Examination of Witnesses(Questions 120-139)
WEDNESDAY 4 DECEMBER 2002
PROFESSOR SIR
GEORGE RADDA
AND MS
JANE LEE
Dr Iddon
120. That is a matter of opinion.
(Professor Radda) No, this is not a matter of opinion.
It is a matter of a scientific judgment. You need to be trained
in a given area of science to say whether in fact this is a project
that is likely to give you significant new scientific information.
Whether the statistics that you worked out that you need so many
people are correct. Whether your protocol that you have drawn
up of saying that you are going to look at people from this particular
age group in order to study heart disease, diabetes and mental
illness is the right age group. You need to know. I do not think
it is arrogance, it is just knowledge of science to be able to
review that. We have consulted the public in a broader sense,
as I said before, but that is not peer review, that is getting
opinions and getting people's views on whether they would be prepared
to be part of something like that.
Dr Murrison
121. Are you concerned about the variable quality
of medical records?
(Professor Radda) Again, that point has been made.
We are obviously going to spend quite a bit of time validating
the medical records. This is why the project is expensive, and
the research nurses associated with the general practices who
carry those records, and that is all going to be part of the scientific
protocol of how you can do something like that. The scientists
in this country are more experienced in doing this sort of large
public health related study, like in clinical trials, like in
epidemiology, and in many other countries we have in that area
substantial expertise who know how to do these things.
122. Biobank is obviously a vast project. Had
you considered perhaps going down the route of a number of smaller
projects to get the same kind of information?
(Professor Radda) Indeed. We have considered and we
have set up patient oriented cohorts who already have diseases
and have DNA samples from them. That is a different project. It
is a very different set of questions you are asking there. The
important thing to remember about Biobank is it is not really
a genetic study. It is as much a study on the environment and
your lifestyle as it is on your genetic make up and it is how
those three interact. The clear advice and the clear statistical
study has shown that if you are going to do that in any reasonable
way, you really need large numbers and you need to do a project
like this.
123. What sort of time frame are we looking
at for getting some real results from this?
(Professor Radda) I believe the reason why the 45
to 69 age range was chosen is a compromise. People thought we
ought to start earlier and then you need 20 years before you get
the first results. People who are going to get heart disease,
who are healthy at 45, in about ten years time, you can calculate
roughly how many you would expect from a random population like
that. So I suspect within the first five to seven years of setting
it up, you will be able to get new information about some of the
major common diseases and how the environment and genes affect
those. Of course, there will be parallel studies and that information
will flow into this as well. So I suspect that, although it is
a 15 year study where we hope to have major results, within five
to seven years you will be able to get some very important new
information.
Dr Iddon
124. What is the Biobank policy on gene patenting
and publishing?
(Professor Radda) No different from any patenting
of genes policy that the MRC has held for many years. If you are
going to use the new information you get from genetics for producing
health care products, you have got to be able to provide some
safeguard to industry who are going to be the ones who are going
to develop the drugs based on that. Therefore, yes genes with
known functions have to be patentable so that we can produce pharmaceuticals
and other products that will help therapy and interventions.
125. Can I just clarify that Biobank is also
considering the interaction between genes and human behaviour?
(Professor Radda) Genes and human lifestyle. Whether
you call that behaviour, I am not sure. It is more about lifestyle,
about socio-economic circumstances, about nutritional factors
and environmental issues. Not so much behavioural issues, I think,
if you take it in that sense.
Chairman
126. Not genes and criminality and all that
nonsense?
(Professor Radda) No, that is certainly not part of
it. If that is what you meant by behaviour, it is definitely not.
Dr Iddon
127. Finally, have you got any plans to include
samples which will enhance proteomic research?
(Professor Radda) I know that that issue is being
raised by a particular individual. The answer to that is that
with current technologies and current ways of doing things, that
could be a very expensive operation, but the samples will be in
a form that if the proteomics field advances, it will be possible
to add that kind of study.
128. Within your current costs which we have
discussed today—
(Professor Radda) That is not in the current costing.
129. So you would have to go to Government for
extra money?
(Professor Radda) No. People who wanted to do that
on Biobank would have to put in an application for grants in a
competitive way and those would have to compete with other awards
that we would make for individual researchers who want to use
Biobank or any other facility of this kind.
Chairman
130. Who would they apply to? The MRC through
the back door?
(Professor Radda) The MRC or BBSRC or Wellcome. BBSRC
have a big interest in proteomics.
Bob Spink
131. Will you be applying the Human Genetic
Commission's guidelines on informed consent that they set out
in their report Inside Information?
(Jane Lee) Our planning has gone in parallel with
that report being drafted and in many ways that is why we have
not moved faster because we wanted to know the outcome of that
study.
132. Are you concerned about the possibility
or the fact that you are not going to be able to necessarily give
a 100% guarantee of confidentiality, for instance?
(Professor Radda) We are concerned that something
could go wrong and that we need to make sure that there is protection
against that. But the way that the consent is given, we hope that
that will be protected.
133. I know you are going to give a balanced
answer to the next one, Sir George. How do you resolve the problem
when you seek consent; do you go for just vague general consent
that will leave open future possibilities, or very restricted
specific consent that would constrain what you can do in the future?
How do you choose between these two?
(Professor Radda) In this kind of study it cannot
be a restricted consent and since it is an opt-in volunteer operation,
if you are concerned that we would use your information to do
studies that are not ethically acceptable to you and you would
like it to be used for cancer only, then the advice will be do
not enter the study.
134. You surprise me. I thought you would say
it is a difficult balance to achieve.
(Professor Radda) I do not think it is a difficult
balance. We know what we want to achieve.
135. What provision will there be for people
to withdraw from Biobank?
(Professor Radda) They will be able to withdraw at
any time if they are not satisfied and, of course, we have this
high level overseeing committee who will make sure that things
will operate according to how we set it up. They would be able
to actually point out things that cannot be done. But anyone who
enters and is in the study at any time during the thing, if they
are concerned, can withdraw.
136. Would you be able to guarantee that 100%
of their information would be removed from the database?
(Professor Radda) Their information will be removed
from the database.
Geraldine Smith
137. Coming back to consultation, the Consumers'
Association believes that your consultation concerning Biobank
was inadequate. What do you say to that?
(Professor Radda) We have not finished the consultation
yet. We are still working with consumers, and with our Consumer
Liaison Group. We have got plans for a number of other things,
including an event that our Chairman is going to run on issues
of Biobank in April. So we have not finished and we will continue.
138. Can you give us a few details about the
consultation process that you are currently carrying out?
(Jane Lee) Do you mean that we have done or that we
will do?
139. Both really, what you have done so far
and what you are going to do.
(Jane Lee) So far it has been a number of things;
partly talking one to one to organisations like the Consumers'
Association, the Human Genetics Commission, which has been very
helpful; and partly the sort of qualitative research that I referred
to earlier through the usual sort of focus groups and so on, done
by independent consultants and both of those studies have been
published on the web site. People told us that they were worried
about things like confidentiality, which has been mentioned, questions
of how much feedback they would get while the study was ongoing
and the latest consultation, as I think I have mentioned already,
was done in the age group that we are talking about and we are
now intending to go back to those people—or the consultants
we have been using are—to see whether they would be prepared
to help us further with developing the study. There was a workshop
earlier this year on the more ethical governance side of things
and that report has also been published. We will be setting up
a smaller group to take things forward, particularly, the governance
issues. That is a group not just of scientists but ethicists,
lawyers, people with a consumer, lay and different perspective.
So it is very much an ongoing process.
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