The Ethics Blog

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

Tag: legislation (Page 4 of 5)

Revised European data protection will make data about rare diseases even rarer

30 April, 2013 / / 0 Comments

EU is currently discussing changes to the European privacy laws. The intention is to strengthen the protection of privacy and to give people more control over their data.

The problem, which I highlighted on The Ethics Blog, is that the new proposal applies also to research. Presently there is an exception for scientific research about health and disease. The proposed revision of the privacy regulation, however, allows no exceptions.

Every person who has given data to a register must according to the new proposal be asked for consent each time researchers want to study some new disease pattern. Patient data can never be used in research without specific consent, and not even historical registers and data from diseased persons are given exception in the new proposal.

A recent article in Nature Reviews Genetics by Deborah Mascalzoni et al. highlights a patient group that is especially vulnerable to the proposed revision: patients suffering from rare diseases. In Sweden a disease is defined as rare if it affects less than a hundred persons in a million.

Data on rare diseases are, as a matter of course, rare. We therefore know little about these diseases and it is difficult to develop effective medical treatments. To achieve statistically significant analyses, researchers must typically share data over national borders. Every lost piece of data about rare diseases can mean dramatically impaired prospects of new drugs and treatments for these patient groups.

Rare diseases are thus a further strong reason for maintaining the current exception for scientific research in the data protection legislation. Read more on the CRB website.

Pär Segerdahl

Approaching future issues - the Ethics Blog

Share this post

Don’t shoot at the patient (or at the messenger)

2 April, 2013 / / 0 Comments

The newly proposed European Data Protection Directive overprotects research participants and exposes patients to greater risks of contracting illness and dying.

Thus dramatically a recent article in The Lancet Oncology can be summarized, written by Mats G. Hansson at CRB together with Gert Jan van Ommen, Ruth Chadwick and Joakim Dillner.

People who provide data to research registers are not exposed to physical risks, like participants in interventional research. The risks associated with register-based research are informational: unauthorized release of information about participants. One might ask if it even makes sense to say that people “participate in research” when researchers process large data sets.

Patients (and people in general) have significant protection from disease thanks to register-based research. For example, it is estimated that the HPV vaccine will save about 200 women from dying in cervical cancer each year, in Sweden alone. This cancer-preventive treatment became possible because researchers had access to samples dating back to the 1960s providing evidence for a causal connection between a certain virus infection and cervical cancer later in life.

  • Despite this vital value in biobanks and registers,
  • despite the fact that risks are only informational,
  • despite rigorous safety routines to prevent unauthorized spread of information,
  • despite the fact that researchers don’t study individuals but statistical patterns, and
  • despite the question if people really are “participants” in register-based research,

the EU committee proposing the new directive treats the integrity of “research participants” as so pivotal that researchers who process data not only must be subjected to the same ethical review process as for invasive research, but also must obtain informed consent from each and every one who once gave their data to the register, whenever the researchers want to study a new disease pattern.

Data protection efforts easily lose their sense of proportions, it seems, at least concerning register-based research. Not only is one prepared to expose patients to greater physical risks in order to protect research participants from (already rigorously controlled) informational risks.

One also is prepared to disturb data providers who hardly can be described as “participating” in research, by forcing researchers to recontact them about informed consent. Not only on one occasion, but time and again, year after year, each time a new disease pattern is explored in the registers. That’s what I call privacy intrusion!

Pär Segerdahl

We participate in debates - the Ethics Blog

Share this post

Research for the sake of the patient

7 September, 2012 / / 0 Comments

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

Share this post

Neither innate nor learned

11 July, 2012 / / 0 Comments

A child begins to speak; to say that it is hungry, or does not want to sleep. Where was the child’s language hiding before it began to speak? Did the child invent it?

Certainly not, experts on language development would insist. A child cannot create language. Language exists before the child starts to speak. All that is happening during language development is that language is being transported to the child.

The big question is: transported from where? There seem to be only two alternatives:

  1. Language is innate. It is prepared in our neural structures. When the child hears its parents speak, these structures are stimulated and soon start supporting the child’s own speech.
  2. Language is learned. It exists in society. Children have social learning skills; through these skills, language is transported from the social environment to the young pupil, soon supporting the child’s own speech.

These are the alternatives, then. Language is either inside or outside the newborn. Language development is either a process of “externalization” or a process of “internalization” of language. There can be no third alternative.

I have written about the ape Kanzi, who was raised by a human mother. I’ve written about him both on The Ethics Blog and in the book, Kanzi’s Primal Language. This bonobo and his half-sister Panbanisha developed language in a manner that does not clearly correspond to any of these two alternatives.

Since it is hardly credible that human language is innate in apes, ape language researchers typically try to teach apes language. These attempts fail.

Kanzi’s human mother, Sue Savage-Rumbaugh, avoided teaching Kanzi. Instead, she simply spoke to him, as parents do, in a shared Pan/Homo culture. As a result of this humanlike cultural rearing, he developed language as nativists believe only human children do: spontaneously, without the parent having to play the social role of a teacher.

The humble purpose of this blog post is to introduce the idea we have to think more carefully about human changeability than we have done so far. We tend to think that human changes are either lying dormant in our nature or are being taught to us by the society.

Kanzi entices us to think differently.

Spontaneous language development in a nonhuman suggests that being reared in culture is more than simply a matter of internalizing social norms. Being reared in culture means participating in the culture: a more creative and masterful role than that of a mere pupil.

I believe we are caught in an adult/child dichotomy. The creative role of the child becomes invisible because the dichotomy categorically portrays her as a novice, as a pupil, as a learner… as a vacuous not-yet-adult-human.

Perhaps, if we manage to liberate us from this dichotomy, we can see the possibility that language – together with much else in human life – is neither innate nor learned.

Pär Segerdahl

Understanding enculturated apes - the ethics blog

Share this post

“The Route” is taking shape

27 June, 2012 / / 0 Comments

Our plans for the interactive part of the conference program for HandsOn: Biobanks, in Uppsala 20-21 September 2012, are taking shape. This part of the program is called “the Route.”

During coffee and lunch breaks, participants can walk through an interactive exhibition illustrating the process of informed consent, data and sample sharing, and new legislation.

Within the Route, participants can also meet law scholars, ethicists, biobank researchers and journalists. They can listen to and participate in conversations on a broad range of issues, such as the role or trust in biobank research, handling of incidental findings, patents, and regulatory processes.

Finally, the LifeGene debate will be discussed with representatives from LifeGene, EpiHealth, the Swedish Data Inspection Board, and the Central Ethical Review Board.

Curious? Do you want to partake in the Route?

Registration is open until September 11.

Pär Segerdahl

Share this post

Research before health care

10 May, 2012 / / 0 Comments

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

Share this post

Collection of papers brings out neglected aspect of ethics

26 April, 2012 / / 0 Comments

If you wrestle with ethical and legal difficulties associated with genetic science, a recent virtual issue of the Hastings Center Report could be good to think with.

The issue collects earlier material on ethics and genetics. There are pieces about the perils of genetic-specific legislation; about the difficulties of understanding behavioral genetics; about the prospects of personalized medicine; about the meaning of transhumanism; and much else.

Reading the virtual collection, it strikes me that our ethical difficulties surprisingly seldom are of a purely evaluative kind, or about what is morally right or wrong, or about what we ethically should or should not do.

Our ethical challenges are more typically about thinking well; about understanding complex facts properly; about avoiding tempting oversimplifications in our descriptions of reality.

In short, our ethical challenges are very much about facing reality well.

The philosopher Bernard Williams spoke of thick ethical concepts: notions like “courage” that seem to have both evaluative and descriptive content.

I am inclined to say that ethics is “thick” in this sense. Ethics is more often than not about describing reality justly. Ethical challenges are surprisingly often about coming to terms with oversimplified descriptions that prompt premature normative conclusions.

Just consider these two tempting oversimplifications of genetics, which produce an abundance of normative and political conclusions:

  1. The mistaken assumption that if the main source of variation is not genetic, it will be fairly easy to make environmental interventions.
  2. The mistaken assumption that if the primary source of variation is genetic, environmental interventions will be useless.

These assumptions are discussed in Erik Parens’ paper about why talking about behavioral genetics is important and difficult (on page 13).

Even though it is not its purpose, the virtual collection of papers on genetics makes it conspicuous how often our ethical challenges are of a descriptive kind.

Pär Segerdahl

We recommend readings - the Ethics Blog

Share this post

Interactive conference seeks the value of biobanking

20 April, 2012 / / 0 Comments

I have the privilege of belonging to a group of ethicists and law scholars that currently discuss how to visualize ethical and legal dimensions of biobanking.

We organize an interactive part of the scientific conference program for HandsOn: Biobanks in September. The conference invites participants to Uppsala to explore the values of biobanking and to take part in its interactive exhibition.

Biobanking is hot in medicine. There are hopes that it will substantially improve diagnosis, treatment and prevention of widespread as well as rare diseases. At the same time, however, the route to such values is difficult to survey, and the goals of large biobank investments are not always entirely transparent.

HandsOn: Biobanks is an ambitious attempt to explore and visualize the values of biobanking and the path towards them.

The conference asks: What are the values sought after? How can they be achieved in practice? There are the ethical, legal, scientific and commercial challenges, but there are also challenges for the industry. How can biobanking affect public trust in medical research and industry?

The conference combines keynote presentations with idea labs and educational sessions. The interactive part of the conference where I participate is called “the Route.” It follows the research process from ethical review, consent, sampling, storage and analysis, to end results that hopefully add value in ethics and trust, in clinical practice, in health economy, and in drug development.

If you want to participate in this interactive conference and help us better understand the values of biobanking, or simply are curious to see how we manage to solve the tricky problem of visualizing ethical and legal aspects – keep these dates in mind:

We are in the midst of brainstorming “the Route.” I hope that future blog posts can share with you some of the ethical and legal issues that we want to visualize and make accessible to participant interaction.

Registration is open – hope to see you in September!

Pär Segerdahl

Share this post

The Swedish government announced new rules for research registers

29 February, 2012 / / 0 Comments

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

Share this post

Blood samples to be destroyed in Minnesota

10 February, 2012 / / 0 Comments

Privacy concerns and public health endeavours sometimes clash with each other.

A recent example comes from the state of Minnesota.  After a ruling from the state’s supreme court, one has begun to destroy blood samples taken routinely from newborns in  a screening program. The practice is seen as a violation of privacy, since consent was not obtained first.

Read more in Science, News of the Week.

Pär Segerdahl

Share this post
« Older posts Newer posts »