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 15. Assurance Compliance Oversight Procedures

15.1 Allegations on Noncompliance

The ANO shall investigate any allegation or indication of noncompliance with NPD 7100.8, or with this NPR, which comes to his or her attention with regard to NASA-conducted or supported research. The ANO may at any time modify an MPA to require interim corrective actions to remedy such noncompliance. The ANO may also suspend an MPA during an investigation if it is necessary to protect human research subjects.

15.2 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.

15.3 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 shall 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, as appropriate.

15.4 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), as appropriate, with an invitation for individual identification of errors of fact.

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

15.4.2 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.

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

15.4.4 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.

DISTRIBUTION:
NODIS