A blog from the Centre for Research Ethics & Bioethics (CRB)

Tag: data protection

Digital biomarkers to test new drugs for mental health

Somewhat simplified, we usually understand biomarkers as substances in the body that can be detected, for example, through blood or urine tests, and that indicate a biological state, such as cancers or diabetes. Biomarkers can be used to make a diagnosis, predict disease risks and to monitor an ongoing treatment.

Nowadays, people also talk about digital biomarkers. To get an idea of what it is all about, think of the smartphone applications that can record movement patterns, heart rate and more. The new digital biomarkers are measurable physiological or behavioural data that are collected in a similar way and where the measuring equipment is usually portable or placed in the body. This data can be followed in real time to monitor the patient’s health status and recovery, without the need for the patient to make repeated hospital visits. However, the question of how these digital data can be understood as biomarkers does not seem completely clear.

Some concurrently published articles in the journal Frontiers in Psychiatry discuss the possibility of using digital biomarkers to test the safety and efficacy of new drugs in mental health. For this to work, these new ways of collecting data and monitoring changes in real time must of course also work safely and effectively. They must moreover satisfy ethical and legal demands on data protection and oversight. The articles discuss these and other challenges. In one article, for example, the question of how we should understand “bio” when we go from traditional biomarkers to digital ones is discussed. Another paper presents results from an attempt to use a digital biomarker to predict cognitive function.

In the editorial introducing the articles, Deborah Mascalzoni, among others, emphasizes that the use of digital biomarkers still lacks a satisfactory regulated context and that issues of data protection and risks of discrimination when data of this kind are collected must be addressed. You can find the editorial here: Digital biomarkers in testing the safety and efficacy of new drugs in mental health: A collaborative effort of patients, clinicians, researchers, and regulators. There you will also find a link to all articles.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

Johanna Maria Catharina Blom, Cristina Benatti, Deborah Mascalzoni, Fabio Tascedda and Luca Pani. Editorial: Digital biomarkers in testing the safety and efficacy of new drugs in mental health: A collaborative effort of patients, clinicians, researchers, and regulators. Frontiers in Psychiatry, 2023. https://doi.org/10.3389/fpsyt.2022.1107037

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Data sharing in genomics: proposal for an international Code of Conduct

In genomics, not only individual genes are studied, but the entire genome. Such studies handle and analyse large amounts of data and are becoming increasingly common internationally. One of the challenges is managing the sharing of data between countries around the world. In addition to data protection legislation varying internationally, there are concerns that researchers and research participants from low- and middle-income countries may be exploited or disadvantaged in these exchanges.

Lawyers and bioethicists have therefore called for an international Code of Conduct for data sharing in genomics. A proposal for such a code was recently published in an article in Developing World Bioethics. The article, written by Amal Matar and nine co-authors, describes the process of developing the Code of Conduct and concludes with a nearly 4-page proposal.

The Code of Conduct is intended for researchers and other actors responsible for data management in international genomic research. The code lists ten ethical principles of direct relevance to data sharing. Next, best practices are described in 23 Articles covering seven areas: Data governance system; Data collection; Data storage; Data sharing, transfer and access; Compelled disclosure; Data handling from low- and middle-income countries; Public and community engagement.

Read the article with the proposal for a Code of Conduct here: A proposal for an international Code of Conduct for data sharing in genomics.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

Matar, A., Hansson, M., Slokenberga, S., Panagiotopoulos, A., Chassang, G., Tzortzatou, O., Pormeister, K., Uhlin, E., Cardone, A., & Beauvais, M. (2022). A proposal for an international Code of Conduct for data sharing in genomics. Developing World Bioethics, 1– 14. https://doi.org/10.1111/dewb.12381

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Neuroimaging the brain without revealing the person

Three contemporary trends create great challenges for researchers. First, science is expected to become increasingly open, among other things by making collected data available to new users and new purposes. At the same time, data protection laws are being strengthened to protect privacy. Finally, artificial intelligence finds new ways to reveal the individuals behind data, where this was previously impossible.

Neuroimaging is an example of how open science, stronger data protection legislation and more powerful AI challenge the research community. You may not think that you can identify the person whose brain is imaged by using a magnetic camera? But the image actually also depicts the shape of the skull and face, including any scars. You could thus recognize the person. In order to be able to share neuroimaging data without revealing the person, it has hitherto been assumed sufficient to remove the shape of the skull and face in the images, or to make the contours blurry. The problem is the third trend: more powerful AI.

AI can learn to identify people, where human eyes fail. Brain images where the shape of the skull and face has been made unrecognizable often turn out to contain enough information for self-learning face recognition programs to be able to identify people in the defaced images. AI can thus re-identify what had been de-identified. In addition, the anatomy of the brain itself is individual. Just as our fingers have unique fingerprints, our brains have unique “brainprints.” This makes it possible to link neuroimaging data to a person, namely, if you have previously identified neuroimaging data from the person. For example, via another database, or if the person has spread their brain images via social media so that “brainprint” and person are connected.

Making the persons completely unidentifiable would change the images so drastically that they would lose their value for research. The three contemporary trends – open science, stronger data protection legislation and more powerful AI – thus seem to be on a collision course. Is it at all possible to share scientifically useful neuroimaging data in a responsible way, when AI seems to be able to reveal the people whose brains have been imaged?

Well, everything unwanted that can happen does not have to happen. If the world were as insidiously constructed as in a conspiracy theory, no safety measures in the world could save us from the imminent end of the world. On the contrary, such totalized safety measures would definitely undermine safety, which I recently blogged about.

So what should researchers do in practice, when building international research infrastructures to share neuroimaging data (according to the first trend above)? A new article in Neuroimage: Reports, presents a constructive proposal. The authors emphasize, among other things, increased and continuously updated awareness among researchers about realistic data protection risks. Researchers doing neuroimaging need to be trained to think in terms of data protection and see this as a natural part of their research.

Above all, the article proposes several concrete measures to technically and organizationally build research infrastructures where data protection is included from the beginning, by design and by default. Because completely anonymized neuroimaging data is an impossibility (such data would lose its scientific value), pseudonymization and encryption are emphasized instead. Furthermore, technical systems of access control are proposed, as well as clear data use agreements that limit what the user may do with the data. Moreover, of course, informed consent from participants in the studies is part of the proposed measures.

Taken together, these safety measures, built-in from the beginning, would make it possible to construct research infrastructures that satisfy stronger data protection rules, even in a world where artificial intelligence can in principle see what human eyes cannot see. The three contemporary trends may not be on a collision course, after all. If data protection is built in from the beginning, by design and by default, researchers can share data without being forced to destroy the scientific value of the images, and people may continue to want to participate in research.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

Damian Eke, Ida E.J. Aasebø, Simisola Akintoye, William Knight, Alexandros Karakasidis, Ezequiel Mikulan, Paschal Ochang, George Ogoh, Robert Oostenveld, Andrea Pigorini, Bernd Carsten Stahl, Tonya White, Lyuba Zehl. “Pseudonymisation of neuroimages and data protection: Increasing access to data while retaining scientific utility,” Neuroimage: Reports, 2021,Volume 1, Issue 4

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Approaching future issues

Biobank news

Pär SegerdahlThe first newsletter for 2015 from CRB and BBMRI.se is now available for reading:

The main news item, by Anna-Sara Lind, is about the still unclear status for a new European data protection regulation (intended to replace the old directive).

You’ll also find items by Josepine Fernow about our blog books, about a newly released anthology on biobank regulation (edited by Debora Mascalzoni), and information about a new online course in research ethics (developed by Stefan Eriksson and given for the first time next autumn).

You’ll also find a link to the PDF version of the newsletter.

Pär Segerdahl

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