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

Tag: register-based research (Page 5 of 5)

Biobank research on the Sámi people should be more transparent

Ethnicity is a sensitive issue, so sensitive that one might want to remain silent about it.

Anna Lydia Svalastog at CRB recently published an article about genetic research on the Sámi people in Sweden. She highlights ethical problems associated with the fact that the Sámi focus in these studies is not made transparent.

Svalastog was surprised to discover that 50 years of genetic research on the Sámi people was invisible in the biobank register at the Swedish National Board of Health and Welfare. The reason, she guesses, is that ethnicity is considered unacceptable as a basis for creating registers and biobanks.

Still, some registers and biobanks are in practice Sámi, since data collection was carried out in traditional Sámi areas like Karesuando. When Svalastog studied the way research was carried out she found further tendencies to downplay ethnicity, although it was central in practice.

The Sámi focus of the research was downplayed by a more neutral vocabulary of people living in certain geographic areas. Also the questionnaires downplayed ethnicity. Questions could instead concern livelihood, which, however, can function as an indicator of Sámi ethnicity, since reindeer herding is an exclusively Sámi occupation.

Ethnicity can be reconstructed from the answers, then, but in a manner that risks reinforcing old stereotypes, since many see themselves as Sámi without being reindeer herders.

I don’t think that Svalastog is opposed to biobank research about the Sámi people, but her point is that ethnicity, and the fact that the Sámi is a native people, must be made transparent. Otherwise it becomes difficult to discuss and handle the ethical problems that ethnicity can imply.

The article is published in New Genetics and Society. Svalastog highlights the importance of talking about ethnicity, because it is sensitive.

Pär Segerdahl

Minding our language - the Ethics Blog

No consent for maintaining high-quality health care?

Collecting biological samples and health information from healthy donors in the construction of biobanks and research registers obviously requires the donors’ informed consent.

But is a similar demand for consent reasonable when patients provide their doctor with samples for diagnosis, undergo medical examination and treatment, and answer the doctor’s questions? Or can patients be expected to accept that their traces in the health care system – for example, data about experienced side effects – are monitored to optimize the quality of medical diagnosis and treatment?

A recent article by Mats G. Hansson at CRB discusses the issue. The article in Theoretical Medicine and Bioethics is well-argued and challenges common assumptions.

The basic argument is that quality registers and biobanks within the health care system play such a decisive role in optimizing the quality of the care that we expect as patients, that no consent should be required for collecting and studying our traces as patients (provided that the purpose is maintenance of high-quality health care, and nothing else).

Consent is associated with costs, in the form of drop-out of data. This impairs the value of the information in quality registers and biobanks, and thereby also the conditions for optimizing medical diagnosis and treatment.

Privacy is not the only ethical concern. Quality of care carries moral weight too.

Perhaps we are prepared to accept certain access to our patient histories, if such access is a precondition to maintaining and developing high standards of health care?

Pär Segerdahl

We recommend readings - the Ethics Blog

Research for the sake of the patient

We regularly tell strangers about sensitive aspects of our lives. We do it every time we visit the doctor. We do it without hesitating, in spite of the fact that the information won’t stay with the doctor to whom we give it.

The information is archived and will be read by health care staff in the future, when we visit a hospital again. As patients, we are satisfied with this state of affairs. Typically, we are happy that our samples are saved for future use, and that research is being done on our data to improve the quality of the care.

It is obvious to us that these actions are taken for our sake as patients, or as future patients.

However, when the same kind of data is collected for similar overall purposes, but outside of the health care sector, in the construction of biobanks and registers for future medical research, it suddenly becomes more tempting to worry about the safety of our data.

In spite of the fact that the researchers’ information about us

  1. normally is less comprehensive than in the doctor’s journal,
  2. is coded so that the connection to us is as safe as in a bank vault,
  3. isn’t used to do research on us individually, but to explore human patterns of disease,

a tendency to imagine nightmarish scenarios of surveillance appears. – Why?

One reason could be an assumption that researchers only want to answer their own questions. They don’t do research for our sake. They are curious and need our support to realize their own research goals.

Another reason could be an assumption that if medical research has commendable purposes related to health and health care, these purposes are very general and societal: Improved Public Health; Decreased Health Care Costs; A Flourishing Pharmaceutical Sector etc.

Who cares about little me?

When I visit the doctor, the connection to my own health and care is obvious. When I donate blood to the biobank for future research, on the other hand, the connection to me as a patient, or as a future patient, is less obvious.

Still, today’s health care depends on yesterday’s research.

The information I give the doctor would not help me a bit as a patient, if millions had not already provided medical research with their data. My doctor wouldn’t even be able to suggest a diagnosis, or recommend an effective treatment.

I believe we need to defuse the issue of personal data in biobanks and research registers; calm down our tendency to think that the information is collected without regard to us, and for wholly different purposes than in health care. Even in research, our data are collected for our sake: so that we, the day we visit the hospital and tell the doctor about our troubles, can expect well-founded diagnoses and effective treatments.

If you want to reflect more about our interest as future patients that there is ongoing biobank and register research, I want to recommend a coming dissertation:

  • Biobank Research – Individual Rights and Public Benefit

Author is Joanna Stjernschantz Forsberg at CRB, who defends her dissertation the 6th of October in Uppsala.

I also want to recommend the interactive conference, HandsOn: Biobanks, in Uppsala 20-21 September, which tries to illuminate the values of biobanking. You can register for the conference until the 11th of September.

Pär Segerdahl

We challenge habits of thought : the Ethics Blog

Research before health care

Last week I blogged about the unique status that personal data have in science. Researchers are not interested in the persons behind the data and they have no intention of returning to them; an intention that most other personal data collectors have.

In an age of increasing integrity threats, it is uplifting that biobanks and research registers function like depersonalized scientific spaces where our data can orbit between research projects without tendency to return to us and disturb us.

Scientific aims disentangle us from our data.

Simultaneously with my blogging on this topic, Mats G. Hansson here at CRB wrote a letter to Nature on almost the same subject.

Nature recently reported on recommendations to US biobanks to inform participants about medically relevant incidental findings about their DNA. Mats G. Hansson warns that following such recommendations would be irresponsible.

Genetic risk information is highly complex. It is often unclear what the discovery of a particular genotype variant actually says about an individual’s disease risk. And even if increased disease risk can be proven, further research is needed to ascertain which preventive measures would be efficient.

Research must be allowed run ahead of attempts to provide (what looks like) health care services. Reporting incidental findings that have not been validated “could be putting the cart before the horse,” Hansson warns.

Making sure that biobank research runs ahead of (what looks like) health care services has one further function. It sustains the depersonalized status of personal data in research.

I believe this is important when data protection legislation is about to be sharpened to meet new perceived integrity threats. Research might be unduly affected by the new legislation, especially if the unique status of personal data in research is not clear.

When authorities share personal data, the aim typically is to be able to return to individuals with these data – perhaps in court. It is in the nature of scientific data sharing, however, that the individuals behind the data are uninteresting and are not included in the purpose of the data sharing.

Biobank infrastructure is very much about facilitating scientific data sharing. If these infrastructures are well-built, they can serve as reassuring examples in times where integrity threats are assumed to hide behind every corner.

People could then say: “There actually are depersonalized spaces where personal data can circulate safely without burdening the persons behind the data. They are called biobanks.”

Pär Segerdahl

We participate in debates - the Ethics Blog

Research with my data, but not about me

It is perplexing how the websites of large internet companies continuously adapt to me. It looks like the entire business activity of Amazon was about the musical artists I listened to yesterday.

These companies evidently collect data about what I search out on their websites and automatically adapt to my computer, making the presentation of products as attractive as possible to me.

It is rather annoying to get one’s own internet history in the face like that.

The example illustrates a common property of personal data. When data about me are collected, the data sooner or later return to me: in the form of an adapted website; in the form of a demand to pay tax arrears; or in the form of more expensive insurance premiums.

No one would bother to collect my data if they did not intend to return to me on the basis of the data.

Me, me, me: my data are about me. Sooner or later they come back to me.

There is, however, one brilliant exception from my data’s stubborn tendency to return to me: research. When researchers collect my blood sample or ask questions about my health, they are not interested in my person. My data will not return to me in any form.

Researchers are interested in general patterns that can be discerned in data from thousands of people. If researchers should return to participants, it is to collect further data that (for example) can make the patterns of ageing appear.

Patterns, patterns, patterns: research is about patterns. It is not about any one of us who supplied the data.

I’m therefore inclined to see research registers as categorically distinct from the tax authorities’ data about my incomes. Researchers launch my data up into a depersonalized scientific space. Up there, my data hover weightlessly and my person cannot attract them back to me. They do research with my data. But it is not about me.

I don’t primarily have in mind the fact that researchers code my data so that the connection to me is obscured. I’m thinking of the elementary fact that they collect my data without any intention of returning to me on the basis of the data.

When the integrity of research participants is debated, it is important to keep this unique status of research registers in mind. The purpose of collecting scientific data about me is not at all about me. The purpose “scientific research” disentangles me from my own data.

Biobank research here encounters a difficulty.

Suppose that researchers discover in my blood sample a genetic disposition for a disease that can be prevented if measures are taken in advance. Should they then take down my data from their depersonalized orbit in scientific space, and inform me about the disposition?

It may seem obvious that they should inform me. But it would simultaneously be a departure from how science typically treats personal data without intention of returning to participants on the basis of the data.

How should biobank researchers handle discoveries about individual participants that may save their future health? This important and difficult question will be investigated in the dissertation work of our most recent doctoral student at CRB, Jennifer Viberg.

I’m certain that the Ethics Blog will return many times to Jennifer’s work on incidental findings in biobank research.

Pär Segerdahl

We like challenging questions - the ethics blog

UK Biobank invites researchers

After many years of data collection, UK Biobank is now open for research on human health and disease.

Like the Swedish biobank investment LifeGene, the British investment is big and prospective. Blood and urine samples were collected from 500 000 participants aged 40-69. Participants also underwent medical examinations and answered questions about health, disease and lifestyle.

The news is that researchers can now start planning projects using these data. Nevertheless, it will probably be a long time before interesting findings are reported…

It may seem cynical, but before UK Biobank can support valuable research, sufficiently many participants must develop various diseases, while others remain healthy. This is what will allow researchers to go back to the original data and identify patterns in how genetic and environmental factors contribute to health and disease.

The value of biobank infrastructure, like UK Biobank, increases with time, as participants develop cancer, depression, diabetes, or heart disease… while others remain in good health.

The fact that biobank infrastructure initially has unclear scientific value and reveals its potential only with time tends to invite skepticism. In the UK as well as in Sweden, investments in biobank infrastructure were interpreted by some as if they concerned unusually obscure research projects, lacking proper scientific goals and procedures.

I think that this is a misunderstanding.

As the recent opening of UK Biobank shows, it is not until now that clearly defined research projects can start being planned. If I am right, however, we might even have to wait somewhat longer…

The data collected between 2006 and 2012 might not support much interesting research until 2022, if I understand the temporality of these research processes. Since the research concerns health and disease in ageing humans, the significance of the research cannot develop any faster than humans grow older.

Rather than holding the initial lack of scientific prosperity against investments like UK Biobank or LifeGene, I am struck by the patience and foresightedness of those who planned and decided about these investments.

Understanding the infrastructural preconditions of biobank research seems to require an attitude to the pace of human life that I thought had become extinct in an age obsessed with short-term agendas.

Sometimes, we have to wait for the future to reveal itself. Only when the time is ripe can the goals and procedures of scientifically interesting biobank projects be defined.

Pär Segerdahl

Approaching future issues - the Ethics Blog

The Swedish government announced new rules for research registers

Will new Swedish rules for research registers enable LifeGene to continue?

In December 2011, the Swedish Data Inspection Board (DI) decided that the large biobank investment LifeGene is against the law.

In its motivation, DI focused on the purpose of the data collection and the information to participants about this purpose. According to DI, LifeGene’s purpose – “future research” – is too unspecific to be in accordance with the Personal Data Act.

Yesterday (February 28), the Swedish government announced new rules for research registers. These rules are supposed to enable LifeGene to continue. If you read Swedish, you might want to study the government’s press release.

I am not a legal expert, but it seems to me that even if the government’s new rules can make LifeGene lawful as a research register, other laws become relevant when the register is being used in research… for example, the Personal Data Act, surveyed by DI.

I happen to believe that LifeGene’s purpose can be interpreted as being sufficiently specific even for the demands of the Personal Data Act. LifeGene does not bluntly state “future research” as its purpose, but specifies the kind of diseases that will be studied, as well as the goal of creating new tools to prevent, diagnose, and treat these diseases.

Karolinska Institutet (that administers LifeGene) has appealed against DI’s decision to stop LifeGene. If DI does not withdraw its decision, my uncertain layman guess is that the result of this legal process might still be relevant for the possibility of continuing LifeGene as planned.

Pär Segerdahl

Following the news - the ethics blog

The Swedish Data Inspection Board stops large biobank

Swedish biobank research suffered serious defeat last week. The Swedish Data Inspection Board decided that the ongoing collection of biological samples and health data to the large biobank LifeGene is against the law.

Karolinska Institutet (that runs LifeGene) must now stop collecting further data and is not allowed use already collected data. The reason for the decision is said to be the loosely formulated purpose of LifeGene: “future research.” Participants cannot give consent to anything that vague, the Data Inspection Board argues.

Well, that openness happens to be the point of this new type of biobank!

LifeGene is not a research project, nor is it part of a research project. LifeGene is intended as infrastructure of future biobank projects. Researchers are invited to apply for access to the biobank within specific studies of, for example, genetic and environmental risk factors for widespread diseases.

The more specifically formulated research purposes enter later in the process!

Collecting hundreds of thousands of biological samples and health data anew, each time researchers want to ambitiously study widespread diseases, is unfeasible. Therefore, LifeGene was developed as standing infrastructure of such biobank research in the future.

… And now it has been decided that developing such infrastructure is illegal. Because the purpose cannot be specified as in the research projects that later use the biobank!

This is a category mistake, as philosophers say when what is fundamentally distinct is conflated. In this case, research infrastructure is conflated with research projects.

Other posts about biobanks on this blog are directly related to the risk of the decision that the Swedish Data Inspection Board made:

My views can be summarized in two simple points:

  1. Infrastructure for biobank research must not be treated as if it were one of the projects meant to use it.
  2. My given blood sample does not make me a research participant (who must give consent each time the sample is used).

LifeGene represents a new reality in the making. It remains for the authorities, for legislators, and for all of us to better understand it!

Pär Segerdahl

We challenge habits of thought : the Ethics Blog

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