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This Document is Obsolete and Is No Longer Used.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 E. Guidance for Human Research Subject Mishap Investigation by an IRB

E.1 Introduction

E.2 IRB Investigation Panel

a. Based on the nature of the research subject mishap the IRB Chair will determine the composition of the investigating panel.

b. The panel may consist of the entire IRB membership, a sub-set, or a single member, but should always include the Office of Safety and Mission Assurance IRB member.

c. The IRB Chair may supplement the IRB panel membership with additional expertise (e.g., physician with appropriate expertise within the area of interest; other technical experts).

E.3 IRB Process Description

a. In investigating the mishap the panel should consider, at a minimum, the following factors:

(1) Relevant human factors issues, including psychological and physiological factors. Examples:

(a) Fatigue (work-rest cycles)

(b) Possible drug or alcohol influence

(c) Research team communication

(2) Management, operational and system factors. Examples:

(a) Research protocol design

(b) Proper procedure guidelines documented and implemented

(c) Biomedical/research equipment or technical failures

(d) Staffing and scheduling issues

(e) Proper training and appropriate certification of research personnel

(f) Competency of personnel to conduct and oversee research protocol.

(g) Proper supervision of research activities

c. Witnesses - All witnesses will be informed that their statements may not be confidential and that they will be interviewed upon their consent.

d. Possible Criminal Behavior - If a criminal violation is suspected, the appropriate NASA legal counsel (i.e., the Office of General Counsel and the Office of Inspector General) and CHMO must be immediately notified. The investigation will stop pending further guidance from the appropriate NASA legal counsel and CHMO.

E.4 IRB Findings and Reporting

a. The panel will determine the cause(s) of the mishap, identify all relevant factors that contributed to the mishap, and make recommendations regarding the implementation of the research protocol, personnel training and/or certification, hardware safety and study procedures, or any other aspect of the research deemed necessary.

b. The panel may make a recommendation as to whether the protocol should be continued, and if suspended if it should be permanently cancelled, resumed with modification, or resumed as originally designed.

c. The panel will report the findings and provide all relevant records and data collected to the IRB Chair, and submit recommendations for final disposition through the IRB.

d. Based on the findings and recommendations of the panel, the IRB will make a determination regarding the status of the research protocol and any remedial actions that should be taken.

e. The IRB Chair will inform the PI, the relevant NASA research funding program, and the CHMO in writing of the panel findings and actions taken.

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