Consent to using human tissue
BMJ 2003; 327 doi: https://doi.org/10.1136/bmj.327.7418.759 (Published 02 October 2003) Cite this as: BMJ 2003;327:759
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Sir,
I wrote the 'universal consent form' below a few years back, almost
in a fit of pique, late one Friday afternoon after trying to produce a
single form of consent for genetics in the aftermath of Alder Hey, but it
would now seem germane in view of Prof Furness' leader on consent to
tissue and the general theme of the BMJ this week.
A major part of my work as a clinical cancer geneticist depends on
testing archival material from tumours to diagnose familial cancer. The
surviving relatives I see in clinic are invariably pleasantly surprised
and only too thankful that pathologists have kept such material in the
past. Those recently diagnosed with tumours are most impressed to find
out that recently introduced tests, developed using archived tissue, can
help diagnose familial cancer traits.
A year ago, at another hospital, I had a cholecystectomy - on my
teaching hospital consent form I specifically added that I would be upset
if my operation/case/tissue was NOT used for teaching and research.
Afterwards, my histopathologist colleague didn't know how to get my gall
bladder and stones bottled for teaching purposes because 'we don't do it
any more, sorry', so it now resides on the shelf above my head, in its
original plastic pot.
Yours,
Ian Frayling
Dr Ian M Frayling MA MB BChir PhD MRCPath
Consultant in Genetic Pathology & Director of Clinical Genetics
Laboratory
"By signing this I agree that my doctor is a reasonable person,
applying common sense and trying to do their best in circumstances for
which society takes collective responsibility. My doctor will attempt to
do the best they can, but I accept that nobody is perfect and human beings
are only human. In particular, any effective treatment is not without side
-effects and all tests are fallible; in an attempt to reduce risks to a
minimum, I understand drugs and procedures may have been tested on
animals, first. I accept that my doctor may not mention every possible
side-effect or complication because life is too short and they
understandably wish not to worry me unnecessarily. My doctor or their
delegate(s) can access and/or make available to others anything of use to
my situation, me, my family or other humans or animals. For medical
science to progress I accept clinical trials are necessary, but I will not
complain if my case cannot be included in a clinical trial or study. Any
tissue, gas, liquid or solid removed/expelled/exhaled/evaporated/derived
from my body ceases to be my property; I understand that my body is no
different from any other organism, in that ultimately all its components
will be recycled in, for example, the carbon and nitrogen cycles. I agree
to a post-mortem examination of my body, given that that is the only way
of finding out what really went wrong in the end, and that it will benefit
society as a whole, if not my nearest and dearest as well. All this does
not affect my right to sue for damages in case of, for example,
negligence, but I take responsibility that the overall cost of thus
disaffecting the system may ultimately be to mine and everyone else's
disadvantage."
Competing interests:
Doctor, pathologist, patient and member of society
Competing interests: No competing interests
Patient consent to the use of human tissue taken from NHS patients, and stored for research purposes
Rapid response: Furness, P. Consent to using human tissues. BMJ
2003;327:759-760 (4 October)
Patient consent to the use of human tissue taken from NHS patients,
and stored for research purposes
Nicholas J.Wald, Professor and Head of Department of Environmental
and Preventive Medicine, The Wolfson Institute of Preventive Medicine, St
Bartholomews and the Royal London School of Medicine and Dentistry.
Carol Dezateux, Professor and Head of Centre for Paediatric
Epidemiology and Biostatistics, Institute of Child Health.
Ann Bowling, Professor of Health Services Research, University
College London Medical School, Royal Free Campus.
Peter Furness [1] argued that the use of tissue specimens from
living patients is likely to be severely limited by the proposed new
regulations which will replace the 1961 Human Tissue Act [2]. We agree.
It is likely to damage medical research and public health surveillance.
The problem arises from introducing a requirement to obtain consent for
the use of data and samples routinely collected.
Furness further raises the impracticality of obtaining consent to the
use of human tissue in teaching, laboratory quality control and research
[1]. The DoH document on the use of human organs and tissue states that
“Organs and tissues should be removed, retained or used only for purposes
for which patients have had the opportunity to give valid consent“ [2].
This apparently includes blood and urine samples. The paper continues that
this implies that patients must be provided with explicit information
about this, have the opportunity to ask questions and be able to give
consent or register their objection [2]. Exception may apply for ‘quality
assurance, in-service training, formal education, public health
surveillance and investigating the performance of laboratory test kits’.
Distinction between surveillance and research may be hard to define and
these fine distinctions may prove to be to the detriment of public health.
As Furness suggests, the proposed new regulations seem to have taken
consent to participate in clinical trials as the model even though this is
inappropriate for non-interventional research using existing samples since
there is no possibility of harm given that patients’ identities are not
revealed. While in-service training and quality assurance and audit
would not require specific patient consent other non-interventional
research would do so, even though the procedures and the implications for
the patients are the same. This is inconsistent. Public health
surveillance, which includes testing tissues (such as blood or urine)
that are left over from clinical tests, would be jeopardised. The DoH
document also states that ‘Patients have the right to ask for their
samples not to be included in such surveys’ [2]. Such an “opt-out”
provision may affect the validity of the research (since patients who opt
out might be those whose outcomes or exposure differ in important ways to
those who agree) and so prevent it from being done altogether.
Of course patients should be given clear information about what may
happen to remnant blood samples and other similar samples. This does not,
however, mean that patients should have the right to demand withdrawal of
their data or samples when this would have no detrimental effects to
themselves yet be of great value to improving medical care. It divorces
rights from responsibilities and, in effect, sanctions selfish behaviour
that needlessly jeopardises the collective good. Requiring consent to the
use of identifiable remnant samples would have prevented much valuable
research such as the discovery that high AFP can be used to screen for
open neural tube defects or that H pylori infection is associated with
stomach cancer (critical evidence in showing that the infection is a cause
of stomach cancer). It may not be widely recognised that often the
research idea only emerges after the samples have been collected, when it
may be impossible to obtain explicit prior consent. How can it be right
to abandon a worthwhile research project that would cause no one harm?
Residual tissue or samples such as blood, serum, saliva and urine
should be allowed for use without consent provided this is for medical
research conducted by a person under a professional duty of care (i.e. who
could be suspended from a professional register for a material breach) and
on the basis that no person will be identifiable in the results of the
research so there is no possibility of harm or embarrassment arising from
the research. There should be a clear public statement on this so the
public are aware of the position and the safeguards regarding
confidentiality.
The objective should be that all observational medical research
should be permitted without consent subject to enforceable professional
guidelines such as those in the Royal College of Physicians Working Group
Report [3]. This would be simple, clear, protect the rights of individuals
and encourage valuable research, and also consistent with the utilitarian
ethical principle of action for ‘the greater good’.
We have written to this effect, along with 66 co-signatories, to the
Chief Medical Officer at the Department of Health.
References
1. Furness, P. Consent to using human tissue BMJ 2003;327:759-760 (4
October).
2. Department of Health. The use of human organs and tissue. An
interim statement, London: Department of Health, April 2003.
(www.doh.gov.uk/tissue/
3. Royal College of Physicians Working Group Report Independent
ethical review of studies involving personal medical records. J. Royal
College of Physicians of London, 1994;28:439-443.
Competing interests:
None declared
Competing interests: No competing interests
Professor Furness highlights the concern felt by many in the NHS and
Universities about the current regulations for the use of human materials
in research (1). In our practice over 300 patients have been consented
for use of surplus segments of artery and vein following coronary artery
bypass surgery for research purposes. Over 99% of patients have agreed to
take part in the research project.
Two patients refused to consent to the research. Both felt that the
consent process compounded pre-operative anxiety to the point that they
were unable to discuss matters further. In neither case was there a
fundamental objection to the retention of surplus tissues for research.
One of the patients felt strongly enough to make the comment that 'he was
now upset as he would not be helping patients in the future.'
With the current political climate (following events at Bristol and
Alder Hey), and the rigorous current regulations, research using human
tissue has become increasingly difficult. This risks stifling any
advancement in the field of cellular and organ pathophysiology
In our experience and that outlined by Professor Furness there is an
overwhelmingly positive response from patients for the use of human tissue
for research. Thus, we believe that with ethical committee approval
implied consent should suffice for research projects. This would avoid
unnecessary patient anguish, at an already stressful time and allow a more
efficient utilisation of research time.
Currently it is ethical to accept implied consent to use surplus
tissues for quality control (2). It therefore follows that it is ethical
to use implied consent for research purposes. In the long term it is the
patient that will benefit.
References
1. Furness P. Consent to using human tissue. BMJ 2003; 327, 759-760.
2. Department of Health. Good practice in consent implementation
guide: consent to examination or treatment. London: Department of Health,
2001. www.doh.gov.uk/consent/implementationguide.pdf (accessed 07 Oct
2003). (Tissue section, p 23.)
Competing interests:
All of the authors are involved in research using surplus human tissue
Competing interests: No competing interests
It is interesting to see how the arguements have evolved since the
celebrated cases, which triggered off this debate. It is also extremely
ironic that the consent issue over post mortem tissue has such an
emotional element resulting in a relatively low response. One can
understand this in most circumstances however it is not a good principle
to encourage the idea of ownership where it comes to human remains. This
idea has gained ground in during the last few years and has been promoted
by a number of commentators who have been seeking to take advantage of
public sensitivity over the issue.
One does not wish to be insensitive where it comes to human tissue
but I am troubled by the consequences of 'delegating' decisions on
sensitive issues to a public that has been pulled in all directions often
with scant regard to the fundamental values that are at stake. Of course
there is now the mater of the genie that cannot be put back in the bottle
and positions that have become entrenched.
Will it now be possible to reverse the damage that has been done? I
think that the only course of action is to convince the public by means of
a coordinated campaign based on the undeniable fact that without proper
access to human tissue for research and audit we will all suffer in the
long term.
Competing interests:
None declared
Competing interests: No competing interests
I agree with Dr. Knowles that it is essential to have names of
patients with Cellular Pathology requests. I am proud that every cytology
slide and histology section in this lab bears the patient's name as well
as a unique number. Our lab has recently enforced minimum labelling
requirements - name, DOB and NHS number or hospital number. We had an
interesting incident recently when a GP submitted specimens from three
different patients but gave them all the same NHS number.
The name on the slide indicates exactly who that tissue comes from. I
find it very hard to understand the politically correct thrust for
anonymity when patients themselves do not demand it; rather they are
becoming more open. It has become a rarity for us to receive an anonymous
cervical smear from the G-U medicine department. G-U medicine patients are
asked whether they want to withhold their name from the lab. These days
very few do; evidently they trust us.
Withholding names from laboratory or other health care staff would be
a further step in the dehumanization of medicine. Pathologists and other
lab staff remember and use names as much as any other doctor. A name can
immediately give me recall of past medical history and previous specimens
which a number just would not do. Anonymity would not do justice to the
vast majority of patients who are happy for their name to be used. It
would not give them the choice to be known by their name. A very common
complaint by hospital patients is that they do not want to be "just a
number" - they want to be known by their name! If someone who wants my
opinion does not trust me with their name why should I trust them with my
name?
I entirely agree with Professor Furness and others that use of
surplus tissue and cells should be governed by implied consent. Otherwise
we are imposing a huge burden on health care staff, both in clinics and
laboratories to collect and record consent data, which I am sure most
patients would think was a waste of valuable time and money.
Competing interests:
Consultant Pathologist hoping to still be able to train new medical, laboratory and other staff.
Competing interests: No competing interests
In this for UK standards provoking article “Consent to using human
tissue“ the right arguments have been put forward illustrated by good
examples, why, in case of using left over tissue for medical science, most
of the consent procedures ask too much for too little. It shows how
consent procedures can be out of balance. Consent procedures have
initially been developed to protect the interests of patients. Offering
protection against involuntary use of their tissue for scientific
experiments as main interest. In later stages other aspects emerged making
most consent procedures too elaborate, using scarce resources of
scientists and medical staff and therefore become an obstacle for doing
even the most simple translational research experiments. The consequence
is of the consent procedure is that it protects the patient from
involuntarily use of there tissue, but in the long term harms the patient
and future patients in innovation of their treatment.
The solution here suggested “implied consent” looks very similar to the
“Code Proper Secondary Use of Human Tissue” developed by the Federation of
Medical Societies (FMWV) in the Netherlands. The Code was developed by
bringing together all interest groups for secondary use on left over
tissue. The consent procedure if tissues are coded linked is based on an
opt-out system and forms a good balance between patient interests and
scientific interests. As suggested, it can properly serve the small number
(0.06%) of people who refuse their use tissue for commercial scientific
purposes. People visiting the hospital are informed by a flyer, which can
be found in waiting rooms and can even be handed out before undergoing
surgery, describing the possibility that the patients left over tissue can
be used in scientific medical experiments. In case the patient objects
against the use of their tissue, they can fill out a form included in the
flyer and send it to the hospital administration. The data on the form is
entered in the hospital database and is checked against the contents of
left over tissue banks. Tissues stored for experimental use derived from
objecting patients will be destroyed.
It offers protection against involuntary use and because it is not an
elaborate and expensive procedure it allows translational research, from
which hopefully the patient and future patients can benefit. In this way
scientists and medical staff can fulfill their duty towards the patient to
find ways to make the health care system better by using their scarce
resources for performing translational research on left over patient
material.
In addition, this opt out system of consent, when making use of coded
linked tissues, protects healed patients or worse, in the unfortunate case
the patient has deceased, their family against unwanted and ethically
difficult to defend questions concerning the permission to use left over
tissue.
It is of course instrumental that the flyer properly informs the public on
the terms of the use of their left over tissue. It also gives the
opportunity to make layers in the form of consent by letting people chose
from a list of different possibilities, e.g. informed consent, commercial
use etc. The text of the Code Proper Secondary Use of Human Tissue is
available in English on the Internet:
http://www.fmwv.nl/
Competing interests:
None declared
Competing interests: No competing interests
I agree with Peter Furness. The pendulum has swung too far in the
direction of autonomy, at the expense of the duty of the individual to the
greater good. My training and several of my research papers depended
upon an assumption that tissue taken at surgery could be used for (non-
malificent) research and teaching.
But here we are, in 2003 and we must make the most of the culture in
which we live and work. Our professional insensitivity to changes in
community values was used as a defence against more serious accusations
arising from Bristol and Alder Hey. We cannot use the same excuse a
second time.
Professor Furness has raised a point about duty which, far from being
scurrilous is, in my opinion entirely arguable. I am attracted to his
analogy with taxation, so here’s my suggestion:
A. Those individuals who decline to allow the constructive use of
their tissues should be taxed at a higher level.
B. Conversely, the Professor should be allowed to remove 0.45Kg of
tissue from any individual found in criminal breach of tax law for use in
research without further consent.
Simon Knowles
Competing interests:
I sit on a local research ethics committee and I still try to do a bit of research when I'm not banging on about consent.
Competing interests: No competing interests
Dear Sir,
It is now mandatory for consultant pathologists in the UK to take
part in one or more External Quality Assurance (EQA) Schemes before being
allowed to undertake certain types of work. Unsupervised reporting of
cervical cytology and breast screening histopathology are two examples.
The purpose of these schemes is to identify at an early stage poorly
performing pathologists before they cause actual harm to living patients
and act as an educational tool as part of continuing professional
development. Most of the material is from resected tissue or routine
cervical smears but may include post mortem material in some instances.
Although the slides that are circulated to participants are
anonymised, some linkage to the original patient is essential in some
cases so that follow up or further biopsy may verify the original
diagnosis. However, much of the recent guidance on the use of human
material could potentially threaten these schemes.
It is ironic that the very institutions that on the one hand impose
these schemes to improve standards, on the other make it impossible to
utilise tissue for anything other than diagnostic purposes without
specific consent to do so. It is not only the teaching autopsy that is
under threat by this very restrictive legislation but all forms of
education for students and doctors. In the end it will be the patients
that are the overall losers.
Competing interests:
I take part in and contribute material to several EQA schemes to maintain and improve standards in histopathology and cytopathology in the UK.
Competing interests: No competing interests
As the author of this article, naturally I agree with Dr Knowles and
De Heliwell and I am grateful for their supportive comments. Concerning
anonymisation, Dr Kerr proposes a solution which is sort of just about
workable if, as Dr Knowles rightly points out, histopathologists cease to
have clinical contact, which in my view would be disastrous. And it’s not
a solution which would satisfy the latest published proposals from our
Chief Medical Officer (reference 13 in the editorial).
But there’s a more fundamental problem with the very variable
understanding of the term ‘anonymisation’. Much of the recent literature
on this subject accepts anonymisation as an alternative to explicit
consent only if it’s irreversible. Anything less – such as Dr Kerr’s
proposal – is ‘linked anonymisation’ or ‘secure coding’, and would still
be seen by many as inadequate to permit research use of tissue samples.
Irreversible anonymisation poses numerous problems. Quite apart from
the limit it puts on the power of research, especially translational
research, it can sometimes be positively unethical, notably because it
prevents feedback of useful information. I have several examples, perhaps
the most notable being where an ethics committee’s unthinking insistence
on irreversible anonymisation quite possibly led to the failure to detect
a baby with neonatal hypothyroidism. If that happened – and we will never
know - then in my opinion the ethics committee was responsible for brain
damage in a child. When ethics committees say ‘no’, it is not always an
ethically ‘safe’ decision.
But my other purpose for commenting is to toss into the ‘rapid
responses’ a scurrilous thought which it just wouldn’t do to put in a
formal editorial.
Running the UK’s National Health Service obviously requires money.
So we all pay taxes. Anyone who exercises their personal autonomy by
refusing to pay taxes is a criminal. Society regards such people as
selfish and immoral and would ultimately put such an individual in prison.
Running the UK’s National Health Service also requires human tissue,
at the very least for teaching, training and laboratory quality control,
even if we do let other countries do the research. So how do we feel
about those who exercise their autonomy by refusing to allow the NHS to
use resected tissue to keep the NHS running, by insisting that it must be
incinerated???
Actually I think it’s great that the altruism of the majority means
that we can allow individuals the choice of deciding what happens to their
tissues. If only we could do the same with taxes! But let’s be clear;
IF you want the benefits of a modern health service, then controlling the
use of resected tissue is a privilege granted by the generosity of others,
not a basic human right.
Any comments?
Peter Furness
Competing interests:
The authos is involved in non-commercial research using human tissue
Competing interests: No competing interests
Implied consent or objection
Views of ethicst and new regulation can paralyse the arms of
histopathology.
Kennedy inquiry at Bristol Royal Infirmary and Redfern inquiry at the
Liverpool Children Hospital adds to the over-reaction in the mind of
people.The balance of wishes of people and research has to be elaborately
discussed.
Huge archive of sample of human tissue,organ are coorelating with the
scientific research .Examples like archived autopsy of 198 soldiers helped
to determine 1918 influenza pandemic.Auerbach's lung autopsy demonstrate
the significance of smoking in the dysplasia in bronchial tissue.
We have to see the participants in research should be respected and
an adequate research design may make the purpose more acceptable.
An effective oversight system is required to protect the needs of
participants and also get approved ethically.
This will indeed help the rationalisation and positive outcome of
histopathology research .
Dr Gargi Sanyal
Competing interests:
None declared
Competing interests: No competing interests