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Institutional Review Board (IRB)

About the Decatur Memorial Hospital Institutional Review Board

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor research involving human subjects. In accordance with OHRP guidelines and 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 participants.

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 in research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human participants of research.

The DMH IRB reviews research projects which involve human participants to ensure that two broad standards are upheld: first, that participants are not placed at undue risk; second, that they give uncoerced, informed consent to their participation.

With representation from a wide range of scientific disciplines and from within and outside the academic community, the IRB gives rapid but individualized attention to the numerous research projects here at DMH. The entire IRB process has been streamlined by going electronic.

Decatur Memorial Hospital’s process for protecting human research participants reflects federal regulations developed in response to such cases as the Public Health Service syphilis study and the U.S. government radiation experiments. The Department of Health & Human Services (HHS) Office for Human Research Protections (OHRP) oversees the operation of the IRB, and the Food and Drug Administration (FDA) enforces regulations for the use of experimental drugs and devices.