- Please note that this page reflects the current regulations in effect. We will be revising this page in the near future to incorporate the regulation changes going into effect on January 19, 2018. Please see our Informed Consent Changes webpage for the latest information and guidance on the revised Common Rule.
The following samples are templates from which consent and recruitment forms can be developed. The language does not have to be repeated verbatim, although all the required elements of informed consent must be included. The consent form should be written in terms understandable to an average subject in your subject population (avoid or define technical terminology, adjust for educational background and ages, provide translations in other languages when subjects do not understand English).
Separate consent/assent form(s) must be submitted for each group of subjects. Consent forms must be written in non-technical, jargon-free language at an 8th grade level. Assent forms must also be written in age-appropriate language. Investigators with projects involving more than minimal risk and/or those working with special populations (children, people with intellectual or developmental disabilities, prisoners, pregnant women) may be required to include additional information in the consent forms.
If you plan on compensating participants, please see our page on compensation for additional required consent language.
Sample Consent Documents:
- Informed Consent TEMPLATE
- Invitation Letter for Anonymous Survey
- Oral Consent Script
Sample Assent/Permission Documents:
Sample Recruitment Documents: