Jan 19, 2022, 16:59 PM
Mar 20, 2022, 20:45 PM
Feb 17, 2022, 11:24 AM
Feb 9, 2022, 14:15 PM
Jan 20, 2022, 11:37 AM
Jan 19, 2022, 17:01 PM
Resources: For Accreditation - Evaluation Instrument
Table of Contents
Regulatory and guidance references
- DOE: 10 CFR 745, DOE Order 443.1B, Chg. 1 (April 21, 2016), DOE Notice 443.1 (January 21, 2016), and their accompanying Contractor Requirements Documents (CRDs)
- ED: 34 CFR 98.3
- FDA: FDA-Good Clinical Practice
- ICH-GCP: 4.1.3, 4.4.1, 4.5.1
- VA: VHA Handbook 1200.05, 9
- 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 the principal researcher, local site researcher, and researcher must uphold professional and ethical standards and practices and adhere to all applicable VA and other federal requirements, including the local VA facility’s standard operating procedures, regarding the conduct of research and the protection of human participants. The responsibilities of the researcher may be defined in the protocol or IRB application.
- When following DOE requirements:
- Policies and procedures indicate researchers are required to follow DOE requirements for the protection of personally identifiable information by completing and complying with the requirements of the “Checklist for IRBs to Use in Verifying that HS Research Protocols are in Compliance with DOE Requirements”, as outlined at: https://science.osti.gov/ber/human-subjects
- When following ED requirements:
- Policies and procedures indicate that for research funded by the U.S. Department of Education:
- All instructional material--including teachers' manuals, films, tapes, or other supplementary instructional material--which will be used in connection with any research or experimentation program or project must be available for inspection by the parents or guardians of the children engaged in such research.
- Research or experimentation program or project means any program or project in any research that is designed to explore or develop new or unproven teaching methods or techniques.
- Children are persons enrolled in research not above the elementary or secondary education level, who have not reached the age of majority as determined under state law.
Common types of materials that may be used to meet the element
- Researcher manual
- Researchers and research staff are knowledgeable about and follow all legal and regulatory requirements and the organization’s policies and procedures that pertain to their research.
- Researchers and research staff adhere to the requirements of the IRB or EC.
- Researchers and research staff follow the requirements of the research plan or protocol.