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

Table of Contents

Preface

P.1 Purpose
P.2 Applicability
P.3 Authority
P.4 Applicable Documents and Forms
P.5 Measurement/Verification
P.6 Cancellation

Chapter 1. Introduction

1.1 Human Subject Research at NASA
1.2 Common Rule Implementation

Chapter 2. Roles and Responsibilities

2.1 Chief Health and Medical Officer, Institutional Official, and Office of Research Assurance
2.2 NASA Institutional Review Board Chair
2.3 Center Directors
2.4 Program Personnel
2.5 Principal Investigators

Chapter 3. Criteria for NASA Institutional Review Board Approval

3.1 Criteria for all Research
3.2 Additional Criteria for Human Research Genetic Testing

Chapter 4. NASA Specific Requirements

4.1 Research Modifications
4.2 Medical Data
4.3 Withdrawal from Research
4.4 Adverse Events
4.5 Sanctions and Disciplinary Action

Appendix A. Definitions
Appendix B. Acronyms
Appendix C. References

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.