Informed Consent Overview
For most research, informed consent is documented in writing to provide key information about the research. The consent form should:
- provide information for the subject's current and future reference, and
- document the interaction between the subject and the investigator.
However, even when a signed consent form is used, this alone does not create an adequate consent process. "The informed consent process is an ongoing exchange of information between the investigator and the subject and could include, for example, use of question and answer sessions, community meetings, and videotape presentations. In all circumstances, however, individuals should be provided with an opportunity to have their questions and concerns addressed on an individual basis." (OHRP FAQs)
Guidance for specific research questions
- Consent Writing Tips
- Consent Templates
- Informed Consent Checklist
- Legally Effective Informed Consent
- Phone Consent
- Remote Consent 03/2020
- Electronic consent for minimal risk research 06/2019
- REDCap eConsent Information: Training videos related to REDCap eConsent are available through Vanderbilt University REDCap eConsent - Part-11 Documentation Sharing. For questions regarding REDCap eConsent, please contact the Department of Medical Informatics at firstname.lastname@example.org with any questions.
- Consent without participant's signature
- Consent involving Surrogate Decision-Makers
- Consent of Non-English Speaking Subjects
- Informing participants of new information - Guidance 12/2020
- Enrolling illiterate English-speaking subjects
- Informed Consent FAQ's from the federal Office for Human Research Protections (OHRP)
Consent Writing Tips
Tips are offered to assist investigators to communicate effectively with potential research participants.
- Aim for 8th grade or lower reading level. Microsoft's Word readability tools can provide a general indication of the reading level. The IRB recognizes that 8th-grade level may be difficult to achieve in biomedical research; however, the suggestions below will lower the language level and improve comprehension.
- Write short, simple, direct statements.
- Use active verbs.
- Keep paragraphs short and limited to one idea. Avoid large blocks of printed text.
- Use a conversational tone. Some research indicates that comprehension is improved with a question-and-answer consent format.
- Use lay language for medical terms. For example, substitute "high blood pressure" for hypertension; substitute "adjust" for titrate; substitute "measure" for assess.
Resources / Lists
- Glossary of Lay Terminology (University of California Davis IRB Administration)
- PRISM Readability Toolkit (Group Health Research Institute) gives helpful examples of consent language before and after simplification.
- Contact Interpreter Services for assistance translating consent forms, 913-588-1564.