NASA Procedural Requirements

NPR 7100.1 Effective Date: March 28, 2003 Expiration Date: September 07, 2013

Subject: Protection of Human Research Subjects (Revalidated 7/7/08)

Responsible Office: Office of the Chief Health & Medical Officer

Preface

P.1 PURPOSE

P.1.1 This NASA Procedural Requirements(NPR) outlines the implementing procedures and guidelines for the Agency to conduct or support research involving human subjects.

These guidelines follow the provisions of "Federal Policy for the Protection of Human Subjects" as codified for NASA in Title 14 CFR Part 1230 and for the U. S. Department of Health and Human Services (DHHS) in Title 45 CFR Part 46. These regulations are implemented by the DHHS, Office for Human Research Protections (OHRP).

P.1.2 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. This shall cover all volunteers who participate in any research utilizing NASA facilities, including NASA aircraft and spacecraft, directed by NASA personnel or onsite contractors, and in any NASA-conducted or supported research.

P.2 APPLICABILITY

P.2.1 These requirements apply to NASA Headquarters (HQ), and all NASA Centers and component facilities engaged in experiments involving human subjects conducted or supported by NASA, conducted in NASA facilities, aircraft and spacecraft, or which involve NASA to any degree. The terms and conditions of this NPR, as applicable, are required to be incorporated in any contract, cooperative agreement, grant, or reimbursable arrangement, which involves human subject research entered into by NASA and another Government agency, private entity, non-Federal public entity, or foreign entity.

P.3 AUTHORITY

a. 42 U.S.C. 2473(c1), Section 203(c1) of the National Aeronautics and Space Act of 1958, as amended.

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

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

P.4 REFERENCES

a. 5 U.S.C. 552, The Freedom of Information Act (FOIA), as amended.

b. 5 U.S.C. 552a, The Privacy Act of 1974, as amended.

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

d. NPR 1441.1D, NASA Records Retention Schedules.

e. NPD 8900.1F, Medical Operations Responsibilities in Support of Human Space Flight Programs.

f. NPD 8900.3F, Astronaut Medical and Dental Observation Study and Care Program.

g. NPD 7100.8E, Protection of Human Research Subjects.

h. NPR 8621.1, NASA Procedures and Requirements for Mishap Reporting, Investigating, and Recordkeeping.

P.5 CANCELLATION

None.

ORIGINAL SIGNED BY:

/s/ Richard Williams, M.D. FACS
Chief Health and Medical Officer

DISTRIBUTION:
NODIS