Society's Choices Social and Ethical Decision Making in Biomedicine (1995) / Chapter Skim
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Bioethics Commissions: What Can We Learn from Past Successes and Failures?
Bioethics Commissions: What Can We Learn from Past Successes and Failures?
Pages 261-306
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From page 261... ...
, the final report of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.] Developments in biomedical and behavioral research, and changes in medical practice and the health care system, have raised many challenging ethical and policy problems in recent decades.
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From page 262... ...
—The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the National Commission) and the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (the President's Commission)
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From page 263... ...
(Defining Death by the President's Commission is a case in point, having had a widespread impact on state laws while leaving some philosophers unsatisfied.) Although it is certainly fair to judge a report by the quality and weight of the evidence it assembles and logic of its analysis, a commission's influence may depend as much or more on its prestige3 and the skill with which it attends to political considerations.
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From page 264... ...
Staff director/initial staff selected by NIH official Staff director served primarily management and quality-control ~ . tunctlons Had National Commission as a model Research involving human subjects was one of several major responsibilities; commission had a more diverse mandate than the National Commission and had power to add topics to it Eleven members appointed by President; all to be distinguished—three in biomedical or behavioral research; three in medicine or provision of health care; and five in ethics, theology, law, the natural sciences, the social sciences, the humanities, health administration, government, and public affairs Commissioners appointed to two-, three-, or four-year terms, resulting in complications of changing commission membership; a total of 21 commissioners served Independent agency Had annual budget authorization of $5 million; was subject to budget negotiations with OMB and through the .
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From page 265... ...
In the aggregate, the commissioners and staff represented a complex mix of bureaucratic sawy, interest in law and ethics, concern to reform or defend the status quo, and political and academic values. Both commissions held hearings, commissioned many papers, and sponsored major empirical studies.5 Both were covered regularly by major newspapers and the trade press, and both issued ten reports, though the President's Commission also issued a very useful summary report.
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From page 266... ...
, on institutional review boards that review the ethical acceptability of proposed research, and on the basic ethical principles that should underlie research involving human subjects. However, the National Commission was also asked to report on several other topics: psychosurgery, ethical issues in DHEW-supported health services programs, and the applicability of the Freedom of Information Act to research proposals submitted to NIH.
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From page 267... ...
Lowe took an active role in managing the work of the staff and the perception grew that there was a conflict-between his role as an NIH official and the commission's need to independently examine ethical issues in NIH-spon
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From page 268... ...
Only three members of the President's Commission, including its chairman, served throughout the commission's life. The President's Commission had no experiences parallel to the National Commission's intensive first few months on the topic of fetal research (the President's Commission's first report, Defining Death, was issued two years after the commission was appointed)
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From page 269... ...
Although this was valuable on certain topics (particularly those addressed in the report Making Health Care Decisions) , Abram was essentially an informed layperson on most of the issues addressed by the commission.
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From page 270... ...
Includes such items as commission reports and publications, meeting transcripts, and Federal Register notices of proposed and final regulations.
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From page 271... ...
, 1981-1992 Cites in Cites in Federal Register Name of Report Court Cases (regulations) Total Research on Fetus 3 3 Research Involving Prisoners 6 6 Research Involving Children 1 1 Psychosurgery 1 1 Disclosure of Research Information Under Freedom of Information Act 1 1 Research Involving Institutionalized Mentally Infirm Institutional Review Boards 4 4 The Belmont Report 2 2 Ethical Guidelines for Delivery of Health Services by DHEW The Special Study on Implications of Advances in Biomedical and Behavioral Research Swine Flu Consent Review*
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From page 272... ...
There had already been considerable activity regarding Research on the Fetus, Research Involving Children, Research Involving Those Institutionalized as Mentally Infirm (proposed regulations that were never adopted) , and Institutional Review Boards.
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From page 273... ...
Name of Report 1981-1989 1990-Present Total Research on Fetus 10 4 14 Research Involving Prisoners 2 2 Research Involving Children 1 1 2 Psychosurgery 1 1 Disclosure of Research Information Under Freedom of Information Act Research Involving Institutionalized Mentally Inf rm 1 Institutional Review Boards The Belmont Report 5 4 9 Ethical Guidelines for Delivery of Health Services by DHEW The Special Study on Implications of Advances in Biomedical and Behavioral Research Cites to the commission itself 2 2 Commission cited as identifier of an individual 2 2 Total .
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From page 274... ...
, 1981-1993 Cites in Name of Report Court Cases Cites in Federal Register (regulations) Total Defining Death Protecting Human Subjects Compensating for Research Injuries Making Health Care Decisions Whristleblowing in Biomedical Research Deciding to Forego Life-Sustaining Treatment Implementing Human Research Regulations Screening and Counseling for Genetic Conditions Securing Access to Health Care Splicing Life Total 37 1 7 36 1 52 3 5 11 56 7 37 0 ~1 11 08
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From page 275... ...
Protecting Human Subjects was hardly mentioned, perhaps because the recommendation in question was reached easily and involved no issues with ethical bite.) Splicing Life also appeared several times in the Federal Register as NIH established the Human Gene Therapy Subcommittee of the Recombinant DNA Advisory Committee, but most commission reports were in little or no evidence in the federal government's outlet for announcing regulatory activity.
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From page 276... ...
Making Health Care Decisions, Def ning Death, and Securing Access to Health Care were in a middle group, with Genetic Screening and Splicing Life also receiving important attention. The other four reports Compensating for Research Injuries, Protecting Human Subjects, Implementing Human Research Regulations, and Whistleblowing in Biomedical Researc~received almost no scholarly attention.
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From page 277... ...
In this regard, they were asked first about which reports had a "critical impact on public policy in the U.S.," which ones had a "significant impact on thought in the field of bioethics," and which ones had gone "on the shelf tto] collect dust." Then they were asked two pages of questions about each report.
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From page 278... ...
Chi Idren) ; clear enunciation of issues Clarified issues and key matters (e.g., "therapeutic research"; differences between physicians' and researchers' roles; differentiated scientific and ethical issues)
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From page 279... ...
Good data collection and new empirical information Important compilation of data on issue (e.g., Securing Access) Opened new avenues of discussion; framed future discussions; clarified issues; conceptual impact; provided good overview of problem Achieved consensus, and helped build wider consensus on complex ethical issue and provided basis on which future debate can take place Resolved some contentious issues; shaped public policy Provided authoritative crystallization of work in field; provided groundwork for subsequent policymaking Highly influential on professional thinking and public discourse; background effect on medical education Demonstrated need for and usefulness of IRB site visits by knowledgeable people Became standard citation on issue; frequent and/or continued citation Became the model (the "Bible")
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From page 280... ...
The Successes Four reports were identified by most respondents as having had a critical impact on public policy and/or a significant impact on the field of bioethics: The Belmont Report, which identified the basic ethical principles that should underlie the conduct of research involving human subjects; Research on the Fetus and Research Involving Children, which defined the boundaries on ethically permissible research involving these two categories; and Institutional Review Boards, which examined the primary mechanism for protecting the rights and welfare of human subjects. (Although half of the respondents saw Research Involving Prisoners as having had a significant impact on public policy, they did not all agree that this impact was beneficial.)
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From page 283... ...
grappled with together. Institutional Review Boards evaluated an existing regulatory mechanism for protecting human subjects and made recommendations for improvements; matters of fundamental disagreements over ethics were not involved.
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From page 284... ...
Although a thick volume was published, the commission's report made up only the first ten pages; the remainder was appendices. A common characteristic of the failures was their periphery to the commission's core concern about the ethics of research involving human subjects.
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From page 285... ...
However, in the case of the National Commission, neither commissioners nor the staff director had much interest in the topics outside of the commission's core concerns with research involving human subjects. Even the appointments to the commission reflected its core duties.
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From page 286... ...
Though several respondents criticized the report for not being sufficiently critical of medical professionals who ignore patients' desires, or for not dealing with all issues adequately this report seemed to have had the desired impact at all levels. The Partial Successes On the basis of the responses of former members and staff, five President's Commission reports could be classified as partial successes with regard to impacts on public policy and bioethics.
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From page 289... ...
The Dust Collectors Four reports of the President's Commission were seen by most respondents as having had little effect on public policy or on the field of bioethics and as having gone on the shelf to collect dust. These were the three reports on research with human subjects the two biennial reports that were part of the commission's mandated oversight function, and the report on Compensatingfor Research Injuries and the report on Whistle-Blowing.
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From page 290... ...
The fact that only a few respondents perceived an impact is probably not surprising, although some noted that the report had opened a topic that has become more important in subsequent years. In sum, respondents agreed that only two reports, Defining Death and Decisions to Forego, had a critical impact on public policy, and several mentioned Making Health Care Decisions in this regard.
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From page 291... ...
, and Making Health Care Decisions (4~. However, in contrast to the National Commission, all of the other reports were seen by at least two respondents as at least "partially successful." So, compared to the members and staff of the National Commission, respondents from the President's Commission saw it has having hit fewer home runs, but also as having struck out less often.
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From page 292... ...
Excellent staff work Assembly or development of pertinent information through commissioned papers, new research, and site visits Public policy and scientific need; public interest in the topic Some topics were outside the commission's expertise Impact of some reports on vulnerable populations was reduced once the Belmont Report and the principles it identified were released Commission had no authority on some topics Subsequent interventions by politicians (e.g., Fetal research) Subsequent poor regulation writing by DHHS (e.g., Institutionalized Mentally Infirm)
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From page 293... ...
Moreover, the Reagan appointees mostly had different ideological views on certain issues than did the commissioners and staff that had already done substantial work on a topic, particularly the report on access to health care.) There were also allusions to conflicts between the executive director and staff members assigned to particular topics, perhaps an inevitability when both roles are filled with people with strong credentials and, in some cases, with disciplinary differences.
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From page 294... ...
Politics White House Politics Research on the Fetus Research Involving Prisoners Research Involving Children Psychosurgery Disclosure of Research Information Research Involving Institutionalized Mentally Infirm Institutional Review Boards 1 2 The Belmont Report Ethical Guidelines for Health Services Special Study Total Mentions 2 1 5 5 3 1 4 6 12 1 6 1 * Those citing budget constraints were referring to the absence of budget constraints.
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From page 295... ...
Thus, while a typical National Commission recommendation included specification of regulatory actions a particular agency should take, the President's Commission's conclusions and recommendations (Defining Death, Protecting Human Subjects, and Compensating Injured Research Subjects excepted) were aimed at a broad audience of policymakers, professionals, and the public at large.
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From page 296... ...
Name of Report White Time Budget External Congress. House Constraint Constraint Interest Politics Politics Research on the Fetus Research Involving Pr~soners Research Involving Children 1 Psychosurgery Disclosure of Research Information Research Involving Institutionalized Mentally Infirm Institutional Review Boards The Belmont Report Ethical Guidelines for Health 5 3 3 3 4 4 2 1 6 4 1 2 2 2 2 Services 5 3 3 2 1 Special Study 4 2 2 1 1 Total Mentions 25 6 20 17 6 whether these are objective differences, since different evaluators are involved.
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From page 297... ...
The National Commission made recommendations that enabled important research to proceed within a regulatory framework that both policymakers and the research community found acceptable. There were times when that did not seem possible.
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From page 298... ...
suppressed because of commission's or staff director's views and desire for professional support of report and to keep report in line with emerging consensus in field (Defining Death) Commissioners generally less qualified and involved than staff Some topics were not priorities; some reports less substantial Strong language in one report (Securing Access)
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From page 299... ...
These create difficult problems for a study commission that is striving to reach agreement on difficult value questions. Time-consuming conflicts on reports-in-progress can result from membership changes.
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From page 300... ...
Name of Report Time Budget External Constraint Constraint Interest White Congress. House Politics Politics DeJin~ng Death Protecting Human Subjects Compensating for Research Injuries Making Health Care Decisions W7zistleblowing in Biomedical Research Deciding to Forego Life-Sustaining Treatment Implementing Human Research Regulations Screening and Counseling for Genetic Conditions Securing Access to Health Care Splicing Life Total Mentions 1 4 2 3 1 12 1 1 1 2 2 3 1 1 1 1 4 4 29 4 3 Lesson Three The appointment of commissions is a very complicated matter, full of trade offs and dangers.
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From page 301... ...
and those who bring substantive expertise; between recommendations designed to be adopted by policymakers and recommendations that are intellectually satisfying to rigorous thinkers; between recommendations that will solve an immediate problem and recommendations that will not be accepted but may be admired and even adopted some years later; between consensus achieved by making language general or fuzzy and a strong, clear recommendation accompanied by a strong, clear dissent. There is no one right answer for any of these matters, but the itemization shows how many balances must be stuck in the course of designing and executing the work of a commission.
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From page 302... ...
White Time Budget External Congress. House Name of Report Constraint Constraint Interest Politics Politics Defining Death 1 1 Protecting Human Subjects 2 1 1 Compensating for Research Injuries 2 1 5 2 2 Making Health Care Decisions 5 Whistle blowing in Biomedical Research 1 1 Deciding to Forego Life-Sustaining Treatment 5 1 1 1 Implementing Human Research Regulations Screening and Counseling for Genetic Conditions Securing Access to Health Care 3 Splicing Life 3 4 3 1 3 1 1 1 2 2 4 8 Total Mentions 27 7 15 10 14 Lesson Four A strong staff can overcome serious shortcomings of a co~nmimion itself.
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From page 303... ...
If a commission is asked to study and make recommendations on several topics, a particular topic can become an orphan. If this happens, a perfunctory report may result (as with the National Commission's Special Study or its report on ethical issues in the delivery of services by the Department of Health, Education, and Welfare)
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From page 304... ...
Second, reports can fail to have an impact when there is no particular target for the recommendations, as was the case with the President's Commission's report Making Health Care Decisions. The most that staffers could realistically expect of the report's call for more shared decision making between doctors and patients was to have an influence on medical education; this is a very diffuse kind of impact and no one had much confidence that the issuance of a commission report—even one that based a satisfying ethical argument on solid empirical grounds (including survey data on
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From page 305... ...
The congressionally created Biomedical Ethics Advisory Committee foundered over issues of mandate and appropriations and disbanded without ever issuing a report. Earlier, the Ethics Advisory Board, which was created by the Department of Health, Education and Welfare in 1978, demonstrated its ability to respond in a timely fashion to issues of biomedical ethics, but was eliminated with the stroke of a bureaucrat's pen when funds were needed elsewhere.
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From page 306... ...
5. The major examples were the National Commission's study of the Institutional Review Board system and the President's Commission's extensive survey research project of the public and physicians to provide documentation for its report Making Health Care Decisions.
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