Memorandum
TO: Members of the Research Community
FROM: Dr. Arthur S. Levine and Dr. James V. Maher
DATE: May 10, 2002
Protection of Human Research Subjects and the IRB
Research to advance scientific knowledge is core to this University's mission. Research involving human subjects plays a very important role in our overall research program, leading directly to medical advances that alleviate human suffering and disease and advances in the social sciences that help to improve our schools, our social institutions, and our understanding of ourselves. Not surprisingly, research involving human subjects is also one of the most highly regulated areas of the entire research enterprise. Within the Department of Health and Human Services, the Office of Human Research Protection ("OHRP") has been reorganized, and, in the wake of highly publicized failures of human subject protection at other institutions, has recently issued new policies and regulations, which have led to further changes in the operation of our Institutional Review Board ("IRB"). New regulations, and new interpretations by OHRP of existing regulations, create challenges for both investigators and the IRB members and staff, who must adapt to a continually changing set of standards. All indications from Washington suggest that further changes in these regulations will be forthcoming over the next several years.
IRB Overload
In the midst of this increased regulatory scrutiny, the University's research activities have also continued to grow and, as a result, the number of protocol submissions to our IRB has risen steadily over the past three years. Based on year-to-date data, it is anticipated that the IRB Office will process 4,780 submissions of various types (e.g., new submissions, renewals, modifications) during 2002, an increase of 27 percent over the submissions processed during calendar year 2000. It is projected that the number of submissions requiring review by a convened IRB committee during 2002 will increase by more than 50 percent compared to 2000. Although this is a sign of the success of our faculty, it has been and continues to be severely taxing to our systems. In response to the rising workload of the IRB Office and IRB committees, and in an effort to improve service to investigators while ensuring continued compliance with all FDA and OHRP requirements governing human subject protections, we have adopted certain changes in the operation of the IRB Office and the IRB itself, and these will increase the responsibilities of the academic departments to meet the University's commitment to human subjects protection.
Increase IRB Capacity
We plan to immediately expand the IRB by two additional committees. This will include the hiring of additional IRB Office staff and an additional IRB Vice Chair, along with the rental of additional IRB Office space. This expansion is in addition to our previous financial commitments associated with the establishment and support of our current four IRB committees and associated with the employment of four IRB Office staff dedicated to the administrative review of minimal risk research studies. These additional committees, staff and space should help to address the current deficiencies associated with the prompt review of IRB submissions. We plan also to consult with outside experts on the IRB process in its entirety with the goal of maximizing the efficacy and efficiency of our internal process. Please note that the increase in IRB capacity will require additional human resources (i.e., IRB members) from the schools and departments whose research involves human subjects.
IRB Fee for Industry Sponsored Studies
To off-set the costs associated with expansion, the University will, effective July 1, 2002, charge for review of pharmaceutical company- and device company-sponsored ("industry-sponsored") research protocols. This charge, which will be borne by the industry-sponsors, will be $1,500 for initial review of industry-sponsored protocols, and $500 for annual renewals. Based on surveys of other comparable academic institutions, we understand that it is commonplace for institutions to charge such a fee for the IRB review of industry-sponsored research studies. We have asked the IRB Office to prepare a separate communication outlining the details of this policy as well as a procedure to seek "fair but rare" waivers to the fee for scientifically significant studies.
Increase IRB Member Pool
The maintenance of four, and soon to be six, IRB committees requires the active, shared involvement of research investigators as committee members. Both OHRP and FDA regulations require a quorum (greater than 50 percent) of the committee membership, including individuals with appropriate expertise in the research proposed, in order for the IRB to conduct its human subject protection functions. We must have full participation of all members of the IRB to have an effective system. Recruitment of active IRB members has been a difficult and time-consuming task for the IRB Office staff.
To achieve a more effective IRB system, the University will adopt a policy, effective July 1, 2002, requiring any University faculty or staff investigator listed on an IRB submission that requires review by a convened IRB committee to be placed in a pool for IRB service. The length of IRB service will include active participation on an IRB committee for a minimum of a three-year period. Active participation shall be defined as routinely attending meetings of the IRB committee to which the individual is assigned and participating fully in the IRB review process. As research studies requiring review by a convened IRB committee predominantly emanate from the faculty of the Schools of the Health Sciences, the Office of Clinical Research, Health Sciences, is well-positioned to oversee this process. In recognition of the fact that certain investigators may already be involved in other critical service functions, an appeals process will be included in the policy. However, in most cases it will be the obligation of the Department to provide the name of another faculty member from that Department if the Investigator on the original IRB submission is unavailable for pool service. The Office of Clinical Research, Health Sciences will issue a memorandum in the near future detailing the operations of this service pool.
Quality of IRB Submissions
Currently, approximately 35 percent of all new research protocols submitted for full-board IRB review require reconsideration by a convened IRB committee due to incomplete or inadequate information. This situation creates not only a considerable delay in obtaining IRB approval to conduct the research, but also a substantial increase in the workload of the IRB committees and IRB Office. The IRB Office will monitor this activity and work with the schools and departments to provide education to reduce this high number of necessary reconsiderations. A goal of 10% or fewer reconsiderations over the next year has been set by the IRB. The IRB and the departments/schools should address this goal with concrete plans that will include education efforts. The IRB Office and the Office of Clinical Research stand ready to assist the departments/schools in formulating such plans, and will continue to review IRB policies, procedures and workflow in an effort to assist investigators in meeting their regulatory responsibilities in the most efficient manner.
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Protection of human subjects participating in research is a shared responsibility of investigators and the institution. The steps we are taking, as described above, will help us, working together, to further enhance our ability to meet this responsibility in the interest of our research subjects and our research efforts.