The Ethics Blog

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

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

Antimicrobial resistance: bringing the AMR community together

Tuberculosis-Photo-by-CDC-Pixabay
5 December, 2023 / / 3 Comments

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

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

Breastfeeding mother and baby, photo by Monica Turlui
28 November, 2023 / / 1 Comment

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

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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

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How should coercive care be regulated within somatic healthcare?

21 November, 2023 / / 1 Comment

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

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Thinking about law

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Neuroethics: don’t let the name fool you

Brain growing out of a tree, illustration by Gugacurado on Pixabay
14 November, 2023 / / 1 Comment

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

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Empirical ethics nuances ethical issues

crowd
17 October, 2023 / / 1 Comment

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

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Ethics needs empirical input

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

Looking through a looking glass
3 October, 2023 / / 1 Comment

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

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Thinking about authorship

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Data for gender equality in European research organizations

Woman scientist
26 September, 2023 / / 1 Comment

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

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We want solid foundations

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Participation in biomedical research with dynamic consent

19 September, 2023 / / 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.

Roberta Biasiotto

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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

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Precision medicine algorithms and personal encounters

12 September, 2023 / / 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.

Pär Segerdahl

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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

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The importance of ethical review in research with severely ill children

5 September, 2023 / / 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. 

Kajsa Norberg Wieslander

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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

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