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The NIH Inclusion Guidelines: Challenges for the Future

1996; Hastings Center; Volume: 18; Issue: 3 Linguagem: Inglês

10.2307/3564038

2326-2222

Karen H. Rothenberg, Eugene G. Hayunga, Joyce Rudick, Vivian W. Pinn,

Health Systems, Economic Evaluations, Quality of Life

Karen H. Rothenberg, JD, MPA, is Marjorie Cook Professor of Law and director, Law & Health Care Program, University of Maryland School of Law, Baltimore, Maryland, and from 1995-1996 she served as special assistant to the director, Office of Research on Women's Health, National Institutes of Health; Eugene G. Hayunga, PhD, is research policy officer, Office of Research on Women's Health; Joyce E. Rudick, BS, is senior program analyst, Office of Research on Women's Health; Vivian W. Pinn, MD, is associate director for Research on Womens Health of the National Institutes of Health, and director of the Office of Research on Women's Health. Risks (OPRR), and the Office of Extramural Research (OER), convened a meeting of representative IRB chairs to discuss their role in implementation of the guidelines. It became clear from this meeting and from the written responses to the guidelines received during the one-year public comment period,2 that a number of practical concerns would have to be addressed as implementation of the guidelines progressed. On 22 February 1996, ORWH, in collaboration with ORMH, OPRR, OER, and the Office of Intramural Research, reconvened these IRB chairs, along with representative members of the ORWH Recruitment and Retention Task Force, NIH intramural IRBs, and other experts, to share experiences and to better understand the