participate in training sessions. For new IRB members, their orientation to the role is seldom much more than a stack of materials to read and on-the-job learning. RECOMMENDATIONS We found the stresses on the IRB system to be significant enough for us to make a number of strong recommendations to NIH/OPRR and FDA. The thrust of our recommendations was for a more streamlined approach to providing human-subject protections, both at the local and Federal levels. At the same time, we called for a greater emphasis on accountability, performance, and results. Our recommendations included a number of actions, many of which, in the near-term, could help to address the vulnerabilities in the system. Some of our key recommendations were as follows. Grant IRBS Greater Flexibility but Hold them More Accountable for Results We called for eliminating or loosening a number of the procedural requirements that Federal regulations currently impose on IRBs, to allow IRBs to meet the significant challenges facing them. Greater flexibility could allow IRBs, for example, to concentrate their limited time and resources on protocols involving substantial risks to subjects. A quid pro quo for allowing IRBs greater flexibility is an increased emphasis on accountability. Therefore, we recommended regular, Federal performance-focused evaluations, whose results should be Criminal Justice, Drug Policy, and Human Resources Subcommittee House Government Reform Committee December 9, 1999 made public, and more extensive representation on IRBs of nonscientific and noninstitutional members. Reengineer the Federal Oversight Process We suggested reorienting the Federal oversight system to focus on IRB performance. In particular, NIH/OPRR should rework its assurance process so that it rests essentially on an institutional attestation to conform to the Federal IRB requirements in order to free scarce OPRR resources for on-site reviews and education sessions. FDA should search for ways of revamping its inspections, so that they focus less on narrow compliance matters and more on performance issues. FDA and OPRR should combine efforts to require a registration process whereby IRBs would submit basic descriptive information annually to HHS. This simple information would allow Federal bodies to more effectively target their oversight and facilitate dissemination of education materials. Strengthen Continuing Protections for Research Subjects The IRB system has long relied on an ethic of trust in the research community. However, trust alone does not provide sufficient continuing protection. IRBs need to be more aware of what is actually happening at the research site. For example, they spend a significant amount of time reviewing and editing the language of an informed consent documentdocuments that can run up to 20 pages in length. But, they know little about what actually happens in the interaction between subject and investigator. Criminal Justice, Drug Policy, and Human Resources Subcommittee December 9, 1999 Another key mechanism of ensuring IRBs' meaningful reviews of approved research is requiring certain outside sources to provide IRBs with valuable information. Data Safety Monitoring Boards oversee many large-scale trials and continually monitor the safety and efficacy of trials. Assessments of adverse events across many disparate sites could help IRBS in their continuing reviews and reduce their workload. Also, the FDA should provide IRBS with feedback on actions it takes against investigators that are engaged in research at the IRBS' institution. Enhance Education for Research Investigators and IRB Board Members Investigators are the ones who actually interact with and consent subjects. Investigator education can help convey to investigators that along with the considerable independence that they have in the research process, there exists a significant responsibility to ensure human-subject protections. Investigators, who are adequately sensitized to human-subject protections, can also serve to minimize the need for regulatory intervention by the Federal government or by IRBs themselves. Board members must also be trained on Federal requirements. There are also many hidden ethical issues, particularly with the newer types of research such as genetics, to which IRBS must be sensitive. Criminal Justice, Drug Policy, and Human Resources Subcommittee December 9, 1999 Page 9 AN UPDATE Our reports were released a year and a half ago. Since then there have been some encouraging developments. But, the system of protections is still in jeopardy and the need for strong federal action is still compelling. I'll close by elaborating on each of these points. Encouraging Developments Federal Initiatives. Progress has been made at the Federal level, mainly in the activities of OPRR. In the year before our report was issued, OPRR made only one on-site visit to a research institution. Since that time, it has conducted a number of such visits, including one that resulted in the temporary termination of all federally sponsored research at the Duke University Medical Center. Some of their reviews represent the most probing and resultsfocused inquires we have found of IRB performance, resulting in strong recommendations to the IRBS. They are also taking a more active role in issuing further educational outreach programs. NIH has issued guidance on the transmittal of information to IRBs from datasafety boards used for trials it funds. Local Efforts. These Federal efforts, in particular the recent shutdown at Duke University, in tandem with our reports and recent media attention have served as a catalyst for change at Criminal Justice, Drug Policy, and Human Resources Subcommittee December 9, 1999 IRBs and their institutions. Many IRB representatives told us that they have been able to garner more support and resources from their institutions. For example, an IRB Chair from a small community research institution called to ask for 20 copies of our report in order to hold their first-ever IRB training program. Professional Responses. There is a newly developed momentum to certify IRB administrators and to develop a system for the private accreditation of IRBS. Both of these efforts represent potentially important ways of raising the bar in current IRB practice. A System Still in Need of Reform As encouraging as the above developments are, the system of protections provided by IRBS remains in jeopardy. The same danger signs are widespread: expanded workloads, quick reviews, threats to IRB independence, inadequate information, and insufficient training. Underlying pressures on IRBS continue to build and make it more difficult for them to do their job: Increasing Commercialization of Research. One of the most significant challenges IRBS face is the commercialization of research. Industry is now the largest sponsor of clinical research in the country. With the increasing prominence of industry comes the pressure for "more, faster, better" IRB reviews. Investigators are Criminal Justice, Drug Policy, and Human Resources Subcommittee House Government Reform Committee December 9, 1999 |