IRB Electronic Submission

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

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

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

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

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

IRB at Pace

Current Process

• IRB website available with instructions, FAQs, and documents to download

• Researchers submit copies in person or via email (paceirb@pace.edu) 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

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

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

Researchers input screen

New application – functions for researchers

Update Submission

• If needed, a submitted proposal can be updated and updates to documents can be uploaded

Researchers listing of submitted proposals

Researchers can view submitted proposals and documents with a link to create a new application

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

IRB coordinator and reviewers screen to update status and send comments

IRB coordinator and reviewers listing

Reviewers view of proposal with the ability to view and download documents

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