Institutional Review Board (IRB)
Research is a systematic investigation designed to develop or contribute to generalizable knowledge. Clinical practice differs from research in that its goal is to enhance the well-being of individual patients. Investigational practice is defined as a therapeutic, diagnostic, or preventive procedure or modality performed or administered with the intent and reasonable prospect of yielding a direct health-related benefit to the patient, but which differs from customary practice. Examples are innovative cancer therapy, the use of new techniques or tests, the use of new drugs or devices, or the use of FDA approved drugs or devices in a manner that differs substantially from approved uses.
When the outcomes of investigational practice are collected from individual patients, analyzed, and published, it becomes research as well as treatment. In general, whenever an investigational practice is employed it should be made part of a research protocol designed to establish its safety and effectiveness.
The goal of the IRB review process is to protect the rights and welfare of those individuals who contribute to the research process by participating as subjects. In protecting the research subject, the IRB also protects the institution and the researcher from the potential harmful consequences of an inadequate consent process or the exposure of the subject to excessive risk.
Research involving human beings here at UMMS, sponsored by UMMS, conducted by or under the direction of UMMS faculty , staff, or students (regardless of location) and research involving the use of patient records maintained by UMMS faculty or staff, must be approved by the IRB.
The IRB reviews each research plan and consent process in order to safeguard the rights and welfare of human subjects. It must determine that each study conforms to ethical standards including
- A reasonable balance of risks and anticipated benefits.
- Adequate provisions for informed consent.
- Equitable selection of subjects.
More information about the review process can be found on the IRB website.