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IRB Jonathan E. Miller, CIP IRB Officer and Assistant Director

IRB Jonathan E. Miller, CIP IRB Officer and Assistant Director. What is the IRB?. Institutional Review Board Ensures that ethical guidelines are followed to protect the rights and welfare of participants. Composition of the IRB.

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IRB Jonathan E. Miller, CIP IRB Officer and Assistant Director

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  1. IRBJonathan E. Miller, CIPIRB Officer and Assistant Director

  2. What is the IRB? • Institutional Review Board • Ensures that ethical guidelines are followed to protect the rights and welfare of participants.

  3. Composition of the IRB • Individuals with varying qualifications, backgrounds, and institutional affiliation. • Representation from the community • Non-scientist required for quorum

  4. Those who cannot remember the past are condemned to repeat it. - George Santayana

  5. Nuremberg Trials The Tuskegee Study – 1932 to 1972 Wichita Jury Study of 1953 Thalidomide Jewish Chronic Disease Hospital Stanley Milgram – Obedience to Authority

  6. Clips from Miss Evers’ Boys

  7. Congress Gets Involved • National Research Act of 1974 • Established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research • Belmont Report • Current regulations – The Common Rule

  8. Belmont Report • Issued in 1978 • Summarizes the basic ethical principles underlying research • Respect for persons = Autonomy, informed consent • Beneficence = Maximizing possible benefits while minimizing possible harms • Justice = Equitable selection of subjects

  9. Lessons from Tuskegee • Informed consent • Deception • Placebo instead of treatment • Annual continuing review • Coercion • Monetary • Authority • Vulnerable subjects

  10. What Requires IRB Review? IRB Review is required for all research studies involving human subjects. • So what is research?…and what is a human subject?

  11. 45 CFR 46 - Research • Research means a systematic investigation… designed to develop or contribute to generalizable knowledge.

  12. 45 CFR 46 – Human Subject • Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains: • Data through intervention or interaction with the individual, or • Identifiable private information.

  13. Intervention or Interaction • Intervention: • Physical procedures – Blood draws, X-rays, etc. • Interaction: • Communication or interpersonal contact between investigator and subject – Surveys, interviews, etc.

  14. Study of Existing Data or Specimens Existing data constitutes HSR if: Individual level data, Not public information, and Includes direct or indirect identifiers.

  15. Risk The levels of review largely depend upon risk of harm or discomfort to subjects. Risk means the probability and magnitude of harm

  16. Probability of Harm What is the likelihood that a harm will occur?

  17. Magnitude of Harm What is the severity of the harm(s) that could occur?

  18. Risks • Physical harm • Psychological harm • Criminal liability • Civil liability • Financial standing • Employability • Insurability • Reputation

  19. IRB Authority For research involving human subjects, the IRB may: Approve Require modifications (to obtain approval), or Disapprove the research. Includes modifications and continuations of previously approved research.

  20. IRB Authority Audits Suspension and termination of HSR

  21. Researcher Responsibility Promptly report to the IRB any unanticipated problems involving risks to subjects or others (At MSU = within 10 days of incident) Promptly report proposed changes in project (All changes must be approved by IRB prior to instituting any changes)

  22. Informed Consent… A process, not just a form!

  23. Informed Consent The consent form serves 3 purposes: Baseline of information Reference during the study Documentation of voluntary participation

  24. Confidentiality vs. Anonymity Which will you promise in the consent process? Confidential means, “I know who you are, but I will not tell others what you say, think or feel.” Anonymous means “I do not know who you are and therefore cannot tell others what you say, think or feel.” Each has implications for data security after collection is complete.

  25. Recruiting Any attempt to recruit subjects is part of the research process and may not be undertaken prior to IRB approval. Recruiting materials (emails, flyers, advertisements, announcements, etc.) must be approved by the IRB prior to implementation.

  26. Data Safety Data safety means monitoring your data to see if an adverse event or effect is occurring or is likely to occur. Data Safety Monitory Committee The Stanford Prison Experiment Thalidomide

  27. Data Security • Physical measures • Locked doors and filing cabinets • Don’t collect identifiers if not needed • Strip identifiers as soon as possible • Store identifiers separately from data

  28. Data Security • Electronic data • Firewalls • Passwords (not taped to computer monitor) • Encryption • Project specific data storage procedures • Laptop? • Flash drives? • External hard drives?

  29. Data Security

  30. Data Security

  31. Data Security Consequences of previous data breaches: • Employees placed on administrative leave • Computers and data seized • FBI Investigations • Providing credit monitoring for those affected • 500,000 people X $75/year = $37,500,000

  32. Vulnerable Populations • Pregnant women • Prisoners • Children • Employees • Students • Cognitively impaired • Substance abusers • Economically or educationally disadvantaged

  33. Why follow the regulations?

  34. Importance of compliance Noncompliance by one investigator could compromise funding for the whole University Universities “shut down” due to human subject violations: Duke Virginia Commonwealth UAB (partially) Johns Hopkins

  35. Bottom Line The bottom line is this: Good research = Ethical research = Protection of human volunteers At some point, you, your child, spouse, or parent is likely to be a research subject. Treat each subject justly, with respect and only include them in endeavors which are likely to be beneficial.

  36. Additional Resources • Office for Human Research Protections (OHRP) http://www.hhs.gov/ohrp/ • Belmont Report http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm • IRB Forumhttp://www.irbforum.org/ • ORC Website http://www.orc.msstate.edu/

  37. Additional Resources • Carlen Henington, Ph.D.IRB Chaircdh@colled.msstate.edu662-325-7099 • Jonathan E. Miller, CIPIRB Officer and Assistant Directorjmiller@research.msstate.edu662-325-2238 • Christine Williams Compliance Administratorcwilliams@research.msstate.edu 662-325-5220

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