Validity, Specificity, and Reliability Of Informed Consent 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 Washington, D.C., U.S.A.

Informed Consent Definition Validity, Specificity, and Reliability Of Informed Consent Eliot 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

Validity, Specificity, and Reliability Of Informed Consent Eliot 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.

Validity, Specificity, and Reliability Of Informed Consent Eliot 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.

Validity, Specificity, and Reliability Of Informed Consent Eliot 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.

INFORMED CONSENT: DEFINITION Validity, Specificity, and Reliability Of Informed Consent Eliot 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

Their comprehension of the information Validity, Specificity, and Reliability Of Informed Consent Eliot 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.

Disclosure of Relevant Information Validity, Specificity, and Reliability Of Informed Consent Eliot 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

Disclosure of Relevant Information Validity, Specificity, and Reliability Of Informed Consent Eliot 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

Language intelligible by less than a high school graduate Validity, Specificity, and Reliability Of Informed Consent Eliot 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

Free of coercion, undue influence Validity, Specificity, and Reliability Of Informed Consent Eliot Sorel, M.D., D.F.A.P.A. Voluntary Agreement Free of coercion, undue influence Participant and/or authorized representative

Children, adolescents, adults, seniors General medical, psychiatric Validity, Specificity, and Reliability Of Informed Consent Eliot Sorel, M.D., D.F.A.P.A. SPECIFICITY Children, adolescents, adults, seniors General medical, psychiatric Research terminology

Universally applicable, culturally specific Outcome research Validity, Specificity, and Reliability Of Informed Consent Eliot Sorel, M.D., D.F.A.P.A. RELIABILITY Illness category Lifecycle stage Universally applicable, culturally specific Outcome research

Value of Medical Research: Validity, Specificity, and Reliability Of Informed Consent Eliot 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

Education, shelter, security, common goods Validity, Specificity, and Reliability Of Informed Consent Eliot 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

Social contract review and revision Validity, Specificity, and Reliability Of Informed Consent Eliot 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

Ethical Guidelines and Policy, continued Health: Availability Validity, Specificity, and Reliability Of Informed Consent Eliot Sorel, M.D., D.F.A.P.A. Ethical Guidelines and Policy, continued Health: Availability Accessibility Affordability Accountability Quality Satisfaction

Ethical Guidelines and Policy, continued United States managed care Validity, Specificity, and Reliability Of Informed Consent Eliot 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

Validity, Specificity, and Reliability Of Informed Consent Eliot 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