Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Correspondence
  • Published:

Big-data studies need to be part of policy discussion

Nature Human Behaviour volume 2, page 94 (2018)Cite this article

Subjects

To the Editor — The new definition of clinical trials by the National Institutes of Health (NIH) has raised manifold comments by scientists working in the field of basic behavioural and brain research both in the United States and internationally. Clearly, the aim of increasing accountability and transparency of clinical research is not controversial, and measures need to be identified to support that goal. However, the new definition changes the scope of prototypical clinical trials from the concept of ‘medical strategy, treatment or device’ and ‘medical approaches’ to ‘health-related biomedical or behavioural outcomes’, that is, from ‘healthcare’ to ‘health related’. It might be argued that the new definition leads to an inflationary use of the term for studies addressing almost any change in the physiological range of normal behaviour or body reaction. This could be interpreted as pathologization (or medicalization) of normal processes and life cycles with all its philosophical, ethical and sociological dimensions and societal implications.

Moreover, a definition emphasizing health-related and behavioural outcomes as a result of intervention could eventually include big-data approaches. An increasing number of studies, including non-medical research, collect and analyse biomedical and behavioural data. Deep learning represents an increasingly powerful tool to extract detailed information regarding health status or personality traits from seemingly non-health-related data, such as motion profiles or buying behaviour. The concrete context hereby defines whether a study is health related or not.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on SpringerLink
  • Instant access to the full article PDF.

USD 39.95

Prices may be subject to local taxes which are calculated during checkout

References

  1. Wilbanks, J. T. & Topol, E. J. Nature 535, 345–348 (2016).

    Article  CAS  PubMed  Google Scholar 

  2. Epstein, R. & Robertson, R. E. Proc. Natl. Acad. Sci. USA 112, E4512–E4521 (2015).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  3. Kramer, A. D. I., Guillory, J. E. & Hancock, J. T. Proc. Natl. Acad. Sci. USA 111, 8788–8790 (2014).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Cécile and Oskar Vogt Institute for Brain Research, University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany

    Katrin Amunts

  2. Institute for Neuroscience and Medicine, INM-1, Research Centre Jülich, Jülich, Germany

    Katrin Amunts

Authors
  1. Katrin Amunts
    View author publications

    Search author on:PubMed Google Scholar

Corresponding author

Correspondence to Katrin Amunts.

Ethics declarations

Competing interests

K.A. is deputy chair of the German Ethics Council, which in November 2017 published a statement on big data and health. She is also scientific director of the European Human Brain Project, which connects neuroscience and computational approaches on a large scale. K.A. declares present funding by the NIH. She does not and has never held an advisory role for the NIH, and she is not and has not been involved in any planning of clinical trials policy or implementation.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Amunts, K. Big-data studies need to be part of policy discussion. Nat Hum Behav 2, 94 (2018). https://doi.org/10.1038/s41562-018-0292-9

Download citation

  • Published:

  • Version of record:

  • Issue date:

  • DOI: https://doi.org/10.1038/s41562-018-0292-9

This article is cited by

Search

Advanced search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing