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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 3. NASA Specific Requirements

3.1 Research Modifications

The Flight Surgeon lead for the mission may temporarily suspend research until substantive changes to spaceflight protocol are reviewed by the Flight IRB.

3.2 Medical Data

Medical data recorded during research for medical monitoring purpose will be available to appropriate medical personnel and will be included as part of the Informed Consent agreements. Research data will be available to the medical personnel (including flight surgeons) for issues involving safety of flight, safety of mission, medical emergencies,

contingencies, and as required in the care of the patient.

3.3 Withdrawal from Research

3.3.1 Research subjects may withdraw from participation at any time without explanation, penalty, or loss of benefits to which they are otherwise entitled.

3.3.2 In the event a subject withdraws from participation, NASA reserves the right to replace that individual with another test subject.

3.4 Adverse Events

Upon occurrence of an Adverse Event, the IRB Chair shall notify the NASA Center Safety Officer, the Authorized NASA Official (ANO), the NASA Center Chief Medical Officer (where applicable), the relevant NASA research funding program, and the Flight Surgeon (in the case of astronaut involvement).

Note: Human research mishaps are reported and controlled per NPR 8621.1.

3.5 Sanctions and Disciplinary Action

3.5.1 If PIs do not comply with this NPR or with the IRB approved protocol, the appropriate IRB or Institutional Official may suspend or terminate the research. Such noncompliance may be cause for revocation of funding or other appropriate remedies including disciplinary action against the PI.

3.5.2. If a Federalwide Assurance for a NASA Center or any institution is suspended or terminated for cause, the ANO with the concurrence of the Office of the General Counsel and the Office of Procurement may recommend to the NASA Administrator that all NASA funding for human research to that institution be suspended or terminated.

3.5.3. Any evidence of alleged criminal wrongdoing at any level related to information obtained from IRB activities and oversight by the CHMO will be reported to the NASA Office of the Inspector General.

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