Institutional Review Board (IRB) Approval is the formal consent and endorsement obtained from an IRB, also known as an ethics committee or research ethics board. This approval signifies that the research protocol, methods, and informed consent procedures meet ethical and regulatory standards. It ensures the protection of participants' rights, safety, and well-being, allowing the study to proceed in compliance with established ethical guidelines.
Definitions
ICH E6
The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements [1].
See also
References
- ↑ ICH website, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf