Ceding Review: Multiple I nstitutions , one IRB Review

1. Ceding Review:  Multiple Institutions, one IRB Review Julie M. Kaberry, MHP, CIP Administrative Chair, HSPH IRB jkaberry@hsph.harvard.edu

2. What is a Reliance Agreement? • Formal, (written) document between multiple institutions • Mechanism for an institution engaged in research to delegate institutional review board (IRB) review to an IRB of another institution. • When multiple institutions are engaged in the same non-exempt, human subjects research

3. What is a Reliance Agreement? Different descriptive terms: • Cede review • Reciprocal agreement • Reliance agreement • Cooperative agreement • IRB authorization agreement (IAA)

4. When is a Reliance Agreement Used? • When a trial/study is conducted at multiple sites • Reducing administrative burden and duplicative efforts • When a participating institution does not have its own IRB • When a study involves special populations (e.g. prisoners), or when a trial requires specialized IRB expertise • This agreement applies not only to new protocols, but can also be to add a new site to an existing protocol.

5. Reliance Agreements at LMA IRB? Requirements (to rely on another IRB): • Organization has a current, unexpired Federalwide Assurance and: • participating institution of the Harvard Catalyst • AAHRPP accredited organization • affiliated investigator is a collaborator on human research primarily • research is conducted at another organization and the investigator’s role does not include interaction or intervention with subjects • HSPH is engaged in the Human Research solely because it is receiving federal funds.

6. Reliance Agreements at LMA IRB? To request a cede review: • Submit and IRB Authorization Agreement (form) through ESTR • Submit a Application For IRB Review of Multi-Site Researchthrough Harvard Catalyst • The online request form may be used for any multi-site studies which involve at least one of the 24 Harvard Catalyst participating institutions

7. Reliance Agreements at LMA IRB?

8. What the IRB Needs to Know? To request a cede review: • Name of investigator (PI) at the affiliated site and names of all affiliated study staff • Who is the agreement covering? • Which IRB is the investigator requesting be the IRB of record? Why? • Specific role of all affiliated study staff • If study is already approved, protocol number and date of latest approval (e.g. date of modification to add staff) • Contact information for non-catalyst institution

9. Multiple institutions, one IRB review Harvard Catalyst IRB Ceded Review Request System Elizabeth Witte Regulatory Affairs Officer Harvard Catalyst Regulatory Knowledge and Support Program Sabune J. Winkler, JD Director, Regulatory Affairs Operations Harvard Catalyst Regulatory Knowledge and Support Program 10/02/2013

10. Introduction to System and Processes: Overview and Policy Cede Review Form Policy and Overview • What is the form for? • Request that one IRB review proposed multi-site clinical protocols on behalf of all involved IRBs; or • Request single IRB review when adding new site(s) to existing protocols • NOTE: This is a CEDE REQUEST form; it DOES NOT replace the IRB review process • Who may complete the form? • The PI, Site Investigators, or Study Staff • The form requires HU ID or eCommons login and thus applications may only be completed by individuals from Harvard Catalyst participating institutions (though your research may involve outside institutions) • When will study teams use the form? • Before submission of an IRB application but after your research plans have been finalized. • Request review by a single IRB when adding a new site to an existing, reviewed, and approved protocol.

11. Introduction to System and Processes: Before you start We suggest compiling the following required information before filling out the form: • Your HMS eCommons ID and password or Harvard PIN. Applicants can only access the Cede Review Form using their eCommons or Harvard PIN credentials. • The name of the center where the overall principal investigator (PI) is "primarily employed." Although investigators may have appointments at multiple institutions, they are usually considered an "employee" or a "workforce member" of only one institution. The institution from which the Overall PI receives his/her paycheck is generally considered the institution of primary employment. For Harvard University employees, this would be the school at which their primary appointment is held. • Which IRB is being requested to review and the reason(s) why. • Title and brief description of your research. • Any supporting documents that might help the IRBs consider your request.These include: a protocol, a work plan, diagrams, informed consent language, recruitment materials, investigator brochures, etc. • The sites where the research will be conducted. • The activities which will be conducted at each site. • The contact information for the site investigators. • The names of the other research personnel at each site who will work on the proposed study. • If this research has already been approved by an IRB, the protocol's IRB approval number. • Your funding information.

12. Introduction to System and Processes: Where Can I Find the Form? • The Application form is located on the Harvard Catalyst website under Resources and via the Regulatory Knowledge and Support Program Page • http://catalyst.harvard.edu/programs/regulatory/ • http://catalyst.harvard.edu/services/irbcede/ • https://cbmi.catalyst.harvard.edu/cede/cedeApplicationList.jsf

13. Application Process Introduction to System and Processes: Harvard Catalyst IRB Ceded Review Request Process Flow PI is from Harvard or Catalyst affiliate PI/Site Investigator/Study team completes form and submits (can save and return) Notifications (w/ PDF of application) sent to: •PI/applicant and site investigators; and •IRB of PI’s institution of primary employment; and •IRB of each institution named in application (unless this is a non-Catalyst institution, in which case a separate notification goes to that IRB contact as well as to regulatory@catalyst.harvard.edu) cc email sent to: • If cancer-related = Y (Question 7) - DFCI •If industry funding indicated (Question 16) - Clinical Trials office of participating institutions PI identifies Harvard/affiliate collaborator to complete form PI is NOT from Harvard or Catalyst affiliate Review Process Reviewing IRB sends automated or customized decision letter to PI/study team and involved institutions’ IRB administrators. Review request closed. IRB Director at institution of PI’s primary employment leads response and contacts IRB director(s) of relying institution(s). If this is a non-Catalyst institution, other institutions take lead IRB Negotiations occur offline. Reviewing IRB logs into system and completes Decision form Yes / No

14. Introduction to System and Processes:Basic System Workflow States andAbility to Revert or Deactivate Applications and Decisions Standard Workflow States Revise Applications or Determinations or Remove Application From System

15. Applicant Interface • From here you can: • Start a new application • Edit a saved, IN PROGRESS application • See if an application has been SUBMITTED or REVIEWED • The current interface is minimal BUT enhancements are in the works

16. Tabs On The Form • Instructions • PI and Institutional Information • Institutional Responsibility • Funding and Resources • Summary

17. Instructions Tab

18. Introduction to System and Processes:PI and Institutional Information Page • This tab captures: • Overall/Requesting PI • PI Primary Employment • Requested Reviewing IRB • Reason for requesting Reviewing IRB • Name and contact information for individual completing form (if not overall PI) Note: Your Selections on Questions 1 and 2 determine which IRBs receive notification of your application. The institution of the PI’s Primary Employment takes the lead on decision-making.

19. Introduction to System and Processes:PI and Institutional Information Page • This tab also captures: • Research title • Brief description of Research – be clear about who is doing what, and where • Upload of supporting documents • Indication if research is cancer-related • List of sites involved in the research If the focus of your research is cancer-related, DFCI will also be notified of the application Note: Your Selections on Question 8 also determine which IRBs are notified upon submission of your application If an institution (or investigator/personnel from an institution) is involved in any way, that institution should be selected here, even if no activities are happening at the site.

20. Introduction to System and Processes:Institutional Responsibilities Page • For each site, this tab captures: • Review date and protocol # for previously reviewed research (if applicable) • OR • Site investigator • Other research personnel • Types of research participants • Activities • Tissue use • Data Analysis of health information • Research data storage • Ancillary services • Note: you should indicate the activities and personnel specific to each site. If no activities are happening at the site you may indicate that here.

21. Introduction to System and Processes:Funding and Resources Page • This tab captures • Types of Funding • Federal, Industry, Foundation/Other Non-Profit, Institutional Award, State Government, Other • Indication of industry funding triggers email to designated CTO contact • PI of the Award (if differs from overall PI) • Primary Awardee Institution and subcontract information If Industry Funding is indicated, a contact from the institutions’ Clinical Trials Offices may be notified as well

22. Introduction to System and Processes:Funding and Resources Page • This tab also captures • Use of Harvard Catalyst Resources in support of the proposed research: • Research resources • Consulting Services • Educational Resources • Funding Resources • Other • This information helps Harvard Catalyst better understand usage of available resources.

23. Introduction to System and Processes:Summary Page • This tab shows • All information entered in previous tabs • Applicants should review carefully • Applicants may navigate back to make corrections • Upon “submit” email notifications go out to: • PI, Site Pis listed on the application, and the individual filling out the form • IRBs of institutions listed on the application, and any other institution contacts, if so indicated (ie, cancer-related or industry-funded research). Note: The “Brief Description” section and Supporting Documentation Upload feature may be used to clarify any aspects of the research project that you feel have not been adequately conveyed through the questions on the form. Contact your IRB or Harvard Catalyst Regulatory Knowledge and Support Program for assistance.

24. Thank You Page • Upon Successful Submission of the Application: • You, the PI, and Site Investigators listed on the form will receive notification of the submission • The IRBs of the institutions included in Questions 1, 2, and 8 on the application will be notified of your application request. • The Institution of the PI’s Primary Employment will take the lead on discussions • Decision-making about the ceded IRB review request occurs off-line • You may be contacted to provide additional information, as needed • Once a determination is reached, an IRB administrator will log the determination in the system and notify all parties (either via a system-generated email or a separate email, as needed). • Based on the determination, IRB applications or amendments may then be submitted to the appropriate institution(s)

25. Questions • For questions about filling out the form for your specific study, or for information about the status of a submitted application, contact the designated IRB representative from your home institution and/or the PI’s home instittuion. See Participating Institutions and contacts at http://catalyst.harvard.edu/services/irbcede/participating_institutions.html. • For additional questions about how to use the IRB Ceded Review Request System or to make changes to an existing application, contact: • Elizabeth Witte 617-432-7633 Elizabeth_Witte@Hms.Harvard.edu • For Technical Issues please complete the feedback form on the Harvard Catalyst website (http://cbmi.catalyst.harvard.edu/formsJsf/feedback.jsf). Completing this form will immediately notify our bioinformatics department of the issue.