Examination of Witnesses (Questions 342
- 357)
THURSDAY 13 MARCH 2008
Lord Patel and Dr Janet Wisely
Q342 Chairman: We welcome
our guests, Lord Patel and Dr Wisely. Welcome. We are very pleased
that you have been able to come and help us with our inquiry.
So far we have quite a wealth of evidence but there are some details
which we hope you will be able to help us with today. Before we
start I have to go through a sort of housekeeping list. The first
thing for you to know is that we are going to be televised today.
We are looking forward to hearing from you because we do think
this is a particularly important inquiry. Just to remind you,
we are not looking at organ donation per se; our responsibility
is to look at the way the Commission is thinking about it but
to remember that we have to have some understanding of the baseline.
That is why it is very important that we understand the nature
of the work that you undertake as we move forward into our inquiry.
We have Professor Bobbie Farsides with us, who is our specialist
adviser, who will be helping us when we put the report together.
We are open to the public today. As you can see, we have vast
arrays of people at the back there. The material will be televised
live and on the parliamentary website and may be shown later on
TV parliamentary channels. As you know, a verbatim transcript
will be taken of your evidence and this will be put on the public
record. A few days after this session your office will be sent
a copy of the transcript and we would be grateful if you could
check it for accuracy speedily and return it. The turnaround,
as Lord Patel will know well, in this place is very speedy. You
can submit supplementary evidence after the session if you think
we have not understood or you wish to amplify or clarify any points
that we have not be able to do today. This room is not easy acoustically.
You can hear that I am speaking as if I am in a public place.
We would be really grateful if you could do that because we do
want to hear what you have to say. When you do start, could you
start by stating for the record your name and official title.
You may or may not wish to make a short opening statement, and
then we will go into the questions, of which you have a list,
although you know Members may ask alternative questions. I am
sorry that is so long and boring but it is important that we have
the ground rules to start with. Your areas are ones that we have
not really had a chance to look at in great detail, the National
Patient Safety Agency and the National Research Ethics Service.
We know that the first encourages greater transparency and accountability
and the second works with colleagues in the UK to maintain the
wider system of ethical review. Could you begin either by making
a statement if you wish to or go straight into the question, describing
the work, which I think probably is part of the statement, of
the NPSA and NRES which relates to issues associated with organ
donation and transplantation, and what are the specific ethical
issues that have been addressed in this field. Lord Patel, maybe
you would begin.
Lord Patel: Lord Chairman, thank you very much.
It is a pleasure to address such distinguished company. I think
we might just go to the questions that you have because it will
cover any statement that we might want to make. Dr Wisely is going
to take the first question you have, particularly in relation
to what the National Research Ethics Service is all about and
what it is for.
Dr Wisely: I am Janet Wisely and I am the Director
of the National Research Ethics Service. It is a division within
the National Patient Safety Agency. As you describe, the National
Research Ethics Service is responsible for the Research Ethics
Committees in England and works with colleagues in Scotland, Wales
and Northern Ireland to maintain a UK-wide system for the ethical
review of research applications. The last four years have seen
a period of significant change for the National Research Ethics
Service with the introduction of procedures to improve the efficiency
and effectiveness of the service provided to protect actual and
potential research participants. The National Research Ethics
Service provides operational support, funding, guidance, training
and quality assurance programmes for the ethics committees essentially
to ensure they are fit for purpose, but the ethics committees
themselves make independent ethical decisions on the research
applications. We have an administrative database but it is possible
through that, although it is not designed as a research base database
itself, to estimate from keyword searches that we have received
a relatively small number of research applications relating to
organ donation and transplantation, I estimate around 200 in the
four years from April 2004, which is less than 1% of the number
of applications that we have reviewed in this period. Of these,
90% of the studies have been approved by the research ethics committees
but with 65% of those first receiving a provisional opinion and
the ethics committee requesting changes before they could give
their approval. The majority of the studies identified were looking
at clinical outcomes around organ donation and transplantation,
with a smaller number looking at attitudes, risk perception and
longer term quality of life factors. In terms of the ethical issues
raised, they are, as you may expect, predominantly around the
issues of informed consent. We encourage the ethics committees
themselves to rely on the licensing process for the assurance
regarding quality and safety, and any of the studies that will
be reviewed by the ethics committee will have a licence in place
for the transplantation and organ donation itself. Therefore,
the ethics committees can focus on the additional ethical issues,
which will be around consent, including future use; the burden
on the individuals; support for the individuals; confidentiality;
and fundamentally to ensure that research participants fully understand
what will happen at each part of the research study, if they agree
to take part in it. Consequently, many of the issues raised by
the ethics committees relate to the participant information. I
thought it may be helpful for the Committee to hear some actual
feedback from some of these research applications that have been
ethically reviewed by the committees. The first is from a study
that received a favourable opinion after a provisional opinion
had been put in place and the ethics committees requested some
changes. The committee wanted to be reassured that patients had
consented for the future use of their blood samples for the studies,
and requested a copy of the clinical consent form used when patients
give blood samples for the transplant programme, and also asked
for any background to the clinical consenting process as we were
concerned that some of this may be verbal. A second study, which
received an unfavourable opinion for a number of reasons, but
including: the patient documentation did not provide sufficient
information for the patient and should explicitly detail what
will happen to the patient; it should detail all the extra hospital
visits, the number of blood tests, side-effects and any potential
risks. Finally, a third study that also received an unfavourable
opinion for a number of reasons, including: any data of patients
being used outside of the NHS, for example, on a home computer,
must be anonymised and the key to participants held separately
by the chief investigator; and a second point, the researcher
should disclose to all participants that she is a transplant recipient.
This raised questions for the committee on whether the researcher
may have a conflict of interest. I would like to draw to the attention
of the committee that, whilst these quotes are from correspondence
from applications relating to organ donation and transplantation,
they represent really issues that are generic to many of the research
applications that would be coming through the ethics committee
system.
Q343 Chairman: Lord Patel,
do you want to make any additions?
Lord Patel: No.
Q344 Chairman: Can I just
ask a supplementary question before we move on? One of the issues
that we have heard time and time again from witnesses to the Committee
is how you make clinical diagnosis on the safety and quality of
organs, and I just wondered, if you are having so little research
in that area, how that comparator information is gathered.
Lord Patel: I am not familiar with transplantation
and how they make this judgement about the safety of donation
of organs. We may be going into the second question to a degree
but if I might take it as such, the two bullet points in annex
A which the Directive wishes to establish, which relate to a common
set of quality and safety standards, and also means of ensuring
traceability and reporting of serious adverse events, and your
second question particularly related to what views we might have
in NPSA on the potential value of the EU Directive relating to
quality and safety I think is an important question. That is where
the supplementary that you ask spills over. Let me give you some
examples first of all, and you must take this with a little bit
of latitude because the numbers I am going to give you might well
be an overestimate, because the way safety incidents are reported
and the way we then access the data using the software can produce
an overestimate, depending on the people who reported the incidents
and how many times they might have used the term "transplant",
"safety", "incident", et cetera. After that
proviso, nonetheless, from October 2006 to September 2007 we had
800 patient safety incidents reported in relation to transplant
or donation, which is a significant number, you might say, but
remember what I said; there might be an overestimate. Nevertheless,
what is important when you break it down is that they fall into
treatment procedures, consent issues, and medication issues. One
particular example that I would like to tell you about is how
an error in putting data on a computer resulted in the wrong kidney
being transplanted to a patient, which then had to be removed.
That is a serious example of safety, but I use it to highlight
that one important recommendation that you can make that covers
both these bullet points is a safety-style checklist in both donation
and receipt of transplant organs that could be used EU-wide and
could be developed by professionals and others, so that every
time there is a transplant donation or recipient, that checklist
is gone through. The second one would be relates to an EU-wide
reporting system of incidents in all transplant patients. It is
not rocket science to do that but, if it were an EU-wide reporting
system of incidents—and I do not use the word "errors";
these are patient safety incidents, from which comes much learning,
and if there were an EU-wide reporting system and a way of analysing,
there could be a central data collection point. If it so happens
it might be the NPSA, we would be delighted because we already
have the infrastructure required to do that, but that would be
an important area, an important recommendation that would make
patient care in transplantations much safer and reduce the errors
of the kind that I have just highlighted. That is a real case.
Fortunately, it is a one-off. There was a lot of learning from
it. It identified the causes and the systems failure. Most of
these are systems failures.
Chairman: This is Lord Lea's question and he
will want to pursue this issue.
Q345 Lord Lea of Crondall:
I have no ownership of the question but it is very interesting
that you should come to annex A, and if I can slightly rephrase
the question, are there some bullet points which you think are
particularly good ones and some that you think are perhaps not
necessary?
Lord Patel: I only focus on those bullet points
that relate to quality and safety.
Q346 Lord Lea of Crondall:
I am talking about the bullet points under that EU Directive on
quality and safety.
Lord Patel: Yes, that is what I am talking about.
Q347 Lord Lea of Crondall:
I know that is what you are talking about. You think the whole
lot are useful, all of those, 1, 2, 3, 4, 5?
Lord Patel: Yes, I think they are, but I was
particularly focusing on the ones that relate to quality and safety
standards and means of ensuring traceability and reporting of
serious adverse events. That is the one I referred to and I think
they are important.
Q348 Lord Lea of Crondall:
Do the others not follow from that? Obviously, the first one is
a logical consequence of the second and the third.
Lord Patel: Correct.
Q349 Lord Lea of Crondall:
How do you see the others fitting together with those two that
you attach importance to?
Lord Patel: The ones for the establishment of
inspection structures and control measures: in any transplant
you will have some kind of control measures. Inspection is about
whether it is a soft-touch inspectorate or a hard-line inspectorate
that is required. I have focused on the importance of safety for
patients and I think having one format EU-wide that registers
all the data, that reports on incidents and that there is learning
from would be a very good idea.
Q350 Baroness Young of Hornsey:
Just on a point of information, are there other organisations
across the EU with a similar function to yours? Do you think there
would be any kind of value in looking at an EU-wide organisation
with responsibility for these issues?
Lord Patel: I think for transplant purposes
particularly it would be valuable to have an EU- wide safety check
procedure for all transplant surgeons, whoever they are.
Q351 Baroness Young of Hornsey:
With a body to oversee that?
Lord Patel: Yes. The analogy I am using is rather
like an aircraft check system. There are plans to introduce such
a check system in surgery generally, but it particularly applies
to transplants and I have highlighted the example. If there were
a check system, that incident might not have occurred. Such incidents,
if they occur once because there is a system failure, they will
occur again unless you stop it.
Q352 Chairman: We have heard
time and time again that it is the systems that count.
Lord Patel: Correct.
Chairman: I would just ask the Committee if
there are any other questions they would ask of our two witnesses
before they leave us?
Q353 Lord Trefgarne: A question
that I guess I should have put to all the witnesses, or at least
to some of them, and to which I do not know the answer: I am clear
that during the course of my lifetime my body is my own and therefore
I can decide what happens to it but after the end of my life,
who owns my body?
Lord Patel: Shall I ask the noble Lord Eames?
Maybe he does not want to get involved! It is a good question
to ask. If you have already consented that parts of your body
can be used or if you have a law that says consent is generically
agreed to, i.e. the discussions which are going on just now: if
I do not carry a card that says my organs must not be used, there
is presumed consent that my organs can be used, but it is implied.
But the body belongs to you if you have made a decision as to
what should happen to it after your death. If not, maybe your
next of kin can decide.
Lord Trefgarne: I gather this question is challenging
undertakers, to be honest, if the next of kin do not agree on
whether a body should be cremated or not, for example.
Q354 Lord Eames: Leaving theology
aside, there is an extremely difficult legal area over this whole
field. The question of leaving something to your kith and kin
does create certain obligations, but if you die and do not leave
any stipulation whatsoever, there is a sense, some of the commentators
believe, that in fact you belong to nobody; your body belongs
to nobody. That is the legal side of it but I do not want to take
it on.
Lord Patel: I was going to concentrate on safety.
Fortunately, I am not yet asked to look after the safety of dead
bodies.
Baroness Neuberger: You should be grateful.
Q355 Chairman: We have spent
a lot of time discussing opt-in and opt-out and the point of death
and the involvement of relatives, and we are very grateful to
you for actually giving us another dimension, particularly focusing
on the EU point, because that is where we are going to have to
look. It has been, I think, very interesting to hear you talk
about the safety issues, and in particular the gathering of information
and research, because I think that is somewhere where we have
had a bit of a gap in terms of the gathering of information.
Lord Patel: I think a strong recommendation
that relates to an EU-wide reporting system of incidents, an EU-wide
safety check of transplant recipients particularly, and an EU-wide
protocol would go a long way to making transplantation safer.
Q356 Chairman: There is a
distinction in what you call an "incident" between those
that are to do with consent and those that are to do with clinical
or medical outcomes.
Lord Patel: Yes, correct.
Q357 Chairman: We need to
be clear that that is another issue in terms of the way we look
at it.
Lord Patel: The bullet point says it is about
quality and safety of transplantation.
Chairman: That is extremely helpful. Thank you
very much for your time. I know how busy you are, Lord Patel.
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