The NASA IRB is an Agency-wide IRB that is charged with oversight of research involving human subjects to ensure the ethical, safe, and equitable treatment of human subjects.
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The IRB was established by the Office of the Chief Health and Medical Officer (OCHMO) Office of Research Assurance and reviews all research involving human subjects in the Agency to ensure the ethical, safe, and equitable treatment of subjects. It applies 14CFR1230, and NASA policies and guidelines (NPD 7100.8, and NPR 7100.1) to comply with federal regulations. When applicable, regulations from the Food and Drug Administration (FDA) must be followed if it pertains to human subjects research involving food, drugs, biologics, and devices. 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 IRB Office is comprised of IRB Coordinators, an IRB Chair, an IRB Lead, and the Institutional Official (IO). Additionally, the office often consults with the Protocol Compliance Officer, Safety Officer, and IT.
The IRB is constituted according to the regulations found at 14CFR1230.107. 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. Once a month, the IRB office will meet with those members and discuss human subjects research being reviewed at NASA. The 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.
Human Subjects Regulations
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 and Human Subject Regulations
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.
