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When a person agrees to volunteer his or her time (and possibly assume
some risks) to participate in a research study, the institution sponsoring
the research has an ethical obligation to monitor that study's progress.
This monitoring process is called continuing review. In the past few years
it has received increasing emphasis in the operations of Institutional
Review Boards (IRB's), the bodies charged with overseeing the conduct of
human research.
Continuing review has several purposes. One is to discover unanticipated
developments in carrying out the research, whether they be adverse reactions
to the treatment, problems of recruiting or retaining participants, or
new findings which may change our understanding of the risks and benefits
involved. Another is to monitor the inclusiveness of recruitment
into the study by gender and race or ethnicity.
The type and frequency of formal re-reviews by an IRB are related to
the risks inherent in the research. Projects which entail more potential
risk, or which involve "vulnerable" participants such as children, generally
require continuing review by the full membership of the IRB. They may also
require more frequent reviews than the required minimum yearly review period.
Progress reports are the mechanism
by which IRB's maintain their oversight. At least once a year investigators
are asked to submit a report summarizing their experiences in carrying
out their studies. No grace period is allowed for filing progress reports.
IRB approval for carrying out human research expires on the anniversary
of its initial approval. For the study to continue, a progress report must
be received and approved.
Some IRB's put an expiration date on the study consent form to remind
investigators of the need for re-review. IRB's also notify investigators
a month or so prior to the expiration date that a progress report is due.
Federal regulators expect IRB's to take the filing of progress reports
very seriously. If no progress report has been submitted and approved
by the expiration date, the IRB is required by federal regulations to suspend
the research until the progress report has been reviewed and reapproved.
In 1999, the Cook County Bureau of Health Services began a program of
research quality assurance to monitor and oversee
human research during the time between IRB approval and the submission
of a progress report. This program includes internal site visits of active
research sites in the Bureau, as well as education, training and
consultation for investigators and research staff.
See Also:
OHRP/OPRR
Reports: Continuing Review of Human Research
Bureau Approval Forms
Multiple Project Assurance
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