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  1. Protecting Human Subjects in Research Joe Brown, MHS Office of Research Integrity

  2. What Needs IRB Review? • Activity meets definition of both Research & Human Subjects; OR • FDA’s definition of Clinical Investigation

  3. Human Subjects • A living individual about whom an investigator conducting research obtains: • (1) data through intervention or interaction with the individual, or • (2) identifiable private information • 45 CFR 46.102 (f)

  4. Research • A systematic investigation designed to develop or contribute to generalizable knowledge • 45 CFR 46.012 (d)

  5. Do Class Projects Need IRB Review? • Class projects or assignments involving the collection of data from human subjects may or may not meet the definition of research. Course instructors are responsible for making the decision whether the activities meet the definition of “research.”

  6. Does a Masters Thesis or Doctoral Dissertation Need IRB Review? • Graduate work which involves research on human subjects or a clinical investigation and results in a thesis or dissertation requires IRB review and approval.

  7. IRB Review Process?

  8. Mechanisms for IRB Review • Exemption Certification • Expedited Review • Full Review • Other Reviews (Continuation Review, Modification Requests, Report of Unanticipated Problems)

  9. Exemption Certification • Research fits into one or more specified categories • Categories do not apply in certain situations

  10. Exemption Categories • Educational setting • Educational tests, survey, interview, observation • Educational tests, survey, interview, observation (public officials) • Existing data • Research/demonstration projects • Taste and food quality evaluation

  11. No exemption if: • Prisoners • Fetuses • Review of medical records if identifiable • Survey or interviews with minors • Observation of minors* • Discomfort or harassment • Deception

  12. Mechanics of Exempt Review • Exemption (Medical & NonMedical) • Two copies, including: • Study instrument • Grant application • Reviewed upon receipt by one IRB member • Outcome • Approved • disapproved/another review type recommended • minor changes • ORI Contact – Joe Brown

  13. Expedited Review • Not greater than Minimal Risk • Research fits into one or more specified categories

  14. Minimal Risk • The probability of harm or discomfort anticipated in the research are not greater in and of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests • 45 CFR 46.102 (f)

  15. Expedited Research Categories • Clinical studies in certain conditions • Blood samples • Biological specimens by noninvasive means • Noninvasive procedures routinely employed in clinical practice

  16. Expedited Research Categories • Materials collected - nonresearch purposes • Voice, video, digital, image recordings • Individual or group characteristics or behavior…or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation or quality assurance methodologies

  17. Mechanics of Expedited Review • Expedited Review (Medical) • Deadline/meeting dates apply • Two copies, including: • Study instrument • Grant application • Reviewed by 1 IRB member • Outcome – • Approved • Changes • or Full Review recommended • ORI Contact – Joanne Hines

  18. Full Review • Research that cannot meet the criteria for Exempt or Expedited Review must be submitted for Full Review

  19. Mechanics of Full Review • Full Review (Medical) • Deadline/meeting dates apply • 20 copies, including: • Study instrument • Grant application • PI must attend meeting • Outcome – • Approved • Disapproved • changes recommended • ORI Contact – Bev, Suzanne, Amy

  20. Ongoing IRB Review • Other IRB Reviews: • Modification Review • Protocol Violations • Unanticipated Problems/Adverse Events • Continuation Review (at least once a year) ORI will send you a reminder 3 months in advance – ensure we have your current, correct address!!!!!!!!!!!

  21. Consent Form – Basic Elements • Statement study involves research; explanation of purposes; expected duration; description of procedures; identification of any experimental procedures • Description of risks or discomforts • Description of benefits to subjects or others

  22. Consent Form – Basic Elements • Disclosure of alternative procedures, if appropriate • Description of the extent to which confidentiality will be maintained • For research involving more than minimal risk explanation as to whether compensation and medical treatments are available if injury occurs

  23. Consent Form – Basic Elements • Explanation of whom to contact if questions arise about; a) the research; b) the subjects’ rights; or c) whom to contact if research-related injury occurs • Statement that participation is voluntary, and that refusal to participate involves no penalty or loss of benefits, and that subjects may discontinue at any time

  24. IRB Approved ICF Once study is approved, ORI will send you a stamped original informed consent form (unless waiver approved). Make copies of the original stamped form from ORI. Enroll ONLY using a stamped, approved informed consent form. IRB Approval 08-XXXXPA This form valid 07-01-08 - 07-01-09 EXAMPLE Page 1 of 12/ Version1

  25. Consent Process • Provide sufficient time to make decision • Provide sufficient opportunity to ask questions • Include strategies to minimize coercion • Avoid overstating benefits • Ensure subjects understand risks/research

  26. Consent Process • Train individuals obtaining consent • Be sensitive to subject’s needs • Make adjustments in process as necessary • Obtain IRB approval for changes

  27. Special Topics For Researchers • Waiving Documentation of Informed Consent • Waiving Informed Consent • International / Non-English Speaking Subjects • Vulnerable Populations

  28. Waiving Documentation of Informed Consent • The only record linking the subject and the research would be the consent document and the principal risk would be harm resulting from breach of confidentiality • The research presents no more than minimal risk and involves no procedures for which written consent is normally required • 45 CFR 46.117 (c)

  29. Waiving Informed Consent • Involves no more than minimal risk • Rights and welfare of subjects will not be adversely affected • Could not practicably be carried out without waiver • When appropriate, the subjects will be provided pertinent information after participation • 45 CFR 46.116 (d)

  30. International Research &Non-English Subjects • Subjects should be provided a consent form in their native language • International research requires a cultural consultant. • Research is appropriate for the culture

  31. Vulnerable Populations • Minors • Decisionally-Challenged Subjects • Prisoners

  32. Investigator Responsibilities • Educational Requirements • Avoiding Research Misconduct • Compliance

  33. UK Requirements • Training Requirements • Dunn & Chadwick • CITI • Educational Resources Available

  34. Educational/Resource Material • IRB Survival Handbook • Written Policies and Procedures • IRB Resource Guide • Ethics & Regulations • VHS Video Tapes • The Belmont Report • Balancing Society’s Mandates • Evolving Concern

  35. Research Misconduct:Government-wide Definition • Research Misconduct is defined as fabrication, falsification or plagiarism in proposing, performing, or reviewing research or in reporting research results. • Research misconduct does not include honest error or differences of opinion.

  36. Research Misconduct • Fabrication • Falsification • Plagiarism

  37. Compliance • Federal Regulations • Common Rule • HIPAA Privacy Rule • FERPA Privacy Rule • Others • Institutional Requirements

  38. Compliance • Should not be seen as something that must be done just because it is required by human subject protection regulations • Should be seen as the “right thing to do” because it helps protect the rights and welfare of the subjects of human research • Protecting Study Volunteers in Research, Cynthia McGuire Dunn, M.D., & Gary Chadwick, Pharm.D., MPH, 2001

  39. Office of Research IntegrityAreas of Responsibility • Human Subjects (5 IRBs) • HIPAA In Research • Animal Care (IACUC & Veterinarian) • Radioactive Drugs (RDRC) • Research Misconduct • Emerging Ethical/Regulatory Issues

  40. Office of Research Integrity • Guides the University in developing and implementing policies/procedures which ensure compliance with federal requirements for the ethical conduct of research

  41. Office of Research Integrity • Provides administrative assistance to the IRBs, the Radioactive Drug Research Committee and the Institutional Animal Care and Use Committee • Advises faculty, staff and students regarding federal regulations

  42. Office of Research Integrity • Disseminates IRB, RDRC and IACUC application forms • Prepares and maintains federally mandated reports • Assists in handling IRB, IACUC, and RDRC reports of noncompliance

  43. www.research.uky.edu/ori/

  44. ORI Contact Information • Ada Sue Selwitz, M.A. • Director • Larry Iten, D.V.M. • Associate Director • Helene Lake-Bullock, Ph.D., J.D. • Compliance Officer

  45. ORI Contact Information • Joe Brown (7-9084) • Exemptions • Privacy Issues • Joanne Hines (7-7467) • Medical Expedited