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NASA Ball NASA
Policy
Directive
NPD 7100.8F
Effective Date: March 29, 2019
Expiration Date: March 29, 2024
COMPLIANCE IS MANDATORY
Printable Format (PDF)

(NASA Only)

Subject: Protection of Human Research Subjects

Responsible Office: Office of the Chief Health & Medical Officer



1. POLICY


It is NASA's policy that all human research conducted, sponsored, or supported by NASA will follow all regulations contained in 14 CFR pt.1230 (Common Rule).

2. APPLICABILITY

a. This NPD 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 NPD 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.

3. AUTHORITY

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

4. APPLICABLE DOCUMENTS AND FORMS

Protection of Human Subjects, 14 CFR pt. 1230.

5. RESPONSIBILITY

a. The Chief Health and Medical Officer (CHMO), the Authorized NASA Official (ANO) for the protection of human subjects, is responsible for:

(1) Delegating the duties of the ANO to an Office of the Chief Health and Medical Officer (OCHMO) senior-level official, as necessary.

(2) Ensuring all Agency programs, procedures, and activities involving human research subjects comply fully with applicable Federal laws, regulations, and guidelines, follow best practices, and are appropriately harmonized across NASA.

(3) Ensuring the Administrator, appropriate Mission Directorate Associate Administrators, Office of Safety and Mission Assurance, NASA General Counsel, and NASA Inspector General (when appropriate) are kept well- informed, through official channels, of significant actions, problems, or other matters of substance related to the exercise of this authority.

(4) Approving each Center Director's annual summary of research and Institutional Review Board (IRB) activities for the preceding year.

(5) Representing NASA in forums with the external community, including in part, with other Federal Agencies and international partners, on protection of human subject matters.

(6) Establishing a Flight IRB, with charter, whose function is to review all research proposals that use:

(a) Astronaut research subjects and technicians.

(b) Non-astronaut research subjects in spacecraft research.

(c) Non-astronaut research subjects and technicians in aircraft research conducted or sponsored by Johnson Space Center (JSC) and other Centers per agreement.

(d) Animal, biological, or toxic material research that could be expected to interact with the humans onboard the spacecraft.

(7) Appointing, with concurrence from the JSC Center Director, the Flight IRB located at the JSC.

(8) Establishing and maintaining mechanisms to obtain timely information and notify the NASA IRBs, Center Directors, Institutional Officials (IO), and Program Managers of reports of noncompliance with NASA policy and applicable Federal laws, regulations, and guidelines received from non- NASA institutions where human subject research is supported by NASA.

(9) Reviewing all sanctions imposed by IOs or IRBs to determine if further actions are warranted and/or, at his discretion, initiating investigations of alleged noncompliance with NASA policy.

b. The IRB Chairs are responsible for:

(1) Overseeing the development, coordination, and implementation of protocol and program reviews and facility inspections for the IRB in compliance with Federal laws, regulations, and guidelines.

(2) Overseeing the development and submission of required reports and documents to the IO and Center Director, as appropriate.

c. The NASA Center Directors are responsible for:

(1) Serving as the Center's IO. The IO role may be delegated to a senior- level official with administrative and operational authority; however, Center Directors retain the ultimate responsibility for ensuring compliance with this NASA policy and Federal laws, regulations, and guidelines.

(2) Filing a Federalwide Assurance with the Office for Human Research Protections for human subject research at their Centers.

(3) Establishing a Center IRB, with charter concurred by the CHMO, or coordinating with another Center's IRB, whose functions are to:

(a) Review research involving non-astronaut research subjects in ground research.

(b) Review research involving non-astronaut research subjects and technicians in aircraft research conducted or sponsored by the Center.

(c) Prepare program plans and annual reports as required to obtain and maintain Federalwide Assurance.

(d) Ensure Center personnel conducting research with human subjects at another location are doing so under IRB approved protocols.

(4) The JSC Center Director will host the Flight IRB and concur on CHMO appointments to the Flight IRB.

(5) The JSC Center Director will serve as the IO for the Flight IRB. The IO role may be delegated to a senior-level official with administrative and operational authority; however, the Center Director retains the ultimate responsibility for ensuring compliance with this NASA policy and applicable Federal laws, regulations, and guidelines.

(6) Establishing written IRB procedures.

(7) Submitting an annual summary of research and IRB activities for the preceding year to the ANO. This summary will include a review of compliance activities, initial and continuing education, and IRB membership.

d. The Center Institutional Officials are responsible for:

(1) Establishing, supporting, and overseeing the functions of their Center's IRB consistent with NASA policy. This responsibility may be accomplished through the use of another Center's IRB via the OCHMO documented reliance agreement (https://www.nasa.gov/offices/ochmo/policy_stds/index.html).

(2) Determining and administering sanctions in cases of noncompliance with NASA policy in accordance with the applicable Federal laws, regulations, and guidelines and notifying appropriate funding officials and the ANO.

e. Program Managers who fund human subject research are responsible for the following:

(1) Ensuring compliance with NASA Policy through verification of flight or ground IRB protocol approval.

(2) Ensuring IRB approval at the institution receiving NASA funding prior to conducting research involving human subjects.

(3) Ensuring peer review and technical implementation feasibility assessments have been performed for planned flight experiments using human research subjects and the IRB has concurred with the assessment prior to selection of an experiment for flight.

f. The NASA project officials (e.g., Project Managers) are responsible for ensuring this policy is incorporated into the governing agreement (e.g., contract, grant, cooperative agreement, reimbursable agreement, public- private partnership, other transaction or other arrangement) for activities involving human research subjects.

g. Principal Investigators are responsible for complying with Agency and Center policies and procedures for the conduct of human research and are required to familiarize themselves with Agency and Center policies and procedures for the conduct of human research.

6. DELEGATION OF AUTHORITY

None.

7. MEASUREMENT/VERIFICATION

None.

8. CANCELLATION

NPD 7100.8E, Protection of Human Research Subjects, dated May 31, 2002.

/s/James F. Bridenstine
Administrator



ATTACHMENT A: DEFINITIONS

Authorized NASA Official (ANO) - The NASA Administrator's representative responsible for all NASA activities involving human reseach subjects. This individual is responsible for implementation of the provisions of this policy and for ensuring Agency programs involving human research subjects comply fully with all applicable Federal laws, regulations, and guidelines.

Institutional Official (IO) - An individual who has administrative and operational authority to commit institutional resources to ensure compliance with Federal laws, regulations, and guidelines.

Principal Investigator - A civil servant or non-civil servant (e.g., contractors and parties to agreements) researcher who has overall responsibility for all aspects of the funded and/or sponsored research project. Responsibilities for non-civil servant researchers are implemented through a contract or agreement.

Program Manager - The person designated by NASA to manage each program in which NASA has a research or payload interest. Programs may consist of several projects.

ATTACHMENT B: ACRONYMS

ANO - Authorized NASA Official

CHMO - Chief Health and Medical Officer

IO - Institutional Official

IRB - Institutional Review Board

JSC - Johnson Space Center

OCHMO - Office of the Chief Health and Medical Officer

(URL for Graphic)

None.

DISTRIBUTION:
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