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Tne A l EOC Ccc-.:c~?e z;r++z ir. ?rir.ci?le with this rec mna at i or. ark ageccies as5 t o iccrease m qat i bil it y with otner currert fde ral policies. c0r.cezr.s of the Ccrrmissior: tna: unnecessary a ~ ccmfusirq reyu1atior.s
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Tne --Az: EOC Cm i its e concurred with the find in s s of the Eesiaent's Carmission t h a i there 1s already close correlation beteeen the major provisions of the HHS regulations and czrrent pli cie s and procedures of other federal is intended to fur:.'ler reduce the diversity so t h a t nonfeceral researzn
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plicy is patterned after changea to "de?arment or provisiors of the followirr;
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rei at i or : to inves:iya:orr, to their ins:itutions, and to tbe spnsors of a private29y sic is z v x ccnCLczs research un z elated to the Medicaid yrqram a & i in iste red 3,. tire s moaS er q are federally reirbursec',.
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" (2) Researcn involving the use of eau cation al tests dire ccl y cr i.?rD<3? ies nci fier slinked to tne i ? f c - ~ + ri on oka inez is recordec i n sucn a wit xx t chmicai ac2i:ives are ccmuned cr if a limited mount of a food is Consu~& tia : contains a food addi:ive 0: agricultural che ical aL or -1% a level aayroved by the Food and A ministration, the Environmental Protection Ayency, or the
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e & ro9rrate for several ocnsr a ~ encis sa s well, is intended to exenpt certain @icy exe,qt s tz ste anz f d qizllty evaluation studies which involve Consurer acce?t:ance testing an: quality evaluation studies if a limited a,munt of foo: vii, be c3ns - w ~ csr(:siz:n< 5 food additive or agri cult urz l cnemical a t me current USW
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B icreiy; :r?s:i:siDc wnicz cacplies with guidelines consistent with ttlc: i975 ,dorlc xe zira l Xs sea iy Declaration (Helsinki 11) issued eitner 9 y 0: numzn rkseart:: su2;ects is internationally recqnized.] In these procedures ;reszri*c by the institution afford protections that are a t .least ec:iveleR:= t 3 those providec: in this policy, the desrtment or ayency tns p x e ; ~ r a l rr+irments prwiaed in this plicy. Excep when OtherdlSe cf 1-35 rtvies; and a,-;roval until 60 Secs. lCli(2; or :il. done; with the sutmission of an agplication or progsal fcr a?>rzvaf o r su?Frt, an institution with an approved assurance coverin< t3e research shall certify that the application or pro-al rias keen reviewed and a?provec by the I-. witncut an aa;rzwed assxance coveriq tne research sbzll certify within 30 days after rece.ipt of a request for such a certification frcm the desartmen: or agency, that the application or proposal has within-these time liiiits, the a;plication or proposal may be returned If the certification is not sumitted
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wit ns us - srtin, - federal acencies or dep arment s must specify of asency hea2c SX,, ecce;: t ne existence of a current assurance, a??rosria:e fer :zt rcscsrsT: in question, aaproved by and on file
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acd exxr:lse of its merbers, and the diverslty of the memSezs incluclr.; cocsiderztion of race, Gender, ar.d cultural backgrounds ar.d sezsiclvlty to such issues as ccmmrcity attitudes, to pranote to coordihte tns in+lerner.tatioc of the model policy developed unde: Reccme.?ca~lor..~.Hwever, the Ad tioc Camittee d i d cot XIieve--
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ase ? arazs aSS2rancE, in zi via a1 dei.)armen:s and a yen cie s shall accegt a cilrrezt E% as sx ance a?prwed sy and on fi ie in OM if it is a?prq:ia:s ts the res ez r chin question. In lieu of n qo tia tiny
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(3) OF.?sheii, when appropriate,mend and republish the list of Of t3e Feaerzl tcmr:inzting Council for Science, Ewineerinc; ana Tne ---4: Em Cu mitte ek eli eve6tnat if these coord in at iq steps are taken -
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tne Lzqlmr.ta:ior. cf tna noda1-p:icy when necessary and a pyro pri ate. Tne --Ac Hoc Camittee further Delieved that over many yealcs the OPHR has esta Slr shed souncf c recent lal s in the protecci on of hwn suDJects. feseercrr wiz fr ew rr exe 15 cealln; with the delicate %lance of pra'nOting4 bio action recpirei on Rezame'ndation 3will be needed i f tke procedures outline c in respxse to Recmencktiors 1 and 2 are adoated.
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h ~ ~ z rsL=leccs s m d c require principzi invesilgators to sumit, as part c: t n r i r arinual repzrts t 3 tne IR3 anc the funainy agency, information reuarcin! the nuer oz scD;.scts wop a xi c ip tec in eacn research prolect as-weli as tne nature a x frequency of adverse eftects. me --A 5 m c Ccrnlittee qilestioned t3e feasibility of develoginr; a major data collection of nLnzers of h~'il2f: subjects who participate i n Feaerally ca:z re lac in st c resezrz.7 iz pries anc adverse reactions ana recqnized I t acknowleayec the importance of sound difficulties rsce~::~. e-.:cc.:sr?z 4' the VA i n collection of data on hcan research sc:;ez:e. ?r:t V;. had issued circulars to its medical centers wh:ch were cor,cxtir,; researcn involving hcman subjects. circulars regueszoz t ! i S a : thie centers collect data regarding the incidence of adverse results or effects of 2ariicipation i n bianedical and behavioral Fidures rsceivec in Nov c2er 1981 provide? the V.9 witn unreliable and me collecte2 d a t a were fo-varded to the central VA office.
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iccmqlete repcrzs cf n u r x . suSjects icjured or otherwise adversely of definitiocal proSiers, misuricerstandiqs on t h e part of field research personnel, confcu,din; of merapdtic and research data and irstances of sot!^ underrexrzizg and cuerreFrcing, the data were corsidered misleadirq or mearingless. Tne Caza weze cot amenable to synthesis. Giver. the existis; ceficicional probierns and the expcted pax quality of . - resuitiq date, :ne --Ae ExCm ~ icte ebelieved that the exp di ture of The z c sic err ' s ~mr.:~::::. r.c:?.= r n its cmrects OT. this recumendatior. that corsiaeriq t!!e feasljility of amll - scale ewrimer.t i n which Several irstitutions ww16 receive fei.e?zl support ovez three to five years for the adnicis:rctive ad irsuraxe casts of providing corcpersatim OTA a nonfault basis to injured research suSjects. , ~ n gother aspcts of
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this re cm nc at i or, has Seen met by a&ninis:rative action, and no legislation is require.: If Otner such entities are i dem if lei,the fedora lOis Sur S iry
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4 j CPR 46.103, wkicr. s ~ clfle st h e minimuin requirements for an institutional See. 103(5)(5)of the prop & mde1 policy rewires that in as s uz ances Su tR it tei to heads of de?ar-ments 0'; agencies conduct ix or swp pr ting research
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a?;ro?riare 1rs : it ut ional officials, and the de ix run ent or agency nezC (1) any una xi c ip : e 5 ixoblems 0: scientific misconduct involvLn2 risk st cn ' m n smjects of others, (11) any alleyation or frncinj of seriws or mn tin u iq noncangliance with this policy or the require rents of aete-%nations of the IRB, and. (iii) any scspensior. or terni nation of IW ai>p:oval." Tne --Ac Hoc Ca+.rr,itts? COx l Wee that addition of this lanyuaye uoula pe-mit con:ractors ail eec tc have enca-e=: i n misconduct in Fec e rally sup-mrted
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The --AC i.0~Cumittee generally Concurred w i t h the recamendation for tne estaSlisbect of yovermentwide procedures for making determinations on contractcrs on t.haz date. m e Office cf MaMjezen: sze 3aci;et is now developing standards and rtSthmlSiits for 2 governmentwide system for assistance prqruls. ...
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Tne interagency iicer,ar, SuSjects Coordinating Carnittee will be aSle to c a m e x on yro-psals for the eSta9lishment of governmentwide suspension ant oemmr,: procedures, addressing st>ecifically tne effect of the .