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Senstc Carnmtttee on Governmental Affairs Hearlng on Implementation of ACHRE’s Recomrnendrrtions research lsubjcctc In 1)OD-sponsorcd experiments? Da you feel that current rcguletions arc‘suf’llcient to ensurc that the mistakes of the past won’t be rcpcaled? What is your rricssrnent of the current !’kamework fur prahctlng huinarr The Department of Dcfcnse (DOD)recently completed a thorough rcview of i t s policies conccrning the protection of the rights and intcrcsts of Iiumuii research sub.jects, as dii.ected by thc Prcsideiit i n Hxwulivc Ordcr 12975 of Octobcr 3, 1995. 111 the conduct of this rcview, the Dcpartineiit was parliculnrly scnsitive to the findings and rccomniendutions of rlic Advisory Commit~cor1 I-furnan Radiation Experiments The Department bclicvcs that its current policics and pructices fc)r ptoiccling the right6 and intcrcsts of human rmcarch sabjccts arc strong, dynaiilic atid effective, wid arc iiidicutive of ihc crucial improvements in fcdcral policy and practice madc ovcr the past qua~tcrcentury. The Dcpat-tmnt docs ugree with thc Advisory Committee that gaps still remain in ccitaiti aspects ofthc currctit federal system for protcclion of tlie rights unb interests of human rcscwch subjects. In its final iep~rt,the Advisoly Committee listed a nunibcr of rcconitiictidations specifically dirccted to the pivtcction of thc rights and ititcrests of human subjccts in fhc futurc. Tlic Department will implement scvcral of these rtcommendation~thmugh revifiion of its policy directives and the implenicnling regulations arid instructions of the Militivy Dcpwtmcnts and DOL) Agencies. Others arc bcyond the scope of DOD regulations and niay require uincndment of the federal “Cornmiion Rulc” or legislative action. Soinc dcal with broud, overurching ethical considerations and will fall nnder the purview of the ncwly-crcatcd National Bioethics Advisory Commission. The Depurtment believes that thc currcnt fcdcrd system for protecting the rights and interests of liuiiian research subjects, strengthened by implcincnting spccific rccommondutions of the Advicory Commnittcc, will cnsuie thot pus1 mistakes will not bc What spcificlrlly Is the Department doing to implement Rccummcndntian 10 Recoirrriiciidation 10 of the Advisory Committee's Finn1 Rcporr suggests five churiges io the Insiitutionnl Rcvicw Board (IRR) component of thc fcdcral systctii for tlie protection of human subjccts: (1) bctter focus on studies that pose more than minimal risk; (2) better mechanisms for providing information to potential subjccts that distinguishes rcscarch from treutment, realisiically portrays benefits, arid cleurly describes
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poierrtial pain and discomfort; (3) bctlcr itiforination lo pottntiul subject&on sponsors and purposes of the rtsciuch; (4) better mechanisms for providing inforrnution to porcntial subjwtR on tinaticial implications; and ( 5 ) rccogtiition that tlic lRBs must dclcriiune if the qusitty. of sciencc justifies the risk. As rccoinnxnded by the federal Human Radiution IntCfagCl?Cy Working Group nnd will pwvide ovcrsight and rcvicw to ensure compliance. The Deparlmcnt will work cluscly with the JA WG staff, the Nalional Bioethics Advisory Commission and thc National Science ilnd Tcchnology Council in carrying out tlicsc rccommendulions. Specifically, the Ihpmrncnt will issue writtcn guidance to its I R B s crnphasizing the Rcgululionrr, Part 219) for rescarch involving no mote than i l n i m d risk, in ordcr that IRBs muy devotc inorc of lheir tiinc to critical review of studies that pose rnorc than sniniind risk. Wtiltcri guidance will also instruct. IRBs of their duty to determine that thc sciencc in I study is of a quality to wurranl the itnpsition of risk or inconvcriiencc 011 Through rcvision of the Dcpartmcni's directive governing protection of human subjccts in rescirch, Dcpai-tment policy will rcquirc that, in uddition to thc clcmcnts of informd consent mandntcd by the faderill "Common Rulc", infomniutjan providcd fo patcntial subjects shslll c ~ w l ydistinguish research from trcatrncnt, milistically portray tlic likelihood that subjects niuy bcncfit mcdicelly from their pariicipalion in itsearch and the nature of thc potentid bcncfit, and clearly cxplaiii the potential for pain and discoinfoit thut may itwornpatry participation in the research. Thc Department's revised dimtivc will icquire ulscj that infortnation providcd to potential subjects clcarly idciitify the DOD component conducting or sponsoring thc rcscnick pivjtct in whole or in part, and all purposes for which the research is being conducted or supported. What Is Doll dulng b evaluate and implement ACHKE recurnrnundrrtlan Rccornmcridation 12 of the Advisory Commitkc's Find Report ieconiiiietids four steps to jmprovc ptolcction of !lie rights and jiitercsls of mililnry pcrsonncl with respect tu human subjects mearch: (1) rcvicw of policies and proccdures; (2) ducaiing senior Icadcrs and invcstigutors; (3) maximizing voluntarincss; atid (4) maintaining t~ wgistiy of As rccommcndcd by the Advisory Cornmiltee and dircctcd by the Piesident.in Exccurivc Ordcr 12975, the Depurtnienf bun reviewed in detail its cxisting policics and proccdurcs for protccting the rights and interests of all humiln subjwis of m~carch, including our uniformcci Scivicc inen and women. The Department's current policy dimctive ~ n dthe implementing instructiuns of' the Military Dcpanmcnrs rcquirc thc vduntnry nnd fully iiiforiiicd cotisciit of any person, military or civilian, participating ils a
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subject in rclscnrch projects coiiducled or sponsored by the DOD,in accordance with thc fed& "Common Rule" and Title 10 United States Code, Section 980. Deparlmcntal policy clcwly dialinguishes uclivitics that we JiRcrctionary on thc part of Swvicc pcrsonnel from oibcr activities that are obligatory, such LISindividual or group fraitiirrg extrci.c;csand medical interventions intcnded to protect Scrvice pcrtjonncl. The Advisory Committec: tccoin~ncridedthc Department efitablish mcchunisms 10 ensure that officers having conunund responsibilities and all officers engagcd in research, developmctit, testing and cvnluation have an adcquate uppreciation of rules and rcprlttticm that bear on the conduct of itseutch involving human wbjccts. Accordingly, the Dcpartment is rcvising its policy to rcquirc that the Military Depurtmcnts provide education in humnn subjects regulations, policies und practices in executive-lcvcl training for coinmundenc and scnior civilinn lclldcrship who may bc iiivolvcd in dccisionfi regarding reficarch involving human subjects. Thc Dcpartmcnt's reviscd policy will reyuirc also that the Militiuy Departments pinvide detnilcd training in human subjccts regulutions, policies and practices for individual invcstigiiturs, institutiond review hoard tnemlws, research administrators and support pcrsonncl under their cognizance. To implcincnt tlw Advisory Conunittce's iwommendations to muxiinize voluntaritrcss, the hparmiciit is revising its policy directive to require ilia1 officcrs and senior noncomrilissioned officers (NCOs)in the chain of co~nmnandiiot1% present during rcwarch recrujtment brictings involving their units. Officersand NCOs so cxcludcd will hc afforded the opportunity to participate as i.cseluch subjccts in a separute recruitinen( session, Thc Dcpuitment's rcviscd policy will q u i r e also that at all such unit recruitment sessions, an ombudsman, not wnncctcd in any way with the proposcd rcscarch, be piwent to monitor that tlic volunttlriiiess of participation is adequately strcssd and that the informntion provided about the mcarch is adcquate and uccurute. The Depnmncnt will also direct that the Military Dcpartiiients establish und maintain a registry of voluntccrs that participute in hiomedical studics conducted under rcscarch, development, testing and evaluation progrtlms. Does DOD have a pnsltion on the ACHRE recummcndrrtion 15 regarding Rccommcndtltion IS of the Advisory Conunittcc's Fiiial Report~r.ecommcndedh e IAWG adopt a fcdcrd policy requiring the informed conscnt of all huinaii subjects of clussified research and tliat the requirement not be subject to cxcrnption or waiver. The Advisoly Committee also rccommcndcd cstablishment of tlll independent review pnncl for classified rcsc,mh composed of nongovernment experis and citizcn representatives, all with upproprinte security clcnranccs. Current DO])policy rcquircs tlic voluntary and fully informed conscnl ofall hutiraii subjccts of research, in uccordance with rcquimncnts of the federal ''Coi~~inon
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Rulc" and 10 USC 980, and makes no distinction betwccn clwified and unclossified studies. The Advisory Conunittee is, howcvcr, paiticularly conccmcd with n provision in the ftderal "Conmm Rule" that grants an agcncy hesd the aulhority to wuive any rcquirernetit of thc "Conunon Rule" for atiy kind of human subject research as lorig 8s ndvnncc notice is givcn to the Ikpunment of Ncdth and Human Services' Officc for l'roicction from Research Risks (OPRR)and rlic action i s announccd in the Fcderul Register. Thc Advisory Comdttcc believes this mute to informal cotmiit exemption would pose tension bct.ween the duty to fully disclose and the tieed to keep infortnation Ttic Dcpartruent cannot at prcscnt conduct classified research without obtaining the voluntnry md fully informed consent of ptenlial huinan subjects,ginw 10 USC! 980 prohibits cxpenditurc of DO13 funds for huintln subjec&sr~carcliunless informed consent the Prcsidcnt or the federa1 agcncy heuds 10 direct that there be no waivcrs of informed consent for hoinnn subjects of federally conducted or supportcd classified research. The Depwtincnt is reluctant 10 support the crcutivn of a ncw oversight body for tlic sole purpose of revicwitig propusd clnsfiificd mearch studies involving human subjects. In the contemporay en,cltlssifed studies involving human subjccls arc cxcccdingly rare events. Thc Department believes that the curitat IRR system, which olready rcquires the inclusion of at least one member not aMliatcd with the institution, can bc strengthened Lo providc specid protections for hiirnan subjects of classificd rcsearch