Volume 9 Research
Chapter 0401 Policy for Human Assurance Committee Review for Non-Georgia Health Sciences University Investigators
Responsible Office: Office of Human Research Protection
Originally issued: 11/01/01
The Human Assurance Committee (HAC) at Georgia Health Sciences University can function as an Institutional Review Board (IRB) for a Principal Investigator or sub-Investigator who holds an adjunct or clinical faculty appointment, but not a full-time appointment, at Georgia Health Sciences University, if the individual does not have access to another IRB. The study must be conducted in the Augusta area, the investigator must enter into a formal contract with Georgia Health Sciences University, and a fee for use of the HAC must be paid.
Reason For Policy
Many advances in prevention and treatment of diseases have been derived from widespread programs of research conducted at universities, within the private sector, or by the government. Human subjects involved in these studies must be protected against possible harm or abuse. Georgia Health Sciences University agrees to serve as the Institutional Review Board for non-Georgia Health Sciences University investigators conducting such studies, under the conditions of this policy.
Entities Affected By This Policy
Any individual conducting clinical or other research involving human subjects or human-derived materials who does not have a full-time appointment at Georgia Health Sciences University and desires to use Georgia Health Sciences University Human Assurance Committee as the Institutional Review Board for that study are affected by this policy.
Who Should Read This Policy
Any individual conducting clinical or other research involving human subjects or human-derived materials who does not have a full-time appointment at Georgia Health Sciences University but is interested in using Georgia Health Sciences University Human Assurance Committee as the Institutional Review Board for that study should be aware of this policy.
|Director, Office of Human Research Protection||706-721-1480||mailto:email@example.com
|Assistant Director, Office of Human Research Protection||706-721-1379||mailto:firstname.lastname@example.org
|Chairperson, Human Assurance Committee||706-721-1483||mailto:email@example.com
These definitions apply to these terms as they are used in this policy:
|Non-Georgia Health Sciences University Investigator||Any clinician or researcher who does not have a full-time academic appointment at Georgia Health Sciences University, but who holds an adjunct or clinical faculty appointment.|
|Human-derived materials||Material or information coming from or pertaining to human subjects, including: medical records, electronic or hard copy; data store (i.e., database, spreadsheet, or other document or electronic type); fetal material including the placenta, amniotic fluid, fetal membranes, and umbilical cord; teeth; pathological specimens; diagnostic specimens (blood, sputum, urine), hair, and nail clippings collected in a non-disfiguring manner; deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; permanent teeth if routine patient care indicates a need for extraction; excreta and external secretions (including sweat); uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric acid solution to the tongue; placenta removed at delivery; amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; sputum collected after saline mist nebulization; primary cell lines (or those not generally available through commercial sources).|
|Human Assurance Committee (HAC)||The internal Institutional Review Board at Georgia Health Sciences University.|
|Human subject||A “human subject” is a living individual about whom an investigator obtains either: (1) data through interaction or intervention with the individual, or (2) identifiable private information.|
|Institutional Review Board (IRB)||A committee or group composed of scientists and non-scientists established to protect the rights and welfare of human research subjects and human-derived materials.|
|Research||Any systematic investigation designed to develop or contribute to generalizable knowledge.|
Georgia Health Sciences University recognizes that all research using human subjects or human-derived materials must obtain Institutional Review Board approval prior to the initiation of the research. This is a federal requirement. Most academic and research institutions have their own Institutional Review Boards in place to review such research protocols. However, Georgia Health Sciences University recognizes that some clinicians or other individuals without full-time affiliation with an academic or research institution might wish to perform research involving human subjects or human-derived materials. Therefore, Georgia Health Sciences University will allow such non-Georgia Health Sciences University investigators to use its Institutional Review Board, known as the Human Assurance Committee (HAC), to review their protocols under the conditions set forth in this policy.
The use of Georgia Health Sciences University Institutional Review Board by non-Georgia Health Sciences University investigators is allowed so that the institution can provide a valuable service in encouraging the development of new biotechnology business in the Augusta area while ensuring that Georgia Health Sciences University’s HAC is capable of exercising appropriate oversight of these activities.
The Human Assurance Committee of Georgia Health Sciences University will function as the Institutional Review Board for non-Georgia Health Sciences University’s investigators based upon the following guidelines:
- 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. Georgia Health Sciences University 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.
- Georgia Health Sciences University 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 Documents, investigator’s brochure, risk/benefit determination, advertisements, and site visits as appropriate.
- Continuing Review: $ 500.00
Re-review of protocol, amendments, and subject’s Informed Consent Documents, adverse events, and site visits as appropriate.
- Subsequent Charges:
Administrative changes to Informed Consent Document not required by HAC: $100.00
Addition or change in Sub-Investigator, Study Coordinator, or Investigator: $250.00
- 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.
- Each individual or entity submitting a protocol to the HAC for review must enter into a formal contract with Georgia Health Sciences University. Each individual or entity must also comply with appropriate legal documentation and requirements as ascertained by the Office of Legal Affairs.
The responsibilities each party has in connection with Academic, Research, and Student Affairs Policy 9.0401, Policy for Use of Human Assurance Committee Review for Non-Georgia Health Sciences University Investigators, are:
|Director, Office of Human Research Protection||Administers the human research protection program and oversees efforts to promote high quality human research.|
|Assistant Director, Office of Human Research Protection||Manages the Human Assurance Committee and serves as an institutional resource for clinical research regulations.|
|Chairperson, Human Assurance Committee||Determines if a project is research, follows all applicable federal and state regulations and laws as well as institutional policies and procedures, and chairs the Human Assurance Committee meetings.|
OHRP Audit Worksheet: http://www.georgiahealth.edu/research/ohrp/audit_compl/index.html
OHRP Medical Record Audit Form: http://www.georgiahealth.edu/research/ohrp/audit_compl/index.html