Trends in Genetics
Volume 27, Issue 2, February 2011, Pages 41-47
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Disclosure of individual genetic data to research participants: the debate reconsidered

https://doi.org/10.1016/j.tig.2010.11.004Get rights and content

Despite extensive debate, there is no consensus on whether individual genetic data should be disclosed to research participants. The emergence of whole-genome sequencing methods is increasingly generating unequalled amounts of genetic data, making the need for a clear feedback policy even more urgent. In this debate two positions can be broadly discerned: a restrictive disclosure policy (‘no feedback except life-saving data’) and an intermediate policy of qualified disclosure (‘feedback if the results meet certain conditions’). We explain both positions and present the principal underlying arguments. We suggest that the debate should no longer address whether genetic research results should be returned, but instead how best to make an appropriate selection and how to strike a balance between the possible benefits of disclosure and the harms of unduly hindering biomedical research.

Section snippets

Feedback of genetic research results: an evolving debate

As a result of rapid developments in next-generation sequencing technology, the question of whether individual genetic data should be disclosed to research participants – and if so, which data are to be disclosed and by whom – has increasingly become a topic of debate. This debate, however, has become highly complex and theoretical. It covers a wide variety of genetics and genomics research, from biobank and archived tissue research to genome-wide association studies (GWAS; Glossary) and from

Distinguishing between the different types of disclosure

First, it is important to distinguish between the different types of disclosure. Although several types of disclosure have been proposed, the debate has centred on the question whether researchers should actively offer individual genetic research results [7].

Scope of disclosure

A second issue concerns the scope of disclosure of genetic research results. At one end of the spectrum it is argued that no individual genetic research results should be disclosed whatsoever. This, however, is an exceptional position, because only one publication adhered strictly to a ‘no disclosure at all’ policy, even of life-saving information – and this article was restricted to biobank research [15]. At the other end of the spectrum it is argued that all individual genetic data should be

Arguments in favour of a (very) restrictive disclosure policy

A restrictive disclosure policy would mean that genetic research results should not be returned to individual research participants with the exception of life-saving data [18]. Five different arguments have been put forward to support this restrictive disclosure policy.

Arguments in favour of a qualified disclosure policy

An intermediate position of ‘qualified disclosure’ holds that genetic findings should be disclosed if they meet particular conditions. Although the majority of commentators and guidelines adopt a variant of a qualified disclosure, the conditions for disclosure and the underlying argumentation vary widely. Below we set out the five arguments deployed in the literature to defend a qualified disclosure policy.

Concluding remarks

Having identified the main positions and arguments it is now time to develop an research ethics policy for the disclosure and communication of genetic research results. In developing concrete guidelines the following ingredients warrant consideration.

First, it is interesting that the two extreme positions of ‘no disclosure whatsoever’ and ‘full disclosure’ are seldom defended. A duty to inform when this could save the life of a research participant appears to be widely recognized. The

Acknowledgements

This work was supported by the Netherlands Organisation for Health Research and Development (ZonMW).

Glossary

Ancillary care
ancillary care is that which is not required to make a study scientifically valid, to ensure the safety of a trial, or to redress research injuries.
Analytic validity
a result is analytically valid when it accurately and reliably identifies a particular genetic characteristic.
Archived tissue research
retrospective research using stored tissue left-over after a clinical treatment or tissue taken purposefully for a specific research project.
Biobank
a ‘library’ or collection of human

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