Enhancing Oversight of Human Subjects Research

American College Of Surgeons, Chicago IL

Investigators

Linked publications & trials

Abstract

The American College of Surgeons proposes to accomplish the following specific aims: (1) Establish written, approved, and widely disseminated policies and procedures to assure an efficient and effective working relationship with the Institutional Review Board that will review existing and proposed projects of the College involving human research. (2) Establish internal procedures and record keeping systems to assure that IRB approvals have been granted at each of the institutions participating in multi-institutional College-sponsored studies prior to commencement of the research at each institution and to assure that annual reviews are completed satisfactorily in order for the research to continue at these institutions. (3) Through the use of an external, contracted organization, conduct audits of research being conducted at 5 academic medical centers of an AHRQ-supported study being conducted through the College in order to assure that the medical centers are complying with applicable regulations as well as to identify particular problems that will form the basis for the design of a monitoring system for subsequent multi-institutional studies. (4) Incorporate consideration of the requirements of the HIPAA patient privacy regulations into the design of current and future studies.