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CMF submission to Nuffield Council on Bioethics consultation: Give and take? Human bodies in medicine & research
Published: 13th July 2010
1. Nature of human bodily material and first-in-human trials
Human bodily material
1. Are there any additional types of human bodily material that could raise ethical concerns?
No type has been omitted, but we note no mention is made here of the genetic significance of material – there are potential implications for others should genetic testing be performed.
2. Should any particular type(s) of human bodily material be singled out as 'special' in some way?
Yes. 'Reproductive material' intended to 'result in the birth of a child genetically related to the person providing the material' has a whole further dimension of significance. The 'provider' is potentially becoming a parent, and the relationship responsibilities of this are, or should be, enormous.
The products of conception from aborted fetuses deserve respect amounting to legal protection in that they represent parts of an individual made in the image of God (see response at Q30) who has no say in their use.
3. Are there significant differences between providing human bodily material during life and after death?
Yes. In life consent can be given, modified, and removed. These possibilities disappear at death, so any prior permission for use must be clear, valid, and applicable.
4. What do you consider the costs, risks or benefits (to the individual concerned, their relatives or others close to them) of providing bodily material? Please distinguish between different kinds of bodily material if appropriate.
Costs and risks:
Blood: minor inconvenience.
Bone marrow, kidneys, other organs: involves considerable risk including anaesthesia, surgical procedure, pain, morbidity, time off work. Kidney: the individual puts self at risk of renal failure should the one remaining kidney become diseased.
Reproductive material: knowing that a child could be born who is related to oneself, but whom one may never know or have a relationship with, and knowing that any such child will not know one or both of his/her biological parents.
Blood, tissues, organs: knowing that one's donation is being used to benefit another. (Jesus said 'It is more blessed to give than to receive'.) The altruistic sense of satisfaction is probably proportional to the type of material/organ donated, and perhaps the 'cost' involved.
Reproductive material: for those who have fully considered all ethical aspects, knowing that one has helped an infertile couple to have a child.
The relatives of post-mortem donors
Costs: for some, depending on their worldview, distress at the thought of material being removed from their loved one's body.
Benefits: knowing their loved one has not died in vain, but that something good has come from it.
Participation in first-in-human trials
5. What do you consider the costs, risks or benefits (to the individual concerned, their relatives, or others close to them) of participating in a first-in-human clinical trial?
Costs and risks: being exposed to a new drug with unknown risks which could be serious; undergoing monitoring procedures which may be invasive or unpleasant.
Benefits: financial reward; knowing one may be helping future patients if the research is successful.
2. Purposes of providing bodily material/volunteering in a trial
6. Are there any additional purposes for which human bodily material may be provided that raise ethical concerns for the person providing the material?
We can think of no additional purposes. The differentiation of the 4 purposes has been useful. It is perhaps worth pointing out that for all 4 purposes, there will be cases where no benefit will be obtained – eg donated material is found to be unfit for purpose, reproductive material may be donated but a live birth not achieved, in-human research may lead to the conclusion that the drug does not work or is not safe. Donors and volunteers should be made aware of the statistical likelihood of such possibilities in order that their involvement may be fully informed.
7. Would you be willing to provide bodily material for some purposes but not for others? How would you prioritise purposes?
Because of the importance we place on human relationships, and parental responsibilities in particular, the donation of 'life-creating' material belongs in a special category.
We would anticipate that some might be willing to donate for treatment purposes but not for research.
8. Would your willingness to participate in a first-in-human trial be affected by the purpose of the medicine being tested? How would you prioritise purposes?
Increasingly the pharmaceutical industry has moved into so-called 'lifestyle' drugs aimed at trivial conditions for which there may well be more appropriate interventions. People putting themselves potentially at risk have a right to expect a good purpose which is aimed at treating genuine threats to health.
3. Ethical values at stake
9. Are there any other values you think should be taken into consideration
See response at Q30.
A significant number of important concepts have been omitted:
- The traditional concept of deontological ethics (duty based) where the rule determines the result
- The more recent concept of consequentialist ethics where the results determine the rule
- Virtue ethics where the character of the decision maker is critical
- Utilitarianism should be named, as much of the consultation indicates the potential for a future crude cost-benefit calculus
Absent values include:
- Protecting the vulnerable – relevant to the question of financial incentives being more likely to cloud judgment in the poor
- Sanctity of life – life begins at conception, and embryos must be treated as full human beings worthy of respect and legal protection
- The importance of family relationships – taking responsibility for individuals created
Even the 'ethical values' mentioned are merely listed and no coherent ethical framework is apparent.
10. How should these values be prioritised, or balanced against each other? Is there one value that should always take precedence over the others?
At Q30 we argue that there must be a serious consideration of worldviews, before a coherent ethical framework can be agreed. We present our worldview, and indicate the ethical framework that follows.
However, we single out here 'first do no harm'.
11. Do you think that it is in any way better, morally speaking, to provide human bodily material or volunteer for a first-in-human trial for free, rather than for some form of compensation? Does the type or purpose of bodily material or medicine being tested make a difference?
At Q30 we argue that the altruistic gift aspect of donation (which has genuinely arisen from fully informed consent) fulfils our Christian obligation to love our neighbour as ourself. Christians therefore support the principles of organ and tissue donation and emphasise the primacy of altruism as a selfless gift to others.
In performing the altruistic act of living donation, the greater the risk involved, the greater the personal sacrifice and therefore the greater the gift. (As a corollary, where compensation/payment are involved, the greater the risk, the more important it is to evaluate the motives involved.)
12. Can there be a moral duty to provide human bodily material, either during life or after death? If so, could you give examples of when such a duty might arise?
No. Taking Christ's free sacrifice of himself for all mankind as our example, the concept of freewill offering transcends all concepts of moral 'duty', or obligation. Any obligation at all diminishes the worth of the act, which is then no longer a donation, a gift.
13. Can there be a moral duty to participate in first-in-human trials? If so, could you give examples of when such a duty might arise?
While individuals who have the condition being investigated may want to give special consideration to any obligation they feel, there can be no over-riding moral duty. See 12.
4. Responding to demand
14. Is it right always to try to meet demand? Are some 'needs' or 'demands' more pressing than others?
No. 'Needs' and 'demands' are not necessarily the same thing. The concept of 'need' has a substantial objective element; 'demands' are more subjective – what individuals and groups perceive they need and therefore ask for (see for example the growing move towards 'lifestyle' treatments).
Some form of 'rationing' will always be necessary, and the danger of moving to ever more extreme measures to increase supply is that demand will be stimulated and rise even faster. There has to be greater societal agreement about what constitutes 'need'.
15. Should different forms of incentive, compensation or recognition be used to encourage people to provide different forms of bodily material or to participate in a first-in-human trial?
In principle we would have no objection to considering different forms. A key issue is whether vulnerable people are put under particular pressure (eg the poor being offered financial rewards) such that their involvement no longer follows fully informed consent. There are well documented examples in 'transplant tourism' of poor people in the developing world selling organs.
16. Are there forms of incentive that are unethical in themselves, even if they are effective? Does it make any difference if the incentive is offered by family or friends, rather than on an 'official' basis?
Yes. It depends on the nature of the incentive. We support altruism and regret moves towards commodification. Excessive financial incentives lead society towards the buying and selling of human material, which from respect for human dignity we resist.
It will never be possible in practice to prevent private arrangements within families and between friends.
17. Is there any kind of incentive that would make you less likely to agree to provide material or participate in a trial? Why?
See 16. We should not commodify the human body. Over-generous offers of financial reward might raise suspicions of a disregard for safety and desperation to recruit.
18. Is there a difference between indirect compensation (such as free treatment or funeral expenses) and direct financial compensation?
In an ultimate philosophical sense, no. However, we recognise that they may be perceived differently, and this may affect acceptability. For example, indirect compensation is specifically directed, eg to funeral expenses. It is not just money in the pocket open to the financial choices of the recipient.
19. Is there a difference between compensation for economic losses (such as travelling expenses and actual lost earnings) and compensation/payment for other factors such as time, discomfort or inconvenience?
Some losses are clearly quantifiable, others are not. By compensating loss but no more, the sacrificial 'gift' element remains, and altruism is an important concept that should be encouraged. Payment moves the process towards commodification, which we resist.
20. Are you aware of any developments (scientific or policy) which may replace or significantly reduce the current demand for any particular form of bodily material or for first-in-human volunteers? How effective do you think they will be?
Structural changes in transplantation services following the Organ Donation Task Force report should increase supply and reduce demand by meeting need.
A generation or so from now, adult stem cells may be providing ethical and effective treatments. The consultation document mentions new mechanical technologies. Xenotransplantation (to which we have no fundamental ethical objection but only safety concerns) should be encouraged.
We recognise these latter possibilities are all some way away, but would counsel against any rush into short term measures intended to increase supply but which also cause serious ethical concern.
5. The role of consent
21. In your opinion are there any forms of encouragement or incentive to provide bodily material or participate in first-in-human research that could invalidate a person's consent?
Yes. As the consultation document acknowledges, it will be very difficult to assess 'undue influence'. Is there significant 'influence'? If so, would it be 'undue' in general, to all or most people? Would it be 'undue' to that individual?
22. How can coercion within the family be distinguished from the voluntary acceptance of some form of duty to help another family member?
It cannot. The worldviews of different cultural and ethnic groups would be very relevant. Even a trained independent assessor (a psychiatrist, psychologist, lawyer) interviewing the potential donor alone would sometimes find it impossible.
23. Are there circumstances in which it is ethically acceptable to use human bodily material for additional purposes for which explicit consent was not given?
We accept the concept of 'generic consent' and the additions in the Human Tissue Act.
24. Is there a difference between making a decision on behalf of yourself and making a decision on behalf of somebody else: for example for your child, or for an adult who lacks the capacity to make the decision for themselves?
Yes. It is far more difficult to exercise 'substituted judgment' on behalf of others and the responsibility is thereby heightened. For the Christian, the love for others which Christ commands means that the moral responsibility is also greater, when compared with making a decision for oneself.
25. What part should family members play in deciding whether bodily material may be used after death (a) where the deceased person's wishes are known and (b) where they are unknown? Should family members have any right of veto?
While we uphold mutual responsibilities within marriage and within the family, after death family members should not be able to veto the clear wishes of the deceased. As we argue at Q30, the Christian position is 'My body is God's, to be used for his worship and to serve others' and if that individual has clearly wished to serve others by donating after death, their autonomy should be upheld.
Where wishes are unknown, then discussion should be held with families in as sensitive and worldview-respecting a manner as possible, to seek their fully informed consent to donation.
6. Ownership and control
26. To whom, if anyone, should a dead body or its parts belong?
A dead body belongs to God, its Creator, but in a temporal and legislative sense, it belongs to no one. However, where known, the clear wishes of the deceased should always be respected.
27. Should the laws in the UK permit a person to sell their bodily material for all or any purposes?
No. See 16.
28. Should companies who benefit commercially from others' willingness to donate human bodily material or volunteer in a trial share the proceeds of those gains in any way? If so, how?
We reiterate that the Christian position is that 'My body is God's, to be used for his worship and to serve others'. It may be entirely appropriate for an individual to enter into an arrangement with a commercial organisation, and the terms of that should be clear to both parties from the beginning, but direct reward should not return to that individual.
It would be appropriate and good if the agreed arrangement stipulated that some return from the 'profit' went altruistically into patient care or further research into the condition in question.
29. What degree of control should a person providing bodily material (either during life or after death) have over its future use? If your answer would depend on the nature or purpose of the bodily material, please say so and explain why.
We support the concept of consent, thus providing some degree of control, but without granting any legal right of ownership.
Following proper ethical discussion there should be societal and governmental agreement about the limits individuals can set on use of their material. For example, a blanket refusal to donate to any member of another race would not be acceptable. If the potential donor cannot after discussion accept that limit, then their offer should be refused.
30. Are there any other issues, connected with our Terms of Reference, that you would like to draw to our attention?
The remit is huge
Several years ago, Parliament tried to combine in a single piece of legislation human tissue matters with human fertilisation and embryology matters. Thankfully they realised that this was too complex and broke the contents down into two separate (and lengthy) bills. This consultation seeks to combine even more…
Frustration with the format
We understand the convenience of online consultations and have responded thus, but unfortunately the format of this one has not allowed us to describe at the beginning who we are, in order to set a context for our response. We have felt uncomfortable answering some questions, which have been theoretical or almost 'academic', in a vacuum. We now describe ourselves and then move to other substantive comments.
Who are we?
The Christian Medical Fellowship (CMF) is an interdenominational organisation with over 4,000 British doctors as members. All are Christians who desire their professional and personal lives to be governed by the Christian faith as revealed in the Bible. Members practise in all branches of the profession, and through the International Christian Medical and Dental Association are linked with like-minded colleagues in over 100 other countries.
CMF regularly makes submissions on ethical and professional matters to Government committees and official bodies. All submissions are on our website (www.cmf.org.uk/publicpolicy/submissions/). We have recently responded to Nuffield Council consultations on Dementia: ethical issues (2008) and on The Ethics of Prolonging Life in Fetuses and the Newborn (2005), as well as to several House of Lords Select Committee consultations on the Inquiry into The EU Commission's Communication on organ donation and transplantation: policy actions at EU level (2007 and 2008).
Omitting to consider worldviews
Worldviews are the understandings each one of us has about the way the universe is. All our thoughts, beliefs and actions are based on these fundamental presuppositions about reality, and although often unacknowledged they are therefore critical in medical ethics and practice. Different worldviews will sometimes lead to radically different decisions.
With respect, we are not convinced that those who have constructed this questionnaire have fully taken on board the significance of the many different worldviews at play. The belief system implicit within the questionnaire seems to assume some kind of secular humanist, neutral, value-free objectivity which does not actually exist. Although it is doubtless unintended, there appears to be a 'one size fits all' approach to the many wide ranging issues covered in the consultation, and we counsel against this.
Worldviews are not just to do with philosophical questions about belief. They are inextricably tied to the way we behave, the choices we make, and the way we interact with others. The UK has rapidly and recently become very pluralistic and multicultural. Although 72% of the population chose in the 2001 Census to describe themselves as 'Christian', in reality the UK of today contains many different belief systems which apply to individuals', families', and communities' understanding of the issues in this consultation.
The Bible's Old Testament gives Christians (and Jews) the over-arching themes that God is the Creator, Sustainer and Lord of all life and that we are accountable to him for what we do in the world. All human life is made in the image of God, belongs to God, and should be treated with the utmost respect from its beginning to its natural end.
Jesus summarises the entire Law in the command to love, applied in two dimensions: 'Love the Lord your God with all your heart and with all your soul and with all your strength and with all your mind' and 'Love your neighbour as yourself'. The famous Parable of the Good Samaritan makes clear that we should respond compassionately as best we can to anyone we come across in need, and has been taken by Christian health professionals as a paradigm for care.
This obligation to love is heightened when Jesus Christ says, just before giving his life for all mankind – 'My command is this: Love each other as I have loved you'. He continues with the text that above all has inspired Christians to give sacrificially: 'Greater love has no-one than this, that he lay down his life for his friends'.
The altruistic gift aspect of donation which has genuinely arisen from fully informed consent fulfils our Christian obligation to love our neighbour as ourself. Christians therefore support the principles of organ and tissue donation, and this position is the foundation for our answers to the preceding 29 questions. We would urge the Council to consider what positions underpin the answers of other groups or individuals.
Critique of '3. Ethical Values at stake'
See Q9. Not only have a significant number of important concepts been omitted but the ones mentioned are merely listed and not held coherently. No ethical framework is apparent. This perhaps illustrates the failure to appreciate the fundamental importance of considering worldviews.
As will be apparent from our brief individual answers to the specific questions, we wish to uphold the principles of altruism and to resist moves towards commodification. We detect within the consultation the danger of a shift from 'My body is God's, to be used for his worship and to serve others' to 'My body is mine and I trade it as best I can' or perhaps even 'My body is the State's and I accept they will do with it what they wish'.
With this in mind, it would be possible for our society unwittingly to move towards fulfilling the aphorism: 'We know the price of everything and the value of nothing'.
We wish the Council well in their continuing deliberations and encourage them to recognise both the breadth and depth of the vitally important issues involved.
For further information:
Steven Fouch (CMF Head of Communications) 020 7234 9668
Alistair Thompson on 07970 162 225
Christian Medical Fellowship (CMF) was founded in 1949 and is an interdenominational organisation with over 5,000 doctors, 900medical and nursing students and 300 nurses and midwives as members in all branches of medicine, nursing and midwifery. A registered charity, it is linked to over 100 similar bodies in other countries throughout the world.
CMF exists to unite Christian healthcare professionals to pursue the highest ethical standards in Christian and professional life and to increase faith in Christ and acceptance of his ethical teaching.