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.
There are several useful informed consent templates that investigators should use as a model when writing their documents. However, the IRB strongly believes that participants’ rights are best protected when investigators determine the appropriate tone, language, and format of the consent based on what they believe will best convey study information that is accurate and understandable to their participants. Bottom line: use templates but tailor them so that they’re appropriate, informative, and understandable to your research subjects.
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. We suggest that it be written at no more than an 8th grade reading level.
- Avoid technical and legal terms.
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 templates and sample documents.