Tag: legislation (Page 2 of 5)

More biobank perspectives

27 September, 2016 / josepinefernow / 2 Comments

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

This post in Swedish

bbmri.se

Legal abortion: the right to move on

13 April, 2016 / Pär Segerdahl / 0 Comments

With brave new ideas you can astonish the world. In the past months the youth association of the Swedish party, the Liberals, made several proposals that astonished not least the mother party – for example, that incest and necrophilia should be allowed. The state should not control individuals’ love life.

Probably, the young politicians are quite proud of their radicalism. They are more liberal than liberalism itself. But what is their radicalism made of?

In March, another radical proposal was made. This time it was about abortion. Women have the right to choose abortion until the 18th week of pregnancy. But men don’t have a corresponding right to opt out of their parenthood. The proposal is about correcting this unfair distribution of the freedom to decide about parenthood.

How? By giving men the right to disclaim paternity until the 18th week of pregnancy: so-called legal abortion. Through the proposal, men get the same right as women to decide if they want to become parents. Thus, justice is restored.

One can surmise that the mother party dreams of making their own little abortion. But listen to how splendid it can sound when one astonishes the world with brave new ideas:

“It’s about men also being able to choose whether they want to become parents or not.”
“Men should have the same right to opt out of parenthood.”

Indeed, it sounds magnificent: the liberal youth association wants to correct a fundamental asymmetry between the rights of men and women! They are fighting for a more equal society!

I suggest that the “equality” here is purely verbal. It sits on the surface of an individualist language of rights and freedoms, with the words “man,” “woman” and “equal right.” Scratch the surface and the beautiful symmetry disappears.

One thing that is hidden by the jargon, for example, is that the woman’s decision concerns a fetus. But if she doesn’t abort, the man’s abortion decision will be about a child who will be born, and who will live, “legally aborted.”

Another thing that is hidden is that if the woman chooses abortion, neither party becomes a parent, because no child is born. But if she gives birth to the baby, the man will be the father of the child, whether he disclaims legal paternity or not. Law is not everything in life. When a child is born, there is a parenthood that cannot be disclaimed, for the child can say: “My father aborted me.” Only the woman’s abortion decision can completely abolish parenthood.

A third thing that is hidden is that something rings false in the individualist talk about parenthood as my parenthood and your parenthood; as the woman’s parenthood and the man’s. To crown it all, the fetus as well as the child are absent in this reasoning about male and female parenthood – curious! Are they already aborted? Did the young politicians forget something rather central, in their eagerness to develop truly liberal ideas about parenthood?

In order not to be disturbed by all this, in order not hear how false it rings, one must purify an individualist jargon of rights and freedoms, and then lock oneself in it. This is where the youth association’s radicalism lies: in language. It purifies (parts of) the language of liberalism, but as mere linguistic exercises with the words “man,” “woman” and “equal right.”

The radicalism isn’t political, but linguistic. Therefore, one feels instinctively that the discussion that the youth association wants to start up cannot be political, but merely continued exercise of pure concepts – like when schoolchildren plod through grammatical examples to one day be able to speak a language that still is foreign to them.

Ludwig Wittgenstein described such pure conceptual exercises as language that idles, like an engine can idle without doing its work. In this case, it is the language of liberalism that is idling.

I propose a good dose of Wittgenstein.

Pär Segerdahl

This post in Swedish

Global bioethics: each culture its own “ethnobioethics”?

6 April, 2016 / Pär Segerdahl / 0 Comments

With globalization bioethics is spread over the world. The process isn’t without friction, since bioethics is associated with Western philosophy. Is that thinking applicable to other cultures? Parts of the world where bioethics is spread may also have a colonial history, such as Africa. Should they now once again come under Western influence?

In an article in the Cambridge Quarterly of Healthcare Ethics, Sirkku K. Hellsten discusses the role of philosophy in global bioethics. She uses the example of Africa, where discussions about a unique African philosophy have been intense. But she also quotes Henry Odera Oruka, wondering why so much time is spent discussing what distinguishes African philosophy, when so little time is devoted to actually practicing it.

To investigate the role of philosophy in global bioethics, Hellsten distinguishes (inspired by Odera Oruka) four forms of philosophy. I reproduce two of them here:

Ethnophilosophy: Here it is assumed that different cultures often have incommensurable conceptions and worldviews. Bioethical key concepts – personhood, rationality, autonomy, consent, human nature, human well-being – have as many interpretations as there are cultures. The aim seems to be to develop these interpretations of Western ethical concepts and principles, to develop culture specific “ethnobioethics.”
Professional philosophy: Professional philosophers, says Hellsten, are academically trained in critical, impartial, logical argument. (She distinguishes professional philosophy from the ideological tendencies of Peter Singer and John Harris). Although professional philosophers are influenced by their culture, they can recognize these biases and subject them to self-critical examination. Professional philosophy is self-correcting.

Hellsten points out that ethnophilosophical thinking, in its quest to carve out culture specific “ethnophilosophies,” on the contrary tends to make sweeping generalizations about cultural views, creating false oppositions. Moreover, ethnophilosophical thinking is at risk justifying double standards in biomedical practices. It can make it seem reasonable to ask for individual consent in individualistic cultures but not in collectivist.

Hellsten suggest that what global bioethics needs is professional philosophy. It can impartially scrutinize arguments and reveal contradictions and unclear thinking, and it can keep ethics at arm’s length from politics and rhetoric. It is a universal form of human thought that should be accessible to all cultures. Through professional philosophy, global bioethics can become universal bioethics.

What do think about this? I believe that Hellsten’s emphasis of “universality” does not quite strikingly describe the point I think she actually has. In order to understand in what sense she has a point, I believe we need to understand that bioethics is not only as a form of “thinking,” but also a concrete component of contemporary social structure.

Law (to take another example) isn’t just a form of “thinking” but also an organized part of the social structure: a legal system. During the twentieth century, we saw the birth of bioethics as another part of the social structure: as an organized way to deal with certain issues of health care and biomedical research (other parts of the social structure). Bioethics therefore has an obvious place in the social structure, and that place is: the university, with its resources for research and education.

So where do I locate Hellsten’s point when she claims professional philosophy’s role in global bioethics? Not in the view that professional philosophy supposedly is “universal thinking,” but in the fact that the university is the place of bioethics in the social structure. If we build hospitals and invest in advanced medical research and education, and if we develop legislation for these activities, it is in the university that bioethics finds the resources it needs to play its role.

So why is “professional philosophy” relevant for bioethics in Africa? In my view, precisely because one builds hospitals and makes investments in medical research and education. It would be odd if the efforts to build such a society were combined with an emphasis on tradition-bound “ethnophilosophy.”

We need to be clear about where we are: in the midst of an ongoing construction of society. And we need to be clear about the fact that ethics, in addition to being a personal concern, also has become an important “apparatus” in the social structure. In Africa, and elsewhere, it will certainly be faced with unique bioethical issues, like the legal system is faced with unique problems in different parts of the world.

At the same time, it is important to emphasize, as Hellsten does, the open and self-critical nature of global bioethics.

(I want to thank the Global Bioethics Blog for drawing my attention to Hellsten’s article.)

Pär Segerdahl

This post in Swedish

Online course in research ethics, spring 2016

27 January, 2016 / Pär Segerdahl / 0 Comments

Anyone who manages research also needs to be able to reflect on research. Not only the researchers themselves, but also funding bodies, journal editors, members of research ethics committees, administrators, journalists, organizations, politicians, and others.

How do you act if you suspect research misconduct, and what is it? What are the ethical and legal regulations governing data management or research on humans and animals?

If you want to learn more about these issues, or perhaps about publication ethics and authorship rules, conflicts of interest, mentor/trainee responsibilities, biosecurity and more – then we can help you. We give an online course in research ethics for medicine and the life sciences.

The course runs for ten weeks, from April 4 to June 10, every week with its own theme (the last week is devoted to sharing what you learned with your home institution). The course includes video lectures and texts to read, but also interactive exercises and regular e-meetings with other students and with the teacher.

The course is given in English and is open to students from all over the world. If you want to know what some of the former students have to say about the course, you can read more here. And if you want to know who the course is aimed at, read more here.

Research ethical responsibility is vital and it is important that ethics education reaches out. The course fee is € 1.125 (including tax), and to students who cannot receive financial support from their home institution we offer a limited number of scholarships for which application deadline is February 15.

If you don’t need a scholarship you can apply for the course until course start.

Pär Segerdahl

This post in Swedish

Fourth issue of our newsletter about biobanks

22 December, 2015 / Pär Segerdahl / 0 Comments

Now you can read the fourth newsletter this year from CRB and BBMRI.se about ethical and legal issues in biobanking:

Biobank perspectives: current issues in biobank ethics and law

The newsletter contains three news items:

Moa Kindström Dahlin describes the work on ethical and legal issues in the European platform for biobanking, BBMRI-ERIC, and reflects on what law is.
Josepine Fernow features two PhD projects on research participants’ and patients’ preferences and perceptions of risk information.
Anna-Sara Lind discusses the ruling of the European Court of Justice against the Safe Harbour agreement with the United States.

(Link to PDF version of the newsletter)

And finally, a link to the December issue of the newsletter from BBMRI.se:

biobank SWEDEN.

Merry Christmas and a Happy New Year!

Pär Segerdahl

Open data access is regulated access

11 November, 2015 / Pär Segerdahl / 0 Comments

We usually associate open access with the publication of scientific articles that anyone with internet access can read, without price barrier.

The concept “open access” is now being used also for research data. I have written about this trend towards open data earlier on the Ethics Blog: Openness as a norm.

In many cases, research data are made as freely available as the open access articles that anyone can read; often in connection with the publication of results based on the data. This occurs, for example, in physics.

There is a strong trend towards open data also in medical research; but here the analogy with articles that anyone can read is no longer valid. Biobank and register-based research work with sensitive personal data, to which a number of laws regulating data access apply.

Yet one could speak of a trend towards open data also in this domain. But it then means something different. It’s about making data as accessible as possible for research, within the regulations that apply to this type of data.

Since the relevant laws and ethical frameworks are not only opaque but also differ between countries, the work is largely about developing common models for researchers to work within. One such attempt is made in an article by, among others, Deborah Mascalzoni and Mats G. Hansson at CRB:

International Charter of principles for sharing biological specimens and data

The article formulates 15 principles for sharing of biological samples and personal data between researchers. It also includes a template of the written agreements that scientists can make when one research group transfers data or materials to another research group.

Take a look at these principles, and the template of the agreements, and you’ll soon get an idea of how many strict conditions that must be met when biological samples and personal data are shared for research purposes.

Given how open access often is associated with the possibility for anyone at any time to read articles without price barrier, one should perhaps avoid using the term in this context. It may mislead, since this form of data access is heavily regulated, although the aim is to support researchers to share their data and samples.

Pär Segerdahl

This post in Swedish

All you need is law? The ethics of legal scholarship (By Moa Kindström Dahlin)

9 June, 2015 / Pär Segerdahl / 0 Comments

Working as a lawyer in a multidisciplinary centre for research ethics and bioethics, as I do, often brings up to date questions regarding the relationship between law and ethics. What kind of ethical competence does academic lawyers need, and what kind of ethical challenges do we face? I will try to address some aspects of these challenges.

First, I must confess. I am a believer, a believer of law.

That does not mean that I automatically like all regulations, it is just that I cannot see a better way to run the world, but through a common system of legal norms. Believing in law means that I accept living in a different universe. I know the non-lawyers cannot always see my universe, but I see it clearly, and I believe in it. You’ll have to trust me – and all other lawyers – through training and education, we see this parallel universe and believe in it.

I do not always like what I see, but I do accept that it exists.

I think that understanding a lawyer’s understanding of what law is, is a necessary precondition for going deeper into the understanding of what I here refer to as the ethics of legal scholarship. So, what is law? This question has a thousand answers, stemming from different philosophical theories, but I choose to put it like this:

Law is an idea as well as a practical reality and a practice.

As a reality, law is the sum of all regulation, locally (e.g. Sweden), regionally (e.g. Europe) and internationally. For example, the statutes, the preparatory works, court decisions, the academic legal literature, the general legal principles and other legal sources where we find the answers to questions such as “Is it legal to do this or that?” or “Might I be responsible for this specific act in some way?”

The practice of law has to do with the application of general legal knowledge (whatever that means) to a specific case, and this application always involves interpretation. This means that law is contextual. The result of its application differs depending on situation, time and place.

Law as an idea is the illusion that there are legal answers out there somewhere, ready to be discovered, described and applied. Lawyers live in a universe where this illusion is accepted, although every lawyer knows that this is oversimplified. There is rarely an obvious answer to a posed question, and there are often several different interpretations that can be made.

The legal universe is a universe of planets and orbits: different legal sources and jurisdictions, different legal traditions and ideas on how to interpret legal sources. There are numerous legal theories, perspectives and ideologies: legal positivism, critical legal studies, law and economics and therapeutic jurisprudence to name a few. The way we, the lawyers, choose to look at the law – the lens of our telescope if you like – affects how we perceive and decipher what we see.

Law is sometimes described as codified ethics. The legal system of a state often provides structures and systems for new technologies and medical progress. Therefore, law plays an important role when analyzing a state’s political system or the organization of its welfare system.

Law, in short, is a significant piece of a puzzle in the world as we know it.

This means that the idea of law as something concrete, something we can discover and describe, creates our perception of reality. Yet, we must be aware of the fact that the law itself is intangible, and answers to legal questions might differ, depending on whom (which lawyer) is making the analysis and which lens is being used.

Sometimes the answer is clear and precise, but many times the answer is vague and blurry. When the law seems unclear, it is up to us, the lawyers, to heal it.

We cannot accept “legal gaps”.

The very idea that law is a system that provides all the answers means that we must try to find all the answers within the system. If we cannot find them, we have to create them. Therefore, proposing and creating legal answers is one of the tasks for legal scholars. With this task comes great power. If a lawyer states that something is a description of what law is, such a description may be used as an argument for a political development in that direction.

Therefore the descriptions of what law is and what is legal within a field – especially if the regulation in the field is new or under revision – must always be nuanced and clearly motivated. If the statement as to what law is emanates from certain starting points, this should be clarified in order to make the reasoning transparent.

This is what I would like to call the ethics of legal scholarship.

It is worth repeating: Research within legal scholarship always requires thoughtfulness. We, the scholars, have to be careful and ethically aware all the time. Our answers and statements as to legal answers are always normative, never just descriptive. Every time an academic lawyer answers a question, the answer or statement might itself become a legal source and be referred to as a part of the law.

Law is constantly reconstructing itself and is, to some extent, self-sufficient. But if law is law, does that mean that all you need is law?

Moa Kindström Dahlin

Second issue of our newsletter about biobanks

2 June, 2015 / Pär Segerdahl / 0 Comments

Now you can read the second newsletter this year from CRB and BBMRI.se:

Biobank perspectives: current issues in biobank ethics and law

The newsletter contains four news items:

1. Anna-Sara Lind presents a new book, Information and Law in Transition, and the contributions to the book by CRB researchers.

2. Anna-Sara Lind describes the situation for the temporary Swedish law on research registries.

3. Mats G. Hansson reports on a modified version of broad consent for future research.

4. Josepine Fernow presents a new article by Jennifer Viberg on the proposal to give research participants freedom of choice about incidental findings.

(Link to PDF version of the newsletter)

Pär Segerdahl

The Swedish Data Protection Authority rejects extension of temporary law on registry research

28 April, 2015 / Pär Segerdahl / 0 Comments

Since the new Swedish law on research databases is delayed, there is a proposal to extend the current temporary law on certain registries for research about what heredity and environment mean for human health (until December 31, 2017).

The Swedish Data Protection Authority rejects extension, because major deficiencies noted previously have not been addressed and since the requirements for purpose identifications are not sufficiently specific and explicit.

Regarding specific and explicit purposes, the Authority gives special weight to a statement by the European so-called Article 29 Working Party, cited in the opinion:

“The purpose of the collection must be clearly and specifically identified: it must be detailed enough to determine what kind of processing is and is not included within the specific purpose, and to allow that compliance with the law can be assessed and data protection safeguards be applied. For these reasons a purpose that is vague and general, such as for instance ‘improving user’s experience’, ‘marketing purposes’, ‘IT-security purposes’ or ‘future research’ will – without more detail – usually not meet the criteria of being ‘specific’.”

This I regard as problematic in two ways.

First: In the cited statement the Article 29 Working Party equates the purpose “future research” with purposes like “improving the user experience” and “marketing purposes”. It is unclear if one can equate research purposes with such purposes, since researchers do not intend to return to the persons whose data are collected, to give them specifically profiled consequences. Personal data circulate in a categorically different way in research.

Secondly: The website of the Article 29 Working Party begins with a disclaimer. The group emphasizes that all material on the website solely reflects the group’s views, not the position of the European Commission. The group only has an advisory status and acts independently.

The group’s reasoning about research purposes can be questioned, and it seems to relinquish at least some of the authority that the Data Protection Authority ascribes to it in its opinion.

Pär Segerdahl

Experts on assignment in the real world

14 April, 2015 / Pär Segerdahl / 0 Comments

Experts on assignment in the real world cease in part to be experts. Just consider computer experts who create a computer system for the tax authorities, or for a bank, or for a hospital.

In order for these systems to work on location, the computer experts need to be open to what they don’t know much about: the unique activities at the tax authorities, or at the bank, or at the hospital.

Computer experts who aren’t open to their non-expertise on the site where they are on assignment perform worse as experts and will deliver inferior systems.

Experts can therefore not in practice be only experts. If one exaggerates one’s role as an expert, one fails on assignment in the real world.

This should apply also to other forms of expertise. My guess is that legal experts almost always find themselves in this precarious situation of being experts in a reality that constantly forces them to open themselves to their non-expertise. In fact, law appears to be an occupation that to an unusually high degree develops this openness systematically. I admire how legal experts constantly learn about the multifarious realities they act in.

Jurists should be a role model for computer experts and economic experts: because they methodically manage their inevitable non-expertise.

This post indicates the spirit in which I (as legal non-expert) took the liberty to question the Swedish Data Inspection Board’s shutting down of LifeGene and more recent rejection of a proposed law on research databases.

Can one be an expert “purely” on data protection? I think not. My impression is that the Data Inspection Board, on assignment in the world of research, didn’t open itself to its non-expertise in this reality. They acted (it seems to me) as if data protection issues could be handled as a separate field of expertise, without carefully considering the unique conditions of contemporary research and the kinds of aims that research initiatives can have.

Perhaps the temptation resides in the Board’s role as a public body: as an authority with a seemingly “pure” mission.

Pär Segerdahl

Tag: legislation (Page 2 of 5)

Legal abortion: the right to move on

Online course in research ethics, spring 2016

All you need is law? The ethics of legal scholarship (By Moa Kindström Dahlin)

The Swedish Data Protection Authority rejects extension of temporary law on registry research

Experts on assignment in the real world

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