Award for
Excellence in Human Research Protection
Best
Practice 2005
Washington University
School of Medicine, Human Studies Committee, Saint Louis, MO
Submitted by: Sarah Frankel, PhD, Education Specialist
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 purpose of the St. Louis IRB Consortium is to provide a
forum where local IRB staff and members can meet to share ideas and educational
opportunities, discuss regulations and ethics governing research and assist
each other with problem solving. The
objectives are to educate Consortium members on the protections for human
subjects, to facilitate the sharing of information regarding ethical and
regulatory standards, and to assist members in the development and maintenance
of submission and review processes. The
primary method used to accomplish objectives is quarterly meetings. During these meetings information is
presented and explained to Consortium members so that they can then pass along
this information to their respective institutions’ committee members and staff.
In addition, Consortium Members are invited to educational events hosted by one
of the member organizations. Current Consortium members include, Washington
University (Originating and Founding Organization), St. John’s Mercy
Medical Center (Founding Organization), Saint Louis University (Founding Organization),
Veterans’ Administration (Founding Organization), Missouri Baptist
Medical Center, Logan College of Chiropractic, and Southern Illinois University
at Edwardsville. Presentations to
Consortium members are based on their needs and requests. Topics have included: “Standard
Operating Procedure for the Reporting of SAE's,” “Device Evaluations as Research,”
“Vulnerable Populations,” “Informed Consent,” and
“Washington University's Quality Assurance/Quality Improvement
Program.”
Genesis: In recent years, IRBs have
faced media criticism regarding their ability to effectively protect human
subjects. Numerous articles have
also pointed to the need for greater consistency between IRBs. It was within
this context that the Washington University Human Studies Committee began
seeking ways to improve the effectiveness of not only its IRB but also that of
local IRBs.
Experience: The first meeting of the St. Louis IRB Consortium was April
17, 2002. Only members from two institutes attended. Following the example of the Midwest
Bioethics Center, there was no formal structure. Once a formalized structure was
established — with a charter, meeting agenda, a key topic and meeting
minutes — the Consortium began to flourish.
Compliance: The St. Louis IRB
Consortium firmly believes in the need for on-going education of IRB
professionals. The Consortium’s innovative approach is consistent with
the AAHRRP Principals for Accreditation of Human Research Protection Program
1-2. The IRB Consortium not only reviews
federal regulations, but also discusses ethical ramifications of institutional
policies that can be changed or modified to better protect individuals involved
in human studies. The IRB Consortium encourages its members to go beyond the
minimum specified in regulations to explore additional ways to protect people.
The IRB Consortium ensures that IRB staff and appropriate personnel maintain
continuing knowledge of ethical issues, regulations, etc., as consortium
members educate each other, allowing members to educate PI’s and other
staff at their respective institutions.
Protection of human subjects: Protecting the rights and welfare of
human research participants is a top priority for The IRB Consortium. It provides the ideal forum for sharing
ideas, relaying common problems, discussing regulations, pondering ethics and
assisting each other with educational strategies and events.
Monitoring and evaluation/outcomes: The continued growth, success and
interest in the Consortium lets Consortium members know that programmatically
they are on the right track. Another way
the effectiveness of the program is monitored is through the informal feedback
of government representatives. OHRP has
encouraged others to form Consortiums.
Innovation: Partnerships have increasingly become the norm for medical
institutions. However, it is quite rare
that local Institutional Review Boards talk to each other and discuss issues
pertinent to the protection of human subjects.
Because of the growing collaborative nature of medical research and an
increasing emphasis on educating professionals concerning the various aspects
of human subjects protection, collaborative education is needed among
IRBs. Members of the St. Louis IRB Consortium
acknowledge that there is a lot to be learned from each other — and that
the protection of human subjects is not just an institutional responsibility
but has global ramifications. The IRB Consortium reaffirms the spirit of human
research protection — which is to protect human subjects in general; not
just the ones involved in research at a particular institution.
Replicability: This is a highly
replicable and adaptable program for
any institution that is receptive to and supportive of research education.
Justification for award: The St. Louis IRB Consortium
provides an inclusive forum for anyone involved in research and participant
protection programs in the greater St. Louis area. The comprehensiveness and flexibility of this
group demonstrates participating institutions’ commitment to research
excellence and the importance placed on collaborative education. This program
differs from other human subjects protection programs in that it was developed
by IRB professionals to meet each others’ needs. Because of its practical nature, this program
is appreciated and utilized by IRB professionals. The program is flexible and can easily evolve
to include new information; expand or contract, based on need. This model also
uses local talent to present at its workshops, seminars and retreats, expanding
the body of those knowledgeable about human subjects protections within the participating
organizations.
For additional information:
Sarah Frankel
Tel: 314-633-7456
Fax: 314-367-3041
Email: frankels@msnotes.wustl.edu