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

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 CHMO, IO, and Office of Research Assurance
2.2 NASA IRB Chair
2.3 Center Directors
2.4 Program Personnel
2.5 Principal Investigators

Chapter 3. Criteria for NASA Institutional Review Board (IRB) 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:
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