Model Federal Policy for Portection of Human Research Subjects

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. W e 1 Federal mlicy for Set.::; Ex:+::& Fteview pr xe dure s for Certain Kinds of 2esarct; 1r.volving No Ere tnar, Minimal Risk, and fcr KicQr Charges i n Zqqroved Research. S?c. 112 Review Sy I rst it uti or..

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Sec. 11 5 IZB Records. SusFr.sior.or Te-mlnatior. of Iw Approval of Research. Coogra: ive Research. General Requirements for Info-med Consent. &?liCatiOPS and E ops als Lacking Definite Plans for 1nvdvemer.t of H m n Subjects. ( a i Cite;: as provided ir, prasraph ( 5 ) Selcw, this policy asglies to a i l research invDlving hurnar, Subjects conducted, sq s rte5 cr otherwise Subject to regulation by any federal deprc,-ner.tor agomy which takes appropriate administrative actlor. to make the policy apgliccale to such research. This includes resezrch conducted by federal civilian ql oye es or milita-y persorxel, exce?t that each deparunect or agency head my a d o p such procedural mcdificatiors as may be

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inciuoes resezzcr. cc nested, supported, or otherwise sua~ect to re Jul ation by tne fweral government outside the United

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sxpcts c m ce identif i&, directly or throush identifiers iincec tc the swjects; and ( 1 1 ) any disclosure of the hunan place the sajects at risk of criminal or civil liability or be cz?..a;inq to the subjects' financial standing or enployability. ( 3 ) ' Sesearch involving the use of educational tests is ;IC: e>cs:?Z Under pragraph (21, if: 6 3: s;l=;e:: :c LCle approval of department or agency heads, and wnicn ere Cesigez to study, evaluate, or otnerdise exa-ine: oatainirq benefits or services under those prqram: ( i i i 1 possible changes in or alternatives to those programs O r procedures; cf(iv) possible charqes in methods or levels of papen t for benefits or se--vices under those prcgrai.

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(5) Tas:'c an: fom qs ali ty evaluation studies, if wholesane a sri cul zur al chenizal a t or belm a level ap2roved by the Food and mu; Ac2,in is t ration I the Envizormental Protection AgencyI of the (si l?,ik pLic:* coes not affect any fore isn laws or adc it ions lp roter zi crs to human s.&jects of resexch. Zt'lerdise be app lica S le and which provide foreisn ccxlniries, prccedures non;;ally fol ldin the foreign counzries t o protect nman suS;ects.may differ fr cn those set forth in mis plicy. [ ~ ne xaqle is a for ei cn institution

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wnicn cmilies with yui a e lines consistent witt l the 1975 either sovereign states or by an organization whose function for the protection of hunan research subjects is oe?ar-;nent or agency head dete-mines that the procedures prescrl5e:: q' the institution afford yroteccioffi that are at le=: eq J iv alex to those provided i n this plicy, the desar-,-r:er;: cr agency head may aya f we the substitution of i n tne FE3S:L XGISTER or i n such other manner as provided in de pr tw x or agency proceaures.

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federal de pir ment or agency and any other officer or wloyee (Zl.*i~Sti;stlO~."rntans any puS li c OLT private entity or . ars intencsz :c ezc-lss those reseerch activities for which . In ves rig ation el -ac:ivities whicn are incidentally regulated by a federal Dru ~r e quire n ents administered by the It does not include research

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2eparzne.n: cr agency solely as part of the department's or ac;en=;'s brmaer 'Ces=x>nsibility to regulate certain types of a civ i ties wnet3er research or non-research in nature (for exaT$le, Kape and Hour reqdirements administered by the D q arc nen t of Labor). an in ves ii gst z r (whether professional or student) conducting I, --2cerJsztioE" includes both physical procedures by which data exscz :-&E: 1;2 &e--vation or retordiq is tak irq place, and a: ini,ivic;el anc which the in div iau al can reasonably expect Eiv ace ir,fzna:ion must be individually ident if i - l e (i.e., t!! i oen city of tne SuS j ect is or may readily be ascertained & t!e invest is at or or associated with the information)in order for o5tair.ing the infomation to constitute research (3) "IRB appr wal " means the determination of the IRB that tho reset z ch has Seen r'evieued and may be conducted a t

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an i~sci~zcio:witnin trie constraints set forth by the I U magituce of ha-m oz discomfor: anticipated in the research e r e 33: greater in and of themselves than those ordinarily encoc;nter+z i n daily life or during the performance of routine acczrse-tc v i x t!.e reqdirensccs of tSis policy, thac a ( $ 1 %s:aencs and agencies will conduct or support .researcn cover e ~y this @icy only if the institution has an 2ss’Jrance a???r=wed as provided in this seczion, and Only i f m e institution has certified to the deprtinent or ac;enq he!& tnBC the research has Seen d i e b e d and appoved Sy an

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Ti.m.. 2rm:dec for in the assurance, and will be SubJeCt to federally su2;prted or conducted research shall at aminh (1) A ststement of principles governin;. the institution in the discharge of its zespnsibilities for protectiy the. :i;zcs an5 welfare of hunan subjects of research conducted incl3;C? er; a;;rqJriate existing code, declaration, or a r e ~ Z Z Efrr metzin; spzce 2nd sufficient staff to support the ,--asb r &certifications, licenses, etc., sufficient to describe eaca meme:'s caief anticipated contributions to IW . deliberations; a m any eqloyment or other relationship between each m a r and the institution: for example: e.qAoyee, part-time errplcyee, menbe: of poverning panel or bcrard, .

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( 4 ) hriccsn Frocecures which the IW w i l l Iollow ( i ) for conducting its initial and conti nu in s review of research and for re;>ortrn; its findings and actions to the investigator re+:rc revie; 13x2 o f t e n tnan annually and wnicn projects nee5 ver iii cer ix fx ~succes other than the investigators that no m:eriel crimp have occurred since previous IR3 review; and

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(cj he aes run ent or ayency heaa wil ? evaluate all assurances Shit ted in accordance With this policy t'lroqh sucn &&icersan< employees of the dega-rtment or agency and such ex re rts or cm sultan ts engaged for this pur ps e as the dep arment or asency heac oete-mines to be aV2rosriate. acenq head's eV duat iOn will take into consideration the adequacy of tne 2rqms.e: IEin 1iS;ht of the anticipated scope of the irs:i:gti=n's research activities an3 the types of subject w;c:18:ions l i ~ e l yto be involves, the aqro2ria te ness of initial and cmt in u iy revierc; procedures i n \ f ) -A:. Lie, of ne got i a tir xj a sep rate assurance, in civiC x lae sara ez t or agency heads shall a2proved by and or! file with the Office for (SI Cert if ice tion is required when the research is 'su;.prted 4' a federal department or agency and not othe-wise

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su;)pr:, an institction w i t h an aproved assurance covering the researcn shall certify t h a t the application or proposal witno;: an e?;roveC assurance coverinr; the research shall __.._..33 cays after receipt cf a repesc for such a Moncj wit n the, cult xal Sacksrmnds and sensitivity to such issues as mrmunicj attitudes, to prcmote respect for its advice and counsel i n

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to possessing the professional canptence necessary to review sFcific research ?ctivities, the IW shall be aSle to ascertain the acce2tability Of propxed research in t e r n of institutional mih ents and regulatiors, applicable law, and standards of prcfessional conduct ana yractice. The IRB shall therefcre include persons knowledyeable in these areas. If an I% rec;ularly reviews research that involves a vulnerable. cate;q: of s*t;jects, sucn as children, prisoners, pregnant me-=: has a cozflicti- interest, exceyt to provide (e) A? nay, in its discretion, invite individuals with m qx ten ce in sscial areas to assist in tfie'review of issues which reqdire exixrtise beyond or in addition to that These individuals may not vote with

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I n order :a fi;?fiiithe requirements of this policy ( a ; Foilw written procedures inthe same detail as des cri x eia Sc.103(5)(41 and, i f ap?licaSle, Sec.103(51(5). ( 2 ; Exce;;: uhsr, an e x M i t s 6 review procedurs is used (see SSC.::~!, revitr ? rz p sed research at convened meetings a t whicn in the IPS‘S ~ u d ~ e n ct3e info mt i or : Icrould mean is fully add t o tne proteczior: of tn s rights and welfare of subjects. (c) iu: IRE s:iall r squire documentation of informed consent or may wEive doc ment ation in accordance wit:, Sec.117. inciting of its decision to approve or disasprove the

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or Sock cf t h e foilwins: a ? pear iq on t!!e list and found by tne reviewers t o involve no more than minimal risk,(2) minor changes i n previously a pix ov s researcn during the priod ror which approval is (1') sane or all of the research Under an expedited review procedure, t!!e review prqpsez T~SEZ:C:'L activity, or of id if i cations required to decides to disap?rove a research activity, it shall include If me IW i n its gritten notification a statement of the reasons for 1:s dec:s\-on an3 Give the investigator an o apr t unity to res on d in person or in writ in s. (ej A-I 1.- shall conduct conti nu irq review of zesearch covere5 z2. cis @icy at in ten a is app opiate to the degree

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expr ien ce i reviewers designates q the chai-won frcm exce;;: t natt ne rcviewers m y not disa2prove .the researcn. I n reviewing tne research, the unnecesszrrly ex_=iose s sJ ect s to risk, and (11) whenever qpro?ria:e, b2v usins pr x eau res already be in s prfo-med on the s u ~ )ect sfor diagnostic or treat nen t purposes. -

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( 2 : ~isrcsto su q ect s are reason as le ' in relation to antlc:gaztc Een ef its, if any, t o Subpi?CtS, and the W rt ance I n evaluatin,? risks and benefits,the IRB should consider only tms e risks and benefits that may result frm the researcn (as distinguished fran risks and benefits of t3ere;ies suSjects would receive even if not participating lonG-rene effec:s of applying knwiedge gained in the Tne IRB should not consider WsiSle in acccrdance wit>, and t o the extent required by Sec.116. .(5) Ir.forme5 cansent will be appropriately docunented, i n (6) hhen a?pro?riate, the research plan mkes adequate "?rcxision for monitorimj the data collected t o ensure the

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Coop rat ive researcn projects are those ' proJects covered by - cond xt of cooperative research proJects, each institution is resSzsi3le fx safe yu ard iw the rights and welfare of hwn sci5;eccs a m for car Gly iq vit n this Slicy. of me c epr w nt cr agency head, an institution participating ir. a coo8ra:ive project may enter into a joint review kith the approval trrET.~t3e.?:, -'rc1**u-n there vie v of another qualified IW, A- L?C::::ZLSZ, or waen as pro pri ate an I%, shall inves:i;ctors, anc rep rts of injuries to swjects. ( 2 ; Kimtes of 1.U meetirqs which shall be insufficient deteil t3 shcr; 2t:encance a t tne meetings; actions taken by the 1-33; the vate on these actions including the nunber of menSers vo:is for, against, and abstaining ; the basis for re quir iq cn a qes in or d is as pov ing research; and a written -Sam-?, of the d isms sion of controve,zed issues and their

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(4; Cqies cf a i lcc rr espn a en ce between me IRB and the .(5)A list of IN3 men bets in the same detail as described Sxze;: as ;z:.-keC els2wherc i n this policj, no researcr. t mer cd 2;’ this @icy unless the invest is at or has An in ves ii Gators k all seek such consent only undez Circxurstances that provide the pros pct ive suSject or the not to p?.-”cicipate and that minknize the possibility Of coercion or undue’lnfluence. me information that is given t o the s.mject Of L!e rei xe sent at ives hall be i n language

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ex culpa tz T language through which the subject or the re2re sex at ive is made to waive or a?pear to waive any of the inver:ic2Ecz, the sponsor., the institution or its agents fm ot9ers *':ic:: 7.2; reasonably be exec ted fran the research; mrses cf : re a a ent,if any, that might be advantageous to confident i elit y of records identify14 LCle subject will be (6) For research involving more than mink1risk, an

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infozzrion nay be obtainec; consisi cf, or where further prziner,: cuescizr?s amd: t n e research and research suS]ectS'

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( 5: As c ace ~ er.t that sign rf i cant new fina in csd eve lom e,*-; :he cocrse of t n e .research vaich m y relate to the (2) ;l;ir ese irc r : ccd d not practicably be carriecj Out ( 6 ;A7 1.- riz)' apsrove a consent procedure which does n o t incl-Jde, or wfkr, eltefs, scme or all of the elements of info- mn sent sec forth abve, or waive the re qi rm ents to oSt a in in fc - m c consent provided the IREf inds and d xun ents that :

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il; Tnc resezrck invoives no more tnan minim j l risk to the ( 2 ; me waiver or alteration w i l l not adversely affect the rig-& m i weifare of tne subjects; ( 2 ) Tr~ereseafcn could not practicably be carried out witkc : tx saiver or alteration; and infsm5 copsent rwi,-edby Sec.116. mis form my be read t o

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b ~ :in any evecc,- t n s investigator shall give either the subject or t!e representative ademate opportunity to read it before i t is sisned; or (1: %a: the only recorb link iq the sm.ect and the ,,risk wuia SS ptential ham resilltiw fran a breach of confidentiaiity. Each subject will be asked whether the subject wants docmentation linking the subject with the 'research, and the subject's wishes will govern; or

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(Lj Tna: tne resedrcn presents no more tnan rnlnunal risk of he?, to sc3Iecc-s and involves no procedures for which written corssri; is no-?i;ally required outside of the research 13 casss i n w~ic:! the aocumentation requlrement is waived, t x 153 rzy req:lrs L!!Z investigator to provide suSjects

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sy trre I.=,as ;rwicea in this pl icy, and certification s*-,itte< t3 the ce j z rt nen t or agency. sec.119 Researcn Unaeztaken Without the Intention of Involving Hman Suojects. Intne event researcn is unaertaken With cut the intention of …