FOURTH REPORT
20 MARCH 2001
By the Select Committee appointed to consider Science
and Technology.
Ordered to Report
HUMAN GENETIC DATABASES:
Challenges and Opportunities
FOREWORD
- Human beings, like all
living things, have within them a blueprint - their genome, containing
their set of genes - that helps determine their individual characteristics.
For the very first time, it is becoming possible to read that
blueprint and, moreover, to begin to understand what it means.
The United Kingdom has made a significant contribution to the
major scientific advances underlying this new knowledge.
- It is certain that understanding the genome -
through the new science of genomics - will bring substantial improvements
in medicine. Some are with us already and others will follow over
coming decades. For those who want to know, it is already possible
to alert them to certain inborn pre-dispositions to conditions
such as breast cancer and to allow early screening or other measures.
It will eventually become possible to make drugs much more effective
by tailoring them to the needs of particular individuals and avoiding
drugs that either will not work for them or may have unacceptable
side effects. It may also become possible to correct faults in
the blueprint - gene therapy.
- To realise these benefits it is essential to
understand how the genes work. This involves studying both genetic
data and the medical histories of many individuals. In this way
it will be possible to establish whether particular medical conditions
are associated with particular genetic features and/or lifestyles.
Genetic information is obtained by analysing human biological
samples (such as blood or saliva), perhaps many years after the
sample was collected. So that comparisons of very large numbers
of samples can be made, genetic and other relevant information
is accumulated in computerised databases.
- Information about individuals and their health
can be very sensitive - and genetic data are particularly so.
Our present understanding of what genetic data mean for health
is very limited. As the meanings are discovered, however, the
information will say something about family members as well as
the individual directly concerned. In view of these sensitivities,
our Inquiry has paid particular attention to how data held in
genetic and allied databases are collected, protected and used.
- The challenge is to find a way of protecting
the interests of individuals while at the same time making essential
information available to medical researchers. Meeting that challenge
will allow opportunities for new discoveries which can then be
turned into valuable treatments to help future generations.
- A very great deal of medical practice is based
on what doctors have learned from treating earlier generations
of patients. We believe that most people appreciate this and,
subject to reasonable safeguards for their personal privacy and
concerns, are only too glad for information about them to be used
to help others. That said, some individuals could have reservations
about particular kinds of research. Personal information must,
therefore, be safeguarded to the highest standards and, as is
both possible and appropriate for most purposes, used anonymously.
This may involve completely de-linking identifying information
from the data, or using a secure code held by a trusted third
party. Any particular reservations expressed by the individual
should be linked with their information.
- The Data Protection Act 1998 offers significant
protection to individuals over the use of their personal data.
It is, however, the nature of research that there are always surprises
around the corner. There may be future imperatives to use non-anonymised
data in ways that could not be foreseen when samples are collected.
It may often be impracticable - and may also be unnecessary -
to consult individuals about this. Among our various recommendations,
we propose a new independent body, the Medical Data Panel, to
safeguard their interests. The Panel would also have responsibility
for overseeing research using data from cancer and other disease
registries.
- An important novel research project is about
to be launched by the Medical Research Council (MRC) and The Wellcome
Trust in collaboration with the Department of Health. This will
involve genetic studies and analyses of the health of half a million
volunteers. This project has the potential for making major contributions
to health care and the development of new treatments. It will
involve mutually supportive partnerships between industry and
the public sector. There may well be difficult questions over
intellectual property and patenting but these should be soluble.
- This project, and the many similar studies that
will certainly follow, will make massive demands on computing
technology that needs to be supported by people with skills which
are already in short supply. Shortage of human resources may well
limit future UK contributions in this important area. We give
our full support to current efforts to provide training in the
necessary statistical, computing, medical and biological disciplines.
- In the United Kingdom, the National Health Service
(NHS) records provide a unique reservoir of information on the
health of the nation but, to a large extent, they are not in a
form that allows them to be used in support of the genetic and
other studies that are in prospect. It is urgent that the NHS
should adopt and implement uniform standards and protocols for
medical records. This is important not only for genetic studies
but also for broader considerations relating to the health of
the nation.
- Underpinning our detailed recommendations[1]
is our belief that the United Kingdom is uniquely positioned in
the field of genetics. To succeed, we must:
- ensure that we have a regulatory regime that
is sympathetic to the work, but which offers individuals the privacy
they have a right to expect; and
- do all we can to ensure that the work has the
considerable financial and human resources on which it will depend.
1 Set out in paragraphs 1.11 to 1.29. Back
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