Submission Process to the IRB part 2 Revisions to Protocol

1. Submission Process to the IRB part 2Revisions to Protocol Lifespan

2. This session will cover: • How to navigate the ORA/IRB web pages • How to obtain the forms • How to prepare and submit a request for revision to protocol for review by the IRB Lifespan

3. Navigating the ORA/IRB Web pagesORA Website www.lifespan.org/research/ Lifespan

4. Navigating the ORA/IRB Web pagesIRB webpage http://www.lifespan.org/research/irb/irb.asp From the ORA web page, select (IRB) Human Subjects Lifespan

5. Navigating the ORA/IRB Web pagesIRB forms webpage http://www.lifespan.org/research/irb/irbformslist.asp From the IRB webpage, select IRB Forms Lifespan

6. Navigating the ORA/IRB Web pagesIRB forms webpage http://www.lifespan.org/research/irb/irbformslist.asp From the IRB forms webpage, scroll down to the bottom of the list to: Forms for Previously Approved Studies Lifespan

7. Steps to submitting a Request for Revision to Protocol for review by the IRB 1. Determine which aspects of the project will be revised (e.g. protocol, consent forms, advertisements, personnel, etc) 2. Obtain required form for IRB review from the ORA website www.lifespan.org/research/irb/irbformslist.asp Lifespan

8. Steps to submitting a Request for Revision to Protocol for review by the IRB 2. Complete the revision request form. 3. Be sure to answer all questions completely and correctly. Please note: “See Attached” is not an acceptable response 4. Please be certain to include clean and highlighted or tracked copies of any documents which will be revised (such as consent forms, advertisements, abstract) Lifespan

9. Steps to submitting a Request for Revision to Protocol for review by the IRB If the revision includes information that must be communicated to currently enrolled subjects (such as altered schedules, revised compensation, newly identified side effects), then you must describe the plan for notifying enrolled subjects and attach any documentation that will be used for this purpose. Lifespan

10. Steps to submitting a Request for Revision to Protocol for review by the IRB 5. Does your request require Full Board or Expedited review? • Revisions to currently approved projects usually qualify for expedited review if they do not present greater than minimal risk . • Significant changes and/or revisions which alter the risk:benefit ratio for enrolled subjects require review by the convened (full board) IRB. Lifespan

11. Steps to submitting a Request for Revision to Protocol for review by the IRB • For Expedited Review: Submit the original request and one complete copy (including attachments). Revision requests can be dropped off or sent by mail to the IRB Office (Aldrich 507) Please allow two -three weeks for the processing and review of your request. • For Full Board Review: Submit 25 complete, collated copies of the revision request (including all attachments) on or before the deadline for the next full board IRB meeting. Lifespan

12. What happens after I submit my revision request to ORA staff? 1. ORA committee staff review the submitted request for completeness. After the request is accepted, it is processed for review. Expedited Reviews: Revision requests that are accepted for expedited review are sent to the IRB Chairperson. After review, the PI will be notified as to whether there are corrections to be made. If the request was approved as submitted, the approval documents will be sent by mail to the PI. Please Note: The IRB Chairperson has the authority to refer any item to the full board for review. Lifespan

13. What happens after I submit my revision request for full board review to ORA staff? Full Board Reviews: Applications that are accepted for full board review are placed on the agenda for the next committee meeting (full board review). 2. IRB agendas include specific time assignments for each protocol that will receive full board review and are sent to investigators approximately one week before the meeting. Principal Investigators, or their representatives, are required to appear before the committee to address any questions or concerns raised by the reviewers. Lifespan

14. What happens after I submit my revision request for full board review to ORA staff? • After the IRB meeting, ORA committee staff prepare the minutes from the meeting and send a summary of the discussion and comments to the investigator. 4. Investigators make the committee required changes and return any requested information/clarifications to ORA committee staff. Lifespan

15. What happens after I submit my revision request for full board review to ORA staff? 5. If the request was “approved pending receipt of requested revisions”, then ORA committee staff will verify that the requested changes were made and process approval documents Lifespan

16. Contacts for IRB Questions If you have any questions you can contact: • Patricia Houser, Manager Research Review Committees and Communication at phouser@lifespan.org 444-2099 • Adrienne McParlin, Coordinator Research Review Committees at amcparlin@lifespan.org 444-3527 • Jacqui Poore, Coordinator Review Committees and Compliance at jpoore@lifespan.org 444-2093 • Dawn Roux, Coordinator Research Review Committees at droux@lifespan.org 444-7547 Lifespan