Bioethics Commissions: What Can We Learn from Past Successes and Failures?

BRADFORD H. GRAY, Ph.D.

Professor, Institution for Social and Policy Studies, Yale University

Who will live and who will die? Who decides, and on what grounds? Are there certain characteristics-when "defining" life or setting the boundaries of permissible genetic experimentation-that are essential for "humanness"? In distributing risks and benefits, when should choices be left to the consciences of individuals and when should they be constrained collectively-by expert or lay groups, legislators, administrators, or judges? [From Summing Up (1983), 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. Policymakers, the courts, scientists, medical practitioners, patients and their families, and the public at large have been presented with new dilemmas (and new versions of old problems) that involve conflicts between deeply held values. When faced with problems that involve such conflicts, factual disputes, or complicated technical issues, policymakers often create commissions (or turn to commission-like bodies at the Office of Technology Assessment and the Institute of Medicine) for advice.

The question of whether a new bioethics commission is needed is again on the policy agenda. The Office of Technology Assessment is nearing completion of a new report to Congress called "Biomedical Ethics in U.S. Public Policy." The Institute of Medicine's Committee on Social and Ethical Impacts of Developments in Biomedicine is also considering the question.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine Bioethics Commissions: What Can We Learn from Past Successes and Failures? BRADFORD H. GRAY, Ph.D. Professor, Institution for Social and Policy Studies, Yale University Who will live and who will die? Who decides, and on what grounds? Are there certain characteristics-when "defining" life or setting the boundaries of permissible genetic experimentation-that are essential for "humanness"? In distributing risks and benefits, when should choices be left to the consciences of individuals and when should they be constrained collectively-by expert or lay groups, legislators, administrators, or judges? [From Summing Up (1983), 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. Policymakers, the courts, scientists, medical practitioners, patients and their families, and the public at large have been presented with new dilemmas (and new versions of old problems) that involve conflicts between deeply held values. When faced with problems that involve such conflicts, factual disputes, or complicated technical issues, policymakers often create commissions (or turn to commission-like bodies at the Office of Technology Assessment and the Institute of Medicine) for advice. The question of whether a new bioethics commission is needed is again on the policy agenda. The Office of Technology Assessment is nearing completion of a new report to Congress called "Biomedical Ethics in U.S. Public Policy." The Institute of Medicine's Committee on Social and Ethical Impacts of Developments in Biomedicine is also considering the question.

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine TABLE 1 Reports of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research National Commission Reports President's Commission Reports Research on the Fetus, 1975 Defining Death, 1981 Protecting Human Subjects, 1981 Research Involving Prisoners, 1976 Compensating for Research Injuries, 1982 Research Involving Children, 1977 Making Health Care Decisions, 1982 Psychosurgery, 1977 Whistleblowing in Biomedical Research, 1982 Disclosure of Research Information Under the Freedom of Information Act, 1977 Deciding to Forego Life-Sustaining Treatment, 1983 Research Involving Those Institutionalized as Mentally Infirm, 1978 Implementing Human Research Regulations, 1983 Institutional Review Boards, 1978 Screening and Counseling For Genetic Conditions, 1983 The Belmont Report, 1978 Securing Access to Health Care, 1983 Ethical Guidelines for the Delivery of Health Services by DHEW, 1978 Splicing Life, 1983 The Special Study (Implications of Advances in Biomedical and Behavioral Research), 1978 Summing Up, 1983 This paper is written at the request of the IOM committee, which asked for an analysis of the lessons to be learned from the experience of two earlier commissions that are both generally cited as successes 1--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). The National Commission issued ten reports between 1975 and 1978; the President's Commission also issued ten reports (plus a summary report) between 1981 and 1983. (These reports are listed in Table 1.) This paper will explore the senses in which these two commissions were successful and the reasons behind their successes and failures. WHAT MAKES A COMMISSION SUCCESSFUL? The question of what makes a commission successful is far from straightforward. 2 A report that helps to break a policy impasse may be viewed as successful by advocates of one policy option and as a disaster by

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine their opponents. Contemplating the same report, a philosopher or legal scholar might judge its success largely by the intellectual quality and rigor of its analysis, a matter that is distinct from its success as a political document. (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. Even a report whose conclusions or recommendations are rejected in the political process might be considered a success if it becomes the starting point for future discussions of the topic. In terms of its legislative impact, the Commission on the Cost of Medical Care in 1930 failed. Nevertheless, its work is discussed in health policy circles to this day. (Indeed, its final report, Medical Care for the American People [1932], is still in print.) This suggests that the evaluation of a commission's success may depend not only on the criteria that one applies, but also upon one's time horizon. One report's "success" in resolving an issue may prove to be quite temporary, while another report's significance may grow over time. None of this should be surprising. After all, commissions are established under many auspices for a great diversity of purposes-to marshal facts to explain an event, to assess the evidence on a controversial topic, to call attention to (or increase understanding of) a problem, to clarify policy options and make recommendations for action, or to substitute for action when politicians need to do something but cannot agree upon what. A commission may be created either to play up or play down an issue. All of these considerations create perplexing problems for the evaluator of "success." At the very least they suggest that different criteria might be applied to different commissions and to different reports. THE TWO ETHICS COMMISSIONS Table 2 summarizes the similarities and differences between the National Commission (1975-1978) and the President's Commission (1980-1983). Both were established legislatively to deal with ethical issues in research. Both sets of commissioners were selected through a process that reflected both substantive and political considerations. Appointees did not necessarily have expertise in the matters assigned to the commission, although some certainly did, and many had connections with key politicians.4 Whether or not this is desirable-arguments can be made either way-it is probably inevitable, since officials responsible for appointments may pick particular individuals either as an expression of appreciation or respect or because their views on the issues are seen as congenial.

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine TABLE 2 Key differences between the National Commission and the President's Commission National Commission President's Commission Was the first bioethics commission Had National Commission as a model Research involving human subjects was core mandate, but several other topics were involved 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 Secretary, DHEW; law required them to be "to be distinguished in the fields of medicine, law, physical, behavioral and social science, philosophy, humanities, health administration, government, and public affairs," with five (and nor more than five) engaged in biomedical or behavioral research involving human subjects Eleven members appointed by President; all to be distinguished-three in biomedical or behavioral research; three ethics, in medicine or provision of health care; and five in ethics, theology, law, natural sciences, the social sciences, the humanities, health administration, government, and public affairs Members served for life or commission; except for loss of two commissioners through death, no membership charges occurred Commissioners appointed to two-, three-, or four-year terms, complications of changing commission membership; a total of 21 commissioners served Located at NIH; archived independent by discharging initial Executive Director, an NIH official Independent agency Budget negotiations internal to NIH, but budget limitations were not problematic and did not jeopardize commission's independence (though the potential was present) Had annual budget authorization of $5 million; was subject to budget negotiations with OMB and through the congressional appropriations process; potential threat to commission's independence did not become a problem; total expenditures were less than $4 million Staff directory / initial staff selected by NIH official Staff director selected by commission chair and hired other staff Staff director served primarily management and quality-control functions Staff director was key intellectual leader of the enterprise and primary author of several reports

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine National Commission President's Commission Issued homely self-published reports available from the commission Issued professionally designed, glossy reports through the U.S. Government Printing Office Most staff did not begin as specialists in ethics Many staff defined bioethics as their primary professional activity before working for the commission Most staff served for the life of the commission and participated, to a greater or lesser extent, in the entire mandate (though most were identified primarily with particular topics) Many staff worked only on particular reports and had little or no involvement with others Commission created for 24 months, later extended by one year Commission created for four years, later extended by three months There were other similarities in the two commissions. The professional mix of commissioners was specified legislatively and included scientists, ethicists, lawyers, and others. Commissioners maintained their regular positions outside of government, while attending regular (usually monthly) commission meetings. Both commissions had full-time staffs, which prepared background materials and drafted reports, under the guidance of the commissions. Both staffs were headed by lawyers. In both instances the staff was a combination of full-time employees (some were long-term federal employees; others were hired from the outside), part-time employees, and consultants. Some staffers worked on numerous reports; others were specialized. In the aggregate, the commissioners and staff represented a complex mix of bureaucratic savvy, 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. The fact that each commission issued many reports provides an opportunity to understand better the complicated nature of commission success. As we will see, neither commission was uniformly successful across all of its reports. There were also many differences between the two commissions. These differences pertained to the crucially important matters of mandate and the role of commissioners and staff.

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine The Commissions' Mandates The National Commission's core focus was clearly on ethical issues in research involving human subjects. It was directed to issue reports on four types of subject populations (the fetus, children, the institutionalized mentally infirm, and prisoners), 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. Finally, the commission's mandate included Senator Walter Mondale's idea for a "Special Study" of the implications of new developments in biomedical and behavioral research. The President's Commission had a more diverse mandate, which eventually included almost every burning bioethical issue (except abortion itself) on the policy horizon. Certain topics were assigned to the commission by the legislation that created it: informed consent in research and medicine, the definition of death (particularly for patients whose brain function had ceased but whose other major organ systems were still operating, often with mechanical assistance), genetic testing and counseling, differences in access to health services, and issues of privacy in research and medicine. It was also directed to report biennially on the adequacy of federal policies (and their implementation) for protection of human subjects. In addition, the authorizing statute gave the commission the mandate to "undertake an investigation or study of any other appropriate matter which relates to medicine or biomedical or behavioral research ... and which is consistent with the purposes of [the legislation]." As a result, the commission studied and issued reports on genetic engineering in humans (at the request of the White House), compensation for injuries to research subjects, and decision making for terminally-ill patients and seriously defective newborns. Significantly, as we shall see, this last topic, undertaken on the commission's own initiative, became the commission's most successful report. The Roles of Commissioners and Staff The commissions also differed with regard to bureaucratic location, who appointed the commissioners, and the ways the chairs and staff were selected. These differences, in turn, help account for some more subtle differences in the functioning of the two bodies. Both of these commissions issued reports that were innovative, well-documented, carefully argued, persuasive, and influential. But the relative strengths of the mem-

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine bership and staff of the two commissions were quite different from each other. The strength of the National Commission lay in its membership and chair. The President's Commission's strength lay in its staff. The difference between the commissions was not a simple matter of credentials and intellectual strengths of their members. Like the National Commission, the President's Commission had distinguished members, particularly the original set of appointees. The differences lay in other areas. The National Commission's membership strength came from several factors. The first was its commitment and continuity. The commission had the same membership, except for the death of two members who were not replaced, throughout its existence. With its first report-on fetal research-due four months after the members were installed, the National Commission established a pattern of meeting monthly on a Friday and Saturday. Under time pressure and with considerable attention from national media and trade publications (meetings were public), the commissioners struggled intensively to find ways to reconcile their differences, particularly their deep moral division over the abortion issue. They held hearings, commissioned and discussed background papers, and had extended, passionate deliberations. The divisiveness of the issues and the differences between the commissioners-not only regarding abortion but also in their professional backgrounds (ranging from the chairman of obstetrics/gynecology at Harvard, Kenneth Ryan, to deeply anti-abortion law professor, David Louisell) could have destroyed the possibility of respectful working relations among the commissioners. The chemistry worked in another way, however, and the pattern was established of members taking each other's views very seriously and seeking common ground on which to base recommendations. (Also contributing to the working relationships among commissioners and staff was a practice, established at the very beginning, of a social occasion or dinner on the Friday night of the commission's two-day meeting. Bonds and a group history developed that would be hard to match.) One other early development in the National Commission's life set the tone for the relative roles of the commission itself and its staff. Under the legislation that created the commission-the National Research Act of 1974-members were appointed by the Secretary of Health, Education, and Welfare and the commission was located administratively in the National Institutes of Health, even though several of the topics assigned to the commission fell outside of NIH's jurisdiction. NIH appointed Charles U. Lowe, M.D., a career employee, as executive director, and he hired the staff director and staff, which included two members of his own staff. 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-

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine sored research. The tensions grew quickly in the first few months of the commission's life and culminated in the commission's decision to request Dr. Lowe's resignation. These events dispelled any doubt regarding whether the enterprise belonged to the commission or the staff, and left the staff in the hands of staff director Michael Yesley, a career government lawyer who had been hired from the Department of Commerce. Yesley devoted himself to making sure that the staff was doing what the commission wanted. An important, regular staff responsibility was to convert the commission's discussions into draft material-the meeting transcripts that arrived in the staff office a few days after the meeting were reviewed very closely for guidance-that would be mailed ten days before the next monthly meeting. (The staff also engaged in many other activities, such as commissioning background papers requested by the commission, organizing hearings and site visits, and planning and overseeing empirical research in support of the commission's deliberations.) All of this contrasted with the President's Commission. The President's Commission experienced enormous turnover of membership. Two of its initial 11 members had to be replaced during the first year because the enabling legislation did not allow federal employees to be members, and another was replaced the next year. Then, in 1992, eight of 11 commissioners were replaced in the last year of the commission's life as a result of the law's provision for a rotating membership and the election of Ronald Reagan. Thus, while a total of 11 individuals served on the 11-member National Commission, 21 individuals served on the 11-member President's Commission. 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) or the National Commission's frequent social occasions. As one staffer noted, there was never a ''family" feeling within the President's Commission. There were also leadership contrasts. The National Commission's chair, Kenneth Ryan, M.D., was elected chair by the commission itself at its first meeting. He was the commission's own designated leader. As a physician and researcher from a prestigious institution (chairman of obstetrics/gynecology at Harvard Medical School and chief of staff at Boston Hospital for Women), he was able to speak with authority on the core topics in the commission's mandate. Ryan had extensive experience with many of the issues considered by the commission and was the clear leader of the entire enterprise through the commission's life. By contrast, the chair of the President's Commission was appointed.

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine Although Morris Abram's appointment by the President unquestionably carried enormous prestige, it was understood that the appointment was a reflection of President Carter's gratitude for Abram's role in Carter's election. Abram's most pertinent experiences were as a patient who had received experimental treatments for a potentially fatal disease. 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. Perhaps in recognition of this, he selected a staff director, Alexander Capron, who was a nationally recognized expert on legal and ethical issues in medicine and science and who had published books and articles on many of the topics that were taken up by the commission. Abram worked closely with Capron for guidance about how the commission should address the issues on its agenda and was relatively distant from both the staff and other members of the commission. Capron, in turn, hired a strong staff made up primarily of professionals who had made career commitments (in law, philosophy, sociology, and medicine) to the issues on the commission's agenda. Individually and as a group, the President's Commission's staff probably had stronger professional credentials than did the commission itself. So, the National Commission's staff was dominated by career governmental employees for whom the staff role was already familiar. The President's Commission staff was dominated by people from outside of government who identified primarily with their fields of professional activity and disciplinary work. As was evident in my survey in 1993, they continue to evaluate the President's Commission's reports primarily in terms of its scholarly quality. The National Commission was clearly more interested in finding a set of recommendations that they could agree upon than in laying out a rigorous line of reasoning regarding how they got there. METHODS OF THIS INQUIRY What does it mean when the National Commission and the President's Commission are said to have been successful? And how and why did this success vary across their various reports? I approached these questions by using objective measures of influence as well as seeking the views of former members and staff of the two commissions. For each commission, the major variable across reports was the topics themselves.6 I sought lessons about the success of these two commissions by seeking to understand the differences in impact from report to report. Two methods were used. The first involved searches of on-line databases (Nexis, Lexis, and Medline) for citations to the reports of each commission. The second involved a survey of former members and staffers of the two commissions to obtain their assessments of their work and of differ-

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine ences in the success of the reports issued by their commission. (I should note that I served on the staff of the National Commission and was a long-term consultant to the President's Commission. My views about the two commissions and their reports are not among those reported later in this paper, but my experiences no doubt influence my interpretations.) Citations to Commission Reports In April and May of 1993, searches were done of pertinent databases for citations to the two commissions and their reports. Table 3 shows citations to both commissions in the news media covered in the Nexis online service. Table 3A shows cites to the two commissions in the National Library of Medicine's Bioethicsline database. It shows a similar number of cites for the two commissions. Tables 4, 5, and 6 respectively, show citations to each National Commission report in court cases and the Federal Register,7 medical journals (including the ethics journals included in the National Library of Medicine's Medline database), and law reviews. Tables 7, 8, and 9 have similar tables for the President's Commission's reports. Unlike the Nexis and legal databases, the Medline data base does not contain the full text of articles; the searches reported in Tables 5 and 8 report only mentions of the two commissions in the titles or abstracts of articles, not in the text or footnotes of the articles. Thus, the data provide TABLE 3 Number of Citations in News Database (Nexis Omni) to the Two Commissions, Through 1992 National Commission: 57 President's Commission: 238 NOTE: The impact of the National Commission is substantially undercounted here because this database did not exist until five years after the National Commission began. These data are presented for information only. TABLE 3A Citations to Both Commissions in National Library of Medicine's BIOETHICSLINE Database, Through 1992   News and Scholarly Articles and Books All Citations* National Commission 177 234 President's Commission 171 214 *Includes such items as commission reports and publications, meeting transcripts, and Federal Register notices of proposed and final regulations.

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine TABLE 4 Citations to the National Commission in Court Cases (Lexis— GenFed Mega search) and in the Federal Register (Lexis—GenFed Allreg search), 1981-1992 Name of Report Cities in Court Cases Cities in Federal Register (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* 6   6 Cites to the commission itself 1   1 Total 11 14 23 NOTE: The Lexis data base does not begin until 1981, three years after the last National Commission Report was issued. * Under the legislation that indemnified manufacturers of swine flu vaccine in 1976, the commission reviewed the consent forms prepared by the Centers for Disease Control for the Swine Flu Program. This activity did not result in a published report. an indication of the relative frequency of articles about reports of the two commissions, but this approach is far from a full measure of the impact of these reports on the scholarly and scientific literature. A further caveat about these tables is needed. Except for the Bioethics line (Table 3A), these tables should not be interpreted as comparing the two commissions' impact. The other databases did not come into existence until several years after the National Commission's reports were issued and so do not capture the initial responses to the National Commission's work. This is important because commission reports generally receive the most intense attention while reports are being prepared and immediately after publication. The value of these tables is in the comparison across each commission's reports. The data in the tables are a much more complete indicator of the President's Commission's impact than the National Commission's. Even so,

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine TABLE 18 Factors that at Least One Respondent Saw as Having a Negative Effect on National Commission Reports. Fixed-response Items from Survey of Members and Staff, 1993   Factors Cited as Positively Affecting each Report by any Respondent (number citing each factor) Name of Report Time Constraint Budget Constraint External Interest Congress Politics White House Politics Research on the Fetus 5     4   Research Involving Prisoners     4 2 1 Research Involving Children 1   1     Psychosurgery 3   6 4 1 Disclosure of Research Information 3 1 2 2   Research Involving Institutionalized Mentally Infirm 3   2 2 2 Institutional Review Boards 1         The Belmont Report           Ethical Guidelines for Health 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. Critics of the President's Commission may be tougher, because the experience is fresher, because there was more conflict and disagreement between staff members and the executive director and commission, and because more of the former staff members are academics who may apply scholarly, rather than policy, criteria to reports. Even so, the commissioner-driven versus staff-driven character of the two commissions, described earlier in this paper, may explain the difference. The National Commission staff tended to take its lead from the commission itself, so a topic might be handled in a cursory way if no commissioners cared much about it. By contrast, the executive director of the President's Commission made staffing provisions for all topics, and the staff's performance reflected both on their professional credibility and on the executive director himself. The work of a commission is a combination of three broad factors topics, commissioners, and staff.13 The experience of these two commissions, each of which issued reports that were of highly variable success, demonstrates the importance of all three factors.14 Complex relation-

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine Composition of Commission Role of Staff Framing of Charge Bureaucratic Location Papers/ Studies Done for Commission Public Hearings   1 1 1     1   1 3     3 1   1     2   1 2   3 1 1   1         2 1           1           1     2 2 1 3 1 1 4 1 3 3 2 1 13 6 9 17 3 5 ships between these three factors have enormous implications for commission success. Many of these implications can be summarized into seven "lessons." Lesson One Ethics commissions can play a useful role in helping policymakers, practitioners, and the public at large deal with the value conflicts and ethical dilemmas that accompany new developments in biomedical and behavioral research and technology. A substantial list can be made of the beneficial consequences of the work of these two commissions. (It must be acknowledged that the methods used in this project were not likely to elicit the most critical of views.) 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. President's Commission's reports had an

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine TABLE 19 Explanations Offered to Account for Success or Failure of Reports of the President's Commission. Open-ended Responses from Survey of Former Members and Staff of President's Commission, 1993 Explanations of Success Explanation of Failure The characteristic of the topic-with clear need for clarification and high public interest; time ripe for an authoritative analysis; an eager audience awaited it; issue susceptible to philosophical analysis The particular problem turned out not to be serious or extensive; not a burning issue; little interest in issue   No natural audience for a particular report Existence of substantial scholarly literature on topic Report difficult to translate into action (Making Health Care Decisions) Good background papers by consultants Key aspects of issue had been dealt with already (i.e., by National Commission) Involvement of legal and medical community (Defining Death); involvement of agency liaisons (Implementing Human Research Regulations) Topic did not hold attention of commissioners (Compensating Research Injuries) because of technical difficulty and seeming lack of importance Solid work on law, philosophy, sociology, and history of topic Topic not sexy (Making Health Care Decisions) Investment of time and effort; depth and quality of report; scholarly analysis; new data; strength of underlying philosophical analysis Some arguments in staff drafts were watered down by commissioners Hard and excellent staff work Staff views (and intellectual rigor) 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) Critical interaction between commission and intellectual staff; good staff diplomacy re the commission   Individual commissioners' contributions on certain new topics   Report crystallized ''progressive mainstream thinking" and took apart myths and dogmas Commissioners generally less qualified and involved than staff Clarity of the analysis and writing in the report Some topics were not priorities; some reports less substantial The grounding of difficult issues (e.g., Deciding to Forego LifeSustaining Treatment) not only in philosophical, theological, sociological, and legal terms but also in the experiences of health professionals, families, and patients Strong language in one report (Securing Access) gutted because of changing commission membership; recommendations not specific enough   Report's reasoning too arcane (Compensating Research Injuries)   There are limits to what can be accomplished at once; competing priorities on reports   Acceptance or implementation was defeated by vested interests, bureaucratic resistance, or Reagan era ideology/ political climate

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine enormous effect on very difficult issues regarding the terminally ill and the definition of death. While they existed, both commissions played a valuable role in providing a focal point for work in the field of bioethics, and reports from both groups both lowered the temperature on some heated issues (research involving children, genetic screening) and became important points of reference for much subsequent scholarly work and policy debate. Lesson Two Design details can make an enormous difference in the performance of commissions. Although it is difficult to draw sweeping conclusions based on two case studies, a number of aspects of the ways these commissions were designed seemed to have important consequences. These include: The creation of these bodies as governmental, rather than private entities. Governmental bodies are required to operate under sunshine laws. This was still new when the National Commission was in operation; despite initial concerns, broad agreement eventually developed that the attendance of the press and interested members of the public had a beneficial effect on the process. Appointment versus election of the chair. The National Research Act's unusual requirement that the chair of the National Commission be elected from within its membership had important, positive consequences for the leadership of the commission. Establishing rotating, overlapping terms for commissioners. 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. The rotation of membership will also tend to increase the power of staff. It seems wiser to give a commission a life span and a mandate and to appoint a new commission (with a new mandate) at the end of that life span. Administrative location of the commission. Independence has both perceptual and substantive importance for ethics commissions. The President's Commission's existence as an independent agency had significant advantages over the National Commission's NIH location. Where ideological divisions exist, the appointment process is fraught with potential problems. This is particularly true when political control of the appointing authority changes, as with the Reagan election of 1980. That experience proved that legislative language about "distinguished" appointees or categories of expertise are subject to widely differing interpretations.

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine TABLE 20 Factors that Respondents Saw as Having a "Major Positive" Impact on President's Commission reports. Fixed-response Items from Survey of Members and Staff, Spring 1993   Factors Cited as Positively Affecting each Report by any Respondent (number citing each factor) Name of Report Time Constraint Budget Constraint* External Interest Congress Politics White House Politics Defining Death 1 1 4     Protecting Human Subjects     1     Compensating for Research Injuries     2     Making Health Care Decisions     3     Whistleblowing in Biomedical Research     1 1   Deciding to Forego Life-Sustaining Treatment 1 1 12     Implementing Human Research Regulations     1     Screening and Counseling for Genetic Conditions     1 1 1 Securing Access to Health Care 2 2 3 1 1 Splicing Life     1 1 1 Total Mentions 4 4 29 4 9 Lesson Three The appointment of commissions is a very complicated matter, full of trade-offs and dangers. Clearly, trade-offs and competing considerations exist in many aspects of creating a commission and carrying out its work. Will members be appointed for their expertise or because membership is a plum to be given to acknowledge past political favors? How much does the official who is making the appointments care about the commission and its mandate? Might the official care too much about one or another possible outcome? The experience of the President's Commission shows how the process can be politicized. The combination of a rotating membership and a presidential election can be volatile. And it was not only the Reagan appointees that are the issue here; some observers looking at the commission and staff assembled under the Carter administration found the staff to be better

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine Composition of Commission Role of Staff Framing of Charge Bureaucratic Location Papers/ Studies Done for Commission Public Hearings   6 2 2 4 2 1 3 3 2 1     2     1   4 11 3 1 9 2   3     4 2 3 10 4 2 7 6 1 4 3 2 3 1 3 5 1 1 3 1 1 9 2 2 7 7 1 3 1   2 1 14 56 19 12 41 22 qualified than the commission. Such a perception on the part of a staff makes for complicated dealings with the commission, but no one would suggest that the answer is to appoint a weaker staff. But how does one guarantee that a highly qualified commission will be appointed? Many other trade-offs could be noted: between commissioners who bring visibility to the activity (e.g., Magic Johnson on the AIDS Commission) 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.

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine TABLE 21 Factors that at Least One Respondent Saw as Having a Negative Effect on President's Commission Reports. Fixed-response Items from Survey of Members and Staff, 1993   Factors Cited as Positively Affecting each Report by any Respondent (number citing each factor) Name of Report Time Constraint Budget Constraint* External Interest Congress Politics White House 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         Whistleblowing in Biomedical Research 1   1     Deciding to Forego Life-Sustaining Treatment 5 1   1 1 Implementing Human Research Regulations 3 1 3 1 1 Screening and Counseling for Genetic Conditions 4 1 1     Securing Access to Health Care 3   2 4 8 Splicing Life 3 1 2 1 1 Total Mentions 27 7 15 10 14 Lesson Four A strong staff can overcome serious shortcomings of a commission itself. Conversely, a strong commission can overcome serious staff problems. Both of these commissions are widely viewed as successful. But, as was described earlier, the relative strengths of the membership and staff of the two commissions were quite different. The strength of the National Commission lay in its membership and chair, and to a lesser extent its staff. The President's Commission's strength lay in its staff. Accordingly, the two commissions were characterized by different staff/commissioner relations. Members of the National Commission debated among themselves down to the smallest details of reports, in many cases going line by line over staff drafts to make sure that the staff had captured exactly what commission members had agreed to among themselves. By contrast, staff members of the President's Commission were much more

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine Composition of Commission Role of Staff Framing of Charge Bureaucratic Location Papers/ Studies Done for Commission Public Hearings   1 1       2           5   3 2 1 3 1             1 1       6           1   1       1           9 1 1 1     2 2 2 2 2 1 27 5 9 5 5 4 engaged in trying to work through their own ideas and solutions to the problems assigned to the commission, and meetings had more of a flavor of commissioners providing oversight over what staff had done and of staff trying to sell the ideas that had been developed. Lesson Five Topics need champions-an influential member or staffer who cares about it and insists that the commission care. 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). Or the commission may decide not to even issue a separate report (as with the President's Commission's

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine statutory mandate regarding privacy and confidentiality issues in research and medical care). Because the personal interest of influential commissioners or staff members is so important, the experience of the President's Commission demonstrates that topics that are self-assigned by the commission itself can be handled with enormous distinction. The report Deciding to Forego Life- Sustaining Treatment was not part of the commission's legislative mandate; it was a topic that was undertaken in response to issues that came to the fore during the work that led to the report Defining Death. Lesson Six Although several definitions of success can be applied to commissions, nothing substitutes for having a perceptible impact on either policy or practice. Although the success of a commission is multidimensional and may be difficult to assess objectively, people who are engaged in the enterprise as commissioners or staffers clearly believe a report must make a difference if it is to be considered a success. No matter how well reasoned and carefully documented a report may be, if it does not change something in the world it will be viewed as a failure. Even very high quality reports can fail to have a significant impact on policy or practice. A commission report can contribute to the ripening of a topic by bringing attention to it, but it is also true that carefully documented reports with clear recommendations can be ignored. This is particularly likely under two circumstances. The first is when the policy changes that implementation would require are tightly controlled by vested interests and there is no significant constituency behind the recommendation. (The President's Commission's report Compensating for Research Injuries is a case in point, requiring action by the Department of Health and Human Services with virtually no outside prodding, except from the commission; bureaucratic inertia easily killed the recommended ideas. The same was true of the National Commission's report on Those Institutionalized as Mentally Infirm.) 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

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine people's desire for information and data linking good communication to positive health outcomes)-was likely to have a substantial impact on entrenched patterns. Lesson Seven Recommendations are not self-implementing. Commissions that want to see their recommendations enacted in law or policy need to keep an eye on how agencies or legislative bodies deal with their recommendations. Recommendations issued near the time that a commission disbands and with little publicity and no follow-up are easily ignored by policymakers who have other agendas. The early reports by both commissions tended to have the best chance of being adopted in policy. Requirements that agencies respond publicly to commission recommendations can play a valuable role in this regard-it was particularly important for the National Commission's regulatory recommendations but other mechanisms (e.g., congressional hearings) can play a role. The importance of the public information function and the dissemination of findings in forms in addition to formal reports should be recognized. ACKNOWLEDGMENTS The author acknowledges with gratitude the assistance of Andrea Adams, Mary Anastasio, Jennifer Morgan, and Annie Elizabeth VanDusen. NOTES 1.   Other bodies have had less success. 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. 2.   A substantial literature exists on presidential commissions. Examples include David Flictner, 1986, The Politics of Presidential Commissions: A Public Policy Perspective (Dobbs Ferry, NY: Transnational); Terrence R. Tuchings, 1979, Rhetoric and Reality: Presidential Commissions and the Making of Public Policy (Boulder: Westview), and Thomas R. Wolanin, 1975, Presidential Advisory Commissions: Truman to Nixon (Madison: University of Wisconsin Press). 3.   Prestige is to some extent a function of the prominence of the individual members, but the designation, "President's Commission," itself carries weight and commands attention from the press and the public. This is one reason why the politically powerful sometimes like to create commissions and the politically vulnerable worry about the attention and legitimacy that may be given to a cause or point of view to which they are opposed, and why people from many camps will seek to influence the membership of the commission.

OCR for page 261
Society's Choices: Social and Ethical Decision Making in Biomedicine 4.   For example, both Senator Kennedy and Senator Buckley, who had reached a key legislative compromise involving fetal research-creating a moratorium pending recommendations from the Commission-had visible hands in the selection of commission members, and the chair of the President's Commission was owed a large political debt by President Carter. Political connections undoubtedly had a role in other members' appointments; the least subtle instances occurred when President Reagan made several appointments to the President's Commission after the terms of several Carter-appointed commissioners expired. 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. 6.   This statement requires some qualification, since there was some turnover of commissioners and staff, especially in the instance of the President's Commission. Moreover, since staff members tended to concentrate on certain reports and since the interest and commitment of individual commissioners varied across topics, it could be argued that in a sense the commission and staff both varied from topic to topic or report to report. Yet, for both commissions, there was one staff director and one chairman and substantially the same set of commissioners and staffers throughout the commission's life. 7.   Federal Register citations should be interpreted with caution because the same action may appear numerous times. Moreover, a report may be cited more than once without final regulatory action ever taking place. 8.   In legislation to indemnify vaccine manufacturers so that they would produce the swine flu vaccine, Congress required the Centers for Disease Control to consult with the National Commission regarding the issue of informed consent; the commission met with CDC officials and sent them a letter with recommendations. The consultation (though not the commission's letter) was cited in several lawsuits alleging injuries from the swine flu vaccine. 9.   Rust v. Sullivan; Cruzan v. Missouri Department of Health; Bowen v. American Hospital Association. 10.   In the view of some, this was also a problem with the report on the institutionalized mentally infirm. 11.   A methodological point arose with regard to responses of staffers of the President's Commission, many of whom devoted much or all of their effort to particular topics and who had little or no involvement with other topics. Unlike staffers of the National Commission, who generally attended all parts of all meetings, many President's Commission staffers went to commission meetings (or parts of meetings) only when their particular topic was on the agenda. As a result, President's Commission staffers had more difficulty assessing the process and outcome of the whole group of reports than did National Commission staffers. 12.   Perhaps the best example of timing was the coincidental release of the report on Definition of Death on the same day that an anti-abortion Constitutional amendment that would define the beginning of human life was introduced on Capitol Hill. The juxtaposition was too delicious to be ignored by the media and led to a Nightline appearance that night by the executive director and a member of the Commission, as well as other news coverage. 13.   I first heard a similar formulation from David Goslin regarding projects at the National Research Council. 14.   Adequate resources are also a requisite, but this was not an issue in either of these cases.