NASA Procedural Requirements

NPR 7100.1 Effective Date: March 28, 2003 Expiration Date: September 07, 2013

Subject: Protection of Human Research Subjects (Revalidated 7/7/08)

Responsible Office: Office of the Chief Health & Medical Officer

TABLE OF CONTENTS

Change History

Preface

P.1 PURPOSE
P.2 APPLICABILITY
P.3 AUTHORITY
P.4 REFERENCES
P.5 CANCELLATION

CHAPTER 1. Responsibilities

1.1 Authorized NASA Official (ANO)
1.2 Inform the Administrator
1.3 Approval of Multiple Project Assurances (MPA)
1.4 NASA Center Directors
1.5 Establish IRB
1.6 Protection of Rights
1.7 Other Institutions Responsibilities

CHAPTER 2. NASA Institutional Review Boards (IRB)

2.1 IRB Authority
2.2 IRB Responsibility
2.3 IRB Functions

CHAPTER 3. IRB Membership

3.1 Membership Requirements
3.2 Cultural Diversity
3.3 IRB Conflict of Interest
3.4 Nonvoting Expert Consultation
3.5 Recording Secretary
3.6 Term of Appointment

CHAPTER 4. NASA IRB Convening Authority

CHAPTER 5. IRB Records

5.1 Preparation and Maintenance of Records
5.2 Record-Retention Requirement

CHAPTER 6. NASA Flight IRB

6.1 Establishment of NASA Flight IRB (NFI)
6.2 NFI at Johnson Space Center (JSC)
6.3 Membership
6.4 Conflict of Interest
6.5 Ad hoc Members
6.6 Recording Secretary
6.7 Term of Membership
6.8 Research Monitor
6.9 Principle Investgator (PI) Certification of Safety and Health Risks
6.10 Integrative Proposal Review
6.11 IRB Approval Prior to Beginning of Training
6.12 No Waiver or Reciprocity With Any Other IRB
6.13 NFI Conform With NPG

CHAPTER 7. Informed Consent

7.1 Required Informed Consent
7.2 Elements of Informed Consent
7.3 Subject Withdrawal From Nonspace-Based Research
7.4 Subject Withdrawal From Space-Based Research
7.5 Supplementary Elements of Informed Consent
7.6 Waiver of Consent Elements
7.7 NPG Shall Not Preempt Current Laws
7.8 Physician Right to Practice Emergency Medicine

CHAPTER 8. Documentation of Informed Consent

8.1 Written Consent Required
8.2 The Consent Form May Be Either of the Following

CHAPTER 9. Criteria for IRB Approval of Research Involving Human Subjects

9.1 Requirements for IRB Approval of Research

CHAPTER 10. Expedited Review

10.1 Minimal Risk
10.2 Authority of Expedited Reviewer
10.3 Report to the IRB for Expedited Review

CHAPTER 11. Reports on Injuries, Illness, or Disease and Medical Care

11.1 PI Responsibility for Reporting
11.2 Responsibility for Recordkeeping
11.3 Determination of Suspension of Research
11.4 Reporting to NASA Headquarters
11.5 Review by IRB Required to Resume Research
11.6 Health Care Provisions for Research Subjects

CHAPTER 12. Protocol Modifications

12.1 IRB Review of Protocol Modifications
12.2 Peer Review Suggested Modifications

CHAPTER 13. Assurances from Participating Institutions

13.1 MPA on File
13.2 NASA IRB Approvals and Non-NASA Research
13.3 Format for MPA
13.4 Term of MPA

CHAPTER 14. The Approval of Assurances

14.1 Approval by Authorized Official
14.2 Non-NASA Institutions
14.3 Site Review
14.4 Evaluation of Requirements for MPA Approval

CHAPTER 15. Assurance Compliance Oversight Procedures

15.1 Allegations of Noncompliance
15.2 Center Responsibility
15.3 Onsite Evaluation
15.4 Reporting Requirements

CHAPTER 16. Sanctions and Potential Disciplinary Action

16.1 PI Research Suspended
16.2 Non-NASA PI
16.3 Funding of Suspended Research

CHAPTER 17. Measurements

APPENDIX A. Definitions

APPENDIX B. Mandatory Portion of a NASA Human Subject Research Proposal

APPENDIX C. Types of Research Activities That May Be Reviewed Through Expedited Review Procedures

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