Subject: Protection of Human Research Subjects

Responsible Office: Office of the Chief Health & Medical Officer

Chapter 2. Responsibilities

2.1 Chief Health and Medical Officer, Institutional Official, and Office of Research Assurance

2.1.1 The CHMO has appointed the Director, Health Operations and Oversight, as the Institutional Official (IO).

2.1.2 The IO is responsible for:

a. Acting for, and on behalf of, NASA to obligate the Agency to the terms of the Federalwide Assurance for the Protection of Human Subjects.

b. Providing the resources and support necessary to comply with all requirements applicable to research involving human subjects.

c. Designating the NASA IRB and approving its charter.

d. Appointing NASA IRB members, including the Chair, with concurrence of the respective member’s Center Director or equivalent.

2.1.3 The Office of Research Assurance ensures compliance with all applicable Federal laws and regulations, policies, and guidelines. The Office of Research Assurance is responsible for:

a. 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.

b. 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.

c. Reviewing NASA IRB activities annually and submitting a summary of research and NASA IRB activities for the preceding year to the CHMO. This summary will include a review of compliance activities, initial and continuing education, and NASA IRB membership.

d. Maintaining a Federalwide Assurance with the Department of Health and Human Services, Office for Human Research Protections, for human subject research at NASA.

e. Establishing and maintaining mechanisms to obtain timely information and notify the NASA IRB, Center Directors, 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.

f. Reviewing all sanctions imposed by the NASA IRB or IO to determine if further actions are warranted including initiating investigations of alleged noncompliance with NASA policy.

g. Ensuring that, consistent with 42 U.S.C. § 2000ff et seq and The Privacy Act of 1974, as amended, 5 U.S.C. § 552a, NASA-supported use of human genetic information obtained or analyzed for research purposes provides sufficient ethical, privacy, security, and data use protections.

h. Representing NASA in forums with the external community, including in part, with other Federal agencies and international partners, on protection of human subject research matters.

2.2 NASA IRB Chair

The NASA IRB operates in accordance with Federal regulations, laws, and guidelines. The NASA IRB Chair is responsible for overseeing the development, coordination, and implementation of human subject research.

2.3 Center Directors

2.3.1 The Center Directors are responsible for:

a. Ensuring Center personnel conducting human subject research at their Center or other locations are doing so under NASA IRB approved protocols.

b. Concurring (including providing resources) on appointments of their Center’s personnel to the NASA IRB.

2.4 Program Personnel

2.4.1 Program Managers who fund or support human subject research, or designee, are responsible for:

a. Ensuring compliance with NASA Policy through verification of IRB protocol approval.

b. Ensuring IRB approval for research at the institution receiving NASA funding prior to conducting research involving human subjects.

c. Ensuring peer review and technical implementation feasibility assessments have been performed for any research involving human subjects and that the NASA IRB has acknowledged the assessment.

d. Ensuring availability and support for securing and maintaining research data, including genetic information, in PIs' systems and/or institutional systems and other required repositories. All locations and systems used to store, process, analyze, and transmit data will comply with applicable data privacy and security requirements defined in funding agreements and this policy.

e. Ensuring this policy is incorporated into the appropriate legal instrument for activities involving human research subjects.

2.5 Principal Investigators

2.5.1 Civil service PIs, and non-civil service (e.g., contractors, grantees, and parties to agreements) PIs via their funding mechanism, are responsible for:

a. Complying with applicable Federal, state, and local laws, regulations, and guidelines as well as Agency, Center, and home institution policies and procedures for the conduct of human research and protection of information generated as part of such research.

b. Familiarizing themselves with Agency and Center policies and procedures for the conduct of human research.

c. Incorporating adequate resources into research proposals for complete study support, and for ensuring privacy and security of the data, including timely and secure transmission of raw and analyzed data to required NASA data repositories. For genetic studies, these resources may include genetic counseling or education of participants as required by the NASA IRB.

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