1. Bioethics: the subject, purpose and objectives of the health care system. Bioethics biomedical experiments. International documents on bioethics and human rights.

2. Learning outcomes Introduce bioethics through an overview of the tools of the trade Introduce bioethics through an overview of the tools of the trade Develop ability to identify, analyse, and solve ethical dilemmas in the biomedical sciences Develop ability to identify, analyse, and solve ethical dilemmas in the biomedical sciences

3. For the first time the idea that man is responsible not only to others, but before all other creatures, was made a great humanist, a German doctor, missionary, theologian and musicologist Albert Schweitzer.

4. Since the beginning, the founder fathers - Van Rensselaer Potter and Fritz Jahr proposed Bioethics as this. Even Aldo Leopold, that uses Land Ethics concept instead of Bioethics, used this approach. Interdisciplinarity is a core characteristic of Bioethics.

5. Why do we need and what is bioethics? – Many (or all?) people feel the need to justify their behaviour to explain why their behaviour is (un)acceptable to explain why their behaviour is (un)acceptable – Bioethics: how scientists and health professionals ought to behave in the biomedical sciences

6. What is bioethics? Modern medicine is the difficult social-cultural system which deals with transhistoic and transculutural phenomena of human life (health, life, birth and death, illness, survival and maintainance of man). All, without an exception, people are the participants of process of recreation of these phenomena (as the special sort of values) and thus enter into permanent, but each time specific relationships with medicine. Exactly it and allows to talk, that a hodegetics, as form of estimation of human relations, can not be only by the report of professional rules and prohibitions. It regulates and estimates the relations of people in the world - religious, class, ethnonational, political and other the contexts - therefore limitation of ethics of medicine by specific clinical relations or relations "doctor-patient illegally.

7. Why is bioethics important? Realisation that ‘not everything goes’, e.g. Realisation that ‘not everything goes’, e.g. – Tuskegee Syphilis Experiment – Nazi human experimentation (Nuremberg Trials, 1945- 1949) – TGN1412 trial: Did something go wrong? – Dr Shipman – DDT (Rachel Carson’s ‘Silent Spring’) Therefore: need for justification Therefore: need for justification

8. Bioethics and environmental ethics Both developed significant momentum in last quarter of 20 th century Both developed significant momentum in last quarter of 20 th century Increasingly considered to be inseparable Increasingly considered to be inseparable

9. Some key resources Journal of Medical Ethics Journal of Medical Ethics Bioethics Bioethics Cambridge Quarterly of Healthcare Ethics Cambridge Quarterly of Healthcare Ethics Hastings Center Report Hastings Center Report American Journal of Bioethics American Journal of Bioethics Journal of Agricultural and Environmental Ethics Journal of Agricultural and Environmental Ethics Environmental Politics Environmental Politics Ethics and the Environment Ethics and the Environment Journal of Public Health Ethics (new in 2008) Journal of Public Health Ethics (new in 2008) Journal of Animal Ethics (new in 2008) Journal of Animal Ethics (new in 2008)

10. Two dimensions law and professional guidelines law and professional guidelines reflection reflection

11. How does it work? Establishing knowledge of the relevant legal and professional guidelines Establishing knowledge of the relevant legal and professional guidelines Exercise your ability to reflect: How? Exercise your ability to reflect: How?

12. A range of tools A range of tools Principle of non-contradiction Principle of non-contradiction Analogies Analogies Thought experiments Thought experiments

13. Principle of non-contradiction A researcher who carries out research on patients with advanced dementia says the following: A researcher who carries out research on patients with advanced dementia says the following: I believe that researchers who want to carry out research on patients should only proceed if patients give their voluntary, informed consent to research participation. I believe that researchers who want to carry out research on patients should only proceed if patients give their voluntary, informed consent to research participation.

14. Analogies When a research project is likely to kill human research subjects, research should not proceed. When a research project is likely to kill human research subjects, research should not proceed. When a research project is likely to kill nonhuman research subjects, research should not proceed. When a research project is likely to kill nonhuman research subjects, research should not proceed. Is this a valid analogy? Why/why not? Is this a valid analogy? Why/why not?

15. Thought experiments Imagine the explosion of a nuclear reactor, leaving your one year old child exposed to nuclear fall out. Numerous children develop leukaemia, including your own. Bone marrow can now be generated most successfully by reprogramming brain cells, which are more resistant to radiation damage than bone marrow. Unfortunately, a whole brain must be destroyed. The extracted stem cells could be reprogrammed to treat ten children. Imagine the explosion of a nuclear reactor, leaving your one year old child exposed to nuclear fall out. Numerous children develop leukaemia, including your own. Bone marrow can now be generated most successfully by reprogramming brain cells, which are more resistant to radiation damage than bone marrow. Unfortunately, a whole brain must be destroyed. The extracted stem cells could be reprogrammed to treat ten children.

16. Since a one in eleven chance of certain death seems preferable to a one hundred percent chance of imminent death, the question is: would you enter your child into a lottery and risk a 1/11 chance of your child being sacrificed (by being killed to treat others) or refrain from entering your child into such a lottery (which would mean certain death for your child)? (Savulescu J. The Embryonic Stem Cell Lottery and the Cannibalization of Human Beings. Bioethics 2002;16:508-529.) Since a one in eleven chance of certain death seems preferable to a one hundred percent chance of imminent death, the question is: would you enter your child into a lottery and risk a 1/11 chance of your child being sacrificed (by being killed to treat others) or refrain from entering your child into such a lottery (which would mean certain death for your child)? (Savulescu J. The Embryonic Stem Cell Lottery and the Cannibalization of Human Beings. Bioethics 2002;16:508-529.)

18. Some ethical theories Consequentialism Consequentialism Deontology Deontology Virtue theory Virtue theory Principlism Principlism

19. Consequentialism Good: what is likely to produce more good than bad consequences. Good: what is likely to produce more good than bad consequences. Bad: what is likely to produce more bad than good consequences. Bad: what is likely to produce more bad than good consequences. – E.g.: utilitarianism: good is what produces the greatest utility (usually understood in terms of ‘happiness’) for the greatest number. Often used for resource allocation issues: how can we promote the largest amount of happiness with limited resources? Often used for resource allocation issues: how can we promote the largest amount of happiness with limited resources? – Example: Savulescu’s thought experiment

20. Consequentialism Problems: Problems: – Can we know the likely consequences of our actions? What if there is great uncertainty? – Impartial moral theory  Some would say that we have a duty to be partial. – Certain rules may be ignored (yet some forms of consequentialism take some deontological principles into consideration)

21. Deontology From the Greek word for ‘duty’ From the Greek word for ‘duty’ rules, which express our duties rules, which express our duties – E.g. killing someone to give their organs to someone else may ignore our duty to respect that person’s right to life.

22. Deontology Problems: Problems: – Always following rules of conduct can lead to negative consequences e.g. allowing a massive bomb to explode by refusing to torture someone e.g. allowing a massive bomb to explode by refusing to torture someone e.g. not fabricating a research result might mean admitting that your study found nothing that is interesting. e.g. not fabricating a research result might mean admitting that your study found nothing that is interesting.

23. Virtue theory focus on the agent of action, rather than on rules or consequences focus on the agent of action, rather than on rules or consequences Role-model Role-model Problems: Problems: – It may fail to guide our actions, as there are no clear, golden rules that can be applied. – What is ‘virtue’? Might ‘virtue’ be ‘vice’?

24. Principlism ‘The four principles’ approach ‘The four principles’ approach – The most widely used approach in Western bioethics – Incorporates elements from both consequentialist and deontological theories

25. What are these 4 principles – Autonomy Right of self-determination Right of self-determination – Related to ‘informed consent’ – In order to give consent: autonomy/competency/capacity must be possessed. – Beneficence – to do well, to promote well-being – Non-maleficence – to do no harm, to avoid doing harm – Justice – treat like alike (T. Beauchamp and J. Childress, Principles of Biomedical Ethics, 5 th edition, New York/Oxford: Oxford University Press, 2001.)

26. Theories in environmental ethics Strong anthropocentrism (speciesism) Strong anthropocentrism (speciesism) Weak anthropocentrism Weak anthropocentrism Pathocentrism Pathocentrism Biocentrism Biocentrism Ecocentrism Ecocentrism

27. A selection of prominent issues Should scientists consider the possibility that their research might encourage bioterrorism? Should scientists consider the possibility that their research might encourage bioterrorism? Should regulations underpinning good research be the same everywhere? Should regulations underpinning good research be the same everywhere? – E.g. research on Aids/HIV Why are health resources scarce (in some countries) and how should resources be allocated? Why are health resources scarce (in some countries) and how should resources be allocated? – E.g. malaria tablets, HIV/Aids drugs When is withholding/withdrawing treatment appropriate? When is withholding/withdrawing treatment appropriate? Should euthanasia be legalised in the UK? Should euthanasia be legalised in the UK?

28. A selection of prominent issues Is research on those who cannot give consent permissible? Is research on those who cannot give consent permissible? – E.g. children, adults who lack capacity, nonhuman animals How should we assess capacity/competence? How should we assess capacity/competence? Should human embryos be used for research? Should human embryos be used for research? Should abortion legislation be changed? Should abortion legislation be changed? Should nonhuman animals be used for research? Should nonhuman animals be used for research? Is genetic modification acceptable? Is genetic modification acceptable?

29. A selection of prominent issues Should people who suffer from ‘self-inflicted diseases’ be treated in the same way as people who suffer from diseases not caused by their own lifestyles? Should people who suffer from ‘self-inflicted diseases’ be treated in the same way as people who suffer from diseases not caused by their own lifestyles? – E.g. alcohol, smoking, obesity, … Should people be encouraged to take their health (more) seriously? Why? Should people be encouraged to take their health (more) seriously? Why? Which measures to promote public health are acceptable? Which measures to promote public health are acceptable? – E.g. compulsory vaccination? What are the purposes of pre-implantation genetic diagnosis and pre-natal diagnosis? Can these purposes be justified? Which means are acceptable? What are the purposes of pre-implantation genetic diagnosis and pre-natal diagnosis? Can these purposes be justified? Which means are acceptable? Should treatments which are not recommended by NICE be available on the NHS anyway? Should treatments which are not recommended by NICE be available on the NHS anyway?

30. The legal context of biomedical research in the UK The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031): regulation in relation to clinical trials The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031): regulation in relation to clinical trials Mental Capacity Act 2005: provides legal definition of ‘capacity’ and details how to research involving adults who lack capacity (apart from clinical trials) Mental Capacity Act 2005: provides legal definition of ‘capacity’ and details how to research involving adults who lack capacity (apart from clinical trials) MRC Ethics Guide, Medical Research Involving Children, London, 2004: provides guidance on the role of children in research MRC Ethics Guide, Medical Research Involving Children, London, 2004: provides guidance on the role of children in research

31. Does my research need ethical approval? Two possibilities: My research involves: Two possibilities: My research involves: – A: NHS staff or patients – B: others

32. If A research needs to be approved by a LREC (Local Research Ethics Committee) research needs to be approved by a LREC (Local Research Ethics Committee)

33. National Research Ethics Service a directorate within the National Patient Safety Agency, replaced COREC a directorate within the National Patient Safety Agency, replaced COREC co-ordinates activities of the Research Ethics Committees in England co-ordinates activities of the Research Ethics Committees in England

34. If B Many research councils and other funders have their own research ethics committees. Many research councils and other funders have their own research ethics committees. Universities (and some Faculties/schools) have research ethics committees. Universities (and some Faculties/schools) have research ethics committees.

35. Some questions to ask in relation to personal research projects What is the aim of my research? What is the aim of my research? Whose interests will be served by my research? Whose interests will be served by my research? What are the risks? What are the risks? What are the opportunity costs? What are the opportunity costs?

36. Prominent ethical codes Oath of Hippocrates (4 th c BC) Oath of Hippocrates (4 th c BC) Nuremberg Code (1947): issue of human experimentation Nuremberg Code (1947): issue of human experimentation Declaration of Helsinki (1964) (WMA): issue of human experimentation Declaration of Helsinki (1964) (WMA): issue of human experimentation – First serious attempt of medical community to regulate itself Declaration of Geneva (1948) Declaration of Geneva (1948) – Issued as a development on the Oath of Hippocrates CIOMS Guidelines (1993) CIOMS Guidelines (1993) – ‘International Ethical Guidelines for Biomedical Research Involving Human Subjects’ (CIOMS: the Council for International Organizations of Medical Sciences) Universal Declaration on Bioethics and Human Rights (UNESCO; United Nations Educational, Scientific, and Cultural Organisation) (2005) Universal Declaration on Bioethics and Human Rights (UNESCO; United Nations Educational, Scientific, and Cultural Organisation) (2005)