Institutional review board (IRB) – is a committee responsible for reviewing, approving, and monitoring biomedical research involving human subjects. The primary purpose of the IRB is to ensure the protection of the rights, safety, and well-being of human participants involved in research studies.
Definitions
ICH E6(R2)
- 1.31 Institutional Review Board (IRB):
- An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects [1].
Title 21 Code of Federal Regulations Part 56
- 21 CFR 56.102:
- Institutional Review Board (IRB) means any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects. The term has the same meaning as the phrase institutional review committee as used in section 520(g) of the act [2].
Role of Institutional review board
Key responsibilities of IRB an typically include:
- Reviewing study protocols to ensure they meet ethical standards and regulatory requirements.
- Reviewing informed consent documents to ensure clarity, accuracy, and appropriate tailoring to the study population.
- Conducting periodic reviews of ongoing research studies to ensure continued compliance with ethical standards, applicable laws and regulatory requirements.
History of Institutional review board
The composition of the IRB traces back to the Nuremberg Code of 1945, a response to the unethical experiments conducted by the Nazis during World War II, and the Tuskegee Syphilis Trial in the United States, where Black men were denied treatment.
- IRB were formally created by National Research Act signed into law in 1974.
- Currently, the structure and operation of the IRB are outlined in 21 CFR Parts 16 and 56, which were implemented in 1981 [3].
See also
Another relevant pages
Links to this page
- Ethics committee (← links)
- Regulatory inspection (← links)
- IRB (redirect page) (← links)
- Institutional Review Board (IRB) (redirect page) (← links)
- Safety (← links)
- Standard operating procedures (← links)
- Trial site (← links)
- Well-being (← links)
- Comparison of IRB and IEC requirements (← links)
References
- ↑ ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023
- ↑ Code of Federal Regulations, Title 21 CRF PART 56 – Institutional Review Boards § 56.102 Definitions, https://www.ecfr.gov/current/title-21/section-56.102 Accessed Apr 2024
- ↑ FDA, 1981, Protection of Human Subjects; Standards for Institutional Review Boards for Clinical Investigations, https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/protection-human-subjects-standards-institutional-review-boards-clinical-investigations
External links
- FDA Information sheet, 1998, Institutional Review Boards Frequently Asked Questions, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions Accessed Apr 2024
- OHRP, Database of IRB Organizations/IRBs registered with the United States Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) https://ohrp.cit.nih.gov/search/irbsearch.aspx Accessed Jul 2024