National Library of Medicine, Office of Acquisitions Management, Building 38A, Room B1N17, 8600 Rockville Pike, Bethesda, Maryland 20894

R -- PROGRAM MANAGEMENT/SUPPORT SOL NLM 99-019/LTN DUE 122898 POC Liem T. Nguyen, Contract Specialist, 301-496-6546; Karen D. Riggs, Contracting Officer, 301-496-6546 E-MAIL: click here to contact the contract specialist via, liem_nguyen@nlm.nih.gov. It is the intent of the National Bioethics Advisory Commission (NBAC), a Presidential National Commission which is administratively supported by the National Institutes of Health (NIH), Office of the Director to procure management support services on a sole source basis from Duke University Medical Center, Durham, NC 27710. The Duke University Medical Center will conduct intensive case studies with eight (8) international sites that have substantial experience conducting clinical research with US funding. Possible sites include Australia, Brazil, Cameroon, England, Equador, Haiti, Kenya, Panama, Philippines, South Africa, Taiwan, and Thailand. The case studies will involve week-long site visits that include interviews and observation. Interviews will be conducted with local researchers, IRB Members, persons implementing informed consent in ongoing studies, and members of a National Ethics Committee. Area of investigation include the experience with US regulations regarding biomedical research; how US regulations correspond to the moral views and how conflicts, if any, are reconciled; and recommendations regarding current US regulations for international biomedical research. Duke University Medical Center has researchers who have conducted extensive research on Human Radiation Experiments, as well as feasibility research focusing on international research ethics, all of which are closely related to the international issues the NBAC is addressing. Duke University Medical Center's researchers have published extensive literature on international health and ethics issues, including but not limited to justice in research, ethics in research with and protections of human subjects, methods in medial ethics, and informed consent in clinical trials. In addition, this facility has researchers with a unique professional knowledge and experience in this type of study which makes Duke University Medical Center the only source that can successfully provide the required management support services. This is not a Request for Quotations (RFQ) nor is an RFQ available. ***** Posted 12/10/98 (W-SN279029). (0344)

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