PROGRAM BACKGROUND    

In June 1999, the Human Research Quality Improvement Program (QI Program) was established at Partners HealthCare System, Inc. as part of Partners Human Research Affairs, which oversees human studies conducted at Massachusetts General Hospital (MGH) and Brigham & Women's Hospital (BWH).  

The goal of this program is to help fulfill the institution's responsibility for ensuring compliance with Federal and State regulations governing human research, and to promote an environment in which human subject research will be conducted according to the highest standards.  

In doing so, the QI Program has developed and implemented various quality assurance and improvement initiatives to serve the Partners clinical research community.  

Since January 2000, the QI Program has worked with nearly 800 Partners investigators (primarily from BWH and MGH to date) through a variety of quality assurance/improvement (QA/QI) activities.  

 

ETHICAL PRINCIPLES, REGULATIONS AND GUIDELINES

All QI Program quality assurance and improvement initiatives are governed by:

The Belmont Report 

Code of Federal Regulations (CFR) governing human research

DHHS 45 CFR 46 

DHHS 45 CFR 164 

FDA 21 CFR 11 

FDA 21 CFR 50 

FDA 21 CFR 54

FDA 21 CFR 56 

FDA 21 CFR 312 

FDA 21 CFR 812

 

ICH Good Clinical Practice (GCP) Guidelines 

Partners Guiding Principles for Human Studies 

Partners Human Research Committee Policies and Procedures 

Partners Human Research Committee Guidance Documents

 

AUTHORITY

The QI Program is a program within Partners Research Management that is independent of the Partners IRBs.  The focus of the QI Program is assisting with ongoing monitoring of studies and the education of investigators.  The Director of the QI Program reports to the Director of Partners Human Research Affairs.

The QI Program is responsible for and has the authority to:

Perform routine evaluations on any study that has been approved by the Partners IRB.  This includes:
On-site reviews by the QI staff [e.g., assessment of study documents and interviews with Principal Investigators (PI) and study staff. 

Review of self-assessments conducted by Principal investigators and study staff using the QI Program self-assessment tool. 

Conduct directed (for-cause) audits at the request of the Partners IRB or institutional official.

 

Respond to findings of non-compliance from on-site reviews by:

Identifying corrective actions- this may include mandatory re-assessment at a future date

If identified matters require reporting (e.g., adverse events, protocol violations), the QI Program will call attention to the way in which these should be reported to the IRB if they have not already been reported.

 

Providing investigators with quality improvement recommendations to ensure that research is conducted in accordance with good clinical practice guidelines. 

Recommending action to the IRB, based on on-site observations during for-cause audits. 

Reporting serious or continuing non-compliance with applicable regulations or Partners HRC requirements to the IRB and/or institutional official.

 

 

 

 

 

Human Research Quality Improvement Program 2009