The purpose of an informed consent is to help investigators protect research participants by informing them about the nature of the research, including the procedures to be followed and any associated risks or benefits to participation. In compliance with federal regulations, the IRB carefully reviews informed consent documents.
Consent documents vary in the way they are written and formatted. The IRB discourages the use of a “model” consent document because it believes that participants’ rights will be better protected if investigators determine the appropriate language, format, and tone of the consent based on what they feel will best convey study information that is accurate and understandable to their participants.
Regulations require that certain basic elements be included in an informed consent. As a general rule, the following points should be considered when writing an informed consent:
- Include the basic required consent elements specified by the federal regulations.
- Use simple language. Many IRBs suggest that a consent form be written at no more than an 8th grade reading level.
- Avoid technical and legal terms.
The IRB does provide some previously approved sample documents. These samples include the basic language and informed consent elements that are typically required by the IRB; the specific details should be tailored to your study. For certain minimal risk studies, the use of a “study information sheet” may be more appropriate than collecting written signatures of participants on a standard informed consent document. Please contact the IRB Administrator to learn more about when the use of an information sheet is appropriate.
Visit the IRB Forms & Policies page for sample consent/assent and information sheet documents.