Ethical Considerations in Human Subjects Research Stacey Berg, M. D
tarix 06.09.2018 ölçüsü 487 b. #78542
Stacey Berg, M.D. Texas Children’s Cancer Center Definitions IRB review Informed consent Confidentiality + HIPAA Human material Chart reviews Definition of Research Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge 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 Subjects involved? Human Subjects Research IRB approval Informed consent full written consent altered or waived consent 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 What does an IRB do? Review informed consent Conduct continuing review Have authority to observe consent process and research 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 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? Risk-benefit ratio favorable How much risk? To individual To family? To society? How much benefit? Protocol endpoints Safety monitoring 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 Informed consent What the research is Procedures involved Risks, benefits Treatment/compensation for injury Alternatives Right to withdraw Confidentiality Contacts for questions Informed consent Unforeseeable risks Circumstances for termination of participation Additional costs Procedures for withdrawal Approximate number of subjects 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 HIPAA Privacy rule “Limiting the ways that health plans, pharmacies, hospitals and other covered entities can use patients’ personal medical information.” Applies in some settings where research regs don’t Waiver of Consent? Special types of research Tissue samples only Databases Do not need IRB approval for operational use DO need IRB approval for research on data Chart reviews Need IRB approval (HIPAA) Tissue Banks Critical research resource Genomics Proteomics Futuromics Samples held indefinitely Future uses unpredictable Sample used in other studies Clinical correlation valuable Types of sample Anonymous Coded A link exists Tissue recipient does not have key Repository does Identified Tissue recipient can connect tissue to donor Kinds of IRB review 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 Consent considerations 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? 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 Tissue Collection Exempt? Chart Reviews IRB approval Informed consent? Not (usually) if retrospective review Yes if prospective data collection “Dear colleague” letter passive approval from other MDs 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) 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” 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.pdfDostları ilə paylaş:
