QA/QI for Human Studies Review, w/Addt'l Institutions

Massachusetts General Hospital, Boston MA

Investigators

Linked publications & trials

Abstract

Over the past five years, Partners HealthCare System (PHS) has invested in the development of an integrated research management system referred to as Research Express (or REX). This system integrates information from all functional units within research management, including grants and contracts, animal studies, and human studies. Central administrators from Massachusetts General Hospital (MGH), Brigham and Women's Hospital (BWH), Dana Farber Cancer Institute, and McLean Hospital use the system for human studies protocol management and scheduling of Institutional Review Boards across the network. We received an award under HSREP for enhancement of REX. At the present time, only research management administrators have access to REX and they use it for data management and tracking of applications, amendments, violations, and continuing review. In June 1999, the Partners Quality Improvement and Human Subject Protection Program (QI Program) was established. This program is based at the MGH and BWH which collectively have more than 3,000active human studies conducted by approximately 600 investigators. The goal of the program is to fulfill the institutions' responsibility for ensuring compliance and to promote an environment in which human subject research can be conducted according to the highest standards. The current infrastructure of the QI Program has proven to be successful and invaluable to Partners' human subject protection efforts. However, the QI Program activities have been only available to the MGH and BWH investigators. The PHS consists of other smaller general hospitals such as Newton Wellesley and Faulkner Hospitals; specialty hospitals such as Spaulding Rehabilitation Hospital and some practice groups such as PCHI. Although these hospitals recognize the importance of QA/QI initiatives in research protection, only one has begun a formal program that is similar to and based on the Partners QI Program. This HSREP award is sought to support assisting these other institutions in developing QA/QI programs.