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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
Because of (1979), all IRB reviewed studies at W&M, including exemptions, must include an informed consent/parent permission/minor assent (for minors ages 7 and up) process unless researchers provide a scientific justification or participant protection reason for not doing so.
Consent Templates
Protocols must use the W&M-approved study information sheet or Informed Consent Form (ICF).
About Study Information Sheets 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 sheets."
Exempt Study Information Sheets
About Informed Consent Documents for Non-Exempt Studies
Non-exempt studies (expedited and full board) 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
Template Language for Specific Populations, Procedures, or Other Situations
Occasionally, research will cross into other regulated areas such as health care, international data laws, AI, etc. When this occurs, researchers must ensure that the study information sheet and/or consent includes these unique elements. Below is a document that provides "template" language for researchers to include to be compliant.
Broad Consent
Broad consent enables the research team to retain, manage, and reuse identifiable or re-identifiable private information or biospecimens for future research projects that are not specifically defined at the time of the initial study, with the participants' agreement. An adult participant/parent/legal guardian cannot be required to give Broad Consent.
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)