Research Ethics: a Philosophical Perspective. Dr. Alexandra Couto Lecturer in Philosophy University of Kent

Transcription

1 + Research Ethics: a Philosophical Perspective Dr. Alexandra Couto Lecturer in Philosophy University of Kent

2 + Research Ethics: a Philosophical Perspective What are the ethical principles that ought to guide our research? What are the ethical foundations for these ethical principles? How do different moral theories help us interpret the principles of research ethics? Focus on clinical research ethics

3 + Outline of the Talk I. Introduction II. III. Moral Theories: A Brief Introduction Consequentialism and its critics Deontology and its critics Three core principles of research ethics and their relationship to consequentialist and deontological ethics.

4 + Instances of Unethical Research Nazi doctors during the Second World War placing healthy innocent people in freezing water until they froze to death. The Tuskegee syphilis study ( ) The Willowbrook study ( s)

5 + Various Bodies Regulate Clinical Research Ethics in UK Research involving human participants should be clearly formulated in an experimental protocol and reviewed by a committee independent of the researcher. Royal College of Physicians British Medical Association Medical Research Council Common law: Human Rights Act 1998, the Human Tissue Act 2004, the Mental Capacity Act

6 + Core Ethical Principles of Research Ethics 1. The rights and dignity of individuals and groups should be respected (ESRC) 2. Research should aim to maximise benefit for individuals and society and minimise risk and harm (ESRC) 3. Whenever possible, participation should be voluntary and appropriately informed (ESRC)

7 + Moral Theories: An Introduction

8 + Features of a moral theory A moral theory is normative: it generates moral norms or standards that guide our actions. Three main features : 1. Systematic: it has to be consistent and coherent 2. Composed of moral rules and principles 3. Comprehensive: it can be applied to thousands of different situations that we might find ourselves in.

9 + Three different moral theories Deontology Certain actions that are intrinsically right or intrinsically wrong, and it is our duty to perform them or avoid them. Consequentialism Right acts are defined as those that promote the good (however the good is defined). Virtue ethics Virtue ethics argues that we ought to do as a virtuous person would do. But virtue ethics doesn t give us principles

10 + Consequentialism Consequences of our actions determine whether our actions are right. The right is defined as what maximizes the good. Maximising: we should make the world as good a place as it can be. Different possible theories of good: Hedonism, preference-satisfaction and objective list theory of well-being

11 + Utilitarianism: One version of consequentialism Actions are right in proportion as they tend to promote happiness; wrong as they tend to produce unhappiness. J.S. Mill

12 + Trolley Cases

13 + Peter Singer: Famine, Affluence and 13 Morality (1972) Peter Singer: Famine, Affluence, and Morality (1972) We should give substantive amount of what we have to the global poor. By sacrificing comparatively little, you can make a big difference and save lives.

14 + Objections to Consequentialism

15 + Trolley Cases

16 + The Transplant Case

17 + 1. Rights Fails to respect individual rights Separateness of persons (John Rawls) Response: Rule-Consequentialism: an action is morally right if and only if it conforms to that set of rules that, if generally followed, would result in the best consequences overall.

18 + 2. Demandingness According to maximizing act-consequentialism we are always required to do as much as we possibly can to make the world as good as possible But that is too demanding! Maximising the good isn t promoted by most of our daily activities.

19 + 3. Not Enough Partiality Bernard Williams: One Thought Too Many

20 + Deontological Ethics

21 + Deontological ethics Certain actions are right and others are wrong whatsoever their consequences. Derives from the Greek word for duty (deon) and science or study of (logos). Common Sense Morality Christian ethics Kantian ethics

22 + Kantian ethics What makes a choice right is its conformity with a moral norm. The Formula of the Universal Law of Nature: Act only according to that maxim [principle] through which you can at the same time will that it become a universal law. On Kant s view, lying is always wrong. Not using others as mere means to ones ends (Kant 1785). Agents are ends in themselves. Key concepts: dignity, rationality and autonomy.

23 + Doing and Allowing The distinction between active euthanasia and passive euthanasia. In commonsense morality: contrast the wrongness of killing someone with the permissibility of not giving to charities that help the global poor.

24 + Advantages over Consequentialism Better accommodates many intuitions: e.g. transplant. But this could also be addressed by endorsing some form of rule consequentialism. It leaves space for agents to give special concern to their families, friends and projects (at least if it doesn t contain strong duty of general beneficence).

25 + Objections to Deontological Ethics

26 + Objections to deontological ethics Strict deontologists would refuse to kill one person to save ten thousands people. If you think that you ought not to kill, it is presumably because death is bad. But then if death is bad, why not try to minimize the number of deaths overall? Recall One Thought Too Many: it is still a problem if you are saving your spouse from duty!

27 + Doing vs Allowing: Is it worse to do harm than to allow harm? Rachels (1975) puts into question the distinction between killing and letting die: Both Smith and Jones will gain a large inheritance if their sixyear old cousin dies. Smith sneaks into the bathroom while his cousin is having a bath and drowns the child Jones sneaks into the bathroom sees the boy slip, hit his head and fall face down in the water. Jones stands by the bath-tub waiting until he is sure the child has drowned.

28 + Core Principles of Research Ethics

29 + Core Ethical Principles of Research Ethics 1. The rights and dignity of individuals and groups should be respected (ESRC) 2. Research should aim to maximise benefit for individuals and society and minimise risk and harm (ESRC) 3. Whenever possible, participation should be voluntary and appropriately informed (ESRC)

30 + 1. Rights The rights and dignity of individuals and groups should be respected (ESRC) Nuremberg Code awarded directly rights to research participants. The declaration of Helsinki (World Medical Association 2000) states: In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society The Research Ethics Service and Research Ethics Committee (NHS) protects the rights, safety, dignity and well-being of research participants and to facilitate and promote ethical research

31 + Rights Deontological ethics can provide a normative account of the value of rights. Simple act-consequentialism can t provide a normative account of the value of rights. But rule-consequentialism can do.

32 + 2. Maximise benefits and minimise harm Research should aim to maximise benefit for individuals and society and minimise risk and harm (ESRC) Any risks to participants are in proportion to the potential benefit. Risks, pain or discomfort must always be kept to a minimum. Kent University Research Services Research ethics checklists include almost always questions pertaining to how the research will add to existing knowledge risk assessment analysis

33 + Maximise benefits and minimise harm Human tests of a medical intervention typically pose some risks of harm to subjects no matter how many laboratory and animal tests have preceded them. Minimising harm requires assessing risk: the probability of the harm and the degree of harm. Risks: death, disability, pain but also information risks When is it ethically permissible to expose research subjects to risks of harm for their own benefits? When is it ethically permissible to expose research subjects to risks of harm for the benefits of others?

34 + Maximise benefits and minimise harm The risk /benefit profile of the treatment might be as favorable to subjects as the risk /benefit profile of available alternatives Or the participation in research poses net risks, that is risks of harm which are not or not entirely justified by potential clinical benefits to individuals subjects.

35 + Maximise benefits and minimise harm The guidelines markedly restrict the degree of risk that competent adults can take voluntarily when participating in medical research. Contrast with sports (Savulescu and Hope). Within the acceptable limits of risk, some trade-offs allowed between risk to participants and the value of research to those in the future.

36 + Maximise benefits and minimise harm This principle can be seen as reflecting a consequentialist view but could also be seen as giving weight to both consequentialist and deontological considerations. Differences in the interpretation of the principle: Consequentialists would recommend greater risks of harm for the sake of other people that would be treated in the future. From a deontological view, you have rights not to take beyond the minimum amount of risks (otherwise you might be treated as a mean). Current way of assessing risks in clinical research ethics seems to point to a very conservative approach to risks, closer to a deontological interpretation than a consequentialist one.

37 + Illustration: Thrombolytic drug trial Gold standard of clinical research: thrombolytic drugs improved outcome after heart attack. 1982: first analysis pointed out that thrombolytic drugs very likely reduced the rate of death after heart attack. A very large trial was designed to test one version of these thrombolytic drug: GISSI trial. Confirmed that these drugs reduced mortality by 18 percent with a statistical certainty of p= While the GISSI was on, another trial was commenced (1988): ISIS-2. Placebo given to half of the patients. Over the span of ISIS-2, 238 more deaths occurred in the group receiving placebo over the thrombolytic drug.

38 + Illustration: Thrombolytic drug trial When should we withdraw patients from the trials? We should withdraw when. we know the right answer? Only probability at the point that would lead to the best outcome (fewest death overall) taking both trial subjects and future patients into account? as soon as there is reasonable minimum evidence that one drug is better? when the clinician decides? when the patient decides?

39 + 3. Voluntary Informed Consent Whenever possible, participation should be voluntary and appropriately informed (ESRC) Nuremberg Code of research ethics: The voluntary consent of the human subject is absolutely essential. Declaration of Helsinki, principle 22: The physician should obtain the subject s freely-given informed consent, preferably in writing.

40 + Consequentialist Justification Simplest rationale: it protects patients and participants health and welfare. Research participants are the best judges of what is good for them (protection from investigators zealous attempts and paternalism). But. Why honor informed consent requirements when they aren t for the best interests of the patients? And why honor the requirement when it imposes setback on the development of a new drug in the future?

41 + Deontological Justification Respect for autonomy: predominant justification of informed consent. Kantian spirit: Recognition of every human being as having a unique dignity as human, and as therefore being an end in every relation in which others may morally stand to him, entails that no human being may legitimately be interfered with in pursuing his conception of his happiness in whatever way seems best to him. (Donagan, 1977)

42 + Informed consent can clash with minimising harm Jesse Gelsinger was an 18 year old man with a mild form of ornithine transcarbamylase (OTS) deficiency which could be controlled by diet and drug treatment. A more severe form of the disease occurs in the newborn which is normally lethal. Gelsinger was recruited into a trial of gene therapy... He died four days later. (Savulescu, 2001:148) Consent was judged to be more important than harm.

43 + Conclusion I have argued that the ethical foundations for some of the core ethical principles in research ethics are to be found in deontological ethics and in consequentialist ethics. Principles in research ethics seem to give weight to both theories. But depending on the justification you endorse, this might have implications for how you interpret the principles.