Considerations for hospital approval of human participant research.

Abstract

BACKGROUND: Hospitals often accept as sufficient the federal requirement that human participant research studies have Institutional Review Board (IRB) review and approval, but IRBs usually do not consider many practical matters that arise in the implementation and operation of an interventional clinical trial in the complex environment of the modern acute care hospital. METHODS: A large hospital system in Texas implemented a policy requiring that any activity associated with human participant research receive prior hospital system review and approval. This hospital system review and approval process, which occurs in parallel with IRB review, focuses separately on patient safety and operational, financial, and special risk issues. RESULTS: A centralized research institute proactively gathers information needed to evaluate a proposed research study and forwards this information to unit directors and other key personnel in the affected hospitals for their review. When all reviewers have signed off on the study and the institute is satisfied that all pertinent issues have been resolved, it authorizes the principal investigator to begin the study in the designated hospitals. CONCLUSIONS: This review and approval process reduces risk, benefiting patients, hospital personnel who support research studies, research teams, and hospitals as institutions.