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Ethical Considerations in Human Subjects Research

Ethical Considerations in Human Subjects Research. Stacey Berg, M.D. Texas Children’s Cancer Center. Definitions IRB review Informed consent Confidentiality + HIPAA Human material Chart reviews. Definition of Research.

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Ethical Considerations in Human Subjects Research

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  1. Ethical Considerations in Human Subjects Research Stacey Berg, M.D. Texas Children’s Cancer Center

  2. Definitions • IRB review • Informed consent • Confidentiality + HIPAA • Human material • Chart reviews

  3. Definition of Research • Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge Publication plans irrelevant

  4. Definition of Subject • Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains: • (1) data through intervention or interaction with the individual • (2) identifiable private information

  5. Subjects involved? Interaction due to research? Yes No Identifiable info? Subjects involved No subjects

  6. Human Subjects Research • IRB approval • full board • expedited • Informed consent • full written consent • altered or waived consent

  7. Research Exempt from Approval • Educational testing • Some surveys • Some studies of existing data or specimens • Study of public service programs • Taste and food quality evaluation IRB, not investigator, decides

  8. What does an IRB do? 45 CFR 46 • Review, approve, require modifications or disapprove research • Review informed consent • Conduct continuing review • Have authority to observe consent process and research

  9. Criteria for approval • Risks to subjects are minimized • Risks to subjects are reasonable relative to benefits • Selection of subjects is equitable • Provisions made for data, safety monitoring • Provisions made to protect confidentiality • Safeguards in place for vulnerable subjects • Informed consent will be sought, documented

  10. Risks minimized • Background/importance of problem • Study design issues • Good endpoints • Justifiable sample size • Appropriate biologic correlates • Leverage clinical procedures • Less risky way to get answer?

  11. Risk-benefit ratio favorable • How much risk? • To individual • To family? • To society? • How much benefit? • To individual • To society • Adequate data analysis plan • Protocol endpoints • Safety monitoring

  12. Informed consent • Tell people why you’re doing this and what’s going to happen to them! • Risks (not underestimated) • Benefits (not oversold) • 7th grade language

  13. Informed consent Basic elements • What the research is • Procedures involved • Risks, benefits • Treatment/compensation for injury • Alternatives • Right to withdraw • Confidentiality • Contacts for questions

  14. Informed consent Additional elements • Unforeseeable risks • Circumstances for termination of participation • Additional costs • Procedures for withdrawal • Notification of new findings that might affect willingness to participate • Approximate number of subjects

  15. Confidentiality • Consider subject privacy • Where you’ll talk • How intrusive? • Safeguard confidentiality of data • Locked doors • Password protected files • Consider risks if confidentiality breached • Genetic info- parentage, insurance • Psychological harm • Job status • Who gets access, what circumstances • What happens to samples

  16. HIPAA • Privacy rule • “Limiting the ways that health plans, pharmacies, hospitals and other covered entities can use patients’ personal medical information.” • Authorization to use PHI usually part of consent form • Applies in some settings where research regs don’t

  17. Waiver of Consent?

  18. Special types of research • Tissue samples only • Tissue banks complex • Databases • Do not need IRB approval for operational use • DO need IRB approval for research on data • Chart reviews • Need IRB approval (HIPAA) Consult with IRB

  19. Tissue Banks Research specimen from subject • Critical research resource • Genomics • Proteomics • Futuromics • Samples held indefinitely • Future uses unpredictable • Sample used in other studies • Clinical correlation valuable

  20. Repository Bank SOPs Advisory Board Bank IRB Consent Form Collection Distribution Local PI Subject Local IRB Consent Distal PI Usage agreement Distal IRB No consent

  21. Types of sample Defined by link to donor • Anonymous • No links exist anywhere • Coded • A link exists • Tissue recipient does not have key • Repository does • Identified • Tissue recipient can connect tissue to donor

  22. Kinds of IRB review Determined by type of sample • Anonymous samples • Can be exempt from IRB review • Coded or identified samples • IRB review required • Expedited review may apply if minimal risk • Samples all from decedents • Exempt from IRB review (not human subjects) • Still need HIPAA review

  23. Consent considerations Prospective sample acquisition • Informed consent required • Special considerations • Subject contact: • What PHI being collected? • Duration of follow-up • Recontact re: future studies? • Sample use: • This study only? • Any study related to condition? • Unspecified future studies?

  24. Waiver of consent? • Only if minimal risk • Confidentiality well protected • No release of PHI • Rights of subject not compromised • Adequate plan to reveal important findings • AND impracticable to get consent Most applicable to previously banked specimens Few good reasons if prospective collection

  25. Tissue Collection Exempt?

  26. Chart Reviews • IRB approval • usually expeditable • Informed consent? • Not (usually) if retrospective review • Justify waiver of consent and authorization in IRB application • Yes if prospective data collection • “Dear colleague” letter • passive approval from other MDs

  27. Databases • If for TPO (or education), no IRB or HIPAA issue • If collecting PHI but not for research, need authorization (or waiver) • If collecting PHI for research, need informed consent (or waiver)

  28. QI/QA • Effectiveness of programs • Improvements in health care delivery in particular settings • Not usually research if intended for internal program evaluation without generalization • Difficulty is in deciding when insight becomes “generalizable” Lynn, Ann Intern Med. 2007;146:666-673

  29. http://brain-prod.bcm.tmc.edu/brainlogin.asp

  30. Helpful links • 45 CFR 46 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.111 • Belmont Report http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm • NIH guide on informed consent http://www4.od.nih.gov/oba/rac/ic/appendix_m_iii_b.html • Data monitoring http://grants.nih.gov/grants/guide/notice-files/not98-084.html • IRB Manual https://intranet.bcm.tmc.edu/apps/research/oor/a_c/document/irb_manual.pdf

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