Informed Consent for Research Using Biospecimens, Genetic Information and Other Personal Data

Abstract

While human subjects research once consisted primarily of research on people, advances in biobanking, genetics and big data have transformed the research landscape. Personal data and biospecimens are increasingly at the centre of research, giving rise to difficult questions about whether and how to apply legal and ethical principles – such as informed consent – that were developed for research on people. The first part of this article explores questions about consent that arise in the context of authorising research on personal data and biospecimens, focusing on the legal and ethical basis of the consent requirement, the use of specific versus broad consent and the use of anonymisation and other exceptions to consent. The second part of the article looks at issues of consent that arise beyond the individual's decision to participate, focusing on the return of individualised research results, community consent and the ownership of biospecimens.

Key Concepts

  • Human subjects research no longer consists primarily of research on people, as advances in biobanking and big data have transformed the research landscape.
  • Personal data and biospecimens are increasing at the centre of research, giving rise to difficult questions about whether and how to apply legal and ethical principles that were originally developed for a research model in which people were at the core.
  • The requirement to obtain informed consent for research on personal data and biospecimens can be grounded in many of the same considerations that justify requiring consent for research on people – for example autonomy, welfare and public trust – though there are important differences.
  • The requirement of ‘specific consent’ is a poor fit for long‐term research on personal data and biospecimens – as the future research uses will often be inconceivable at the time of consent – raising questions about whether alternative models, such as broad or dynamic consent, should be used instead.
  • While the anonymisation of personal data and biospecimens eliminates the requirement to obtain consent under many sources of law, this approach has been criticised as infringing the informational autonomy of the sources, undervaluing the potential harms of reidentification, and undercutting the public's trust in research.
  • Consent plays a role in deciding issues beyond simply whether or not to participate in research; it also affects broader research governance issues such as commercialisation, return of research findings to the participant and sharing of research data with other scientists.
  • The controversial question of whether researchers should return individual research findings to a participant turns not only on disagreement about what is required by general ethical principles such as informed consent and respect for autonomy, but also on the extent to which the findings are validated, significant and actionable.
  • The fact that research using genetic material and information will often reveal information about both the individual donor and a broader group of related individuals has generated controversial proposals for requiring ‘community consent’ in addition to individual consent.
  • Stating that they did not consent to commercialisation or patent protection is one of several ways individuals have sought to limit how their biospecimens are used and commercialised; another approach has been to claim residual property rights in their biospecimens.

Keywords: informed consent; biospecimens and personal data; genetics research; anonymisation; return of research results; return of incidental findings; community consent; property rights

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Further Reading

Corrigan O, McMillan J, Liddell K, et al. (eds) (2009) The Limits of Consent: A Socio‐Ethical Approach to Human Subject Research in Medicine. Oxford: Oxford University Press.

Dworkin G (1988) The Theory and Practice of Autonomy. Cambridge: Cambridge University Press.

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Jasanoff S (ed.) (2011) Reframing Rights: Bioconstitutionalism in the Genetic Age. Cambridge, MA: The MIT Press.

Manson N and O'Neill O (2007) Re‐thinking Informed Consent in Bioethics. Cambridge: Cambridge University Press.

Miller F and Wertheimer A (eds) (2010) The Ethics of Consent: Theory and Practice. Oxford: Oxford University Press.

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Solbakk JH, Holm S and Hofmann B (eds) (2009) The Ethics of Research Biobanking. London: Springer.

Stranger M and Kaye J (eds) (2016) Principles and Practice in Biobank Governance. London: Routledge.

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How to Cite close
Liddell, Kathleen, and Skopek, Jeffrey M(Jan 2018) Informed Consent for Research Using Biospecimens, Genetic Information and Other Personal Data. In: eLS. John Wiley & Sons Ltd, Chichester. http://www.els.net [doi: 10.1002/9780470015902.a0027983]