Category: In the research debate (Page 4 of 33)

Participation in biomedical research with dynamic consent

19 September, 2023 / Roberta Biasiotto / 1 Comment

Imagine that you are asked to participate in a biomedical research project and to provide biological samples and health data to the project. Imagine also that this research project is meant to be long-term and that you will be invited, occasionally, to provide more data and samples. If you decide to participate, you will be asked to sign an informed consent, which is a sort of social contract between you and the research study. Through this document, you consent to the use of your data and samples in scientific research, and your rights as a participant are defined. In this situation, which kind of informed consent would make you feel at ease? What would be the most appropriate consent, balancing the researchers’ need to maximize the use of data and samples against the respect for your values and rights to make autonomous decisions? Would it be an acceptable option to sign the consent form and never be contacted again? Or would you expect researchers to communicate with you and keep you updated on what is happening with the data and samples you provided? If so, you might want to feel engaged and reasonably aware of what is happening in the research, but not overwhelmed by continuous communication with the project. But how much would the “right amount” of communication be? And which ways of communicating with you would you find the easiest and most appropriate?

Ethicists, philosophers, and law experts have debated the most suitable informed consent model for biobanking research. Among the different types of consent, such as specific, broad, and meta-consent, dynamic consent has been proposed as an apt solution in the context of biomedical research, especially in long-term research endeavors such as biobanking and longitudinal studies, where research participation is foreseen to be long-lasting and require repeated participant engagement over the years.

What characteristics of dynamic consent make it particularly relevant in such a context? Participants are regularly informed about the research being conducted with their data and samples and can change their choices on participation over time. Information technology plays a central role in dynamic consent: through an online interface, participants can access and review their informed consent and obtain information about the research in which they participate. In dynamic consent, communication between researchers and participants is thus an integral part of the informed consent process. Communication ensures that participants can make autonomous decisions about their participation throughout the time they are involved in the research. Dynamic consent thus acknowledges that participants’ values and life circumstances may change over the years and that their decision on research participation may differ at a later point in life, or depending on the further development of the research. Dynamic consent makes it possible to combine broad research aims with specificity of information in long-term projects, and ongoing communication is key to this.

What might dynamic consent look like in practice? An example of a study that uses dynamic consent is Cooperative Health Research in South Tyrol (CHRIS), a longitudinally designed study conducted in Italy. Our ELSI research team is led by Deborah Mascalzoni and is located at Eurac Research. In an article, we describe crucial aspects of dynamic consent as developed in the CHRIS study. We discuss the ten years of experience of dynamic consent in the study and what we have learned so far through observations and empirical evidence. I would like to point out two elements that that we found particularly important and what the participants in our studies thought about them. One concerns the possibility of changing choices over time and the other is about the communication.

First, CHRIS participants can change their choices about the level of participation and the amount of information they want. For example, they can change their choice regarding the return of research results, decide whether they wish to be re-contacted for research and communication purposes, or want their data and samples to be shared with other research institutions. Although the overall rate of change was low, CHRIS participants appreciated being able to change choices and having detailed options, because these options were important for them and made them feel comfortable.

Second, CHRIS communication uses multiple tools and media, adapting to the socio-cultural context and aiming for accessibility. For example, the study uses both traditional and online strategies, it engages the local press, and it uses both German and Italian. The introduction of a film about the study during the consent process shortened the enrollment time because the film was perceived to provide answers to the questions participants had previously asked CHRIS study assistants. CHRIS participants appreciated the multimedia strategy, which enhanced their understanding of the study, and they valued the communication from the study.

Our studies of CHRIS participants’ experience with dynamic consent thus gave us relevant insights into the issues discussed in this blog post. If you want to read more, you can find the above-mentioned article here: Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process. A general lesson from our work is that researchers can learn from the experiences of research participants to refine the informed consent process and adapt it to the needs of participants and researchers while meeting ethical and legal requirements.

Written by…

Roberta Biasiotto is a research fellow at the Department of Biomedical, Metabolic and Neural Sciences of the University of Modena and Reggio Emilia and a researcher at the Institute for Biomedicine at Eurac Research, Italy.

Mascalzoni D, Melotti R, Pattaro C, Pramstaller PP, Gögele M, De Grandi A, Biasiotto R. Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process. Eur J Hum Genet (2022). https://doi.org/10.1038/s41431-022-01160-4

Approaching future issues

Precision medicine algorithms and personal encounters

12 September, 2023 / Pär Segerdahl / 1 Comment

The characters in Franz Kafka’s novels go astray in the corridors of bureaucracy. Impersonal officials handle never-defined cases as if they were robots controlled by algorithms as obscure as they are relentless. Judgments are passed without the convicted receiving any comprehensible information about possible charges.

Please excuse this dramatic introduction, which, in a perhaps slightly extreme way, is only intended to highlight a point in an article about precision medicine. Namely, the importance of placing the methods of precision medicine within the framework of the meeting between patient and physician: the importance of “personalizing” precision medicine.

Precision medicine is the name for methods to optimize disease management on the basis of the patient’s individual genetic profile. A bit like in a dating app that is meant to identify the best potential partner for you. Algorithms are used to calculate how patients with different genetic variants are likely to respond to drug treatments for some disease. There are advantages to this. The most effective and safe treatment for the patient in question can be identified. It also means that you can avoid treatments from which a patient with a certain genetic profile has very serious side effects. Or from which the patient is unlikely to get any positive effect, but would only suffer the side effects.

Together with several co-authors, Åsa Grauman at CRB recently published an interview study on precision medicine. Patients with a form of blood cancer (AML) in Finland, Italy and Germany were interviewed about how they viewed precision medicine, and about their preferences for being involved in this new way of making treatment decisions. Something I found interesting was that several (not all) participants wanted and valued information, but not for the purpose of making decisions. They wanted information to prepare themselves mentally, to know what to expect and to understand why different measures were being taken. They wanted information to be able to make the transition to being patients, I would like to say.

Almost all participants were unfamiliar with precision medicine. When the interviewer described the concept to them, most of them felt that precision medicine made sense and they were hopeful that the methods could be useful in the future. For example, to avoid unnecessary treatments with severe side effects in patients with a certain genetic profile. But even if the participants had faith in the algorithms that may be used in precision medicine, they emphasized that the algorithms are only a tool for the physician. They said that the physician can see the human side of the patient and the disease, and that the physician should be able to go against the algorithm depending on factors in the patient other than those included in the algorithm. The algorithm must not replace the physician or run over the patient. Many participants thus seemed to hold the view that difficult treatment decisions can be left to the physician, if the physician has listened to both the algorithm and the patient. Participants also highlighted the problem of not fitting into the algorithm: being denied treatment because the algorithm does not consider one to be the right patient for the available treatment options.

In their discussion, the authors highlighted a particularly interesting aspect of the situation of making treatment decisions. Namely, that the patient can weigh benefits and risks differently than both the physician and the algorithm. Incorporating the patient’s own trade-offs is therefore fundamental, they write, for precision medicine to be considered personalized care. Read the thought-provoking interview study here: Personalizing precision medicine: Patients with AML perceptions about treatment decisions.

To summarize, one could say that patients need to meet not only their algorithmically optimized treatment. In order to understand and influence their situation as patients, they above all need to meet their physician. Even if the patients feel that the decisions are too difficult and are positive to the possibilities of precision medicine, they want to talk to the physician and they want their meeting to influence the decisions. Perhaps treatment in an important sense begins even before the treatment decision is made, when the patient first meets the physician and they begin to find their way together through the hospital corridors. Corresponding meaningful encounters were never experienced by the characters in Kafka’s novels.

Written by…

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

Åsa Grauman, Mika Kontro, Karl Haller, et al. Personalizing precision medicine: Patients with AML perceptions about treatment decisions. Patient Education and Counseling 115, 2023, https://doi.org/10.1016/j.pec.2023.107883

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In dialogue with patients

The importance of ethical review in research with severely ill children

5 September, 2023 / kajsanorbergwieslander / 1 Comment

Research ethics committees play an important role in safeguarding human beings in research. Respect for human dignity in research has not always been self-evident. The emergence of research ethics has taken place in the wake of ethical scandals and abuses in which society’s most vulnerable have been used and exploited in the name of science. I am thinking, for example, of the Nazis’ cruel medical experiments on children and other vulnerable people.

At a time when the role of ethical review is being vigorously debated in the media and the research community, it is important to do research on the significance of ethical review. In particular, we should explore the question how ethical review serves to protect those most vulnerable from being exploited in research.

In a recent study conducted by myself together with Anna T. Höglund, Sara Frygner-Holm and Tove Godskesen, we focus on ethical issues in research with ill children, who are often considered a particularly vulnerable group in research. We have interviewed members of the Swedish Ethical Review Authority about their perceptions of ethical issues in research applications involving ill children, for example children with cancer.

One thing that members really emphasized was how crucial it is that the researcher provides good, age-appropriate information to children when they invite them to research. Without good information, children are excluded from being involved in a meaningful way in decisions about research participation. Many of the members we interviewed were concerned that good information for children was often missing from research applications. This suggests that we as researchers may need to increase our efforts to really take children’s legal right to information and participation seriously and not leave the decisions about research participation to the parents alone. There might be a need for more practical guidance on how we can inform and ask children about research in an ethically sound and sustainable way.

Children’s active participation in decisions about research participation is ethically important, but so is of course also children’s right to be protected from various risks associated to research. Some populations of severely ill children are “heavily researched,” among them children with cancer. This is of course very good because it enables groundbreaking medical advances in childhood cancer care and treatment. But at the same time, we know that children and their parents can be particularly vulnerable when recruited to research, due to their challenging life situation. They are also very dependent on the healthcare system. For such reasons, the committee members in the study considered it essential that the children’s physical as well as mental health and integrity are sufficiently protected. This means that as a researcher, you should not only focus on medical risks, but also consider how the whole child is affected, both short and long term, by being part of your research project.

The members we interviewed felt they had an ethical responsibility to protect children from “bad research” – when severely ill children give of their precious time and energy, it is especially important that the research is of high scientific quality and answers research questions that are truly important, new and urgent. It has been controversial whether or not research ethics committees should assess the design and quality of research. However, as shortcomings in design and quality can significantly reduce the potential benefits of a project, such aspects should be assessed as part of the ethical review, so that ill children can be spared participation in research that is not likely to lead to new knowledge or medical advances.

Ethical review is governed by laws and regulations. Some members were concerned that the ethical review system risks becoming too one-sidedly focused on legal compliance and formalities, giving ethical reflection to little space. Ethical review of research involving severely ill children undoubtedly places high demands not only on legal competence, but also on clinical and ethical competence, good teamwork and personal qualities such as accuracy and responsibility. Moreover, the emergence of new advanced technologies in research and healthcare constantly presents research ethics committees with new complex ethical issues to ponder and address. Thankfully, philosophy and its ethical principles offer invaluable tools!

So, what is the role and significance of ethical review in research with ill children? As our study suggests, ethical review and research ethics committees have, among other things, a crucial role in monitoring and promoting children’s right to information, participation and protection from harm and risks in research. These are urgent tasks, both from a children’s rights perspective and a research ethics perspective. If you want to know more about our results and read our discussion of the findings, you can find the study here: Research ethics committee members’ perspectives on paediatric research: a qualitative interview study.

Children’s perspectives have not been represented in research ethics to any great extent and more knowledge is therefore needed regarding children’s own experiences of research participation. Therefore, in an upcoming study, we will now interview children with cancer and their parents about how they experienced being asked to participate in research.

Written by…

Kajsa Norberg Wieslander, PhD student at the Centre for Research Ethics & Bioethics, is exploring ethical and clinical aspects of recruiting children with cancer to research studies.

Norberg Wieslander, K., Höglund, A. T., Frygner-Holm, S., & Godskesen, T. (2023). Research ethics committee members’ perspectives on paediatric research: a qualitative interview study. Research Ethics, 0(0). https://doi.org/10.1177/17470161231179663

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Ethics needs empirical input

Philosophically anchored psychotherapy

20 June, 2023 / Pär Segerdahl / 3 Comments

Philosophy is often regarded as impractical and useless. At the same time, philosophy has a therapeutic aspect. Socrates practiced philosophy with people he met in Athens. He tried to persuade them to care not only about their bodies, their money and the affairs of the state, but to also examine themselves and take care of their soul. The same can be said of the Stoics, who emphasized that philosophy must be put into practice and actually change our ways of life. They gave public inspirational speeches about the importance of bringing order to our chaotic souls and they talked to people about how we can live completely fulfilling lives. How impractical and useless is that?

Both Socrates’ art of conversation and the life advice of the Stoics have inspired the emergence of cognitive behavioral therapies. In recent times, Asian philosophy and meditation have also inspired psychotherapy in the form of so-called mindfulness, used as a method to manage stress, anxiety and pain. However, there is a tendency to gloss over the philosophical influence behind these methods, as if philosophy were something impractical and useless! There is a risk that, in an effort to present a clinically effective facade, one covers up the philosophical depth, while the problems one tries to treat are often connected with superficial hopes for quick and effective solutions.

Can today’s psychotherapies more openly and directly draw inspiration from philosophy? Are there already such bridges to philosophy that can be strengthened? If so, what distinguishes them? These questions are investigated by Sylvia Martin, researcher at CRB and a practicing psychotherapist herself. In a review article, she focuses on work with values in various forms of cognitive behavioral therapy as a bridge to philosophy that could be strengthened. I will give an example from the article of such work, which suggests how patients can be supported to find a more stable and fulfilling attitude to life.

Many people seek meaning in life through various objectives and projects, which they then try to realize. They believe that happiness will only come if they get to travel to Beijing, find a new job, buy a house or get a dog. Objectives do not provide stable meaning and fulfillment. On the contrary. The satisfaction when objectives are realized is short-lived and soon turns into a feeling of emptiness that must be filled by new exciting projects. There is of course nothing wrong with travel, jobs, houses or dogs, but when chasing new objectives becomes a pattern it can be unfortunate. Soon a whole life is filled with objectives that do not give the stable fulfillment that one is really longing for. The pattern of seeking new objectives and projects that will give meaning and satisfaction becomes a self-destructive lifestyle, which it eventually becomes difficult to get out of. But through therapy, people can be helped to see the unfortunate pattern. For example, they can be given the task of imagining the objective of “traveling to Beijing”: how they save money for the trip, learn Chinese and plan the trip. They can imagine all the fun they have in Beijing. But how does it feel to come home again? To come home is to return to meaninglessness and immediately the same old emptiness must be filled by a new project. Values such as compassion and truth differ from objectives by being more like a road that never ends. Values can be cultivated and deepened without end. The path becomes the destination, fulfillment lies in walking it, and the elusive notion of “finally finding fulfillment” dissolves. But all of this of course assumes that the therapy is not perceived as a “trip to Beijing” that will finally bring fulfillment. There are no easy solutions to the problem of a meaningless life, such as new trips, new jobs, new houses… or new therapies.

Philosophically anchored psychotherapy can contribute to the deepening required, so that the work with values does not become another project that reinforces superficial attitudes to life. Perhaps the impression that philosophy is impractical and useless is even related to the restless attitude that a meaningful life requires objectives to be effectively realized? Philosophy is not a project, but more like a lifelong path. Read Sylvia Martin’s review article here: Using values in cognitive and behavioral therapy: a bridge back to philosophy.

Written by…

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

Martin, S. Using values in cognitive and behavioral therapy: a bridge back to philosophy. Journal of Evaluation in Clinical Practice. 2023; 1- 7. doi:10.1111/jep.13872

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We challenge habits of thought

Using artificial intelligence with academic integrity

6 June, 2023 / Pär Segerdahl / 1 Comment

AI tools can both transform and produce content such as texts, images and music. The tools are also increasingly available as online services. One example is the ChatGPT tool, which you can ask questions and get well-informed, logically reasoned answers from. Answers that the tool can correct if you point out errors and ambiguities. You can interact with the tool almost as if you were conversing with a human.

Such a tool can of course be very useful. It can help you solve problems and find relevant information. I venture to guess that the response from the tool can also stimulate creativity and open the mind to unexpected possibilities, just as conversations with people tend to do. However, like all technology, these tools can also be abused and students have already used ChatGPT to complete their assignments.

The challenge in education and research is thus to learn to use these AI tools with academic integrity. Using AI tools is not automatically cheating. Seven participants in a European network for academic integrity (ENAI), including Sonja Bjelobaba at CRB, write about the challenge in an editorial in International Journal for Educational Integrity. Above all, the authors summarize tentative recommendations from ENAI on the ethical use of AI in academia.

An overarching aim in the recommendations is to integrate recommendations on AI with other related recommendations on academic integrity. Thus, all persons, sources and tools that influenced ideas or generated content must be clearly acknowledged – including the use of AI tools. Appropriate use of tools that affect the form of the text (such as proofreading tools, spelling checkers and thesaurus) are generally acceptable. Furthermore, an AI tool cannot be listed as a co-author in a publication, as the tool cannot take responsibility for the content.

The recommendations also emphasize the importance of educational efforts on the ethical use of AI tools. Read the recommendations in their entirety here: ENAI Recommendations on the ethical use of Artificial Intelligence in Education.

Written by…

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

Foltynek, T., Bjelobaba, S., Glendinning, I. et al. ENAI Recommendations on the ethical use of Artificial Intelligence in Education. International Journal for Educational Integrity 19, 12 (2023). https://doi.org/10.1007/s40979-023-00133-4

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We care about education

Encourage children to take responsibility for others?

30 May, 2023 / Pär Segerdahl / 1 Comment

It happens that academics write visionary texts that highlight great human challenges. I blogged about such a philosophically visionary article a few years ago; an article in which Kathinka Evers discussed the interaction between society and the brain. In the article, she developed the idea that we have a “proactive” responsibility to adapt our societies to what we know about the brain’s strengths and weaknesses. Above all, she emphasized that the knowledge we have today about the changeability of the brain gives us a proactive responsibility for our own human nature, as this nature is shaped and reshaped in interaction with the societies we build.

Today I want to recommend a visionary philosophical article by Jessica Nihlén Fahlquist, an article that I think has points of contact with Kathinka Evers’ paper. Here, too, the article highlights our responsibility for major human challenges, such as climate and, above all, public health. Here, too, human changeability is emphasized, not least during childhood. Here, too, it is argued that we have a responsibility to be proactive (although the term is not used). But where Kathinka Evers starts from neuroscience, Jessica Nihlén Fahlquist starts from virtue ethics and from social sciences that see children as social actors.

Jessica Nihlén Fahlquist points out that we live in more complex societies and face greater global challenges than ever before in human history. But humans are also complex and can under favorable circumstances develop great capacities for taking responsibility. Virtue ethics has this focus on the human being and on personal character traits that can be cultivated and developed to varying degrees. Virtue ethics is sometimes criticized for not being sufficiently action-guiding. But it is hard to imagine that we can deal with major human challenges through action-guiding rules and regulations alone. Rules are never as complex as human beings. Action-guiding rules assume that the challenges are already under some sort of control and thus are not as uncertain anymore. Faced with complex challenges with great uncertainties, we may have to learn to trust the human being. Do we dare to trust ourselves when we often created the problems?

Jessica Nihlén Fahlquist reasons in a way that brings to mind Kathinka Evers’ idea of a proactive responsibility for our societies and our human nature. Nihlén Fahlquist suggests, if I understand her correctly, that we already have a responsibility to create environments that support the development of human character traits that in the future can help us meet the challenges. We already have a responsibility to support greater abilities to take responsibility in the future, one could say.

Nihlén Fahlquist focuses on public health challenges and her reasoning is based on the pandemic and the issue of vaccination of children. Parents have a right and a duty to protect their children from risks. But reasonably, parents can also be considered obliged not to be overprotective, but also to consider the child’s development of agency and values. The virus that spread during the pandemic did not cause severe symptoms in children. Vaccination therefore does not significantly protect the child’s own health, but would be done with others in mind. Studies show that children may be capable of reasoning in terms of such responsibility for others. Children who participate in medical research can, for example, answer that they participate partly to help others. Do we dare to encourage capable children to take responsibility for public health by letting them reason about their own vaccination? Is it even the case that we should support children to cultivate such responsibility as a virtue?

Nihlén Fahlquist does not claim that children themselves have this responsibility to get vaccinated out of solidarity with others. But if some children prove to be able to reason in such a morally complex way about their own vaccination, one could say that these children’s sense of responsibility is something unexpected and admirable, something that we cannot demand from a child. By encouraging and supporting the unexpected and admirable in children, it can eventually become an expected responsibility in adults, suggests Jessica Nihlén Fahlquist. Virtue ethics makes it meaningful to think in terms of such possibilities, where humans can change and their virtues can grow. Do we dare to believe in such possibilities in ourselves? If you do not expect the unexpected you will not discover it, said a visionary Greek philosopher named Heraclitus.

Jessica Nihlén Fahlquist’s article is multifaceted and innovative. In this post, I have only emphasized one of her lines of thought, which I hope has made you curious about an urgent academic text: Taking risks to protect others – pediatric vaccination and moral responsibility.

In summary, Jessica Nihlén Fahlquist argues that vaccination should be regarded as an opportunity for children to develop their sense of responsibility and that parents, schools, healthcare professionals and public health authorities should include children in debates about ethical public health issues.

Written by…

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

Jessica Nihlén Fahlquist, Taking Risks to Protect Others – Pediatric Vaccination and Moral Responsibility, Public Health Ethics, 2023;, phad005, https://doi.org/10.1093/phe/phad005

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Approaching future issues

When ordinary words get scientific uses

16 May, 2023 / Pär Segerdahl / 1 Comment

A few weeks ago, Josepine Fernow wrote an urgent blog post about science and language. She linked to a research debate about conceptual challenges for neuroscience, challenges that arise when ordinary words get specialized uses in science as technically defined terms.

In the case under debate, the word “sentience” had been imported into the scientific study of the brain. A research group reported that they were able to determine that in vitro neurons from humans and mice have learning abilities and that they exhibit “sentience” in a simulated game world. Of course, it caused quite a stir that some neurons grown in a laboratory could exhibit sentience! But the research team did not mean what attracted attention. They meant something very technical that only a specialist in the field can understand. The surprising thing about the finding was therefore the choice of words.

When the startling choice of words was questioned by other researchers, the research team defended themselves by saying that they defined the term “sentience” strictly scientifically, so that everyone should have understood what they meant, at least the colleagues in the field. Well, not all people are specialists in the relevant field. Thus the discovery – whatever it was that was discovered – raised a stir among people as if it were a discovery of sentience in neurons grown in a laboratory.

The research group’s attitude towards their own technical language is similar to an attitude I encountered long ago in a famous theorist of language, Noam Chomsky. This is what Chomsky said about the scientific study of the nature of language: “every serious approach to the study of language departs from the common-sense usage, replacing it by some technical concept.” Chomsky is of course right that linguistics defines its own technical concepts of language. But one can sense a certain hubris in the statement, because it sounds as if only a linguistic theorist could understand “language” in a way that is worthy of serious attention. This is untenable, because it raises the question what a technical concept of language is. In what sense is a technical concept a concept of language? Is it a technical concept of language in the common sense? Or is it a technical concept of language in the same inaccessible sense? In the latter case, the serious study of language seems to degenerate into a navel-gazing that does not access language.

For a technical concept of language to be a concept of language, our ordinary notions must be taken into account. Otherwise, the technical concept ceases to be a concept of language.

This is perhaps something to consider in neuroscience as well. Namely to the extent that one wants to shed light on phenomena such as consciousness and sentience. Of course, neuroscience will define its own technical concepts of these phenomena, as in the debated case. But if the technical concepts are to function as concepts of consciousness and sentience, then one cannot neglect our ordinary uses of words.

Science is very serious and important. But if the special significance of science goes to our heads, then our attitude risks undermining the great importance of science for humanity. Here you can read the views of three neuroethicists on these important linguistic issues: Conceptual conundrums for neuroscience.

Written by…

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

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Minding our language

Taking care of the legacy: curating responsible research and innovation practice

25 April, 2023 / josepinefernow / 1 Comment

Responsible research and innovation, or RRI as it is often called in EU-project language, is both scholarship and practice. Over the last decade, the Human Brain Project Building has used structured and strategic approaches to embed responsible research and innovation practices across the project. The efforts to curate the legacy of this work includes the development an online Ethics & Society toolkit. But how does that work? And what does a toolkit need in order to ensure it has a role to play?

A recent paper by Lise Bitsch and Bernd Stahl in Frontiers in Research Metrics and Analytics explores whether this kind of toolkit can help embed the legacy of RRI activities in a large research project. According to them, a toolkit has the potential to play an important role in preserving RRI legacy. But they also point out that that potential can only be realised if we have organisational structures and funding in place to make sure that this legacy is retained. Because as all resources, it needs to be maintained, shared, used, and curated. To play a role in the long-term.

Even though this particular toolkit is designed to integrate insights and practises of responsible research and innovation in the Human Brain Project, there are lessons to be learned for other efforts to ensure acceptability, desirability and sustainability of processes and outcomes of research and innovation activities. The Human Brain Project is a ten-year European Flagship project that has gone through several phases. Bernd Stahl is the ethics director of the Human Brain Project, and Lise Bitsch has led the project’s responsible research and innovation work stream for the past three years. And there is a lot to be learned. For projects who are considering developing similar tools, they describe the process of designing and developing the toolkit.

But there are parts of the RRI-legacy that cannot fit in a toolkit. The impact of the ethical, social and reflective work in the Human Brain Project is visible in governance structures, how the project is managing and handling data, in its publications and communications. The authors are part of those structures.

In addition to the Ethics & Society toolkit, the work has been published in journals, shared on the Ethics Dialogues blog (where a first version of this post was published) and the HBP Society Twitter handle, offering more opportunities to engage and discuss in the EBRAINS community Ethics & Society space. The capacity building efforts carried out for the project and EBRAINS research infrastructure have been developed into an online ethics & society training resource, and the work with gender and diversity has resulted in a toolki t for equality, diversity and inclusion in project themes and teams.

Read the paper by Bernd Carsten Stahl and Lise Bitsch: Building a responsible innovation toolkit as project legacy.

(A first version of this post was originally published on the Ethics Dialogues blog, March 13, 2023)

Written by…

Josepine Fernow, science communications project manager and coordinator at the Centre for Research Ethics & Bioethics, develops communications strategy for European research projects

Bernd Carsten Stahl and Lise Bitsch: Building a responsible innovation toolkit as project legacy, Frontiers in Research Metrics and Analytics, 13 March 2023, Sec. Research Policy and Strategic Management, Volume 8 – 2023, https://doi.org/10.3389/frma.2023.1112106

Part of international collaborations

Does the severity of an illness qualify the moral motivation to act?

18 April, 2023 / Pär Segerdahl / 1 Comment

I have to admit that I had a little trouble cracking the code in the article which I will now try to summarize briefly. I hope that the title I have chosen is not already a misunderstanding. Moral philosophy is not easy, but the subject of the article is urgent so I still want to try.

Illness is generally perceived as something bad, as an evil. If we are to speak in terms of value, we can say that illness has negative value. Individual cases of illness usually create a moral motivation in us to mitigate the ill person’s negative condition. How strong this motivation is depends on several factors, but the severity of the disease is a relevant factor. The motivation to act typically increases with the severity of the disease.

This of course comes as no surprise. The motivation to alleviate a person’s cold is not very strong because a cold is not a severe condition. A runny nose is nothing to complain about. But in the face of more severe conditions such as blood poisoning, diabetes and cancer, the moral drive to act increases. “This condition is very severe” we say and feel that it is very important to act.

So what is the problem that motivates the article? If I am interpreting the authors correctly, the problem is that it is not so easy to convert this obvious use of language into a rule to follow. I recently bought a kettle that came with this warning: “Do not fill the kettle with an excessive amount of water.” The warning is, in a way, self-evident. Of course, you should not fill the kettle with an excessive amount of water! The motivation to pour should have stopped before the water level got excessively high. Even though the language is perfectly obvious, the rule is not as obvious, because when is the water level excessively high? When should we stop pouring?

The problem with the word “severity” is similar, or at least that is my interpretation. “Severity” is an obvious linguistic tool when we discuss illness and the need to do something about it. But at the same time, it is difficult to define the term as a description of when conditions are (more or less) severe and when it is (more or less) motivated to do something about them. Some philosophers have therefore criticized the use of “severity” in discussions about, for example, priority setting in healthcare. The situation would become somewhat paradoxical, since an obviously relevant concept would be excluded because it is unclear how it can be transformed into a description that can be followed as if it were a simple rule.

If I understand the article correctly, the authors want to defend the concept of severity by showing that severity qualifies our moral motivation to act when someone is ill. They do this by describing six other concepts that it is more generally accepted should qualify how morally important it is to do something about a condition, including the concepts of need and lack of well-being. None of the six concepts coincides completely with the concept of severity, but when we try to assess how they affect the need to act, we will often simultaneously assess the severity. And when we assess the severity of an illness, we will often at the same time assess how the illness affects well-being, for example.

The authors’ conclusion is that the concept of severity is a morally relevant concept that should be considered in future discussions, as severity qualifies the moral motivation to act. However, I may have misunderstood the reasoning, so if you want to be on the safe side, you can read the article here: Severity as a moral qualifier of malady.

I want to end the post with a personal side note: I am inclined to say that the philosophical difficulty in defining the concept of severity (when we talk about disease) is similar to the difficulty in defining the concept of excess (when we talk about water levels). What makes these concepts so useful is their great pliability. It is difficult to say what “severe disease” or “excessively high water level” is, because it depends on so much. Pliable words like these are like tracking dogs that sensitively move through the terrain in all possible relevant directions. But if we try to reconstruct the tracking dog’s sensitivity in general intellectual terms, without access to the dog’s sense of smell, experiences and instincts, we run into great difficulties.

Should these philosophical difficulties motivate us to get rid of the dog? Of course not! Just as we learn incredibly much from following a tracking dog, we learn incredibly much from following the words “severe disease,” even if the journey is arduous. This underlines the authors’ conclusion: severity should be considered a morally significant concept that continues to deserve our attention.

Written by…

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

Solberg, C.T., Barra, M., Sandman, L. et al. Severity as a moral qualifier of malady. BMC Medical Ethics 24, 25 (2023). https://doi.org/10.1186/s12910-023-00903-2

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We like challenging questions

Ethical challenges when children with cancer are recruited for research

28 March, 2023 / Pär Segerdahl / 1 Comment

Cancer is a common cause of death among children, but improved treatments have significantly increased survival, especially in high-income countries. A prerequisite for this development is research.

When we think of a hospital, we think mainly of the care given to patients there. But care and research are largely developed together in the hospitals. Treatments given in the hospitals are tested in research carried out in the hospitals. This overlap of care and research in the same setting creates ethical challenges. Not least because it can be difficult to see and maintain the differences when, as I said, the activities overlap.

Kajsa Norbäck, PhD student at CRB, investigates in an interview study Swedish healthcare professionals’ perceptions and experiences of ethical challenges when children with cancer are recruited for research in the hospitals where they are patients. Research is needed for future childhood cancer care, but what are the challenges when approaching children with cancer and their parents with the question of research participation?

The interview material is rich and difficult to summarize in a blog post, but I want to highlight a few findings that particularly impressed me. I recommend those interested to take the time to read the entire article in peace and quiet. Interview studies provide a living direct contact with reality from the perspective of the interviewees. Kajsa Norbäck writes that interview studies give us informative examples of ethical challenges. Such examples are needed to give the ethical reflection concreteness and grounding in reality.

The interviewed healthcare professionals particularly emphasized the importance of establishing a trusting relationship with the family. Only when you have such a relationship does it make sense to discuss possible research participation. Personally, I cannot help but interpret it as meaning that the care relationship with patient and family must be established first. It is within the framework of the care relationship that possible research participation can be discussed in a trusting manner. But trust can also be a dilemma, the interviews show. The interviewees stated that many families had so much trust in healthcare and research that it could feel too easy and predictable to get consent for research participation. They also had the impression that parents could sometimes give consent to research out of fear of not having done everything they could to save the child, as if research was a last chance to get effective care.

The challenge of managing the overlap of care and research also extends to the professional role of the physician. Physicians have a care responsibility, but since the care they can offer rests on research, they also feel a research responsibility: they feel a responsibility to recruit research participants from among their patients. This dual responsibility can naturally create conflicts of interest, of which they give informative examples in the interviews.

In the middle of this force field of challenges we have the child, who may have difficulty making itself heard, perhaps because many of us have difficulty being a listener. Here is what one of the interviewees says: “We often talk about informing and I think that’s a strange word. I think the greatest competence is to listen.” There is a lot to listen to in Kajsa Norbäck’s interview study as well, more than I can reproduce in a blog post. Read her article here: Ethical concerns when recruiting children with cancer for research: Swedish healthcare professionals’ perceptions and experiences.

Written by…

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

Norbäck, K., Höglund, A.T., Godskesen, T. and Frygner-Holm, S. Ethical concerns when recruiting children with cancer for research: Swedish healthcare professionals’ perceptions and experiences. BMC Medical Ethics 24, 23 (2023). https://doi.org/10.1186/s12910-023-00901-4

This post in Swedish

Ethics needs empirical input

Category: In the research debate (Page 4 of 33)

Precision medicine algorithms and personal encounters

Philosophically anchored psychotherapy

Using artificial intelligence with academic integrity

Encourage children to take responsibility for others?

When ordinary words get scientific uses

Taking care of the legacy: curating responsible research and innovation practice

Does the severity of an illness qualify the moral motivation to act?

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