The Ethics Blog

A blog from the Centre for Research Ethics & Bioethics (CRB)

Tag: research participant (Page 3 of 6)

Macchiarini and the spirit of fraudulence

10 February, 2016 / / 0 Comments

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

30 September, 2015 / / 0 Comments

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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Ethics research keeps ethical practices alive (new dissertation)

25 August, 2015 / / 0 Comments

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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Openness as an ethical ritual

3 August, 2015 / / 0 Comments

Pär SegerdahlBarbara A. Koenig wrote last year about how informed consent has acquired a “liturgical feel” in biomedical research ethics. Each time the protection of research participants is challenged by new forms of research, the answer is: more consent!

The procedure of informing and asking for consent may feel like assuming a priestly guise and performing an ethical ritual with the research participant.

The ritual is moreover sometimes practically impossible to implement. For example, if one is to inform participants in genetic research about incidental findings that might be made about them, so that they can decide whether they want to be re-contacted if researchers happen to discover “something” about them.

If it takes one hour to inform a patient about his or her actual genetic disease, how long would it take to inform a research participant of all possible kinds of genetic disease risks that might be discovered? Sorry, not just one participant, but hundreds of thousands.

How then can research participants be respected as humans, if informed consent has become like an empty ritual with the poor participant? (A ritual that in genetic research sometimes is impracticable.)

In the August issue of Nature, Misha Angrist suggests a solution: we treat participants as partners in the research process, by being open to them. How are we open to them? By offering them the researchers’ genetic raw data, which can be handed over to them as an electronic file.

Here we are not talking about interpreted genetic disease risks, but of heaps of genetic raw data that are utterly meaningless for research participants.

Openness often has important functions. Making scientific articles openly accessible so that everyone can read them has a function. Making researchers’ data available to other researchers so that they can critically review research, or use already collected data in new research, has a function.

But offering files with genetic raw data to research participants, what is its function? Is it really the beginning of a beautiful partnership?

Openness and partnership seem here to become yet another ethical ritual; yet another universal solution to ethical difficulties.

Pär Segerdahl

We think about bioethics : www.ethicsblog.crb.uu.se

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Letting people choose isn’t always the same as respecting them

5 May, 2015 / / 0 Comments

Jennifer Viberg, PhD Student, Centre for Research Ethics & Bioethics (CRB)Sequencing the entire genome is cheaper and faster than ever. But when researchers look at people’s genetic code, they also find unexpected information in the process. Shouldn’t research participants have access to this incidental information? Especially if it is important information that could save a life if there is treatment to offer?

The personal benefits of knowing genetic information can vary from individual to individual. For one person, knowledge might just cause anxiety. For another, genetic risk information could create a sense of control in life. Since different people have different experiences, it could seem tempting to leave it for them to decide for themselves whether they want the information or not.

Offering participants in genetic research a choice to know or not to know is becoming more common. Another reason for giving a “freedom of choice” has to do with respecting people by allowing them to make choices in matters that concern them. By letting the participant choose, you acknowledge that he or she is a person with an ability to make his or her own choices.

But when researchers hand over the decision to participants they also transfer responsibility: A responsibility that could have consequences that we cannot determine today. I recently wrote an article together with colleagues at CRB about this in Bioethics. We argue that this freedom of choice could be problematic.

Looking at previous psychological research on how people respond to probabilities, it becomes clear that what they choose depends on how the choice situation is presented. People choose the “safe” outcome before taking a risk in cases where the outcome is phrased in a positive way. But they are more prone to taking a risk when the result is phrased in a negative way, despite the fact that the outcome is identical. If a participant is asked if he or she wants information that could save their life, there is a risk that they could be steered to answering “yes” without considering other important aspects, such as having to live with anxiety or subjecting themselves to medical procedures that might be unnecessary.

The benefit of incidental findings for individual participants is hard to estimate. Even for experienced and knowledgeable genetic researchers. If we know how difficult the choice situations are, even for them, and if we know how psychological processes probably will steer the participants’ choices, then it seems that it is hardly respectful to give the participants this choice.

There are good intentions behind giving participants freedom to choose, but it isn’t respectful if we can predict that the choices won’t be free and well grounded.

If you want to learn more, you find further reading on CRB’s web, and here is a link to our article: Freedom of choice about incidental findings can frustrate participants’ true preferences

Jennifer Viberg

We like real-life ethics : www.ethicsblog.crb.uu.se

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Perplexed by autonomy

30 April, 2014 / / 0 Comments

PÄR SEGERDAHL Associate Professor of Philosophy and editor of The Ethics BlogDuring the seminar this week we discussed an elusive concept. The concept is supposed to be about ordinary people, but it is a concept that ordinary people hardly use about themselves.

We talked about autonomy, which is a central notion in ethical discussions about how patients and research participants should be treated. They should be respected as persons who make their own decisions on the basis of information about the options.

The significance of this is evident if we consider cases where patients are given risky treatments without being informed about the risks and given the opportunity to refuse treatment. Or cases where vulnerable persons are forced to function as research subjects in various experiments.

“Respect people’s autonomy!” is comprehensible as a slogan against such tendencies.

What makes the concept more elusive, however, is that increasingly it is used more speculatively as the name of a valuable quality in the human, perhaps even the superior and most distinctive one. Instead of functioning as a comprehensible slogan in a real context, the notion becomes utopian, demanding that individuals constantly be informed about options and making decisions.

Autonomy becomes the superior imperative in all areas of human life.

Such a totalized imperative displaces the meaning of these areas of life, for example, the meaning of health care. Health care no longer seems being primarily about treating people’s diseases (while respecting their autonomy), but as being about developing diagnoses and treatments that give individual patients more information and options to choose between.

The concept of autonomy becomes a utopian construct that does not face the real-life challenges that made the slogan comprehensible, because it aims towards an ideal solution without need of the slogan. Every human practice is turned into an arena that first of all supports autonomy.

The speculative concept is somewhat self-contradictory, however, since it is imposed paternalistically as the essence of the human, while the humans concerned hardly use it to understand themselves. Well, then we’ll have to turn them into such individuals!

No, I confess I’m quite perplexed by the utopian-intellectual refinement of otherwise comprehensible slogans like autonomy, justice and freedom. These efforts appear like the noblest efforts of humankind, and yet they run amok with our words and displace the meaning of every human practice.

Pär Segerdahl

We like real-life ethics : www.ethicsblog.crb.uu.se

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The risk with knowing the risk

5 March, 2014 / / 0 Comments

PÄR SEGERDAHL Associate Professor of Philosophy and editor of The Ethics BlogInforming individuals about their genetic risks of disease can be viewed as empowering them to make autonomous decisions about their future health.

But we respond to risk information not only as rational decision makers, but also with our bodies, feelings and attitudes.

An American study investigated elderly people whose genetic test results showed a predisposition for Alzheimer’s disease. One group was informed about the risk; the other group was not.

In subsequent memory tests, those who were informed about the risk performed markedly worse than those who weren’t informed.

Knowing the genetic risk thus increased the risk of a false positive diagnosis of dementia. The informed participants performed as if they already were on the verge of developing Alzheimer’s.

The risk with knowing the risk is thus a further complication to take into consideration when discussing biobank researchers’ obligation to return incidental genetic findings to individual participants.

Returning information about genetic risks cannot be viewed only as empowering participants, or as giving them valuable information in exchange for contributing to research.

It can also make people worse, it can distort research results, and it can lead to false diagnoses in clinical care.

Pär Segerdahl

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Why do cancer patients participate in clinical trials?

5 February, 2014 / / 0 Comments

PÄR SEGERDAHL Associate Professor of Philosophy and editor of The Ethics BlogHearsay and good intentions won’t suffice. If a new treatment is chosen for a patient with cancer, one must first have seen that the treatment is at least as efficient as the conventional treatment. And one must have looked at side effects and right dosages.

Seeing this, however, presupposes that some patients agree to test the treatment… before one has clearly seen its efficacy. This is done in so-called clinical trials arranged in phases where first side effects and dosages are studied, and finally efficacy is compared to conventional treatment.

This gives rise to questions: Why are some patients prepared not to be patients on the same conditions as other patients? Why are they prepared to test a treatment one hasn’t yet seen is most efficient?

Do they understand what they agree to participate in? Since they participate in a study of a new treatment, do they understand that in order to see its efficacy, some in the group will be given just the conventional treatment?

Tove Godskesen, PhD student at CRB, noticed that such questions were relatively unexamined in the context of Swedish clinical cancer trials. She therefore did a survey study with cancer patients in several Swedish phase 3 clinical trials (where experimental and conventional treatments are compared).

Godskesen’s study (done together with Mats G. Hansson, Peter Nygren, Karin Nordin and Ulrik Kihlbom) was recently published online in the European Journal of Cancer Care:

The article contains many interesting findings. For example, patients-participants seemed generally to have understood the information about the “seeing” that they were willing to support by not being patients quite the same way as others.

Most important and salient, however, was that patients have two main motives for participating. They hope for a cure; and they wish to help future patients.

I would like to say: Patients hope that they will be given the new treatment already and that it will turn out to be more efficient than the conventional one. And they want to help future patients get the treatment that one has seen is most efficient.

Sight and future, patient role and research participant role, hope and altruism, in complex association.

Pär Segerdahl

We have a clinical perspective : www.ethicsblog.crb.uu.se

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Beware of the vanity of “autonomy”

26 November, 2013 / / 0 Comments

Important words easily become totalitarian. They begin with communicating some humanly important point, so we listen with attention. But then it is as if the words suffered from vanity and assumed that our attention was directed at them; not at what they were used to say.

Over time, the words become like grammatical codes of importance in human life.

A word that underwent such a process in bioethics is autonomy. It was first used to communicate an urgency, namely, that patients and research participants must be respected. They have a right to information about what is about to happen, and to decide whether they want to undergo some treatment or participate in some experiment.

Patients and research participants have this understandable right to autonomy.

But as the word was used to communicate this urgency, the importance seemed to move into the word. If patients have a right to “autonomy,” mustn’t autonomy be a valuable trait that can be supported so that we increase the value?

Is autonomy perhaps even the most valuable aspect of the human: our characteristic when we are in our most rational state as rational animals. Perhaps autonomy is human essence?

From having been a comprehensible right, autonomy assumed the appearance of a super important value to constantly look for, like for a holy grail.

The question arose: Should we restrict people’s freedom to make own choices, if the choices threaten future autonomy?

We occasionally do disrespect people’s choices: for their sake. What I’m blogging about today is the tendency to replace “for their sake” with “for the sake of future autonomy.”

A new article in the Journal of Medicine and Philosophy deals with the question. You find the article by clicking the link below:

The article is written by Manne Sjöstrand, Stefan Eriksson, Niklas Juth and Gert Helgesson. They criticize the idea of a paternalistic policy to restrict people’s freedom in order to support their future autonomy.

The authors choose to argue from the opponent’s point of view. They thus start out from the interpretation of autonomy as super important value, and then try to show that such a policy becomes self-defeating. Future autonomy will be threatened by such a policy, much like the dictatorship of the proletariat never liberated humans but chained them to a totalitarian order.

The article is well-argued and should alert those enchanted by the word “autonomy” to the need of checking their claims.

Even though the article does not disenchant the concept of autonomy through the philosophical humor that I described in a previous post, I was struck by the tragicomedy of claiming that the ultimate reason why healthcare staff should not comply with a patient’s request for help to die is that… assisted death would destroy the patient’s autonomy.

Pär Segerdahl

Minding our language - the Ethics Blog

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Questionable questionnaires

30 October, 2013 / / 0 Comments

Questionnaires are increasingly frequent in bioethics. They can provide information about how ethical issues are real for the parties concerned: for patients, for families, for nurses, for physicians, for research participants, for donors…

Questionnaires can counteract professional isolationism where bioethicists believe they know exactly which issues should concern people, and on the basis of this “expertise” export ethical policies without importing impressions.

Unfortunately, isolationism isn’t that easily remedied. Kevin P. Weinfurt warns that questionnaires can conceal isolationism, if responses are interpreted by bioethicists who have other points of view and other linguistic habits than the respondents.

Interpretations are easily biased to speak to issues internal to the bioethical debate. You find Weinfurt’s warnings here:

How can ethicists’ points of view bias interpretations? By asking THEIR questions as if every human housed a bioethicist experiencing the same issues. Concerning clinical trials, for example, bioethicists estimate “chance of benefit from experimental therapy.” Thus, it is natural for them to query research participants how THEY consider their chance of benefit, as if participants too perceived the situation as a decision tree with chances of disease control and risks of death.

How can ethicists’ linguistic habits bias the answers? By being so thoroughly trained in a bookish scholarly culture that they interpret people literally. If a respondent answers the question,

  • “How confident are you that the experimental therapy will control your cancer?”

by encircling 80 %, they believe that the respondent DESCRIBES his private assessment of the probability. But communication does not consist only in describing inner mental states. People DO a great number of things with words, for example, they VOICE HOPE.

When a respondent who answered 80 % afterwards was interviewed about why other people would answer 10 %, he didn’t answer in terms of divergent prognostic factors, but said:

  • “Oh, man, I feel sorry for them… They’re just not…they’re just…they’re hopeless. They have no hope left. For some reason, they’ve been beat down so bad that they can’t think positive anymore… Maybe they don’t have the same kind of support in their life that I do.”

If Weinfurt’s warnings are right, assuming that patients’ hope of recovery causes unrealistic assessments of chance of benefit may be a misconception. Patients may not make such assessments at all. It is the questionnaire that causes the illusion.

They voice their hope, that’s all.

Pär Segerdahl

In dialogue with patients

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