More biobank ethics and law

March 13, 2017

Biobank and registry research comes with particular sets of legal and ethical issues. We explore some of them in our Biobank Perspectives newsletter.

In this issue, you can read about some of the challenges that arise when biobanking stem cells in relation to a new project on the legal and ethical aspects of using stem cells to treat type 1 diabetes. We also offer a progress update from the B3Africa project and present the new Swedish legal officer BBMRI-ERIC ELSI helpdesk.  You can also read about the Swedish Government Inquiry  that was presented recently, proposing a new legal framework for handling and investigating research misconduct, with a new act suggested to enter into force on 1st of January 2019.

Josepine Fernow & Anna-Sara Lind

We recommend readings - the Ethics Blog


Stem cells: unique biobank material?

March 7, 2017

Pär SegerdahlStem cells are perhaps not what first springs to mind as biobank material. Yet, even stem cells can be biobank material and there are biobanks that focus on stem cells. The use of this biobank material, however, has some unique features.

Stem cell researchers process not only data from human material. The material itself is “processed” and sometimes transplanted to research participants. Commercializing stem cell research moreover implies that cells derived from donated human tissue appear in products on a market. This gives rise to ethical and legal questions.

Does the law allow patenting cell lines derived from human donated material? Is buying and selling such material lawful? Another issue concerns research participants’ right to withdraw their consent at any time. Human embryonic stem cell research uses stem cells from donated spare embryos from IVF treatment. How far does embryo donors’ right to withdraw consent stretch? Must transplanted devices with matured cells be removed from research participants, if the embryo donor withdraws consent? Moreover, assuming that researchers share stem cell lines with companies, are these companies willing to invest in the development of stem cell products if embryo donors may withdraw their consent at any time?

Another difficulty is the purpose to which embryo donors are asked to consent. According to the law, human embryos can be donated only for research purposes (or to other IVF patients). Yet, medical research loses its meaning if results cannot be commercialized. It cannot then reach patients. It is important to inform donors about this broader context of embryo donation. Does that information imply that the consent becomes broader than has support in the law? Or is there support since embryos are not used in product development, only derived material?

The answers to these questions probably depend on whether one can distinguish between donated embryos and cell material derived from embryos (using various inventions). This raises also more philosophical questions about how to view embryos, stem cell lines, matured cells, and human tissue.

Pär Segerdahl

An earlier version of this text was published in Biobank perspectives.

This post in Swedish

Approaching future issues - the Ethics Blog


The pharmaceutical industry and altruism

January 16, 2017

Pär SegerdahlI am currently thinking about a common gut reaction to the pharmaceutical industry. I sometimes have this reaction too, so this is an examination of my own reaction.

The reaction is a feeling of discomfort, when a central actor in the management of something as important as human health and disease is a multibillion-dollar industry with profit as overall goal.

Is it really possible to combine such a businesslike aim with a genuine desire to cure the sick?

Let us compare with another industry that radiates more compassionate desire to cure, namely, alternative medicine. Here too products are sold to people with various ailments. There is clearly a market and a business mindset. Yet the actors on this market radiate more love of mankind. It can sometimes even appear as if the products were manufactured and sold out of pure goodness!

What makes these business practices seem imbued with good will to cure? I suggest that it depends on the strong belief in the healing effects of the products. I do not deny that many of the products have beneficial effects. My point is only that beliefs about good effects are at the forefront and can make the provision of the products appear like an ethical act of noble actors.

The pharmaceutical industry is different from alternative medicine partly through being prohibited from being permeated with beliefs about the healing effects of the products. It is actually illegal for the pharmaceutical industry to act as nobly and compassionately as the actors within alternative medicine. It could invite quackery.

The pharmaceutical industry operates on a highly regulated market. There is specific legislation for pharmaceutical products and special authorities supervising the industry. Satisfying the quality and safety demands often requires decades of research and development. This means huge investment costs, which presupposes profits.

This is how we have solved the problem of providing safe and effective treatments through the health care system. By having a pharmaceutical industry that is not permeated with good faith and good intentions, but instead is highly regulated and supervised. The products must satisfy the quality requirements, period. Beliefs and good intentions are irrelevant.

Research, industry and healthcare together constitute a regulated system for managing health and disease. Within this system, researchers can be driven by curiosity, and industry by profit, while doctors want to cure their patients, and research participants want to support research that could lead to more effective treatments.

The point I am trying to make is that the gut reaction probably overlooks just this division of motives: In order for a whole system to work for the good, not every actor in the system needs to place good intentions first. It can rather pose a risk for the entire system.

There is no reason to glorify the pharmaceutical industry. Rather there are reasons to question it, for example, the marketing of products, which sometimes tries to create the faith that is prohibited in the development and approval of the products.

The industry is not altruistic. It is driven by profit. But through its place within the system it can make altruism and good will possible.

Pär Segerdahl

This post in Swedish

We challenge habits of thought : the Ethics Blog


Ethics and law of stem cell treatment of diabetes

December 21, 2016

Pär SegerdahlMany people support in various ways medical research, which they perceive as urgent in view of the needs of various patient groups. But patients typically won’t benefit from research unless the results are translated into development of medical products.

Type 1 diabetes is an incurable disease that requires daily life-sustaining treatment and strict dietary rules. Disease onset usually occurs at an early age.

In Sweden, about 50 000 people have this form of diabetes and of these around 8 000 are children. In type 1 diabetes, the immune system attacks the insulin-producing cells. Without insulin the body cells cannot use glucose for energy, and the sugar level in the blood rises. Energy is recovered instead from fat and protein, which causes waste products that can cause diabetic coma and attacks on vital organs.

Today, diabetes is treated with daily insulin injections, or by using an insulin pump. This requires continuous measurement of blood sugar levels, as incorrect doses of insulin entails risks and can be life-threatening. It is not easy to live with diabetes.

An alternative treatment, which is still at the research stage, is to generate new insulin-producing cells using human embryonic stem cells. The insulin-producing cells detect blood sugar levels and regulate the secretion of insulin. In order not to be attacked by the immune system, the transplanted cells are encapsulated in a protective material. It may become easier to live with diabetes.

But research alone doesn’t treat diabetes. Encapsulated insulin-producing cells need to be produced and made available also to patients; not only to research participants. But this is a big step and a host of ethical and legal issues, including embryo donation, patentability and consent, need to be examined and discussed.

The Swedish Research Council recently granted funding for a project to examine these issues. The project is led by Mats G. Hansson at CRB and is a collaboration with Olle Korsgren, professor of transplantation immunology, as well as with lawyers Anna-Sara Lind and Bengt Domeij, and philosophers and ethicists Jessica Nihlén Fahlquist and Pär Segerdahl.

The step from stem cell research to available treatments requires reflection. I look forward to start thinking about the ethical and philosophical questions.

Pär Segerdahl

This post in Swedish

Approaching future issues - the Ethics Blog


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

This post in Swedish

Approaching future issues - the Ethics Blog


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

This post in Swedish

We recommend readings - the Ethics Blog

 

 

bbmri.se


Legal abortion: the right to move on

April 13, 2016

Pär SegerdahlWith 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

Minding our language - the Ethics Blog


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