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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Identifying individuals while protecting privacy

August 24, 2016

Pär SegerdahlResearch ethics is complex and requires considering issues from several perspectives simultaneously. I’ve written about the temptation to reduce research ethics to pure protection ethics. Then not as much needs to be kept in mind. Protection is the sole aim, and thinking begins to resemble the plot of an adventure film where the hero finally sets the hostages free.

Protection is of course central to research ethics and there are cases where one is tempted to say that research participants are taken hostage by unscrupulous scientists. Like when a group of African-American men with syphilis were recruited to a research study, but weren’t treated because the researchers wanted to study the natural course of the disease.

Everyday life is not one big hostage drama, however, which immediately makes the issues more complex. The researcher is typically not the villain, the participant is not the victim, and the ethicist is not the hero who saves the victim from the villain. What is research ethics in everyday situations?

There is currently a growing concern that coding of personal data and biospecimens doesn’t sufficiently protect research participants from privacy invasions. Hackers hired to test the security of research databases have in some cases been able to identify the individuals who provided their personal data to research (in the belief that the link to them had been made inaccessible to outsiders through advanced coding procedures). Such re-identified information can obviously harm participants, if it falls into the wrong hands.

What is the task of research ethics here? Suddenly we can begin to discern the outlines of a drama in which the participant risks becoming the victim, the researcher risks becoming the villain’s accomplice, and the ethicist rushes onto the scene and rescues the victim by making personal data in research databases completely anonymous, impossible to identify even for researchers.

But everyday life hasn’t collapsed yet. Perhaps we should keep a cool head and ask: Why are personal data and biological samples not fully anonymized, but coded so that researchers can identify individual patients/research participants? The answer is that it’s necessary to achieve scientific results (and to provide individual patients the right care). Discovering relationships between genetics, lifestyle and disease requires running several registries together. Genetic data from the biobank may need to be linked to patient records in healthcare. The link is the individual, who therefore must be identifiable to the research, through the use of advanced code keys.

The need to identify participants is particularly evident in research on rare diseases. Obviously, there is only scant data on these diseases. The data needs to be shared between research groups, often in different countries, in order to collect enough data for patterns to appear, which can lead to diagnoses and treatments.

An overly dramatic heroic effort to protect privacy would have its own victims.

In an article in the European Journal of Human Genetics, Mats G. Hansson and co-authors develop a different, more sustainable ethical response to the risk of re-identification.

Respecting and protecting participants’ privacy is, of course, a central concern in the article. But protection isn’t the only perspective, since science and health care are ethical values too. And here you need to be able to identify participants. The task the authors assume, then, is that of discussing the risks of re-identification, while simultaneously considering the needs for identifiable data.

The authors are, in other words, looking for a balance between different values: simply because identifiable data are associated with both risks and benefits.

You can read a summary of the article on the CRB website. What I focus on in this post is the authors’ overall approach to research ethics, which doesn’t emphasize the hero/villain/victim opposition of certain dramatic situations.

The public image of research ethics is very much shaped by its function in response to research scandals. But research ethics is usually, and less dramatically, about making everyday life function ethically in a society which contains research. Making everyday life run smoothly is a more complex and important task than playing the hero when everyday life breaks down. In this work, more values and challenges need to be taken into account simultaneously than in emergency scenarios where ethicists, very naturally, focus on protection.

Everyday life may not be as exciting as a research scandal, but if we don’t first and foremost take responsibility for making everyday life work smoothly, as a complex whole, then we can expect more drama.

Keep a cool head and consider the issues from a variety of perspectives!

Pär Segerdahl

Hansson, M. G. et al. The risk of re-identification versus the need to identify individuals in rare disease research. European Journal of Human Genetics, advance online publication, 25 May 2016; doi: 10.1038/ejhg.2016.52

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Research ethics is not only protection ethics

June 6, 2016

Pär SegerdahlSystems for ethical review of research would never have been developed if it were not for the need to protect research participants from being exploited, exposed to excessive risks, or injured.

Considering how several research scandals strengthened this protection motive, it is easy to believe that protection is the sole aim of research ethics. This is not the case.

The starting point has always been that research is something worthwhile; something ethically important. Medical research provides knowledge that can lead to better diagnoses and more effective treatments. The humanities and social sciences can provide knowledge that supports more informed debates and more thoughtful political decisions.

Ethics review is about striking a balance between ethical values. Are the risks in proportion to the value of the research? Are the risks minimized, or can the research questions be examined more safely? Are research participants properly informed about the research purpose and the risks that participation might entail? Do they get the opportunity to freely decide whether to participate or not?

The “novelty” of research ethics is thus the balancing of ethical values. It’s not that ethical values are turned against research, for research itself is regarded as an ethical value. Also researchers are learning to balance values when they plan their research. The balancing is done not only in the review system, then, but pervades research itself more and more.

Doing the balancing is rarely easy. Moreover, as already mentioned, it is easy to overlook the starting point: that research is regarded as a value. This invites interpreting research ethics as pure protection ethics, which threatens to make ethics review one-sided.

For these reasons, well-written manuals are needed for members of ethical review boards, and for researchers. Manuals that not only inform about regulations and legislation, but also discuss the difficulties of balancing ethical values, and highlight how research ethics is “balance ethics” and not just protection ethics (except when protection law applies).

A new book, Balanced Ethics Review (Springer 2016), by Simon N. Whitney, is such a manual. It is written from within the American review system. But by openly discussing the difficulties of balancing ethical values, and by bringing to the fore how research ethics functions as “balance ethics,” the book has greater universality. – Perhaps precisely where the need for guidance is greatest.

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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Macchiarini and the spirit of fraudulence

February 10, 2016

Pär SegerdahlI assume you heard of Paolo Macchiarini, the “star surgeon” who, with the willpower of a general, simply would win a great battle at the frontline of research – by creating new tracheae using the patients’ own stem cells. That the endeavor had costs in terms of a few soldiers’ or patients’ lives is sad, but some losses must be accepted if one is to win a major battle in the service of cutting-edge experimental research.

It is difficult to avoid such an interpretation of Macchiarini’s mindset, after seeing the Swedish TV-documentaries about him (“Experimenten”/”The Experiments”). You feel the presence of a dominating iron will to carry out a plan and to win. It feeds a warlike spirit in which collegial doubts must be suppressed because they corrupt the morale and slow down the march forward, toward the frontline.

Truth is, as we know, the first casualty of war. Losses must be described as successes, in order not to lose readiness for action in the final battle – which, of course, will be won, don’t for a moment doubt that! The condition of patients who after surgery barely can breathe must thus be described as if the surgery had given them a nearly normal respiratory function. Macchiarini’s misconduct follows the logic of war.

Imagine this rigid winner, waiting impatiently for patients for whom his unproven methods (with some good will) could be interpreted as a last chance to survive. Does he approach the patients as a doctor who wants to offer a last treatment option? Hardly, but the possibility of interpreting the situation in such a way takes him to the frontline: he gets the opportunity to operate on them.

Does he then relate to the patients as a researcher to his participants? Not that either. For the treatment is only improvised in the heat of battle and can hardly even be called experimental; and all failures will be covered up by more scientific fraudulence.

The fact that research ethics developed in the shadow of the Second World War is hardly a coincidence. Something that worries in the Macchiarini case is that research itself – with its competition for funding and more – obviously can be animated by a warlike and strategic spirit of winning, which corrupts individuals as well as institutions…

It goes without saying that suspected research misconduct should not be investigated by the universities themselves; that there is a need for an independent body that handles such matters.

Pär Segerdahl

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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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