Research Ethics- Is there a moral obligation to participate in research?

1. Research Ethics-Is there a moral obligation to participate in research? Prof Orla Sheils Department of Histopathology, TCD

2. The moral imperative of research • We all benefit from living in a society in which scientific research is performed and which utilizes the benefits of previous research. • We feel more secure and hopeful for the future - for ourselves and our descendants- when research and its fruits are given priority.

3. We take comfort in the notion that research is ongoing which may benefit conditions we are likely to be confronted with, and • We take comfort in the benefits of past research in the form of vaccination programmes and disease eradication, • in the form of the knowledge of the connection between diet, exercise and heart disease.

4. Precautionary Approach • International agreements and protocols (e.g. The Declaration of Helsinki) have been directed principally to protect individuals from the dangers of participation in research and that to ensure that, when they do participate their full informed consent is obtained. • The presumption is that participation in research is a superogatory and possibly a reckless act NOT an obligation.

5. Suspicion of doctors and researchers in particular is well founded: • Original Declaration of Helsinki prompted the trials at Nuremberg • Further fueled by : • Tuskegee Study of Untreated Syphilis in the US • Removal and retention of organs in UK and Ireland

6. The Belmont Report states that "an injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly.“ • http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

7. Unfair selection of research participants is the manifestation of injustice in research and can occur in two ways: • prohibiting research participation without justification or • unjustifiably over-including certain categories of participants, leading to undue burden for that population.

8. In the wake of significant abuses of vulnerable persons in research, protection has sometimes become synonymous with nonparticipation. • Excluding some entire categories of individuals from research denies them the opportunity to obtain potentially beneficial treatments available only within clinical trials and excludes information about their participation from the generalizable knowledge that the research generates.

9. Vigilance against wrongdoing is one thing but inability to identify wrongdoing with the result that the good is frustrated and harm caused is something else.

10. In conversation with Andrea Sarti (who was about to smuggle the heretical manuscript Discorsi out of Italy, Galileo said of his research: • “The battle for a measurable heaven has been won thanks to doubt; but thanks to credulity the Rome housewife’s battle for milk will be lost time and time again. Science, Sarti, is involved in both these battles. A human race which shambles around in a pearly haze of superstition and old saws, too ignorant to develop its own powers, will never be able to develop those powers of nature which you people are revealing to it. To what end are you working? Presumably for the principle that science’s sole aim must be to lighten the burden of human existence. If the scientists, brought to heel by self interested rulers, limit themselves to piling up knowledge for knowledge’s sake, then science can be crippled and your new machines will lead to nothing but new impositions. You may in due course discover all that there is to discover, and your progress will nonetheless be nothing but a progress away from mankind. The gap between you and it may one day become so wide that your cry of triumph at some new achievement will be echoed by a universal cry of horror....

11. ...Had I stood firm the scientists could have developed something like the doctors’ Hippocratic oath, a vow to use their knowledge exclusively for mankind’s benefit. As things are, the best that can be hoped for is a race of inventive dwarfs, who can be hired for any purpose.”

12. Is it reasonable to assume we can continue to benefit from research without a moral obligation to participate in research ?

13. John Harris suggests that participation in or support for research, particularly medical research, is a moral duty.

14. What sort of research? • Balance required. • Research aimed at preventing serious harm or providing significant benefit to humankind. • Degree of harm or benefit must justify the burden on subjects, individuals or society. • Projects must be well designed with reasonable prospects of beneficial outcome.

15. Questions to be addressed: • Is it not unfair to accept the benefits of research without contributing something back in the form of support for, or participation in, research? • Do we have a social duty to maintain those practices and institutions that sustain us, such as those which contribute to medical knowledge? • Doesn’t rely so heavily on fairness…

16. Should we consider the future benefits of research? • research is an effective way to discharge a duty to rescue others from serious illness or death, therefore we have a duty to research.

17. 1 First Do No Harm • Powerful obligation not to harm others • Duty of Beneficiance: • Basic moral obligation to help others in need. • rule of rescue - dramatic events • BUT • rescue occurs when people faced with threat or danger receive help that mitigates that danger.

18. Disease creates needs • in those affected and a wider circle of family, friends, carers etc. • If medical research is a necessary component of relieving disease therefore we have a moral obligation to further research.

19. 2 Fairness and Equity • Appeals to unfairness of being a ‘free-rider’. • We all benefit from the advances in medical technology so why should only a few contribute to its continuance.

20. What about Autonomy and a person’s right to choose? • Should we consider individual or collective autonomy?

21. Is there an Enforceable Obligation to Participate? • Sacrifices commonly made in public interest which deny autonomy or violate bodily integrity: • limited access to dangerous drugs • control of road traffic • vaccination • genetic profiling of suspected criminals • jury service • Is Medical Research Different?

22. Limitation: • when risks to individual or burden is onerous

23. Human Medicine? • What about humans as medicine? • We are familiar with blood transfusions and organ donation... • What about stem cells?

24. Thought experiment: • Child impervious to infectious disease • Should doctors/researchers collect samples of blood (with parents’ consent)? • How about some stem cells? • How far should we go?

25. Subsequently found to have regenerative capacity in each organ. • Is it reasonable to collect tissue samples?

26. Conditional Consent... • Child’s father is a stock-broker and sees the potential market value: • Refuses to allow sample collection unless paid €500,000 with a guaranteed 20% of any profits from drugs in the future.

27. What if in order to generate new drugs we need access to every organ... • Can we kill him in the public interest? • We conscript young men and women every day to fight in war zones for the greater good. • Why is this different?

28. What if he is killed in an accident • Can we harvest his tissue then?

29. Rosalind Franklin “...You look at science (or at least talk of it) as some sort of demoralising invention of man, something apart from real life, and which must be cautiously guarded and kept separate from everyday existence. But science and everyday life cannot and should not be separated. Science for me, gives a partial explanation of life. Insofar as it goes, it is based on fact, experience and experiment... In my view, all that is necessary for faith is the belief that by doing our best, we shall come nearer to success and that success in our aims (the improvement of the lot of mankind, present and future) is worth attaining.”