1. MRes induction: Research ethics setting the scene for the bioethics component of ‘MMB8100: Research skills and principles for the biosciences’ by Jan Deckers, School of Medical Education 1

2. Objectives To reflect on what ethics is. To develop your skills as an ethical researcher. To prepare yourself to apply for ethical approval from research ethics committees. 2

3. What is ‘ethics’? Ethics ‘deals with the standards and principles of moral reasoning’. (Rachels, 1998, 15) Internet Encyclopedia of Philosophy: ‘ethics (or moral philosophy) involves systematizing, defending, and recommending concepts of right and wrong behaviour’ 3

4. So, what is ‘ethics’? a theory of –how we ought/ought not to act –which values or principles ought (not) to guide our actions ethics is about evaluating/justifying particular actions 4

5. What is ‘meta-ethics’? the study of the status/meaning of ethical theories the study of moral justification 5

6. Three meta-ethical positions: e.g. ‘X is wrong’ Moral absolutism –‘I know that X is wrong (and anyone who disagrees is wrong).’ Moral relativism –‘X might seem wrong to you, but what is right and wrong is entirely subjective (nothing but a matter of taste).’ Pyrrhonian moral scepticism –‘I believe/think that X is wrong (but those who disagree may be right).’ 6

7. ‘Pyrrhonian’ moral scepticism A school of thinking named after Pyrrho –a Greek philosopher who lived from c. 360 to c. 270 BC 7

8. Why do we need ethics? Many people feel the need to: –justify their behaviour –to explain why their behaviour is (un)acceptable These explanations often relate actions to principles. A theory is an account of which principles should be followed, and how to balance them against each other. Many (or all?) things deserve moral consideration = subjective aspect = objective aspect 8

9. Objective dimension: What sorts of things should we value? Key questions –Which things are proper objects of ‘moral consideration’? –How much ‘relative moral significance’ should we give to different things? Key distinction –Intrinsic value: value for oneself ≠ –Instrumental/use value: value for others 9

10. What is bioethics, and what is research ethics? Bioethics = the study of how human actions that affect biological organisms can or can’t be justified. Research ethics = the study of ethical issues that pertain to research. 10

11. Two dimensions 1. Law and professional guidelines 2. Reflection 11

12. How does it work? 1. Establishing knowledge of the relevant legal and professional guidelines 2. Exercise your ability to reflect........ –How? 12

13. The tools of the trade clarity the principle of non-contradiction the use of analogies and thought experiments 13

14. clarity: the importance of defining concepts reportive definitions –= lexical definitions –to reflect the existing meaning of a term stipulative definitions –to assign new meaning to a term clarifying definitions –may combine the above –to give more precise meaning to a term 14

15. rationale for emphasising clarity the ‘what do you mean?’ question may resolve a lot of moral disputes 15

16. Example: a simple disagreement between James and John James: Animal research is unacceptable. –P (P= premise) 1 (major): Inflicting pain is unacceptable. –P2 (minor): Animal research causes pain. –Conclusion: Animal research is unacceptable. John: Animal research is not necessarily unacceptable. –Agrees with James about P1, but does not accept P2 as not all research inflicts pain. –Conclusion: Animal research is not necessarily unacceptable. 16

17. How to resolve this dispute? James may come to agree with John that not all animal research is unacceptable as he may question P2, e.g. after John has explained to him that his definition of ‘animal research’ includes studies that merely observe animals in nature. 17

18. the importance of defining concepts = the virtue of clarity Aiming for clarity may help you to: –scrutinise what you think before you say something. –scrutinise what others say before you decide to (dis)agree with it. 18

19. the principle of non- contradiction/consistency example: 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 taking part in the research.” 19

20. arguing by reductio ad absurdum (reduction to absurdity) 1. Start from the assumption that X is right. 2. Try to find a counterexample. 3. If a counterexample can be found, conclude that X cannot be right. 20

21. example Premise A: Research that involves research subjects should not happen unless subjects give their consent. Premise B: If no research was done with people who suffer from advanced dementia, people with this condition might be excluded from medical progress. Conclusion: People with advanced dementia should not be excluded and premise A should be rejected/modified. 21

22. the use of analogies Example: –When a research project is likely to kill me (healthy), research should not proceed. ↓ –When a research project is likely to kill healthy others, research should not proceed. What is at work here is the principle of universalisability –Is this a valid analogy? 22

23. the use of analogies Example: –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. Is this a valid analogy? 23

24. the use of thought experiments A thought experiment is an analogy between a real case and an imaginary case whereby the latter is claimed to shed light on how to handle the former. 24

25. The use of thought experiments Example: Julian Savulescu (2002)’s leukaemia case: –Imagine: A nuclear reactor has exploded, leaving your child exposed to nuclear fall out. Numerous children develop leukaemia, including your own. Bone marrow can be generated most successfully by reprogramming brain cells from children. Unfortunately, a child must be killed, as no brains from those who have deceased are available. The extracted stem cells could then be reprogrammed to treat ten children. 25

26. 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)? –If you do, Savulescu claims that you should also enter all human embryos into a similar lottery as the real world would be similar to this imaginary world: the real world is a world that lacks the great benefits that we would have had if there had been less objection to embryonic stem cell research. 26

27. Why use analogies and thought experiments? Rachels (1998, p. 22): ‘like cases should be treated alike and different cases differently’ 27

28. Some common ethical theories Consequentialism Deontology Principlism 28

29. Consequentialism Focus on consequences Example: Utilitarianism: consequences are measured in terms of whether or not they produce happiness 29

30. Deontology Focus on rules and motives 30

31. Principlism The ‘four principles’ approach: 1.Autonomy (self-determination) 2.Beneficence (well-being) 3.Non-maleficence (no harm) 4.Justice (1&4 are deontological?; 2&3 are consequentialist?) = a very popular approach in bioethics Ref: Beauchamp & Childress, 2001. 31

32. Why is research ethics important? Many people would agree that ‘not everything goes’ in relation to research. Some examples: –Tuskegee Syphilis Experiment For 40 years (between 1932 and 1972) 399 black men with advanced syphilis were told they were treated for ‘bad blood’ by the US Public Health Service. They were never told they had syphilis, and never received treatment for it. The aim of the study was to examine the effect of syphilis on the human body. The data were collected from the autopsies. –The TGN1412 trial 32

33. Ryan Wilson, one of the victims (picture from: http://news.bbc.co.uk/1/hi/health/5121824.stm) 33

34. The TGN1412 trial Phase 1 clinical trial conducted in 2006 by Parexel, an independent clinical trials unit based in London £ 2000 paid to 6 healthy volunteers All ended up in hospital 4 developed multiple organ dysfunction and suffered from a cytokine storm 34

35. Applying the four principles 1. Did it respect the autonomy of research participants? –Could the fact that a financial incentive was provided have undermined their autonomy? 2. Did it promote beneficence? –There may be little doubt that the research was done with the aim to promote the well-being of future patients, but how important was this motive compared to the motive to make a profit? Does it matter which was the primary motive? 35

36. 3. Was it non-maleficent? –The research caused harm. Could this harm have been avoided? –Could paying these participants be considered to have caused harm? How does it compare with payments for other physical interventions, e.g.: blood donations tattoo adverts (Sandel, 2012) 4. Was it just? –Was it legal? –Other considersations, e.g. moral rights: –Would I like to be treated like that? (The “how would you feel....” test, or “don’t do unto others what you would not want others to do unto you” ) 36

37. Case 1 James Strong is a researcher who has drafted an information sheet that he would like to use to recruit research participants. He includes the following: –‘This research will not expose you to any risks as previous research has not found any evidence that the D drug is harmful. This research merely repeats what has already been shown by other studies, so you can trust what we are going to do. This research has already been funded and it has also been granted ethical approval from Newcastle University’s Research Ethics Committee.’ 37

38. Case 2 Claire is working on a research project aimed at making tomato plants more resistant to frost. She hopes that isolating a gene from a flounder fish which can resist very cold temperatures and inserting this gene into tomato plants will make these plants resistant to frost. 38

39. Case 3 David does not support animal experimentation. Newcastle University is building a new facility to develop its research on animals. David wants to stop the University from building this facility, and speak up for the plight of animals. David decides to organise a protest in Newcastle with some like-minded people. They take to the streets and shout ‘stop the animal lab’. Afterwards, they go to the pub for a bar meal. David orders a pint of lager and a lamb pie with chips. 39

40. References Beauchamp, T. and Childress, J., Principles of Biomedical Ethics, 5 th edition, New York/Oxford: Oxford University Press, 2001. Deckers J., The New EU Directive on the Use of Animals for Research and the Value of Moral Consistency, in Journal of Bioethical Inquiry 2012; 9: 377-379. Internet Encyclopedia of Philosophy (http://www.iep.utm.edu/ethics/)http://www.iep.utm.edu/ethics/ Jamieson, D., Method and Moral Theory, in Singer, P. (ed.), A Companion to Ethics, Oxford: Blackwell, 1993, pp. 476-490. Rachels, J., Ethical Theory and Bioethics. In Kuhse, H. & P. Singer (eds.), A Companion to Bioethics, Oxford: Blackwell, 1998, pp. 15- 23. Sandel, M., What Money Can’t Buy. The Moral Limits of Markets, Allen Lane, 2012. Savulescu, J., The Embryonic Stem Cell Lottery and the Cannibalization of Human Beings, in Bioethics 2002;16: 508-529. 40

41. Conclusions Ethics is about the attempt to justify particular actions. Logic and the making of valid analogies are the tools of the trade. In bioethics, the focus is on biological organisms. Research ethics focuses on ethical issues in research. Various formal theories exist on what ethics should be about, including consequentialism, deontology, and the 4 principles approach. Many institutions have ‘research ethics committees’ and demand approval from them before research projects can commence. 41