PURPOSE. This NASA Procedures and Guidelines (NPG) outlines the implementing procedures and guidelines for the Agency to conduct or support research involving human subjects. These guidelines follow the provisions of "Federal Policy for the Protection of Human Subjects" as codified for NASA in Title 14 CFR Part 1230, and for the U. S. Department of Health and Human Services (DHHS) in Title 45 CFR Part 46. These regulations are implemented by the DHHS, Office for Human Research Protections (OHRP).

The primary intent of these guidelines is to provide instructions on setting up oversight protection for the rights, medical safety, and well-being of human subjects involved in research. This shall cover all volunteers who participate in any research utilizing NASA facilities, including NASA aircraft and spacecraft, directed by NASA personnel or onsite contractors, and in any NASA-conducted or supported research.

APPLICABILITY. These guidelines apply to NASA Headquarters (HQ), and all NASA Centers and component facilities engaged in experiments involving human subjects conducted or supported by NASA, conducted in NASA facilities, aircraft and spacecraft, or which involve NASA to any degree. The terms and conditions of this NPG, as applicable, are required to be incorporated in any contract, cooperative agreement, grant, or reimbursable arrangement, which involves human subject research entered into by NASA and another Government agency, private entity, non-Federal public entity, or foreign entity.

Research activities are exempted from this NPG if their involvement of human subjects is limited solely to the use of surveys or interviews unless (1) the information obtained is recorded in such a manner that human subjects are identified directly or can be identified indirectly through designators or through identifiers linked to the subjects, and (2) disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk for criminal or civil liability or could damage their financial standing, employability, or reputation. Also exempt is research involving the collection or study of existing data, documents, records, and pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded by the Principal Investigator (PI) in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects. Research activities using identifiable specimens archived after space flight are not exempt from the guidelines of this NPG.