Policy responses and statements
- Name of organisation:
- Nuffield Council on Bioethics
- Name of policy document:
- Give and take? Human bodies in medicine and
research - Consultation paper
- Deadline for response:
- 13 July 2010
Background: Should more people be expected to donate
organs, eggs and sperm and, if so, how far can we ethically go in encouraging
them to donate? The Council would like views on how we should respond
to the current demand for organs, sperm, eggs and other human material
for use in medical treatment and research.
The Council is interested in a number of questions, including:
- How far should we as a society go in encouraging or even incentivising
people to provide material?
- What control should a person providing material have over its
future use?
- Can useful comparisons be made with people taking part 'healthy
volunteer' clinical trials where people 'give over' their body for
a short time for research purposes?
The Nuffield Council on Bioethics has established a Working Party
to examine the ethical issues that arise in connection with a person’s
decision to ‘donate’ some part of their body (including
whole organs, eggs and sperm, blood, and other bodily material such
as bone, skin, heart valves and corneas) or to ‘volunteer their
body’ through participation in ‘first-in-human’ clinical
trials of new medicines.
The Nuffield Council first discussed some of these issues in its 1995
report ‘Human tissue: ethical and legal issues’, which
considered ethical concerns across a wide range of possible uses of
human bodily material. Fifteen years later, after considerable scientific,
social and legal change, the Council feels that it is timely to return
to this field, focussing specifically on the ethical issues that arise
for the individuals concerned, when a person comes to make his or her
decision to provide bodily material or volunteer for first-in-human
research. In particular, it is interested in exploring the regulatory
differences between providing eggs or sperm, providing other forms
of bodily material, and volunteering for first-in-human research, and
in considering whether or not such regulatory differences can be justified.
Any form of human bodily material that may be provided for the benefit
of others in medicine or research is potentially within the remit of
the enquiry, although clearly some forms of material, or the circumstances
in which they are provided, will raise more pressing ethical questions
than others. The primary focus of the enquiry is within the United
Kingdom, although some aspects will inevitably cross national boundaries.
Factors being considered include:
What degree of encouragement to provide human bodily material or volunteer
in a first-in-human trial is ethically acceptable? Is there a point
at which it must be accepted that supply cannot meet demand?
What is required for a valid consent to provide bodily material or
to volunteer? What might undermine a person’s consent?
What future control can the ‘donor’ or ’volunteer’ reasonably
exert, for example over later uses of donated material?
What policy implications are there for government, and for intermediaries
such as the NHS, pharmaceutical companies, biobanks and private fertility
clinics, in a global context where activities that are banned or tightly
regulated in one country are permitted in another?
What consistency of approach should there be, both across the different
forms of donation/volunteering and across the different purposes for
which people donate/volunteer?
The Working Party requested views from anyone who has an interest
in this field, whether professional or personal. The consultation document
provides background information and raises questions on some of the
issues the Working Party is currently considering.
COMMENTS ON
NUFFIELD COUNCIL ON BIOETHICS
GIVE AND TAKE? HUMAN BODIES IN MEDICINE AND
RESEARCH - CONSULTATION PAPER
The Royal College of Physicians of Edinburgh (RCPE) is grateful for the opportunity
to respond to this consultation paper on the ethical issues associated with
the use of human bodies in medicine and research. Bioethics are subject
to personal beliefs as well as professional opinions, and individuals can hold
opposing yet valid views. The RCPE sought responses from its Fellows,
and there was sufficient broad agreement to generate this collective response. The
clinical expertise of the physicians responding is heavily weighted towards
the organ donation issues rather than the other areas in the terms of reference,
such as sperm and egg donation. The responses of the RCPE to the 30 specific
questions asked are detailed below.
1. Are there any additional types of human bodily material that could
raise ethical concerns?
No. However, the issue of participation in neurological
research during life prior to brain donation for research study after death
was thought worthy of specific reference.
2. Should any particular type(s) of human bodily
material be singled out as ‘special’ in some way?
Life-generating material (ie sperm, eggs and embryos)
is clearly different and “special”. In the future, cloning from stem cells may
blur the margins as other tissue may potentially become life-generating. However,
that is so far in the future and the implications in terms of ownership and
relationship so huge that it is not discussed further. If the reason
to single out sperm and eggs is because of future issues linking the donor
to the beneficiary (ie a new child), non-reproductive tissue donation could
also have consequences linking the donor to the beneficiary eg transmission
of infection. Therefore, there is scope for research into whether the
public regard the two as different. However, the consequence and implications
of donation of reproductive and non-reproductive tissue remain fundamentally
different.
Brain tissue would be regarded by the lay public as special
because it is the source of thought and consciousness. However, brain transplant (as
opposed to donation of brain material for research) is not even on the horizon. There
is lay concern regarding transmission of donor characteristics by organ donation
eg between opposite sexes. This is a legitimate concern even although there
is no scientific evidence to support it.
3. Are there significant differences between providing human bodily
material during life and after death?
Yes. Firstly, there is a difference in the risk to the donor. There
is no risk after death, although there remains lay concern, however unjustified,
that agreement to donation after death will influence end-of-life care. Secondly,
there is a potential difference in the nature of consent. The RCPE’s
view is that consent should not be different in the two circumstances. This
is supported by the Human Tissue Act which gives the individual the final say
regarding donation, either before or after death, which should not be able
to be over-ruled by others eg relatives 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?
The risks, and to a lesser extent the benefits and costs,
dominate the medical discussion about potential live organ donation. Risks to health are perceived
very differently by individuals, making it difficult to generalise, and between
potential donors and their medical team. Often the donors themselves
are willing to accept far higher risks than the medical profession.
The benefits, which are real and documented, include
the “feel-good” factor
which goes with an act of altruism and, in the case of donation to relatives,
direct benefit to the family unit.
Costs are usually considered only in immediate financial
terms eg time off work. There would be a risk of future costs and liabilities
if anonymity of the donor is not preserved. This is one reason why
the RCPE favours the right to anonymity of the donor.
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?
It is not immediately obvious that first-in-human trials
should be included in this discussion, despite the justification that the
body of the participant is “on loan” for experimentation during such studies. If
so, then the costs are actual expenses incurred, including loss of income;
the risks are adverse reactions to the drug, making such research only ethically
acceptable if standards of safety and monitoring are high; and the benefits
are both tangible eg payment for volunteer studies and also intangible eg society
benefits from medical advances.
All this refers to the usual situation of first-in-human
studies being in healthy volunteers. In the rare situation where these studies involve
patients, there is concern that such patients may have false expectation of
benefit from a new treatment, whereas first-in-human studies are usually designed
for dose-finding and safety rather than treatment efficacy. Therefore,
in this unusual situation, the limited benefit to the patient must be explicit
in the informed consent.
6. Are there any additional purposes for which
human bodily material may be provided that raise ethical concerns for the
person providing the material?
No.
7. Would you be willing to provide bodily material
for some purposes but not for others? How would you prioritise purposes?
There is theoretical logic to prioritising the purposes
eg life-saving ahead of life-prolonging or life-enhancing. However,
in reality which purposes are chosen are likely to be determined by individual
experience eg research on a disease suffered by a friend or relative.
This touches on whether organ donors should be allowed
to specify to whom material can be donated. Living organ donation is usually directed to
a relative (or close friend) of the donor, but it is considered unethical,
even immoral, to specify types of recipients for receipt of organ donation
after death eg only to certain racial groups or not to people with self-inflicted
disease (eg alcohol misuse). Such practice is correctly illegal on the
grounds of unacceptable discrimination.
With regard to living organ donation, current UK guidance
does not permit altruistic but directed organ donation. Altruistic non-directed donation
(for example choosing to donate a kidney to an unidentified stranger), though
rare, is allowed, as is the far commoner situation where an individual donates
a kidney to a close relative or friend ie fully directed donation. These
two situations represent two ends of a spectrum and therefore
it would seem ethically sound to also allow donation between two individuals
with intermediate, more tenuous relationships, providing the principles of
avoiding coercion are maintained.
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 theory, one might prioritise on the basis of the severity of the disease
for which the treatment is designed but, in practice, the choice is more likely
to be determined by personal experience.
9. Are there any other values you think should be taken into consideration?
One might add beneficence and non-malefience ie the need
for net benefit over harm. In the case of donating bodily parts, there is
no tangible benefit to the donor (disregarding the “feel-good” aspect
of donation), therefore applying this principal means there is an absolute
duty to minimise potential harm.
10. How should these values be prioritised, or balanced against each
other? Is there one value that should always take precedence over the others?
The RCPE does not have a consensus view on this. A case can be made
to give precedence to any one of justice, dignity and autonomy. This
emphasises the lack of a “right and wrong” answer. Although
the precedence of these values can be debated in abstract terms, all need to
be kept in mind in real-life situations.
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?
With regards to organ donation, this is often seen as
a “rich society
v poor society” debate. Rich societies with established welfare
systems have the luxury of moralising over the preferment for free rather than
paid donation. Poor societies may have no such qualms, and argue that
if autonomy is the right to choose, why should they not choose to risk donation
for payment which financially benefits them and their families? However,
the very real dangers of exploitation which would result from turning bodily
material into a marketable commodity override this argument. Therefore the
RCPE favours the current situation in the UK where sale of organs or other
bodily tissue is illegal.
For first-in-human research, some modest payment is the
norm and acceptable to the pharmaceutical industry and to most, but not all,
doctors. It probably is, morally speaking, better for participation to be
altruistic as it removes any questionable motives. However, it is only fair and practical that
compensation, usually financial, should be allowed for the inconvenience and
risk suffered. On this point, the industry guidelines specify that payment
should not be proportional to risk. This seems counter-intuitive, and
the RCPE question the reasoning behind that stance.
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?
The proven benefits of organ transplantation allow the
argument that organ donation after death could be perceived as a moral duty
unless the individual has specific and valid objections. For example, is it morally acceptable
to refuse to allow the use of one’s organs after death yet be prepared
to accept organ transplantation oneself if necessary? This leads to the “opt-in” versus
opt-out” debate ie whether the current UK situation, where organ donation
after death only takes place following specific consent, should be changed
to a system where such donation is the norm unless specific objections are
raised. However, the vast majority of the population favours organ transplantation,
and the UK initiatives to improve the process of donation within the current
legal framework are favoured by the RCPE. There is a risk that even if
arguments for these moral duties are philosophically compelling, they may be
personally counter-productive.
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?
The RCPE does not accept that participation in research trials could be viewed
as a moral duty.
14. Is it right always to try to meet demand?
Are some ‘needs’ or ‘demands’ more
pressing than others?
The key here is what are reasonable and acceptable means
of bridging the supply-demand gap. Within present-day medicine reducing
rather than abolishing the gap is a more realistic aim.
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?
The RCPE is opposed to direct payments for providing
bodily material. However,
non-financial recognition valuing their contribution is not only acceptable
but desirable. Recompense for financial costs incurred should take place, and
there is a grey area where such recompense could be modestly boosted to take
some account of their commitment. For participation in first-in-human
studies, see the response to Q11.
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?
See discussion about payment for organs, and the risk
of exploitation in Q11. Payment
for organs might well increase the donation rate but is a morally unacceptable
practice. For participation in research studies, payment is acceptable
providing it is modest. Large payments would run the same risks as for
organ donor payment, namely exploitation of the poor and vulnerable.
17. Is there any kind of incentive that would
make you less likely to agree to provide material or participate in a trial? Why?
No comment.
18. Is there a difference between indirect
compensation (such as free treatment or funeral expenses) and direct financial
compensation?
Yes, there are significant differences. At present in the UK payment
of expenses is allowable, but not beyond that. There is a grey zone where
reimbursement could “compensate” for risk (see answer to Q15). Payment
of funeral expenses for patients whose organs were donated after death has
been proposed as a financial inducement. Transplant doctors are divided as
to whether this “soft” incentive would be allowable to boost organ
donation, or whether it would be the slippery slope towards paid donation which
would therefore be unacceptable.
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?
Yes, see answers to Q15 and 19.
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 are potential developments undergoing research,
such as the generation of organs from stem cells. Such a development
would revolutionise the field of organ transplantation, but is still decades
away and, indeed, may never become a reality.
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?
Although there is a spectrum of views on whether such
encouragements and incentives are appropriate, the RCPE does not feel that
they would invalidate the person’s
consent, provided it was fully-informed consent.
22. How can coercion within the family be distinguished from the voluntary
acceptance of some form of duty to help another family member?
Covert coercion, by its very nature is not apparent. Whilst efforts
should and are taken to detect and negate overt coercion (in the case of living
organ donation by donor advocate multi-disciplinary teams), subtleties of
family coercion may be impossible to fully avoid. Coercion can work in
reverse, where the potential recipient dissuades his/her relative from donating.
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?
Current legislation allows the retrospective use of samples,
provided they were obtained as part of a study for which there is ethical
approval. It
has been suggested that it may be ethically acceptable to use human bodily
material in the absence of explicit consent if the donor is not and cannot
be identifiable, but the RCPE does not have a consensus view on this point.
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, these are very different situations. Because of the difficulties
of consent, children and adults without capacity would not usually donate organs
or tissue or participate in first-in-human trials. However, for donation
of organs after death of a child, the parents are the source of consent, which
is no different from the next of kin consenting to cadaveric organ donation
where the wishes of the deceased relative are unknown.
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?
The RCPE feel strongly that where the deceased’s wishes are known, relatives
should not have the right to veto or change that decision. That is the
current situation following the Human Tissue Act although, in reality, transplant
co-ordinators will not insist if relatives decline donation, even if the deceased
had registered his willingness by joining the Organ Donor Register. At
present, the decision to donate does lie with relatives if the deceased’s
wishes are unknown. Although many argue to rescind this process and adopt
an “opt-out” policy, this is not supported by most in the transplant
community despite the shortage of donor organs because it implies state ownership
of deceased persons’ bodies, and there is not the background understanding
and culture in UK society at present to support such a step (see also
the answer to Q12).
26. To whom, if anyone, should a dead body or its parts belong?
This question has been touched on in the answers to Q12
and Q25. Neither
the relatives nor the state “own” a deceased person’s body
in the conventional sense of owning property. However, the state does
cede responsibility for the body - eg funeral arrangements and costs - to the
relatives, implying that they in fact do have more “ownership” of
the body than the state. As indicated above, that current status would
change if an “opt-out” scheme were adopted: such a scheme is morally
acceptable in many countries, but doubts persist about its application to the
UK.
27.Should the laws in the UK permit a person to sell their bodily
material for all or any purposes?
No, as explained in Q11, the position in the UK is that
payment for organs is wrong and the RCPE does not wish this law to change. In
addition to the exploitation argument, part of the opposition to creating
a market for bodily material is that the gift status central to all altruistic
donation, whether of blood, organs or other tissue, would be lost.
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?
Companies have to make a profit to operate, but that must not be from income
generated by use of human tissue, as that would reduce the special nature of
such human tissue to a marketable commodity.
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.
Allowing individuals to exercise control over future
use of donated tissue is a minefield. The best option here is to cede
all rights to directing future use in exchange for preservation of anonymity
of the donor.
30. Are there any other issues, connected with our Terms of Reference,
that you would like to draw to our attention?
No.
SUMMARY:
The RCPE approves of the application of sound and fair ethical principles
in all matters associated with the use of human bodies in medicine and research. However,
the RCPE believes the issues raised in this consultation paper are too diverse
to fall within a single over-arching ethical code.
Despite the shortage of donor organs for transplantation, the RCPE does not
favour radical policy shifts such as adopting an “opt-out” system
for consent to cadaveric organ donation, or payment for organ donation (beyond
recompense for financial losses).
Copies of this response are available from:
Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.
Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939
[9 July 2010]
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