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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  This NIH policy will eventually be superceded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

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