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Research Projects Involving Human Subjects

The NIH has determined that provision of materials for a research project constitutes Federal support.  Recipients of Federal support must adhere to 45 CFR Part 46, the regulations dealing with research involving Human subjects.

If a research project involves human tissues, then a Federal Wide Assurance number (FWA#) is required before the material transfer can be authorized.

You can check if your institution has a FWA# on the Office for Human Research Protections (OHRP) web site listing the Approved Assurances: http://ohrp.cit.nih.gov/search/fwasearch.aspx

If your institution is not registered with OHRP, please review the procedure for applying for a FWA# on their website: http://www.hhs.gov/ohrp/assurances/assurances/index.html

This FWA# should be referenced in the research plan of the PHS MTA , the agreement we use for this transfer. In addition to including a FWA#, we will need to modify the agreement slightly.  Please email the Technology Development Coordinator (see contact information page for email addresses) an electronic copy of the MTA so we can ensure it is correct before signatures are initiated.​​​​

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This page last updated: May 28, 2014