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Aside from the daily challenges of identifying and resolving potential problems, part of your job description requires you to prepare for big changes to the research field. Caught between the pharmaceutical companies with millions of research dollars and a public clamoring for new cures, IRBs find themselves attempting to create harmony between researchers and patients while appeasing governmental watchdogs.
In light of the challenges of appeasing several interests, IRB administrators can survive. Here are some suggestions on preparing for change:
• Play mediator in the debate until the dust settles over which group is responsible for the problems. Researchers and federal regulators alike contend there are several problems accounting for patients "slipping through the cracks" of IRB monitoring, but both sides disagree over who’s to blame.
Researchers at the University of Colorado Health Sciences Center in Denver contend the problems are associated with the rapid increase of multicenter clinical trials as a dominant form of clinical research.1 Local IRBs were not designed to handle the initial evaluation and ongoing review required by the increasing number of multicenter trials, they suggest. Regulatory actions, for example, increased threefold in 1998 and 1999, according to the researchers. Most notable were the actions taken against IRBs in academic medical centers. Only one was taken in 1997, but there were 14 in 1999, they note.
The difficulties facing IRBs can be attributed to "low-yield, time-consuming tasks that dissipate their energies. Those and other factors are eroding the motivation of academics to serve as IRB members," counters Robert J. Levine, MD, professor of medicine at Yale University School of Medicine in New Haven, CT. Levine’s editorial countering the findings of the University of Colorado researchers appeared in the same issue of the Annals of Internal Medicine.2 Levine suggests IRBs should be re-evaluated and their charges restated. He would add high-quality education as a priority for IRB staff and their members. He also calls for an accreditation and certification system.
• Stay abreast of regulatory changes so you’ll know who you report to. Last year’s announcement by the U.S. Department of Health and Human Services (HHS) to move the primary oversight body from a lesser known position to one of higher prominence was considered by many to be a knee-jerk reaction to high-profile genetic therapy research taking place across the country.
The unfortunate death of Jesse Gelsinger in an experimental genetic therapy trial in September 1999 proved to be the straw that broke the camel’s back for human subject research, opponents argued. As a result, the Clinton administration responded with a regulatory change in who IRBs report to, and are subsequently monitored by.
In June, 2000, previous HHS Secretary Donna Shalala announced the Office of Protection from Research Risks (OPRR), hidden among various agencies and offices within the National Institutes of Health, would be moved to the Secretary’s office and given a new name. (See "Responsibilities of the OHRP," in this issue.) The former agency is now christened the Office for Human Research Protections (OHRP), and includes several new policy changes:
— Register your IRB with the OHRP. All IRBs engaged in human subject research must register with OHRP using a new form and new registration process. (To see the IRB registration form, click here. Also, see "How to register your IRB using the new process," in this issue.) Previous registrations under the system established by OPRR are no longer valid.
The initial phase of implementing a new, simplified process of registering an IRB is expected to last three months. Eventually, OHRP will make any necessary changes to the registration process based on comments and suggestions from the implementation phase. An interactive, on-line version will take the place of the existing paper-based method, but entities without Internet access may continue to file paper-based registrations.
— File a federalwide assurance (FWA) for your IRB. Each legally separate institution must file an FWA with OHRP. Any registered IRB can be designated under an institution’s FWA, however, as long as the IRB agrees to the designation and satisfies the guidelines for knowledge of the local research context.
By filing an FWA, domestic IRBs are stating the human protections administrator (the contact person working on a daily basis ) and IRB chairperson have completed the OHRP basic educational module or training certified to OHRP by the institution as equal to the OHRP module. Additionally, all researchers, members, and staff of the IRB must complete a training program before research can begin. Staff who sign the FWA are known as institutional signatory officials by the OHRP.
Multiple project assurances, cooperative project agreements, and single project assurance will continue to remain in effect until their expiration date or Dec. 31, 2003, whichever comes first. (To see the FWA registration form, click here. Also, see "How to file an FWA using the new system," in this issue.)
• Start preparing now for peer review and voluntary accreditation. The Association for the Accreditation of Human Research Protection Programs was established in March 2000 to develop an accreditation system for human research protection programs.
While several organizations already offer certification programs for IRB administrators, no such accreditation program exists for the entire IRB monitoring program. The Applied Research Ethics National Association (ARENA) in Boston offered its first certification exam for IRB professionals in 2000 and awarded the CIP [certified institutional professional] designation to more than 100 professionals. An additional certification is offered through the Atlanta-based National Association of IRB Managers.
Despite the tumultuous changes taking place in human research protection, there is an even greater need for IRB administrators now more than ever. Primarily, IRB administrators are needed to educate, says Levine.
Violations in research ethics generally are caused by lack of awareness rather than malice, notes Cynthia McGuire Dunn, MD, director of the clinical research institute and assistant professor of medicine at the University of Rochester (NY) School of Medicine and Dentistry. The importance for training for researchers cannot be over stressed, she notes. "If all researchers were well-versed in ethics and complied with regulations, institutional review boards and other oversight mechanisms would not be as necessary."
1. Burman W, Reves R, Cohn D, et al. Breaking the camel’s back: Multicenter clinical trials and local institutional review boards. Ann Intern Med 2001; 134:152-157.
2. Levine R. Institutional review boards: A crisis in confidence. Ann Intern Med 2001; 134:161-163.
[Editor’s note: The Council for Certification of IRB Professionals administers the ARENA certification exam through the Professional Testing Corporation. Applications are due Sept. 1, 2001 for the Oct. 20, 2001 examination. Additional dates for the examination are available through special testing centers for an additional fee. The examination for ARENA members costs $300. Nonmembers: $400. The special testing center fee is $150. For more information concerning the examination, contact Professional Testing Corporation, 1350 Broadway, 17th Floor, New York, NY 10018. Telephone: (212) 356-0660.
For information concerning the CIM (certified institutional manager) credential, contact the National Association of IRB Managers, P.O. Box 640006, Atlanta, GA 30364-0006. Telephone: (404) 766-9890. Fax: (404) 768-0140. Web: www.naim.org.]