Conclusions Concern for the adequacy and uniformity of the rules for the protection of human subjects is raised most immediately by the Federal entities that currently lack procedures and standards that conform with HHS regulations. A lack of internal consistency occurs in two agencies that apply HHS policies and standards to some, but not all, research conducted under their auspices: the Department of Education and NASA. The Commission believes that such regulatory anomalies should be corrected. Further, the policy statements of several agencies that merely refer to HHS regulations "for guidance" should provide more explicit directives. The Commission believes that achieving uniform regulations throughout the Federal government is an important goal. The high costs of nonuniform rules were forecefully articulated in the findings of the Commission on Federal Paperwork: If other agencies are permitted to deviate from or even to paraphrase the NIH/HEW regulations [45 CFR 46], the result will be unnecessary duplication of reporting, recordkeeping, and other activities on the part of the Government as well as the organization involved. Some agencies, including the National Science Foundation and the Department of Agriculture, have accepted the NIH/HEW regulations by reference, without finding it necessary to paraphrase, interpret, or expatiate. Others, even while recognizing HEW's precedence, phrase their regulations so as to require conformity to their own policies. This creates conflict if future changes in their policies and in HEW's are not identical and simultaneous. In addition, it requires multiple submission of general assurances, which are frequently intricate and lengthy documents and which must be updated periodically, 20 The achievement of uniform Federal regulations on the protection of human subjects appears to be an achievable objective, since the present HHS regulations provide common ground which most of the affected agencies can apparently accept. Moreover, HHS regulations permit sufficient flexibility for agencies whose involvement with research is limited. For example, the HHS requirements on IRB review and consent for the collection of personally identifiable incal and Legal Issues of Social Experimentation, The Brookings Institution, Washington (1975); Advisory Committee on Experimentation in the Law, Federal Judicial Center, Experimentation in the Law, U.S. Government Printing Office, Washington (1981). 20 A Report of the Commission on Federal Paperwork: Education, U.S. Government Printing Office, Washington (1977) at 40. formation might be supplemented by the Justice Department if it believes that more extensive safeguards are needed to protect the confidentiality of the sensitive data that are often involved in its research projects. Similarly, the activities of the Department of Housing and Urban Development would not be impeded by inappropriate requirements since it supports primarily social science research, much of which is now exempt from HHS regulatory requirements. If any of the research funded by HUD is of the sort to which HHS regulations apply, however, it should be subjected to IRB review using the standards set forth in those regulations. The three remaining Federal entities that appear to have less than fully adequate policies for the protection of human subjects are part of the Department of Transportation which after four years continues to report that it is in the process of developing department-wide regulations to conform with those of HHS. In summary, the President's Commission has identified the following problems with respect to adequacy and uniformity of Federal rules governing research with human subjects: (1) lack of uniformity among component parts of a department or agency (the Department of Defense, the Department of Justice, and the Department of Transportation); (2) inconsistency with respect to applicability of regulations to all categories of research within a single Federal entity (the Department of Education and NASA); and (3) lack of complete uniformity among all Federal departments and agencies. The Commission believes that all research involving human subjects that is supported by public monies should conform to a uniform "core" of regulations. The provisions announced by the Department of Health and Human Services earlier this year and codified in 45 CFR 46 provide an acceptable starting point for any attempt to achieve uniformity. The Commission notes, however, that many of the variations adopted by other agencies appear sensible and should be reviewed for possible incorporation in the regulations of HHS which, thereafter, should become the standard for all research regulated, conducted or supported by Federal agencies or by direct appropriations from Congress. Specific recommendations for improving the adequacy and uniformity of Federal regulations governing research with human subjects appear in Chapter Five. The Adequacy and 3 In evaluating the implementation of regulations governing research with human subjects, the Commission determined that its most appropriate focus would be not on the IRBs themselves but on the procedures of Federal agencies and on the knowledge these agencies have about the implementation of their rules for protecting human subjects. The Commission reached this conclusion for several reasons. First, it had neither the statutory life nor the budget to undertake an empirical examination of IRBS comparable to the two million dollar study supported by the National Commission for the Protection of Human Subjects from 1975 to 1977. More important, that study is recent enough so that its findings continue to have a great deal of cogency. One of those findings was that IRBS were not consistently implementing Federal policy particularly with respect to the adequacy of consent documents and IRB involvement after initial review of research proposals. Consequently, in making its recommendations on IRBS, the National Commission stressed the need for the Department of Health, Education, and Welfare (as it was then known) to engage in vigorous "compliance activities" to determine how well its regulations were being implemented and to supply necessary education, encouragement or punishment.1 By focusing on implementation from the Federal side, the Commission intends also to encourage an examination of some basic issues about the regulation of human research. The ambiguous nature of the IRB system for regulating human research has never been resolved; indeed, 1See, National Commission for the Protection of Human Subjects, Report and Recommendations: Institutional Review Boards (hereinafter, IRB Report) U.S. Government Printing Office, Washington (1978) at 9-12 (Recommendation 2 and comment). it has seldom been addressed. To answer the simple question, "What is an IRB," one must confront the tension that is so often found with organizational hybrids. Or, to borrow from the fable, the IRB is like an elephant being described by blind men each of whom perceives it differently. The central difference in perception is between a research institution's vantage point and that of the Federal government. In the view of the former, its IRB is a local body; moreover, it is a outgrowth of the traditional informal mode of "peer review" that characterizes collegial, academic settings. Yet from the Federal viewpoint—and as a matter of historical fact2-the IRB today is a local body established under, and responsive to, Federal rules; in effect, it performs delegated functions under the supervision of Federal officials.3 Thus, while past descriptions have emphasized the institutional aspects of the IRB system it seemed appropriate for the Commission to begin its examination of the "adequacy and uniformity of the implementation of the regulations" by focusing on the Federal aspects. In taking up this specific statutory mandate, the Commission does not want to be understood as denying the importance of trust in the IRB system nor as pointing inevitably toward the displacement of such trust by formal review mechanisms. Rather, the Commission began its study of "the implementation of the regulations" by asking responsible officials to report on their means for knowing that the authority delegated to local institutions was being exercised so as adequately to protect human subjects. The result of this initial inquiry was the finding that most agencies, including the grant and contact wings of HHS, have only limited first-hand knowledge of the actual performance of IRBs. The paucity of systematic data was acknowledged by responsible officials, who described for the Commission efforts that have recently been made or that are planned to provide a better ongoing picture of the regulations' actual application. A richer and more detailed understanding of "the implementation of the 2 Bernard Barber, John J. Lally, Julia L. Makarushka and Daniel Sullivan, Research on Human Subjects-Problems of Social Control in Medical Experimentation, Russell Sage Foundation, New York (1973) at 145-48. 3 Although many IRB members may feel uncomfortable with such a description of their role, the reality of their Federal responsibilities cannot be denied. Nonetheless, an IRB is not confined to the functions required by the Federal rules nor need it allow such responsibilities to prevent it from playing a role of internal leadership within its institution. Robert Levine has written tellingly of the cost to an IRB's "local credibility" if it identifies the source of its authority and responsibility as resting outside the institution. Robert J. Levine, Ethics and Regulation of Clinical Research, Urban and Schwarzenberg, Baltimore (1981) at 227. regulations" came from a second source, namely the Commission's examination of the response of Federal agencies to several reports of regulatory violations or of other serious misconduct by grantees and contractors. While the few instances of alleged misconduct and institutional or Federal failings are not regarded by the Commission as representative of contemporary research or of the functioning of the system to protect human subjects, the Commission is acutely aware of the vulnerability of the present system to (probably unjustified) adverse judgements in the absence of systematic data that would allow the "problem cases" to be viewed in proper perspective. The Commission sought information not only from the relevant Federal agencies but also through testimony from IRB members and institutional administrators, papers prepared under contract, conferences attended by members of its staff, and recent articles that have appeared in the literature. (In this discussion, as in the previous chapter, the primary focus will be on the policies and procedures of HHS with which other Federal agencies will be compared and contrasted.) Do Federal Agencies Know How IRBs are Within HHS, two methods are used for obtaining information about IRBs. One approach was developed in NIH for grantee institutions; the other was developed by FDA for research in support of new drug applications. The former approach relies largely on a promise of faithful execution of certain regulatory responsibilities by those at local institutions who have agreed to undertake those responsibilities; the FDA system relies primarily on a system of routine inspections performed during or after the conduct of the research. The Negotiation of "Assurances" by HHS. The procedures set forth in 45 CFR 46 require all grantee institutions to provide written assurance that they will comply with the HHS regulations to protect human subjects. An institution's assurance of compliance must be approved by the Office for Protection from Research Risks (OPRR) within the Office of the Director, NIH. The information contained in an assurance provides the basis on which a determination is made that the composition and operating procedures of the institution's IRB meet regulatory requirements and that the institution is, therefore, eligible to receive HHS grants and contracts for the conduct of research involving human subjects. In the wake of the revisions to the regulations that took effect in July 1981, new assurances of compliance must be negotiated by all institutions. This process will take a year or more. Indeed, the Director of OPRR reports that ne |