1. Institutional Review Board (IRB) for Human Subject Protections: Working with the IRB Erin A McClure, PhD Department of Psychiatry and Behavioral Sciences Addiction Sciences Division

2. Previous Training

4. The Belmont Report   3 Basic Principles for Protection of Human Subjects: – –Respect   voluntary informed consent   privacy   protections for vulnerable populations – –Beneficence – –Justice

5. Beneficence  Persons treated in an ethical manner  Protecting them from harm  Helping to secure their well being

6. Justice “ Who ought to receive the benefits of research and bear its burdens?” Equals ought to be treated equally Fairness in distribution

7. Informed Consent Essential to the ethical conduct of clinical investigation Potential subject chooses whether or not they will participate Obtained after full information is given and understood Explanation of study objective, potential benefits, risks, inconveniences, subject’s rights and responsibilities

8. Valid Informed Consent 3 Key Components 1. Informed 2. Understood 3. Voluntary

9. Ensuring Adequate Informed Consent   Given the imperative to protect the rights of participants, how can we be sure that our informed consent process is sufficient?   Ideas: – –Reading aloud – –Ask the participant questions – –Quiz – –Signatures and dates

10. Advances in Informed Consent  Remote services (telehealth, etc.) and research –Doxy me (https://doxy.me) https://doxy.me

11. Advances in Informed Consent  Apple ResearchKit (http://www.apple.com/researchkit/) http://www.apple.com/researchkit/

12. Therapeutic Misconception  Most studies are not designed to directly benefit study participants  Important to help participant understand that research is not the same as clinical treatment  If participant does not understand the difference, consent is not valid

13. IRB Purpose   To protect the rights and welfare of human research subjects   Authority to approve, require modification and disapprove any research involving human subjects   Ongoing review of study procedures

14. Protecting Participants from Harm   Does not mean study must be minimal risk   Have appropriate selection criteria to exclude individuals at greater risk of harm   Have study procedures to evaluate participants’ safety   Have DSMB to monitor study progress   Potentially stop study early / revise protocol if there are significant risks or benefits identified

15. Institutional Review Board Responsible for verifying 1.Safety 2.Integrity 3.Human rights 4.Public reassurance 5.Scientific content

16. What information is reviewed?   Protocol   Informed Consent Document(s)   Informed Consent process   HIPAA Authorizations/Waivers   Personnel-including who will obtain consent   Recruitment process/plan   Advertisements   Investigator’s brochure   Compensation   FDA information (if applicable)   Medical device information   Adverse events/DSMB

17. Recruitment Process   How you recruit for your study must be approved by the IRB: – –Advertisements – –Word of mouth – –Medical Record Review – –Asking medical providers to provide letter to possible participants – –Directly approaching potential participant – –“Cold calling” is not allowed

18. Investigator Obligations Responsible for  All procedures conducted  All data collected May delegate work in conducting study but they retain responsibility

19. OHRP Suspensions   During the last 10-15 years, OHRP has suspended all human research at the following institutions: – –University of Illinois, Chicago University of Colorado – –Duke University – –University of Pennsylvania – –Johns Hopkins University (all federally funded research was shut down; 2400 protocols) – –And others

20. Submitting an IRB Application   Pay attention to deadlines! – –http://academicdepartments.musc.edu/research/ori/irb/d eadlines.html   Clearly articulate what you are doing for research purposes   Do a mental walk through of your study – –Where will it be done? By whom? – –What will participants do? In what order? – –What data do you need? How/where will data be stored?

21.  Lessons learned –They are doing their job! i.e., protecting human subjects –Support your study and procedures with evidence –Pick your battles –Communicate frequently with IRB staff –“Better to ask for forgiveness than permission.” Well, sometimes…. Working with the IRB

22. Informed consent while under the influence Examples and Experiences

23. Deception or withholding information Examples and Experiences

24. Remote collection of data Examples and Experiences

25. Pregnancy and urine drug screens “If you are or become pregnant and test positive for illegal drugs, it is a law that the South Carolina Department of Social Services (DSS) must be notified. You and your family will be evaluated by the agency. You could be ordered to mandatory drug treatment, lose custody of your children, or possibly be jailed.” Examples and Experiences

26. Conducting research with adolescents Examples and Experiences

27. Use of experimental devices or investigational drugs Examples and Experiences

28. Conducting multi-site studies Examples and Experiences

29. Regulatory Support Call the SUCCESS CENTER At 792-8300

30. Useful Regulatory/Policy Material  MUSC IRB  http://academicdepartments.musc.edu/research /ori/irb/ http://academicdepartments.musc.edu/research /ori/irb/ http://academicdepartments.musc.edu/research /ori/irb/  http://academicdepartments.musc.edu/research /ori/irb/deadlines.html http://academicdepartments.musc.edu/research /ori/irb/deadlines.html http://academicdepartments.musc.edu/research /ori/irb/deadlines.html  Office for Human Research Protections  http://www.hhs.gov/ohrp/ http://www.hhs.gov/ohrp/  Food & Drug Administration  http://www.fda.gov/oc/ohrt/irbs/default.htm http://www.fda.gov/oc/ohrt/irbs/default.htm