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 6. NASA Flight IRB (NFI)

6.1 Establishment of NASA Flight IRB

The ANO shall establish a NASA Flight IRB whose function is to review all research proposals that (1) propose the use of astronauts/crewmembers as research subjects and/or research technicians; (2) all space flight or aircraft research proposals that use noncrew human research subjects; (3) all aircraft research proposals that use noncrew as research technicians if it is deemed that their participation could effect their health or safety; and (4) all space flight or aircraft research proposals that use animals, biological, or toxic materials that could be expected to interact with the humans onboard the space or aircraft. The NFI may also evaluate other proposals at the discretion of the ANO.

6.2 NFI at Johnson Space Center (JSC)

The NFI shall be located at JSC; however, meetings of the NFI may be at any appropriate location.

6.3 Membership

In consultation with the JSC Center Director, the ANO shall appoint the membership of the NFI which shall include (1) the Chairperson; (2) a NASA safety representative; (3) an active NASA Astronaut; (4) a NASA flight surgeon (5) a non-NASA employee from the bioethics or health profession communities; and (6) other members as required to have sufficient expertise and diversity to adequately evaluate research proposals. The Center Office of Chief Counsel or the Headquarters Office of General Counsel (OGC), as appropriate, shall provide legal advice to the NFI.

6.4 Conflict of Interest

No NFI member may participate in the review of any proposal in which that member has a conflicting interest, except to provide information requested by the Board.

6.5 Ad hoc Members

The NFI may invite nonvoting experts to help review and resolve special or difficult issues, which require competence beyond or supplementing that available on the Board.

6.6 Recording Secretary

The recording secretary shall be appointed by the Chairperson of the NFI for recordkeeping and for general administrative Board functions.

6.7 Term of Membership

NFI members shall be appointed for a 3-year term and can be reappointed at the end of their term. NFI members may not be removed from their positions before the end of their terms except in cases of misconduct.

6.8 Research Monitor

The NFI may require that a NASA safety and health monitor (which may be the crew surgeon) must be available to observe all research studies involving NASA astronauts/crewmembers.

6.9 PI Certification of Safety and Health Risks

If human subjects are to participate in multiple flight research protocols at the same time, the NFI shall review all the research proposals as an integrated protocol to assess the risks to the research subject.

6.10 Integrative Proposal Review

All research proposals that are required for review by the NFI shall be approved by the NFI prior to the initiation of astronauts/crew or subject briefing.

6.11 IRB Approval Prior to Beginning of Training

The NFI will review only those proposals that have undergone successful scientific peer review, are funded for definition and/or feasibility studies, and are proposed as part of a flight payload complement.

6.12 No Waiver or Reciprocity With Any Other IRB

No waiver or reciprocity with any other IRB shall be accepted for any research proposal falling under chapter 6.

6.13 NFI Conform With NPR

The NFI shall conform to all appropriate parts of this NPR.

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