Overview of Introduction

1. Overview of Introduction �Ethics and Compliance: Competing or Complementary Approaches?� In Ethical Research in Mental Health James M DuBois, PhD, DSc

2. Why Focus on Research Ethics in Behavioral Health? History: Difficulty of finding effective tx; severe nature of exp tx.s; lack of informed consent; lack of input from consumers Intrinsic: Obstacles to informed consent � e.g., cognitive impairments; financial need Heightened risks: loss of employment, suicide, stigma

3. Current Environment of Research Ethics Risk management approach to research ethics � reaction to shut downs and deaths Remediation of shortcomings typically at level of IRB IRB as profession and industry Mandated training focuses on regulatory compliance � not real ethics training Federally sanctioned framework for ethics ironically pre-empts serious ethical analysis

4. Historical Antecedents Willowbrook (discussed in case) Tuskegee syphilis trial: 1932-72 Over 400 subjects; 200 controls Studied course of untreated syphilis Informed consent was deceptive and unduly influential (said they had �bad blood�, offered high incentives, free medical �care�) Penicillin withheld even after determined effective Secondary health problems not treated PHS did not respond to criticism; expos� in 1972

5. Reactive Regulations Response: 1974: DHEW issued regulations (NIH�s policies) 1974: Congress created National Commission for the Protection of Human Subjects� Focus was on protections Regulatory approach trumped arguments for self-regulation, educational approach, and tort approach (civil courts, trial law)

6. Regulations Can�t Replace Ethics Strengths: Can change some behaviors Moral statement by government Weaknesses: Slow to adapt to needs of people (e.g., justice) Sets only minimum standards Oversight is limited Expertise is limited Shifts focus away from respect for participants Content of regulations can be bad

7. Overview of Chapter One An Ethical Framework for Research

8. Are There Transcultural Principles? The problem: Some at PHS thought Tuskegee was unobjectionable Krugman always defended Willowbrook � and many agreed with him Justification of paternalism in consent process appealed to evolution in thinking Additionally, we hear about how inadequate US rules are in international research

9. The Belmont Principles Attempt to identify principles applicable to all human subjects research Respect for persons: respect autonomous choices; protect those lacking autonomy Beneficence: do not harm; maximize benefits, minimize harms Justice: fairness in distribution; treat equals equally

10. Belmont Principles: Applications Respect for persons implies: obtain informed consent; extra protections for those who are not self-determining Beneficence implies: minimize risks, conduct risk/benefit assessment Justice implies: recruit subjects to distribute benefits and burdens evenly; don�t target the vulnerable for convenience

11. Are the Belmont Principles transcultural? What justification was offered for the principles? �three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research �� Problematic: No claim to being transcultural; bad cultural norms can also be widely accepted; our society is culturally diverse; and we do international research

12. Humanizing the Principles Assumption: we ought to work with 4 principles for reasons Beauchamp & Childress (B&C) give Why humanize the principles? To provide a foundation that � Shows the principles aren�t arbitrary � explains why common morality has embraced them Reminds researchers of the humanity they share with participants Provides a transcultural foundation � shared human nature

13. The Mother of All Principles Respect for human beings Respect = showing regard for the worth of someone or something Worth or dignity of persons does derive from our nature as rational and self-determining But � We�re all human even if more or less actualized Respect cannot be reduced to respecting only the rational, self-determining aspect of us

14. The 4 Principles Humanized Autonomy: respect for humans as rational and self-determining Beneficence: respect for humans as finite and in need of basic goods Non-maleficence: respect for humans as vulnerable to harms Justice: respect for the equal worth of all humans

15. Limits of principles Strengths: Reminds us of key dimensions of person that deserve respect; provides language and framework for discussion Weaknesses: Principles can conflict Principles can be interpreted differently Case approach will introduce a justification method for resolving conflicts

16. Rights Talk Regulations speak of protecting rights; does not clarify what rights are Rights = statements of obligations other have toward us (whether legal or moral) Problem with IRBs considering non-legal rights: vague � anyone can claim them IRBs may consider more than legal rights, but then they go beyond regs, and should offer arguments

17. Virtues Remind us of the importance of intentions E.g., getting a signed consent form to comply vs. getting genuine informed consent out of respect Introduces idea that some character traits are needed to live according to principles Examples of professional virtues for researchers: honesty, intellectual humility, competence, trustworthiness But we can�t derive what is right from virtues; need principles

18. Ethical Process Both content and processes matter Two key process issues Oversight Inclusion

19. IRB Oversight IRBs provide review of regulatory requirements: risk/benefit analysis; justice in recruitment; consent; confidentiality; safety monitoring Additional oversight: ongoing review, may observe consent process, may review ongoing safety; may halt studies

20. Community Partnerships May enhance ethics of a study: Show respect, clarify desired benefits and risks of concern May enhance quality of study Design, recruitment and retention But may also introduce challenges to scientific integrity and a new political element Must be aware of limitations and correct each other in process of dialogue