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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 |


P.1 Purpose

This directive outlines the implementing procedures and requirements for the Agency to conduct and support research involving human subjects. These guidelines follow the provisions in 14 CFR pt. 1230 (Common Rule).

P.2 Applicability

a. This NPR is applicable to NASA Headquarters and NASA Centers, including Component Facilities and Technical and Service Support Centers. This language applies to the Jet Propulsion Laboratory (a Federally Funded Research and Development Center), other contractors, recipients of grants, cooperative agreements, or other agreements only to the extent specified or referenced in the applicable contracts, grants, or agreements.

b. This NPR is applicable to all research involving human subjects conducted, sponsored, or supported by NASA.

c. In this directive, all mandatory actions (i.e., requirements) are denoted by statements containing the term "shall." The terms: "may" or "can" denote discretionary privilege or permission, "should" denotes a good practice and is recommended, but not required, "will" denotes expected outcome, and "are/is" denotes descriptive material.

d. In this directive, all document citations are assumed to be the latest version unless otherwise noted.

P.3 Authority

a. The National Aeronautics and Space Act, 51 U.S.C. § 20113 (a).

b. NPD 7100.8, Protection of Human Research Subjects.

c. NPD 7170.1, Use of Human Research Genetic Testing.

P.4 Applicable Documents and Forms

a. The Privacy Act of 1974, as amended, 5 U.S.C. § 552(a).

b. The Genetic Information Nondiscrimination Act of 2008, 42 U.S.C § 2000ff et seq.

c. Protection of Human Subjects (Common Rule), 14 CFR pt. 1230.

d. NPD 8621.1, NASA Mishap and Close-Call Reporting, Investigating, and Recordkeeping Policy.

P.5 Measurement/Verification

a. The Chief Health and Medical Officer (CHMO) will measure compliance with this directive by:

(1) Monitoring the number and type of research proposals reviewed and approved by the IRBs.

(2) Monitoring the number and type of protocol non-compliances, corrective actions taken, and sanctions imposed.

(3) Monitoring audit findings and corrective measures adopted.

P.6 Cancellation

NPR 7100.1A, Protection of Human Research Subjects, dated February 22, 2018.

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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.