of the IRB apply to the IRB, whether operated by the VAMC, the affiliated university, or jointly.

SOURCE OF STANDARDS

These draft standards were compiled from regulations and other applicable policies that apply to research conducted at VA medical facilities and by VA employees. The principal sources were:

  • VA regulations at 38 CFR 16-17;

  • DHHS regulations at 45 CFR 46;

  • FDA regulations at 21 CFR 50, 56, 312, and 812;

  • VA policy as documented in Chapter 9 of the M-3 manual;

  • FDA Information Sheets;

  • International Conference on Harmonisation Good Clinical Practice Guideline; and

  • OHRP Compliance Activities: Common Findings and Guidance.

Accreditation standards may not necessarily match a specific regulation word-for-word. In general, if a regulation specifies an activity that must occur the standard reflects this fact, and focuses on measurable evidence that it occurred. Where allowed by a regulation, standards are flexible, for example, with respect to methods to be used to achieve a specified process or outcome. If a regulation has a specified intent, but does not specify how such intent shall be achieved, the required level of achievement, or other relevant details, standards were developed that are consistent with the expressed regulatory intent. Because these standards focus on VA research, they do not cover all regulations and policies pertaining to the conduct of international research, research involving children, fetuses, and prisoners, or genetic research.

ORGANIZATION OF THE STANDARDS

In this document unless otherwise specified, the term “standards” encompasses the rationale, standards, requirements, and elements, inclusively. The standards are organized into the following six domains:

  1. Institutional Responsibilities;

  2. IRB Structure and Operation;

  3. Consideration of Risks and Benefits;

  4. Subject Recruitment and Selection;

  5. Privacy and Confidentiality; and

  6. Informed Consent.

Each of the six domains of standards includes a statement of rationale. Following in hierarchical fashion, are standards, requirements, and elements that



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