Subject: Protection of Human Research Subjects

Responsible Office: Office of the Chief Health & Medical Officer

Chapter 4. NASA Specific Requirements

4.1 Introduction

NASA’s mission to explore, use, and enable the development of space for human enterprise is unique. Therefore, while NASA’s program of human subject research complies, to the greatest extent possible, with all applicable Federal laws and regulations, policies, and guidelines, some aspects of NASA’s program of human subject research implementation are specific to spaceflight, and, therefore, may depart from the norm of human research implementation.

4.2 Research Modifications

4.2.1 The Flight Surgeon shall intervene in and/or terminate any on-orbit research activity to ensure astronaut health and welfare.

4.2.2 Protocols for human research subject activities may need to be modified inflight as research design and procedures are refined to satisfy operational constraints or experimental variation. When this occurs, the NASA IRB shall review and approve significant modifications to the protocol prior to implementation.

4.3 Medical Data

Medical data recorded during research for medical monitoring purposes will be available to appropriate medical personnel, included as part of the Informed Consent agreements as documented in NASA IRB standard operating procedures and are subject to 5 U.S.C. § 552a and such Privacy Act system of records as noticed in the Federal Register as Health Information Management System (10HIMS), 72 FR 55813 (Oct. 1, 2007). Research data will be available to the medical personnel (including flight surgeons) for issues involving safety of flight, safety of mission, medical emergencies, contingencies, and as required in the care of the patient.

4.3 Adverse Events

Upon occurrence of an adverse event, the NASA IRB Chair shall notify the NASA Center Safety Officer, the NASA Center Chief Medical Officer, the IO, Office of Research Assurance, the relevant NASA research funding program, and the Flight Surgeon (in the case of astronaut involvement).

Note: Human research mishaps are reported and controlled per NPR 8621.1, NASA Mishap and Close-Call Reporting, Investigating, and Recordkeeping Policy.

4.4 Sanctions and Administrative Action

4.4.1 If PIs do not comply with this NPR or with the NASA IRB approved protocol, the NASA IRB, IO, or Office of Research Assurance may suspend or terminate the research. Such noncompliance may be cause for revocation of funding or other appropriate action against the PI.

4.4.2. Any evidence of alleged criminal wrongdoing, waste, or abuse of process or procedures at any level related to information obtained from NASA IRB activities and oversight by the CHMO, shall be reported to the NASA Office of the Inspector General.

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