NASA Procedures and Guidelines
This Document is Obsolete and Is No Longer Used. Check the NODIS Library to access the current version: http://nodis3.gsfc.nasa.gov
NPR 7100.1A Eff. Date: February 22, 2018 Cancellation Date:	Protection of Human Research Subjects
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Appendix F. Multiple Project Assurance Compliance Oversight Procedures

F.1 Allegations of Noncompliance

The ANO may at any time modify an MPA to require interim corrective actions to remedy any identified noncompliance. The ANO may also suspend an MPA during an investigation if it is necessary to protect human research subjects.

F.2 Center Responsibility

The ANO may request the NASA Center or other institution to either acknowledge the institution's report of noncompliance or notify the NASA Center or institution's Assurance Signatory Official (ASO) of the possible noncompliance and, as necessary, request that the institution investigate the matter and report back. The ANO may communicate directly with other affected institutional officials or personnel or, if the noncompliance involves a specific research investigator, may notify that investigator directly.

F.3 Onsite Evaluation

The ANO may initiate an onsite evaluation of protections under an MPA even in the absence of specific allegations or indications of noncompliance. The ANO may convene a NASA HQ review panel to investigate the circumstances surrounding any cases of noncompliance. A designated senior NASA HQ official who has no apparent or real conflict of interest will chair the review panel. The membership shall consist of five members, as a minimum, with participation from the OGC and the OSMA. After review of the circumstances, the ANO in consultation with the OGC may prescribe and publicize sanctions.

F.4 Reporting Requirements

If the Authorizing Official determines that a formal report of findings is warranted, he or she shall notify the NASA Center or other institution's ASO that a formal report is required. The report may include (1) an invitation to the Signatory Official for institutional identification of errors of fact, and/or (2) the complainant(s), with an invitation for individual identification of errors of fact.

4.1 The Authorizing Official will establish a Data Safety Monitoring Board (DSMB) to review clinical studies.

4.2 The DSMB membership will be multidisciplinary in nature and, as a minimum, will include experts in biostatistics, experimental design, and bioethics. The DSMB will be established for particularly high-risk research or research where the blinded nature of data might put subjects at risk in ways that are not immediately apparent to blinded researchers.

4.3 The relevant IRB's, in consultation with the Office of CHMO, will determine which protocols warrant the establishment of particular levels of DSMB oversight.

4.4 All investigators who work with human subjects must be trained in basic principles of human subjects' protection. Minimum training should include the history and basic principles of human subject research protections, risk or benefit assessment and informed consent procedures, and institutional responsibilities. Research investigators must demonstrate that they have completed such training to be eligible to submit research proposals to a NASA IRB.

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