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This Document is Obsolete and Is No Longer Used.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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Chapter 9. Assurances from Participating Institutions

9.1 Multiple and Single Project Assurances (MPA and SPA)

All NASA Centers or other institutions proposing research involving human subjects supported by NASA shall give written institutional multiple project assurance (MPA), or a single project assurance (SPA) (Appendix F), as provided in 14 CFR 1230.103, to the ANO. Assurances from international institutions must follow the U.S. ethical and legal standards.

9.2 IRB Review and Approval

For any protocol by a non-NASA investigation, which utilizes NASA facilities, equipment, or personnel, in addition to the IRB of the extramural participants, a NASA IRB review and approval shall be required. Therefore, in this instance, other institutional assurances certified by DHHS OHRP or international oversight bodies for extramural projects will not suffice.

9.3 Term of MPA

The term of an MPA shall not exceed 5 years.

9.4 Evaluation and Reporting

9.4.1 The ANO shall evaluate the MPAs from NASA Centers and shall certify such MPA's that are deemed appropriate for the protection of human subjects if the submissions are satisfactory and meet the requirements in NPD 7100.8, Protection of Human Research Subjects, and this NPR (NASA Centers not conducting or supporting human research will file an annual notice with the ANO).

9.4.2 Other interested institutions, including public, private, and international institutions may submit an application for a NASA-approved MPA. The ANO with the concurrence of the OGC shall evaluate these MPA's and may certify such MPA's that are deemed appropriate for the protection of human subjects if the submissions are satisfactory, meet the requirements in NPD 7100.8, and this NPR, and are in NASA's best interests.

9.5 Site Visit

9.5.1 A site visit may be required for evaluation of either a new or renewal MPA to assess the adequacy of the NASA Center or other institution's procedures for protecting human research subjects. The site visit for a new approval shall evaluate the facilities to determine:

a. the institution's ability to safely perform research involving human subjects;

b. the expertise of the officials who shall oversee the assurances;

c. the facilities for maintaining adequate records;

d. the institutional commitment for adequately funding the oversight efforts; and

e. compliance may be audited at a site visit for renewal or at other times and the training of IRB and staff members shall also be monitored.

9.6 Factors for Approval

9.6.1 Approval of an MPA shall be based on the evaluation of the following factors:

a. administration including jurisdiction of the IRB, establishment and membership of the IRB, recordkeeping, institutional responsibilities, the assurance itself, staff, space, and supplies, communication, institutional procedures and guidelines, identification of the authorized NASA Center or other institutional official, training of IRB and staff members, and process for internal audits;

b. regulations and policies regarding Federal laws and the common rule and their use by the IRB;

c. description of the way the IRB interacts with other interested oversight bodies, e.g., safety, legal;

d. basic IRB review policies including risk or benefit analysis, requirement for the disclosure of risks and benefits in the consent form, continuing review and monitoring of data, requirements and documentation for the informed consent

e. policies for monitoring and observation of research activities; and

f. appropriate guidelines for the use of special classes of subjects.

9.7 Noncompliance

The ANO shall investigate any allegation or indication of noncompliance with NPD 7100.8, or with this NPR, which comes to his or her attention with regard to NASA-conducted or supported research, following the procedures for MPA compliance described in Appendix F.

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