Release Date: November 21, 2001
BUFFALO, N.Y. -- The University at Buffalo has instituted changes in the structure of its Institutional Review Boards (IRBs) that are designed to increase the effectiveness and efficiency of the system responsible for protecting human volunteers in research projects conducted at the university.
The effort is in keeping with what Jaylan Turkkan, UB vice president for research, calls a heightened profile nation-wide of the issues surrounding the protection of human research volunteers following the deaths earlier this year of some research volunteers at the University of Pennsylvania and Johns Hopkins University.
UB has consolidated its eight IRBs into two boards: the Health Sciences IRB (HSIRB) and the Social and Behavioral Sciences IRB (SBSIRB). The consolidation brings UB in line with the national model that is common at most other institutions, in which one IRB focuses on biomedical research and another IRB focuses on non-biomedical research, Turkkan says.
In fact, the move from eight to two IRBs is the final phase in a consolidation process begun many years ago, she says, noting that at one time, there were as many as 13 IRBs at UB-one for every affiliated hospital and others serving nearly every school.
The Millard Fillmore IRB will be phased out during the first half of 2002, while the Veterans Administration IRB will continue to operate independently, she says.
Although IRB stands for Institutional Review Board, it could more accurately be called a Research Volunteers Protection Board, notes Edward Zablocki, sponsored programs coordinator in the Office of the Vice President for Research. Before any research project involving humans can be initiated at UB, an IRB -- composed of UB faculty and staff members, as well as members of the community -- must review and approve it.
The IRB applies three ethical principles in its review, Zablocki says. The panel considers respect for persons -- the rights of the research subject -- and reviews the consent process through which the prospective research subjects are to be fully informed about all aspects of the research project. It also considers beneficence -- assessment of the proposed research to ensure that the risks are minimized and potential benefits maximized, and justice -- review of how research subjects will be selected, including consideration of fairness in terms of what groups are to be excluded or included in the proposed research.
In the course of applying these principles, Zablock points out that the IRBs also ensure that researchers comply with applicable federal regulations.
Turkkan says having only two IRBs at UB "will allow us to be both more efficient and more effective.
"We've added administrative support to the Health Sciences IRB and the Social and Behavioral Sciences IRB so that investigators will be able to reach knowledgeable professionals with IRB-related questions during normal business hours," she says, adding that both IRBs have Web sites where all pertinent information is available, including new procedures for developing informed consent and reporting adverse events, as well as forms for initial and continuing reviews.
The two IRBs also will be using the same forms and similar procedures and evaluation standards to achieve "a consistency of review," she says.
The HSIRB, chaired by Monica Spaulding, professor of medicine, and co-chaired by Ronald Moscati, assistant professor of clinical emergency medicine, is responsible for all research protocols involving drugs, devices, invasive medical interventions or retrospective/prospective chart reviews.
The HSIRB submission deadline is the first day of the month, with meetings held on the third Tuesday. Protocols that involve minimal risk to volunteers are reviewed continuously.
The SBSIRB, chaired by Ann McElroy, associate professor of anthropology, is responsible for all research protocols that involve surveys, interviews, observational studies, behavioral studies that do not involve drugs or internal devices, and research on individual or group characteristics/ The submission deadline is the last Tuesday of the month, with meetings held on the first Wednesday of the next month. Protocols that involve minimal risk to volunteers are reviewed continuously.
Turkkan says the membership of the boards of both IRBs is being reconstituted to increase the breadth of expertise, serve a broader constituency and fulfill a federal mandate for enhanced diversity of membership.
She points out that a researcher's affiliation with a particular school or faculty does not determine which IRB is appropriate to conduct a review. For example, a psychological study employing drugs will be reviewed by the HSIRB. Surveys performed in medically related disciplines may be reviewed by either IRB, depending upon the example. Anyone with questions should contact the IRBs.
Also new to the IRB process is a requirement that all investigators and key research personnel involved in the design, conduct and reporting of the research must complete an on-line tutorial to fulfill educational requirements mandated by the federal government. A certificate of completion of an on-line tutorial must be included with the submission of the protocol for review.
All researchers submitting protocols to the HSIRB must complete the National Institutes for Health human subjects protection tutorial. Investigators submitting protocols to the SBSIRB must complete either the NIH or the UB protection of human research subjects tutorial.
An electronic administrative record exists for any faculty member who has completed the UB tutorial since Jan. 1, 2001 using his or her UB IT name.
Recent incidents at some of the leading research universities in the country involving the deaths of human research subjects-in particular, the death of teenager Jesse Gelsinger in a gene transfer study at the University of Pennsylvania-have placed the issue of protecting human research volunteers in the national spotlight-both in the media and within the federal government Turkkan says.
Congress has shown significant interest in the question of how well the system is doing in protecting research volunteers, she says.
Moreover, the Office of Human Research Protections (OHRP)-the federal agency that oversees this field-has been elevated within the Department of Health and Human Services, and now reports directly to the department secretary, she says.
In addition, the OHRP has instituted new requirements, including the continuous education of everyone involved in the system, including researchers, IRB members and IRB administrators. OHRP also has come down hard on institutions that were in gross violation of federal regulations, temporarily halting all research at such institutions as Duke and Johns Hopkins.
"The feds are telling institutions that they will be evaluated on the basis of the adequacy of their institutional commitment to a protection system for human volunteers, including, of course, the financial commitment needed to develop a quality system," Turkkan notes.
She adds that all institutions conducting research soon will have to meet accreditation standards, noting, for example, the Association for the Accreditation of Human Research Protection Programs recently was established to achieve this end by the Association of American Medical Colleges, the Association of American Universities, and the National Association of State Universities and Land Grant Colleges.