Conducting Research at Lincoln IRB/HRPP Policies, Procedures & Good Clinical Practices

1. Conducting Research at LincolnIRB/HRPP Policies, Procedures& Good Clinical Practices B Kanna MD, MPH, FACP Associate Program Director of Internal Medicine IRB Chairman Associate GME Director for Research Lincoln Medical & Mental Health Center, New York

2. IRB / HRPP • IRB – Institutional Research Review Board • HRPP – Human Research participants protection

3. Guiding Ethical Principles • Nuremberg Code of 1947 • Declaration of Helsinki, 1964 (last updated in 2004) • Belmont Report 1979

4. Belmont Principles 1) Respect for persons: • Individuals should be treated as autonomous agents (such as providing informed consent); • Persons with diminished autonomy may need additional protections. 2) Beneficence: • Researchers should do all they can to maximize possible benefits and minimize possible harm to their research subjects. 3) Justice: • Researchers must treat participants fairly and equitably • Including the equitable selection of subjects (in terms of who may bear the risks and who may receive the benefits of the research)

5. Historical facts • Second World War camps – Nuremberg Code • Hepatitis study • Tuskegee study

6. IRB Regulations • 45 CFR* 46 • 21 CFR 50; 56; 312; 812 *CODE OF FEDERAL REGULATIONS • IRBs are required by federal law to review human research that is either federally funded or subject to FDA oversight.

7. Functions of the IRB • The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. • The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. • Research that has been reviewed and approved by an IRB may be subject to review and disapproval by officials of the institution. • However, officials may not approve research if it has been disapproved by the IRB

8. IRB Committee • Scientific members • Non-scientific members • Community members • Meets monthly in Lincoln • Conducts voting on new studies before approval

9. IRB review of studies • All human research must be reviewed and approved by IRB • e.g. Clinical trials; observational studies; chart review studies • What do you do if you are not sure ? • Contact IRB before you plan any study • X 5339 (Nikol Celestine,IRB Administrator)

10. Initial steps • You have an idea for a research study • Discuss this with your mentor or research director • Prepare a draft protocol • Contact IRB • Prepare a full protocol and other documents • Know what is an IRB review and what happens at the IRB meeting

11. IRB pre-review • Occurs before IRB review • Principal investigator and IRB administrator review the protocol and document requirements • Type of review is determined • Date for IRB review is planned

12. IRB initial review • Types of review: Full; Expedited and exempt • Full reviews must be reviewed at IRB meeting • Expedited review will be reviewed by the IRB Chair or IRB member • Exempt review is determined by IRB – not by the investigator

13. IRB initial review • Full review • More than minimal risk • Reviewed by an IRB member ( primary reviewer) • Submit all documents 2 weeks prior to next meeting • Investigator required to present briefly the protocol at the IRB meeting

14. Documents for Initial review • Full protocol • Lay summary • Consent/Waiver • HIPAA/waiver • Conflict of Interest • CV/HIPAA training & HPPER certificate • Contracts/Budgets for funded studies • Fliers/brochures, etc

15. Initial Review • Submit all documents to IRB • Fill out Application for initial review • REASON application system for administrative review and approval

16. Administrative Review • Separate from IRB review • Is a LMMHC/HHC requirement • REASON application system • Review occurs in parallel with IRB review

17. Deadlines • Full review submission: 2 weeks before IRB meeting • Expedited review: 1 week before IRB meeting • Other reports: As per IRB operating procedures • IRB meeting: 2nd Tuesday of every month • Approval time: 2-4 weeks

18. Expedited initial review • 45 CFR 46 provides guidelines • 9 categories under expedited review • Need not be discussed in IRB meetings • Approved by IRB Chair or member • Still needs administrative review • Deadline for submission: 1 week before IRB meeting • Approval time: 2- 4 weeks

19. Initial Approval • No study can be started unless final HHC Central Office approval is obtained in written • IRB approval is a part of final approval • Approval is maximum for 1 year period • PI must remember this and submit continued review in 1 year • PI will be reminded 1-2 months before end of initial approval period

20. Continued review • All studies that have been reviewed and approved by IRB must be re-reviewed within 1 year • Dates are very important • A summary of the study must be available • If no subjects enrolled – justification to continue study must be made clear • CR approval for additional 1 year maximum until study is closed

21. Additional IRB review • An adverse event; unanticipated event must be reported to IRB immediately • Document requirements specific for each event • Time lines are very important in reporting • e.g – loss of data; side effects of rx

22. Study Closure • Must be reported to IRB • Study summary and required documents must be submitted • Reason for study closure • If PI is leaving institution, must be cleared by IRB on the seperation form

23. IRB Guidelines • IRB standard operating procedures • OHRP website • 45 CFR 46 • IRB website • IRB Office • Research Director /IRB member

24. IRB templates • Initial review: • Application for initial review • COI • HIPAA/Waivers • Consent/Waivers • Continued review: • CR application • Study closure: • Closure form • Adverse events: • AE form • Safety updates form

25. IRB templates • IRB reviewer • Initial review ( Full & expedited) • CR ( Full & Expedited) • Consent review template • IRB administrator • Determination of type of review • OHRP tool for audits

26. IRB information • IRB website • IRB representative from department • IRB Office: • X 5339 • Nikol Celestine, IRB administrator

27. New model Old model Director Institution QA/QI Patient Advocates Education IRB Chief of Staff Subjects Research compliance AO Medical Records Biosafety Clinical managers IRB Public Affairs Subjects Finance Office Pharmacy Investigators DSMB Radiation Safety Study Coordinators Sponsors Conflict of Interest Committee Grants & Contracts

28. Questions ?