What is an IRB?
An Institutional Review Board (IRB) is a committee whose primary responsibility is to protect the rights and welfare of human research subjects. In accordance with Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA) regulations, an IRB reviews research proposals to ensure risks have been minimized and the potential for benefit has been maximized before human subjects participate in the research. The authority conveyed to the IRB includes decisions to approve, disapprove, require modifications, monitor, suspend and terminate research projects involving human subjects.
The IRB also ensures, as required, that human subjects volunteer to participate in research only after providing legally effective informed consent. Investigators may not solicit subject participation or begin data collection until they have received approval from the appropriate IRB or written concurrence that the research has been determined to be exempt from IRB review.
Certain populations of human subjects may be particularly vulnerable in a research setting, e.g., children, prisoners, pregnant women, fetuses, persons with physical or mental disabilities, and economically or educationally disadvantaged persons. When reviewing research involving these subject populations, the IRB will apply additional protective safeguards as required by federal and state law, institutional guidelines, and any other applicable agency/entity regulations.
All research activities involving human subjects must be reviewed and approved by an IRB unless the Office of Research & Sponsored Programs can prospectively determine that the research falls into a category of exemption established by federal regulation. See “Exempt Research”for more information.
Responsibilities of the Institutional Review Board
The WSU IRB operates under the principles of The Belmont Report. The Belmont Report exists because of the unfortunate history of unethical research conducted on human subjects. It clearly explains the three principals that are the main tools that all IRB members should use to evaluate the ethics of specific research proposals. Respect for Persons is the first principle which mandates that subjects voluntarily consent to participate in research, that they are adequately and thoroughly informed about the research and what is required, and that their privacy and confidentiality are protected. Beneficence is the second principle which mandates the risks of research are justified by potential benefits to the individual or society and that those risks are minimized. Justice is the third and final principle which mandates the equitable distribution of risks and benefits among those who may benefit from the research, meaning that one subset of a population should not take on all the burden of risk and reap all of the rewards; risks and rewards should be applicable and available to all subsets of a community.
Does My Project Require IRB Review?
Wright State University has assured the federal regulatory agencies that the institution will review and approve all research involving human subjects before it is initiated. The IRB may determine that the project is exempt from IRB oversight; however, only the IRB may make that determination.
Federal Definition of Research
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.