| In the space of less than one year during 1998 and 1999, four
major medical institutions had their research programs severely sanctioned
by the federal Office for Protection from Research Risk. These sanctions
were imposed because of insufficient protection of human subjects. Two
of these institutions were in Chicago: the University of Illinois
Chicago and Rush-Presbyterian-St. Luke's Medical Center.
The number and magnitude of these incidents has provoked serious questions
about how well researchers truly understand the expectations placed on
those who experiment with human beings. The system of Institutional
Review Boards was intended to insure that human research is done carefully
and ethically. Unfortunately, even the most conscientious IRB, composed
as it usually is of unpaid volunteers, cannot provide close scrutiny of
the actual operation of research projects. Most of the information
available to the IRB consists of summaries on paper submitted by the investigator,
usually at yearly intervals. Whether the research is actually performed
as described is not known, unless something goes terribly wrong.
In an attempt to proactively monitor research, the Bureau in 1999 established
a program of Research Quality Assurance, and hired a full-time Research
Quality Coordinator.
The Research Quality Coordinator, reporting to the Director of Research
Development, is assigned to carry out research site visits and report back
to the IRB responsible for the project. Such surveys include review of
charts and project records and interviews with research staff for evidence
of:
1) appropriate informed consent;
2) appropriate subject eligibility, recruitment and assignment to group;
3) adequate notification of Scientific Committee (IRB) of revisions,
study progress, renewal of protocol approvals, adverse events, or other
information requiring IRB notification;
4) maintenance of patient confidentiality and privacy;
5) completeness of data entry;
6) maintenance of blinding procedures;
7) consistency in carrying out study protocols;
8) any other research quality issues as requested by the Scientific
Committee.
County investigators are urged to consult
with the Research Quality Coordinator if they have
any questions about the appropriate procedures and standards to be followed.
Investigators, their staffs and collaborators are expected to cooperate
fully with any site visit or survey activities carried out as part of the
scientific quality assurance program.
|
