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 12. Protocol Modifications

12.1 IRB Review of Protocol Modifications

The protocol shall not be modified unless the IRB or the reviewer (in the case of an originally expedited review) approves a formal request with appropriate justification. If the IRB determines that the modification increases the risk(s) to the subject, a revised informed consent shall be required.

12.2 Peer Review Suggested Modifications

Space flight experiment research protocols may require modification during flight, as procedures are refined to comply with operational constraints. Substantive human research protocol changes during flight require the majority approval of a quorum of the IRB. The Chairperson or designee shall expeditiously seek this approval in a meeting or by teleconferencing, if appropriate, with members of the NFI IRB. The Mission Operations Control Room Surgeon must be immediately informed of this requested substantive change and has the authority to temporarily suspend the experiment until the IRB can review the request. All such approved changes to the research protocol shall also be approved by the crewmember volunteering for the research prior to the initiation of the research protocol changes.

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