Research data, health cyberspace and direct-to-consumer genetic testing

December 14, 2016

josepine-fernow2We live in a global society, which means there are several actors that regulate both research and services directed at consumers. It is time again for our newsletter on current issues in biobank ethics and law. This time, Biobank Perspectives  lets you read about the legal aspects of direct-to-consumer genetic testing. Santa Slokenberga writes about her doctoral dissertation in law from Uppsala University and how the Council of Europe and the EU interact with each other and the legal systems in the member states. She believes direct-to-consumer genetic testing can be seen as a “test” of the European legal orders, showing us that there is need for formal cooperation and convergence as seemingly small matters can lead to large consequences.

We also follow up from a previous report on the General Data Protection Regulation in a Swedish perspective with more information about the Swedish Research Data Inquiry. We are also happy to announce that a group of researchers from the University of Oxford, University of Iceland, University of Oslo and the Centre for Research Ethics & Bioethics at Uppsala University received a Nordforsk grant to find solutions for governance of the “health cyberspace” that is emerging from assembling and using existing data for new purposes. To read more, download a pdf of the latest issue (4:2016), or visit the Biobank Perspectives site for more ethical and legal perspectives on biobank and registry research.

Josepine Fernow

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Approaching future issues - the Ethics Blog


The apparent academy

November 29, 2016

Pär SegerdahlWhat can we believe in? The question acquires new urgency when the IT revolution makes it easier to spread information through channels that obey other laws than those hitherto characterizing journalism and academic publishing.

The free flow of information online requires a critical stance. That critical stance, however, requires a certain division of labor. It requires access to reliable sources: knowledge institutions like the academy and probing institutions like journalism.

But what happens to the trustworthiness of these institutions if they drown in the sea of impressively designed websites? What if IT entrepreneurs start what appear to be academic journals, but publish manuscripts without serious peer review as long as the researchers are paying for the service?

This false (or apparent) academy is already here. In fact, just as I write this, I get by email an offer from one of these new actors. The email begins, “Hello Professor,” and then promises unlikely quick review of manuscripts and friendly, responsive staff.

What can we do? Countermeasures are needed if what we call critical reflection and knowledge should retain their meaning, rather than serve as masks for something utterly different.

One action was taken on The Ethics Blog. Stefan Eriksson and Gert Helgesson published a post where they tried to make researchers more aware of the false academy. Apart from discussing the phenomenon, they listed deceptive academic journals to which unsuspecting bioethicists may submit papers (deceived by appearances). They also listed journals that take academic publishing seriously. The lists will be updated annually.

In an article in Medicine, Health Care and Philosophy (published by Springer), Eriksson and Helgesson deepen their examination of the false academy. Several committed researchers have studied the phenomenon and the article describes and discusses what we know about these questionable activities. It also proposes a list of characteristics of problematic journals, like unspecified editorial board, non-academic advertisement on the website, and spamming researchers with offers to submit manuscripts (like the email I received).

Another worrying trend, discussed in the article, is that even some traditional publishers begin to embrace some of the apparent academy’s practices (for they are profitable). Such as publishing limited editions of very expensive anthologies (which libraries must buy), or issuing journals that appear to be peer reviewed medical journals, but which (secretly) are sponsored by drug companies.

The article concludes with tentative suggestions on countermeasures, ranging from the formation of committees that keep track of these actors to stricter legislation and development of software that quickly identifies questionable publications in researchers’ publication lists.

The Internet is not just a fast information channel, but also a place where digital appearance gets followers and becomes social reality.

Pär Segerdahl

Eriksson, S. & Helgesson, G. 2016. “The false academy: predatory publishing in science and bioethics.” Medicine, Health Care and Philosophy, DOI 10.1007/s11019-016-9740-3

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Approaching future issues - the Ethics Blog


The brain develops in interaction with culture

November 16, 2016

Pär SegerdahlThe brain develops dramatically during childhood. These neural changes occur in the child’s interaction with its environment. The brain becomes a brain that functions in the culture in which it develops. If a child is mistreated, if it is deprived of important forms of interaction, like language and care, the brain is deprived of its opportunities to develop. This can result in permanent damages.

The fact that the brain develops in interaction with culture and becomes a brain that functions in culture, raises the question if we can change the brain by changing the culture it interacts with during childhood. Can we, on the basis of neuroscientific knowledge, plan neural development culturally? Can we shape our own humanity?

In an article in EMBO reports, Kathinka Evers and Jean-Pierre Changeux discuss this neuro-cultural outlook, where brain and culture are seen as co-existing in continual interplay. They emphasize that our societies shape our brains, while our brains shape our societies. Then they discuss the possibilities this opens up for ethics.

The question in the article is whether knowledge about the dynamic interplay between co-existing brains-and-cultures can be used “proactively” to create environments that shape children’s brains and make them, for example, less violent. Environments in which they become humans with ethical norms and response patterns that better meet today’s challenges.

Similar projects have been implemented in school systems, but here the idea is to plan them on the basis of knowledge about the dynamic brain. But also on the basis of societal decision-making about which ethics that should be supported; about which values that are essential for life on this planet.

Personally I’m attracted by “co-existence thinking” as such, which I believe applies to many phenomena. For not only the brain develops in interaction with culture. So does plant and animal life, as well as climate – which in turn will shape human life.

Maybe it is such thinking we need: an ethics of co-existence. Co-existence thinking gives us responsibilities: through awareness of a mistreated nature; through awareness of our dependence on this nature. But such thinking also transcends what we otherwise could have imagined, by introducing the idea of possibilities emerging from the interplay.

Do not believe preachers of necessity. It could have been different. It can become different.

Pär Segerdahl

Evers, K. & Changeux, J-P. 2016. “Proactive epigenesis and ethical innovation: A neuronal hypothesis for the genesis of ethical rules.” EMBO reports 17: 1361-1364.

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Approaching future issues - the Ethics Blog


How to listen to (the right) patient voices?

October 25, 2016

Ulrik Kihlbom, Academic co-lead of PREFER's methodology work packageWe all think patients’ voices are important. But how do we make sure we listen to the right ones? Patient engagement and patient perspectives have come into focus in health care in recent years. Though this is especially true for the clinical setting, this development can be expected to continue for decision-makers at other levels.

We are just starting to research these questions in a project called PREFER. The aim is to establish which methods to use to bring in patient perspectives into important decisions regarding medical drugs; decisions made by different stakeholders, such as physicians, regulatory and reimbursement authorities, and the industry. In short: how and when should decision makers listen to the patients?

But, how can we make sure that the methods enable decision-makers to listen to the right patient voices?

Now, the expression “the right patient voices” should plausibly be understood as comprising several aspects such as being representative of the actual views patients have, being adequately informed, and as being non-biased. Each of these aspects require thorough consideration and also methodological development. I am myself responsible for one task that will specifically address these questions. One of the many intriguing issues here is when, during the process of falling ill, coming under treatment, and hopefully convalescing, a patient’s voice should be listened to? The patient’s preferences will probably change during the trajectory of illness. Imagine that you fall seriously ill, are treated and recover, and suppose also that your preferences for a risky treatment change during this period of time. Do you know when your preferences are such that your physician should listen to them? And when they merit less attention? I am myself far from sure how to answer this question.

Another set of questions concerns how the (right) patient perspective should be incorporated into the decision making. How, for example should a reimbursement authority weigh the patient perspective against cost-effectiveness when making a decision of subsidising a medical drug? Or how should a regulatory authority, such as EMA in Europe, FDA in the US, and Läkemedelsverket in Sweden, weigh patient effectiveness against safety concerns? It seems fair to say that everybody agrees that the patient perspective should have a weight, but no one has an established scale.

These are some of the very hard and intriguing questions that the PREFER project will address over the coming five years. 33 partners from academic institutions, patient organisations, health technology assessment bodies, small companies and the pharmaceutical industry are putting their heads, competence and resources together. Uppsala University is coordinating the project, with CRB’s director Mats G. Hansson at the helm. Apart from me and Mats, Josepine Fernow, Elisabeth Furberg, Jorien Veldwijk and Karin Schölin Bywall at CRB are involved in PREFER. We are looking forward to interesting research questions, but also to learning by working in, and leading, a public-private partnership of this size.

In the autumn of 2021, the project will issue recommendations. By then we will know better how decision makers may find and listen to the (right) patient voices. And how patients’ voices can make themselves heard in the decisions of regulators, health technology assessment bodies, reimbursement agencies, and pharmaceutical companies.

Ulrik Kihlbom

About PREFER: The Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115966. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. The contents of this text reflects the author’s view and not the view of IMI, the European Union or EFPIA.

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More biobank perspectives

September 27, 2016

If you did not get your fill during the Europe biobank week in Vienna, we give you more biobank related news in the latest issue of Biobank Perspectives, our newsletter on current issues in biobank ethics and law.

This time, Moa Kindström Dahlin describes what BBMRI-ERIC’s new federated Helpdesk for ELSI-issues can offer. We also invite you discuss public-private partnerships in research at a workshop in Uppsala on 7-8 November.

The legislative process on data protection in the EU might be over for now but there is still activity in government offices. Anna-Sara Lind gives you her view on the consequences for Sweden. We are also happy to announce that the guidelines for informed consent in collaborative rare disease research have received the IRDiRC Recognized Resources label.

You can read the newsletter on our website, or download a pdf version.

Josepine Fernow & Anna-Sara Lind

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Identifying individuals while protecting privacy

August 24, 2016

Pär SegerdahlResearch ethics is complex and requires considering issues from several perspectives simultaneously. I’ve written about the temptation to reduce research ethics to pure protection ethics. Then not as much needs to be kept in mind. Protection is the sole aim, and thinking begins to resemble the plot of an adventure film where the hero finally sets the hostages free.

Protection is of course central to research ethics and there are cases where one is tempted to say that research participants are taken hostage by unscrupulous scientists. Like when a group of African-American men with syphilis were recruited to a research study, but weren’t treated because the researchers wanted to study the natural course of the disease.

Everyday life is not one big hostage drama, however, which immediately makes the issues more complex. The researcher is typically not the villain, the participant is not the victim, and the ethicist is not the hero who saves the victim from the villain. What is research ethics in everyday situations?

There is currently a growing concern that coding of personal data and biospecimens doesn’t sufficiently protect research participants from privacy invasions. Hackers hired to test the security of research databases have in some cases been able to identify the individuals who provided their personal data to research (in the belief that the link to them had been made inaccessible to outsiders through advanced coding procedures). Such re-identified information can obviously harm participants, if it falls into the wrong hands.

What is the task of research ethics here? Suddenly we can begin to discern the outlines of a drama in which the participant risks becoming the victim, the researcher risks becoming the villain’s accomplice, and the ethicist rushes onto the scene and rescues the victim by making personal data in research databases completely anonymous, impossible to identify even for researchers.

But everyday life hasn’t collapsed yet. Perhaps we should keep a cool head and ask: Why are personal data and biological samples not fully anonymized, but coded so that researchers can identify individual patients/research participants? The answer is that it’s necessary to achieve scientific results (and to provide individual patients the right care). Discovering relationships between genetics, lifestyle and disease requires running several registries together. Genetic data from the biobank may need to be linked to patient records in healthcare. The link is the individual, who therefore must be identifiable to the research, through the use of advanced code keys.

The need to identify participants is particularly evident in research on rare diseases. Obviously, there is only scant data on these diseases. The data needs to be shared between research groups, often in different countries, in order to collect enough data for patterns to appear, which can lead to diagnoses and treatments.

An overly dramatic heroic effort to protect privacy would have its own victims.

In an article in the European Journal of Human Genetics, Mats G. Hansson and co-authors develop a different, more sustainable ethical response to the risk of re-identification.

Respecting and protecting participants’ privacy is, of course, a central concern in the article. But protection isn’t the only perspective, since science and health care are ethical values too. And here you need to be able to identify participants. The task the authors assume, then, is that of discussing the risks of re-identification, while simultaneously considering the needs for identifiable data.

The authors are, in other words, looking for a balance between different values: simply because identifiable data are associated with both risks and benefits.

You can read a summary of the article on the CRB website. What I focus on in this post is the authors’ overall approach to research ethics, which doesn’t emphasize the hero/villain/victim opposition of certain dramatic situations.

The public image of research ethics is very much shaped by its function in response to research scandals. But research ethics is usually, and less dramatically, about making everyday life function ethically in a society which contains research. Making everyday life run smoothly is a more complex and important task than playing the hero when everyday life breaks down. In this work, more values and challenges need to be taken into account simultaneously than in emergency scenarios where ethicists, very naturally, focus on protection.

Everyday life may not be as exciting as a research scandal, but if we don’t first and foremost take responsibility for making everyday life work smoothly, as a complex whole, then we can expect more drama.

Keep a cool head and consider the issues from a variety of perspectives!

Pär Segerdahl

Hansson, M. G. et al. The risk of re-identification versus the need to identify individuals in rare disease research. European Journal of Human Genetics, advance online publication, 25 May 2016; doi: 10.1038/ejhg.2016.52

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Approaching future issues - the Ethics Blog


Genetic screening before pregnancy?

June 20, 2016

Pär SegerdahlGenetic diseases can arise in strange ways. So-called recessive diseases require that both parents have the gene for the disease. The parents can be healthy and unaware that they are carriers of the same non-dominant disease gene. In these cases, the risk that the child develops the disease is 25 percent.

In families with a history of some recessive disease, as well as in communities where some serious recessive disease is common, genetic screening before pregnancy is already used – to determine whether couples that are planning a child are, so to speak, genetically compatible.

As these genetic tests have become more reliable and affordable, one has begun to consider offering preconception genetic screening to whole populations. Since one doesn’t know then exactly which genes to look for, it’s not just about screening more people, but also about testing for more recessive traits. This approach has been termed expanded carrier screening (ECS).

In the Netherlands, a pilot project is underway, but the ethical questions are many. One concerns medicalization, the risk that people begin to think of themselves as being more or less genetically compatible with each other, and feel a demand to test themselves before they form a couple and plan children.

Sweden has not yet considered offering expanded carrier screening to the population and the ethical issues have not been discussed. Amal Matar, PhD student at CRB, decided to start investigating the issues in advance. So that we are prepared and can reason well, if preconception expanded carrier screening is suggested.

The first study in the PhD project was recently published in the Journal of Community Genetics. Interviews were made with clinicians and geneticists, as well as with a midwife and a genetic counselor, to examine how this type of genetic screening can be perceived from a Swedish health care perspective.

Ethical issues raised during the interviews included medicalization, effects on human reproductive freedom, parental responsibility, discrimination against diseased and carriers, prioritization of resources in health care, as well as uncertainties about what to test for and how to interpret results.

The study serves as an empirical exploration of the ethical issues. Some of these issues will be examined philosophically further on in Amal Matar’s project.

(Read more about Amal Matar and her work at CRB here.)

Pär Segerdahl

Matar, A., Kihlbom, U., Höglund, A.T. Swedish healthcare providers’ perceptions of preconception expanded carrier screening (ECS) – a qualitative study. Journal of Community Genetics, DOI 10.1007/s12687-016-0268-2

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