Download to read offline
ETHICAL ISSUES FINAL.pptnriennejekejbe r
- 1. Ethical Issues forHuman Subjects Research
- 2. Ethical Issues inResearch • When using humans or animals for research, important ethical issues must be addressed – Historically, these issues were addressed by the professional code of ethics – Codes of conduct have evolved and now have been codified into law.
- 3. • World WarII—The Nuremburg Trial – Joseph Mengele and unethical experiments performed by Nazi doctors
- 4. Nuremburg Code • Requiresvoluntary consent • Experiments must be rational • Experiments must be based on animal studies and knowledge of the disease • Experiments should avoid suffering • No experiment should involve excessive risks, except in those studies where physical experimental physicians also serve as subjects
- 5. Nuremburg Code • Degreeof risks should be determined by importance of the problem • Precautions should be taken to avoid against even remote possibilities of injury, disability, or death • Experiment should be conducted only by scientifically qualified persons • Subjects should be able to end experiment at any time • The scientist in charge must be prepared to terminate the experiment at any stage, if they believe the experiment is likely to result in injury, disability, or death to the subject
- 6. Belmont Report • NationalCommission submitted the Belmont Report to President in 1979 – Led to 1981 revision of 1974 guidance (45 CFR 46) for human research committees – 45 CFR 46-has become the bible for reviewing research funded by DHHS • Required appointment of Institutional Review Boards or IRB’s to review human subject studies • Provided standards for appointment of IRBs, record-keeping and oversight in research
- 7. Institutional Review Boards •Makeup of IRB – At least 5 members – Male/Female – Professionals/laypersons – External “non-affiliated” member – Must represent community – Lay person must be at meeting for reviews
- 8. Institutional Review Boards •IRB’S must be guided by principles outlined in Belmont Report: – Respect for persons: respect for patient autonomy – Beneficence: maximize benefits and minimize harm – Justice: Equitable distribution of research burdens and benefits
- 9. IRB Review ofResearch • Three categories of Review: – Exempt – Expedited – Full Review
- 10. IRB Review ofResearch • Exempt-by Chair or Administrator – Research in educational settings involving normal educational practices • Instructional strategies • Effectiveness of instructional techniques • Comparison of techniques or curricula, etc.
- 11. IRB Review ofResearch • Exempt-by Chair or Administrator – Research involving educational tests (cognitive, diagnostic, aptitude)
- 12. IRB Review ofResearch • Exempt-by Chair or Administrator – Survey research without identifiers; interviews, observation of public behavior
- 13. IRB Review ofResearch • Exempt-by Chair or Administrator – Collection or study of existing data, documents, records, pathological or diagnostic specimens
- 14. IRB Review ofResearch • Exempt-by Chair or Administrator – Research and demonstration projects conducted by or subject to approval by DHHS to study, evaluate or examine: • Public benefit or service programs • Procedures for obtaining benefits or services from these programs • Other changes in these programs – Taste and food quality evaluation and consumer acceptance studies
- 15. • Expedited Review –Research activities reviewed by Chair or designee – Two cautions however: • Only for activities involving minimal risk-i.e., no more risks than those in everyday life • Cannot be used if subject responses might pose civil or criminal risk to subject, unless – Reasonable protections can be implemented so that risks related to invasion of privacy and breach of confidentiality are minimal
- 16. IRB Approval • Tobe approved: – Risks must be minimized by sound research design – Risks must be reasonable in relation to benefits – Selection of subjects must be equitable – Informed consent will be sought from each subject
- 17. IRB Approval • Tobe approved-continued: – Informed consent will be appropriately documented – When appropriate, research plan must ensure continued safety of subjects – Where appropriate, provisions made to protect privacy of subjects and data – When working with subjects vulnerable to coercion, must consider added safeguards
- 18. Continuing Review • Forresearch continuing more than one year, an annual review is required • New standards under review: – Will probably require IRB monitoring of some clinical trials – Constant assessment of conflict of interest of the investigators
- 19. Informed Consent • Notneeded for exempt studies • Required for Expedited Review-but may be simplified for low risk studies • Rigorous consent for Full Review projects • May be waived by IRB for emergency Medicine research-controversial issue
- 20. Informed Consent • Consentmust address critical elements or points outlined by Federal Law • Consent signed by subject or legal representative and investigator • Subject must be given copy of consent • No exculpatory language may be used in the written consent
- 21. Basic Elements ofConsent • Explanation of purpose and duration • Description of risks • Description of benefits • Disclosure of alternatives to participation
- 22. Basic Elements ofConsent • Explanation of Confidentiality of Records • Who to contact regarding patient rights – For research with more than minimal risks, comment on compensation and care for injury • Right to withdraw without prejudice • Statement regarding unforeseen risks, especially to unborn child
- 23. Additional Elements forConsent • Statement that investigator may terminate patient participation • Information regarding any costs • Statement regarding consequences of withdrawing-especially for drug studies • Number of subjects in study
- 24. SEVEN REQUIRMENTS FORDETERMINING WHETHER A RESEARCH TRIAL IS ETHICAL REQUIREMENTS EXPLANATION Scientific Value Evaluation of a treatment, intervention or theory that will improve health and well being or increase knowledge. Scientific Validity Use of accepted scientific principles and methods including statistical techniques to produce reliable and valid data. Fair Subject Selection Selection of subjects so that individuals are not targeted for risky research. Favourable risk benefit ratio Minimization of risks, enhancement of potential benefits, risks to the subject are proportionate to the benefits to the subject and society. Independent Review Review of the design of the research trial Informed Consent Provision of information to subjects about purpose of the research, its procedures, potential risks, benefits and alternatives so that the individual understands this information and can make a voluntary decision whether to enrol and continue to participate. Respect for potential and enrolled subjects - Permitting withdrawal from the research. - Protecting Privacy. - Informing subjects of newly discovered risks and benefits. - Informing subjects of results of clinical research - Maintaining welfare of subjects.