Protecting the Rights and Welfare of Human Subjects – What is an IRB?

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 Responsible Research Practices (ORRP) can prospectively determine that the research falls into a category of exemption established by federal regulation. See exempt research for more information.

…(read more).

Environmental Justice
Environment Ethics

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