Institutional Review Board

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 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 protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

The DMH IRB reviews research projects which involved human subjects to ensure that two broad standards are upheld: first, that subjects 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 outside the academic community, the IRB gives rapid but individualized attention to the numerous research projects at DMH. Currently, there are thirteen active board members, including 2 co-chairs.

Decatur Memorial Hospital’s process for protecting human research subjects 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.

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