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Public Affairs Update

  • Human subjects protection advisory committee is to be revamped . . . . The charter of the Department of Health and Human Services’ (DHHS) National Human Research Protections Advisory Committee (NHRPAC) expired in early June, was extended, and is now being allowed to lapse. The panel is being reconstituted—in accordance with the interests of DHHS Secretary Tommy Thompson—to have a broader scope, which includes issues surrounding biomedical research on children. New members will be appointed, but it is possible some previous members will continue to serve on the panel, according to DHHS, which has characterized the development as “standard operating procedure,” since DHHS routinely reviews its committees. However, many NHRPAC members expressed bewilderment and claim they were specifically told by DHHS Assistant Secretary for Health, Eve Slater, this summer that NHRPAC’s charter would not lapse. Also, the 17-member committee had learned it would be reduced to 11 members but were told expressly that any changes would be with minimal disruption to its operation. Now that it has lapsed, all operations, including planned conferences and its October meeting have been cancelled. NHRPAC members maintained there are two possible explanations for such an action: DHHS wants to dissolve the committee completely or DHHS intends to appoint all new members. There is speculation that the development may be linked to pressure from conservative groups to align federal policy with their policy positions (e.g., establishing rights for fetuses as research subjects). A DHHS spokesperson dismissed claims that the dissolution of the committee was politically motivated. Administratively supported by DHHS’ Office for Human Research Protections (OHRP), the committee was formally established by Clinton DHHS Secretary Donna Shalala in 2000. One possible near-term loss is a project to update an Internal Review Board handbook for clinical research. First released in 1993, the well-regarded guide was on track for a revised release this fall. NHRPAC’s expired charter specified, “The Committee shall advise … pertaining to the continuance and improvement of human subjects protection functions within the authority of HHS. The committee will provide advice on … collaborations and communications between HHS and its operating and staff divisions and other pertinent elements of the federal government; the biomedical, academic, and research communities; non-governmental entities; and other organizations as necessary to further the interests of the human subjects protection enterprise.” In a similar vein, DHHS’ postponement of a Secretary’s Advisory Committee on Genetic Testing (SACGT) August meeting, relates to the panel’s August 10 expiration of its four-year charter. DHHS is reviewing this group’s scope for potential expansion into areas such as genetic discrimination and ethical issues related to genetic tests. As with NHRPAC, committee members had assumed that the SACGT’s renewal was “pro forma,” until DHHS announced in July that the August meeting was cancelled and that DHHS was systematically reviewing all its advisory groups to assess their purposes and identify overlapping charges. DHHS has subsequently indicated the committee is discontinued and its charter would not be renewed.

  • New Director of the National Institute of Mental Health (NIMH) . . . . Thomas R. Insel, MD, has been named by National Institutes of Health (NIH) Director Elias Zerhouni, MD, to be director of the nation’s primary mental health research agency, NIMH. Insel, who is currently Professor, Department of Psychiatry and Director of the Center for Behavioral Neuroscience at Emory University School of Medicine, in Atlanta, GA, begins his appointment in mid-November. Insel will oversee NIMH’s $1.3-billion research budget. ASA itself has received significant funding from NIMH over the past 30 years. The Institute also administers an extensive intramural research program. Authorized in 1946 as one of the first NIH institutes, NIMH is now one of the 27 units of NIH, the nation’s primary public funding source for biomedical research. Insel joined NIMH in 1979 as a clinical associate in the Clinical Neuropharmacology Branch, and during his 15 years at NIMH, he conducted research in Obsessive-Compulsive Disorder (OCD), initiating some of the first treatment trials for OCD using serotonin reuptake inhibitors. Five years later, Insel launched a research program in social neuroscience, focusing on the neurobiology of complex social behaviors in animals. Insel’s laboratory has demonstrated the importance of specific neuropeptides in maternal behavior, pair bond formation, and aggression. As director of Yerkes Regional Primate Research Center, Insel built one of the nation’s leading HIV vaccine research programs. He currently serves as the founding director of the Center for Behavioral Neuroscience, funded by the National Science Foundation. Insel continues to study the role of oxytocin in social attachment and behavior and is involved in the development of an autism research center.

  • Ting-Kai Li, MD, is new director of NIH’s alcohol research institute . . . . National Institutes of Health (NIH) Director Elias Zerhouni, MD, has appointed Ting-Kai Li, MD, as the new director of NIH’s National Institute on Alcohol Abuse and Alcoholism (NIAAA). Li is currently Distinguished Professor, Department of Medicine, and of Biochemistry and Molecular Biology, at Indiana University School of Medicine in Indianapolis, where he also serves as Director of the Indiana Alcohol Research Center. Li is will assume his new duties this fall, replacing Raynard Kington, MD, PhD, who has served as Acting Director of NIAAA since January 2002. The author of more than 400 journal articles and book chapters, Li has produced groundbreaking research in several areas, including alcohol metabolism and animal models of alcoholism. Li received his medical degree from Harvard University in 1959, joined the faculty of Indiana University School of Medicine in 1971 and served as the Associate Dean for Research from 1986-2000. He is the current editor of the journal Alcoholism: Clinical and Experimental Research.