IRB Electronic Submission

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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
  (paceirb_at_pace.edu) to the Office of Scholarly
  Research at Pace Universitys 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