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Independent Institutional Review Board
IRB Initiation Procedures
The protocol, consent form, case report form and background information, such as the investigator's brochure, should be provided in confidence to the Institutional Review Board administrator approximately 2 to 3 weeks before regularly scheduled meetings which will take place on or about the last week of each month. At that time, the fee will be determined, the authorization given, and the review process begun. On the day following the Institutional Review Board meeting, you will be notified by telephone of the board's decision and what remedial steps, if any, must be taken. This will be followed immediately by the written signed decision of the board. If remediation is necessary for final approval, that material should be forwarded to the Institutional Review Board administrator who will review it, pass it on to the chairperson and however many additional individuals are required. This can usually be accomplished within several days without the necessity of reconvening the entire IRB.
Client or Investigator Progress Reports
The Institutional Review Board requires that progress reports of clinical
studies be provided to the board at six month intervals with each institutional
review being valid for a maximum of a one year period of time. After this period of time, the review process must be reinitiated with the inclusion of appropriate progress reports. There is a requirement that a final report of any clinical evaluation completed must be submitted to the Institutional Review Board. Additionally, any severe adverse effects, proposed protocol amendments or changes, must be submitted immediately to the Institutional Review Board
for its consideration and evaluation before any changes or further subjects
can be studied
Expedited Review
In those cases provided by regulation, expedited institutional review
can be obtained by either using the normal time schedule or via
special emergency expedited review procedures which can be accomplished
in only a few days.
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