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NPR 7100.1B
Effective Date: February 15, 2019
Expiration Date: February 15, 2024
Printable Format (PDF)

Subject: Protection of Human Research Subjects

Responsible Office: Office of the Chief Health & Medical Officer

| TOC | Preface | Chapter1 | Chapter2 | Chapter3 | AppendixA | AppendixB | AppendixC | ALL |

Chapter 1. Introduction

1.1 Human Subject Research at NASA

1.1.1 Research designed to understand and overcome the effects of aerospace-relevant conditions, contributing factors, and environments on the health and performance of flight and ground crews often requires Principal Investigators (PI) to rely on 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. There are five NASA IRBs. Four of these IRBs address ground and aircraft research: the Johnson Space Center (JSC) IRB, Langley Research Center IRB, Ames Research Center IRB, and Kennedy Space Center IRB. In addition, there is one IRB that addresses space flight and aircraft research: the Flight IRB which is located at JSC. The JSC IRB is the IRB of record for Glenn Research Center and Marshall Space Flight Center.

1.2 Common Rule Implementation

The Common Rule applies to all research involving human subjects conducted and supported by NASA. NPD 7100.8, NPD 7170.1, and this NPR are consistent with, but not duplicative, of the common rule. All four documents taken together 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 five NASA IRBs implement these requirements through charters and/or other Center documentation and report annually to the CHMO.

| TOC | Preface | Chapter1 | Chapter2 | Chapter3 | AppendixA | AppendixB | AppendixC | ALL |
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