NASA Procedures and Guidelines
This Document is Obsolete and Is No Longer Used. Check the NODIS Library to access the current version: http://nodis3.gsfc.nasa.gov
NPR 7100.1A Eff. Date: February 22, 2018 Cancellation Date:	Protection of Human Research Subjects
| TOC | ChangeHistory | Preface | Chapter1 | Chapter2 | Chapter3 | Chapter4 | Chapter5 | Chapter6 | Chapter7 | Chapter8 | Chapter9 | Chapter10 | AppendixA | AppendixB | AppendixC | AppendixD | AppendixE | AppendixF | ALL |

CHAPTER 8. Documentation of Informed Consent

8.1 Modification of Protocol

A protocol shall not be modified unless the IRB or the reviewer (in the case of an originally expedited review) approves a formal request with appropriate justification. If the IRB determines that the modification increases the risk(s) to the subject, a revised informed consent will be required.

8.2 Reporting and Approval

8.2.1 Space flight experiment research protocols may require modification during flight, as procedures are refined to comply with operational constraints. Substantive human research protocol changes during flight shall require the majority approval of a quorum of the NFI IRB.

8.2.2 The Mission Operations Control Room Surgeon shall be immediately informed of this requested substantive change and has the authority to temporarily suspend the experiment until the IRB can review the request.

8.2.3 All such approved changes to the research protocol will also be approved by the crewmember volunteering for the research prior to the initiation of the research protocol changes.

| TOC | ChangeHistory | Preface | Chapter1 | Chapter2 | Chapter3 | Chapter4 | Chapter5 | Chapter6 | Chapter7 | Chapter8 | Chapter9 | Chapter10 | AppendixA | AppendixB | AppendixC | AppendixD | AppendixE | AppendixF | ALL |

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