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

Category: In the research debate (Page 2 of 32)

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

This post in Swedish

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

This post in Swedish

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.

This post in Swedish

We recommend conferences

Antimicrobial resistance: bringing the AMR community together

According to the WHO, antibiotic resistance is one of the biggest threats to global health, food security and development. Most of the disease burden is in the global south, but drug resistant infections can affect anyone, in any part of the world. Bacteria are always evolving, and antibiotic resistance is a natural process that develops through mutations. We can slow down the process by using antibiotics responsibly, but to save lives, we urgently need new antibiotics to fight the resistant bacteria that already today threaten our health.

There is a dilemma here: development of new antibiotics is a high-risk business, with very low return of investment, and big pharma is leaving the antibiotics field for precisely this reason. Responsible use of antibiotics means saving new drugs for the most severe cases. There are several initiatives filling the gap this creates. One example is the Innovative Medicines Initiative AMR Accelerator programme, with 9 projects working together to fill the pipeline with new antibiotics, and developing tools and infrastructures that can support antibiotics development.

Antimicrobial resistance (AMR) to antibiotics and other anti-infectives is a community problem. Managing it requires a community coming together to find solutions and work together to develop research infrastructures. For example, assessing the effectiveness of new antibiotics requires standardised high-quality infection models that can become available to projects, companies and research groups that are developing new antibacterial treatments. Recently, the AMR Accelerator COMBINE project announced a collaboration with some of the big players in the field: CARB-X, CAIRD, iiCON and Pharmacology Discovery Services. This kind of collaboration allows key actors to come together and share both expertise and data. The COMBINE project is developing a standardised protocol for an in vivo pneumonia model. It will become available to the scientific community, along with a bank of reference strains of Gram-negative bacteria that are clinically relevant, complete with a framework to bridge the gap between preclinical data and clinical outcomes based on mathematical modelling approaches.

The benefit of a standardised model is to support harmonisation. Ideally, data on how effective new antibiotic candidates are should be the same, regardless of the lab that performed the experiments. The point of the collaboration is to improve quality of the COMBINE pneumonia model. But who are they and what will they do? CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership that supports early-stage antibacterial research and development. They will help validation of the pneumonia model. CAIRD (Center for Anti-Infective Research and Development) is working to advance anti-infective pharmacology. They are providing a benchmark by back-translation of clinical data. iiCON has a mission to accelerate and support the discovery and development of innovative new anti-infectives, diagnostics, and preventative products. They are supporting the mathematical modelling to ensure optimal dose selection. And finally, Pharmacology Discovery Services, a contract research organisation (CRO) working with preclinical antibacterial development, will supply efficacy data.

At the centre of this is the COMBINE project, which has a coordinating role in the AMR Accelerator: a cluster of public-private partnership projects funded by the Innovative Medicines Initiative (IMI). The AMR Accelerator brings together academia, pharma industry, patient organisations, non-profits and small and medium sized companies. The aim is to develop a robust pipeline of antibiotics and standardised tools that can be used by others in this community, to help in the fight against antimicrobial resistance.

In parallel, the effort to slow down antibiotic resistance continues. For example, Uppsala University coordinates the COMBINE project, and in 2016, the University founded the Uppsala Antibiotic Center, a multidisciplinary centre for research, education, innovation and awareness. The centre runs the AMR Studio podcast, showcasing some of the multidisciplinary research on antimicrobial resistance around the world. The University is also coordinating the ENABLE-2 antibacterial drug discovery platform funded by the Swedish Research Council, with an open call to support programmes in the early stages of discovery and development of new antibiotics.

Our own efforts at the Centre for Research Ethics & Bioethics are more focused on how we as individuals can help slow down the development of antibiotic resistance, and how we can assess the impact of how you frame antibiotic treatments when you ask patients about their preferences

Josepine Fernow

Written by…

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

Do you want to know more?

EurekAlert! News release: Collaboration to improve the quality of in vivo antibiotics testing, 14 November 2023 https://www.eurekalert.org/news-releases/1007971.

Ancillotti M, Nihlén Fahlquist J, Eriksson S, Individual moral responsibility for antibiotic resistance, Bioethics, 2022;36(1):3-9. https://doi.org/10.1111/bioe.12958

Smith IP, Ancillotti M, de Bekker-Grob EW, Veldwijk J. Does It Matter How You Ask? Assessing the Impact of Failure or Effectiveness Framing on Preferences for Antibiotic Treatments in a Discrete Choice Experiment. Patient Prefer Adherence. 2022;16:2921-2936. https://doi.org/10.2147/PPA.S365624

A shorter version of this post in Swedish

Approaching future issues

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.

This post in Swedish

Part of international collaborations

How should coercive care be regulated within somatic healthcare?

Coercive measures against patients are regularly used in healthcare outside of psychiatry, for example in neurosurgical care. Examples of such measures are belting, boxing gloves, holding patients down, forced medication and hidden medication. It is mostly nurses who carry out these coercive measures. The most common motive for forcing patients is to protect them from harming themselves or others: patients may be confused or aggressive and try to pull out vital ports for intravenous drug administration or abuse staff, often without understanding what they are doing themselves. Because the staff act in a legal and moral gray zone, they often feel moral stress exercising coercion.

How can we regulate coercive care in a way that balances ethically relevant considerations about the measures, so that staff no longer have to act in a gray zone?

Different countries have chosen different paths to regulate coercive care within somatic healthcare. In Sweden, it is in principle illegal to use all forms of coercion without the support of compulsory psychiatric care. An overarching problem in the regulation of coercive care is to ensure that patients with reduced decision-making capacity receive the care they need and at the same time ensure that patients with a sufficient degree of decision-making capacity are not forced into care they do not want. In an article in the Journal of Medical Ethics, Amina Guenna Holmgren and I and two co-authors try to sort out these difficulties. Arguments about justice, trust in healthcare, minimizing harm and respect for autonomy are made for and against different national regulations. We conclude that a regulation that includes an assessment of the patients’ decision-making capacity and takes the patient’s best interests into account is preferable, in contrast to regulations based on psychiatric diagnoses or regulations where there are no legal possibilities to practice coercive care at all within somatic care.

If you want to take a closer look at our reasoning regarding the regulation of restraint in somatic healthcare and evaluate our proposal, you will find the article here: Restraint in somatic healthcare: how should it be regulated?

Niklas Juth

Written by

Niklas Juth, Professor of Clinical Medical Ethics at the Centre for Research Ethics & Bioethics (CRB)

Guenna Holmgren A, von Vogelsang A, Lindblad A, Niklas Juth. Restraint in somatic healthcare: how should it be regulated? Journal of Medical Ethics. Published Online First: 18 October 2023. doi: 10.1136/jme-2023-109240

This post in Swedish

Thinking about law

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

This post in Swedish

Minding our language

Empirical ethics nuances ethical issues

A few years ago, my colleague Pär Segerdahl published a blog post on why bioethicists do empirical studies. He pointed out that surveys and interview studies on what people think hardly provide evidence that can decide controversial ethical issues, for example whether euthanasia should be allowed. Empirical studies rather give us a better grasp of the problem itself. They help us see what is actually at stake for people. I agree with him that ethical issues are not decided by surveys and interview studies and that such studies rather help us to see more clearly the meaning of the issues.

In this post, I want to further exemplify how empirical methods can nuance ethical questions and help us see what is at stake for people: help us see what we need to consider in the ethical discussion. I have in mind how, through a well-considered choice of empirical method, one can better describe the relative importance of ethical difficulties, values and preferences among stakeholders, as well as conflicts between ethical views. How? I am thinking of methods where respondents do not just answer what they think on certain individual issues, but are faced with complex scenarios where several factors are simultaneously at stake. Even if you have the firm opinion that drugs should not have side effects, are you perhaps still prepared to choose such a drug if it is more effective against your symptoms than other drugs, or is cheaper, or easier to use? In such studies, we create a multidimensional world with nuances for respondents to make complex decisions in.

Here is my example: Soon, therapies based on human embryonic stem cells may become a reality for patients with Parkinson’s disease. But is it morally acceptable to use human embryonic stem cells (hESC) for drug therapy? This has long been a controversial issue, partly because the embryo is destroyed when the stem cells are harvested. Perhaps the question is about to become even more topical now, when countries are changing legislation in a direction that gives the embryo a higher status and more legal protection. It is therefore particularly important that research provides a nuanced picture of the issues. In light of the political landscape and the new possibilities for treating patients with Parkinson’s, a more complex empirical method can support a better contemporary discussion about what types of research and therapies are within the scope of what can be allowed to be done with an embryo. The discussion concerns both ethics and law and must also include scientific challenges to ensure that stem cell research and therapies are carried out in ethically acceptable ways.

A common way to empirically examine the ethical issue is to look at the ethical arguments for and against the destruction of human embryos: to examine how different actors think and feel about this. Undoubtedly, such studies help us see what is at stake. But they can also easily steer respondents towards a yes-or-no answer, a pro-or-against attitude. Therefore, it is important to choose an empirical method that elicits perceived benefits and risks and explores multiple dimensions of the problem. How do patients feel about taking a medicine based on leftover embryos that not only relieves their symptoms but also repairs the damage, while the level of knowledge is low? It is not easy to answer such a question, but reality often has this complexity.

One method that can stage such complex considerations is a choice-based survey called Discrete Choice Experiments (DCE). With that method, we can investigate ethically sensitive issues and use the results to describe more fully the relative importance of ethical difficulties, values and preferences among stakeholders, as well as conflicts between ethical views. DCE provides an understanding of the balance between factors involved in different situations. In a new article in BMC Medical Ethics, my colleagues and I have investigated which factors are associated with the preferences of patients with Parkinson’s disease regarding embryonic stem cell-based treatments for the disease in the future. We invited patients to participate in a web-based choice-based experiment to assess the importance of the following factors: (1) type of treatment, (2) purpose of the treatment, (3) available knowledge about different types of treatment, (4) effect on symptoms and (5) the risk of serious side effects. The results showed that the fourth factor, “effect on symptoms,” was the most important factor in the choice of treatment option. Patients’ previous experience with treatment, side effects and advanced treatment therapy, as well as religious beliefs were associated with what they thought was most important, but not their view of what an embryo is. If you want to read more, you can find the article here: Patients accept therapy using embryonic stem cells for Parkinson’s disease: a discrete choice experiment.

These kinds of results from DCE studies can, in my opinion, help us to understand and frame ethical questions in ways that reflect how people think when multiple factors are at stake simultaneously. I believe that the more realistic complexity of such studies can contribute to more informed ethical considerations. I believe that they could also strengthen democratic processes by giving public conversation a background of more nuanced empirical findings.

Written by…

Jennifer Viberg Johansson, Associate Professor in Medical Ethics at Uppsala University’s Centre for Research Ethics & Bioethics.

Bywall, K.S., Drevin, J., Groothuis-Oudshoorn, C. et al. Patients accept therapy using embryonic stem cells for Parkinson’s disease: a discrete choice experiment. BMC Med Ethics 24, 83 (2023). https://doi.org/10.1186/s12910-023-00966-1

This post in Swedish

Ethics needs empirical input

How clearly are ethical approval and informed consent reported in published articles?

In a scientific article, it is of course essential that the authors describe the aim, methods and results of the study. But all researchers also have a research ethical responsibility to reflect on ethical aspects of the work and to plan and carry out their studies in accordance with relevant laws and guidelines. The ethical approach in the study should also be described in the article. This description is not as extensive as the method description, but certain information about ethical approval and informed consent should be given with sufficient detail. If the study also entailed specific ethical challenges, perhaps because it involved vulnerable participants such as seriously ill or dying patients, then the article should report how the challenges were handled regarding, for example, obtaining informed consent.

Although scientific journals have the standard that information on ethical approval and informed consent must be declared, it is unclear how well this requirement is complied with in practice, by both authors and journal editors. A group of ethics researchers, including Tove Godskesen, William Bülow and Stefan Eriksson linked to CRB, recently investigated this question within a relevant field, namely research on palliative and end-of-life care. Patients who participate in such research can be considered vulnerable and research in this area involves particular ethical challenges. How well do scientific publications in the field meet the requirements for reporting ethical approval and informed consent?

The ethicists’ survey was conducted on 169 empirical studies in 101 journals, published after January 1, 2019. It was limited to studies conducted in Norway and Sweden, as the author group was well acquainted with the regulations and practices of ethical review in these countries and could therefore assess whether the articles contained information about relevant laws and authorities. To rate how well the articles reported ethical approval and consent, a scoring scale was created from 0 to 3. Articles with no reporting at all received a score of 0 and articles with minimal reporting (e.g., “Ethical approval was granted”) received a score of 1. If the article contained clear and concise statements about ethical approval and informed consent, and in addition included one piece of detailed information (such as the name of the committee or authority that gave the approval), then the article received a score of 2.

An original feature of the examination is the detailed requirements for obtaining the highest score. The requirements for scoring 3 are intended to also serve as a suggestion for best practice. They are proposed as a possible basis for clearer guidelines in the future for authors, journal editors and peer reviewers. What details must be reported to get the score 3? No irrelevant details, but perfectly reasonable information if you think about it. For example, the identity of the review board should be disclosed as well as the identification number of their decision. Why? To be able to contact the board for verification or questions, for readers to be able to see that the research complies with relevant laws and ethical guidelines, and for the public to be able to access the information. One should also mention the Act under to which the decision on ethical approval was made. Why? It shows that the researchers are ethically proficient and it helps editors and reviewers to compare the statements with legal requirements in doubtful cases. Regarding informed consent, one should state, among other things, what type of consent was obtained and from whom the consent was obtained. Why? So that one can assess whether the procedures meet ethical requirements in the current case. In palliative care research, for example, both the patients and their families can be involved in the consent process. Also for the informed consent, relevant legislation should be indicated to demonstrate awareness of legal requirements and to enable critical review.

The requirements are therefore about completely reasonable information that should be easy to provide. But what were the results of the survey? I content myself with reproducing the percentage of articles that received the lowest and the highest scores. A non-negligible proportion of the articles contained no reported information at all and got 0 points: 5% for ethical approval and 13% for informed consent. A larger but still small proportion of the articles reported sufficiently detailed information to receive the highest score: 27% for ethical approval and 19% for informed consent.

Considering that the requirements for the highest score can be considered reasonable and not particularly onerous, the results are disappointing. The substandard reporting creates uncertainty about the ethical rigor of studies, the authors write in their conclusion, which is particularly troubling for studies with vulnerable participants, such as patients in palliative and end-of-life care, who require special ethical considerations.

What can we do about the problem? A common measure is training in research ethics, which is of course important. But the authors suggest that a more effective way to quickly bring about change is for scientific journals to start making clearer demands on how ethical approval and informed consent must be reported in articles to be considered for publication. So why not use the requirements to get the highest score on this survey as a template? They are proposed as a reasonable description of best practice. Read the survey here: How do journals publishing palliative and end-of-life care research report ethical approval and informed consent?

In a box in the article, the authors cite an exemplary description of ethical approval and informed consent that includes the details for score level 3. It strikes me how clarifying it is to see a good example, so look for the box in the article.

Pär Segerdahl

Written by…

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

Godskesen, T., Vie, K.J., Bülow, W., Holmberg, B., Helgesson, G. and Eriksson, S. (2023), How do journals publishing palliative and end-of-life care research report ethical approval and informed consent? Learned Publishing. https://doi.org/10.1002/leap.1580

This post in Swedish

Thinking about authorship

Data for gender equality in European research organizations

Inequality is not just a bad feeling that some may have, but a bad reality that we share. Especially in countries where gender equality work is not well established, it is important that inequality is not handled as a contested issue, but as a fact about which more knowledge should be sought. Who has the power over the criteria for what a successful researcher is and who has a better chance of succeeding? Which structures undermine or support gender equality? What does childcare look like? Are the research teams homogeneous and how does that affect the work? Where do women end up in the author order in scientific publications and where do they end up in the competition for research funds? Are there mechanisms and values in science that systematically make inequality invisible and prevent equality?

There is a will in the EU to improve gender equality in research organizations, especially in some of the Member States where gender equality work is particularly neglected. How can the necessary changes be brought about? In Sweden, all state universities are commissioned to collect data on (in)equality. Under the slogan “No data: No policies!” an EU project presents its approach to gender equality plans. The project, MINDtheGEPs, develops and implements gender equality plans in a collaboration between 7 European research organizations in 5 countries: Spain, Poland, Ireland, Italy and Serbia. The focus is on changing the organizations structurally and culturally and increasing women’s participation in research and innovation. The project is coordinated from the Center for Women’s and Gender Studies at the University of Turin. The work is supported by a further 4 organizations: the publishing house Elsevier in the Netherlands, the research organization Knowledge & Innovation in Italy, the National Research Council of Italy, and by the Centre for Research & Bioethics (CRB) at Uppsala University, which leads the communication work.

In the participating countries, there is a lack of sufficient data on factors behind equality and inequality, which means that those who suffer from inequality also suffer from not being seen. Therefore, it is important to carry out studies that map the problems. If the studies are also carried out in one’s own organization and one contributes to producing the data, this can further contribute to making the problems visible and motivating change. Therefore, the organizations in MINDtheGEPs collect data together to develop, adapt and support interventions at the local level. Behind the approach is a reasonable idea: if you cannot provide evidence of inequality, you will not get support to remedy the problems either. The project thus collects data on existing legislation and policy in the 5 countries, as well as data on the proportion of women in governing bodies at different levels, on the proportion of women who apply for and receive research support in competition, as well as data on the existence of gender equality measures. Surveys and interview studies are also carried out with researchers, administrative staff, rectors and vice rectors, department directors and other relevant actors. This large data collection and analysis is the basis for the 7 gender equality plans that are developed and implemented in MINDtheGEPs. Here you will find a presentation of the data collection.

If you want a summary of the work with evidence-based equality plans, you can read this policy brief from the project: No data: No policies! The MINDtheGEP’s approach to evidence-based policies for Gender Equality Plans. The document gives a brief account of structural and cultural measures that are recommended on the basis of the studies in various areas. It is about balance in recruitment and career progression and about balance between work and private life. It is about making gender equality issues visible in research and teaching, for example through courses that highlight gender as an important dimension in these activities. Finally, it is about changing the work in decision making bodies so that more women can reach higher positions within research organizations in the countries in the project collaboration.

The approach in MINDtheGEPs can probably inspire other organizations in addition to those included in the project, even organizations that do not work with research. This is also a thought behind the project. The hope is that the work of developing and implementing gender equality plans in a number of research organizations will influence the rest of society. Without data, gender inequality risks being made invisible as a bad feeling.

Pär Segerdahl

Written by…

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

Solera, Cristina, Balzano, Angela, Turco, Federica, Pisacane, Lucio, & Fernow, Josepine. (2023). No data: No policies! The MINDtheGEPs approach to evidence-based policies for Gender Equality Plans. Zenodo. https://doi.org/10.5281/zenodo.7785413

This post in Swedish

We want solid foundations

« Older posts Newer posts »