Submission Process to the IRB part 1 New and Continuing Reviews Lifespan

This session will cover: How to navigate the ORA/IRB web pages How to determine which forms are needed and how to obtain the forms How to prepare and submit a new application for review by the IRB How to prepare and submit a progress report for continuing review Lifespan

How to navigate the ORA/IRB web pages Lifespan

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

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

From the IRB web page, select Instructions/Info Navigating the ORA/IRB Web pages IRB instructions webpage http://www.lifespan.org/research/irb/irbinstructionslist.asp From the IRB web page, select Instructions/Info Lifespan

Navigating the ORA/IRB Web pages IRB instructions webpage http://www The Instructions page includes the following: How do I submit an IRB Application Informed Consent Checklist IRB Application Checklist IRB Application General Instructions Federal Regulations Pedi Matrix Data Safety Monitoring Information Guidance for Submitting Adverse Events Guidance for Certificates of Confidentiality Instructions for Continuing Review Chart Reviews and the IRB Lifespan

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

Navigating the ORA/IRB Web pages IRB forms webpage http://www.lifespan.org/research/irb/irbformslist.asp From the IRB forms page, select the first item on the list, IRB Application Checklist- print this first The checklist will detail each of the IRB forms that are required for your new application. Each of the forms are available as hyperlinks on the forms list. Lifespan

Navigating the ORA/IRB Web pages IRB forms webpage http://www.lifespan.org/research/irb/irbformslist.asp Specific instructions for completing each of the required forms are also available as hyperlinks on the forms table. Lifespan

How to submit a new application for review by the IRB Lifespan

Steps to submitting a new application for review by the IRB 1. Develop a research plan/grant application or obtain a study protocol from the sponsor 2. Obtain required forms for IRB review from the ORA website http://www.lifespan.org/research/ refer to IRB application checklist and instructions for further information Lifespan

Steps to submitting a new application for review by the IRB 3. Determine when the application is due Deadlines are posted on the IRB web page and are labeled “Deadline/Meeting dates” In most* cases, any of the three Lifespan IRBs can review an application for use at a Lifespan affiliate. * Special circumstances for research to be conducted at Bradley or Newport, and research involving prisoners Lifespan

Steps to submitting a new application for review by the IRB 4. Do you need Full Board, Expedited, or Exempt review? Human Subject applications that do not present greater than minimal risk may qualify for expedited or exempt review. Expedited/Exempt projects are processed on a rolling basis and do not have a deadline and only require 2 copies. Please refer to the policies and procedure manual pages and the federal regulations or contact ORA committee staff if you think that your project may qualify for expedited/exempt review. Lifespan

Steps to submitting a new application for review by the IRB Financial Considerations before you submit your application All applications require a Request for Research Committee Review form as the first page. This form must be completed and include principal investigator and departmental signatures. This form must also indicate the type of funding (internal or external). Projects supported by department funds must include the cost center that will be used. If external funds are to be used (from a grant or contract), then the investigator must also prepare and submit the appropriate business forms. Please refer to the Grants and Contracts web page for further instructions. Lifespan

Steps to submitting a new application for review by the IRB 6. Submit the completed application, with the required number of copies, to ORA committee staff by the due date. Tips: Use double-sided copies whenever possible. Be sure to collate all copies for review. Secure each copy with binder clips or staples. Do not use paperclips. Reminder: Expedited/exempt projects do not have a deadline and only require 2 complete copies. Lifespan

Steps to submitting a new application for review by the IRB 7. Investigators should verify the date of committee review and reserve time in their schedule for the committee meeting. Either the PI or a representative are required to attend the IRB meeting to answer any questions that the IRB members may have. Lifespan

What happens after I submit my application to ORA staff? 1. ORA committee staff review the submitted application for completeness. After the application is accepted, it is processed for review. ORA staff may contact you if further information and/or documentation is required prior to sending the application out to the IRB reviewer. Lifespan

What happens after I submit my application to ORA staff? Expedited Reviews: Applications that are accepted for expedited review are sent to the IRB Chairperson. The PI will be notified after the application has been reviewed and will be informed as to whether the application was approved, or if there are corrections to be made. The IRB Chairperson has the authority to refer an expedited application to the full board for review. Full Board Reviews: Applications that are accepted for full board review are placed on the agenda for the next committee meeting (full board review). Lifespan

What happens after I submit my application to ORA staff? 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

What happens after I submit my application to ORA staff? 3. After the IRB meeting, ORA committee staff prepare the minutes from the meeting and send a summary of the application discussion and comments to the investigator. 4. Investigators make the committee required changes and return any requested information/clarifications to ORA committee staff. Lifespan

What happens after I submit my application to ORA staff? 5. If the study was “approved pending receipt of requested revisions”, then ORA committee staff will verify that the requested changes were made and process approval documents 6. All project require two components before they can be initiated. Committee approval is required from all applicable review committees, and financial activation is required to ensure that adequate funds are in place to support the project. Lifespan

What happens after I submit my application to ORA staff? 7. If the initial application indicated that the study was funded by internal/departmental funds, then the Review Committee approval letter will indicate that the study is approved and also activated. 8. If the initial application indicated that the study was funded by an external source (grant/contract), then the approval letter will specify that the project is approved but not activated and that no activity is allowed until the activation is in place. When the grant/contract has been finalized, an activation notice with the new cost center will be sent to the investigator from the Grants and Contracts Office. Investigators cannot begin any project involving human subjects until IRB approval and financial activation have been received. Lifespan

Continuing Review aka Progress Reports Lifespan

Continuing Review In accordance with Federal Regulations, IRB approval is granted for a period of time not to exceed 12 months. Shorter periods of approval may be assigned depending upon the level of risk. Prior to the date on which the IRB approval of the research expires, the ORA will send you a progress report to be completed on your study. It is ultimately your responsibility to submit the continuing review report in a timely fashion to ensure a lapse in IRB approval does not occur. There is no grace period. If IRB approval of your research study lapses, you must stop any new subject enrollment. If IRB approval expires and you do not respond to emails and/or notices requesting this progress report the IRB will terminate the study for non-compliance. Whenever the IRB takes an action of non compliance the board is required to notify the institutional official, the sponsor if applicable, OHRP and the FDA if applicable. Lifespan

Steps to submitting a progress report for continuing review by the IRB Progress report forms are generated by ORA staff and sent to Principal Investigators 45-60 days before they are due. Email reminders are also sent to PIs and their designated contacts when the progress report forms are mailed. Lifespan

Steps to submitting a progress report for continuing review by the IRB 1. Upon receipt of the progress report form, verify when the report is due back in ORA. The due date is included in the upper right hand corner of the first page of the progress report form. Lifespan

Steps to submitting a progress report for continuing review by the IRB Please note the following: Continuation of the project beyond the anniversary date is contingent upon submission of this report. If the progress report is not received by the due date, approval will expire and no work will be allowed until the report is submitted, reviewed, and approved. Lifespan

Steps to submitting a progress report for continuing review by the IRB 2. Complete the progress report form. 3. Be sure to answer all questions Be sure that the number of subjects recruited, enrolled and refused adds up. Lifespan

Steps to submitting a progress report for continuing review by the IRB 5. Be sure to report the number of subject that withdrew or were withdrawn from the study and the reason for the withdrawal. Withdrew/withdrawn = any subject who decides to stop study treatment/procedures at any time or if the physician makes a decision to stop treatment/study procedures for any reason. 6. Please be certain to include a detailed justification for continuation (question 14) and sign where indicated. Lifespan

Steps to submitting a progress report for continuing review by the IRB 7. Progress report forms generated by ORA include a list of all local adverse event reports that have been received during the past project year and a list of all IRB review activities (i.e., changes to protocol). Please verify that these lists are complete, and attach copies of the adverse event reports and revision request forms for the previous project year. Lifespan

Steps to submitting a progress report for continuing review by the IRB 8. Review the checklist on the last page of the progress report to ensure that you have attached all of the required items 9. It is very helpful to the IRB reviewers and ORA staff if you include page dividers between each section of attachments to more clearly describe the items that are being submitted for review. Lifespan

Steps to submitting a progress report for continuing review by the IRB 10. Be sure to include stamped copies of all consent forms and advertisements that you intend to use for the coming year and clean copies for the new IRB approval stamp. Lifespan

Steps to submitting a progress report for continuing review by the IRB 11. Include the most recent scientific abstract listing key personnel. Be sure that the personnel list is up to date. 12. If you need to add new personnel, submit a Request for Revision to Protocol along with a copy of the updated abstract. Lifespan

Steps to submitting a progress report for continuing review by the IRB 13. All personnel must have certified/recertified in human subject protections within the past three years 14. Principal Investigators must submit an Assurance of Compliance with the HIPAA Security Rule annually. Lifespan

Steps to submitting a progress report for continuing review by the IRB 15. Please use single-sided copies only and do not staple any forms and/or attachments. 16. Submit your completed progress report, required attachments, and one complete collated copy to: Office of Research Admin., Aldrich Bldg, Room 507. Lifespan

Steps to submitting a progress report for continuing review by the IRB 17. If you need to include a request for revision to protocol at the time of continuing review, please contact ORA staff for specific instructions. Lifespan

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