NIH requiring statement of education for PIs using human subjects Sally Eckert-Tilotta 09 Jun 2000 13:00 EST
The following is an excerpt from the NIH Grant Guide. The complete announcement is at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS Release Date: June 5, 2000 NOTICE: OD-00-039 National Institutes of Health Policy: Beginning on October 1, 2000, the NIH will require education on the protection of human research participants for all investigators submitting NIH applications for grants or proposals for contracts or receiving new or non-competing awards for research involving human subjects. Implementation Before funds are awarded for competing applications or contract proposals involving human subjects, investigators must provide a description of education completed in the protection of human subjects for each individual identified as *key personnel* in the proposed research. Key personnel include all individuals responsible for the design and conduct of the study. The description of education will be submitted in a cover letter that accompanies the description of Other Support, IRB approval, and other information in accordance with Just-in-Time procedures. The use of a cover letter is also acceptable for contract proposals. After October 1, 2000, investigators submitting non-competing renewal applications for grants or annual reports for research and development contracts that involves human subjects research must also include a description of such education in their annual progress reports. This NIH policy will eventually be superceded by the DHHS Office of Research Integrity*s institutional assurance on the responsible conduct of research, which is described below. Related Training Requirement The Office of Research Integrity (ORI), Department of Health and Human Services, is developing a policy to implement an extension of the training requirement on the responsible conduct of research (RCR) to all persons supported by PHS research. The protection of human subjects in research will be included in the RCR institutional assurance. A draft of this policy will be posted for comment on the ORI website in June, 2000. Sally Eckert-Tilotta, Ph.D., Associate Director Office of Research & Program Development University of North Dakota PO Box 7134 Grand Forks, ND 58202 Tel: 701-777-2049 Fax: 701-777-2504 Email: xxxxxx@mail.und.nodak.edu ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================