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Kusum Verma A.I.I.M.S. New Delhi

ETHICAL ISSUES IN HEALTH RESEARCH. Kusum Verma A.I.I.M.S. New Delhi. WHY - CONCERN. Research essential for advancement of scientific knowledge. Newer technologies & treatments. Require participation by human subjects.

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Kusum Verma A.I.I.M.S. New Delhi

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  1. ETHICAL ISSUES IN HEALTH RESEARCH Kusum Verma A.I.I.M.S. New Delhi

  2. WHY - CONCERN • Research essential for advancement of scientific knowledge. • Newer technologies & treatments. • Require participation by human subjects. • Essential that rights of research participants are protected as public willingness to participate depends on a trust that research is conducted according to strict ethical standards.

  3. Historical Perspectives • Nuremberg trial (1946) – 23 Nazi physicians • Crimes against prisoners of war • mutilating surgeries; • infections with lethal pathogens; • exposure to extremes of temp. • Nuremberg Code (1947) – fundamental ethical code • Voluntary informed consent • Scientifically valid research design

  4. Misuse of Research • Japanese war crimes • Us radiation experiments • Tuskegee syphilis studies • Willowbrook studies on hepatitis in Institutional children

  5. Historical Perspectives • World Medical Association (1964) – Declaration of Helsinki : Recommendations guiding medical doctors in medical research involving human subjects. • Revised – 1975, 1983, 1989, 1996, 2000

  6. Historical Perspectives • Council for International organisations of Medical Sciences (CIOMS) and WHO (1982) – International ethical guidelines for biomedical research involving human subjects • Revised – 1993, 2002 • International conf. Harmonisation – Good clinical practice (ICH-GCP)-1996) • International ethical and scientific quality standard for designing, conducting, recording and reporting trials involving human subjects.

  7. Landmark article on US abuses –Beecher (NEJM, 1966) • Front line research in medical schools and major medical journals • Dangerous research • No or little benefit to patient • No informed consent

  8. Ethical Principles • Belmont Report (1979) • Established three fundamental ethical principles relevant to all research involving human subjects. • Principles • Respect for persons • Beneficence & Non-male ficence • Justice & Equity

  9. Guidelines in India • ICMR - `Policy statement on ethical considerations involved in Research on human subjects’ (1982) • `Ethical guidelines for Biomedical research on Human subjects’ (2000) • ?Legislation • DBT-guidelines for genetic research (2002)

  10. Concern of all guidelines is to protect and respect rights and welfare of human subjects as participants in research. • OHRP – Office for Human Research Protections.

  11. Human beings have equal worth; their lives are equally valuable; and they deserve equal respect. We may not treat them as worthless, use them as mear means to our ends; misinform them; increase their risks of becoming ill or die; violate the integrity of their intimate relationships and treat with contempt what they deeply value.

  12. Respect for Person • Self determination • Individuals treated as autonomous agents • Enters into research VOLUNTARILY and with adequate information – INFORMED CONSENT. • Persons with diminished autonomy are entitled to protection

  13. Diminished/Reduced Autonomy • Impaired decision making capacity • Prisoners • Students • Subordinate Employees • Services personnel • Adequate justification for their involvement as research subjects

  14. Informed Consent - Elements • Information • Patient/subject information sheet • Comprehension • Simple and understandable language • Local language translations • Voluntariness • Consent

  15. Patient/Subject Information • State & Describe • Nature & purpose of study • Duration of participation • Procedures to be followed • Experimental procedure, if any, to be identified • Describe – reasonably forseeable risks & discomforts • Describe – benefits to • Subject • Community/others • Medical professionals Contd…

  16. Patient/Subject Information • Explain if project involves more than minimal risk • Policy on compensation • Availability of medical treatment for such injuries • Disclose – alternative procedures or treatments • Describe – steps for insuring confidentiality • State • Voluntary participation • No loss of benefits on withdrawal • Explain - whom to contact for questions on more information or in case of injury Contd…

  17. Patient/Subject Information • Studies involving DNA Banking/Genetic material • Right to prevent use of his/her biological sample (DNA/cell line) at any time during conduct of research.

  18. Patient/Subject Information • Disclosure to patient should be continuous • New knowledge must be informed as and when available.

  19. Patient/Subject Information • Incomplete disclosure-justified • Truly necessary to accomplish the goals of research • No undisclosed risks to subjects that are more than minimal • There is adequate plan for debriefing subjects, when appropriate; and for dissemination of research results to them

  20. Patient/Subject Information • Information about risks be never witheld • Truthful answers be always given to direct questions

  21. Informed Consent • Consent valid only for research for which it is given by participant (Primary use). • Information/samples to be used for other purposes or sharing with other investigators (secondary use)-clear mention made during process of obtaining informed consent • New consent needed for any use for which consent not obtained explicitly • Consent not needed-unidentified/unlinked samples.

  22. Informed Consent • Community studies – Consent needed from • Community – group consent • Individuals • Children • Parent/guardian • Assent of child to his/her capability • Mentally Ill • Close biological relative • Legally authorised person • Certificate from psychiatrist • Illiterate persons • Who explains • Thumb impression • Videotape

  23. Informed ConsentGenetic Studies • Necessary & to be taken before • Screening (except mandatory newborn screening). • Diagnostic genetic testing • Treatment • Research • Written consent not necessary for procedures that form part of routine care.

  24. Genetic Databases • Source • Family Hx/Pedigree • Phenotype studies • DNA/RNA/Protein sequence • Samples • Identified • Annonymous • Deidentified (code stored separately)

  25. Genetic Databases • Not to be collected for use • Discrimination • Pursuing eugenics • Appropriate ethical approval mechanism needed to oversee creation and maintenance of genetic databases

  26. Informed Consent DNA Banking • Inform Donors/Patients • Conditions under which samples will be provided to other researchers • How long samples will be preserved • Cost to individual researcher to obtain sample from repository • Commercial benefits – donor, sample collector & repository director

  27. Informed Consent DNA Banking • Donor to have right to order destruction of his/her sample from repository at any time. • Fresh EC clearance for secondary use of material from DNA bank

  28. Informed Consent Transplantation • Cadaveric Donors • By person in lawful possession of the body • Living will • Live Donors • By donor • Interest of donor to take priority over that of the recepient • Children, mentally incompetent persons, persons with restricted patient autonomy – not as donors

  29. Informed ConsentFetal & Embryonic Tissue Transplants • Consent from mother sufficient, unless father objects in writing • Mother’s consent • 2 stages • For abortion • For donation of fetal tissue

  30. Informed ConsentFetal Tissue Transplants • Tissue from aborted fetuses can be cultured and banked for use in research. • Fresh EC clearance for use of stored tissue in research • Fetal tissue transplant in humans • Approval local EC • National/Central EC

  31. Informed Consent-Waiver • May be considered in conditions of emergency if study or use of drug has been earlier approved by EC. • Patient/guardian be informed after he/she regains consciousness or is able to understand the study.

  32. Informed Consent Written or Oral

  33. Confidentiality • EC-How ensured? • Special value in genetic studies & research; and genetic databases. • Indiscriminate disclosure of data may lead to • Psychosocial harm • Stigmatisation • Discrimination • Family members not entitled to know each others diagnosis/test results • Consent to be obtained specifically for revealing information to other family members. • Codification of biological samples.

  34. Confidentiality Vs. Beneficence & Harm

  35. Risk-Benefit Ratio • Risks of research be acceptable in relation to likely benefits • Risks • Physical harm • Psychosocial • Discrimination • Stigmatisation • Breach of confidentiality • Risks can be reduced by screening potential participants and monitoring participants for adverse events.

  36. Risk-Benefit Ratio • Essentiality of research – should lead to advancement of knowledge for the benefit of all members of human species • Research design is sound • Research conducted by professionally competent persons.

  37. Research Related Injury • Inbuilt mechanism for compensation/treatment of unforseeable risks • Treatment – best possible treatment in the country.

  38. Compensation to Participants • No inducements to participate in the study • Investigator may provide for • Cost of travel to hospitals • Various visits • Mandays lost for above visits • Inbuilt mechanism for all foreseeable and unforseeable risks due to research-provide for remedial action. • Insurance cover/other mechanism • All payments, reimbursements to be approved by EC

  39. Justice & Equity • Requires that benefits & burdens are distributed fairly. • Subjects for research selected in a way that burdens and benefits of the research are distributed without arbitrariness, discrimination or caprice. • Economically or socially disadvantaged subjects not to be used to benefit those who are better off than them.

  40. Justice • Vulnerable populations • With poor access to health care • With impaired decision making capacity • Residents of old age/nursing homes • Prisoners • Students • Service personnel • Adequate justification for involvement as subjects • Should not be targeted if other populations would also be suitable

  41. Special Groups- Research Subjects • Pregnant/Nursing women • Only if objective of research to obtain new knowledge about foetus, pregnancy and lactation; and research carries no more than minimal risk to the fetus or nursing infant.

  42. Special Groups- Research Subjects • Children • Not to be involved in research that could be carried out equally well with adults. • New drug trial – in children be carried out after Phase III clinical trials in adults. • New drug trial can be carried out in children only if the drug has a therapeutic value in a primary disease of the chilrdren.

  43. Mandatory that all proposals on biomedical research involving human subjects are cleared by the institutional ethics committee. • Rationale is “that an objective review of research activities involving human subjects by a group of diverse individuals is most likely to protect human subjects and promote ethically sound research”.

  44. Ethics Committee - Role • Watch dog • To adequately protect rights & welfare of human subjects in clinical research. • Committee is “patient’s advocate”. • EC helps and guides but does not give orders • Educate faculty members on principles of biomedical ethics

  45. IRB/EC-Composition • Multidisciplinary and multisectorial • Independent • Competent • Number - 5-10 • - 12-15 max. recommended • Quorum • Chairperson – 0utside institution • Member-Secretary – Same institution

  46. IRB/EC-Composition • Membership • Medical & non-medical • Scientific & non-scientific • Legal expert • Social scientist • Philosopher/ethicist • Lay person • Adequate representation of age, gender, community etc. to safeguard the interests and welfare of all sections of community/ society.

  47. Practice Vs. Research • Practice – “interventions that are designed solely to enhance the well-being of an individual patient that has a reasonable expectation of success” • Research – “activity designed to test an hypothesis’ permit conclusions to be drawn; and thereby develop or contribute to generalizable knowledge”. • Distinction blurred as both often occur together • Like when research is designed to evaluate safety and efficacy of a therapy. • If any element of research in an activity – should undergo review.

  48. IRB Review-Exempt. Research • Research on normal educational practices. • Study of existing records, data, documents, pathological specimens or diagnostic specimens • If publicly available • If information recorded in such a manner that subjects cannot be identified directly or through identifiers linked to subjects.

  49. IRB Review – Exempt Research • Educational tests, survey procedures, interview procedures or observation of public behaviour unless • Human subjects can be identified directly or indirectly • Disclosure of subjects responses could place them at risk for legal liability, damage financial standing, employability or reputation.

  50. ? Exemption • Collection and study of • Samples from deceased individuals • Samples collected for diagnostic purposes. • Samples or data available from commercial or public repositories or registries • Established cell lines publicly available to qualified investigators. • Self sustaining, cell free derivative preparations – viral isolates, cloned DNA or RNA.

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