An excerpt from Dr. Losey’s “Controversies at the IRB” April 5 presentation at Research Affairs “Lunch & Learn”:
- Protocols should be clearly written, direct, and internally consistent. The scientific rationale should be included in the protocol, references should be cited for reviewers who have additional questions, but critical findings from these references should be included in the protocol. Risks should be clearly and directly addressed. For IRB templates on protocols, go to the Sample Protocol Outline.
- Informed consent documents should avoid medical jargon, clearly inform potential subjects of common and serious potential risks of the study, and explain how treatments in the study differ from standard care. A person who does not have a medical background should be able to understand the study after reading the consent. You can find IRB’s consent templates here.