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R -- U.S. AND DEVELOPING COUNTRY RESEARCHERS' EXPERIENCE WITH AND ATTITUTE TOWARDS HUMAN SUBJECTS REGULATIONS SOL N/A!! DUE 062700 POC MoniQue D. Woodard, Contract Specialist, 301-496-6546; or Patricia S. Page, Contracting Officer, 301-496-6546!! WEB: NBAC, ERROR --. E-MAIL: patricia_page@nlm.nih.gov, monique_woodard@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, Office of the Director to negotiate on a sole source basis with The Johns Hopkins University, School of Hygiene and Public Health, 615 N. Wolfe Street, Baltimore, Maryland 21205-1996. Johns Hopkins University will provide professional services to complete the final phase of the "U.S. and Developing Country Researchers' Experience with and Attitude Towards Human Subject Regulations" project. This is a continuation of a Fiscal Year 1998 and 1999 project to assist NBAC in providing advice and recommendations to the President, National Science and Technology Council and other Federal agencies on issues regarding the use of Federal funds for human subjects research. The overall goal of the project is to examine the adequacy and appropriateness of U.S. human subjects protections as they apply to research in other countries. The outcome of this project is to assist the Commission in deciding whether changes in Federal regulations and policies are warranted, and if so, developing recommendations for such changes. This project focuses on the experiences of U.S. researchers conducting international research. It is expanding to include the attitudes of U.S. and developing country researchers regarding U.S. human subject regulations. The final phase of this project will focus on survey distribution and data collection, performing qualitative, quantitative and statistical analyses of the survey data results and producing a final report to the Commission on both the U.S. and International components of this project. NBAC requires the professional services of Johns Hopkins for a period of six months. Specifically, the contractor will provide services in the following areas: 1. Examine the experiences and attitudes of U.S. and developing country investigators regarding the application of U.S. human subjects regulations to researchers' work in developing countries; 2. Interview and distribute survey data forms to investigators' on views about the adequacy and appropriateness of U.S. human subject protections as they apply to research in developing countries; and 3. Assist the Commission in the decision making function as to whether changes in Federal regulations and policies are warranted, and if so, provide assistance to the Commission in targeting their recommendations for such changes. The Johns Hopkins University's previous experience as a research institute for human subjects and its knowledge of the rules and regulations governing human subjects uniquely qualifies this university as the only source capable of successfully providing the necessary professional services. This requirement represents a continuation of services that the Institute is currently providing to NBAC. The University's staff therefore will require no orientation to NBAC's functions and operations. Johns Hopkins University staff has extensive expert knowledge of human subjectrules and regulations and it has a intimate knowledge of the business processes and procedures of NBAC. The University has the vast knowledge and experience in all aspects of the Project, including the organization, the staff, the business requirements, and the technology and functionality of this project. NBAC has determined that Johns Hopkins University is the only source with the unique combination of required expertise and experience to successfully complete the requirements listed above. This notice of intent is not a request for competitive proposals, nor is a Request for Proposals available. However, all proposals received within 45 days after the date of publication of this synopsis will be considered by NBAC. Authority: 41 U.S.C. 253(c)(1) and FAR 6.302-1(b)(1)!! See Numbered Note 22.**** Posted 06/06/00 (W-SN462000). (0158)

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