- Get Started: IRB Review Process
- Forms and Templates
- How To's & Brochures
- Post Approval
- Policies and Guidance
- Taking Part in Research
- Additional Resources
- Contact Us
There are 3 levels of IRB review
A PI may request a level of review, but the IRB Chair or Vice-Chair makes the decision.
(1) Exempt Review
(2) Expedited Review
(3) Full Review
Informed Consent Process
Informed Consent is the knowing consent of an individual or his/her legally authorized representative which is obtained without undue inducement or element of force, fraud, deceit, duress, or other forms of constraint or coercion. Informed consent is not just a form or signature, but a process of information exchange that includes:
- subject recruitment materials
- verbal instructions
- written materials
- questions/answer session
- agreement documented by signature
Checklist of Required Elements: Review this list to make sure your consent form is complete.
Waivers: Review this printout to see if your study is eligible for a Waiver of Informed Consent or Waiver of Documentation of Informed consent
Template: Letter for Waiver of Written Documentation: Download this template to create your letter for an anonymous survey.
HIPAA and Research
HIPAA = Health Insurance Portability & Accountability Act
- Click this link for more information on HIPAA and the Privacy Rule
- Protected Health Information (PHI) - The HIPAA Privacy Rule provides federal protections for personal health information held by covered entities and gives patients an array of rights with respect to that information. At the same time, the Privacy Rule is balanced so that it permits the disclosure of personal health information needed for patient care and other important purposes.
- Click here to learn more about protected health information
- HIPAA - PHI Identifiers
- HIPAA Authorization Checklist
Additional IRB Basics
- Form Completion & Approval of Research: Presentation explaining the narrative section questions and their relation to approval criteria.
- Data Safety Monitoring
- Template: Data Safety Monitoring Plan - Download and edit this word file to create your Data Safety Monitoring Plan
- Certificates of Confidentiality