Dana-Farber/Harvard Cancer Center: Pediatric IRB Review

1. Dana-Farber/Harvard Cancer Center: Pediatric IRB Review Office for Human Research Studies (OHRS) April 2009 (617) 632-3029  ohrs@dfci.harvard.edu

2. Office for Human Research Studies Michele Russell-Einhorn, JD • Senior Director, Office for Human Research Studies (OHRS) • 20 Overland St. • Boston, MA 02115 • 617-632-3032 • Michele_Russell-Einhorn@dfci.harvard.edu

3. DFCI IRB is the IRB of record… for adult and pediatric cancer research at the five Harvard Clinical Institutions: Beth Israel Deaconness Medical Center; Brigham and Womens Hospital; Childrens Hospital Boston; Dana-Farber Cancer Institute; and the Massachusetts General Hospital. 2100 open protocols.

4. DF/HCC Pediatric Research • @167 open protocols that span pediatric and adult populations • @113 open protocols only for under 18 populations

5. DF/HCC Pediatric • CHB and DFCI investigators have join appointments • Not the case with MGH

6. Office for Human Research Studies (OHRS) • Review by ancillary offices • Scientific Review • IRB Review • Activation • Post Approval Events and Issues

7. Process and operations • Once pediatric protocol is submitted: 1. the clock starts ticking; and, 2. the protocol is routed to the appropriate offices. The first issue is where will the research be conducted: CHB, MGH, DFCI.

8. Process and Operations • Pharmacy • Nursing • Radiation Safety • IBC • Pathology • contracting

9. DF/HCC Scientific Pediatric Review • Research is reviewed by the Pediatric Scientific Review Committee (PSRC) pursuant to Cancer Center Support Grant Guidelines (CCSG)

10. DFCI IRB Review Following Scientific Review, the protocol is set for review by the DFCI IRB acting on behalf of the DF/HCC.

11. Composition of IRBs • Adequate pediatric representation

12. Pediatric Protocols • Determination of Regulatory provision • Guidance on Assent • Determinations relating to Parental Permission

13. Informed Consent

14. Informed Consent: A Variety of Issues between Institutions 1. Translated consents including issues relating to the cost of the translation 2. Different policies of institutions (CHB and DFCI) e.g., can a fellow be a PI on a research protocol 3. Different perspectives on assent 4. Different perspectives on what is a direct benefit

15. IRB Approval • Once IRB approval is finalized, we move into the stage of Activation

16. Activation • Each protocol is different. • This is the activation checklist we use at OHRS.

17. Activation • Pharmacy (is drug in stock) • Nursing (has nursing in-service been completed) • Radiation Safety (has CHB signed off on the radiotherapy) • Contracts (has the contract been signed)

18. Activation • From the time of receipt to activation, the time frames can be between 53 days (including scientific and IRB review) and 200 days (where there are significant time lapses because, for example, of a wait for a sponsor approval of an IRB condition)

19. Post Approval Issues • Emergency Uses • Pharmacy distributes investigational drug for the emergency protocol without sponsor approval • ICU staff not trained to manage pediatric patients who are enrolled in research

20. Post Approval Issues • Blood bank incorrectly processes blood and returns the same to subjects • Differences between IRBs in interpreting eligibility criteria

21. Communication • Because the institutions are geographically close, we can communicate easily about process and operations issues. • There is representation from MGH pediatrics and CHB pediatrics on various clinical operations committees and the IRB.

22. Questions