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

Chapter 1. Introduction

1.1 Human Subject Research at NASA

1.1.1 Research designed to understand and improve the safety, well-being, and performance of flight and ground crews and others often requires Principal Investigators (PIs) to recruit human subjects. In some cases, basic and applied research is conducted to understand and predict the ability and successfulness of human performance in simulated or actual ground and flight tasks. In other cases, interventional studies may be conducted to study the efficacy of interventions to mitigate the adverse health effects of these environments. Studies may be conducted by scientists, test engineers, and/or clinicians in laboratories (e.g., human-computer interaction, cardiovascular, neuroscience, musculoskeletal, suit design, exercise, nutrition, immunology labs), work environments (e.g., air traffic and mission control centers as well as on aircraft and spacecraft), and simulated environments (e.g., the Human Exploration Research Analog, the Vertical Motion Simulator, Flight Simulation Facility).

1.1.2 NASA human research may include genetic testing (see Appendix A) to detect and characterize genotypes, mutations, or chromosomal and biochemical changes. The resultant genetic information, as defined in the Genetic Information Nondiscrimination Act of 2008, 42 U.S.C. § 2000ff et seq., can be combined with basic or applied research data to provide deeper insights into human health, performance, and countermeasures to mitigate adverse effects of conditions of interest to the Agency. However, the study of human genetics is accompanied by certain ethical considerations, such as impacts to relatives and the uncertainty of acquiring diseases for which someone might carry a genetic marker. As a result, NASA authorizes research use of genetic information only with assurances that adequate informed consent is provided to subjects and that data privacy and security protections are in place.

1.1.3 An IRB is a committee operating under the Common Rule that reviews research involving human subjects to ensure the ethical, safe, and equitable treatment of the subjects. The NASA IRB, established by the Office of the Chief Health and Medical Officer, Office of Research Assurance, reviews all research involving human subjects in the Agency.

1.2 Common Rule Implementation

The Common Rule applies to all research involving human subjects conducted and supported by NASA. NPD 7100.8 and this NPR are consistent with, but not duplicative, of the Common Rule. All three documents combined form NASA’s policy for research involving human subjects. NPD 7100.8 details the policy and responsibilities of Headquarters and the Centers, while this NPR defines procedures and requirements in addition to the Common Rule. The NASA IRB implements these requirements through a charter.

DISTRIBUTION:
NODIS

This document does not bind the public, except as authorized by law or as incorporated into a contract. This document is uncontrolled when printed. Check the NASA Online Directives Information System (NODIS) Library to verify that this is the correct version before use: https://nodis3.gsfc.nasa.gov.