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 16. Sanctions and Potential Disciplinary Action

16.1 PI Research Suspended

Any NASA PI participating in research involving human subjects, who does not comply with this NPR or with the IRB-approved protocol, may have his or her research immediately suspended or terminated by the appropriate IRB, NASA Center Director, or the ANO. Such noncompliance may be cause for revocation of funding. It may also be the cause for other appropriate remedies including disciplinary action against the PI, i.e. sanctions addressed in this section do not exclude possible personnel actions.

16.2 Non-NASA PI

PI's not employed by NASA, who are responsible for research involving human subjects that is sponsored by NASA or is performed in NASA facilities, aircraft, or spacecraft and who do not comply with this NPR or do not comply with the NASA IRB approved protocol, may have their research immediately suspended or terminated and shall also be subject to appropriate sanctions. NASA shall suspend or terminate funding approval if the investigator's research is suspended or terminated by the originating institution for any reason. NASA may immediately suspend or terminate grant approval for research involving human subjects from non-NASA institutions funded by NASA if that institution's MPA/FMA is suspended or terminated.

16.3 Funding of Suspended Research

16.3.1 If an MPA/FMA for a NASA Center or any institution is suspended or terminated for cause, the ANO with the concurrence of the OGC and the Office of Procurement may recommend to the NASA Administrator that all NASA funding for human research to that institution be suspended or terminated.

16.3.2 Any evidence of alleged criminal wrongdoing at any level related to information obtained from IRB activities and oversight by the Office of the CHMO shall be forwarded to the NASA Office of the Inspector General.

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