NASA Procedural Requirements

NPR 7100.1D Effective Date: April 26, 2024 Expiration Date: April 26, 2029

Subject: Protection of Human Research Subjects

Responsible Office: Office of the Chief Health & Medical Officer

Appendix A. Definitions

Adverse Event. Any untoward or unfavorable medical occurrence involving a human research subject occurring while associated with the subject’s participation in the research. An adverse event is not necessarily a mishap if the protocol-related documents or informed consent documents identify the potential for the medical occurrence.

Biomedical Data. Information related to, or involving, biology or medicine. For NASA purposes, this may include health data or measures, such as genetic markers, suspected to play a role in health.

Genetic Information. Any information as defined in the Genetic Information Nondiscrimination Act of 2008, 29 CFR § 1635.3 (c). This includes information about: (i) an individual's genetic tests; (ii) the genetic tests of that individual's family members; (iii) the manifestation of disease or disorder in family members of the individual (includes family medical history); (iv) an individual's request for, or receipt of, genetic services or participation in clinical research that includes genetic services by the individual or a family member of the individual; or (v) the genetic information of a fetus carried by an individual or by a pregnant woman who is a family member of the individual and the genetic information of any embryo legally held by the individual or family member using an assisted reproductive technology.

Human Genetic Testing. Testing that directly or indirectly generates data about the content, expression, or characteristics of an individual’s genetic constitution. Such testing may include analyses of other factors linked to individual genetics (such as proteins, metabolites, or phenotypes). For the purposes of this document, it may include any of the following:

• Tests that generate data about the sequence, structure, or composition of any part of an individual’s deoxyribonucleic acid (DNA), ribonucleic acid (RNA),
• Tests that may generate data about how an individual’s DNA is expressed as RNA transcripts, proteins, or phenotypes,
• Tests that may generate data about variations, mutations, or other changes in the sequence, expression, structure, or other characteristics of an individual’s DNA, or
• Any other test where such information about an individual’s DNA could be inferred from the results.

Institutional Official. An individual who is legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Assurance.

Principal Investigator. A civil service or non-civil service (e.g., grantees, contractors, and parties to agreements) researcher who has overall responsibility for all aspects of the funded and/or supported research project. Responsibilities for non-civil service researchers are implemented through a contract or agreement.

Program Manager. The person designated by NASA to manage each program in which NASA has a research interest. Programs may consist of several projects.

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