1. path An Introduction to Ethical Reasoning EATG Ethics Training December 8-9, 2005

2. path Origin of Biomedical Ethics

3. path What is Biomedical Ethics? F Ethics is a branch of philosophy that attempts to assist us in deciding what is right and wrong in human conduct F Ethical reasoning takes place whenever there is a need to provide moral reflection on a specific action or behavior, such as a research project or a procedure F The term “bio-medical ethics” was coined in the early 1970s to refer to the application of moral reasoning to vexing questions at the frontiers of biology and medicine

4. path The Evolution of Research Ethics F Ethical review and bio-medical ethics evolved in response to a history of medical abuses –Medical abuses by Nazi doctors (Nuremburg Trial and code of 1947) –Public revelation of the Tuskegee syphilis study in 1974 F These abuses prompted the creation of a series of norms, guidelines, and regulations to help guide the conduct of research

5. path The Evolution of Research Guidelines Nuremberg Code Declaration of Helsinki WHO/CIOMS 1947 1964 1993 UNAIDS Vaccine Guidance 2000 European Commission Directive Uganda India Brazil 2003

6. path Limitations of Existing Guidance F Most have only persuasive force and are enforceable only via sanctions imposed by the professional association that created them F Some have been enshrined in national laws (e.g. US Policy for the Protection of Human Subjects, Ethics Law in Denmark, Brazil and Uganda) F Several take conflicting positions F Few take into account the special circumstances that characterize externally sponsored research in developing countries (p. 54 Nuffield Council).

7. path Ethics Committees: Review of Research F “Ethical review” is now a standard part of approval for most publicly funded scientific research involving human beings F Primary role is to protect people participating in research –Scientific design and conduct of study –Care and protection of research participants –Community participation –Appropriate of informed consent –Confidentiality issues

8. path The Art of “Doing Ethics” The Art of “Doing Ethics”

9. path Principles of Research Ethics F Research ethics rests on a set of fundamental ethical principles F These principles are the most fundamental unit of ethical analysis – all norms and guidelines derive from them F Nonetheless, like constitutions, ethical principles and guidelines need interpretation and debate F Different ethical principles can at times be in conflict F Ethics is not a formula, but a process of reflection and weighing of choices

10. path Ethics is a process Not a rule F How decisions are arrived at is ethically relevant F Different conclusions may result from different ethical reviews of the same issue or proposal and each conclusion may be ethically reached F A conclusion is ethical not merely because of what has been decided but also because of the process of conscientious reflection and assessment by which it is reached F Whose voice is represented in the debate is also important

11. path Core Ethical Principles Belmont Report (1978) –Respect for Persons Autonomy Protection of vulnerable or persons with diminished capacity –Beneficence Maximizing benefits Minimizing harms –Justice

12. path Respect for Persons F Autonomy, self-determination –Those capable of deliberation should be treated with respect for their capacity for self determination –Underlies requirement for “informed consent” F Special measures for the vulnerable –Those whose decision-making capacity is impaired or diminished due to intrinsic factors or circumstance

13. path Beneficence F Maximize possible benefits F Minimize possible harms or wrongs F This principle gives rise to norms requiring: –On balance, the research should generate more good than harm –Risks of research to be reasonable in light of the expected benefits

14. path From Protectionism to Access F Traditionally, much of the debate over “beneficence” has focused on protecting research participants from harm F But a second major reason for ethical review is to ensure equitable distribution of the potential benefits of research F During the 1980s, emphasis in global ethics discourse shifted from concern with the potential harms of research to a demand for greater access to its benefits.

15. path Justice F People should receive what is due to them F Benefits and risks of research should be fairly distributed F Research participants and sites should be fairly selected

16. path An alternative Articulation of Core Ethical Principles F The duty to alleviate suffering F The duty to show respect for persons F The duty to be sensitive to cultural difference F The duty not to exploit the vulnerable or less powerful Nuffield Council on Bioethics (2002)

17. path Duty to Alleviate Suffering F The duty to alleviate suffering enjoins us to do what we can to reduce the amount of suffering in the world. F The more suffering we help to eliminate, the better our action F Acknowledging the duty, however, does not mean that it overrides all other claims F In situations were resources are limited, the challenge is to strike an acceptable balance between competing demands

18. path “ Ought” implies “Can ” F A person’s duty to benefit another is related to his or her capacity to do so, whether financial or practical. –If a benefit cannot be provided for reasons of practical constraint, the duty to do so is weakened. –Conversely, if a country’s wealth allows it to confer a benefit on the inhabitants of another country, the wealthier country has a stronger duty to provide that benefit.

19. path “Can” implies “should” “ If it is in our power to prevent something bad from happening without thereby sacrificing anything of comparable moral importance, we ought morally to do it.” Peter Singer, Philosophy and Public Affairs 1972:1:229-43

20. path Informed Consent is a process F Informed consent is a process of collaborative communication and decision making, not the signing of a form F Informed consent requires that prospective participants: –Be appropriately informed about the nature of the research –Adequately understand this information and its implications –Voluntarily decide to participate, without coercion –Explicitly consent to participate, orally or in writing

21. path Legal and moral agenda can sometimes conflict Indemnify the research institution Facilitate collaborative decision making VS. Length of forms Degree of technical information imparted Written versus oral consent Emphasis on right to withdraw

22. path Therapeutic Misconception F “Therapeutic misconception” refers to the tendency of some research participants to wrongly assume that whatever drug or intervention they are offered must work or be beneficial (or why would it be offered?) F It occurs when the goals of research and those of therapy or “health care” become confused in the participants mind. F The therapeutic misconception is a major threat to “informed consent.”

23. path Putting it all together: What makes research ethical?

24. path What Makes Research Ethical? F Social or scientific value F Scientific validity F Fair subject selection F Favorable risk-benefit ratio F Independent review F Informed consent F Respect for potential and enrolled subjects F Collaborative partnership Emanual et al., JAMA, 283, 2000

25. path Seven Steps for Ethical Research 1. Priorities: Did the study address a priority issue? Whose? 2. Planning: Was the study well designed to optimize the chances of generating useful knowledge and protecting subjects? 3. Permission: Was the project reviewed and cleared by the relevant institutions? Did the investigators obtain informed consent? 4. Performance: Was the study conducted in a way that respected the rights of the subjects and minimized the risks to them? 5. Processing: Were the results correctly analyzed and interpreted? 6. Publication: Were the results published and disseminated? 7. Programming: Have the findings been translated to policy and action?