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Experiments and Research with Humans: Values in National DCCUNBNT RESUME ED 125 906 SE 020 984 TITLE Experiments and Research with Humans: Values in Conflict. INSTITUTION National Academy of Sciences, Washington, D.C. SPONS AGENCY Department of Health, Education, and Welfare, Washington, D.C.; National Endowment for the Humanities (NFAH), Washington, D.C.; National Science Foundation, Washington, D.C. PUB DATE 75 CONTRACT NO1-0D-5-2116 -------NOZE 231p. AVAILABLE FROM Printing and Publishing Office, National Academy of Sciences,72101 Constitution Avenue, N.W., Washington, D.C. 20418 ($5.00) EDRS PRICE MF-$0.83 HC-$12.71 Plus Postage. DESCRIPTORS Behavioral Science Research; Communications; Conferences; Educational Responsibility;, *Ethics ' Federal Legislation; *Human Resources; *Research; Research' Projects;, *Scientific Research IDENTIFIERS *National Academy of Sciences ABSTRACT This book contains the .foraal presentations and discussions of a public forum organized by the National Academy of Scientes and held in February 1975. The topics discussed include informed consent by the research subject based on a full explanation of :what will be done, the workings of tyre ptocess, and the potential risks and benefits; research on fetuses\and on children.; research, participation by the,econosically poor,military personnel, prisoners, and the insiitutionalized; the teens used .to obtain volunteers for experiments; and the future role of federal legislation. A recurrent. theme, the balance between the promises and perils of human research and betwe'em societal and i dividual I, considerations, isemphasized. In addition, this v ume illustrates the successes and failures of,communication when a ontroversial subject is explored in a public arena. (Author /SD) ***********************************************************#***********- * Documents acquired by ERIC include many informalunpublished * materials not available from other sources. ERIC makes everyeffort * * to obtain the best copy available. ,Nevertheless, items of marginal * * reproducibility are often encounteied and this affects thequality * * of the microfiche and hardbopy teproductions ERIC makesavailable * * via the ERIC Document Reproduction Service (EDRS)..EDRS is not * responsible for the quality of the original document.Reproductions * * supplied by EDRS are the best that can be made from the original. *********************************************************************** 1-0 ,j S DEet.tivENT OV mELT. E0vC71004 t wELCRE 10'011..thST,TuTE OF ACADEMY ED1-sCt,o., YE. FORUM E., . F . PE25.: -;" :z":- L. :. Third ofa Series %E:E=r,4:. L. '_'E P.-S Oti Ca ' EXPERIMENTS AN RESEARCH WITH HUM yANS; VALUES IN CONFLICT NATIONAL ACADEMY Of. SCIENCES rJ I .0 ACADEMY FORUM Third of a Series ir 1 %., EXPERIMENTS AND RESEARCH "WITH p HUMANS: 4, VALUES IN r CONFLICT NIATIQNALACADEMY OF SCIENCES ,WASHINGTON, D.C. 1975 =11.1.,... i C ) e e. .., The work upon wh2ch this publicatiOn is based uas performed pursuant to Contract NO1-OD-5-2116, jointly sponsored by the Department ofHealth,- Education, and Welfare, the National Endowment for the Humanities, and the National Science Foundation. 4. or , s , ternatioRal Standard Book Number: 0-309-02347-S Library of Congress Catalog Card Number: 75 -13985 . ,...- i Available from: Printing and Publishing Office National Academy of Sciences 2101 Constitdtion Avenue, N.W. Washington, D.C. 20418 rrinted in the United States of XMerica e te s t FOREWORD 470 .44 The Forum of the National Academy of Sciences is a public platform for the appraisal and illumination of broad concerns involving controversy surrounding the uses of science and technology. This is the record of the Academy Forum convened on February 18-19, 1975, to consider "Experi- ments and Research.with Humans: Values in Conflict." In bringing scientists and nonscientists together at one time and in one place, the Academy Forum projects the proposition that effectively designed policy and its implementation must recognize the interests and - needs of all relevant constituencies -- private citizens, government, industry, public interest groups, the scientific community-- the full spectrum of al' -thoFt T who are responsible for initiaeing.change-Orelugh -scineeandth-Csd-who-are,affected by it. A Forum actually begins when a topic is-selected. Following the choice of this particularly complex one by the General Advisory Commit- tee in April of 1974, Dr. Frederick C. Robbins and Dr. Lewis Thomas agreed to serve as co-chairmen. During the summer the Program Cpmmit- tee, drawn from a wide range of ,experience and interest, met to define issues and questions posed by the topic. Throughout the fall and winter, numerous discussions were held with individuals and groups to choose-speakers and panel participants who would give the broadest possible frame of reference. Those individuals were then brought to- gether for further discussion. Meanwhile, invitations to attend the Forum were extended by mail and in the public presskto expand the audience to include the widest passible representation. This publication presdnts the culmination of those months of plan- ning when approximately one thousand people came together over the , two-days period in the auditorium of the NationalAcademy of ScienceS. Opinions 6oncerning the success of this Forum undoubtedly are as varied 5 :1 and as numerous as those hho attended it and drab in large part from hhat has expected of it. Eachof the co- chairmen has introduced into the pecord_a retrospective overvieh of the day he chaired. In many hays the reader of this volume has am advantage over the f participants of'the planning and plenary sessions. .He is not callvd upon to make a public statement or compelled to defend a point of vieh. Rembxed from the scene of thoe'frequently turbylent tho days, he can locate, end -refer late the issues; he can observe the wide 1 spectrum of perceptions focused on the subject, identify their sourcds, an&weigh their implications.This opportunity for-the reader is basic to our decisluon to. publish an edited proceedings rather than a summary report, hhich inevitably emerges as only one mor view of whaD'took place. Here, then, in microcosm are many of the toncerns and problems sur- rounding the use of human subjects in research, bringing. into conflict 'not only values but the very purposes and definitions of life itself. Implicit on every page is the increasing ground swell for the right to knob why, where, and how participation in research will be determined. The persistent and salient message that emerges from a review of this record is that men. and homen of integrbty and good will can differ in perspective and terminology while attempting kith deteimination and no little anguish tofind answers that hill beLaedeptablv to all segments of a democratic society. The Academy Forum was initiated to offer a public platform for such dialogue, and :it hill'continue to address some of the hard and unanswered questions posed )erein. Robert R. White Director we. 3 iv CONTENTS . DAY I 1 !!Overifiew Frederick C. Robbins, Chairman 3 9 . Welcome Philip Handler PERSPECTIVES OF BIOMEDICAL RESEARCH 13 A Cultural and Historical View _Francis D. Moore 15 The Benefits of Research Lewis Thomas 51 The Risks of Research Walsh McDermott 36 Inquiry and Commentary 42 INDIVIDUAL RISKSVS.SOCIETAL BENEFITS 57 What Consent Is Needed? Introduction to the Cases Renge C. Fox 59 The Fetus Charles A. Alford, Jr. 62 Frederick C. Battaglia 63 Robert B. Jaffe 66 Audrey K. Brown 70 Elizabeth D. Hay 74 Inquiry and Commentary x.75 The Child William C. Smith 90 Leon Eisenberg 94 Charles R. Halpern 99 Inquiry and Commentary 103 r- 7 DA' II 119 .3.10 Overview.' Lewis Thomas., Chairman 121 Welcome Donald S. Fredrickson 123, INDIVIDUAL RISKS vs. SOCIETAL BENEFITS 125 How are the Risks Distributed? - The Military/The Prisoner Albert B. Sabin 127. Alvin J. Bronstein 130 William N. Hubbard, Jr. 135, Inquiry and Commentary 138 The Poor Franz. J. IngAVnger 150 Henry W. Foster 151 Jay raiz ... 153 laqufF5, and Commentiry 160 REGULATORY, JUDICIAL, AND LEGISLATIVE PROCESSES 171 Remarks by the Honorable CaSpar W. Weinberger 173 Inquiry .and Commentary 179 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 185 Charles U. "Lode The Panel Charles Fried 189 iaurice R. Hilleman ,191 Richard A. Merrill 195 Inquiry and. Commentary 200 FUTURE POLICY OPTIONS AND SUMMARY 207 The Panel Richard E. Behrman 209 Ivan L. Bennett, Jr. 212 Douglas D. Bond 215 Howard H. Hiatt 217 Frederick C. Robbins; . 220 Lewis Thomas 221 Closing Philip Handler 223. Notes and References 225 General Advisory Committee 229 Program Corhmittee I 230 Participants 231 r "vi DAY 14 ; /IP Q i DAY .1 AN OVERVIEW Frederick C. Robbins Chairman 1 This Forum was organized because of the great concern about human ex- perimentation in this country toda . The reasons for this concern aye not all easy to identify, but they include a number of well-publicized real or imagined abuses, a subject which was not dealt with in any detail during the first day of this Forum. Many of the medical inves- tigators who have spoken have indicated that abuses are rare, whereas other participants have implied that they suspect that they are quite common. However, no substantial documentation has been provided by ,either side, nor has there been any discussion of specific cases except for the hypothetical one of the panel on children% Undoubtedly the level of concern is heightened by the discussion of many actual and im- agined advances in science and technology with potential fearsome con- sequences such as genetic engineering, behavior modification, and organ transplantation. As pointed out by Di. Renee Fox, important questions, are being raised within our society concerning the rights of the indi- vidual as opposed to the needs of 'the community as a whole -- authority- is being challenged generally, and this includes the medical profession, which to many has an authoritarian image. Although this may well be healthy for our society, and I am rather incli4ned to think it is, none- theless it presents problems fon many groups of people, including medi= cal investigators.
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