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


Bioethicists suggest broad consent for biobank research

September 2, 2015

Pär SegerdahlIt is still unclear what kind of consent should be used when collecting biological samples for future research. Different forms of consent are practiced, which creates another uncertainty: which research is actually permitted with the collected samples?

This haphazard situation leads to unintended constraints on research. But it also leads to research sometimes being carried out without consent.

Against this background, the US National Institutes of Health (NIH) organized a workshop to discuss whether it is ethically reasonable to manage these uncertainties by using broad consent for future research when collecting biological samples.

The group of bioethicists who attended the workshop, including Mats G. Hansson, recently published their thoughts and conclusions in the American Journal of Bioethics:

The group’s proposal is that broad consent is ethically reasonable and often the best option, if it has three components:

  1. Consent is conducted initially, in connection with sample collection.
  2. There is a system for oversight and approval of future research.
  3. As far as possible, there should be ongoing communication with, and information to, donors.

Biological samples are collected in a variety of contexts. It is here that the haphazard situation arises, if different forms of consent are used, or perhaps no consent at all. By initially informing potential donors of the wide range of research that can be carried out, they can take a position on risks and benefits of donation (given the oversight and the general conditions of the future research that they are informed about).

The group emphasizes that broad consent gives donors control over the use of samples, while minimizing costs and burdens for both donors and researchers.

They also point out that empirical studies show that most people want to decide if their samples may be used for research. Most respondents also say that the decision is not influenced by the specific details of the future research (e.g. what diseases are studied, what techniques are used, or which parts of the sample are studied).

Of course there are examples of research that can be perceived as controversial, such as human cloning. But broad consent can be combined with specific restrictions. Oversight moreover considers whether research proposals can be said to comply with the donors’ values.

If donors still hesitate, they are free to choose not to donate the sample.

Pär Segerdahl

Approaching future issues - 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


Openness as an ethical ritual

August 3, 2015

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


Second issue of our newsletter about biobanks

June 2, 2015

Pär SegerdahlNow you can read the second newsletter this year from CRB and BBMRI.se:

The newsletter contains four news items:

1. Anna-Sara Lind presents a new book, Information and Law in Transition, and the contributions to the book by CRB researchers.

2. Anna-Sara Lind describes the situation for the temporary Swedish law on research registries.

3. Mats G. Hansson reports on a modified version of broad consent for future research.

4. Josepine Fernow presents a new article by Jennifer Viberg on the proposal to give research participants freedom of choice about incidental findings.

(Link to PDF version of the newsletter)

Pär Segerdahl

We recommend readings - the Ethics Blog


Where is consciousness?

May 26, 2015

 

Michele FariscoWould it be possible to use brain imaging techniques to detect consciousness and then “read” directly in people’s brains what they want or do not want? Could one, for example, ask a severely brain injured patient for consent to some treatment, and then obtain an answer through a brain scan?

Together with the philosopher Kathinka Evers and the neuroscientist Steven Laureys, I recently investigated ethical and clinical issues arising from this prospective “cerebral communication.”

Our brains are so astonishingly complex! The challenge is how to handle this complexity. To do that we need to develop our conceptual apparatus and create what we would like to call a “fundamental” neuroethics. Sound research needs solid theory, and in line with this I would like to comment upon the conceptual underpinnings of this ongoing endeavor of developing a “fundamental” neuroethics.

The assumption that visualizing activity in a certain brain area can mean reading the conscious intention of the scanned subject presupposes that consciousness can be identified with particular brain areas. While both science and philosophy widely accept that consciousness is a feature of the brain, recent developments in neuroscience problematize relating consciousness to specific areas of the brain.

Tricky logical puzzles arise here. The so called “mereological fallacy” is the error of attributing properties of the whole (the living human person) to its parts (the brain). In our case a special kind of mereological fallacy risks to be embraced: attributing features of the whole (the brain) to its parts (those visualized as more active in the scan). Consciousness is a feature of the whole brain: the sole fact that a particular area is more active than others does not imply conscious activity.

The reverse inference is another nice logical pitfall: the fact that a study reveals that a particular cerebral area, say A, is more active during a specific task, say T, does not imply that A always results in T, nor that T always presupposes A.

In short, we should avoid the conceptual temptation to view consciousness according to the so called “homunculus theory”: like an entity placed in a particular cerebral area. This is unlikely: consciousness does not reside in specific brain regions, but is rather equivalent to the activity of the brain as a whole.

But where is consciousness? To put it roughly, it is nowhere and everywhere in the brain. Consciousness is a feature of the brain and the brain is more than the sum of its parts: it is an open system, where external factors can influence its structure and function, which in turn affects our consciousness. Brain and consciousness are continually changing in deep relationships with the external environment.

We address these issues in more detail in a forthcoming book that I and Kathinka Evers are editing, involving leading researchers both in neuroscience and in philosophy:

Michele Farisco

We want solid foundations - the Ethics Blog

 


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

May 5, 2015

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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