Award for
Excellence in Human Research Protection
Best
Practice 2005
Partners HealthCare System (PHS), Boston, MA
Submitted by Delia Y. Wolf, MD, Director, Human Research
Quality Improvement (QI) Program
The following information was submitted by the applicant for
the award. The Institute may have edited the text for presentation purposes.
Health Improvement Institute has not verified, and does not guarantee, the
completeness or accuracy of the information for any purpose. Institutions
interested in adopting or adapting the practice would be well advised to
contact the person who submitted the application and to evaluate this and any
additional information for their purposes.
Description: The goal of the PHS QI Program is
to promote an environment in which human subject research is conducted
according to the highest standards. Specific objectives are: (a) to ensure
compliance with Federal and State regulations, institutional requirements, and
ethical guidelines governing human research, and (b) to promote the application
of Good Clinical Practice (GCP) guidelines to all human research. To accomplish
these objectives, the QI Program offers investigators and study staff a variety
of educational and consultative services that have proven to be highly
effective. These methods include: (a) onsite reviews (audits) of ongoing research;
(b) investigator self-assessment checklist; (c) audit preparation; (d) onsite
and online monitoring; (e) annotated regulatory binders; (f) IRB submission
assistance; and (g) formal and informal educational programs.
Genesis: The impetus for establishing the
Partners QI Program was the growing recognition that, while the vast majority
of over 4,000 investigators at Massachusetts General Hospital and Brigham and
Women’s Hospital (PHS affiliates) were highly motivated to comply with
regulatory requirements, many lacked the requisite knowledge or resources to do
so.
Experience: Since its inception in 1999, the
QI Program has worked with 655 investigators on over 800 studies, provided
hundreds of regulatory binders to study sites, and conducted countless educational
sessions for investigators and study staff at all levels. Investigators and their staffs have been
overwhelmingly positive about these services.
Compliance: The QI Program is committed to
ensuring compliance with all federal, state, institutional regulations; GCP
guidelines; and the highest ethical standards.
Protection of Human Subjects: All QI
Program initiatives focus on the protection of human subjects’ safety and
well-being.
Monitoring and Evaluation/Outcomes: The QI
Program staff has conducted several IRB-approved studies to evaluate the
effectiveness of QI Program strategies. Findings indicate that, while both
methods are useful, onsite audit is more effective than investigator
self-assessment for ensuring regulatory compliance. Results also suggest that
the Program’s greatest strength rests with QI specialists’
individualized onsite education of study staff.
Innovation: As one of the first programs to
focus on Quality Improvement, the PHS program has produced numerous tools,
checklists, and other aids (such as an annotated online regulatory binder) that
are available free-of-charge to investigators within and outside PHS.
Replicability: PHS QI Program activities could
be easily adopted or adapted in a variety of settings. All materials are
available via the internet on the QI Program’s website: http://www.partners.org/phsqi/ . In
addition, Dr. Wolf and colleagues have published several papers that highlight
the program’s work, and have delivered invited presentations at local,
state, and national conferences. Requests received from other institutions for
permission to use QI Program materials are consistently granted.
Justification: In its six years of service, the
QI Program has established itself as an essential component of research
practice at PHS that is highly valued by administrators and investigators
alike. It now serves as a national model for other programs that aspire to the
same level of excellence.
For additional information: Delia Y. Wolf, MD
or Lucy Feild, Ph.D., RN
Tel: 617-424-4134 617-424-4139
Fax: 617-424-4133 617-424-4133
E-mail: dwolf@partners.org mlfeild@partners.org