An Institutional Review Board (IRB) reviews proposed research with the goal of protecting the rights and welfare of human research subjects. The review involves ensuring that risks are minimized and that potential benefits to subjects have been maximized. IRBs help ensure that federal, state, and local regulations are complied with for the protection and welfare of subjects, investigators, and the institution. Our IRBs also ensure, when required, that human subjects only volunteer to participate in research after providing legally effective informed consent.
Summa Health System has two IRBs to review research involving human subjects. The IRB committees meet on a monthly basis, usually the third week of the month. Each committee consists of physicians, nurses, other staff and community members.
- IRB1 primarily reviews drug and device studies sponsored by pharmaceutical and device companies.
- IRB2 primarily reviews investigator-initiated studies.
Our IRBs are responsible for the research use and disclosure of protected health information (PHI) as part of the Health Insurance Portability and Accountability Act at Summa Health System. The IRBs review and approve authorization agreements, applications for the use or disclosure of limited or de-identified data sets, and applications for waiver of the authorization requirements.