Speaking to 5-year-olds about research

October 23, 2018

How should we talk to children about research? And how should we go about recruiting them to studies? For children to become research participants, their parents must consent. Regulation states children should also give assent themselves, to as great extent as possible. Our ethics committees require us to provide them with age-appropriate information. Health care providers and researchers think the system works well and is ethically “correct.”

From recruiting numerous children for various research projects, I have some thoughts on the subject. I have put together countless information letters for children of various ages; all reviewed and approved by the ethics committee. But what, exactly, is “age-appropriate information”? With support from developmental psychology and some paediatric research, the ambitious paediatric researcher can get it right. On a group level, that is. We can estimate what the average kid of a certain age group understands. But how appropriate is the “age-appropriate” information for individual children? In his poem Till eftertanke, Søren Kirkegard wrote “To help someone, I must indeed understand more than they do, but first and foremost understand what they understand.”

Today, I value a slow and calm recruiting process. I talk to the children about what research is, most 5-year-olds actually have an idea. We speak about what the project is about, and what we want them to contribute. Perhaps we draw or look at pictures. I tell them that it is absolutely fine to change your mind and leave at any time, and that no one will be angry or upset with them if they do. And then we talk some more… Lastly, and most importantly, I ask the child to tell me what we talked about, and what we agreed upon. It takes some time to understand their understanding. Give yourself that time.

Not until I understand that the child has understood do I ask them to sign the consent form.

Sara Frygner-Holm

This post in Swedish

We care about communication - the Ethics Blog


Internal investigation of research misconduct often fails

May 30, 2017

Pär SegerdahlWhat characterizes a research scandal? In a short article in Hastings Center Report, Carl Elliott uses as an example the case of Paolo Macchiarini at the Swedish Karolinska Institutet.

Macchiarini’s deadly experiments with stem cell-covered artificial trachea, transplanted to patients who did not have life-threatening diseases, have unique features linked to the personality and charisma of the researcher. However, the scandal resembles other scandals on one point, Elliott says. Whistle-blowers who use internal channels at the home university to handle research misconduct often fail. Justice is not done until the press reveals the scandal. In this case, a Swedish documentary film, The Experiments, exposed the scandal.

If Elliott is right, I personally draw two conclusions. The first is that investigative journalism is important. It reveals misconduct that would otherwise not be exposed. My second conclusion is that we cannot be satisfied with this.

Angry customers who want to force the shop assistant to correct what they think went wrong can threaten: “If you don’t fix this, I’ll contact the local newspaper.” A responsible person who suspects research misconduct should not have to act in a way that others can interpret as partial exercise of power. It poisons the situation and increases the risk for the whistle-blower.

If internal channels often fail to handle research misconduct, as Elliott claims, a system of external management is required. Therefore, it is good that a Swedish public inquiry recently suggested that an independent agency should investigate suspected research misconduct.

Contacting the media should not have to be “the way” of effectively exposing research misconduct; it is a way out if the standard way fails. If the way out often is required, something is wrong with the way.

Pär Segerdahl

This post in Swedish

We want solid foundations - the Ethics Blog


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

This post in Swedish

We recommend readings - the Ethics Blog


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

This post in Swedish

Following the news - the ethics blog


Online course in research ethics, spring 2016

January 27, 2016

Pär SegerdahlAnyone 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

We care about education


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

We recommend readings - the Ethics Blog


Ethics research keeps ethical practices alive (new dissertation)

August 25, 2015

Pär SegerdahlI have in two posts complained about a tendency of ethical practices to begin to idle, as if they were ends in themselves.

A risk with the tendency is that bioethics is discredited and attacked as no more than an unhappy hindrance to novel research.

Like when Steven Pinker recently wrote that the primary moral goal for bioethics today should be:

But there is a way to go: self-scrutinizing ethics research.

Bioethics is often misunderstood as merely a fixed and finished framework of ethical rules, principles and review systems: as a cumbersome bureaucracy. I guess that is how Pinker understands it.

But first, the “framework” is the result of novel ethical thinking at a time when we had reason to rethink the position of science. Doing research is important, but it does not justify exploiting research participants. There are other values ​​than Science, which scientists should take seriously.

Secondly, this ethical thinking will never be finished. There are always new problems to subject to self-scrutinizing ethics research.

Not infrequently these problems are occasioned by the bioethical framework. Pregnant women and children are routinely excluded from research, on ethical grounds. But does not the protection of these groups as research participants mean that they are exposed to risks as patients? If new drugs are tested only on adult males, we don’t know what doses a pregnant woman or an infant should receive.

We need self-critical ethics research, to keep ethics alive and to avoid idling.

Therefore, I formulate a different imperative than the one Steven Pinker suggests. Bioethics main goal should be: Think anew, reflect critically, do ethics research!

We follow that imperative at CRB. An example is Tove Godskesen’s thesis,

which will be defended on Friday, August 28, at 09:15, in room A1:107a at BMC (Biomedical Centre, Husargatan 3, Uppsala, Sweden).

This thesis is not about standing in the way of cancer research, but about doing empirical-ethical research to examine how well the ethical practices work when cancer patients are recruited as participants in such forms of research.

Do the patients understand the information they receive about the research? Do they understand that the possibility that they will be cured through research participation is extremely low? Do they understand that cancer research involves certain risks? Do they understand what a randomized study is?

And why do they volunteer as research participants? Because they hope for a new miracle drug? Because they want to help future patients? As thanks for the help they received? Because they feel a duty towards relatives, or because of (perceived) expectations from the doctor?

All these questions are empirically studied in the thesis.

Godskesen’s dissertation also contains reflections on the concept of hope. Her empirical studies show that it is precisely the patients with the least chance to be cured – those who don’t have much time left, and who usually are asked to participate in Phase 1 clinical studies – who primarily are motivated by the hope of a cure, at the last moment.

How should we view this fact? Does it mean that these participants misunderstand the study they have chosen to participate in, and thus participate on false premises? Or is it a hope which gives meaning at the end of life, a hope which might be nourished even if you understand the study design?

These are questions we cannot “step out of the way” of. Tove Godskesen does not step out of their way. Come and listen on Friday (but observe that the examination will be conducted in Swedish)!

Pär Segerdahl

In dialogue with patients


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