1. IRBMED AND CHESAPEAKE IRB General Procedures for Ceding IRBMED Oversight Procedures Specific to Chesapeake IRB Medical School Institutional Review Board (IRBMED)

2. Introductions Representatives  Chesapeake  IRBMED Medical School Institutional Review Board (IRBMED) 2

3. What is a central IRB?  Central IRB – A single IRB that provides regulatory and ethical review services for multiple sites participating in a research study  A central IRB may be independent (sometimes called commercial) or institutional  Independent IRB – Chesapeake IRB  Institutional IRB – University/Hospital IRB Medical School Institutional Review Board (IRBMED) 3

4. What does it mean to cede oversight?  Ceding is a legal agreement that transfers responsibilities from one entity to another  To cede oversight of the ethical review of research, IRBMED must agree to relinquish certain responsibilities and Chesapeake IRB (for example) must agree to assume those responsibilities  IRB Authorization Agreement – IRB regulatory terms  Master Service Agreement – All other contractual terms and responsibilities Medical School Institutional Review Board (IRBMED) 4

5. What are the benefits to ceding IRB oversight?  FDA, OHRP, NIH, and U-M all support the use of central IRBs to improve the efficiency of conducting multi-site trials  Enhance research partnerships  Industry - sponsored research  Cooperative group research  Inter-institutional academic relationships  Ensure consistency between investigative sites by utilizing a single IRB  Avoid individual reviews by local IRBs  Respond to faculty needs Medical School Institutional Review Board (IRBMED) 5

6. U-M Plans and Roll-out  The process is in early stages of roll-out  Completed roll-out in approximately 6 months  U-M plans to seek Master Service Agreements with appropriately qualified central IRBs  Each central IRB may have slightly different procedural elements relationships  The first application for each new central IRB will take add’l time  A new eResearch application type was developed for use by the UMHS/medical school community  Guidance materials are in development Medical School Institutional Review Board (IRBMED) 6

7. How do study teams at U-M utilize a central IRB? 1) As part of the PAF Application, indicate from the drop-down listing which central IRB will be used to ensure that appropriate contractual terms are added 2) Complete the eResearch application “Requesting Review by a Non-UM IRB” (aka Ceding) 3) The ceding application will be reviewed by the ancillary committees and acknowledged by IRBMED Medical School Institutional Review Board (IRBMED) 7

8. Generic Workflow Medical School Institutional Review Board (IRBMED) 8

9. Sections of the Ceding Application 1 General Study Information 2 Sponsor Information 3 UM Study Functions 4-3 Requesting Review by Non-UM IRB 5-2/4Research Design 6-2 Benefits and Risks 7-3 Special Considerations 8 Subject Participation 9-3 Subject Populations 10-6 Informed Consent 11 Confidentiality/Security/Privacy 13 Subject Payment 14 Health Care Treatments and Procedures Medical School Institutional Review Board (IRBMED) 9

10. Terms of the Master Agreement UM  Conflict of Interest  Investigational Drug Service  RDRC/SHUR  CRAO  Protocol Review Committee  (Cancer Center)  IRBMED Acknowledgement Chesapeake IRB  IRB Application  Protocol  Informed consent  Recruitment  All other relevant materials Medical School Institutional Review Board (IRBMED) 10

11. THANK YOU! Additional questions will be answered following the Chesapeake IRB presentation Medical School Institutional Review Board (IRBMED) 11

12. Questions & Answers  How long will it take for ancillary committee review to be completed? Ancillary review remains unchanged.  How long will it take for an IRBMED acknowledgement letter to be issued? Following review by ancillary committees, IRBMED acknowledgement should take approximately 2 business days.  Should the ceding application be used for NCI-cIRB instead of the facilitated review applications? This will be permitted within the next month. Continue to use facilitated review applications until otherwise indicated. Medical School Institutional Review Board (IRBMED) 12

13. Questions & Answers  If my central IRB is not on the list in the PAF or the IRB application, how can it be added? Contact the IRBMED to request consideration of the new IRB.  What central IRBs may be used at this time? Currently, U-M has agreements with Chesapeake IRB and NCI. If you would like to use a different central IRB, it requires negotiation via our normal IRB review and ceding procedures. As other central IRB agreements are finalized, IRBMED will the notify the research community. Medical School Institutional Review Board (IRBMED) 13

14. Questions & Answers  Why does U-M have an agreement with Chesapeake IRB? Chesapeake IRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and has a strong FDA compliant track-record.  Is the process different when working with another University/Institutional IRB? Yes, as UM is able to work individually with other institutions to create IRB Authorization Agreements through a less formal contractual process. Medical School Institutional Review Board (IRBMED) 14

15. Questions and Answers  Is there a fee associated with using a central IRB? Independent IRBs will charge a fee which is usually paid by the research sponsor. The process for payment will vary depending on the Master Agreement with the independent IRB. Work with your sponsor to determine how the fee will be incorporated into your study budget. University/Institutional IRBs may not charge a fee.  I am uncertain as to how to answer some of the questions in the new eResearch ‘ceding’ application. Help text is being written and will be posted as soon as it is available. Medical School Institutional Review Board (IRBMED) 15

16. U-M Contacts  IRBMED 763-4768 Joe Austin (sjaustin@umich.edu) Diana Miller (mildiana@umich.edu) Georgia Marvin (gmarv@umich.edu) Judy Birk (jbirk@umich.edu)  Consult with the IRBMED early in the application process if you wish to use a Central IRB! Medical School Institutional Review Board (IRBMED) 16