Subject: Protection of Human Research Subjects

Responsible Office: Office of the Chief Health & Medical Officer

Preface

P.1 Purpose

This directive outlines the implementing procedures and requirements for the Agency to conduct and support research involving human subjects. These procedures and requirements follow the provisions in 14 CFR pt. 1230, Protection of Human Subjects (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 contractors, recipients of grants, cooperative agreements, or other agreements only to the extent specified or referenced in the applicable contracts, grants, or agreements.

Note: The applicability of this NPD to the Jet Propulsion Laboratory is being re-assessed by NASA. This applicability statement will be updated as necessary when that re-assessment is completed.

b. This NPR is applicable to all research involving human subjects conducted or supported by NASA. This includes, but is not limited to, all human research subject activities conducted by non-federal institutions or in commercial facilities, aircraft, and spacecraft that are funded or supported by NASA or use NASA resources. Human research subject activities by non-federal institutions or in commercial facilities, aircraft, and spacecraft that are not funded by NASA or do not use NASA resources are out of scope.

Note: NASA resources related to operation of the commercial facility, aircraft, or spacecraft having nothing to do with the human research activity does not constitute “use of NASA resources” for the actual human research activity. For example, if the institution or commercial provider only uses KSC services to launch the vehicle, this NPR would not apply.

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. § 552a.

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. Privacy Act System of Records Notice Health Information Management Systems (10HIMS), 72 FR 55813 (October 1, 2007).

e. Privacy Act System of Records Notice Human Experimental and Research Data Records (10HERD), 80 FR 68569 (Nov. 5, 2015).

f. NPR 2810.1, NASA Information Security Policy.

g. NPR 8621.1, NASA Procedural Requirements for 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 NASA Institutional Review Board (IRB).

(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

a. NPD 7100.1B, Protection of Human Research Subjects, February 15, 2019.

b. NID 7100.133, Protection of Human Research Subjects, January 29, 2021.

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