Integration with IRB Review and CTO Activities – Oversight Approval Required PRIOR to IRB Review and CTO Action
Download Intake Form Here
March 30, 2020
Given the volume of COVID-19 research being initiated, leadership at each of our hospitals has established respective COVID-19 MGH and BWH Oversight Committees’ to manage and prioritize all COVID-related clinical studies (e.g., surveys, observational studies, sample collections, trials, etc.). Partners IRB and CTO will now prioritize COVID-related clinical studies including clinical trials when determined by these committees to be appropriate.
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Their formal assessments will need to be completed prior to submission to the IRB or CTO (other than confidentiality agreements). Studies will need to attach written confirmation of approval from the Chair of the MGH or BWH Committee that reviewed the clinical study at the time of submission. If the study is being implemented at both MGH and BWH (one Lead PI and one Site PI), the Lead PI will need to submit approval from each of the Committees.
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Of note, studies performed across our system will take priority. Approval for the hospital with the designated Site PI may continue to be added along with their Oversight Committee’s approval after approval of the Lead PI’s protocol.
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Both IRB and CTO are committed to supporting investigators to rapidly implement their clinical research and are willing to provide guidance to strengthen proposals but will not formally act on the proposals until the oversight committees have approved.
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To submit a project for review by the BWH COVID Scientific Review Committee, please complete a project intake form. Please send the completed intake form and all associated documents to BWHCOVIDreview@partners.org.
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Download the intake form here
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