No consent should be needed for using leftover body material for scientific purposesForAgainst
BMJ 2002; 325 doi: https://doi.org/10.1136/bmj.325.7365.648 (Published 21 September 2002) Cite this as: BMJ 2002;325:648
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Editor,
The debate over the consent requirements for using leftover body
material [1,2] is well timed given the current government consultation on
the removal, retention and use of human organs [3].
The tension between pursuing public benefits and the wish to promote
patient autonomy and protect patient rights is a real one that cannot be
reasoned away. Your ‘For and against’ contributors demonstrate that the
precedence given to either value is very much a personal perspective.
Moderate people will recognise that public benefit or personal autonomy
can never be absolute criteria since the concrete application of either
value will result in folly. We believe the ‘For and against’ authors are
moderate people; they recognise the need for balance and, it appears,
essentially agree with one another.
There are very real examples of harm resulting from un-consented use
of tissue, but there are also very real examples of un-consented use of
tissue resulting in great benefits without any evidence of harm. The use
of irreversibly anonymised specimens, that would otherwise be discarded,
for the national surveillance of HIV and hepatitis infections has been
ongoing in the UK since 1990; over seven million samples have been tested,
six annual reports published and much has been learnt about the changing
distribution of these viruses in the UK population [4]. As coordinators of
these studies, we are not aware of any adverse impact on individual
patients or on the relationship between patient and doctor. The key point
is in the opening line of the ‘against’ piece [2]. What is important is
what we ‘do to patients’. Using leftover tissue without explicit consent
may or may not ‘do’ something to an individual. In theory any tissue that
contains DNA, including discarded tissues such as hair and nails, could be
used for purposes that might seriously harm the patient. But it is
eminently possible to protect patients without blanket requirements for
explicit consent.
The use of leftover tissue without explicit consent is not, as
suggested by Savulescu [2], an attempt to enforce morality. Rather, it is
a pragmatic solution developed by scientists providing necessary public
benefits. Compromises between personal liberty and public good abound in
our society and there is no reason that health should be an exception.
Yours truly,
Dr Peter Horby
Consultant Epidemiologist
Dr O. Noel Gill
Consultant Epidemiologist
PHLS Programme for Unlinked Anonymous HIV Prevalence Monitoring
HIV/STI Division
PHLS Communicable Disease Surveillance Centre
61 Colindale Avenue,
London NW9 5EQ
References
1
van Diest PJ. No consent should be needed for using leftover body material
for scientific purposes. For. BMJ 2002 Sep 21;325(7365):648-51
2
Savulescu J. No consent should be needed for using leftover body material
for scientific purposes. Against. BMJ 2002 Sep 21;325(7365):648-51
3
Human Bodies, Human Choices. The Law on Human Organs and Tissue in England
and Wales. A consultation report. Department of Health and Welsh Assembly
Government, July 2002. Available on-line at:
http://www.doh.gov.uk/tissue/choices.pdf
4
Prevalence of HIV and hepatitis infections in the United Kingdom 2000.
Annual report of the Unlinked Anonymous Prevalence Monitoring Programme.
Report for the Unlinked Anonymous Surveys Steering Group, Department of
Health, December 2001. Available on-line at:
http://www.doh.gov.uk/hivhepatitis/hivhepatitis2000.pdf
Competing interests: No competing interests
Ethicists, patient advocates, and legal experts have struggled for
years with balancing societal interests and needs in improving public
health through advance in medical knowledge and research with the
individual interest osf the patient, either in avoiding potential harm or
surprises associated with clinical research studies.The gap between
scientific and societal perspectives on body parts whether discarded or
taken as donation has been exacerbated by the often defensive reaction
from scientists.
In the famous example in Moore v Regents of the
University of California,(1) a patient sued his physician and a
biotechnology company for using his biopsied splenic tissue without his
consent and transforming it into a parental commercial cell line; the
court sided with the interests of the defendents on arguments for the
plaintiff does not have a property rights to the cell line, but the court agreed
that the researcher failed to adequately disclose the known use of tissue
in the consent process. However, federal government in USA has begun to
integrate cultural values and increased patient rights to control the use
of their body materials.
The research use of archived or discarded human
tissue samples in the era of genetic medicine is further complicated by
the fact that genetic information has ramifications that extend beyond the
traditional patient-physican and patient-researcher relationship.It also
includes duality related to family members (potential insurance
discrimination),and racial and ethnic affiliations which may lead to
prejudice and bias.The American society of Human Genetics and American
College of Medical Genetics recommend that individuals be asked whether or
not they wish to allow its anonymous use before tissue is taken from
them.
Ignoring cultural values and societal concerns is not in the best
interests of science and society.The prolifeation of disputes suggest that
social conceptions of the body serve important purposes for individuals and
society.(2)I am sure nobody in the world wants the surprise that Mr. John Moore
got in Californa in 1980.
1.Moore v the regents of the University of California et al,793 P2d
479(Cal 1990)
2.Anderson L,Nelkin D. Whose body is it anyway? Dispute over body tissue
in biotechnology age.Lancet 1998;351:53-57
Competing interests: No competing interests
Ms Duckworth challenges my argument that of the 27% whose wishes we
have not sought, most are perfectly happy for 'surplus' tissue to be used
in research.
This is not an assumption. As we gradually do manage to trace patients
when they come to their (infrequent) outpatient visits, of those who did
not reply to the questionnaire so far 32 out of 33 have given consent when
asked face to face, avoiding the bother of having to post a letter. That's
just 3% expressing an objection, approximately the same rate as in the
postal responses. So a failure to reply is not a way of voicing objection.
Given the argument of 'easy rescue' proposed on the supposedly 'against'
side of the debate, this surely means that those who can't be bothered to
reply can be assumed to have no objection? You can respect the 97% or the
3%, but not both; which is it to be?
Competing interests: No competing interests
In an ideal world, such as might be populated by the educated and
intelligent readers of the BMJ, informed consent to permit redundant
tissue to be used for research or teaching, etc, would be simple to obtain
from anyone whose religion or culture.
However, the UK is far from such a well educated utopia, and from
events such as Alder Hey it appears that many of the population attach
what appears to me to be an irrational and medieaval, if not pagan,
importance to the burying or cremating complete bodies. This is despite
claiming to be Christian, a religion where it is the soul rather than the
body which matters (for the record, I'm an agnostic). So I don't think the
'informed consent' approach will ever work with this element of our
population, for whom the heart will always rule the head.
I really don't care what has happened to my own redundant tissue, but
I'd be delighted if it has been put to good use. I'm just glad that I
don't have to store it until I peg out, as I assume the 'complete body'
brigade intend to!
Competing interests: No competing interests
I really don't see why the patient's consent should be obtained to
use her/his body material, which will eventually be discarded, for
research and teaching purposes. In our laboratory we have now stored
nearly 88,000 sera, which were originally sent for autoantibody testing.
Whenever I have to show my medical students or fellows-in-training how to
perform and interpret an immunofluorescence test to detect anti neutrophil
cytoplasmic antibodies (ANCA), I pick 2 positive and 2 negative sera from
the freezer and simply do the test with them. The same considerations
applies to research projects, i.e I want to try to identify the target
antigen(s) of liver disease-associated ANCA. In most cases I would never
be able to track the patients to obtain their consent, because sera are
sent to our laboratory from many clinics and departments of our and other
hospitals all over Italy.
Competing interests: No competing interests
Given how few people think ANYTHING through, it is no surprise that
most are unprepared for difficult decisions relating to their, and other
family members', dead physical remains post operation or death. Once
irrational grief has given way to the desire for vengeance doctors
beware!. Somewhat later comes that endemic sickness in Homo Erectus
called greed. Any excuse to blame someone else for the misfortune and to
gain financially by the same is taken. Fairly obviously, the real tragedy
is that access to human tissues, particularly infant tissue, will become
increasingly difficult so teh knowledge and skills base of the
paediatricians MUST decline.
I really believe that doctors have no option but to retain body
tissues without seeking consent. Getting the herd to think this one
through quietly and well before the event is probably not possible. I
speak as one whose left eye went into the hospital incinerator some years
ago and whose marfanoid remains, I hope, will provide medical students in
the future the chance to work with some material that will contribute to
their knowledge base as physicians.
Tal Golesworthy
C Eng M InstE MRSC
Competing interests: No competing interests
Working in New Zealand one soon realises that there are significant
cultural issues involved with the use of tissue for teaching and research.
A number of my patients do not consent to tissue obtained during surgery
being kept for future diagnostic purpose, teaching or research. Instead
they request that the material be returned to them for burial. They have
explained this to me as is in keeping with the traditional Maori value of
"Wairuatanga" (Spirituality).
Secondly, for to argue that, "Alder Hey apart, this practice has not
caused protest" is incorrect. When Green Lane Hospital in Auckland
publicised the fact that a significant number of paediatric hearts and
other organs had been retained after postmortum for teaching and research
purposes, howls of protests were heard and elective paediatric cardiac
surgery was temporarily halted.
Competing interests: No competing interests
EDITOR-- Experience tells us that most patients would like medical
care to improve, and furthermore most patients willingly facilitate this
improvement, often by assuming major risks. Savulescu’s recent discussion
deals with a different issue – accommodating the preferences of a small
group of patients who want the benefits of advanced medical care, but
apparently do not want to make even the simplest contribution to the
further development of that care.1 Savulescu mentions the moral duty of
“easy rescue”, which potentially provides a basis for deciding whether
refusal of consent to donate waste tissue is morally acceptable behavior.
However, he then concludes that “morality should not be enforced”. This
conclusion left me wondering if Savulescu has difficulty coming to a moral
judgment only when faced with patients who feel strongly that they should
not participate in the “easy rescue”, or does his moral pacifism apply to
other areas as well?
Savulescu suggests that “education” may help with the problem of
refusals, but because we do not know that refusal is a result of a lack of
any specific body of knowledge, exactly what would be the form or the
effect of this education? It is possible that the patients who answer “no”
to donating their tissue are not the easiest group to perform any other
type of study on, and the study by Stegmayer and Aspund does not address
the question of why such people say “no”.2 Is there believable evidence
of a betrayal of trust that has resulted in objective patient harm from
studies done on waste tissue, meaning that those people offering a “no”
answer are simply the best informed patients? Is the problem to be
addressed one of innumeracy, in which case modifying behavior would
require a substantial mathematical education to transform these people
into willing participants. Do these patients know little or nothing about
science, and if so, how should they be educated? What if this refusal is
usually a manifestation of a psychiatric disorder.
Obviously society’s
response should vary substantially depending upon whether the “no” vote
results from modifiable ignorance, refractory ignorance, recondite
identification of dangers, or simply neurosis. At present, government has
largely formulated the problem as one of how to sort willing participants
from non-participants, with immoral behavior defined not as refusal to
donate, but as research use without formal patient consent. The result is
a large, intrusive, legalistic and expensive bureaucracy grafted onto
clinical research.
Elliott Foucar, surgical pathologist
University of New Mexico School of Medicine, Albuquerque, NM 87106
foucell@aol.com
1. van Diest PJ, Savulescu J. No consent should be needed for using
leftover body material for scientific purposes- for- against. BMJ
2002;325:648-651 (21 September)
2. Stegmayr B, Asplund K. Informed consent for genetic research on blood
stored for more than a decade: a population based study. BMJ 2002;325:634-
635 (21 September.)
Competing interests: No competing interests
I underwent an appendicectomy in 1997, aged 27, and naively the fact
that samples of my redundant appendix might be kept, for whatever reason,
never crossed my mind. I am a great believer in the benefits to be gained
from robust, systematically performed medical research but on the
publication of the research performed by Hilton et al into the
accumulation of prion protein in tonsil and appendix tissue samples, I
find that tissue from my appendix could well have been used as part of
this research (I have no way of knowing for sure as my consent was not
sought and the research is anonymised). Now I find myself, somewhat
irrationally, wondering 'Am I the One?'in whom an accumulation of prion
protein was found?
Competing interests: No competing interests
The dog-in-the-manger generation
The debate on retained tissues for research and teaching is at the
wrong level. It is not
simply a matter of whether the patient's property (body specimens) is kept
by the clinician
or pathologist.
In every clinical encounter, there is a learning involvement of the
clinician. Existing
beliefs may be either reinforced or challenged. This learning accumulates
for that
clinician and others, providing more evidence for future management of
patients.
To single out tissue retention as requiring patient consent is
without any but the crudest of
materialistic reasons. Knowledge is one aim of the clinical encounter,
and it is the real
justification for retention of case notes, test results and specimens
alike.
Without such knowledge gained from previous generations of clinicians
and patients, there
would be no basis for treating our present patients.
Why should some patients in this particular generation opt out of
what has been so useful
to them? Why the apparent dog-in-the-manger attitude? Are these people
motivated by
greed? I hope not. Are they simply ignorant or confused? Perhaps.
Where do they
think the expertise has come from to treat their own problems? Should
they be allowed to
benefit from knowledge acquired from previous patients without
contributing in the same
way to the welfare of future patients?
Competing interests:
(1) My health in part has depended on samples removed from previous
patients to give
me a better life.
(2) So has my wife's health, and that of many people known to me.
(3) I also make use of tissue specimens and the results from tissues
removed from my
patients and those of other clinicians, for the benefit of my patients and
my students and
their patients in the future.
Competing interests: No competing interests