gations were still in process.35 He then agreed to meet with Commission staff to discuss the possibility of a written response. When the written response was delivered to the Commission in mid-November, Dr. McCarthy stated that it would be premature to answer the series of questions about debarment procedures because Secretary Schweiker had by then agreed to a meeting to discuss those issues, among others.36 On December 3, 1981, Secretary Schweiker, together with the Assistant Secretary for Health, the Assistant Secretary for Planning and Evaluation, and two members of the Executive Secretariat, met with Commission Chairman Abram, and the Executive and Deputy Directors of the Commission. As a result of a full exploration of the issues, the Secretary proposed that the Assistant Secretary for Planning and Evaluation work with senior Commission staff to spell out standards under existing regulations for the Department's response to reports of misconduct that would meet the concerns of the Commission as well as those of HHS and the research community. The Commission welcomes this collaborative effort and fully expects that its next Biennial Report will describe the articulation-and implementation-of the relevant policies and procedures. The FDA's Disqualification Procedures. The FDA has had disqualification procedures in place for a number of years, and since 1964 has invoked those procedures to disqualify 42 scientists from further research under that agency's jurisdiction for varying periods of time. Twenty-six of those disqualifications occurred within the last five years.37 Serious deficiencies in the conduct of research, including fraudulent reporting of data or noncompliance with regulations for the protection of human subjects, can form the basis of a disqualification proceeding at FDA. As explained more fully in Appendix E, however, the process of systematic sharing between NIH and FDA of information about scientists who are the subject of an investigation or who have been subject to agency sanctions is not yet fully developed. Active sharing of information regarding formal findings of misconduct with other Federal 35 Letter to Barbara Mishkin from Charles R. McCarthy (September 1, 1981); see Appendix F. 36"These questions overlap with many of the questions answered in Secretary Schweiker's letter of April 15. Since the Secretary has agreed to meet with the Chairman and Commission staff, it would be premature to amplify what was said in the April 15 letter." Letter to Barbara Mishkin from Charles R. McCarthy (November 10, 1981); see Appendix F. 37 FDA list entitled "Investigators Found Ineligible to Receive Investigational New Drugs" (December 7, 1980). agencies or with appropriate state licensing bodies or professional societies is limited to a "need to know" basis (i.e., if the investigator was employed by a state or is known to have received NIH support). Thus, although the formal findings following an investigation are publicly available on request, only limited efforts are made to alert other organizations that a physician or scientist has been found guilty of serious misconduct in research involving human subjects. Questions Posed to Other Federal Agencies. On June 11, 1981, the heads of each of the 18 agencies known to conduct or support research with human subjects were asked to provide a description of: 1. Policies or procedures (formal or informal) by which their agency evaluates or monitors the actual performance of agency or extramural Institutional Review Boards (e.g., reporting requirements, site visits, record reviews); 2. Standards and procedures to guide the investigation of complaints regarding the review or conduct of research involving human subjects; 3. The number and character of any such reports or complaints received in the last 5 years (FY 1976– 1980); and 4. The manner in which these complaints were disposed of, the findings that were made, and the sanctions, if any, that were imposed. As a result of that inquiry, the Commission finds that the situation in the other Federal agencies that conduct or support research with human subjects is virtually identical to that existing at the NIH, insofar as most of those agencies follow the policies and procedures set forth in the HHS regulations (45 CFR 46). Outside of HHS, only five agencies report having received complaints. The Bureau of Standards, within the Department of Commerce, reported two injuries to subjects, the Bureau of Prisons reported one tort action (arising from research supported by the CIA and conducted between 1955 and 1961); the CIA reported the same complaint and one other also arising out of research conducted in the 1950s; the Environmental Protection Agency reported an incident of accidental exposure of subjects to a throat and eye irritant; and the Veterans Administration reported 5 incidents. (See Appendix B for further details.) Of the five complaints noted by the VA, two proved to be unfounded, two are under investigation, and one resulted in an official reprimand of the principal investigator and his exclusion from further research with human subjects. Most of the agencies reported that they have no formal procedures for investigating or responding to complaints. The exceptions were the Bureau of Prisons, NASA, the Department of Defense and the VA. At the first two, complaints are referred to the Office of General Counsel for investigation. Within the Department of Defense and the Veterans Administration, complaints are dealt with first at the local level and, if necessary, are referred up through normal channels. Within the VA, complaints made directly to the Office of the Medical Inspector in Washington may be investigated either by a local team or by a team designated for that purpose operating out of the Washington Central Office. Activities of the Commission Site Visits to IRBs: An Exploratory Study The Commission decided against conducting another study along the lines of the survey of IRB procedures and performance that was conducted under the auspices of the National Commission for the Protection of Human Subjects. The present Commission's resources of time and money made such a study infeasible. Also, since the system is in some flux after the issuance of new regulations in 1981, the value of such a study would be problematic. Most importantly, however, the Commission concluded that a study of IRBS themselves would fall outside its proper focus: the procedures of Federal agencies and their awareness of the implementation of their own rules. Instead, the Commission has begun an empirical exploration of a new approach that Federal agencies might employ to develop information about the implementation of rules for the protection of human subjects. The approach involves site visits to IRBS by teams of experienced IRB members and administrators from other institutions, with the support of the Commission staff. The Commission's interest in site visits grew from several considerations. First, as has been said, little information currently exists as to how requirements for the protection of human subjects are actually carried out at institutions that receive support for human research from HHS, the largest sponsor of such research. This limitation on existing knowledge has been previously recognized and, indeed, was a factor leading to the National Commission's IRB study. Second, most Federal agencies, including HHS, have no procedures for routinely obtaining such information about IRBs. Third, a new approach for developing such information was proposed by the National Commission, but has not yet been implemented by HHS. Specifically, the National Commission recommended that the then Department of Health, Education, and Welfare carry out "compliance activities, including site visits and audits of Institutional Review Board records, to examine the performance of the Boards and their fulfillment of institutional assurances and regulatory requirements."1 These site visits, said the Commission, should be conducted "routinely" and, in addition to assuring "quality control," should be aimed at "educating, improving performance of IRBS, and providing needed advice. "2 In the Commission's view, this recommendation merits serious consideration. The President's Commission determined that it could play a useful role by specifying the meaning of this recommendation in detailed, operational terms and by exploring on a pilot basis the strengths and weaknesses of this appraoch. Thus, in late 1981 and early 1982, site visit teams formed by the Commission will visit 10-12 institutions. The sites will be selected for their diversity, and will not be "representative" in any statistical sense. The purpose of these exploratory site visits will be to learn whether visits of this type would offer a useful way to develop and share information about IRB functioning. Various methods will be explored, including meetings with IRB members, reviewing records, meeting with investigators, and attending IRB meetings. Each site visit team will be made up of three persons who are experienced IRB members or administrators, in addition to a Commission staff member. 1National Commission for the Protection of Human Subjects, Report and Recommendations: Institutional Review Boards, U.S. Government Printing Office, Washington (1978) at 10. 2Id. at 11. |