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Resources: For Accreditation - Evaluation Instrument
Table of Contents
Regulatory and guidance references
- DHHS: 42 CFR 50.603, 42 CFR 50.606(a), 45
- CFR 690
- FDA: 21 CFR 54.1, 21 CFR 54.2, 21 CFR 54.4, 21 CFR 312.64(d), 21 CFR 812.110(d)
- VA: VHA Handbook 1200.05, 9
- AAHRPP Tip Sheet: Financial Conflict of Interest for Researchers and Research Staff
Required written materials
- Essential requirements:
- Policies and procedures pertaining to Element I.6.B. that address essential requirements.
- When following DHHS regulations:
- Policies and procedures pertaining to Element I.6.B. that address DHHS-specific requirements.
- When following FDA regulations:
- Policies and procedures pertaining to Element I.6.B. that address FDA-specific requirements.
- When following DHHS and FDA regulations:
- Policies and procedures pertaining to Element I.6.B. must also address the written material requirements for this Element. If the same policies and procedures are provided to researchers and research staff, simply reference those documents in the application for this Element. If there are additional materials, such as an Investigator Handbook or Web pages for researchers, that are not included in the materials used to support Element I.6.A., but are in support of Element III.1.B., include them here.
- When following VA requirements:
- Researchers must disclose conflicts of interest. This means disclosing to the IRB any potential, actual, or perceived conflict of interest of a financial, professional, or personal nature that may affect any aspect of the research, and complying with all applicable VA and other federal requirements regarding conflict of interest.
Common types of materials that may be used to meet the element
- Researcher manual
- Researchers and research staff understand the concept of conflict of interest.
- Researchers and research staff disclose required financial interests.
- Researchers and research staff work collaboratively with the organization or independent IRB to manage financial conflicts of interest.