Consent Information
Obtaining informed consent from research participants is a fundamental requirement in research studies. Unless the IRB grants a waiver (e.g. partial waiver [verbal consent, information sheet provided], or complete waiver) a consent form is required and should include information about the study to participants in a clear simple manner so they may make an informed decision if they wish to participation. It is essential to note that informed consent does not stop once a research participant has enrolled in a study. It is an ongoing process throughout the participant’s enrollment. The BRI model consent template below can be used to create your consent form. You may also contact the IRB directly for assistance.
If children are involved in a research study (under 18 years old), an assent form may be required to obtain the child’s assent prior to enrollment. The IRB recommends a stand-alone assent form for subjects age 7–11. For those aged 12-17, it is optional if you wish to use an assent. The IRB recommends adding a unique signature line in the signature section of the model template consent form if appropriate.
Templates/Forms
- Consent Form Instructions and Checklist
- BRI Model Consent and HIPAA Template
- Info Sheet/Oral Consent Template
- Registry and Repository Research Study Consent Template
- Model Assent
- Phone Script Consent
- Translated Consents (Non-English Speaking Subjects)