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Ethical Guidelines on Experimentation with Human Subjects W.H.O./P.A.H.O. Meeting Santiago de Chile 15-17 October, 2003

Ethical Guidelines on Experimentation with Human Subjects W.H.O./P.A.H.O. Meeting Santiago de Chile 15-17 October, 2003. Validity, Specificity, and Reliability Of Informed Consent Eliot Sorel, M.D., D.F.A.P.A. The George Washington University School of Medicine, School of Public Health

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Ethical Guidelines on Experimentation with Human Subjects W.H.O./P.A.H.O. Meeting Santiago de Chile 15-17 October, 2003

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  1. Ethical Guidelines on Experimentation with Human SubjectsW.H.O./P.A.H.O. MeetingSantiago de Chile15-17 October, 2003 Validity, Specificity, and Reliability Of Informed Consent Eliot Sorel, M.D., D.F.A.P.A. The George Washington University School of Medicine, School of Public Health Washington, D.C., U.S.A.

  2. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. OUTLINE • Abstract • Informed Consent Definition • Validity, Specificity, Reliability Criteria • The Value of Medical Research • Ethical Guidelines: from the patient/physician dyad to national and global health care policy decisions

  3. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. ABSTRACT Primum non nocere – first do no harm has been part of the medical Hippocratic Oath since its inception. The rapid evolution of medicine, medical research, and the increasing transition from animal models to research with human subjects challenges the researcher, the clinician, the potential subject, and society, to assure adequate safeguards in protecting human subjects with valid, specific, and reliable criteria for informed consent.

  4. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. ABSTRACT, continued The author hypothesizes that, as these criteria are the gold standard for medical research methodologies, so they must become for informed consent procedures. Such standards enhance the quality of informed consent, and augment the protection of human subjects.

  5. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. ABSTRACT, continued Furthermore, the author postulates that ethical guidelines generated in the patient/doctor experimentation relationship may be relevant to national and global health care policy experiments and initiatives. As individual subjects need the protection of informed consent, so do populations. The challenge to educate the public, the media, the professions and the next generations.

  6. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. INFORMED CONSENT: DEFINITION Consent [permission] by a patient to a surgical or medical procedure or participation in a clinical study, after achieving an understanding of the relevant medical facts [the benefits] and the risks involved. - American Heritage Dictionary, 4th Edition, 2000

  7. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. VALIDITY • Disclosure of relevant information to prospective subjects, about the research • Their comprehension of the information • Their voluntary agreement, free of coercion and undue influence - Source: NIH Office of Human Subject Research 2000 -Signing the document, on-going discussion and process.

  8. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. Disclosure of Relevant Information • Purpose of the study • Research, tests, or procedures • Research drugs or other treatments • Risks, discomforts, and benefits • Alternative choices to the study

  9. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. Disclosure of Relevant Information continued • Financial aspects • Withdrawal option • Confidentiality • Who else is involved • Sharing of outcomes

  10. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. Comprehension • Language intelligible by less than a high school graduate • Headings and brief sentences • Include all basic elements for informed consent • Pregnancy, fertility, or child-bearing concerns included

  11. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. Voluntary Agreement • Free of coercion, undue influence • Participant and/or authorized representative

  12. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. SPECIFICITY • Children, adolescents, adults, seniors • General medical, psychiatric • Research terminology

  13. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. RELIABILITY • Illness category • Lifecycle stage • Universally applicable, culturally specific • Outcome research

  14. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. Value of Medical Research: Chile’s Example • Marked mortality decline- F 33 to 78 • Income – 17-20 % • Educational level – 38% • Generation and utilization of new knowledge – IMR – 45% Source: World Bank, UNDP 1998

  15. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. Ethical Guidelines: from the Patient/Physician dyad to national and global health care policy decisions • Education, shelter, security, common goods • Health Outcomes shared responsibility • Professionals • Individuals • Families • Society

  16. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. Ethical Guidelines and Policy, continued Social contract review and revision • Health • Human development • Economic development • Research • Poverty reduction

  17. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. Ethical Guidelines and Policy, continued Health: • Availability • Accessibility • Affordability • Accountability • Quality • Satisfaction

  18. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. Ethical Guidelines and Policy, continued • United States managed care • A population “experiment” • No proven validity and reliability criteria • Promised cost-saving specificity • Business Ethics vs. Medical Ethics

  19. Validity, Specificity, and ReliabilityOf Informed ConsentEliot Sorel, M.D., D.F.A.P.A. Ethical Guidelines and Policy, continued Future directions • Health care policy validity, specificity, and reliability criteria • Populations’ informed consent • Individual and populations complementarity, outcomes research • Educating the public, media, policymakers professions, next generations

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