Perhaps one of the strongest findings we have is what we consider an inadequacy in the role of continuing to review the research protocols, as opposed to the initial approval of the protocols. We identified threats to the independence of the boards, a lack of training, and a lack of evaluation and oversight. In response, Mr. Shays, to your request that we try to deal with coming to grips with the problem, we concentrated in the reports on offering a framework for solution. In this report we offer, I think, a lot more recommendations than we usually do in our reports; and we tried to present them in a framework that the research community could use to consider some of the problems that we raised in the report. I won't repeat them now because they are in the report and they respond to the findings that we have here. Mr. SHAYS. Let me just say to you, I'm going to roll over the clock, and just expect that you'll stop between the 5 and 10 minute framework. Mr. GROB. OK. I think I can summarize now, perhaps, if you will allow me to put things in perspective. In the most recent reports, we did not attempt to systematically identify the extent of the problem that was out there. We thought that the problems that we had found earlier were enough to warrant a look at the system itself and that's where we concentrated our efforts. In this report, we don't claim that the research abuses are particularly widespread. We just haven't done enough random studies to know that that is the case. And we recognize very much the dedicated and conscientious board members often working long hours as volunteers to deal with these problems. In fact, we even went out of our way to produce one report that showed innovations and promising approaches that these IRBs themselves were developing to improve the way that research is done. Nevertheless, we end with a feeling that this is the time for the reform of this system; and we would urge action to be taken as soon as possible. Thank you very much. [The prepared statement of Mr. Grob follows:] Good morning. I am George Grob, Deputy Inspector General for Evaluation and Inspections in the U.S. Department of Health and Human Services (HHS). I am pleased to testify at today's hearing on Institutional Review Boards (IRBs). With me is Dr. Mark Yessian, Regional Inspector General for Evaluation and Inspections in our Boston office. Mr. Chairman, the IRB system, which has provided important protections for human subjects for so many years, needs to be reformed. While I bring you no evidence of widespread harm to research subjects at this time, I do feel obligated to call your attention to weaknesses inherent in the system that was designed to protect them. Research and medicine have changed dramatically in the past decade. However, our system for ensuring human-subject protections has not kept pace with these changes. Its shortcomings could become more apparent and significant in light of future developments. These include plans to increase the Federal investment in cancer and other biomedical research and a number of recent proposals recommending greater responsibilities for IRBs in the areas of genetics and patient confidentiality. My testimony is based on more than a year of inquiry into the work of IRBs that we have just completed and on an earlier study performed by our office. Today we are releasing four reports that describe the results of our recent work. Our total effort reveals a brittle system Human Resources Subcommittee June 11, 1998 and even a few cracks. I call these to your attention now in the hopes of preventing more serious problems in the future. Background on Our Inquiry We initiated the broad, systemic review in response to concerns raised in a prior Office of Inspector General study. In that study, we examined clinical trials involving four investigational medical devices, and, in each case, discovered limitations related to IRB review. These concerned serious matters such as the implantation of a device in three times the number of human subjects specified in the IRB-approved research protocol, the initiation of a research effort without the changes called for in the informed consent document, and the continuation of a research project for six weeks beyond when the IRB had suspended it. We were also aware of concerns about the IRB system raised by others. For instance, in its 1995 report, the Advisory Committee on Human Radiation Experiments questioned the adequacy of the IRB review process and the effectiveness of Federal oversight. In that same year, the General Accounting Office issued a report identifying numerous factors inhibiting IRB performance. Human Resources Subcommittee House Government Reform and Overnight Committee June 11, 1998 Page 2 In our most recent inquiry, we conducted a broad-based analysis of the IRB system in order to gain an in-depth understanding of (1) the challenges facing IRBs and (2) how the IRBs and the Federal government were meeting these challenges. Toward that end, we developed a multi-faceted methodology drawing on many sources. These included analyses of Federal records; an extensive literature review, site visits to IRBs in 6 academic health centers; additional site visits accompanying FDA inspectors; a survey on the electronic e-mail forum for those associated with IRBs; and the systematic gathering of data from representatives of about 75 IRBS. IRB Role: Trust but Verify The IRB review system is rooted in trust. IRBs work closely and collaboratively with researchers, assuming the best of intentions on their part. This is one of the traditional strengths of the system. At the same time, IRBs have important responsibilities and authorities for verifying that the intended human-subject protections are, in fact, being provided. In the 1970s, the national commission whose work established the foundation for Federal IRB regulations elaborated at some length on the kind of verification efforts that IRBs might undertake. The Federal regulations established in the 1970s and 1980s recognized the importance of such verification by giving IRBs the authority "to observe or have a third party observe the consent process and Human Resources Subcommittee June 11, 1998 the research." Further, it required IRBs to conduct continuing reviews of approved research "at intervals appropriate to the degree of risk, but not less than once a year." The National Institutes of Health has informed IRBs that these reviews must be "substantive and meaningful." Other groups such as clinical audit teams, clinical trials coordinators and research sponsors themselves have responsibilities in overseeing the research process. However, IRBs are the sole bodies whose central mission is the protection of human subjects. This fact emphasizes the importance of IRBs' role in verification. (For further background information on IRBs, see the primer attached at the end.) MAJOR FINDINGS Our overriding finding is that the system of protections that has been so carefully developed over the years is in need of reform. We base this conclusion on six main findings that we present below. 1. IRBs Face Major Changes in the Research Environment. As I mentioned, Federal IRB regulations were established during the 1970s and early 1980s. At that time, most human-subjects research took place under government funding in a H man Resources Subcommittee House Government Reform and Overnight Committee June 11, 1998 Page 4 |