irb electronic submission. irb definition committee formally designated to approve, monitor, and...
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IRB Electronic Submission
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IRB Definition
• Committee formally designated to approve, monitor, and review biomedical and behavioral research involving human subjects
• Goal is to protect the rights and welfare of the research subjects
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IRB at Other Universities
Harvard University
• Applications must be emailed or dropped off at the committee office
• HIRBERT tool for use of the IRB Board members only that facilitates the reviewing and tracking of applications and sending notifications
• Extensive website that includes instructions, forms, FAQs, tips, and contact information for the review board members
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IRB at Other Universities
University of Pennsylvania
• Online utility for submitting applications
• Forms capture extended information including principal investigator, other investigators, campus, department, address, and funding sponsor
• Required forms are uploaded
• Application notifications routed to departments based on information in the form
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IRB at Other Universities
John Hopkins University
• Multistep process for submitting IRB applications
• Requires multiple reviews, including a pre-review, department review, prospective funding review, and an additional review to determine if the application is complete before submission to the IRB
• Investigators use an eIRB application to submit online that requires input of general information about the study, location information, investigator information, and includes a section to upload documents
• Wizard tool available to assist help researchers prepare the application
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IRB at Other Universities
University of Florida
• IRB forms must be dropped off at the IRB office
• Researcher must also pick up approval paperwork from the IRB offices.
• Researchers encouraged to have a representative at the meeting
• Large amount of paperwork causes delays in the approval process
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IRB at Pace
Current Process
• IRB website available with instructions, FAQs, and documents to download
• Researchers submit copies in person or via email ([email protected]) to the Office of Scholarly Research at Pace University’s New York City campus
• Reviewers contact researchers through email if there are issues with the application, or if the application must resubmitted
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Objectives of the new system
Current Process
• Provide a web-based system to eliminate the dependencies on hard copies and the mail service
• Enable an applicant to submit proposal, upload consent forms and other required documentation, and receive notification upon receipt of the application
• IRB Coordinator, and the reviewers, will receive email notifications upon submission, assignment of reviewers, and when a proposal is approved
• Gives the ability for comments to be emailed to the researcher and/or the reviewer
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New application – functions for researchers Create a New Submission
• New User registers with an email address and password
• Requires research project description and project funding deadline
• Requires type of IRB review required – exempt, expedited, or full review
• Requires Contact information, email, and phone number
• Upload required Application packet and NIH certification, and other optional documents
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Researchers input screen
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New application – functions for researchers
Update Submission
• If needed, a submitted proposal can be updated and updates to documents can be uploaded
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Researchers listing of submitted proposals
Researchers can view submitted proposals and documents with a link to create a new application
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IRB Coordinator and reviewers
• IRB Coordinator gets notified when a new IRB proposal is submitted
• IRB Coordinator can login and assign a reviewer by selecting from a drop-down list
• The IRB Coordinator can also review proposals
• When a reviewer is assigned, an email notification is sent letting the reviewer know an IRB proposal is assigned to him/her for review
• The IRB Coordinator can also send comments to the submitter if desired
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IRB coordinator and reviewers screen to update status and send comments
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IRB coordinator and reviewers listing
Reviewers view of proposal with the ability to view and download documents
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Notifications
• IRB coordinator is notified when a new proposal is submitted
• Reviewers are notified when they are assigned a proposal to review
• Submitter of an application is notified when the status of the proposal is changed
• The IRB chairs are notified when any proposal is approved