PHS ANNOUNCES DRAFT POLICY ON INSTRUCTION IN THE RESPONSIBLE CONDUCT OF RESEARCH FOR PUBLIC COMMENT Release Date: July 17, 2000 NOTICE: OD-00-045 Department of Health and Human Services The Office of Research Integrity and the Public Health Service research agencies are developing a new policy on instruction in the responsible conduct of research for institutions receiving PHS funds for research or research training. This policy will apply to all persons conducting research with PHS support. On October 22, 1999, HHS Secretary Donna E. Shalala announced a number of important changes in policy to improve the Department’s research integrity efforts including a statement that through ORI, the Department will require research institutions to provide training in the responsible conduct of research to all staff engaged in research or research training with PHS funds. This decision was based on the Department’s commitment to ensure that all PHS supported researchers receive basic instruction in the key elements of responsible research and are familiar with basic regulatory requirements. The decision was also supported by prior recommendations of the Commission on Research Integrity which stated, in part, that HHS require that each institution applying for or receiving a grant, contract, or cooperative agreement under the Public Health Service Act for research or research training add to its existing misconduct-in-science assurance a third declaration, one certifying that the institution has an educational program on the responsible conduct of research. Through this mechanism, the current NIH research integrity education requirement, now limited to recipients of institutional training grants at NIH-funded institutions, would be augmented by an assurance applied to all individuals supported by PHS research funds. Commission Report, Integrity and Misconduct in Research, p.18 (HHS 1995). Institutions and individuals interested in commenting on the draft policy may access it on the ORI website at <http://ori.dhhs.gov> by clicking on What’s New or obtain it from ORI at the address below. All comments must be received by ORI at 5515 Security Lane, Suite 700, Rockville, MD, 20852, or by E-mail to jegan@osophs.dhhs.gov, no later than August 21, 2000. Following consideration of public comments and appropriate revisions, it is expected that the new policy will be announced by October 1, 2000.


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