Consent based on trust rather than information?

March 21, 2017

Pär SegerdahlConsent to research participation has two dimensions. On the one hand, the researcher wants to do something with the participant: we don’t know what until the researcher tells. To obtain consent, the researcher must provide information about what will be done, what the purpose is, what the risks and benefits are – so that potential participants can decide whether to consent or not.

On the other hand, potential participants would hardly believe the information and consider consenting, if they didn’t trust the researcher or the research institution. If trust is strong, they might consent even without considering the information. Presumably, this occurs often.

The fact that consent can be given based on trust has led to a discussion of trust-based consent as more or less a separate form of consent, next to informed consent. An article in the journal Bioethics, for example, argues that consent based on trust is not morally inferior to consent based on information. Consent based on trust supports autonomy, voluntariness, non-manipulation and non-exploitation as much as consent based on information does, the authors argue.

I think it is important to highlight trust as a dimension of consent to research participation. Consent based on trust need not be morally inferior to consent based on careful study of information.

However, I get puzzled over the tendency to speak of trust-based consent as almost a separate form of consent, next to informed consent. That researchers consider ethical aspects of planned research and tell about them seems to be a concrete way of manifesting responsibility, respect and trustworthiness.

Carefully planning and going through the consent procedure is an ethical practice that can make us better humans: we change through what we do. It also opens up for respondents to say, “Thank you, I trust you, I don’t need to know more, I will participate.” Information and trust go hand in hand. There is dynamic interplay between them.

I guess that a background to talk of trust-based consent as almost a separate form of consent is another tendency: the tendency to purify “information” as cognitive and to idealize humans as rational decision makers. In addition, there is a tendency to regiment the information that “must” be provided.

This tendency to abstract and regulate “information” has made informed consent into what sometimes is perceived as an empty, bureaucratic procedure. Nothing that makes us better humans, in other words!

It would be unfortunate if we established two one-dimensional forms of consent instead of seeing information and trust as two dimensions of consent to research.

Another article in Bioethics presents a concrete model of trust-based consent to biobank research. Happily, the model includes willingly telling participants about biobank research. Among other things, one explains why one cannot specify which research projects will use the donated biological samples, as this lies in the future. Instead, one gives broad information about what kind of research the biobank supports, and one informs participants that they can limit the use of the material they donate if they want to. And one tells about much more.

Information and trust seem here to go hand in hand.

Pär Segerdahl

Halmsted Kongsholm, N. C., Kappel, K. 2017. Is consent based on trust morally inferior to consent based on information? Bioethics. doi: 10.1111/bioe.12342

Sanchini, V. et al. 2016. A trust-based pact in research biobanks. From theory to practice. Bioethics 4: 260-271. doi: 10.1111/bioe.12184

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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.

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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

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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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Global bioethics: each culture its own “ethnobioethics”?

April 6, 2016

Pär SegerdahlWith 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:

  1. 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.”
  2. 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

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Critique of the motivation for dynamic consent to biobank research

March 23, 2016

Pär SegerdahlBiobank research has undeniably challenged research ethics and the requirement for informed consent. We are after all dealing with collection of biological samples for future, yet unspecified research. Thus, one cannot give donors specific information about the research in which their samples will be used. It might seem like asking them to consent to unknown research projects x, y, z.

While some argue that broad consent for future research is specific enough to be genuine consent to something – one can inform about the framework that applies to the research – others argue that biobank research undermines the autonomy of research participants. Something must therefore be done about it.

Dynamic consent is such a proposed measure. The idea is that participants in biobank research, through a website, will be kept continuously informed about planned research, and continually make decisions about their participation. Through this IT measure, participants are placed at the center of decision making process rather than transferring all power to the researchers. Dynamic consent empowers research participants and supports their autonomy, it is claimed.

In an article in the journal Bioethics, Linus Johnsson and Stefan Eriksson critically examine the understanding of autonomy in the debate on dynamic consent.

First, the authors argue that autonomy is misunderstood as a feat. Autonomy is rather a right people have to decide for themselves what to do in situations that matter to them.

Second, they argue that the concept of autonomy is used too broadly, hiding important distinctions. In fact, three different ways of respecting people are conflated:

  1. Autonomy: respecting people’s right to decide for themselves about what to do.
  2. Integrity: respecting people’s right to draw the lines between private and social life.
  3. Authority: respecting people’s right to take responsibility for themselves, for their families, and for their relations to society.

Authority is respected by empowering people: by giving them the tools they need to live responsibly. In dynamic consent, the website is such a tool. It empowers participants to act as responsible citizens concerning the planning and carrying out of research in society.

By separating three forms of respect which are confused as “autonomy,” the authors can propose the following critical analysis of the motivation for dynamic consent. Rather than respecting people’s right to decide for themselves about what to do, the aim is to empower them. But if the empowerment forces them to sit in front of the computer to be informed, it violates their integrity.

Such intrusion could be justified if medical research were a suitable arena for people’s empowerment as citizens – an assumption which the authors point out is doubtful.

Pär Segerdahl

Johnson, L. and Eriksson, S. 2016. “Autonomy is a right, not a feat: How theoretical misconceptions have muddled the debate on dynamic consent to biobank research.” Bioethics, DOI: 10.1111/bioe.12254

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Articles may be retracted if ethics is neglected

September 30, 2015

Pär SegerdahlWhen a scientific article is retracted, it means that the article should never have been published and that data and conclusions from the study should not be used to underpin future research.

Articles are often retracted when it is found that the authors acted fraudulently. They may have been careless, or cheated, or have plagiarized someone else’s (or their own!) previous work. Retracted articles may still be available for reading, but with a notice that they are retracted, and with explanations of the reasons behind the decision.

A rarer and less known reason to retract scientific articles is that the study reported does not satisfy ethical requirements for the protection of research participants.

Human research participation should be voluntary and research on humans must first be approved by an ethical review board. Editors of medical journals are bound by the same requirements. They increasingly require that authors state that the research they want to publish has an ethics approval.

How common is it that published articles are retracted because ethical requirements were neglected? How do editors motivate their decision? And what happens afterwards – are the articles cited and used despite the retraction?

Ethical retractions are uninvestigated, but in an article in the journal Accountability in Research Yusuke Inoue (former guest researcher at CRB) and Kaori Muto, present a study of articles retracted for ethical reasons:

One difficulty they mention is that unethical research may still produce scientifically valid data, results and conclusions – although neglect of ethics is a strong warning sign that other demands may have been neglected. Editors must therefore strike a balance between the requirement to retrospectively protect research participants and the scientific value of the article and its results. And if one decides to retract the article for ethical reasons, the research study may have to be repeated with new participants, which is also ethically problematic.

Yusuke Inoue and Kaori Muto studied retracted medical papers in English in the period 1981-2011. They found that the first ethical retractions did not occur until 2000 (2 articles). The number was then relatively constant (14 articles 2001-2010), but increased dramatically in 2011 (83 articles) – most of them related to a research scandal around anesthesiology researcher Joachim Boldt.

Most retraction notices stated as reason for the decision, simply “lack of ethical review.” However, editors rarely explained the decision more closely, for example, if they judged that the whole study was fraudulent, or judged that the study was well done but lacked ethical review. It then becomes unclear how to assess the contents of the retracted article.

Inoue and Muto also found that the majority of articles that were retracted for ethical reasons continued to be quoted. In some cases, it could be established that citations were deliberately misleading (as when authors cite their own retracted articles without mentioning that they are retracted). In other cases, however, retracted articles were cited perfectly legitimately, to specify that data from them had been excluded.

Inoue and Muto’s conclusion is that editors need to explain more clearly the reason behind their ethical retractions, so that future researchers can better assess the content of the articles. Moreover, discussion is needed on how data from articles that were retracted for ethical reasons may be used.

While we’re discussing scientific misconduct, I take the opportunity to link to an American dissertation that shows that often when misconduct is revealed by the Office of Research Integrity, it does not lead to the retraction of articles:

The number of retracted articles thus gives a poor measure of the extent of scientific misconduct. There are many “fraudulent articles” in circulation!

Pär Segerdahl

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