Research on Vulnerable Populations May 15 th , 2008 Alan Sanders, Ph.D.

1. Research on Vulnerable Populations May 15th, 2008 Alan Sanders, Ph.D. Director, Center for Ethics Saint Joseph’s Health System System Ethicist, Catholic Health East

2. Etiquette • Press * 6 to mute; • Press # 6 to unmute • Keep your phone on mute unless you are dialoging with the presenter • Never place phone on hold • If you do not want to be called on please check the red mood button on the lower left of screen

3. Overview • The nature of vulnerability • Types of vulnerability in research • Federal Regulations • Case Analysis • Cognitively Vulnerable

4. Vulnerable Populations • What is a vulnerable population? • Without adequate protection • Extremely susceptible to harm • Open to attack • Liable to increased penalties • Why concern for vulnerable populations?

5. Responsibility to Vulnerable Populations • ERD #3: • In accord with its mission, Catholic health care should distinguish itself by service to and advocacy for those people whose social condition puts them at the margins of our society and makes them particularly vulnerable to discrimination: the poor; the uninsured and the underinsured; children and the unborn; single parents; the elderly; those with incurable diseases and chemical dependencies; racial minorities; immigrants and refugees. In particular, the person with mental or physical disabilities, regardless of the cause or severity, must be treated as a unique person of incomparable worth, with the same right to life and to adequate health care as all other persons.

6. Types of Vulnerable Populations • Unborn • Prisoners • Economic/Social • Children • Developing Countries • Psychological

7. Cognitive Juridic Deferential Medical Allocational Infrastructural Unborn Prisoners Economic/Social Children Developing Countries Psychological Taxonomy of Vulnerability

8. Unborn • ERD #51 • Nontherapeutic experiments on a living embryo or fetus are not permitted, even with the consent of the parents. Therapeutic experiments are permitted for a proportionate reason with the free and informed consent of the parents or, if the father cannot be contacted, at least of the mother. Medical research that will not harm the life or physical integrity of an unborn child is permitted with parental consent.

9. Prisoners: Types of Research • Causes, effects, and processes of incarceration, criminal behavior • Prisons as institutional structures or of prisoners as incarcerated persons • Conditions affecting prisoners as a class • Practices that have the intent and probability to improve the health or well-being of the subject. • Title 45, Part 46, Subpart C

10. Prisoners: Special Protections • Coercion • Risks no more than accepted by non-prisoners • Fair selection • Information presented in understandable terms • Will have no effect on parole • Title 45, Part 46, Subpart C

11. Children • Research not involving greater than minimal risk. • Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. • Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. • Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. • Title 45, Part 46: Subpart D

12. Children and Assent • Solicit an expression of willingness to accept proposed treatment • Assess patient’s understanding and the factors influencing a response • Help patient achieve developmentally appropriate awareness of condition • Tell patient what they can expect

13. Case Analysis • Study of the cost effectiveness of lead abatement procedures in lower-income rental properties • 3 groups – less than full abatement • Function of level of abatement/cost • 2 control groups – either full lead abatement or no lead paint • 2-year period, measure and compare lead dust levels in children

14. Psychological • Capacity • Communicate a choice • Understanding • Appreciation • Reasoning

15. Recommendations - NBAC • Reviewing Bodies • Research Design • Informed Consent and Capacity • Categories of Research • Surrogate Decision Making • Education and Support

16. Common Themes Consent and Capacity Smaller risk/benefit ratio Concern for direct benefit Types of Vulnerability Unborn Prisoners Economic/Social Children Developing Countries Psychological Review

17. Resources • United States Department of Health and Human Services. Protection of Human Subjects. Title 45, Part 46. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm • National Bioethics Advisory Commission. Report and Recommendations on Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. http://bioethics.georgetown.edu/nbac/capacity/TOC.htm

18. Resources • American Academy of Pediatrics Committee on Bioethics. “Informed Consent, Parental Permission, and Assent in Pediatric Practice.” Pediatrics, 95, no. 2, 1995: 314-317