How Often Does IRB Approved Research Have To Be Reviewed? An IRB must conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year (45 CFR 46.109(e)). How long is IRB approval valid for? A copy of all documentation reviewed is to be maintained for at
When Evaluating Risks Of Harm IRBs Must Determine That? When evaluating risks of harm, IRBs must determine that: Risks are reasonable in relation to anticipated benefits. When the primary potential harm is the breach of individually identifiable data to protect against such disclosure researchers should? When the primary potential harm is the breach of individually
What Is One Of The Criteria That An IRB Uses To Review Research? 1. Risks to subjects are minimized. Procedures are consistent with sound research design and do not unnecessarily expose subjects to risk. Study utilizes procedures already performed for diagnosis/treatment — when appropriate. What does the IRB need to review? Under FDA regulations, an