Institutional Charter on Research Involving Human Subjects

The Medical College of Georgia (MCG) agrees with the principles of the Department of Health and Human Services (DHHS) policies, the Belmont Report, the Nuremberg Code and the Declaration of Helsinki with regard to investigations involving human subjects.  This institution agrees that a review, independent of the investigator, is desirable and necessary to safeguard the rights and welfare of human subjects of research investigations, and to fulfill the moral and legal obligations and commitments of the institution and implemented this review process in October 1967 under the direction of the Dr. Harry Barron O’Rear.  Since 1967, each President of MCG has served as the institutional official and that tradition and respect for research continues today with Dr. Daniel Rahn serving as the current institutional official. 

The MCG has assured the DHHS that it maintains an institutional review board (IRB) known as the Human Assurance Committee (HAC) in compliance with state and federal regulations to review plans of investigations involving human subjects, prior to the initiation of the investigations, to insure adequate safeguards. This review will be carried out in reference to:

1. The rights and welfare of the individuals involved The appropriateness of the methods used to obtain informed consent
2. The risks and the potential benefits of the investigations

The Medical College of Georgia also agrees to exercise surveillance of DHHS supported as well as all research projects using human subjects for changes in protocol which may alter the investigational situation with regard to the criteria cited above.  The Medical College of Georgia further assures that it will provide advice and consultation to investigators on matters of employing human subjects in investigation, and also that it will provide whatever professional attention or facilities may be required to safeguard the rights and welfare of human subjects involved in investigation.

The Medical College of Georgia, Medical College of Georgia Health, Inc., and the Charlie Norwood Veterans Affairs Medical Center has granted the authorities to the Human Assurance Committee and the Chesapeake Research Review, Incorporate to:

• Approve, require modifications to secure approval, and disapprove all research activities overseen and conducted by the organizations of MCG, MCGHI and the Charlie Norwood VAMC
• Suspend or terminate approval of research
• Observe, or have a third party observe, the consent process and the conduct of the research.

All research involving human subjects must be approved by an institutionally designated IRB. No one on the organization may approve research that has not been approved by an institutionally designated IRB.

Records of review and decision on the use of human subjects and of informed consent will be developed and kept by the Medical College of Georgia Human Assurance Committee in compliance with state and federal regulations.  The Human Assurance Committee will be administratively and financially supported by the Office of Human Research Protection but shall report directly to the President of the Medical College of Georgia. 

 

Approved by:                                                                         Approved on:

Daniel W. Rahn, MD                                                              April 22, 2008

President, Medical College of Georgia and

Senior Vice Chancellor for Health and Medical Programs

University System of Georgia