Mr. MICA. We'll hear now from our second witness, Mark Yessian. Dr. Mark Yessian is Regional Inspector General for Evaluations and Inspections for the U.S. Department of Health and Human Services. Welcome. The chair will recognize him. Mr. YESSIAN. Mr. Chairman, Congressman Towns, the current system of protecting human subjects who participate in medical research is in need of major reform. This is a conclusion we emphasized in a June 1998 report; it's one that we reiterate here today. Our June 1998 report was based on a year-long inquiry into the work of the institutional review boards. That inquiry led us to sound a warning signal that the effectiveness of the boards is in jeopardy. Here's what we based that on: IRBs review too much, too quickly with too little expertise. They conduct minimal continuing review of approved research. They face conflicts that threaten their independence. They provide little training for investigators and board members. And, not least of all, they must cope with major changes that are fundamentally transforming the research environment from what it was a quarter of a century ago when the current Federal protections were put in place. In our report we made numerous recommendations to the National Institutes of Health and to the Food and Drug Administration. At the core of them was a search for ways to give IRBs more flexibility so they could do their job better, but to hold them much more clearly accountable for results. Let me provide an update, if I could, on what's happened in the year and a half or so since we issued our report. First, I'd say there are some encouraging developments. At the Federal level, the most notable action has been an increased enforcement effort by the Office of Protection from Research Risks [OPRR]. In the year prior to our report, OPRR had made only one site visit to investigate the adequacy of an IRB's efforts. Since that time, it has made numerous site visits, some very high profile and some resulting in the actual suspension of federally funded research at major medical centers. At the local level, a number of institutions have put more resources into their IRBS and a number of IRBS have undertaken training and other educational kinds of initiatives intended to sensitize principal investigators and IRB board members to issues involving human subject protection. Then also at the professional level it's important to note there's some stirring there, too. There's a movement toward certifying IRB administrators and one toward private accreditation of IRBs. Both of these movements have some significance. But as important as these developments are, the system of protections provided by IRBs remains in jeopardy. From the ground up, if you look at IRBS, you see the same danger signs. Expanded work loads, quick reviews, threats to their independence, inadequate information, insufficient training, minimal outside representation. Moreover, and this is the basic point, the underlying pressures on IRBs continue to build and to make it difficult for them to do their job adequately. Let me touch on three of those pressures. The most important one is the increased commercialization of the research environ ment. Industry sponsors, anxious to bring new products to market and to contain their development costs, seek to expedite the clinical trials process and to conduct their trials in the quickest, most efficient settings. For IRBS, this means doing more quicker and better. It also means that it can be quite difficult to slow down the research process by raising nettlesome questions for instance, about the adequacy of the informed consent process. A second pressure is the continuing and escalating pressure on the IRB members themselves. Most of the time these are volunteers that serve on these boards. They find it difficult to spend the time it takes to review proposals that are increasing both in numbers and complexity. Finally, I'll note there's an intensified quest for human subjects. If you look at this as a supply-demand situation, we have a substantial unmet demand for human subjects. This heightens recruitment pressures for research sponsors and investigators and leaves IRBS with many difficult questions to face. For instance, should they be concerned about recruitment bonuses that sponsors give to investigators for subjects? Should they be concerned about the mining of patient data bases to find potential human subjects? What about the payment of fees to physicians referring their patients as potential subjects? What are the standards or guidelines to answer such questions? Where are they? We end up as we did in 1998 calling for a much stronger Federal presence here, and I'll just touch four of the issues that we highlight. There are others, but certainly one would be more extensive onsite performance based reviews of IRBs. The OPRR has started this. It's a good start, but only a start. We recommend this kind of effort intensify and that it conduct both unannounced and announced site visits. We should also not forget the Food and Drug Administration here. They are actually onsite more often than the OPRR, and have a substantial responsibility here. As we said before, we think it's essential that they broaden their reviews to go beyond simple compliance matters and focus more on performance. My second point is that we need a strengthened commitment to educational outreach and mandates. Everybody says the answer is always more education, but I think it's really crucial to go beyond the talk and have some action. Action at the Federal level where we provide more in the way of web based tutorials and the like. But also mandates that investigators and board members participate in educational programs concerning human subject protections. The third direction we're emphasizing is much more extensive representation of non-scientific and non-institutional members on IRBS community members, if you will. It just simply doesn't seem adequate to have situations, as you often do, where there may be 14 or 15 IRB members and one, maybe two from outside the institution. This noninstitutional member can provide a vital counterbalance to the kind of pressures IRBs face. It's a way of sharpening the focus on subjects and what is in their best interest. And last, as Congressman Towns has already referred to, we simply need a mandate to register IRBs with the Federal Government. This need not be a major burden on anybody, but how can we provide effective oversight and guidance if we don't even know who the IRBs are and where they're at. So some kind of registration requirement with minimally descriptive information would seem to be important. In closing, I'd like to emphasize that notwithstanding what may sound like a rather harsh critique, we recognize the major contributions that investigators, sponsors, IRB members and staff are making in this area. There are a lot of committed, dedicated people here, but they work in a system that needs to be reformed. That's the basic point. Such reform is essential to provide necessary protections for human subjects. It's also essential to sustain the progress we are making in clinical research. Thanks for the opportunity to testify, we are certainly open to questions. Mr. MICA. Thank you. [The prepared statement of Mr. Yessian follows:] HEALTH Testimony Before the Committee on Government Reform United States House of Representatives Institutional Review Boards: A System of Protections Still in Need of Reform Office of Inspector General For Release on Delivery Expected at 10:30am Good morning. I am Dr. Mark R. Yessian, Regional Inspector General for Evaluation and Inspections, in the Office of Inspector General's Boston office, U.S. Department of Health and Human Services (HHS). I am pleased to testify at today's hearing on the Federal role in protecting human subjects of medical research. My testimony will focus on Institutional Review Boards (IRBs), the bodies that for more than 20 years have been charged under Federal law with ensuring human-subject protections. With me is Laura C. McBride who was a key architect of these studies. Mr. Chairman, the current system of protecting human subjects in medical research is in need of major reform. This is a conclusion we emphasized in a series of reports in June 1998. It is one we reiterate today. BACKGROUND In the late 1970s, Federal regulations were established requiring institutional review boards to review research protocols. The review is required to ensure human subjects are protected and are adequately informed of the risks and benefits of participating in research. Within the Department of Health and Human Services (HHS), both the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have responsibilities for human-subject protections and oversight of IRBS. NIH's Office for Protection from Research Risks, however, will soon be relocated to the Office of the Secretary for HHS Criminal Justice, Drug Policy, and Human Resources Subcommittee House Government Reform Committee December 9, 1999 |