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Institutional Review Board: Philosophical, Regulatory and Organizational Principles

Institutional Review Board: Philosophical, Regulatory and Organizational Principles. Ralph Spiga, Ph.D. Organizational Behavioral Management and Educational Research, Associates. What are my objectives?. Overall, to review briefly what every IRB member should be aware of.

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Institutional Review Board: Philosophical, Regulatory and Organizational Principles

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  1. Institutional Review Board:Philosophical, Regulatory and Organizational Principles Ralph Spiga, Ph.D. Organizational Behavioral Management and Educational Research, Associates

  2. What are my objectives? Overall, to review briefly what every IRB member should be aware of. • Describe the social context that occasions increased emphasis on ethics. • Introduce philosophical concepts at the foundation of ethical/moral discourse. • Introduce the basic biomedical ethical principles at the foundation of the Belmont Report and their application to IRB functioning and research. • Describe the IRB Regulations and Guidelines which carry authority of rules and laws • Resources for guidance and direction, • Limits of IRB role and review process, • IRB Responsibilities for documentation. • Describe the recommendations submitted to the President of the United States by the National Bioethics Advisory Commission (NBAC) concerning research participation by persons with Mental Disorders. • Describe issues related to impaired decision-making capacity in prospective research participants. • Review.

  3. What are the implications and consequences? • Human Subject Protections Programs are currently under intense scrutiny. • Evaluation of IRBs reveal lack of institutional support for IRBs. • Lack of understanding rules by investigator, IRB member, and administrative staff. • Loss of public confidence in research • New mandates for investigator and IRB training.

  4. What is the social context for the emphasis on ethics?

  5. What is the social context for bioethics discourse? • Ecological Structure. • Economic/Technological Structure. • Political Structure. • Value Structure.

  6. What is ecological structure and its impact? • Definition: • Distribution of population across space & time. • Examples: • Aging “baby boomers”. • Increases in minority populations.

  7. What is economic/technological structure and its impact? • Definition: • Distribution of goods and resources among segments of the population. • Example: • 35 million uninsured • Increased international competitiveness. • Growth in economic strength of pharmaceutical companies.

  8. What is political structure and its impact? • Definition: • Distribution of power. • Examples: • Increased struggle for control of health care destiny by women, gays and minorities. • Increased federal & private sector collaboration. • Changes in administration of health care.

  9. What is value structure and its impact? • Definition: • Mores & norms of human groups. • Examples: • Belief in natural rights. • Belief in checks & balances (U.S. Constitution). • Assertion of religious principles. • Distrust of the biomedical research & health care community by minorities.

  10. What are the Philosophical Foundations of Research Ethics?

  11. What are the aims of Ethical Theory? • Content • What imperatives should order our actions? • Justification • How can these imperatives be justified? • Adjudication • What principle can be used to decide between conflicting imperatives?

  12. Some philosophical approaches to Research Ethics are… • Natural Law • Kant & the Categorical Imperative • Social Contract • Deontology • Consequentalism/Utilitarianism • Rights-based Approaches • Virtue-based Approaches

  13. Natural Law (Aristotle, Augustine, St. Thomas Aquinas, Locke)… • Definition: • Moral imperatives can be intuited through the exercise of reason. • Example: • Declaration of Independence - Thomas Jefferson.

  14. Categorical Imperative (Kant)… • Definition: • Principle of Universability: Only act in accord with principles that can be applied to all persons. • Example: • “Do unto others as you would have them do unto you.”

  15. Social Contract (Hobbes, Nozick, Rawls)… • Definition: • Natural state is pre-political & breeds insecurity. • People “contract” for mutual benefit & protection. • Example: • Veil of ignorance.

  16. Deontology (Biblical)… • Definition: • Constrains the means for pursuing the “good.” • Example: • Ten Commandments. • “Slippery-slope” arguments.

  17. Consequentalism (Hume, Mill, Bentham)… • Definition: • Every option has a prognosis. • Agent(s) value each prognosis. • Value attaches to option. • Example: • Policy analysis:Social good = max ∑welfare of others. • Game theory.

  18. Virtue Theory (Plato, Aristotle, St. Thomas Aquinas)… • Definition: • Focus on character. • “What person should I be?” vs “What ought I to do?” • Example: • Equipoise

  19. Emotivism (Stephenson, Logical Positivists)… • Definition: • Moral imperatives are claims by others stated as commands. • Example: • Marxist analysis.

  20. Casuistry (Jesuits, Toulmin)… • Definition: • Case-based reasoning. • Morphology, Taxonomy & Kinetics. • Example: • IRB functioning.

  21. Principlism (Beuchamp)… • Definition: • Extracted fundamental principles. • Principles guide considerations. • Example: • Belmont Report.

  22. What are the Principles of Biomedical Ethics? These are at the foundation of IRB functioning… • Respect for Autonomy • Nonmaleficence • Beneficence • Justice

  23. Respect for Autonomy… • Definition: Free from controlling interference by others & from personal limitations preventing choice. • Liberty - Independent of controlling influence. • Agency - Capacity for reflective action. • Health care considerations: • Express choice without coercion. • Assessment of decision -making capacity as prerequisite.

  24. Nonmalficence… • Definition: Obligation not to inflict harm or risk of harm. • Primum non nocere. - “Above all do no harm.” • Health care considerations: • Standard of due care: Risks require commensurate benefits. • Malpractice: Conduct below standard of due care.

  25. Beneficence… • Definition: Act for the benefit of others. • Health care considerations: • Weigh balance of costs and goods. • Conflict between Autonomy & Beneficence. • Imperium Paternale.

  26. Justice… • Definition: Concerns distributive justice, e.g., allocation of benefits and burdens. • Health care considerations: • Access to health care; health care budget. • Distribution of the burden of research risk and benefits in accord with ability to burden.

  27. The relations between ethics, morality, and research… The foundation of IRB reasoning!

  28. Every IRB Member should be familiar with: • Basic ethical principles of the Belmont Report. • Their application to reasoning about protocols. • Operational definition of an “ethical.”

  29. What is the relation between ethics and morality? • Ethics: The disciplined study of morality • Morality: What should one’s behavior and character be?

  30. What do we mean by descriptive ethics Descriptive ethics asks… • What are the moral beliefs and practices of - An individual - Groups of individuals - Institution - Society

  31. What is normative ethics? Normative ethics asks… • What ought morality do? • How should researchers behave? • How should researchers not behave? • What character traits should researchers cultivate as virtues? • What character traits should researchers avoid as vices?

  32. Where did it all begin? The Nuremberg Code • Nazi Doctors’ Trial • Supplement to Nuremberg Trials • Written as part of the judgment • Doctors Convicted of murder, not for being unethical researchers

  33. What did the Nuremberg Code say? • Informed consent essential. • Base research on prior animal work. • Justify by anticipated results. • Qualified scientists must conduct research. • Avoid physical and mental suffering. • No expected death or disabling injury.

  34. What were the defects of the Nuremberg Code? • No effect on research. • Medical profession thought it was: - Implicit to US researchers. - Document to convict Nazi doctors. • Problems with Nuremberg Code: - Created post hoc. - Missed many aspects of research.

  35. Then what… The Declaration of Helsinki • 1964 World Medical Association • Reinterpretation of Nuremberg • Provoked a reaction by medical profession • Journal editors required that research be performed in accordance with the Declaration

  36. Was the US ahead of the game…. No! The Beecher Article… • Beecher H.K. “Ethics and Clinical Research” NEJM June 16, 1966. • 22 studies performed unethically - Major journals. - Respected researchers. - Questionable study design. - No informed consent.

  37. The response… 1966 – All PHS supposed research must undergo prior review to • Protect rights and welfare of subjects • Assure appropriate informed consent • Determine acceptable risk/ benefit balance • Beginnings of the IRB

  38. So how will this familiarization with the process of ethical judgment help? • Provide a structure for analysis and decision making. • Avoid snap decisions. • Make better decisions.

  39. What are the types of ethical decisions? • Deductive – Principle - based reasoning • Inductive – Case - based reasoning

  40. Ethical Theory Principles Rules Particular judgments Ethical Theory Peace Violence never solves anything Refuse to join the army Principle - based Reasoning…

  41. Ethical Theory Principles Rules Particular judgments Ethical Theory Family I must protect my children Join the army Case - Based Reasoning…

  42. Ethical Theory Peace. Violence never solves anything. Refuse to join the army. Ethical Theory Family. I must protect my children. Join the army. Will ethical considerations always lead to agreement? No! ethical conflicts are the norm…

  43. What is the point…Coherence? • Ethical decision - making is both principle based and case based. • Conflict will always exists in ethical reasoning. • Strive for coherence between our principles and individual judgments.

  44. Some definitions… • Conservative: A liberal who has been mugged. • Liberal: A conservative who has been indicted.

  45. What principles are most relevant to the IRB review? • Respect for persons • Beneficence • Justice

  46. Respect for Persons.. • Treat individuals as autonomous agents. • Do not use people as a means to an end. • Allow people to choose for themselves. • Give extra protection to those with limited autonomy.

  47. Relevance of Respect for Persons to IRB review… • How can the consent process maximize autonomy? • How can the protocol maximize autonomy? • What additional protections can be in place for vulnerable populations? • How can the study maximally protect subject privacy?

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