To describe policy for Human Assurance Committee review of research protocols for non-GHSU entities.
The institutional Review Board (IRB) at Georgia Health Sciences University is known as the Human Assurance Committee (HAC) and was founded in 1966. The HAC was established to ensure that:
- risks are minimized and reasonable in relation to anticipated benefits
- informed consent is obtained
- the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated are protected
The HAC must be fair, impartial, and immune from pressure either by the institution’s administration or the investigators whose protocols are brought before it.
The Human Assurance Committee of Georgia Health Sciences University will function as the Institutional Review Board for Non-GHSU Entities based upon the following guidelines:
1. The use of the HAC will be limited to studies where the principal investigator (PI) or sub-investigator holds an adjunct or clinical faculty appointment. Loss of the appointment automatically terminates the HAC approval, subject to appropriate phase out in the interest of the research subjects. GHSU will not provide HAC review to an investigator or entity that already has access to an IRB, except in cases where research is being jointly reviewed with the other IRB.
2. GHSU will collect its full, actual cost in providing HAC review and monitoring.
Initial Review: $3000.00
Review of PI credentials, protocol, subject’s informed consent document, investigators brochure, and risk/benefit determination, advertisements, site visits as appropriate.
Continuing Review: $ 500.00
Re-review of protocol, amendments and subject’s informed consent document, adverse experiences and site visits as appropriate
Administrative changes to Informed Consent
Document [(ICD) not required by HAC] $100.00
Addition of Sub-Investigator, Study Coordinator
or change of Investigator $ 250.00
3. The HAC will only review studies conducted in the Augusta area.
Justification: The cost of traveling to remote sites to review and monitor research is estimated to be too great to provide this service outside the immediate geographic area.
4. Each individual or entity submitting a protocol to the HAC for review must enter into a formal contract with GHSU (see Exhibit A).
Many advances in prevention and treatment of diseases have derived from widespread programs of research conducted at universities, the private sector and by the government. The benefits of research should be preserved, and protection of human subjects against possible harm or abuse should occur simultaneously.
The program described above is designed to provide a valuable service that encourages the development of new biotechnology business in the Augusta area while ensuring that GHSU’s HAC is capable of exercising appropriate oversight of these activities.