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This Document is Obsolete and Is No Longer Used.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
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Preface

P.1 PURPOSE

a. This NPR outlines the implementing procedures and guidelines for the Agency to conduct and support research involving human subjects. These guidelines follow the provisions in 14 CFR pt. 1230 and 45 CFR pt. 46. The Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP) implements these regulations.

b. The primary intent of these guidelines is to provide instructions on setting up oversight protection for the rights, medical safety, and well-being of human subjects involved in research. These guidelines will cover all test subjects who participate in any research utilizing NASA facilities, including NASA aircraft and spacecraft; any research directed by NASA personnel or onsite contractors; and any NASA-conducted or supported research.

P.2 APPLICABILITY

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

b. 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.

c. 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, as amended, 51 U.S.C. § 20113 (a).

b. Protection of Human Subjects, 14 CFR pt. 1230.

c. Protection of Human Subjects, 45 CFR pt. 46.

d. NPD 7100.8, Protection of Human Research Subjects.

e. 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. Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and other Non-Profit Organizations (OMB Circular A-110), 2 CFR pt. 215.

d. NASA Privacy Act regulations, 14 CFR pt. 1212.

e. Genetic Information Nondiscrimination Act, 29 CFR pt. 1635.

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

g. NPR 1382.1, NASA Privacy Procedural Requirements.

h. NPR 1441.1, NASA Records Management Procedural Requirements.

i. NRRS 1441.1, NASA Records Retention Schedules.

P.5 MEASUREMENT/VERIFICATION

Adherence to this NPR will be measured through strict tracking of requirements outlined herein. In general terms, for all NASA-sponsored research involving human subjects, the requirements will include verification of accreditation and certifications, regular monitoring of research activities and sanctions imposed, and corrective actions taken.

P.6 CANCELLATION

NPR 7100.1, Protection of Human Research Subjects, dated March 28, 2003.

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

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