In accordance with federal regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This review serves an important role in the protection of the rights and welfare of human research subjects. According to the Consortium of Independent Review Boards (CIRB), a nonprofit organization of independent institutional review boards committed to the ethical review of clinical research and the protection of human research participants, the purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols (study plans) and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare… ViewPoints Matt Baker, CIM, CIP, Compass IRB LLC As an IRB we are getting inundated with reports that may be required by the sponsor, but not by the IRB. The challenge is to educate both the investigator and the sponsor and work with everyone to ensure a more consistent process. Compass IRB works with researchers and sponsors in an open manner to ensure submissions are processed in a timely and effective manner, thus enabling research to begin on time while never compromising its commitment to protecting human subjects. For more information, visit compassirb.com. Gretchen Bowker, Co-Founder, Pearl IRB LLC Work overload remains a common theme for IRBs. Commercial and local IRBs should continue to share best practices for overall improvement of the process. Pearl IRB is an independent institutional review board whose team is comprised of experts in the fields of medical practice, science, ethics, and clinical research. For more information, visit pearlirb.com. Lynn A. Meyer, CCRP, Managing Partner, IntegReview Ethical Review Board Accreditation of an IRB’s Human Research Protection Program may provide confidence to investigators that the IRB they are working with has policies and procedures in place to ensure compliance. IntegReview has a proven track record of providing thorough ethical review of research; its committee members and staff are trained to provide responsive, knowledgeable service along with multiple levels of quality control. For more information, visit integreview.com Bruce Tomason, CEO, Copernicus Group IRB One of the challenges that we face is keeping pace with ever-changing technology. We have invested resources into developing an e-document management and Web portal. Copernicus Group IRB is an independent institutional review board and is organized and operates in compliance with regulations governing institutional review boards set forth in 21 CFR and ICH guidelines, as well as 45 CFR when applicable. For more information, visit cgirb.com. n accordance with federal regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This review serves an important role in the protection of the rights and welfare of human research subjects. According to the Consortium of Independent Review Boards (CIRB), a nonprofit organization of independent institutional review boards committed to the ethical review of clinical research and the protection of human research participants, the purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols (study plans) and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. CIRB members most commonly act under the authority of the regulations of the Food and Drug Administration (21 CFR §50 and §56) and the Department of Health and Human Services (45 CFR §46). Other federal agencies, such as the Environmental Protection Agency and Department of Defense, have their own regulations requiring the prospective review of proposed research by an IRB. Transparency, EThics, and Compliance IRBs are under tremendous scrutiny and have to comply with strict ethical and government standards. In light of the call for increased transparency, more focus on ethics, and tighter controls, IRBs have to employ best practices to satisfy client needs while maintaining their autonomy. One best practice is to satisfy the accreditation requirements of the Association for the Accreditation of Human Research Protection Programs Inc., or AAHRPP for short. Lynn Meyer, CCRP, managing partner of IntegReview Ethical Review Board, says accreditation of an IRB’s human research protection program (HRPP) may provide confidence to investigators that the IRB they are working with has policies and procedures in place to ensure compliance. “Clearly, ensuring compliance is a shared responsibility," she says. Accreditation benefits research organizations, participants, and the research enterprise as a whole. The accreditation process requires organizations to take a comprehensive look at their HRPPs to identify and address any weaknesses and to build upon their strengths. The result is a more cohesive HRPP, with the systems in place not only to protect research participants but to advance research more efficiently and effectively. The upcoming AAHRPP annual conference in Atlanta, April 12-14, will address how organizations can meet the Final Revised Accreditation Standards (the requirement deadline was March 1, 2010). “Certainly maintaining AAHRPP accreditation since 2004 has strengthened our human research protection program and elevated the spirit of the federal regulations into concrete standards that accredited IRBs put into action," says Bruce Tomason, CEO of Copernicus Group IRB. “In addition, we undergo numerous sponsor/CRO audits each year for clients with whom we work so they can be assured that we are abiding by the regulations and accreditation standard." Investigators and sponsors have responsibility for ensuring that the IRBs they are using comply with GCP and applicable regulations. At the same time, IRBs have the unofficial responsibility to verify that investigators are qualified and compliant. Ms. Meyer says while she has been unable to find a requirement in CFR, Part 56, Institutional Review Boards, that requires an IRB to approve an investigator (section 56.109 of the regulation addresses only IRB Review of Research), it has become the unwritten responsibility of IRBs to ensure the investigator is qualified by education and training to perform study-related procedures and to protect the rights and welfare of study volunteers. “IRBs routinely review investigator CVs and previous research study experience as well as any professional license," she says. “Administrative staff checks licensing information as well as debarment lists prior to submitting the investigator for IRB review. Investigator compliance with regulations as well as IRB requirements can be identified in the action letter, which can be followed by periodic monitoring of the site by the sponsor, CRO, or IRB to further ensure investigator compliance. Additionally, the investigator has a responsibility to report noncompliance to the IRB. “Ensuring IRB compliance is a concern of all parties involved in research projects; the sponsor, investigator, and, of course, the IRB itself," she continues. “Within the past several years one of the best practices for ensuring compliance may be accreditation of human research protection programs. Additional practices include inspections conducted by sponsors and CROs." AdDressing and overcoming challenges According to the CIRB, although it is difficult to produce a single definition of the term “independent IRB" because of the diversity of these entities, in general an independent IRB is a review board that is not owned or operated by the research organization for which it provides review services. While the makeup of the various independent IRBs may vary, they share some very common challenges. Like most entities involved in the life-­sciences space, IRBs face is the challenge of keeping up with ever-changing technology as well as the adoption of new applications. “CGIRB has invested time and resources into developing an e-document management and Web portal, CGIRB Connexus," Mr. Tomason says. “We think it raises the bar in terms of submitting, tracking, and reporting for our clients and clinical sites. Additionally, clients and PIs are insisting on quality in service and documents as never before. As a way of institutionalizing our commitment, CGIRB has undergone a companywide quality initiative, infusing state-of-the-art quality methods into every aspect of our business." Another challenge for IRBs is getting all of the stakeholders on the same page. “Our biggest problem right now is getting investigators to understand how the regulations make required reporting to IRBs uniquely different from required reporting to the sponsor," says Matt Baker, director of business development at Compass IRB. “As an IRB we are inundated with reports that may be required by the sponsor, but not by the IRB." Mr. Baker says the challenge is to educate both the investigator and the sponsor and work with everyone to ensure a more consistent process. Gretchen Bowker, co-founder of Pearl IRB, agrees that work overload remains a common theme for IRBs. “One answer to this challenge is to improve efficiency," she says. “The commercial IRB option uses dedicated resources and business practices that allow the PI and sponsor to clearly understand the review or oversight status, thus improving communication. Commercial and local IRBs should continue to share best practices for overall improvement of the process."F PharmaVOICE welcomes comments about this article. E-mail us at [email protected]. Institutional Review Boards

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