PLEASE NOTE: We have a new site located at the NASA Institutional Review Board (IRB). This site will no longer be maintained after April 30, 2024 so please save the link for the new site.
The NASA IRB, established by the Office of the Chief Health and Medical Officer (OCHMO) Office of Research Assurance, reviews all research involving human subjects in the Agency to ensure the ethical, safe, and equitable treatment of the subjects, and compliance with applicable federal regulations NASA 14CFR1230/HHS 45CFR46 and NASA policies and guidelines (NID NPR 7100.1.1.1.2).The IRB has the authority to approve, require modifications, or disapproval all human subject research activities at NASA.
The NASA IRB holds a Federalwide Assurance (FWA) with the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP), FWA00019876. This is an assurance of compliance with the U.S. Federal regulations for the protection of human subjects in research.
The NASA IRB is constituted according to the NASA Human Subjects regulations at 14 CFR 1230.107. Additionally, the NASA IRB includes members representing Ames, Johnson, Kennedy, and Langley Space Centers, a Crew Representative, Crew Physician, Safety Representative, and NASA as a NASA Legal Representative.
The NASA IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote and must recuse themselves for discussions, deliberations, and votes unrelated to their expertise.
The NASA IRB is first guided in its review of human subjects research by the "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research" of April 18, 1979.
Three principles of the Belmont Report form the basis of ethical research:
- Respect for Persons: Any person who is to be a subject of research, whether designed for his/her direct benefit or for the advancement of scientific knowledge in general, must understand as completely as possible what is to be done and what the potential risks and benefits are. The person must give his/her consent freely, without pressure or inappropriate inducement.
- Beneficence: Before any human subject participates in a research study at NASA, the IRB must consider whether:
- "The risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept those risks" (Federal Register, May 30, 1974).
- The IRB must also assess scientific design and merit in order to assess the risk/benefit ratio. If a study design does not seem adequate to attain the stated aim of the investigation, then no benefit can be anticipated from conducting the study, and there is no justification for placing the subject at risk, however minimal. The design of the study must be sound, and the nature and likelihood of all risks and benefits must be made clear in any application.
- Justice: Both the risks and potential benefits of research should be spread fairly among potential individual subjects and subject groups.
Additionally, NASA has adopted the Common Rule, NASA 14CFR1230 (HHS 45CFR46). When applicable, the NASA IRB must also follow Food and Drug Administration (FDA) regulations as it pertains to human subjects research involving food, drugs, biologics, and devices.
Lastly, all human subjects research under the purview of the NASA IRB must also follow NASA policies and procedures as outlined in the NASA IRB Standard Operating Procedures (SOPs) and including but not limited to NPD 7170.1, NID NPD 7100.8, and NID NPR 7100.1.
For more information about relevant ethical guidance, please visit the sites below.