The second major area of Commission recommendations centers on improving the present handling of reports of harm or misconduct involving human subjects. Although such reports are not frequent, the Federal government already has a number of relevant regulations on the books. The Commission examined these regulations to determine whether they provide adequate protection to subjects and other concerned parties in a manner that is clear and simple to apply for Federal officials and research administrators alike. The resulting recommendations fall into three groups.

First, this Report contains recommendations about the responsibilities of the Federal agencies in responding to reports of misconduct. Revisions are needed because of an apparent lack of well-defined standards and an absence of coordination among various Federal entities. The present processes are still relatively new and few cases of misconduct have been reviewed; in fact, it was not until 1981 that

HHS or its predecessors imposed any sanctions against an investigator for misconduct in research funded by the Department that involves human subjects. Cooperation, not merely between Federal agencies but also among them and state and professional boards, is clearly an important goal [Recommendation 9].

Second, several recommendations are made to allow institutions internal flexibility in how they will investigate and adjudicate complaints against researchers. Although perhaps not intended by the Department the present language of the HHS regulations has been interpreted by some as making Institutional Review Boards (IRBs) responsible for resolving allegations of misconduct and for reporting their determinations directly to the Secretary rather than through institutional channels. The IRB must have a place in the process (at a minimum, it must be kept apprised of the outcome), but it need not perform the investigatory/adjudicatory/reporting roles if those are more properly fulfilled by other offices within an institution [Recommendations 7 and 8].

Finally, the Commission recommends that the number of subjects involved in, as well as the number adversely affected by, each research project be routinely collected by

IRBs and reported by them to the sponsoring agencies [Recommendation 4].

In recommending ways in which the federal regulations on research could achieve greater clarity, simplicity and realism, the Commission is not adopting the view that all problems are ultimately soluble by "better" regulations. The Commission took concerns about excessive regulation into account in framing its recommendations and in drawing up its plans for further study of this subject during the coming year. As Plato observed, in esoteric areas, one must rely also on the wisdom of the expert. If society relied totally on written rules,

the arts as we know them would be annihilated and... could never be resurrected because ... this law [would put] an embargo on all research. The result would be that life which is hard enough as it is, would be quite impossible then and not to be endured.1

Just as society must rely on the experts' wisdom, so too must it rely on their consciences-for which reasonable and well-formulated regulations may still provide both instruction and incentive.

1 Plato, Statesman *229e (J.B. Skemp trans.), Yale University

Press, New Haven (1952) at 208.

Introduction

1

The Mandate

The Commission's mandate regarding the protection of subjects in research with human beings has two major parts: first, to review the Federal rules and policies governing such reseach1 and second, to determine how well those rules are being implemented or enforced. Specifically, Section 1802(c) of the enabling legislation provides that:

The Commission shall biennially report to the President, the Congress, and appropriate Federal agencies on the protection of human subjects of biomedical and behavioral research. Each such report shall include a review of the adequacy and uniformity (1) of the rules, policies, guidelines, and regulations of all Federal agencies regarding the protection of human subjects of biomedical and behavioral research which such agencies conduct or support, and (2) of the implementation of such rules, policies, guidelines and regulations by such agencies, and may include such recom

1Section 1802(c) of the Commission's legislation mandates a report on the rules governing research that Federal agencies "conduct or support." The Commission has chosen, pursuant to its authority to study "any other appropriate matter which relates to biomedical or behavioral research," to include within the present study the rules of the Food and Drug Administration (FDA) governing research regulated but not supported by the Federal government. The FDA was singled out because of its preeminent role in regulating biomedical research supported by private funds (under applicable law, materials submitted to obtain FDA approval of drugs and devices must have been produced through research that meets its requirements, including regulations for the protection of human subjects) and because of the close relationship between the FDA regulations and those applicable to research funded by HHS, of which FDA is a component.

mendations for legislation and administrative action as the the Commission deems appropriate.2

The first portion of the mandate expands the survey of Federal agencies that the Commission's predecessor, the National Commission for the Protection of Human Subjects conducted, to a detailed inquiry into the adequacy of the rules of all agencies. The second portion, which adds a new dimension to the inquiry, has emerged as a major focus of this Commission's activities in the wake of the new rules or research promulgated by the Department of Health and Human Services in January 1981.

The first biennium for this Report, which began when the Commission held its first meeting in January 1980, ends in December 1981. (The second "biennium" will end in December 1982 when the Commission's present authority expires.) This report, therefore, represents two years of study and deliberations during which the Commission held three public hearings on this subject, devoted significant portions of twelve meetings to discussion and deliberation, surveyed over 83 Federal agencies to ascertain their involvement in—and rules governing-research with human subjects, requested detailed information from the five agencies having statutory liaisons with the Commission (the Department of Health and Human Services, the Department of Defense, the Central Intelligence Agency, the Veterans Administration, and the National Science Foundation), and participated in Congressional hearings on several issues encompassed within this aspect of the Commission's mandate.3 During this period, frequent correspondence and meetings took place between officials of the Department of Health and Human Services (HHS) and the Commission. This introductory chapter briefly describes the Commission's activities relating to this portion of its mandate. Initial Recommendations to

the Department of Health and Human Services

In September 1980, following a public hearing held in July on social science and behavioral research, the Commission made recommendations to HHS Secretary Patricia R. Harris (see Appendix D) on the Department's proposed revisions to its rules governing research with human subjects (45 CFR 46). The Commission proposed specific exemptions from prior review for most forms of social science re

2 Title XVII, Public Health Service Act, 42 USC 300v-1(c).

3 Commission staff was also in touch with the Commission on the Federal Drug Approval Process, sponsored by Representatives Scheuer and Gore. That body is now reported to have decided not to disturb the status quo regarding the responsibilities of IRBs or other aspects of the regulations to protect human subjects.

search and some categories of behavioral research that present no risk of physical or psychological harm and no invasion of privacy. These recommendations were in line with the proposals being considered by the Department, but differed from them in that they were organized so as to convey the grounds for each category of exemption to the members of local review boards at research institutions who would have to apply them.

The Commission also informed Secretary Harris of its conclusion that the Department currently lacks statutory authority to require grantee institutions to follow HHS regulations and procedures in reviewing reserch not supported by Departmental funds. The Director of the Office of Management and Budget and the Director of the Office of Science and Technology Policy subsequently endorsed the Commission's position. (Whether such authority should be granted to HHS or other Federal departments is a question the Commission will address in the next Biennial Report.)

The amendments to the HHS rules governing research with human subjects were published on January 26, 1981 to take effect on July 27, 1981.4 In their final form, the regulations incorporated the recommendation made by the Commission to limit the scope of the regulations by abandoning the proposed applicability to research neither funded by the Department nor subject to the regulatory authority of the Food and Drug Administration (FDA). The Department did not, however, adopt the Commission's formulation of the rationale and organization of the exemptions of certain kinds of social science and behavioral research. (The relevant materials appear in Appendix D.)

Summary of the Commission's Activities

Survey of Federal Rules and Procedures Governing Research with Human Subjects. The Commission sent letters of inquiry to 83 Federal agencies that might possibly be conducting or supporting research with human subjects. The responsible officials were asked whether their agencies conduct or support research with human subjects and, if so, what regulations or guidelines they follow to assure that such subjects are protected. In all cases, agencies were asked to include copies of applicable regulations, guidelines, or policies with their response.

Chapter Two of this Report contains an analysis of the adequacy and uniformity of the rules and procedures of the 23 Federal entities reporting that they conduct or support research with human subjects, as well as of the rules and procedures of the FDA, which plays the dominant role in the regulation of biomedical research not funded by the

446 Federal Register 8366, reprinted in Appendix A.