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

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 (PI) 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 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 (OCHMO) 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, Protection of Human Research Subjects, NPD 7170.1, Use of Human Research Genetic Testing, and this NPR are consistent with, but not duplicative, of the Common Rule. All four documents combined form NASA’s policy for research involving human subjects. NPD 7100.8 and NPD 7170.1 detail 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.

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