Writing a Great Consent
A consent is not a contract but an in-depth educational tool to begin the conversation with the subject. Consent is an ongoing process, and subjects should ask questions at any time. Research participants should be referred to as “subjects” to emphasize that they may not receive direct benefit from participating in the trial. More time should be spent on the consent process that on almost any other procedure in the trial. “If you take a medicine, thank a research subject.” A great consent most successfully makes the subject into a research partner.
KeywordsConsent Educational tool Subjects Bullet points Usual and customary Consent date Consent revisions Significant risk Pregnancy consent Genetic consent
- 1.Office for Human Research Protections. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. 1974. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html.