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NASA Ball NASA
Procedural
Requirements
NPR 7100.1
Effective Date: March 28, 2003
Expiration Date: September 28, 2014
COMPLIANCE IS MANDATORY
Printable Format (PDF)

(NASA Only)

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

Responsible Office: Office of the Chief Health & Medical Officer


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CHAPTER 14. The Approval of Assurances


14.1 Approval by Authorized Official

The ANO shall evaluate the MPA's 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 shall file an annual notice with the ANO).

14.2 Non-NASA Institutions

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 may 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.

14.3 Site Review

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 (1) the institution's ability to safely perform research involving human subjects, (2) the expertise of the officials who shall oversee the assurances, (3) the facilities for maintaining adequate records, and (4) the institutional commitment for adequately funding the oversight efforts. Compliance may be audited at a site visit for renewal or at other times. Training of IRB and staff members shall also be monitored.

14.4 Evaluation of Requirements for MPA Approval

Approval of an MPA shall be based on the evaluation of the following factors: (1) 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; (2) regulations and policies regarding Federal laws and the common rule and their use by the IRB;(3) description of the way the IRB interacts with other interested oversight bodies, e.g. safety, legal, (4) 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; (5) policies for monitoring and observation of research activities; and (6) appropriate guidelines for the use of special classes of subjects.



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