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

2. What is a Reliance Agreement? Formal, (written) document between multiple institutions o Master reliance agreement Mechanism for an institution engaged in research to delegate institutional review board (IRB) review/oversight to an IRB of another institution. o 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 human subjects research is conducted at multiple sites o Reducing administrative burden and duplicative efforts When an institution is engaged in human subjects research through funding or an investigator’s role in the study When an engaged 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 or new staff to an existing protocol

5. Reliance Agreements at LMA IRB? Requirements (to rely on another IRB): Organization has a current, unexpired Federalwide Assurance and: o participating institution of the Harvard Catalyst o AAHRPP accredited organization o HLMA is a collaborator on human research primarily conducted at another organization and the investigator’s role does not include interaction or intervention with subjects o HLMA 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 an Application For IRB Review of Multi- Site Research through Harvard Catalyst o The online request form may be used for any multi-site studies which involve at least one of the 36 Harvard Catalyst participating institutions

7. Reliance Agreements at LMA IRB?

8. What the IRB Needs to Know? To request reliance on another institution: Name of investigator (PI) at the affiliated site Which IRB is requested to be the IRB of record 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 any non-catalyst institution

9. Obtaining Single IRB Review for Multi-site Research Elizabeth Witte November 24, 2015 with Harvard Catalyst’s IRB Cede Review Request System Regulatory Affairs Officer; Regulatory Foundations, Ethics, & Law Program Sabune Winkler, JD Director, Regulatory Affairs Operations; Regulatory Foundations, Ethics, & Law Program

10. The Master IRB Reliance Agreement 10 Enables a signatory institution to rely on the review of another signatory IRB

11. Signatories to Master IRB Reliance Agreement 11 36 institutions have signed the agreement: Atrius Health Maine Medical Center Beth Israel Deaconess Medical Center Massachusetts Eye & Ear Boston Children's Hospital Massachusetts General Hospital Boston University - Charles River Campus Massachusetts Institute of Technology Brigham and Women's Hospital McLean Hospital Broad Institute MGH Institute of Health Professions Cambridge Health Alliance Mount Auburn Hospital Dana-Farber Cancer Institute New England Baptist Hospital Dartmouth College Newton-Wellesley Hospital Forsyth Institute Schepens Eye Research Institute Harvard Medical School (HMS) Spaulding Rehabilitation Hospital Harvard Pilgrim Health Care St. Elizabeth's Medical Center Harvard T.H. Chan School of Public Health Tufts Medical Center Harvard University Faculty of Arts and Sciences (FAS) Tufts University Health Sciences Campus Hebrew SeniorLife Tufts University Medford/Somerville Campus Joslin Diabetes Center University of Rhode Island Judge Baker Children's Center University of Southern California - Health Sciences Lahey Hospital & Medical Center University of Southern California - University Park http://catalyst.harvard.edu/programs/regulatory/reliance.html

12. Requesting IRB Reliance for your Study Cede Request System Policy and Overview 1.What is the form for? Request that one IRB review proposed multi-site protocols on behalf of all involved IRBs Request single IRB review when adding new site(s) to existing protocols NOTE: This form allows you to request IRB reliance; it DOES NOT serve as nor does it replace the IRB review process 2.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) 3.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 12

13. Before starting a request Make sure you have the following required information: Your HMS eCommons ID and password or Harvard PIN (required for login) The name of the institution 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) The IRB being requested to review the research, and the reason(s) why Title and brief description of your research Any supporting documents that might help the IRBs consider your request (protocol, work plan, diagrams, informed consent language, recruitment materials, investigator brochures, etc.) The sites where the research will be conducted The Site Investigator (SI) for each site involved (and appropriate contact information) The research personnel and activities that will be conducted at each site If this research has already been approved by an IRB, the protocol's IRB approval number and date All pertinent funding information 13

14. Where to Find the Form 14 The Application form is located on the Harvard Catalyst website under Resources and via the Regulatory Foundations, Ethics, and Law Program page http://catalyst.harvard.edu/programs/regulatory/ http://catalyst.harvard.edu/services/irbcede/

15. 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 Applicant Interface

16. Instructions PI and Institutional Information Institutional Responsibility Funding and Resources Summary Tabs on the request form

17. Instructions

18. 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. PI and Institution Information

19. 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 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. 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. If the focus of your research is cancer-related, DFCI will also be notified of the application PI and Institution Information

20. 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. Institutional Responsibilities

21. 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 Clinical Trials Office of the PI’s institution will be notified as well Funding and Resources

22. This tab also captures use of Harvard Catalyst Resources in support of the proposed research This information helps Harvard Catalyst understand usage and improve offerings. Funding and Resources

23. This tab shows: all information entered in previous tabs Carefully review this page You may navigate back to make corrections Upon “submit” email notifications go out to: PI, Site investigators 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” and Supporting Documentation sections 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 regulatory@catalyst.harvard.edu with any questions.Contact your IRB regulatory@catalyst.harvard.edu Summary

24. 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 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) Thank You / Confirmation of Submission

25. 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 PI’s institution PI is from Harvard Catalyst affiliate PI is NOT from Harvard Catalyst affiliate Application Process Review Process PI identifies Harvard Catalyst affiliated collaborator to complete form PI/Site Investigator/Study team member completes form and submits request (can save & return) 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 Reviewing IRB sends automated or customized decision letter to PI/study team and involved institutions’ IRB administrators. Review request closed. IRB Cede Review Request Process Flow Yes / No 25

26. Need to make a correction? 26 Standard Workflow States Revise Applications or Determinations or Remove Application From System Contact regulatory@catalyst.harvard.edu to request access to revise and resubmit your application or to remove a request from the system.regulatory@catalyst.harvard.edu

27. We are currently working on enhancements to the request system and welcome your input. Have ideas for features or improvements? Please send them to us at regulatory@catalyst.harvard.edu regulatory@catalyst.harvard.edu Have you used the Cede Review Request System?

28. For study-specific questions, or information about the status of a submitted request, contact the designated IRB representative from your institution and/or the PI’s home institution:http://catalyst.harvard.edu/services/irbcede/participating_institutio ns.htmlhttp://catalyst.harvard.edu/services/irbcede/participating_institutio ns.html For additional questions about the IRB Cede Review Request System, or to make changes to an existing application, contact: elizabeth_witte@hms.harvard.edu or regulatory@catalyst.harvard.edu elizabeth_witte@hms.harvard.eduregulatory@catalyst.harvard.edu For technical issues please complete the feedback form:http://cbmi.catalyst.harvard.edu/formsJsf/feedback.jsfhttp://cbmi.catalyst.harvard.edu/formsJsf/feedback.jsf Questions?