Briefing Packet: Advisory Committee on Human Radiation Experiments; July 17 - 19, 1995

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BRIEFING PA CKET A D VISOR Y COMMITTEE ON HUMAN RADIA TION EXPERIMENTS

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ADVISORY COMMITTEE ON HUMANRADIATION EXPERIMENTS TO: Interagency Working Group Points of Contact for Review of ACHRE Final Ellyn Weiss, Department of Energy Gordon Soper, Department of Defense Wendy Baldwin, Department of Health and Human Services Harry Holloway, National Aeronautics & Space Administration Nancy Tackett, Department of VeteransAffairs Brian Latell, Central Intelligence Agency Pat Glynn, Department of Justice T.J . Glauthier, Office of Management and Budget Phil Caplan, white House FROM: Dan Guttrnan RE: Briefing Folder Enclosed are the following briefing materials for the July 17-19 meeting of the Advisory Committee at the Madison Hotel in Washington, DC: Federal Register notice Prospective Recommendation on Compensation for Research Injuries Printed with soy ink on recycled paper

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WIJ a.m. [:all IO Order and Cpoming 135 p.m. Diaccuoion of Re an Dmh Tho rnetctinK i s opun to the pubhc n e chairperson IS rrnpowrrcd :Q ' crmduct tho mwting In a Farhioo cht will faclllrnlo thu orderly condua of bunness. Any member of b e ppbllt rbo wishes to file a -!tun permitted IO du w, either befom tx aher *e meeting. Members of the pubkc who rtatament should coptact Srwve Waidmrn of Ihr Advisory Cumminra nt tho address or irlrphoar numb U od &ova. Requoru must k rocemd I I be mrda to include tho pr0ronmUm 00 Avollablr for publlc review rad qytng at th* offiw of tho Advisay Comtaitlutr at tho addroar lirtwcl .bwr thmugh Friday. uxcapt federal Wdrys Aninp Mpirty Advirvry Commmss. mwu CIIY) w nua iP

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Call to Order Committee Discussion: part I and II chapters to be de tee ed by the Com:nittee] Committee Discussion: part I and II chapters to be de te cxd by the C ~ i ~ initt ~ ] Committee Discussion: Findings (1944-74) part IV, Charz 181 Committee Discussion: Recommenciarions for Remedies :;r rormer Subjects [Part I\.. 11.00 Committee Discussion: Research Proposal Review Projez >xt 111, Chspre;. 15 1 Committee Discussion: Subject Inteniew Study [Part 111. Z k t e r 16j

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3.30 Committe 3iscussion: Recommendations for the Protection of the Rig?:? -:.: Inrerests 4:30 Committe hcussion: Recommendations for the Protection of the Rig?:: -:J Inrerests of Humar I -c‘jects [Part IV, Chapter 19; f continued) 830 A M Approval :fSlinutes of June 21-23, 1995 -Meeting 8 3 5 Comrnitte 3scussion: Strategy and Direction and Sign off of Final R e F c the Rights : f h e Public [Part IV, Chapter 191

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FROM: Advisory Committee Staff Members of the Advisory Committee on Human Radiation Experiments RE: Prospective Recommendation on Compensation for Research Injuries At the June meeting, some Committee members suggested that the Committee provide adchtional support for its recommendation that the federal government review the area of compensation for research injuries of future research subjects (Recommendation 13a, chapter 19, draft date June 9). It was suggested that the Committee indicate that some or all of its members are in agreement with the recommendations and conclusions of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, a group that studied this issue in detail in 1982. Many of you are familiar with the President's Commission two-volume report, ComDensating for Research Iniuries: The Ethical and Legal Imdications of Pronrams to Redress Iniured Subiects. To refresh your memory, and to provide those who are not familiar with it with an opportunity to review it, we have enclosed volume one of the report, which includes a summary. (A table of contents for volume two is also attached. Please contact Tracy Smith if you would like a copy of the 509 page appendix as well.) We recommend that you review this report and then indicate on the attached "ballot" whether you agree with Commission's conclusions and recommendations. Depending on the response, a sentence will be added either to the body of the recommendation or to the explanatory note, e.g., the Committee is [or some or a substantial number of Committee members are] in agreement with the conclusions and recommendations of the President's Commission supporting the review and evaluation of various alternative compensation schemes by the federal government. For additional background reading, we have provided you with a relevant excerpt from a recent report of an Institute of Medicine committee titled Women and Health Research (National Academy Press, 1994). As noted in a footnote to the Advisory Committee draft recommendation, the Institute of M d c i n e recommended that the National Institutes of Health review the area of compensation for research injury. We have attached a "ballot" for you to return by the first day of the meeting (July 17) indicating whether you are willing to indicate your support of the President's Commission conclusions and recommendations. If you have any questions about any of this material, please contact Anna Mastroianni President's Commission for the Study of Ethical Problems in Medicine and Biomedical Research, Compensating for Research Injuries: The Ethical and Legal Implications of Proaams to Redress Iniured Subjects, June 1982, Volume I; and Table of Contents, Volume 11, Appendices. Women and Health Research, National Academy Press, 1994, p. 169 and Appendix D.

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Please fax (202/254-9827) or return to Tracy Smith and Anna Mastroianni by July 17. (Please check one.) 0 I would like to be noted as agreeing with the conclusions and recommendations of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical Research, Compensating for Research Injuries: The Ethical and Legal Implications of Programs to Redress Injured Subjects, June 0 I would not like to be noted as agreeing with the conclusions and recommendations of the President's Commission.

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President's Commission for the Study of Ethical Problems in Medicine and Biomedical Research, Compensating for Research Injuries: The Ethical and Legal Implications of Programs to Redress Injured Subjects, June 1982, Volume I

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Compensating for Research Injurie8: The Ethical and Legal Implications af Programs to Redress Injured Subjects. Volume PERFORMER: President’s Conmission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Washington, DC. See also Volume 2, PB83-236802. reports PCS16.00, PB83-236786 and in set of 15 reports Also available in set of 2 The suggestion of compensation for research injuries has been a mainstay of ethical and public-policy discussions of research w i t h human sirbjects for many yeais. The failure to resolve the issue exp.ses the entire research enterprise to the public recriminations that could fallow from one or a aer?es of serious, uncompensated injuries to subjects. The imporLance of biomedical and behavioral research foz this country is manife8ted in the many billions of dollar8 that 8uch research receives each year in an attempt to conquer disease and to relieve human suffering. The formal ethical standards and individual consciences of investigators, as well as Federal rules &.ad guidelines developed in the past two decades, have done much to protect research eubjccts and to reduce the risk of injury to them. Some risk remains nevertheless-risk that though statistically small nay manifest itself in serious ways for iadividuals. A social policy experiment is needed to see whether compensation programs right provide a feasible means further to reduce the risk of unrelvedied injury to, .... Available from the fational Technical Information Service,

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Re s e arch In.j urie s A Report on the Ethical and Legal Implications of Programs to Redress Injuriet Caused by Biomedkal and Behavioral Volume One: Report President's Commission for the Study of Ethical Problem in Mediche and Biomedical a d Behavioral Research

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-. Volume One: Report President’s Commission for the Siudy of Ethical Prcblems in Medicine and Biomedical and Behavioral Research

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'Iha power of mtdiciae to cure and to prevent illaer.er h a m ixmmwci enormoudy &sing the p-t cenhuy. All thome ha- access to medical cam have b ; n the beneficiaries. Advancements in preventive meaaurea and therapeutic tt&- niquer have reduced the threat of early death and cripplina &ability. The mdt bar been a r@ficant impmvement h the quality as wall (u the +antity of life. An outs- feature of contemporary medicine im ita commitment to research and to the rcientific rppiiation of rsrcprch finding. Exploration and axparimantation distiagubb tha new, mom effective thempsutics f . 9 4 the old rmm than any ntber factor. Indeed. one of modem & a c e ' s most riaiblt dhdy r@aifiunt contributions & the program of medicine in the part B.lf century. The u d a l Wtr of msdiul research have beem aaoimour. .nd ia *.I- is maffirm+ with each o \ .ce uf ut act of treatment or prarmtion. Tht ratio of hfita to coats in dal experlmsntatian kea ban markably f.wwrble. Thto hr keen i d o not d y of the dollar m u of Irrbomtoricr and the hke bat .I.o of tbe hmnu, autr sustained aa maenrchdated icjur!ea At the u m c time. homvsr. thaw human corts must not be w d - ad. New techmquem. ulwa they M adopted blindly. muat k dzrul rtudier but a h the me with hunun 8th- Gf M mattrv how ansueatmu the invmdgaW d add tbe research. Quits obnoirly not dl eqmdmeaty1 h m and treatment* and many expdmeatr Mpdd on Wthy volunreem who need no trsatment m the firrt ph. Evan whn new trentmsnt prom ta k a rahttve tho initid tsrtsd d tart.@ in turn rsguirsr not d y l8bOP.tOly urd

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apakxenu may =:ai that certain paticuts cannot benefit or may be arp?cullg 8uf,csptiblt to toxic side effeds. far lesa fnquently ?baa do the benetits, but t.1 thore who are affected ?hey can be real and serious. Research-re'Ia:ed injuries M harrm' that OCQU u a nearly unavoidabie result of an a mponribility far coUgc~vcsupport if the research is to ksu ~ ful .ar iz attested by the magnitude of hciiag for biomediul reem91from governmental bodiw would ream (o extend to the human coots of the research mterprise. Tbe chaptm which follow address the question: W h . 1 ia a fair system of Fulfilling that re8ponribility? The issue is approached thruugh ranrideration oi the need ior a progrsm. tin ethical aqunentr for and against. and the formulation of pouible pmpoulr *md ncoarmsndation of a social policy Iht balance of thi, chapter attempta to sketch the social d adtural retting of the pmbh of research-related injuries. 'Ibd t u r a l ethos colorr one's appreciation of the facta spe&:.u:ly relevant to the iuuc. Me more. the problem of march irjuriea is not suigensrir. It h but one instance of a presently greppiing. that cf the risks imposed by tethnological progreu. For example. lagMule entarprim such as eneqy pl#luctioa a d rxuu immuaization. while conducted largely forthe social god. put certain individupL at qnxial rid. The plight of tho#. datively fen- in number. who actually rustain tujwy is nu& vivid by the communiutionr media and pmmnta the nation with questions of condence: Who in rsrporuibia for the welfare of tbeae people? What are they owed, and by whom? Why wars they put ai risk and rhoiild Cku policy un mmarch injuria wiU inevitably reflect the development of m y public consensus on &me wider problem of risk lo tun, the policy on research injuries rould conceivably inilwaee the c o m of the larger debate and miaear qwrtionr d "horizontal equity" in redressing bjuries of one in the law tbe k m u axmotm wm&ulmn cw the occumnce of scmething for I) clw a dirtindon, bovam. In this Rem the tamsM umed -y to maan danutp mtrudleu of wrongfdaeso. frult. or -bUty. 81aa. in wmmon pdaacs. the concern of the Report tr .xpaimart to test out dtematiw polidea type but not of O the fa

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To explore the wider cootext in w 9 c h be &dam of compmsarion of injured m a d subid.8 arism, thin chapter &t mnsiders rhe piaca of rl?o =search ecteqrise in society. thut of the volunteer subject. and differ:.: conccptiora of the rdationship between them. Eie varied. often inc!!oate. images of re~~esrchand its sub;ecta patly complicate the h k at hand. In the next section the Cammimian examines ~ b t h e r factor that complicates thinking abou: compenmtioa--.odal attitudes toward risk and toward rpxadiag the rirkr w d those whom they touch directly. The chapter d u d e s by conridering a number of 'basic d o l issue8 that undarii. the debate over research injury.

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risks of mart& .vc borne by ady a tiny h a i o n of the number oi -pesm3who face the k4ks of Gineast and disabiiity that rssearch i3 di3iped to cambat. Mere trnguxhntly. the madesta:ion oi these rsbecrch risks as actual injurier ir not spread evenly over the entire population; they occur for an unfomzmte few among tborc who Wrve as subjects. question of armpansation for ruearch injuries is diradly d € dby the way in which one conceive8 of the rubjact'r role. Two experts Qn these mattcra contend that "bjartuf the diRicultier ?hat have rurrouaded legal and policy effortl to d d with the issue of cornpenssting pervuu far RWBU&- relrtcd injurierscridc in our lack of urrrlerrtandutgabout ?be development wCi.1 mler uui attributes of &tal rtrcueh ltmearch subjectr may be pbpuiuly clothed wit5 arc.In -or example. those of hem. of victim. rad of smployss or confmctor 4 ea& of thme imagn colon our antciurioa, about the character. mom1 statu, and dah Of thr rswarcb subject. The appropriiitenerr of pmviding oompewtion for mearch-related injury varier with the definition of the mbject's role. For the hero. the weUrpnag of public gratitude are overflowing: witnets8 the damtion of fun& to pmvidh S&xLtXQof accident iriurura for the asiroluuta on !he space shuttle. The d a b of the victim i.Merent but aL0 powaful; provisioa of compensation by the Federvl government.' And far 50 employca or contractor. cornpewtion n u y bs maqprdad u a pmper subject of nqptiatlon. The category into which msarcb rubjecta M placed .ire has bearing on the importam urd 8iraifiuaca a?t.chsd to ht n d an b u t ; heroism results from rpontlasour actioa or ddibsrate "raluateaina." Tbe noiioa of victim. hewwer, hu quite different resonancar; ?be victim ir often p.rtive. d viewed as uninfomed or the mu]! of dumas. Consent is mort armp.tible with the imrge of miouch rubject u employee or

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1ri.tiooahip of investigatrz ta subject m a y be aaaimilated parhas uacoaacind y . into the physician-+ tient rdatioaship. Weed. many invadigators ars physician& and umiy subject, am paYents-ait!!mgh meny also are nst. Physicians, in any case. are thought to have important obligations to their tbir iight t.pirysidan a d d have via&ted the patient-rubpct's rights if injury occnrmd without the expectation gf a4cient tbrqxmtic beaefil; compawutioncould conceivably t h a be in cnda dmply M 8 form of reparation. T h a e obIigationa and rights do not obtaia however. if the inw&gatOr is b t e a d conceived of as Gne party who wishes to -&act for the d u t , of mother (or the uae …