Preserving Public Trust Accreditation and Human Research Participant Protection Programs (2001) / Chapter Skim
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Appendix C: VA Human Research Protection Accreditation Program Draft Accreditation Standards
Appendix C: VA Human Research Protection Accreditation Program Draft Accreditation Standards
Pages 135-196
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The VAMC retains responsibility for protecting human subjects of research even when it delegates the performance of some functions (e.g., IRB) to the affiliated university.
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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 .
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Depending on their performance, Human Research Protection Programs can achieve Full Accreditation, Conditional Accreditation, Probational Accreditation, or No Accreditation. Each accreditation outcome brings with it a set of actions by NCQA as well as VA offices.
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An AE can be any unfavorable and unintended sign, symptom, or disease. AFFILIATE'S HUMAN RESEARCH PROTECTION PROGRAM The HRPP of a VAMC's academic affiliate.
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HUMAN RESEARCH PROTECTION PROGRAM (HRPP) The systematic and comprehensive approach by an organization to ensure human subject protection in all research.
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The Assurance, approval of which is a condition of receipt of DHHS support for research involving human subjects, spells out the organization's responsibilities for meeting the requirements of 45 CFR 46. MPAs will be replaced by FWAs.
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UNEXPECTED ADVERSE EVENT Any adverse event that has not previously been observed (e.g., included in the investigator brochure)
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| Comment Privacy and Conf- Requirement 1.B Should the IRB minutes be included as dentiality Data source/method a possible data source/method for evaluating IRB assessment of provi sions to protect privacy in individual proposals All Data Source/method Is a one-year look-back period an ap propriate timeframe for adequate evaluation of an HRPP?
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Key Terms
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