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Consenting Participants for Research

General Requirements for Consent

• All protocols must detail the informed consent process if participants will be involved in the research study.
• Consent documents should be maintained by the PI for at least five 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 .

Consent Templates

Protocols must use the W&M-approved study information sheet or Informed Consent Form (ICF).

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

HIPAA Authorization

HIPAA stands for the , which protects patients from inappropriate disclosures of the patient’s protected health information (PHI) that could cause harm to their insurability, employability, and/or their privacy through the.

The establishes a category of health information, defined as protected health information (PHI), which a covered entity may only use or disclose to others in certain circumstances and under certain conditions.

Uploading to Qualtrics

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

OHRP Resources

• (pdf)