NASA Procedural Requirements

NPR 7100.1 Effective Date: March 28, 2003 Expiration Date: September 07, 2013

Subject: Protection of Human Research Subjects (Revalidated 7/7/08)

Responsible Office: Office of the Chief Health & Medical Officer

CHAPTER 13. Assurances from Participating Instructions

13.1 MPA on File

All NASA Centers or other institutions proposing research involving human subjects supported by NASA shall give written institutional assurance, as provided in 14 CFR 1230.103, to the ANO. A Federal Wide Assurance (FWA) on file with the DHHS OHRP shall satisfy this requirement. Assurances from international institutions must follow the U.S. ethical and legal standards.

13.2 NASA IRB Approvals and Non-NASA Research

NASA IRB review and approval shall be required for any protocol by a non-NASA investigation, which utilizes NASA facilities, equipment, or personnel in addition to the IRB of the extramural participants. Therefore, in this instance, other institutional assurances certified by DHHS OHRP or international oversight bodies for extramural projects shall not suffice.

13.3 Format for MPA

Institutions submitting MPA's and SPA's to NASA should use the sample documents which can be obtained from NASA OCHMO.

13.4 Term of MPA

The term of an MPA shall not exceed 5 years.

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