Response to "Give and take: Human bodies in medicine and research" (2010)
David Albert Jones responds on behalf of The Anscombe Bioethics Centre to an April 2010 consultation paper "Give and take: Human bodies in medicine and research" from the Nuffield Council on Bioethics.
The Anscombe Bioethics Centre is the oldest national bioethics centre in the United Kingdom, established in 1977 by the Roman Catholic Archbishops of England and Wales. It was originally known as The Linacre Centre for Healthcare Ethics and was situated in London before moving to Oxford. The Centre engages with the moral questions arising in clinical practice and biomedical research. It brings to bear on those questions principles of natural law, virtue ethics, and the teaching of the Catholic Church, and seeks to develop the implications of that teaching for emerging fields of practice. The Centre engages in scholarly dialogue with academics and practitioners of other traditions. It contributes to public policy debates as well as to debates and consultations within the Church.
The Centre welcomes the opportunity to respond to the Nuffield Council Consultation Report Give and take?: Human bodies in medicine and research, recognizing that this covers important ethical issues of wide concern. This response generally does not rely on premises held by Catholics only, except where this is explicitly stated. On the contrary, for the most part, the arguments presented are potentially acceptable to those of other faiths, and of no faith. Furthermore, much of this response goes beyond the current teaching of the Church, both because it concerns scientific questions outside the Church's competence (for example, the diagnosis, as opposed to the definition of death), and because this is an area in which Church teaching is still in the process of formation.
Before addressing the consultation questions in detail it is helpful to set out the key orientation of Roman Catholic teaching in relation to the use of human tissue after death.
The use of the human body after death
This is shown, for example, by the right of information that is now given to people who were conceived using donated gametes. The ethical considerations also relate to the donor as the use of sperm or eggs to conceive a child clearly requires the consent of those who will become genetic parents. It is noteworthy that in the United Kingdom the Human Tissue Authority (HTA) is not regarded as a suitable body to oversee these practices but they require their own specialized regulator, the Human Fertilisation and Embryology Authority (HFEA). While the Catholic Church does not endorse the decisions of the HFEA, many of which it regards as excessively libertarian and unduly influenced by the fertility industry, the Church endorses the need for a separate and specicialised oversight of fertility treatment. Use of reproductive tissue raises issues not raised by other somatic tissue transplantation.
These and other ethical considerations are address below in more detail through addressing the questions provided by the Nuffield Councils.
1. Are there any additional types of human bodily material that could raise ethical concerns?
A further type of human bodily material which raises problems is material derived from a controversial or unethical procedure, such as donation or foetal tissue after termination of pregnancy, organ donation (whether voluntary or involuntary) after state execution and, as recently reported in Belgium, organ donation after euthanasia. In all cases the request for consent seems to make the recipient complicit in the original procedure. The issue is less whether subsequent donation might encourage such procedures (abortion, state execution or euthanasia) but more whether it implicitly condones the practice by agreeing to benefit from an ongoing pattern of behaviour.
Some of these issues where considered in the 2002 Department of Health consultation Human Bodies Human Choices. The present consultation might consider examining not only that report but also the submissions made to that consultation, including the submission of the Linacre Centre of Healthcare Ethics.
As argued above, the use of reproductive tissue is a different category from other somatic tissue taken for research purposes. A greater degree of informed consent is necessary if tissue is used for reproductive purposes. Whereas some secondary use of human tissue may be ethically acceptable without explicit consent, it can never be ethical to generate new human life without the consent of both parents. This should be evident in cases where a child is born and will wish to know about his or her ancestry. It is, furthermore, already the case that the generation of a human embryo is an action that absolutely requires the consent of both parents.
The Nuffield Council should give explicit consideration to somatic cell nuclear transfer by which a human embryo or human admixed embryo might be generated. This is not a major area of current research but is significant as it could lead to non-reproductive somatic tissue (blood or skin cells) being used in a reproductive way (i.e. to generate an embryo).
Another area that is controversial is that of the transplantation of neurological material. While it seems pure science fiction to affect personality or transfer mental traits by transplanting brain tissue, experiments in animals have shown the transfer of behavioural traits in this way. Such psychological side-effects would not necessarily rule out this kind of procedure absolutely but they would mark this kind of tissue out as a special category for the purposes of consent and justification.
The association with identity and personality also relates to very recognizable human features such as the face or the eyes. It is not unusual for people to consent to organ donation after death with respect to their internal organs but to make an exception of the eyes. This public human significance of certain body parts does not rule out donation but emphasizes the need for explicit specific consent.
3. Are there significant differences between providing human bodily material during life and after death?
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.
For foetal and embryonic tissue the providing of material is typically the concomitant of the destruction of their lives. There are circumstances where material might be obtained from a spontaneous miscarriage, but the more obvious context is termination of pregnancy. The use of this material is ethically problematic as it involves cooperation with, and perhaps complicity with the deliberate destruction of a human embryo or a foetus. This is incompatible with the ethical principle of the inviolability of all human lives from conception and is not justified by benefits it might bring to the parents or to the born siblings of the unborn child.
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?
6. Are there any additional purposes for which human bodily material may be provided that raise ethical concerns for the person providing the material?
Yes, see 1 above.
7. Would you be willing to provide bodily material for some purposes but not for others? How would you prioritise purposes?*
As discussed above, donation is to be encouraged when this is for medical treatment or research, though not for unethical purposes such as destructive embryo experimentation.
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?*
In principle it is a good and noble thing to participate in such research where they are necessary and conducted in a way to mitigate the risks. Nevertheless, the use of human subjects in scientific experiments or research raises many issues and is difficult to treat adequately when the primary focus of discussion is the use of human tissue. This response primarily confines itself to the ethics of obtaining, storing and using human tissue.
9. Are there any other values you think should be taken into consideration?
Of the list of values presented, Altruism, Dignity, Justice and Solidarity are key values that are widely recognized and are emphasized within the social teaching of the Catholic Church. There is more dispute as to how the values of Autonomy, Maximising health and welfare and Reciprocity should be understood.
While the dignity of free human choice is acknowledged by Catholic and other religious traditions there is perhaps more awareness within these traditions of the dangers of autonomy in the sense of self-assertion or unwillingness to acknowledge the claims of others. Similarly, the exercise of power is generally evaluated relative to the goods it serves, rather than as a good in itself. In particular, it is a mistake to regard the human body as property as though it had no inherent dignity or connection with the human person.
Lastly reciprocity is a positive concept if it connotes active cooperation among individuals and includes relationships of gratitude and just recompense. However, from a Catholic perspective the relationships of exchange, whether of property, services, payment or gratitude, are secondary to a common destination of goods and a common human solidarity. It is important also to distinguish different kinds of reciprocity so that, for example, the relationships of gift, acknowledgement and gratitude are not reduced to relationships of payment and obligation.
In addition to these values explicit attention should be given to the principle of non-maleficence, both in the sense of avoiding undue physical harms and in the more important sense of avoiding injury (unjust harm). The principle of the inviolability of human life should be understood as a particular case of avoiding unjust harms.
Under the heading of dignity should be included not only the dignity of the body but also the dignity of the person. This is the basis of a robust doctrine of human equality and non-discrimination. Discrimination could occur in relation to those who are in danger of being exploited for their organs, whether because of poverty of because of severe ill-health, especially those who are not able to consent.
Another corollary of human dignity is the dignity of human procreation. This principle acknowledges the human significance of biological aspects of reproduction, such as genetic identity, parenthood and inheritance. It has a particular impact on the need for specific consent before tissues are used.
10. How should these values be prioritised, or balanced against each other? Is there one value that should always take precedence over the others?
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?
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?
In general donation of tissue is not a duty and it is certainly not a duty in justice. No one else can have a better claim to my blood or my kidney than me! Donation after death is also not a duty in justice as the body neither belongs to the state nor to any other person. However there is a virtue in solidarity (which Christians would express as the theological virtue of charity) in donating organs and in times of necessity (such as war or national emergency) there may be a duty on people to donate replaceable tissue such as blood. It also would seem ungrateful where someone has benefited from donation, or someone close to the person has benefited, not to express a willingness to donate after death.
Nevertheless, even were there to be a duty on someone to donate this would not justify coercion or confiscation by the state. This would undermine the principle of free donation and demean the body. It would also be likely to have a negative impact on public support to donation.
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?
As stated above this subject requires attention in own right. In brief, there does not seem to be a duty on someone to participate in first-in-human trails. It is not like military service or even like blood donation. It is participation in scientific experimentation as a research subject.
The essence of moral or ethical action is to act in a way that is good, principled and virtuous within a particular situation. This is not compatible with seeking to pursue every possible good or meet every possible demand. Indeed with or without consideration to ethical principles, it is impossible simultaneously to pursue every possible good and meet every possible demand. Within modern healthcare there is an ever increasing number and variety of interventions that could supply some benefit and which could be desired or demanded. Given that it is never possible to supply all demands it seems doubly foolish to subordinate ethical principle for demands that are insatiable. In general to prioritise any one particular good over and against the common good of society and the requirements of virtue, is morally corrosive.
Among the needs and demands of people some are more pressing than others. Emergency medicine is more pressing just because it is intolerable to abandon someone in severe need. Basic care (including adequate nutrition and hydration) and comfort are more pressing than cure. Some needs are greater than others. Nevertheless, the identification of need is complex and need is not to be conflated with ability to benefit.
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 general incentives are dangerous in this area, whether financial incentives or compensation in kind. There is a great danger of exploitation of the poor, which has been a concern of Catholic teaching on organ donation at least from the time of Pius XII. Recognition of generousity should be placed in a different category if it is recognition after the event and is not used as an incentive. It is the attempt to use compensation or recognition as an incentive that threatens to corrupt these practices.
If your answers to any of Questions 16-19 below would depend on the nature or purpose of the bodily material or the medicine being tested in the trial, please say so and explain why.
Financial compensation can be reasonable if it reflects actual expense and is not abused as a system of incentives. Incentives are more dangerous in some contexts than in others. It is no better if offered by family or friends, and indeed the scope for coercion in these contexts may be greater.
17. Is there any kind of incentive that would make you less likely to agree to provide material or participate in a trial? Why?*
This reaction would not come only or primarily from the Catholic community but it is likely that there would be a reaction within the Catholic community, among others, to resist the undermining of the ethos of free donation. If practices were introduced which commodified the human body or which placed undue pressure on people to permit organs to be taken, then these practices should be opposed. Such practices may also fuel suspicion of the medical profession, especially in the context of end of life decisions.
18. Is there a difference between indirect compensation (such as free treatment or funeral expenses) and direct financial compensation?
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?
Compensation for expenses is less open to exploitation and corruption than compensation for inconvenience. Nevertheless, the expenses scandal that has engulfed Parliament shows that expenses against actual costs can also be abused. It is essential that compensation should be modest in scale and should not represent a covert incentive scheme.
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?
There will be developments, such as artificial organs, adult stem cell therapy, and other emerging cell technologies, which may reduce demand for organs and tissues. However, at the same time as these are developed there may well be novel uses for human tissue that increase demand. Furthermore, progress in the success of organ transplantation will itself lead to a widening of patients who could benefit and hence to greater demand. Hence there is little reason to think that technology of itself will lead to a reduction of demand.
If your answers to Questions 21 or 22 below would depend on the nature or purpose of the bodily material or of the drug being tested in the trial, please say so and explain why.
Yes, potentially. The potential for undermining consent will depend on the circumstances of the person donating (income, strong desire for a child etc.) and also the nature of the decision being taken. A small incentive for a blood donation might be innocuous, but if giving the organ posed serious risk then the need for consent would be stronger.
22. How can coercion within the family be distinguished from the voluntary acceptance of some form of duty to help another family member?
This is a very difficult question and one that needs to be taken very seriously. Public policy should not depend on an unrealistic and rosy view of domestic and family relationships but should be aware of the extent of manipulation, pressure and even violence within families.
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?
When material has already been given for a different purpose and where the secondary use is noncontroversial and relevantly similar to the original consent, and where the research is well thought through and likely to be beneficial but it is impractical to re-contact donors for a new consent, then it may be ethically permissible to use material without explicit consent. Nevertheless, each of these conditions is important and most of all the condition that the additional purpose is noncontroversial. For example, if the original research was for a particular disease it cannot be assumed that the donor would be happy to use the material to study ethnicity or population movements. If eggs were given for research into fertility it cannot be assumed that the consent would cover the cloning of embryos for stem cell research. If tissue was retained as a biopsy on a particular patient it cannot be assumed that it could be used to investigate the genetic origins of disease.
Some kinds of research should always require explicit consent because of their character and this is especially true of any research involving human or human admixed embryos. The Church regards all destructive experimentation on human embryos as unjust. It is a further injustice if the embryos are generated without even the consent of the (genetic) parents.
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?
In relation to a child, parents have to make many decisions on their behalf and can reasonably make some choices for the sake of others if these choices to not adversely affect the child. So, for example, it is for the parent to decide whether organs should be taken from a dead child. This is not because they own the body but because this kind of decision is appropriate for parents.
If your answers to Questions 27 or 28 below would depend on the nature or purpose of the bodily material or medicine being tested, please say so and explain why.
26. To whom, if anyone, should a dead body or its parts belong?
This tradition of respect for the dignity of the body has long been enshrined in law in the doctrine that the human body is not property. This legal principle is currently under considerable pressure. Nevertheless, it reflects a deep human truth. Efforts should thus be made to address the legal problems of appropriate and inappropriate use of the body, and who has right and responsibility to make decisions in relation to human tissue, without recourse to the idea that the body is property.
27. Should the laws in the UK permit a person to sell their bodily material for all or any purposes?
The buying and selling of human bodily material directly contradicts the dignity of the body. It not only threatens the vulnerable (who might be tempted to sell their organs) but more fundamental it threatens the respect for the human body.
Those who profit financially from the ethos of donation, for example biotechnology companies, should acknowledge their indebtedness to human generosity, for example by supporting specific charities. This is something many companies do simply to show their awareness of their responsibility to society (and of course for the sake of their reputation).
It may be that this show of gratitude is directed at support to the specific community from which the donors come, whether this is defined by location, by health characteristics or in some other way. The extent of this charitable support should realistically reflect the extent of the profit and the role of voluntary donation in securing that profit.
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.
To give something is to give away control of that thing. There are sometimes problems with attaching conditions to a gift. This is common in charitable giving (there are charities for people in very specific circumstances) but with something as basic as organ donation the virtue of human solidarity strongly argues against setting conditions. For example, a small financial charity might be set up for the education of young women from the South West of England, but people who donate organs cannot restrict the sex, age or location of the donor in this way. Restrictions would limit the usefulness of the gift, but more fundamentally it would adversely affect the ethos of caring for the sick according to need. It is for this reason that conditional organ donation is not to be encouraged.
In donation of tissue for research the ethos of donation is related not directly to medicine but directly to science and to the pursuit of knowledge. In this context the attaching of conditions is the norm rather than the exception. Consent for use of tissues in research should specify the purposes for which the tissues are given. It is reasonable for tissue banks to develop broad generic terms of consent, but the consent is not real if the practices that are not in fact generically alike ethically and politically. If research raises specific ethical questions or generates specific political controversy then these need specific explicit consent.
Another aspect of control is the wish to be involved as a stakeholder in decisions about the sharing of the results of research. Donors may wish to see a different balance between commercial interest and public good, for example wishing to see more sharing of knowledge in the public domain free of the restriction of patents. Even here, where there is a strong case for involvement, giving direct control of decision-making to individuals who donated tissue would undermine the ethos of donation. Nevertheless, it is good practice for companies to listen to groups and individuals who have been involved in the development of medical products through donation. They are stakeholders.
30. Are there any other issues, connected with our Terms of Reference, that you would like to draw to our attention?
The terms of reference of this consultation are too broad to cover all the issues adequately. The protection of human experimental subjects, the need for consent for cadaveric organ donation and the use of tissues in assisted reproduction are diverse ethical areas each with their own complexities. The Nuffield Council report will be most useful if eschews the temptation to comment on every possible ethical aspect of these issues and instead narrows its focus upon a more limited set of questions that emerges from the consultation.
Dr. David Albert Jones
Anscombe Bioethics Centre, Oxford
13 July 2010