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Resources: For Accreditation - Evaluation Instrument
Table of Contents
Regulatory and guidance references
- DOJ: 28 CFR 512.11(a)(7)
- FDA: 21 CFR 312.53(c) (1), 21 CFR 312.60, 21 CFR 312.61, 21 CFR 312.62, 21 CFR 812.43(c) (4), 21 CFR 812.100, 21 CFR 812.140
- ICH-GCP: 4.2.3, 4.2.4
- VA: VHA Handbook 1200.05, 9, 63
- AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)
Required written materials
- Essential requirements:
- Policies and procedures indicate that if the principal researcher or the local site researcher does not personally obtain consent, the researcher must formally and prospectively designate to another research team member in writing the protocol or the application for IRB approval the responsibility for obtaining consent, whether a waiver of documentation of the consent process has been approved by the IRB.
- If the researcher contracts with a firm to obtain consent, the firm must have its own IRB.
- Students and other trainees (including residents and fellows), including VA employees, from schools with an academic affiliation agreement consistent with current VHA policy, may serve as members of research teams, but not serve as principal researcher within a VA facility, or use data, or human biological specimens that have been collected within VA for clinical, administrative, or research purposes.
- A researcher sufficiently experienced in the area of the trainee’s research interest must serve as principal researcher or co-principal researcher and is responsible for oversight of the research and the trainee.
- When following DOJ requirements:
- Policies and procedures indicate that for research conducted within the Bureau of Prisons, the researcher must assume responsibility for actions of any person engaged to participate in the research project as an associate, assistant, or subcontractor to the researcher.
- When following the ICH-GCP (E6) guideline:
- Policies and procedures describe that the researcher maintains a list of appropriately qualified persons to whom they have delegated significant clinical trial-related duties.
Common types of materials that may be used to meet the element
- Researcher manual
- Researchers are involved in the conduct of the research, including recruitment and obtaining consent, and maintain oversight of recruitment, consent, and protocol procedures.
- Researchers hire qualified staff.
- Research Staff indicate that the researcher delegates responsibility to them commensurate with their training and qualifications.
- Researchers are available to research staff when needed.