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

Author: Pär Segerdahl (Page 1 of 39)

Women on AI-assisted mammography

The use of AI tools in healthcare has become a recurring theme on this blog. So far, the posts have mainly been about mobile and online apps for use by patients and the general public. Today, the theme is more advanced AI tools which are used professionally by healthcare staff.

Within the Swedish program for breast cancer screening, radiologists interpret large amounts of X-ray images to detect breast cancer at an early stage. The workload is great and most of the time the images show no signs of cancer or pre-cancers. Today, AI tools are being tested that could improve mammography in several ways. AI could be used as an assisting resource for the radiologists to detect additional tumors. It could also be used as an independent reader of images to relieve radiologists, as well as to support assessments of which patients should receive care more immediately.

For AI-assisted mammography to work, not only the technology needs to be developed. Researchers also need to investigate how women think about AI-assisted mammography. How do they perceive AI-assisted breast cancer screening? Four researchers, including Jennifer Viberg Johansson and Åsa Grauman at CRB, interviewed sixteen women who underwent mammography at a Swedish hospital where an AI tool was tested as a third reviewer of the X-ray images, along with the two radiologists.

Several of the interviewees emphasized that AI is only a tool: AI cannot replace the doctor because humans have abilities beyond image recognition, such as intuition, empathy and holistic thinking. Another finding was that some of the interviewees had a greater tolerance for human error than if the AI tool failed, which was considered unacceptable. Some argued that if the AI tool makes a mistake, the mistake will be repeated systematically, while human errors are occasional. Some believed that the responsibility when the technology fails lies with the humans and not with the technology.

Personally, I cannot help but speculate that the sharp distinction between human error, which is easier to reconcile with, and unacceptably failing technology, is connected to the fact that we can say of humans who fail: “After all, the radiologists surely did their best.” On the other hand, we hardly say about failing AI: “After all, the technology surely did its best.” Technology does not become subject to certain forms of conciliatory considerations.

The authors themselves emphasize that the participants in the study saw AI as a valuable tool in mammography, but held that the tool cannot replace humans in the process. The authors also emphasize that the interviewees preferred that the AI tool identify possible tumors with high sensitivity, even if this leads to many false positive results and thus to unnecessary worry and fear. In order for patients to understand AI-assisted healthcare, effective communication efforts are required, the authors conclude.

It is difficult to summarize the rich material from interview studies. For more results, read the study here: Women’s perceptions and attitudes towards the use of AI in mammography in Sweden: a qualitative interview study.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

Viberg Johansson J, Dembrower K, Strand F, et al. Women’s perceptions and attitudes towards the use of AI in mammography in Sweden: a qualitative interview study. BMJ Open 2024;14:e084014. doi: 10.1136/bmjopen-2024-084014

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Approaching future issues

Mobile apps to check symptoms and get recommendations: what do users say?

What will you do if you feel sick or discover a rash and wonder what it is? Is it something serious? If you do not immediately contact healthcare, a common first step is to search for information on the internet. But there are also applications for mobiles and online, where users can check their symptoms. A chatbot asks for information about the symptoms. The user then receives a list of possible causes as well as a recommendation, for example to see a doctor.

Because the interaction with the chatbot can bring to mind a visit to the doctor who makes a diagnosis and recommends action, these apps raise questions that may have more to do with these tempting associations than with reality. Will the apps in the future make visiting the doctor redundant and lead to the devaluing of medical professions? Or will they, on the contrary, cause more visits to healthcare because the apps often make such recommendations? Do they contribute to better diagnostic processes with fewer misdiagnoses, or do they, on the contrary, interfere with the procedure of making a diagnosis?

The questions are important, provided they are grounded in reality. Are they? What do users really expect from these symptom checker apps? What are their experiences as users of such digital aids? There are hardly any studies on this yet. German researchers therefore conducted an interview study with participants who themselves used apps to check their symptoms. What did they say when they were interviewed?

The participants’ experiences were not unequivocal but highly variable and sometimes contradictory. But there was agreement on one important point. Participants trusted their own and the doctor’s judgments more than they trusted the app. Although opinions differed on whether the app could be said to provide “diagnoses,” and regardless of whether or not the recommendations were followed, the information provided by the app was considered to be indicative only, not authoritative. The fear that these apps would replace healthcare professionals and contribute to a devaluation of medical professions is therefore not supported in the study. The interviewees did not consider the apps as a substitute for consulting healthcare. Many saw them rather as decision support before possible medical consultation.

Some participants used the apps to prepare for medical appointments. Others used them afterwards to reflect on the outcome of the visit. However, most wanted more collaboration with healthcare professionals about using the apps, and some used the apps because healthcare professionals recommended them. This has an interesting connection to a Swedish study that I recently blogged about, where the participants were patients with rheumatoid arthritis. Some participants in that study had prepared their visits to the doctor very carefully by using a similar app, where they kept logbook of their symptoms. They felt all the more disappointed when they experienced that the doctor showed no interest in their observations. Maybe better planning and collaboration between patient and healthcare is needed regarding the use of similar apps?

Interview studies can provide valuable support for ethical reasoning. By giving us insights into a reality that we otherwise risk simplifying in our thinking, they help us ask better questions and discuss them in a more nuanced way. That the results are varied and sometimes even contradictory is therefore not a weakness. On the contrary, we get a more faithful picture of a whole spectrum of experiences, which do not always correspond to our usually more one-sided expectations. The participants in the German study did not discuss algorithmic bias, which is otherwise a common theme in the ethical debate about AI. However, some were concerned that they themselves might accidentally lead the app astray by giving biased input that expressed their own assumptions about the symptoms. Read the study here: “That’s just Future Medicine” – a qualitative study on users’ experiences of symptom checker apps.

Another unexpected result of the interview study was that several participants discussed using these symptom checker apps not only for themselves, but also for friends, partners, children and parents. They raised their concerns about this, as they perceived health information from family and friends as private. They were also concerned about the responsibility they assumed by communicating the analyzes and recommendations produced by the app to others. The authors argue that this unexpected finding raises new questions about responsibility and that the debate about digital aids related to health and care should be more attentive to relational ethical issues.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

Müller, R., Klemmt, M., Koch, R. et al. “That’s just Future Medicine” – a qualitative study on users’ experiences of symptom checker apps. BMC Med Ethics 25, 17 (2024). https://doi.org/10.1186/s12910-024-01011-5

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We recommend readings

Can positive action improve a meritocracy?

Despite political efforts to change the situation, gender imbalance is still evident in European universities and research institutions. A powerful tool for change is positive action. The tool may seem to be at odds with the meritocratic values that distinguish academia. Resistance to such measures may seem particularly well-motivated in science, which is supposed to be value-neutral and only let academic merit be the decisive factor behind researchers’ success in the competition for employment and research grants.

However, merits can be assessed and measured in different ways and merit systems may, for historical reasons, favor men over women. There are still societal expectations that the woman should take the main responsibility for children and aging parents, as well as for other household tasks. This pattern is reflected in working life, where female researchers can be expected to also take care of the academic housework. Dual household work reasonably gives women worse conditions in a competitive work environment that rewards productivity and quantity. Can the merit system then be said to be value neutral? Or does it prevent important changes not only to the gender distribution, but also to the system itself, which possibly favors quantity over quality, certain types of research questions over others, and self-absorbed competition over good collaboration?

Meritocracies, like everything else in this world, are changeable. They can change without ceasing to be meritocracies. Positive action could give the academic merit system a push in a possibly better direction, with better ways of assessing scholarly merit, soon helping to render the tool redundant. We therefore need to approach the question of positive action with our eyes open to both opportunities and risks.

The European project MINDtheGEPs (gender equality in research) recently published a policy brief, intended to support thoughtful implementation of positive action in European research. The tool can be used in three important areas: when awarding research grants and fellowships, when hiring full professors, and in the composition of evaluation committees. The policy brief provides an overview of common arguments for and against in the debate about positive action in European research organizations, divided into these three important areas. It is instructive to see the arguments side by side, as well as the counterarguments against the counterarguments. Because is it really self-evident that positive action must undermine a meritocracy?

Read MINDtheGEPs’ policy brief here: Gender quotas & positive action: An attack on meritocracy? There you will also find case studies of positive action at two Italian universities.

MINDtheGEPs hosts a series of Open Forums to discuss gender equality in the academic and research & innovation sectors, to facilitate knowledge exchange and mutual learning among scholars, practitioners and professionals supporting gender equality policies and measures. On 20 March 2024, their next Open Forum, they will share and discuss the contents of their latest policy brief – exploring the contentious topic of positive action, assessing arguments for and against, and drawing insights from MINDtheGEPs’ Gender Equality Plan development.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

Solera C, Cipriani N, Holm Bodin A. (2023) Gender quotas & positive action: An attack on meritocracy? Zenodo. DOI: 10.5281/zenodo.1002437

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We challenge habits of thought

Time to forget time

A theme in recent blog posts has been our need for time. Patients need time to be listened to; time to ask questions; time to decide whether they want to be included in clinical studies, and time for much more. Healthcare workers need time to understand the patients’ situation; time to find solutions to the individual problems of patients suffering from rheumatoid arthritis, and time for much more. This theme, our need for time, got me thinking about what is so great about time.

It could be tempting to conduct time and motion studies of our need for time. How much time does the patient need to spend with the doctor to feel listened to? How much time does the nurse need to spend with the patient to get the experience of providing good care? The problem with such studies is that they destroy the greatness of time. To give the patient or the nurse the measured time, prescribed by the time study, is to glance at the clock. Would you feel listened to if the person you were talking to had a stopwatch hanging around their neck? Would you be a good listener yourself if you waited for the alarm signal from the stopwatch hanging around your neck?

Time studies do not answer our question of what we need, when we need time. If it was really a certain amount of time we needed, say fifteen minutes, then it should make no difference if a ticking stopwatch hung around the neck. But it makes a difference! The stopwatch steals our time. So, what is so great about time?

I think the answer is well on its way to revealing itself, precisely because we give it time to come at its own pace. What we need when we need time, is to forget time! That is the great thing about having time. That we no longer think about it.

Again, it can be tempting to conduct time studies. How much time does the patient and the doctor need to forget time? Again, time studies ruin the greatness of time. How? They frame everything in time. They force us to think about time, even when the point is to forget it.

Our need for time is not about measured quantities of time, but about the timeless quality of not thinking about time. Thinking about time steals time from us. Since it is not really about time, it does not have to take that long.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

This post in Swedish

We challenge habits of thought

Living with rheumatoid arthritis: how do patients perceive their interaction with healthcare and a self-care app?

Not all diseases can be cured, but medication along with other measures can alleviate the symptoms. Rheumatoid arthritis is one such disease. Medicines for symptoms such as swellings and stiffness have become very effective. As a patient, you can find good ways to live with the disease, even if it can mean more or less regular contacts with healthcare (depending on how you are affected). Not only with the doctor who prescribes medication, but often with an entire healthcare team: doctor, nurse, physiotherapist, occupational therapist and counselor. There are aids that make everyday life easier, such as orthopedic shoes, splints and easier-to-grip faucets at home, and many hospitals also offer patients education about the disease and how you can live and function with it, at home as well as at work.

The symptoms vary, not only between individuals but also for the same individual over time. The need for care and support is thus individual and changing. Therefore, it is important that the interaction between patient and healthcare works efficiently and with sensitivity to the patient’s unique situation at the moment. Since patients to a great extent have to deal with their illness on their own, and over time become increasingly knowledgeable about their own disease, it is important to listen to the patient. Not only to improve the patient’s experience of healthcare, but also to ensure that individual patients receive the care and support they need at the right moment. The patient may not be part of the healthcare team, but is still one of the most important team players.

There are digital self-care applications for rheumatoid arthritis, where the patients who choose to use the tools can get advice and information about the disease, prepare for contacts with healthcare, and keep a digital logbook about their symptoms, experiences and lifestyle. Such digital self-care apps can be assumed to make patients even more knowledgeable about their own disease. The logbook contains relevant observations, which the patient can describe in the meetings with the healthcare provider. What an asset to the care team!

Given the importance of good continuous team play between patient and healthcare in diseases such as rheumatoid arthritis, it is important that researchers regularly examine how patients experience the interaction. Jennifer Viberg Johansson, Hanna Blyckert and Karin Schölin Bywall recently conducted an interview study with patients at various hospitals in Sweden. The aim was to investigate not only the patients’ experiences of the interaction with healthcare, but also their experiences of a digital self-care app, and how the app affected the communication between patient and doctor.

The patients’ perception of their interaction with healthcare varied greatly. About half felt prioritized and excellently supported by the healthcare team and half felt neglected, some even dehumanized. This may reflect how different hospitals have different resources and competencies for rheumatoid arthritis, but also unclear communication about what the patients can expect. Many patients found the self-care app both useful and fun to use, and a good support when preparing for healthcare visits. At the same time, these detailed preparations could lead to even greater disappointment when it was felt that the doctor was not listening and barely looking at the patient.

Collaborative teamwork and clear communication is identified in the study as important contributing factors to patients’ well-being and ability to manage their illness. The patients valued time for dialogue with the rheumatologist and appreciated when their personal observations of life with the disease were listened to. Because some of the interviewed patients had the negative experience that the doctor did not listen to the observations they had compiled in the app, the authors believe that the use of digital tools should be promoted by the healthcare system and there should be an agreement on how the tool should be used at meetings to plan care and support.

For more details about the patients’ experiences, read the article here: Experiences of individuals with rheumatoid arthritis interacting with health care and the use of a digital self-care application: a qualitative interview study.

The study emphasizes the importance of patient-centered care for individuals with rheumatoid arthritis, as well as the importance of considering patients’ psychological well-being alongside their physical health. An important point in the study could perhaps be summarized as follows: appreciate the patient as a skilled team player.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

Viberg Johansson J, Blyckert H, Schölin Bywall K. Experiences of individuals with rheumatoid arthritis interacting with health care and the use of a digital self-care application: a qualitative interview study. BMJ Open 2023;13:e072274. doi: 10.1136/bmjopen-2023-072274

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In dialogue with patients

Moral stress: what does the COVID-19 pandemic teach us about the concept?

Newly formed concepts can sometimes satisfy such urgent linguistic needs that they immediately seem completely self-evident. Moral stress is probably such a concept. It is not many decades old. Nevertheless, the concept probably appeared from the beginning as an all-too-familiar reality for many healthcare workers.

An interesting aspect of these immediately self-evident concepts is that they effortlessly find their own paths through language, despite our efforts to define the right path. They are simply too striking in living spoken language to be captured in the more rigid written language of definitions. However, the first definition of moral stress was fairly straightforward. This is how Andrew Jameton defined the concept:

“Moral distress arises when one knows the right thing to do, but institutional constraints make it nearly impossible to pursue the right course of action.”

Although the definition is not complicated in the written language, it still prevents the concept from speaking freely, as it wants to. For, do we not spontaneously want to talk about moral stress in other situations as well? For example, in situations where two different actions can be perceived as the right ones, but if we choose one action it excludes the other? Or in situations where something other than “institutional constraints” prevents the right course of action? Perhaps a sudden increase in the number of patients.

Here is a later definition of moral stress, which leaves more open (by Kälvemark, Höglund and Hansson):

“Traditional negative stress symptoms that occur due to situations that involve an ethical dimension where the health care provider feels he/she is not able to preserve all interests at stake.”

This definition allows the concept to speak more freely, in more situations than the first, although it is possibly slightly more complicated in the written language. That is of course no objection. A definition has other functions than the concept being defined, it does not have to be catchy like a song chorus. But if we compare the definitions, we can notice how both express the authors’ ideas about morality, and thus about moral stress. In the first definition, the author has the idea that morality is a matter of conscience and that moral stress occurs when institutional constraints of the profession prevent the practitioner from acting as conscience demands. Roughly. In the second definition, the authors have the idea that morality is rather a kind of balancing of different ethical values and interests and that moral stress arises in situations that prevent the trade-offs from being realized. Roughly.

Why do I dwell on the written and intellectual aspects of the definitions, even though it is hardly an objection to a definition? It has to do with the relationship between our words and our ideas about our words. Successful words find their own paths in language despite our ideas about the path. In other words: despite our definitions. Jameton both coined and defined moral (di)stress, but the concept almost immediately stood, and walked, on its own feet. I simply want to remind you that spoken-language spontaneity can have its own authority, its own grounding in reality, even when it comes to newly formed concepts introduced through definitions.

An important reason why the newly formed concept of moral stress caught on so immediately is probably that it put into words pressing problems for healthcare workers. Issues that needed to be noticed, discussed and dealt with. One way to develop the definition of moral stress can therefore be to listen to how healthcare workers spontaneously use the concept about situations they themselves have experienced.

A study in BMC Medical Ethics does just this. Together with three co-authors, Martina E. Gustavsson investigated how Swedish healthcare workers (assistants, nurses, doctors, etc.) described moral stress during the COVID-19 pandemic. After answering a number of questions, the participants were requested to describe, in a free text response, situations during the pandemic in which they experienced moral stress. These free text answers were conceptually analyzed with the aim of formulating a refined definition of moral stress.

An overarching theme in the free text responses turned out to be: being prevented from providing good care to needy patients. The healthcare workers spoke of a large number of obstacles. They perceived problems that needed to be solved, but felt that they were not taken seriously, that they were inadequate or forced to act outside their areas of expertise. What stood in the way of good care? The participants in the study spoke, among other things, about unusual conditions for decision-making during the pandemic, about tensions in the work team (such as colleagues who did not dare to go to work for fear of being infected), about substandard communication with the organizational management. All this created moral stress.

But they also talked about the pandemic itself as an obstacle. The prioritization of COVID-19 patients meant that other patients received worse care and were exposed to the risk of infection. The work was also hindered by a lack of resources, such as personal protective equipment, while the protective equipment prevented staff from comforting worried patients. The visiting restrictions also forced staff to act as guards against patients’ relatives and isolate infected patients from their children and partners. Finally, the pandemic prevented good end-of-life care. This too was morally stressful.

How can the healthcare workers’ free text responses justify a refined definition of moral stress? Martina E. Gustafsson and co-authors consider the definition above by Kälvemark, Höglund and Hansson as a good definition to start from. But one type of situation that the participants in the study described probably falls outside that definition, namely the situation of not being taken seriously, of feeling inadequate and powerless. The study therefore proposes the following definition, which includes these situations:

“Moral stress is the kind of stress that arises when confronted with a moral challenge, a situation in which it is difficult to resolve a moral problem and in which it is difficult to act, or feeling insufficient when you act, in accordance with your own moral values.”

Here, too, one can sense an idea of morality, and thus of moral stress. The authors think of morality as being about solving moral problems, and that moral stress arises when this endeavor encounters challenges, or when one feels inadequate in the attempts to solve the problems. The definition can be considered a refined idea of what moral stress is. It describes more precisely the relevant situations where healthcare workers spontaneously want to talk about moral stress.

Obviously, we can learn a lot about the concept of moral stress from the experience of the COVID-19 pandemic. Read the study here, which contains poignant descriptions of morally stressful situations during the pandemic: “Being prevented from providing good care: a conceptual analysis of moral stress among health care workers during the COVID-19 pandemic.”

Finally, I would like to mention two general lessons about language, which in my view the study highlights. The first is that we can learn a lot about our concepts through the difficulties of defining them. The study took this “definition resistance” seriously by listening to how healthcare workers spontaneously talk about moral stress. This created friction that helped refine the definition. The second lesson is that we often use words despite our ideas about what the words mean or should mean. Spoken language spontaneity has a natural weight and authority that we easily overlook, but from which we have much to learn – as in this empirical study.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

Gustavsson, M.E., von Schreeb, J., Arnberg, F.K. et al. “Being prevented from providing good care: a conceptual analysis of moral stress among health care workers during the COVID-19 pandemic”. BMC Med Ethics 24, 110 (2023). https://doi.org/10.1186/s12910-023-00993-y

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Minding our language

Research nurses on ethical challenges in recruiting participants for clinical research

In clinical research with participating patients, research nurses play a central role. On a daily basis, they balance the values of care and the needs of research. For these nurses, it is clear that patients’ informed consent for research participation is more than just a one-time event completed by signing the form. The written consent is the beginning of a long relationship with the patients. The process requires effective communication throughout the course of the study, from obtaining consent to subsequent interactions with patients related to their consent. The research nurses must continuously ensure that participating patients are well informed about how the study is progressing, that they understand any changes to the set-up or to the risks and benefits. If conditions change too much, a new consent may need to be obtained.

Despite research nurses being so deeply involved in the entire consent process, there is a lack of research on this professional group’s experiences of and views on informed consent. What problems and opportunities do they experience? In an interview study, Tove Godskesen, Joar Björk and Niklas Juth studied the issue. They interviewed 14 Swedish research nurses about ethical challenges related to the consent process and how the challenges were handled.

The challenges were mainly about factors that could threaten voluntariness. Informed consent must be given voluntarily, but several factors can threaten this ethically important requirement. The nurses mentioned a number of factors, such as rushed decision-making in stressful situations, excessively detailed information to patients, doctors’ influence over patients, and disagreement within the family. An elusive threat to voluntariness is patients’ own sometimes unrealistic hopes for therapeutic benefit from research participation. Why is this elusive? Because the hopes can make the patients themselves motivated to participate. However, if the hopes are unrealistic, voluntariness can be said to be undermined even if the patients want to participate.

How do the research nurses deal with the challenges? An important measure is to give patients time in a calm environment to thoughtfully consider their participation and discuss it. This also reduces the risk of participants dropping out of the study, reasoned the nurses. Time with the patients also helps the research nurses to understand the patients’ situation, so that the recruitment does not take place hastily and perhaps on the basis of unrealistic expectations, they emphasized. The interviewees also said that they have an important role as advocates for the patients. In this role, the nurses may need time to understand and more closely examine the patients’ perspectives and reasons for potentially withdrawing from the study, and to find suitable solutions. It can also happen that patients say no to participation even though they really want to, perhaps because they are overwhelmed by all the information that made participation sound complicated. Again, the research nurses may need to give themselves and the patients time for in-depth conversations, so that patients who want to participate have the opportunity to do so. Maybe it is not as complicated as it seemed?

Read the important interview study here: Challenges regarding informed consent in recruitment to clinical research: a qualitative study of clinical research nurses’ experiences.

The study also highlights another possible problem that the research nurses raised, namely the questionable exclusion of certain groups from research participation (such as people who have difficulty understanding Swedish or have reduced cognitive ability). Such exclusion can mean that patients who want to participate in research are not allowed to do so, that certain groups have less access to new treatments, and that the scientific quality of the studies is hampered.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

Godskesen, T., Björk, J. & Juth, N. Challenges regarding informed consent in recruitment to clinical research: a qualitative study of clinical research nurses’ experiences. Trials 24, 801 (2023). https://doi.org/10.1186/s13063-023-07844-6

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Ethics needs empirical input

Medical ethics conference in Uppsala, 10–11 June 2024

Since 2022, an annual conference in medical ethics is organized by Swedish universities. The first conference was organized by Lund University and the second by Karolinska Institutet. The next conference will be arranged on 10–11 June 2024 by us at the Centre for Research and Bioethics at Uppsala University. Conference names vary with the host university, our conference in June is thus named UMEC – Uppsala University Medical Ethics Conference.

We welcome researchers in medical ethics broadly conceived from Sweden as well as other countries, and oral presentations must be in English. If you would like to present your work at the conference, you are welcome to submit an abstract no later than March 31, 2024. We are interested in both normative approaches and empirical studies with normative relevance for issues in clinical ethics, public health ethics, research ethics and medical law.

We hope you want to attend the conference. You can find more information about the abstract and presentation as well as about the conference venue and travel options here: UMEC – Uppsala University Medical Ethics Conference.

Please note that the information is still incomplete and that more details will come as we get closer to the conference date.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

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We recommend conferences

How do we find out if drugs are safe for groups excluded from clinical trials?

Drug development requires that the drug is tested on patients in clinical trials. Not only the drug’s effectiveness is tested on the patients, but also its safety. Does the drug have serious side effects and what dosage is safe? Thanks to such clinical research, approved drugs can be provided with safety information, which enables doctors and patients to make informed decisions about drug treatment.

However, there are vulnerable groups that are often excluded from clinical studies, such as pregnant and breastfeeding women. But this protection of a vulnerable group can make the group extra vulnerable when deciding on drug treatment. If there is no evidence, it is not known whether the medicine the woman needs risks harming her, the fetus or the child being breastfed. It is also not known what dosage should be recommended. Perhaps the woman herself refrains from taking a medicine she needs, or receives advice from the doctor to refrain from it. Not because one knows that the medicine poses risks for the group, but because one does not know.

Are there other ways to obtain evidence on medicine safety for pregnant and breastfeeding women, besides clinical studies? Yes, there are, because pregnant and breastfeeding women must of course often use medication. Several registers already contain data from women who use medicines during pregnancy. In addition, pregnant and breastfeeding women using medicines may be engaged in additional data collection activities. Thus, there is already data as well as additional opportunities to collect data, without involving the group in clinical studies.

Josepine Fernow describes in Uppsala Reports such an attempt to compile existing data and expand the possibilities of collecting new data: the European project IMI ConcePTION. This project is developing several different paths towards better future safety information about drug treatment during pregnancy and breastfeeding. One challenge is to develop a technical infrastructure where data collected in different registers and in different formats are harmonized so that they can be collected and handled in standardized ways. Another challenge is to enable pregnant women to easily report relevant data about their medication use, for example via a mobile application. The project also tries to produce new data on breastfeeding and medicine use. For example, milk is collected and analyzed from breastfeeding women who use various medicines, in order to understand and predict how these medicines are transferred to the breast milk and in what concentration. Two of these breastfeeding studies are underway in Sweden. They are coordinated by CRB and we will write about them on this blog.

ConcePTION is also developing a knowledge bank that will be available online from the end of 2024, which will make the data and knowledge generated by the project useful. There are thus several avenues for research along which one can generate evidence for better safety information about various medicines for pregnant and breastfeeding women, without involving the group in clinical studies.

Read Josepine Fernow’s description of the project here: Making medicines safer for pregnant and breastfeeding women. There you will also find several links to the project and to the project’s publications.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

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Part of international collaborations

Neuroethics: don’t let the name fool you

Names easily give the impression that the named is something separate and autonomous: something to which you can attach a label. If you want to launch something and get attention – “here is something completely new to reckon with” – it is therefore a good idea to immediately create a new name that spreads the image of something very special.

Despite this, names usually lag behind what they designate. The named has already taken shape, without anyone noticing it as anything special. In the freedom from a distinctive designation, roots have had time to spread and branches to stretch far. Since everything that is given freedom to grow is not separate and autonomous, but rooted, interwoven and in exchange with its surroundings, humans eventually notice it as something interesting and therefore give it a special name. New names can thus give a misleading image of the named as newer and more separate and autonomous than it actually is. When the name arrives, almost everything is already prepared in the surroundings.

In an open peer commentary in the journal AJOB Neuroscience, Kathinka Evers, Manuel Guerrero and Michele Farisco develop a similar line of reasoning about neuroethics. They comment on an article published in the same issue that presents neuroethics as a new field only 15 years old. The authors of the article are concerned by the still unfinished and isolated nature of the field and therefore launch a vision of a “translational neuroethics,” which should resemble that tree that has had time to grow together with its surroundings. In the vision, the new version of neuroethics is thus described as integrated, inclusive and impactful.

In their commentary, Kathinka Evers and co-authors emphasize that it is only the label “neuroethics” that has existed for 15 years. The kind of questions that neuroethics works with were already dealt with in the 20th century in applied ethics and bioethics, and some of the conceptual problems have been discussed in philosophy since antiquity. Furthermore, ethics committees have dealt with neuroethical issues long before the label existed. Viewed in this way, neuroethics is not a new and separate field, but rather a long-integrated and cooperating sub-discipline to neuroscience, philosophy and bioethics – depending on which surroundings we choose to emphasize.

Secondly, the commentators point out, the three characteristics of a “translational neuroethics” – integration, inclusiveness and impact – are a prerequisite for something to be considered a scientific field. An isolated field that does not include knowledge and perspectives from surrounding sciences and areas of interest, and that lacks practical impact, is hardly what we see today as a research field. The three characteristics are therefore not entirely successful as a vision of a future development of neuroethics. If the field is to deserve its name at all, the characteristics must already permeate neuroethics. Do they do that?

Yes, say the commentators if I understand them correctly. But in order to see this we must not be deceived by the distinctive designation, which gives the image of something new, separate and autonomous. We must see that work on neuroethical issues has been going on for a long time in several different philosophical and scientific contexts. Already when the field got its distinctive name, it was integrated, inclusive and impactful, not least within the academically established discipline of bioethics. Some problematic tendencies toward isolation have indeed existed, but they were related to the distinctive label, as it was sometimes used by isolated groups to present their activities as something new and special to be reckoned with.

The open commentary is summarized by the remark that we should avoid the temptation to see neuroethics as a completely new, autonomous and separate discipline: the temptation that the name contributes to. Such an image makes us myopic, the commentators write, which paradoxically can make it more difficult to support the three objectives of the vision. It is both truer and more fruitful to consider neuroethics and bioethics as distinct but not separate fields. If this is true, we do not need to launch an even newer version of neuroethics under an even newer label.

Read the open commentary here: Neuroethics & bioethics: distinct but not separate. If you want to read the article that is commented on, you will find the reference at the bottom of this post.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

K. Evers, M. Guerrero & M. Farisco (2023) Neuroethics & Bioethics: Distinct but Not Separate, AJOB Neuroscience, 14:4, 414-416, DOI: 10.1080/21507740.2023.2257162

Anna Wexler & Laura Specker Sullivan (2023) Translational Neuroethics: A Vision for a More Integrated, Inclusive, and Impactful Field, AJOB Neuroscience, 14:4, 388-399, DOI: 10.1080/21507740.2021.2001078

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