Summary and recommendations - Nuffield Council on Bioethics
Summary and recommendations - Nuffield Council on Bioethics
Summary and recommendations - Nuffield Council on Bioethics
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Pharmacogenetics: ethical issues<br />
12 Allowing broad c<strong>on</strong>sent may be of significant benefit to researchers <str<strong>on</strong>g>and</str<strong>on</strong>g> to society’s interest in<br />
the acquisiti<strong>on</strong> of knowledge about health <str<strong>on</strong>g>and</str<strong>on</strong>g> disease. We c<strong>on</strong>sider that it is permissible to<br />
request broad c<strong>on</strong>sent to the use of samples which are an<strong>on</strong>ymous or an<strong>on</strong>ymised. Where<br />
samples collected for a particular study are coded or identified, broad c<strong>on</strong>sent to future<br />
research may also be permissible, but should be sought separately from c<strong>on</strong>sent to the initial<br />
study. This separate c<strong>on</strong>sent may be obtained when the samples are originally taken, or at a<br />
later date. In general, the further removed the future research is from the original study, the<br />
more likely it is that separate broad c<strong>on</strong>sent should be obtained. An indicati<strong>on</strong> of the type or<br />
nature of the research likely to be carried out <str<strong>on</strong>g>and</str<strong>on</strong>g> its implicati<strong>on</strong>s for the individual should be<br />
given where possible (paragraph 3.39).<br />
13 A further questi<strong>on</strong> is whether data protecti<strong>on</strong> laws are compatible with the an<strong>on</strong>ymisati<strong>on</strong> of<br />
pharmacogenetic samples, in particular regarding obligati<strong>on</strong>s to disclose informati<strong>on</strong> to family<br />
members. In the case of pharmacogenetic informati<strong>on</strong>, the likelihood that test results would<br />
be of immediate relevance to a family member is low compared to other genetic tests such as<br />
those for m<strong>on</strong>ogenic disorders. We received c<strong>on</strong>flicting views as to whether the Data<br />
Protecti<strong>on</strong> Act (DPA) imposed an obligati<strong>on</strong> <strong>on</strong> health professi<strong>on</strong>als to disclose informati<strong>on</strong> to<br />
relatives. We recommend that even if sec<strong>on</strong>dary legislati<strong>on</strong> is not required, clarificati<strong>on</strong> should<br />
be provided by the Informati<strong>on</strong> Commissi<strong>on</strong>er to ensure that the DPA is not interpreted so as<br />
to require health informati<strong>on</strong> to be passed to relatives (paragraph 3.43).<br />
14 In some cases, researchers provide individual feedback to patients. In others, researchers elect<br />
to offer individual test results to patients who request the informati<strong>on</strong>. There is no clear<br />
guidance <strong>on</strong> this matter in the UK. We support the view of the Human Genetics Commissi<strong>on</strong><br />
that the feedback of the overall results of research should be promoted (paragraph 3.44). 2<br />
Regarding individual results, while we are sympathetic to the view that patients should have<br />
the opportunity to receive useful <str<strong>on</strong>g>and</str<strong>on</strong>g> validated informati<strong>on</strong> about their medical treatment, we<br />
c<strong>on</strong>sider that <strong>on</strong>ly <strong>on</strong> rare occasi<strong>on</strong>s will such informati<strong>on</strong> be obtained as part of research in<br />
pharmacogenetics. In the atypical cases in which a clinical trial are likely to produce validated<br />
<str<strong>on</strong>g>and</str<strong>on</strong>g> clinically useful data regarding individual participants, we recommend that all<br />
participants should be offered the opportunity to receive individual feedback of such data as<br />
part of the process of obtaining c<strong>on</strong>sent. As far as possible, the nature <str<strong>on</strong>g>and</str<strong>on</strong>g> implicati<strong>on</strong>s of the<br />
informati<strong>on</strong> to be obtained should be explained to participants. We recognise that decisi<strong>on</strong>s<br />
about whether data that may be obtained in the course of research are likely to be clinically<br />
useful, <str<strong>on</strong>g>and</str<strong>on</strong>g> assessments of when findings can be said to be sufficiently well validated, will be<br />
complex. We therefore recommend that researchers should explain their decisi<strong>on</strong>s regarding<br />
the provisi<strong>on</strong> of individual feedback to the relevant research ethics committee (paragraph<br />
3.49).<br />
Regulati<strong>on</strong> of pharmacogenetic tests<br />
15 In the UK, the safety <str<strong>on</strong>g>and</str<strong>on</strong>g> efficacy of medicines is assessed by the Medicines <str<strong>on</strong>g>and</str<strong>on</strong>g> Healthcare<br />
Products Regulatory Agency (MHRA). 3 The MHRA licenses new medicines for use <str<strong>on</strong>g>and</str<strong>on</strong>g> oversees<br />
the provisi<strong>on</strong> of informati<strong>on</strong> <str<strong>on</strong>g>and</str<strong>on</strong>g> warnings about products. Regulati<strong>on</strong> of the quality of<br />
genetic tests is also the resp<strong>on</strong>sibility of the MHRA. Depending <strong>on</strong> the evidence submitted to<br />
the MHRA by a pharmaceutical company that has developed a new medicine, the Agency may<br />
require the use of a pharmacogenetic test as part of the the c<strong>on</strong>diti<strong>on</strong>s of issuing a licence for<br />
its use. Notificati<strong>on</strong> about the need to perform the test before prescribing the medicine would<br />
2 Human Genetics Commissi<strong>on</strong> (2002) Inside Informati<strong>on</strong>: Balancing interests in the use of pers<strong>on</strong>al genetic data (L<strong>on</strong>d<strong>on</strong>:<br />
Department of Health), para. 5.51.<br />
3 The MHRA was formed in 2003 as a result of the merging of the Medicines C<strong>on</strong>trol Agency with the Medical Devices Agency.<br />
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