Institutional Review Board (IRB)
The IRB application collects a lot of information specific to clinical research trials in general. There are different types of scientific design, including randomized controlled trials (or RCTs), retrospective review of data that has already been collected, and prospective registries, which is an observational only trial. Some clinical research endeavors may be exempt from IRB review, some studies able to undergo expedited review, but must will go through a full board review. There are four phases of human clinical research: phase I dose finding (20–100 subjects), phase II assessing safety and efficacy (100–300 subjects), phase III firmly establishing safety and efficacy (300–3000 subjects), and phase IV post marketing for further information. There are some high-risk procedures (such as those involving radiation therapy or viruses that require special approvals.
KeywordsRandomized controlled trial Retrospective review Prospective registry IRB exempt IRB expedited review Phase I FDA testing Phase II FDA testing Phase III FDA testing Phase IV FDA testing Vulnerable population
- 1.Food & Drug Administration. Categories of research that may be reviewed by the IRB through an expedited review procedure. Nov 9, 1998. https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm 119074.htm.
- 2.Food & Drug Administration. Code of federal regulations: title 21, part 56 institutional review boards. 2017. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.107.
- 3.Food & Drug Administration. The drug development process: step 3 clinical research. 2018. https:www.fda.gov/ForPatients/Approvals/Drugs/default.htm.
- 4.Office for Human Research Protections. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. 1979. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html.