Foreward

Seton Hall Law Review, Dec 2002

Carl H. Coleman

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Foreward

Carl H. Coleman 1 0 but the context in which research is conducted also has changed. Twenty years ago, medical research was virtually the exclusive province of academic medical centers, which designed, conducted, and reported on studies financed primarily by the National Institutes of Health. Today, research occurs in a broad range of nonacademic settings, including for-profit contract research organizations, community hospitals, and private physicians' offices. In addition, an increasingly large portion of research funding comes from private sources. This shift away from an academic model of scientific research to a system more closely aligned with private commercial interests has complicated the process of research oversight, by both reducing the transparency of the research enterprise and increasing the prevalence of conflicts of interest. In 1 It has been almost thirty years since federal regulations governing research with human subjects were first developed. Since that time, the world of biomedical research has changed dramatically. Not only has the amount of research increased exponentially * Associate Professor of Law and Associate Director, Health Law & Policy Program, Seton Hall Law School. 1 See 1 NATIONAL BIOETHICS ADVISORY COMMISSION, ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS 4 (2001) (noting that federal research funding almost doubled between 1986 and 1995, from $6.9 billion to $13.4 billion, and that private research funding tripled, from $6.2 billion to $18.6 billion). - expands on Dr. Lo’s keynote address at the beginning of the symposium, highlights one of the most significant deficiencies in the current regulatory regime—the limited applicability of federal human subject protections to research that is not funded by the federal government.2 While some privately-funded research is subject to federal regulatory oversight, either because it involves products regulated by the Food and Drug Administration or because it takes place in institutions that have signed multiple project assurances with the federal government, a significant proportion of privately-funded research fits into neither of these categories.3 One of the most important recommendations of the National Bioethics Advisory Commission (NBAC), therefore, was its call for a uniform system of federal regulation for all human subject research, regardless of source of funding.4 In addition to discussing NBAC’s rationale for expanding federal jurisdiction over research, Lo and Groman’s paper also addresses several other important NBAC recommendations, including those designed to reduce unnecessary regulation of low-risk activities; to increase the proportion of outside members of institutional review boards (IRBs), the committees that review and approve research protocols under the federal regulations; to reform the requirements for waiving informed consent to research; and to provide greater guidance for IRBs’ process of assessing research risks. One of the challenges of overseeing research conducted in nonacademic settings is identifying an appropriate body to review and approve research protocols. As research increasingly moves away from academic medical centers, many of the settings in which research is conducted do not have IRBs. David Forster’s paper examines a type of organization that has emerged to fill this void— the independent institutional review board.5 These organizations, which include the company for which Mr. Forster serves as general counsel, Western Institutional Review Board, operate separate from and unaffiliated with institutions that conduct research activities. Mr. Forster identifies several concerns that have been raised about independent IRBs and offers suggestions for addressing these concerns, including procedures for minimizing the influence of conflicts of interest. In addition, he argues that independent IRBs offer important advantages over traditional IRBs in several respects. 2 Bernard Lo & Michelle Groman, NBAC Recommendations on Oversight of Human Subject Research, 32 SETON HALL L. REV. 493 (2002). 3 See id. at 496 4 See id. 5 David G. Forster, Independent Institutional Review Boards, 32 SETON HALL L. REV. 513 (2002). 2002] The issue of conflicts of interest is the subject of an extensive analysis by Mark Barnes and Patrik S. Florencio, both lawyers with the law firm of Ropes & Gray in New York.6 Financial conflicts of interest “lie at the core of ethical issues surrounding clinical trials,” Barnes and Florencio argue, “and the anecdotal evidence is that these conflicts are widespread.”7 The potential for commercial interests to influence the integrity of research is the result of more than simply private sponsorship of particular studies. Researchers may have financial investments in the drugs or devices under investigation, or they may own stakes in the companies that are sponsoring their studies. In addition, researchers may receive stipends, speaking and consultin (...truncated)


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Carl H. Coleman. Foreward, Seton Hall Law Review, 2002, Volume 32, Issue 3,