Veeeeeeeery Inteeeeeeeresting

[Guest guest]

http://news.bmn.com/hmsbeagle/110/notes/feature12

Genetic Research on the U.K. Population

Do New Principles Need to be Developed?

by Jane Kaye

This article will appear in a forthcoming issue of Trends in

Molecular Medicine.

Posted September 14, 2001 · Issue 110

----------------------------------------------------------------------

----------

Abstract

Governments around the world are beginning to generate population

databases as resources for genetic research. In the U.K., a proposal

has been tabled that plans to incorporate National Health Service

information - a move that will effectively create a database of

around 60 million. However, this new population collection will not

conform to standards established by other national genetic databases,

and the U.K. government report has not accounted for key ethical

issues.

----------------------------------------------------------------------

----------

The first population collection established specifically for genetic

research was the Health Sector Database in Iceland [1]. Since then, a

succession of collections has been proposed in Estonia [2], Tonga

[3], Newfoundland [4], Sweden [5], Singapore [6] and in the U.K.

These large databases of identifiable medical information are

established to facilitate " the search for potentially very subtle

correlations between health outcomes, genetics and environmental

factors [7]. " In March 2001, the U.K. House of Lords Select Committee

on Science and Technology Report on Human Genetic Databases

recommended " a population-based approach to the collection of health

and genetic information through the delivery of routine health care. "

[8] If the recommendations of this Report are followed all clinical

data held by the NHS on the British population over the past fifty

years will be computer linked for the purposes of genetic research.

This is, in effect, a national population collection on a scale of 60

million - far bigger than the other proposed population collections

[9], or the proposed U.K. Biomedical Population Collection of 500,000

[10].

The flaw in the House of Lord's Report is that it regards the linkage

of clinical information for genetic research as being little

different from what the NHS currently does. Although this is true on

one level, at another it ignores the norms that have developed for

population collections and the full implications of establishing a

database linking system of this complexity and comprehensiveness for

genetic research. Although it might be acceptable to link health data

for general purposes, for genetic research on whole populations -

which are in the " super league " of genetic databases - different

normative principles are being established. The purpose of this paper

is to highlight some of the key issues in the establishment of

population collections, which I believe have been ignored in the

House of Lords Report.

Community Consultation

Ethical guidelines for research on populations require that both the

group and individuals should be consulted before the undertaking of

research [11]. It is not sufficient just to seek individual consent

for inclusion of personal information in a population collection.

This is because a population study has implications not simply for

the individual but for families and the population as a whole, in

terms of the potential for discrimination, stigmatization, and the

characterization of potentially negative traits [13]. It is also

important for the population to assess the social implications of

establishing such a comprehensive body of sensitive information, and

to decide upon issues such as access by third parties and whether

uses other than medical research should be allowed. Community

consultation enables the society to debate these issues in a

meaningful and inclusive way, before a collection is

established, " either through the democratic process or through the

media " [14]. Thorough community consultation should also engage the

population " as partners in planning and carrying out the research and

not just as research subjects " [12]. Community consultation provides

information so that individuals can then make an informed decision

when deciding whether to give individual consent.

The House of Lords Report makes no mention of the need for community

consent or for public debate. If the recommendations of the report

are followed, a population collection will be established

incrementally by the systematic linkage of different databases in the

NHS using the NHS number as a national identifier [15], without

public consultation. At the same time the Select Committee did

recognize that it " is essential that there is high public confidence

in this activity, otherwise some or many of the benefits to be gained

from the advances in genetics will not be realised " [16]. One way of

gaining public confidence is through consultation and engaging the

public in the planning of the population collection and its

implications. This approach would treat the population as

participants in the research, and would acknowledge their

contribution.

Consent

It is possible to obtain informed consent for the taking of a DNA

sample, and for inclusion in a specific research project, and this is

regarded as the norm in international research practice [17].

However, it is not clear what kind of consent is required for

secondary research, when all the possible uses of the information

cannot be anticipated at the time of collection [18], or when

existing information, such as medical records, are used for another

purpose such as medical research. Population collections also involve

linking this information to other collections of data to " mine " the

research possibilities of the data. To make it possible to link

individuals across different databases there needs to be a common

personal identifier. Should this kind of research just require

research ethics approval, such as in epidemiology [19] or should

individual consent be required? In Iceland the governments' decision

not to seek consent for the inclusion of medical records in the

population collection provoked domestic and international

condemnation and resulted in this being changed to an " opt out "

system [*]. Since then, all the population collections that have

followed have sought consent, for instance Estonia, Sweden, and

Tonga. Consent, or the possibility of being able to choose whether

your clinical data is used for research purposes has become the norm

for population collections.

In the U.K., the House of Lords Select Committee recommended that the

type of consent should be broad, and that approval for the secondary

use of the data should be entrusted to a Medical Data Panel as in the

Danish health system [20]. With the passing of section 60 of the

Health and Social Care Act in May 2001, personally identifiable

medical information can be used for medical research without consent

if an appointed Committee gives approval. The rationale behind

section 60 was to allow the continued collection of identifiable

information by Cancer Registries [21], but this section could also be

used for approval for the systematic linking of NHS clinical

information to create a population collection for genetic research.

It is still uncertain whether the recommendations of the House of

Lords Report will be followed or whether section 60 will be utilized.

If this section is used, the British population would not have to

give consent or even have the possibility of opting out of research,

which would be contrary to the international principles that have

been established for population collections.

Oversight Mechanisms

There is a tendency to focus on consent as the means to protect

privacy, which ignores the fact that there also needs to be

technical, procedural, and supervisory mechanisms to maintain the

security of the data and public confidence in population collections

[22]. Ironically, the controversy over the handling of consent in the

Icelandic database has led to the development of a good model of

oversight. The features of this model are five separately constituted

bodies to oversee the establishment and running of the database [23],

with clear separation of duties and responsibilities and powers of

enforcement and supervision. This structure ensures that the handlers

of the raw data, the encrypters of the data, the enforcement bodies,

and the licensee (deCODE Genetics), are different organizations. This

transparency, as well as very tight technical computer procedures and

requirements, has helped to build public confidence in Iceland as

well as maintaining investor support, but still remains to be fully

tested.

The type of oversight mechanisms needed for large databases of

sensitive information were not considered fully by the House of Lords

Select Committee. The Report recommended the establishment of a

Medical Data Panel, whose role was to approve projects, write policy

guidelines for research ethics committees, and advise government on

issues relating to secondary medical research [24]. Unlike the

Icelandic model, the Panel has no powers of investigation,

enforcement, or sanction. The Patient Information Advisory Group that

has been established under section 60 of the Health and Social Care

Act could in effect be the Medical Data Panel that was recommended by

the House of Lords. If this is so, the Medical Data Panel has been

reduced to just another tier in the research ethics committee

structure without the broader roles envisaged by the House of Lords.

Tangible Benefits

Genetic research has raised many concerns about the possible

exploitation of a population and the injustice of using information

given freely by individuals for commercial gain that does not

directly benefit them. The existing population collections that have

been established by private enterprises have sought the support of

the community and government with the promise of returning benefits.

Many of the initiators of population collections, have entered

agreements where the community receives benefits in the form of

profit sharing [25], the results of individual genetic tests and

education [26], or free drugs such as in Iceland and Tonga. In

Newfoundland, 1% of the net intellectual property royalties formed as

a result of research work goes to a charity non-profit population

foundation fund [27]. If NHS clinical information is used for genetic

research commercial partnerships will be needed to fund the data

linkage and to develop the results of the research [28]. This issue

was not addressed in the House of Lords Report, but a recent survey

shows that commercial use maybe of concern to the British public

[29]. The untested European Directive on the Legal Protection of

Biotechnological Inventions may require consent from the human source

for patents that are based on biological material [30], which also

has implications for commercially orientated research. Individuals

would have to know that personal information was being used for

genetic research.

The Next Step

The House of Lords Select Committee Report represents a starting

point for an informed debate about the secondary use of clinical

information and the linkage of different databases for medical

research. Since the Report was written section 60 of the Health and

Social Care Act has introduced the possibility that consent may not

be needed for the systematic linkage of clinical information. It is

now up to the NHS and the research community to decide whether the

section 60 avenue is used or whether consent is sought for the

proposed population collection. Consent, transparency, public

consultation, and debate have been features of every population

collection that has been proposed since the Icelandic Health Sector

Database was first initiated. The House of Lords Report does not deal

adequately with these particular issues or the issues of oversight or

returns to the community. To encourage public confidence and support

in this proposal it is essential that these issues be considered in

depth. To ignore them runs the risk of public disapproval and the

possibility of condemnation by the international community.