HRPP SOP 103
- Policy Title: Reporting of IRB Findings and Actions to Principal Investigators and the Institution
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Responsible Office: Office of Research Administration
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Responsible Official: Associate Provost for Research Administration
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Effective Date: March 9, 2018
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Revision Date: Feb. 12, 2019
I. Purpose of This SOP
The purpose of this SOP is to set forth the procedures to be followed by the Brandeis University HRPP office in the reporting of its findings after initial, continuation request and modification request review for research conducted under the auspices of Brandeis University.
II. Scope of This SOP
This SOP applies to human subjects research projects conducted under the auspices of Brandeis University.
III. Statement of SOP
It is the standard operating procedure of Brandeis University that all Institutional Review Board findings and actions regarding initial, continuation request and modification request reviews of human subjects research conducted under its auspices be reported to the principal investigators and the institution in a timely manner.
IV. Procedures
Initial Review
Once the initial review process is complete, the Institutional Review Board administrator notifies the principal investigator of the determination and next steps to be taken:
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For research that has been approved, the IRB administrator emails a formal approval letter to the principal investigator listing the approval start and end dates, and the requirements for requesting a continuation, modification or termination of the research.
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For research requiring revisions, the principal investigator is informed by the IRB administrator via email of the necessary revisions.
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For research that has been disapproved, a formal letter outlining the reasons for the IRB's decision is emailed to the principal investigator with the steps s/he might take to respond to the determination.
A copy of the determination notification is placed in the protocol file and a signed hard copy is available to the principal investigator upon request.
Continuing Review
Once the continuing review process is complete, the Institutional Review Board administrator notifies the principal investigator of the determination and next steps to be taken:
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For continuing review requests that have been approved, the IRB administrator informs the principal investigator via email of the approval start and end dates.
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For continuing review requests requiring revisions or additional materials, the principal investigator is informed by the IRB administration via email of the necessary revisions or additional materials.
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For continuing review requests that have been disapproved, a formal letter outlining the reasons for the IRB's decision is emailed to the principal investigator with the steps s/he might take to respond to the determination.
A copy of the determination notification is placed in the protocol file, and a signed hard copy is available on request of the principal investigator.
Modification Review
Once the modification review process is complete, the Institutional Review Board administrator notifies the principal investigator of the determination and next steps to be taken:
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For modification review requests that have been approved, the IRB administrator informs the principal investigator via email of the approval.
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For modification review requests requiring revisions or additional materials, the principal investigator is informed by the IRB administrator via email of the necessary revisions or additional materials.
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For modification review requests that have been disapproved, a formal letter outlining the reasons for the IRB's decision is emailed to the principal investigator with the steps s/he might take to respond to the determination.
A copy of the determination notification is placed in the protocol file, and a signed hard copy is available on request of the principal investigator.