The Saint Alphonsus IRB is an independent, administrative body established to protect the rights and welfare of human research participants recruited to participate in research conducted at Saint Alphonsus. The IRB meets monthly, and has the authority to approve, require modifications in, or disapprove all research activities as specified by federal and state regulations, and Trinity and Saint Alphonsus policy.
The Saint Alphonsus IRB has at least five voting members with at least one member having a non-scientific background and at least one community member not affiliated with Saint Alphonsus. The Chairperson is appointed by the President of the Medical Staff. The IRB is registered with the Office of Human Research Protections (OHRP) and granted Federal Wide Assurance (#FWA00007980; expiration date of 4/28/2014).
The IRB ensures human participant protection during conduction of research. Informed decisions to participate in research by eligible candidates is ensured through the review of a research investigator's plan for compliance with regulations and equitable participants selection, minimization of risks and disclosure of potential conflicts of interest.
The IRB is administrated through the Department of Research Integrity. Staff provides pre-submission reviews of all study protocols submitted to the IRB and is available to assist investigators the various aspects related to the IRB submission.