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Informed Consent Forms and Process
Summary
Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP. The process begins with recruitment all the way to the end of their participation in the study.
Full Description
General Requirements for Consent
- All protocols must detail the informed consent process if participants will be involved in the research study. This includes exempt and non-exempt studies.
- Consent documents should be maintained by the PI for at least 5 years beyond the end of the study.
- The contact information of the PI and IRB should be listed. If a student is the lead-researcher, the faculty advisor contact information should be listed in addition to the student. Only official W&M email and phone numbers should be used.
- Information about obtaining consent can be found on the HHS website.
Consent Templates
Protocols must use the W&M-approved study information sheet or Informed Consent Form (ICF). To access the templates, please navigate to one of the sections displayed to the right.
- Exempt studies do not require signatures or all required elements of the informed consent. "Consent" documents for exempt studies are referred to as "study information sheet."
- Non-exempt studies must obtain full consent unless a waiver or alteration of consent has been noted in the protocol application (see below)