Enhancing public participation in research is one of the central challenges facing the clinical research enterprise in the United States, and one of its highest priorities. Public concern about the safety of participating in research is increasing, reflected in a rising tide of litigation, negative articles in the popular press, and other published commentaries. Part of this concern focuses on Research Ethics Review Boards (Research ERBs)the entities responsible for ethical review and oversight of human research. These bodies, referred to in federal regulations as Institutional Review Boards (IRBs), are overburdened and often characterized as inefficient and ineffective. The increasing number of multi-center studies is exacerbating current problems, as they often require duplicative reviews. Multiple submissions of a single protocol and its associated consent documents to several Research ERBs for review and alterations create redundancy without necessarily enhancing the protection of research subjects.
Many parties, including the Institute of Medicine (IOM), the National Bioethics Advisory Commission (NBAC), and the Department of Health and Human Services (DHHS), note that these duplicative reviews can actually detract from subject protections by diverting time and resources from more effective uses; they have suggested streamlining review through the use of alternative models. Collaborative approaches to ethical review that capture the best of both central and local processes could be more efficient, less costly and less demanding of limited resources, and also be more effective. They may allow for more timely data collection and analysis of adverse events, address the problem of institutional conflict of interest, and offer more options for unaffiliated investigators and patients with rare diseases.
Central review boards have taken on increasing importance in recent years. Reference to a "central IRB" does not necessarily mean that one Research ERB is always the IRB of record; use of the term "cooperative review" may more accurately reflect the emerging approaches discussed in this article. In a survey by the Association of American Medical Colleges (AAMC) of research deans at institutions using a Central IRB (defined as any noninstitutional board or cooperative arrangement), 53% agreed that its use shortened time to approval of research protocols. Eighty-four percent were pleased with the Central IRB review, and 77% indicated that they were able to maintain excellent local oversight of studies approved by a Central IRB. Notably, some highly respected academic institutions have turned to well-established commercial review boards after deficiencies in their local boards and processes resulted in significant enforcement actions by federal regulatory agencies. One of these private boards was among the first human research protection programs (HRPP) to receive full accreditation by the Association for Accreditation of Human Research Protection Programs (AAHRPP); the Partnership for Human Research Protection (PHRP) also has accredited independent review boards.
Many institutions are hesitant to use cooperative review mechanisms for a variety of reasons. According to the AAMC survey, those who have not used Central IRBs (76% of respondents) did not do so because of concerns about liability (73%), additional costs (60%), the absence of local representation (86%), and the inability to assess the quality of the services (56%). Federal regulations require that research review boards have "sensitivity to such issues as community attitudes," and many institutions feel that local review is an essential component of ethical research; to what extent this view also reflects a desire to maintain institutional autonomy is unknown. Both the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) have responded to the increasing number of multi-center trials by clarifying that existing regulations permit institutions to use joint review, rely on another qualified IRB, or make similar arrangements to avoid duplication of effort for cooperative research. OHRP and FDA also have issued further guidance that clarifies the implementation of such arrangements to ensure that the local context is taken into account.
Already, some academic organizations and the National Cancer Institute (NCI) are utilizing cooperative models to streamline the Research ERB review process. To explore the potential of these emerging ethical review mechanisms, the Clinical Research Roundtable of the IOM recently convened stakeholders in the clinical research enterprise to hear from those involved in these efforts. In this paper, we describe several models of cooperative review, many of which were presented at the meeting. These models include the Multicenter Academic Clinical Research Organization (MACRO), the Biomedical Research Alliance of New York (BRANY), independent Research ERBs, the NCI's Central IRB, and Regional Ethics Organizations (REOs). Many of these models are in the formative stages, and REOs, which are now utilized in the United Kingdom, do not exist in the U.S. at this time. Therefore, key evaluative data regarding existing central review mechanisms are not presently available; indeed, more data are needed to assess both traditional and cooperative review mechanisms and to more fully and scientifically compare these options. Our assessment is based upon the best available data about these efforts. Key issues about centralized review relate to perceived legal liability by cooperating academic institutions regarding the ability to fully reflect and address local concerns.
IRB. 2005;27(3):1-7. © 2005 The Hastings Center
The views presented in this paper are those of the authors and not the Institute of Medicine, the Institute of Medicine's Clinical Research Roundtable, or the Roundtable's sponsoring organizations.
Cite this: Cooperative Research Ethics Review Boards: A Win-Win Solution? - Medscape - May 01, 2005.