1. 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 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. 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

3. 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.

4. 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.

5. 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.

6. 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

7. 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.

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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 – %
Educational level – 38%
Generation and utilization of new knowledge – IMR – 45%
Source: World Bank, UNDP 1998

15. 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

16. 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

17. 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

18. 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

19. 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