The IRB was founded at AUB in 1994. It became the core component of the newly established HRPP in 2010.The IRB is the committee formally designated by HRPP to review and approve the conduct of research involving human subjects who are recruited to participate in research activities conducted at AUB/AUBMC and/or by AUB/AUBMC faculty, students and staff, regardless of the funding source or the location of the research.
All research studies that involve human subjects require review, governance and approval of the IRB. In addition to reviewing and approving all new research proposals, the IRB also conducts annual continuing reviews and issues renewals as appropriate. The IRB categorizes research submissions and thus IRB applications according to the level of risk for human subjects participating in research studies. For instance, studies that incur “less than a minimal risk" are processed as “Exempt" IRB applications, while those that are expected to incur “a minimal risk" are processed as “Expedited" research applications. Studies expected to incur “more than minimal risk", as well as those referred to the board by the IRB chair and those disapproved after an expedited review, fall in the “Full Board Review". The IRB has a specific mechanism to review and handle each of those categories, which also helps the researchers identify which category fit their research protocols best. Furthermore, the IRB has the authority to approve submitted research protocols, require modifications to submitted protocols, deny approval of submitted protocols, and/or suspend or terminate already approved protocols. The IRB processes amendments to approved research proposals, review reports of adverse events, handles instances of protocol deviations, non-compliance and assist HRPP in processing allegations and complaints; It also manages protocol specific and relevant conflict of interest.
The IRB has two boards that are supported by executive and administrative staff. The Biomedical IRB reviews and manages research studies that involve drugs, medical devices and Biological testing. The Social and Behavioral Sciences (SBS) IRB deals with research studies concerned with behavioral methodology, educational research, surveys and analysis. The two IRBs closely communicate with each other and cross refer certain studies when indicated.
The IRB also reviews research by any faculty that involves FDA oversight, specifically clinical research involving an investigational device, drug or testing, research requiring an IND (Investigational New Drug) registration or any other research where the data will be submitted for FDA regulatory review. Review of research by any of these Schools that involves FDA oversight is referred to the Biomedical IRB.
The IRB members have various scientific and non-scientific backgrounds and have accepted to serve as volunteers on the IRB and support its mission. The board members meet on regular scheduled and occasionally urgent basis to review and decide on the approval of research applications referred to the full board.