IRB Basics and Specific Topics
There are 3 levels of IRB review:
(1) Exempt Review
(2) Expedited Review
(3) Full Board Review
Informed Consent Process
Ethical research standards require an Informed Consent process prior to enrolling participants into a research study. 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 guidance document to learn about eligibility for a Waiver of Informed Consent or Waiver of Documentation of Informed consent.
There are various template consent forms available on our website under Forms and Templates.
HIPAA and Research
Health Insurance Portability & Accountability Act (HIPAA) guidance:
- 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.
- HIPAA and the Privacy Rule
- Protected Health Information (PHI)
- HIPAA Authorization Checklist