding applications or Proposals covered by these regulations the SCCrCt3fy MY Like intO account. ill addifiori it) all other eligibility requircinerlt@ and prograrn criteria, factor% itich is wheilicr tile appliczInt h;o; hc'ell "Ubject to a terillination or %u@pcn%imi under xita-mph (a) of this scOtion and wheiht:r Elie applicant or the Person Who %yould dir,-ct Elie scientific ind technical 3spects of ;jn haN irk the judgment of tile Secretary niaterOlly failed to jl%ch@lrge resv ionsdsihiy for tile ilroteclioll t)f itir rights and w0fare I)f hilinan subjec's. (Wilether or ilm Depnitnient fu@ids were involved). 46-114 Conditions. With respoct to any research PFUlect or any clas.@ of reirarch projccl@, itic Secretary may irripose udditional conditions prior to or at MC tivic of fusidine when in tile Secretary's judgtrient additional Condition'; are flecesSary for the Prolectioll of hulliall subjCC18, Niihp,irl 11----Additional Prutections vrt, . -iining ill Resrarch W%elopment, and Related Activifles Iniolving Femes. Pri!Vaant Women, and llum3n lil; Vitro Fertilizatinn, ki @ 40 1-k MZ8 kk1g, 14, 111"1. 43 Fk 41 J R 3. IlOX -46.201 .1 ptflic "Ibi lily. fill ;hO l1_'.VLJLl0Cn, in mo subill;Irt W11 A1T;,k%dflc !o Al Dep@jrtr@u-rlr iC Approved For Release 2001/03/07 : CIA-RDP96-00788ROO1500160010-9 .-..-'--1-,.!-:K - "t, 'Y, , v. T).1 11 "1 EM Approved For Release 2001/03/07 : CIA-RDP96-00788ROO1500160010-9 P@ge 12 ir;ms and contra@:t sunl.)rring re&earch. development, ind related activitic, involving: ( 0 felus. i ,iregnani wornen. and (31 huinan in iii.,yo frriplization. (b) Nothing in this subpart Oiall hC Construed as indicmi.ig that COMPhance with the procedures "Cl forth hercin will in ,,iny rendcr irw;lplicable pertinent Stme or Io--at I,iw,, bearing upon activitics co%cn.@d h@ this subpart, (c) 'The requirements (if this subpart are in addition to C.locc, imposed under the other :;uhoart% t,i' this part, 46.202 Purpose. 1( is thc purpose of' this suhpirt w o@ovidc additional safegu.ird% ill ;-eviewing activities to Which tills @;uhpan is applicable to aksure illat ilicy conforin to jppropni@,te edticai tuli-l'irds ana relate it) important ,ocletal needs 46.203 Nrinitions. As u-,cd in this SLbpart ta) ' 'St-CFC13ry nicans t @ i;: S,@,@.vetjry of Health, and %Velf;m@ 3nJ ;iny other officci ot (:1110loyee of the Depannicrit of llealth, Education,,and Wvltaye to whorn audiority has been @Izh:gatcd. (h) "PI-Cgriancy- Cricoll-imsses thc ,period of time from Confirmation of implantation (through any of the pret;umptive signs (if pregr.,Ancy, such a:, rrlis@.ed mcrises, or by a medically a.,cepsable pregnancy I so r , until cxpukiori or extraction of ille fews (c) "I'Mus nlearis tile projuct oI conception frorn the tinie cJ iniplantation (as CVidellCCL! by ally Of dw presuniptive signs of picenancy. %ue,h as mi%sed nienscs, or i IncJ11cally U,@ceptahlv pregrialicy tcstl@ m -I a dewmiination is made. al 1...)Howing explu%ion or exwtction of 111C IOUs. that it is viable. (,Ji -ViAble- as it pertains to fhe fe-tis rricaits being able, after either sp miaricou.% or induced delivei-y. to sw,vivc (given the bcnct*it ofavailabic rr,cdik:-jl ilricrapy) to the poirit of 11AC,ricildcritly Tylaintairwig 45 CFR 4,1r beat tnkl ru%pnition Tk- Srcretary TI)ay Jg1r,),J1 (111,,C jt@ lln)e. ID10 acc-tilint medi'al ad%am:rs, rublish ill hc Ffm:Rm, It ccw@iL@;t guidehijvs it) ill &@tcrinining Micther a CCUI% 4'%, , ahk for purposes of th:s iubpirt. if it fctus is ,61)!c after delivcry. it is a preniaturr mlant, (C) :N,)uv1j!1Ic tetu%- nic3ns a t*% t,;eri? vilich, Atilough living, is not: vwlk- 0) -Dcad tcws- sicans a fetus ex Uler') whiA C 01hits neil;wr hcal@bt-;11. ;pcinalleotis @cspiralory Ji'liviiv, @pomjocous movcniew of volkinsu iY muscles. nor pol-alittil of 3 S the urnbifiQal cord (if still attached). (g) -Iii var(t means any Irrtilwitiog tit huffian OVA Which UCCW oukidc thc b(xlv of a ferriale, ciiher through idinixtu .re ot donor hurnan % ,pcou @tnd t ,a or by any ottier 1`1103W.. 04 J MJ-Hictl Adylsw,y* lloar,;13. @ (al C'nc or 1-nur-.- U':hicai okdyukory Boards sh@,11 6t, rstablishl7d by (lie I of thcsv boardc;) shali t@,e so 8clect,-d tl,,at t,@c @,oaxdis) @401 bc Voll)pCt'-al to deal "ith viecli@af. sok.,Wj, ethical, afid rcla(vd is@,Ucs and may im-!ude, for @:Xarllplc, %Ncarch scirmisis, physic4ans, Is%Y-4kologists, SMA010)NAS, 1.!dLCjiors, tuwyers, and ethici%ts, i@s wc;f as of tilt! et-ne(Al public, No board wernbcir nmy twe a rrgii1jr, full,tifric cniployce of' tho ;.@op,@ririicnt of Health, Eklu%,m mi, 'ind Wvilarv. (h) At ill. leclu,nA of' tile sccretaly, @hc FClica! Advisory Board rendei id% itv coaskicni with tile vid ict1mrcments tit' this I)arl ah (o efll@%-al i%@ucs, Involvine. vovvicd b@ this SUtr,JJ:Jl-l, riti.,ed h%, mdividuM ;Ipplicatil0ils Or proposals In iddition, upon request by thi: Secrctjr- ,v, ilic Itoard shill render a." to of applicatiow, or tl@oposals and iMier;il P,flickcs, L'IJI'lellorns, aild plocedures. (c) A Boxj iGal% 4-%whlisls, with the apl,fov:d of :!ic S,@crria(y, t-Lis%es (1) Must be suhmitted to tile Board, or (2) need not be Atibinitted to the Board. Wilcre the Board so establishes a claNs of applications of proposals which musi be submittcd. no apimication or proposal within the class rilay be funded by the Department or any component thereof until the application or proposal has been reviewed by the Board and the IloarJ has rrinticred advice as to its acceptability from an ethic3l standpoint. '(d) No application or proposal involving buynan in vitro fertilization mRy he funded by the Department or any component thereof until the application or proposal has been reviewed by the Ethical Advisory Boafd and the Board has rendered advice as to) its acceptability froak an ethical standpoint. 46.2105 Ad4KWa*J dutk@& at t& tw IrLstltuthiuW 14i4- Wkerds in connectilia with activities inviadvivg fetuses, pregnant wonlen, or humun in vitro fertilitatiou, (a) In addition to the rrspon-,ibil i tics prescribed for Icistitutional Review Boards under Subpart A of this part. the applicant 's or offeror's Board shall, with respect to activities covered by this subpan, carry out the following additional duties; 1) Determine that all ij@spects of file activity meet the requirements of tills @;Ilbpjw (2) E)elerfnine that adequate considi.-ration has been given to the manner in which potential subjects will be selected, and adequate provision has been roade by the applicant or offeror for monitoring the actual inforined con%rat process (e,g- through such mechanisais. when approprike, as p3rilicipation by the Inswutional Review Board or subjrcl adV(Waics in., (i) Overseeing the iciual procc!is by which individual com.en:s required by this sut@part are -xcu-ed cither by approving induc-ion of each 111J'VJjJk1;, I I I I r4l() file. @tCtivily or Approved For Release 2001/03/07 : CIA-RDP96-00788ROO1500160010-9 .H e.Lqase 2001103107 : CIA-RDP96-00788ROO1500160010-9 Part 13 %,orifyini% Pcrhaps through 53113pling, I'-.at i,pproved pr(weduircs for i7lduction of individuals. im,) @Iie w@tivit-v are bcing follu%cd, and (iii manitocing the Progress of thc .icirvily and intervening is :jecessarv 1h,rouYll such stcps as visits Io the a@i@v iv site and continuing, :7valualion I . it) kietertnine if any unanticiputed risks have ariscri), (3) C3rry out such other rcsiloosibilities as may be ilss4licki hV tbe Sccretary. (b) No award may be issved urltil the applicant or offeror has ccri,fird to Lite Secretary that the Institutional Rcvtcw Bo3rd has made the drterminations required und;rr p:ir;,graph (a) o( this section and the Secroary has approved these cleivirminations, as provided iii § .16.120 of Subpart A of this part. (c) Applicants or offerers sacking Slipport I .or activitic- covered hy Mis subpJ11 Must PrO,.ide for tile des, gridtion of an lns(itution@a Rct ie,.v Ho 1 rj. @.Ohjcct to approvai by (tic @cc-ciary, where no such Board has bee", under -Sulipart A of fill., Park. 46.:06 General hlnItAt1;).4Ii, @ j INO activity to which this Athpart is applicable may bt C11,1crtaken unless. t@ Appropriate studieN on ,oimais Ed nonpregnant individuals ha,-: hcen Completed. (2) FACept %XhCrt; the rtlipo,o of il@e activity is to meet the fic;tith ncc,!, of the rnother or the p,triicular tct--,, (he ris), to the fems is wininial an't in all Cises, is the lezi,t po%.@lhlc frisk for achieving the oilijectivey, of icliNliY. i Individuals cngagcd in the activ i@ %%ill hakc no part in, 6) Any as to [lie finfling. rrwihod. an,,, procedures uNcd m terminate the pre-riancy. and 60 dvetinining (tie :11111)' OfIthe (rios at the. ivfconaiion of the Pircgriancy; And (Ai No pr(wedural changes which MA'v c:tu!@c grcater than minintal vis@@ % io 011,@ fctus or the pregnant wo"I'm ,A.11 lie intrixtuced into (he procdulC lor h,* Pleb-nano, ill thr vit@-rrq ()t@ the ;,,:tivi th) !14) 111'JuCCIT, W.-M. Monetarv Or k1kt'.CVWist:, may 'IV of(Cred to 1crillinale . MIC, Iur V)Ilrjlosc@, tit tile % " e 4. 4@3 f-k Njt,.jV, N,,. (,. 46.20 ActiNtifies direvted toward III CV.W%AI1( %Y(Men As subjCCIS. (ai No prrt@m;A( wornan may bc involved ji a vabje(-( in an activity @Overcd h@l 1 his -uhparf unic H The vurro@c of On activity is to rnk.-CI the heilth riceds of the inother and the fetui will lie placed at risk only to the minimurn -xiem necessary to rnect wch needs, or (2) the risk to the fetus tlN MMIMid. N All wcivitv pCirmi(tej tigider jmragraph W of this section may tic condu,@u -d k,r,.Iv if Ole mothcr and lialler a1c le@.Aly Compftent alid ila@c givon jbi:ir tvilougned consent alicr ftlllN mlotnwd fr,@,gwdw@ ,loisible on tile fefu%, CAC1';-)I (hAt the k1ther's inforined cim"ims 11c(:kj nor lIc. wCured it: 0) '111e. purpose of ,@Ie 'wovii: 'V is to lilect thc hcal(h neccis of thi@ Mother; (2) his Identity or %"hvicallouls Callnot bt- xt:ertaincd; (3) he is no( veiiNoiiah!@ or 14) tile Pl"91"11" 'ClIkilfed Iloill rape. 46-10N Actii itivs directed tolvard L",wiri fit uteru as 13) 'NO f1lay he to-voINCd i@ "overed ll@ . h I @ % 1,11C pulp")sr ol ih(- i;"tivity lo rylect tit%: 11-ea(,10 :'W`-'dN k f the VilirlicUlm felus 'Lond 01C fvw@ 1"'111 I.-W Illaced at rl@@k only it, Olf- c,'umiltuo, ckterit ne@:cs,.,&ry @) ' lllei@'I 01c"k. of 62) 01c, lisk to Ilic 1@y the rescart:1-i is, 1111I)IIIIA !nd Ow fmi-posc of' the of milion ;iai @1ii,!iiedi-M Lnowictivi.- kxhich Caml-I 1,C 11,4@itdicj by o-l"wr 111tJ51@. (l,)I An !@Cl'Tllflled Ulldel par;%glaph lill, nlav ht: ovi, :1 111(- 11lothcr :wd father are legally cornperen, and have given their informed consent, except thW the, father's consent need not be secuted if: (I) flis identity or realsonably be Jironatned, (2) he is not reasonably jailable, or (-3) lhi: pregnancy resultcd front rope. 146,209 Activitics d1rected towaid fefuw.@i ex utera, including nonviable fettj%es, as stjbjtcts. W Until it has been ascertained whether or not a fetus cx utcro is Viabic. a fetus ex utero may not be involved as a subjuct in an activity covered by this subtpart unless: (1) Them will be no added risk to the fctus resulting from the activity, and the purpose of the activity is the devc1opirrient of impartant biomedical knowledge which eartnut bc obtaincd hl., other means, or (2? Pit, purpose of the activity is to enhance the po.,,Sibilily of survival of thir purticular fews to the point of viability. (hi No non%,ia6l-. fetus may ti@c itividved it,., a %ubji-ct in zn activity ctivercd by this subpart unle-s,.: A, 1) Vital functions of [tic fetus will no( be alliticially illaintained. i2) EAperimcwa) Activities which of' dicinselves would terminate the healthrit or respiration of the fetus will nor b@- Cinploycd, alid 0) The pwposc of the activity ii the of importint hI0nICdlL1ll knowledge WhiCh Cannot he obtained by otat:r means. (0 Ill the cNent the fetus et utero Is found tu be viable, it ntay be Mcladed as a subject in tile activity only W the extent permitted by and in 1ccoidance with the requirements of other sithpairts of this pan. (;,I) An activity pcrmittcd under pata.vim)h (a) or (1)'i of this section lna-,@ bc collduct@d only if (he mother ;Arid tidicy are lk:gally comp'!tCat and have !@,jvun tht!ir inforriled consent, cx-pt Ill v Ili,: faili-ir's informed Con"criff I'lCed not be secured if: (1) his Iflenlily of Ahertabouts cannot rc.,."on-Afly be (I @') he is APProved For Release 200`1/03107 : C IA-RDP96-00788 ROO 1500160010-9 Approved For Release 2001/03/07 4 S C." F R, 46 all rrisoners,and immune from @rhWaiy,inicirvtntion by prison authwilms of Prisoners. Unics." the principal investigator provides to the 13,lard justification in writilli,@ for following softie odtr procedures, Coutrol subiccis, WaU be selecMd randomly (tom the group of fAV2ilable Pri toilers *ho Meet the Charactcristics accdcd for that particular rescareli projvcl, !J) The infonnation is prewivcLi in [Aq,uage which is understancLabic it) th@ Subject population; to') Adequate assurance exists tfi@it @ I , PA191 NU4,w . I P wo rescarch in making decisions ree.arding p@Arolc. and rach prisoner is cfcact.y irtionned in advance that Pw1w..Pation in die rescarch will h3vC !1,1 etlect on his or her paroic, and 01 VVhcre the Board finds there nia,Y tie a 11VCd for follow@up C,k 21n ilia twit ot curt: of PM1iLWJ11(S After ific Crid of their PartJ611:14ion. @ocqwae pri)@ision ha% been niiide tit su,@Ii exAmirtaison or care, taking inio ,!@"CLYJVZ the %arying 1,@ngths ot. mdooluaal on"oners, alid !or Inforilling panicipalt 'is of this fact, it)) lhe flo;trJ %hill,' Carry olit stv-fi of"Irf dlllie@ as 1"ay be assigned by 0"': S,:C@clafv@ -z,:@ The ins:twtion shall 4:crtlf@ to n such form and fnli@;,,"Y as thc secre(ary nlay ('471,11ill", (it ;! 01,! Jutics of the Board tinder this "O"UMI have b"en fulfilled. 46. NM PowmittC4 rfte 'a '-V11 invaiving pr[ioaors., -_ - (") Nlorncdi,@al or behavioral rv,,c.m,h voriducird or ;u@porlml lb,, may involvo prisoners :.is 4MAIY if; I it The ir-oitution responsibL! for @jie.,-oiducs of the research has to tile Secretary that the Review Board his @..pprtwed the tescarch under § 4 6. 305 of !i!1% Subpart; and In tho judgment of the C IA-RDP96-00788 ROO 1500160010-9 Paxe I Secirczary (ht- proposed rcsear@h itivoj%,e,i solely the following: (A) Study of flic possibIc c@ius@,%, effects, and pl@LKrsses of I11curccr-'Ition, and of criwinal N-havior, pr,,widcd that the study presents no 5nore than niiininial ri%k Alld no fl-101-e th3n inC0nVCDlCfWC 10 the suhj'VCL@; (B) stud@ of prlson@ as m%titlitional silvclurc% (- 4 prisoncrs as I,Trsolls, putVided that the stud@ p)rsrtits no mote klizirt ailnitnal .ri %L and io morr than inconvcnicoce to the subject@,@ (C) RM110) On ('01)(Mi0th particularl aticccing prisoners as class (for exanitfle, vaccine trials and other rciciirch of% Ilepatitis which is much 11101', plevaient in Prisclivi Ehall clscwhorc@, and lc@-@arch on social arld mobleni% such as alcoholislo, drll,x@ .1,Jdiction and wntial l-,.Sa1J1s1 providt"d that thc S"ody ln,1Y pro,,ccd wik aiiut thc ScL:rcuiYy tws consuked With appropriate c,,@peris lncludirl, e\J)Cf1S 111 MC-LfikAVe M$d 01`114:'@, 10d i1UhIt:,hCd il thi,' 1: @-Df kk@ R LWS@ LP, ol'his inte it (it ii,pwvc such ploowes, blith t if no@ ativc liiki :,ccvpted, %,whwh haye thc intent and rc@!sonablc pitob.ibility of w1provirto thr heahli or %Nefl- hein@l of the tit cascs in Which those @Autfi7*s rf@,quiirc the Js@fgitrllcllt 0; in a nwyw@n @'@)risislerjt wilh 1,)nvo@,ok approvcd by the. M11 to '-witt'd 1'roups Ahich kilay not it @'rmn ih@- ibc stully nw@, pro,,@t:d oni@ ahor ote %"Cir,ecat @.tl,is cowLAred woh aPpropri"tc @Xpvit. wCkAding k1XP(1r(%, in pci14)Igi;')e Aild ethic". mid pulift-Awd iit tit: v, i,i :@Ie R VWSIFR@ .,)J' At@, MWW it) approvC SU': h re:,c@irch (bi Ekccp@ _S rl@oviiktl )11 paiaqurh t,x) i.)f 01@1 NOTIU-Jic:)l c; rcseanh coliduciv," 01 1.0pp'.11i'd h@ [,'IHLkV ShAl 11of 11% Subject% @ Sub#*A D-A&Mfo&W Protoctiou hir CUM"!a INtailred as SAJOCU W Sourcc: 48 F9 "M Mirch 3, 1993 0 46.401 To what do theme rcgulsdoes apply? (a) 71hii SubpSn applim to all reseacch involving, cMdren a3 subj,-cts, conducted or sup1x)rt&d by the Department of Health arid tillwan ScrVices. (I) 'nils, includes research conducted by Department employem, exccpt that etch licad of all 01wrMling Divii,ition for flit Department rnsy adopt such - n n0nsubstl tive, procedural modifications w ruay be appropriate rrom an administrative stxrtdpaiut@ (2) It also includes rm-arch conducted or supporled by the DepArtment of Fie,@,dth and Human Servicci outside tLe Unitmi Stan, bin in appropriate circutrutances, the Secretary may, under paragraph (C) cf § 46. lot of Subpart A, waive the t aPplicah'tlity of @wrzte or all ofthe relillirrruenti of these regulations for rCs(*1WCh uf this type, (b) (2), (5) and (6) as listed in Subprt A at §46.101(b) arc applicable to this subpart. Exemption (4), rc@@,_,arch involving tile obscit'vation of public twhavior, liStCLI At § 46. 10 1(b), is applicable to thii %ubpjr1 where the investigator(s) does not participate in the activitin bcirig ob'wrved, Exemption (3), re-,earch involving survey or irilerview Proccitfures. listed at J §4( .101(b)does not apply to research covered by this sutpan. (C.) 111c. cxCieptions, additions, And Proviiions for wetiver as they appew- in paragiriphs (c) through (i) of §46,101 of Subpart A arc applicable fx-) this sw-_)Part@ f,".432, Nfinitionit. The drfinifjon@ in § 46@ 102 of Sublitart P, shall be applicable to 11-iii subpart as well. In aldition, a@% used i-,) Otis suipart@ Approved For Release 2001/03/07 : CIA-RDP96-00788ROO1500160010-9 ase 200`1103107 : CIA-RDP96-00788ROOi5ooi6OOiO-9 4S CFR 4 (a) are lwrsons who 'll'ilvc not attained the legal age for C,oll@ent to treatmenu; or procedures invaived in the research, tinder tl@c applicable law of thejur'lsdiction in which the research will lie conducted, (b) "Asai;t" inew'.1i a affirai-auve agreement to Participate ill erwarch. Mere failure to object should not, absent affitraiative agrvement. be construed ,Ls assent, (C) -permiWon" inealls the -)arefit(s) or 9,%lardian u-) 3greenient of 1 file participation of' their hild or %k ard iri research. (d) "Parent" nicaus a child'i Itiological or adopti%t p-.irent. (C) "Guzadian"Mcans An individual who is authorizcd under 3pplicable state or local law to i-)asew on behalf of a child to 1,!,enerjl medical care. '144.403 JUB dutiel. In addition to other @i'iS1gllCJ 10 IRD-s under this p:m, IRD &hall review resz-ai-L:n c:.ivered 6Y thiS SUbP3(t a"'! @fll;'(OVC m0y fescarch which -imtst"@-S the of all applicable of this slibrart. § 46.404 Rt"Amh Kwt@ flav DIV i@lg gro.3ter thu minimal risk. 1111S will conduct 4ir fund research in which the IRB iinds that no greatcr thm awartial risL to children is prewnted. only iftlic I 1-t B finds that adcquale ptovisin't's @IC4: ni-We for soliciting the w"Wnt (if the cl;ddreri and the permisiion of their parents or Suardi;sns, as set forth in @oo& 406. U6.40S (tas mlohnal risk but presendiii the pr%pnt of dirvd bentilt to dz* entliVid" 141hJOC06 IIHS Nvill conduct or fund rc-@ev.fch in which the IRB linds that inore than minirnal risk to children is monotorlag proccdurc that is likely to coutribute to the subject's wcIl-6cing only if dw JR11 finds that. (!i) Thc ri%k a@i justit' 'cki by the antic:1111tcd 1:K'.T1Cflt to the lubjrCts. (it) '17,1,ic (ciation of the anticipated Niqc1h to the risk is tit Imst a% favofable to the subjects as that presenictl by available alterriative Approlicht.s., and tc) AJeLpiate provisions Rrc rnade for solic-lut'g, 01r. msent of file Jiildte)i and permimloa (if their r parcats or guairdifins, j-& set forill tit § 4t). CA. §46.40 Rmarch involving greater than miairmit risk ard tio prm;wt of dlitct N.-nefit 4 ifidividuid rijbJects, hUt fike:@J' It? Vi4,'Id RCflet*JlZQb1C knowledRe,41twit the subject's disorder vr conlitioll. 1111:@ @01 Conduct or fulld WSCat'Clk Ill wlixh tile IRIJ tinds thal more Efian minimal t-i,,k to cioildica k preselowd hy al" twervention Ur procedul" that doc.!, not hol,j t1ut ill,: PrUNPCC1 0(d1lVC( hCT'Cqt !'or d'C illdividual ';ijbjecf" or by it 111001i'.3111)"g jilo'--eJuic which 1% llot IL) ,)llpq.11c to 1111@ wvIl-being of tile oldy if tile N%' H finds thal: (n)The risk r@-prcsents a minor Allr- rea'SC 0%Cl' Illillignal risk. (b)Thc ivteivcntiou or procedure to Subject.s that Lire teasonably conimensusate with thos'e inlivrent In their aclual or expmleAl medi(%il, dullial, OlogicA, sociAl, ov educational tmych . @e) 'I li@@! iri-xrvention or pro<.Tdurc m likely to yield generalizable knowledge about tile Stlbj(..Vt'i' disorder or condition WhiLh is Of viial imixiouitce for tile understamiing of arrichoratioll of tile subjects, th!'ordCr of corldition; 3tid provisions § 46.407 Rev-sra not otherorbe approyable which pr"entj *a epWwturtlty to un(MrstatA preveal@ or allcviate it seirious probleve affectlAg the health or wtifare of childrels. TIHS will conduct or fund rescArch thAt the IRS don not believe mects the requirements of 46.404, 46.405, or 46.406 only if- (a) The IRD finds that the rcw=h Presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious p(oblern affecting the health or welfure of children; and (b) The Smretary. after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics. law) and following opportunity for public review and comment. hu dotcrinitled either: (1) Th4t the rc@,earch in fact satisfics the conditions of §§ 46.404, 46.405, or 46-40C. as applicable, of (2) the f'"110wir)9: (i) The re-.'-@Jrch PCe-sicilts a wasonable opportunity to further thc undervanding, prcvcrttion, or alleviation of a serious probicin :,t.'Tecling lite health or %yelfare of chi4tren; 60 1-ne rescarch will tw. conducted it, accordance with sound ethical ptincipics; (iii) Adequate'provisions are made foi @,oliciting the assent of children and tile permission of their parents or guardimis, as set forth in 146,408. J 44.441 RaqukezwU for pemAsaios by parents or juardianti and far assent by Cw1dren. (a) In addition the to determinations required under other applicable sections of this subpart, the IRD 1hall determine that adequate provisions ut made for soliciting the assent of the children, whtn ill the jud-gruent of the IRD the child;-en are'capAhle of providing assc!it- In delcimining whethcr children capibIc of avwnting, pi-niented by an intervention or In LKxdurc that holds out the 171 osJ'Wct of direct bellefit for tile iwiividual iubject, or by a (6) A&-441iaic are nutdr for soliciting aswilt bf the children and Tivrinission kil'their p-trents or Suardians, as set forth in @ 40.403. CIA-RDP96-00788ROO1500160010-9 uze tbe IRD !;hall take 4ito accmmt the agmi maturity, aW pay0ological st3tC Of the childfen involvM. This judgment Approved For Release 2001103107 :