NASA Procedural Requirements

NPR 7100.1C Effective Date: August 04, 2022 Expiration Date: August 04, 2027

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.

Human Genetic Testing. An analysis of human Deoxyribonucleic acid (DNA), Ribonucleic acid (RNA), chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal and biochemical changes. These tests can include the following:

• Molecular genetic tests that study single genes or short lengths of DNA or RNA to identify variations or mutations.
• Chromosomal genetic tests that analyze the entire genome or whole chromosomes or long lengths of DNA or RNA.
• Biochemical genetic tests that study the amount or activity of proteins or metabolites and wherein any noted changes can indicate changes in (or characteristics of) DNA or RNA.
• Microbiome testing from human subjects (gut, skin, etc.).

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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