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NASA Ball NASA
Procedural
Requirements
NPR 7100.1
Effective Date: March 28, 2003
Expiration Date: March 28, 2019
COMPLIANCE IS MANDATORY

(NASA Only)

Subject: Protection of Human Research Subjects (Revalidated 6/26/14)

Responsible Office: Office of the Chief Health & Medical Officer


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TABLE OF CONTENTS

Change History

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. Responsibilities

1.1 Authorized NASA Official (ANO)
1.2 NASA Center Directors
1.3 Center IRBs
1.4 NASA Contracting Officers (NCO)
1.5 Academic Institutions, Nonprofit Institutions, or Business Enterprises

CHAPTER 2. NASA Institutional Review Boards (IRB)

2.1 IRB Authority
2.2 Membership
2.3 Conflict of Interest
2.4 Meetings
2.5 Documentation and Preparation
2.6 Required Documents
2.7 Retention, Accessibility, and Inspection of Records

CHAPTER 3. NASA Flight IRB

3.1 Function
3.2 Center Designation and Meeting Location
3.3 Membership
3.4 Health and Safety Monitor
3.5 NFI Review Guidance
3.6 Conformance

CHAPTER 4. Informed Consent

4.1 Principle Investigator
4.2 Elements of Informed Consent
4.3 Withdrawal from Research
4.4 Consideration for Withdrawal from Space-based Research
4.5 Other Elements of Informed Consent
4.6 Waiver
4.7 Disclosure of Information
4.8 Emergency Medical Care
4.9 Documentation and Retention
4.10 Forms

CHAPTER 5. Criteria for IRB Approval of Research Involving Human Subjects

5.1 Approval Requirements

CHAPTER 6. Expedited Review

6.1 Expedited Review Process

CHAPTER 7. Research Mishaps, Adverse Events, Injuries, Illness, and Disease and Medical Care

7.1 Mishap/Adverse Event Reporting and Investigation
7.2 Medical Care and Reporting

CHAPTER 8. Documentation of Informed Consent

8.1 Modification of Protocol
8.2 Reporting and Approval

CHAPTER 9. Assurances from Participating Institutions

9.1 Multiple and Single Project Assurances (MPA and SPA)
9.2 IRB Review and Approval
9.3 Term of MPA
9.4 Evaluation and Reporting
9.5 Site Visit
9.6 Factors for Approval
9.7 Noncompliance

CHAPTER 10. Sanctions and Potential Disciplinary Action

10.1 Determination of Sanctions and Potential Disciplinary Action

Appendix A. Definitions

Appendix B. Acronyms

Appendix C. Information Portion of a NASA Human Subject Research Proposal

Appendix D. Types of Research Activities That May Be Reviewed Through Expendited Review Procedures

Appendix E. Guidance for Human Research Subject Mishap Investigation by an IRB

Appendix F. Multiple Project Assurance Compliance Oversight Procedures


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