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 or below.

Templates for Exempt Studies

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."
Exempt Study Information Sheets

Templates for Non-exempt Studies

Non-exempt studies must obtain full consent with signatures of participant or their legally authorized representative (LAR) unless a waiver or alteration of consent has been noted in the protocol application.

Non-Exempt Informed Consent Forms

Uploading to Qualtrics

Uploading information sheets nad consent forms to Qualtrics can be messy. Below is a guide researchers can use to upload PNGs of their Qualtrics form to their surveys.

Uploading Consents to Qualtrics (guide)