Beneficience | Justice | Respect for Persons
Institutional Review Boards (IRB's) act as advocates for human research subjects. IRB's have to be accredited by the United States Government. The document that stands as an agreement between the U.S. Government and an Institution with an IRB is called a "Federal-Wide Assurance (FWA)". IRB's work with researchers to make sure research projects are done safely and ethically.
Federal Oversight of Human Subject Research
The U.S. Department of Health and Human Services (DHHS) and various offices and agencies, including the National Institutes of Health (NIH), the Office For Human Research Protections (OHRP) and the Food and Drug Administration (FDA) share oversight of human subject research.
The Food and Drug Administration's (FDA's) Definition of Institutional Review Boards (IRB's):
"Institutional Review Board (IRB)" is a generic term used by the Food and Drug Administration (FDA) to refer to a group whose function is to review research to assure the protection of the rights and welfare of the human subjects. Each institution may use whatever name it chooses.
Each institution conducting research must either have its own IRB, or it must contract for the services of another IRB. IRB's can be for-profit private companies or they can be a part of a non-profit institution.
IRB's are subject to the FDA's regulations when studies of FDA regulated products (drugs, biologics, devices) are reviewed and approved.
Under Food and Drug Administration (FDA) regulations, an Institutional Review Board (IRB) is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research projects. The IRB assures that:
- Risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- Risks to subjects are reasonable in relation to anticipated benefits (if any) to subjects, and the importance of the knowledge that may be expected to result.
- Selection of subjects is equitable.
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative and will be documented in accordance with, and to the extent required, by the Agency's informed consent regulations.
- Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- Appropriate additional safeguards have been included in the study to protect the rights and welfare of subjects who are members of a vulnerable group.
The Department of Health and Human Services (DHHS) Regulations:
The Department of Health and Human Services (DHHS) regulations apply to all research involving human subjects conducted or supported, in whole or in part, by DHHS. Therefore the regulations may apply to institutions or individuals who participate in research, even if no actual transfer of funds occurs.The regulations provide definitions of "Research" and "Human Subject," by which decisions can be made as to the applicability of 45 CFR 46 (Title 45 of the Code of Federal Regulation, Part 46). These key definitions are:1."Research": a systematic investigation designed to develop or contribute to generalizable knowledge; and2."Human Subject": a living individual about whom an investigator conducting research obtains: (a) data through intervention or interaction with the individual, or (b) identifiable private information.
The current membership of the NGHS IRB includes seven (7) voting members. The membership includes representatives from the community and NGHS. The primary goal of the IRB is to assure that, in research involving human subjects at NGHS, the rights and welfare of the human subjects are adequately protected. To achieve this goal, the IRB will assist the investigators, when needed, in designing their research projects in a manner to minimize potential harm to human subjects, review all planned research involving human subjects prior to initiation of the research, approve research that meets established criteria for protection of human subjects, and monitor approved research to ascertain that human subjects are indeed protected.
Institutional Review Board
Northeast Georgia Health System, Inc.
743 Spring St.
Gainesville, GA 30501-3899