Continuing
Review: Periodic Review and Renewal
Periodic
(Status) Review
To
facilitate the Board's determination of whether changes have occurred
in the risk/benefit estimation, the IRB requires reports from
investigators at the midpoint of the study approval period. Investigators
should use the Periodic Report form to guide
their submission of information. Goodwyn IRB staff will notify
investigators when it is time to submit a periodic report.
Renewal
Application
IRB
approval for each study is for a defined period of time, not to
exceed one year. The approval period for each study is determined
by Goodwyn IRB at the time of original review of the study, and
is based upon the nature of the study, the degree of risk, and
the vulnerability of the population.
If
conduct of a research study is to extend beyond the approval period,
Goodwyn IRB requires investigators to submit a renewal application
for review. Investigators should use the Renewal Application form
to guide their submission.
Before
the investigator's approval is due to expire, Goodwyn IRB staff
will notify the investigator that the study is due for renewal,
along with instructions for submitting the renewal application
and form.
Status
Report Form
(for Periodic reporting and renewal)
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