NASA Procedures and Guidelines
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NPR 7100.1A Eff. Date: February 22, 2018 Cancellation Date:	Protection of Human Research Subjects
| TOC | ChangeHistory | Preface | Chapter1 | Chapter2 | Chapter3 | Chapter4 | Chapter5 | Chapter6 | Chapter7 | Chapter8 | Chapter9 | Chapter10 | AppendixA | AppendixB | AppendixC | AppendixD | AppendixE | AppendixF | ALL |

CHAPTER 1. Responsibilities

1.1 Authorized NASA Official (ANO):

1.1.1 The NASA Chief Health and Medical Officer (CHMO) is the Authorized NASA Official (ANO) and shall be responsible for the protection of human subjects. All or part of the authority may be redelegated, without power of further redelegation, to (a) a senior NASA HQ employee who reports to the ANO, or (b) the NASA Center Director(s).

The ANO shall be responsible for:

a. Informing the Administrator, the appropriate Associate Administrators (AA) sponsoring research involving humans, and the AA for the Office of Safety and Mission Assurance (OSMA), through official channels, of significant actions, problems, or other matters of substance related to the exercise of this authority.

b. Approving all NASA Center Multiple Project Assurances (MPA) or Single Project Assurances (SPA), indicating that NASA-conducted or -sponsored research complies with NASA policy and the body of existing law pertaining to research involving human subjects.

c. Approving each NASA Center's annual summary of the research and Institutional Review Board (IRB) activities for the preceding year including review of compliance activities, membership, initial and continuing education, and an updated IRB membership list.

d. Developing and administering a NASA Human Protection Training program for IRB members and investigators that is congruent with requirements for Federal funding by DHHS. This or similar training will be mandatory for all NASA IRB members and investigators using human subjects receiving NASA funds or involved in NASA-sponsored research.

1.2 NASA Center Directors

1.2.1 NASA Center Directors shall be responsible for:

a. Ensuring that their MPA is filed with the ANO. For NASA Center Directors not filing an MPA or SPA, the Center Director must certify to the ANO that research involving human subjects will not be conducted or sponsored by that Center during the following calendar year.

b. Establishing a Center IRB to review all ground-based, aerospace, and aeronautical flight research that their respective Centers conduct or that utilize NASA facilities, equipment, or personnel (NASA-conducted or -sponsored research). If this is not done, then another NASA IRB, by prior arrangement, will review the research proposals using human subjects.

c. Appointing the members of the Center IRB and selecting a full-time, senior-level NASA employee as the Chairperson.

1.3 Center IRBs

1.1.3 The Center IRBs are responsible for:

a. Protecting the rights and ensure the safety of every person who is a research subject in any NASA facility, including NASA aircraft or spacecraft. This applies to subjects involved in any research conducted or supported by NASA.

b. Reviewing all proposals for NASA-conducted or -sponsored, ground-based, aeronautical, and space flight research (applies to the NASA Flight IRB (NFI) only, chapter 3), that apply to human subjects prior to funding, approval, or execution of research. Except when an expedited review procedure is used, this review of proposed research will be held only at convened meetings at which a majority of the members of the IRB are present including at least one
member whose primary concerns are in a nonscientific area. For the research to be approved by the IRB, it will receive the approval of a majority of those members present at the meeting. If human subjects are to participate in multiple research protocols at the same time, the IRB shall review all the research proposals as an integrated protocol to assess the risks and benefits to the research subject.

c. Conducting a continuing review of research involving humans at intervals appropriate to the degree of risk, but not less than once per year. This continuing review shall include the informed consent particulars, the adequacy of safety precautions taken to date, and a determination as to whether or not proper and comprehensive information was given to the subject during the process.

d. Reviewing all adverse events (whether expected or not), which occur during the conduct of research. In all cases in which there has been an adverse incident reported to the IRB, the IRB shall notify the appropriate NASA safety and legal representatives, the ANO, and other AA's.

e. Defining for each approved experiment the extent to which the actual consent process and/or the conduct of the research will be monitored. If monitoring is deemed necessary, this may be accomplished by appointment of a monitor with specified responsibilities or direct monitoring by selected members of the IRB.

f. Maintaining documentation of IRB activities as prescribed in Chapter 2 of this NPR.

g. Reviewing and monitoring non-NASA research using NASA facilities, equipment, or personnel involving human subjects.

h. Reviewing human-used, ground-based simulators. The IRB shall determine the potential risks of the simulator operations to the research subjects. The IRB may then determine that all or some of the operations in the simulator may be IRB exempt, requires expedited review or requires full IRB review.

i. Investigating research subject mishaps resulting in an injury or illness to an individual or individuals (i.e., Type C, D, or CC mishaps per NPR 8621.1) according to processes established by the Institutional Review Board (IRB) approving the human research study, following the guidance provided in Chapter 7 and Appendix E.

1.4 NASA Contracting Officers (NCO)

1.1.4 The NCO shall be responsible for:

Ensuring that all research proposals involving human subjects (including grants, contracts, cooperative agreements, memoranda of understanding, or other similar legal arrangements) are reviewed by an approved IRB prior to funding. The NCO shall maintain a record of all such IRB approvals.

1.5 Academic Institutions, Nonprofit Institutions, or Business Enterprises

1.1.5 Academic institutions, nonprofit institutions, or business enterprises performing NASA-funded research involving human subjects at non-NASA facilities, and not involving NASA permission to use Government equipment, will be responsible for:

Obtaining approval for their proposed research from an approved IRB, which will generally be the IRB at the institution performing the research. NASA reserves the right to have all such research reviewed by a NASA IRB prior to funding or implementation of this research involving human subjects.

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