ELEMENT III.2.C.

ELEMENT III.2.C.: Researchers and research staff follow the requirements of the research protocol or plan and adhere to the policies and procedures of the organization and to the requirements or determinations of the IRB or EC.

Researchers and research staff should be knowledgeable about and follow all legal and regulatory requirements and the organization’s policies and procedures that pertain to their research. This includes adherence to the determinations and requirements of the IRB or EC. Once a research study is approved by the IRB or EC, researchers and research staff should follow the research plan or protocol as approved by the IRB or EC, and not implement changes until they are approved by the IRB or EC.

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 Directive1200.05(3), 5
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)

Required written materials

Essential requirements:
1. 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:
1. 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-Reviewing Protocols that use PII" available at: https://science.osti.gov/ber/human-subjects/Regulations-and-Requirements/DOE-Specific-Requirements
When following ED requirements:
1. Policies and procedures indicate that for research funded by the U.S. Department of Education:
2. 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.
3. 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.
4. 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

Outcomes

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.

Proceed To: ELEMENT III.2.D.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT III.2.C.