The Ethics Blog

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

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How is ethical review perceived by researchers in the social sciences and humanities?

3 March, 2026 / / 0 Comments

Research involving humans requires ethical review. Ethical review is important to protect the rights and interests of research participants, and to maintain public trust in research. Ethical review was originally developed for biomedical research where it is common to recruit patients as test subjects, for example in clinical drug trials. In Sweden, a central authority is responsible for ethical review, the Ethical Review Authority. In order to conduct research involving humans and sensitive personal data, researchers must first apply for permission from the authority. Researchers who violate the Act on Ethical Review of Research involving Humans can be prosecuted and sentenced to a fine or imprisonment.

Social sciences and humanities are also covered by the Act on Ethical Review. However, it has been questioned whether the requirement for ethical review is relevant for these academic disciplines where humans are not normally recruited as test subjects. However, even here, empirical research involving humans occurs, and the methods used can affect and harm the people in the studies. Furthermore, sensitive personal data is often used in the research. If such aspects justify ethical review of biomedical research, they should also justify ethical review of research in the social sciences and humanities.

At the same time, it should be remembered that research is conducted differently in different scientific fields. For example, research in the social sciences and humanities is usually conducted in a more exploratory and inductive manner than in biomedicine. Aims, questions and methods can be modified during the course of the research work, as data is collected and analyzed. It can therefore be difficult for researchers in these disciplines to provide sufficiently specific information about aims, questions and methods in their ethics review applications. Furthermore, in the social sciences and humanities, researchers often work with publicly available personal data: they may have appeared in newspapers. Do researchers have to apply for ethical permission to conduct research on sensitive personal data that anyone can access, such as opinions expressed in debates in the media?

The requirement for ethical review in the social sciences and humanities has been debated and questioned by representatives of these disciplines. It is therefore valuable to empirically examine researchers’ perceptions of ethical review. Do the critical opinions in the debate have broader support among researchers? Together with three co-authors, William Bülow reports on an interview study with 18 Swedish researchers in business, language, history, political science, sociology, gender studies, religious studies and other disciplines within the academic domain. The article is published in the Journal of Academic Ethics. Questions that were sought to be answered were how researchers believe the ethical review system works within their academic disciplines, what advantages and disadvantages researchers experience with the system, and how they believe it can be adapted for research in the social sciences and humanities.

The interviews revealed a broad spectrum of experiences and perceptions. Some considered it an advantage that research projects are ethically reviewed by an external authority that has the necessary expertise, infrastructure and independence. Others saw it as a disadvantage that researchers, faculties and universities were deprived of their personal and collegial ethical responsibility. Does one not take deeper ethical responsibility by continuously discussing one’s research with colleagues, for example at the research seminar? Many of those interviewed described the difficulties that researchers in the social sciences and humanities may experience when they have to specify the research in advance in the application form, since aims, questions and methods can be modified during the work. Some described how they had to find a balance between providing the specific information required in an ethics review application and leaving room for the changes in the design that the research itself may require.

A recurring theme in the interviews was that the application form was too focused on biomedical research with human test subjects. Many of the questions in the form were perceived as irrelevant and almost unanswerable. For example, forms were requested that were better adapted for document studies. Many also experienced a lack of guidance and support from the Ethical Review Authority when filling in the form. Others, however, considered that such criticism of the form and the support from the authority was exaggerated.

The system of ethical review also gave rise to emotions. For example, fear of making mistakes in the ethics application that lead to losing important research time, or concerns about whether researchers are allowed to use publicly available personal data without applying for ethical permission. Some stated that colleagues could opt out of empirical research to avoid these uncertainties that the system could create. Some considered it unreasonable that they, as researchers, could be sentenced to fines or imprisonment for not following the Act on Ethical Review. An important theme in the interviews was that the system of ethical review can influence researchers’ choice of questions, materials and methods in order to avoid perceived uncertainties about ethical review.

In their discussion, the authors argue that the interview results speak against some of the objections that representatives of the social sciences and humanities have directed at the Swedish system of ethical review. For example, it has been argued that regulation can lead to de-professionalization, where researchers no longer take ongoing responsibility for ethical problems that arise in their research work. Although such concerns were expressed in the interviews, others emphasized that, on the contrary, there were very lively discussions about research ethics at their institutions and that the legal requirement for ethical review has increased awareness of research-ethical issues.

A particularly problematic interview result, according to the authors, is that fear and uncertainty about the requirement for ethical review, reinforced by the risk of legal action such as fines and imprisonment, can influence researchers’ choice of questions and methods. There is a risk that questions that one is genuinely curious about are investigated to a lesser extent, or with less empirical depth, in order to avoid the requirement for ethical review. In short, important research risks not being carried out if researchers choose more theoretical approaches or limit their material and questions to avoid perceived uncertainties about ethical review.

Overall, the interview results do not speak against the Swedish ethical review system, according to the authors. However, the results indicate that certain aspects of the system may need to be improved and adapted to the social sciences and humanities. The Ethical Review Authority probably needs to make the application process and form more flexible to suit different scientific fields. The authority probably also needs to consider better support for researchers who are unsure about the application process or the ethical requirements that apply to research in the social sciences and humanities.

For more results and the authors’ discussion, read the article here: Experiences of Ethical Review: Perspectives of Swedish Researchers in Social Science and Humanities.

Pär Segerdahl

Written by…

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

Bülow, W., Johansson, M., Persson, V. et al. Experiences of Ethical Review: Perspectives of Swedish Researchers in Social Science and Humanities. Journal of Academic Ethics 24, 35 (2026). https://doi.org/10.1007/s10805-025-09702-3

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Were many clinical trials during the COVID-19 pandemic unethical?

Two caregivers and a digital tablet. Photo: Nappy, from Unsplash.
10 December, 2024 / / 1 Comment

It is understandable if the COVID-19 pandemic spurred many researchers to conduct their own studies on patients with the disease. They wanted to help in a difficult situation by doing what they were competent to do, namely research. The question is whether the good will sometimes had problematic consequences in terms of research ethics.

For a clinical trial to have scientific and social value, a large number of participants is required. This is in order to be able to compare groups that are treated differently and with a sufficiently high probability demonstrate real connections between treatment and outcome. 20 years ago, small so-called underpowered trials were common, but the pandemic made them flourish again. Some COVID-19 studies had fewer than 50 participants.

Is it then not good that researchers do what they can in a difficult situation, even if it means that they do research on the smaller patient groups that they manage to recruit? The problem is that underpowered clinical trials do not provide valid scientific knowledge. Thus, they have hardly any value for society and it becomes doubtful whether the researchers are really doing what they feel they are doing, namely helping in a difficult situation.

You can read about this in a commentary in the Journal of the Royal Society of Medicine, written by Rafael Dal-Ré, Stefan Eriksson and Stephen Latham. They point out that researchers sometimes defend underpowered clinical trials with the argument that smaller studies are easier to complete and that data from small trials around the world can be pooled to achieve the required statistical power. This is correct if the studies used sufficiently similar research methods to make the data comparable, the authors comment. This is often not the case, but requires that researchers plan from the outset to pool data from their respective studies. Another problem is that underpowered clinical trials more often have negative results and that such studies are less often published. Pooled data from underpowered studies published in journals are therefore not representative. Data from such studies would therefore need to be posted on freely accessible platforms, the authors argue.

Exposing patients to the risks and inconveniences involved in participating in a clinical trial is unethical if the study cannot be judged to provide scientifically valid knowledge with social value. The authors’ conclusion is therefore that research ethics committees that review planned research must very carefully assess that the studies have a sufficiently large number of participants to achieve valid and useful knowledge. If underpowered studies are nevertheless planned, participants must be informed that the results may not be scientifically valid in themselves, but that they will be pooled with results from similar studies in order to achieve statistical power. If there is no agreement with other researchers to pool results, underpowered studies should not be approved by research ethics committees, the three authors conclude. Not even during a pandemic.

Read the commentary here: Underpowered trials at trial start and informed consent: action is needed beyond the COVID-19 pandemic.

Pär Segerdahl

Written by…

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

Dal-Ré R, Eriksson S, Latham SR. Underpowered trials at trial start and informed consent: action is needed beyond the COVID-19 pandemic. Journal of the Royal Society of Medicine. 2024;0(0). doi:10.1177/01410768241290075

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We want solid foundations

Citizen scientists as co-authors

Woman looking into a pair of binoculars in the woods. Photo: Kayla Farmer, Unsplash.
19 November, 2024 / / 1 Comment

A recurring theme on this blog is the question of who can be counted as an author of a research article. You might be thinking: how difficult can it be to determine if someone is the author of an article? But the criteria for academic authorship are challenged on several fronts and therefore need to be discussed. I recently blogged about a debate about two of these challenges: huge research projects where a large number of researchers and experts in different fields contribute to the studies, and the use of AI in research and academic writing (for example ChatGPT).

Today I want to recommend an article on publication ethics that discusses a third challenge to the authorship criteria. The challenge is called citizen science. Similar to the big research collaborations I mentioned above, a very large number of individuals often contribute to citizen science. The difference is that the professional researchers here collaborate with voluntary participants from the general public and not just with other researchers or experts. It may involve ordinary citizens reporting their observations of plant and animal life, helping astronomers categorize large amounts of photographed astronomical objects, contributing to solutions to mathematical problems or perhaps even discussing the design of research projects. Citizen science is important, for example, when data collection requires the efforts of so many observers in so many places, that the observations would otherwise be too expensive or time-consuming. Citizen science is also important because it gives citizens insight into research, increases trust in science and creates contacts between research and society.

The so-called Vancouver rules for authorship have been criticized for allegedly excluding citizen scientists from authorship, even though the voluntary contributions are sometimes so significant that they could merit such recognition. The rules state (slightly simplified) that to count as an author you must have made significant contributions to the research study (e.g., design, data collection, analysis, interpretation). But you must also have participated in the writing process, approved the final version of the article, and accepted responsibility for the research being carried out correctly.

An important point in the article that I recommend is that it is not necessarily the Vancouver rules that exclude citizen scientists from authorship. On the contrary, it may be that the researchers leading the projects do not follow the rules. In addition to the four criteria above, the Vancouver rules say that individuals who meet the first criterion should be given the opportunity to meet the other three as well. Citizen scientists who have made significant contributions to the study should therefore be given the opportunity to write or revise relevant sections of the text, approve the final version and accept responsibility for the accuracy of at least their own contribution to the study. In citizen science, it is also often the case that a small number of “superusers” account for the bulk of the work effort. It should be possible to treat these individuals in the same way as one treats professional researchers who have made significant contributions, that is, give them the opportunity to qualify for authorship.

A more difficult issue discussed in the article is group authorship. In citizen science, the collective contribution of the whole group is often significant, while the individual contributions are not. Would it be possible to give the group collective credit in the form of group authorship? Not doing so could give a false impression that the professional researchers made a greater effort in the study than they actually did, the four publication ethicists argue in the article. It can also be unfair. If individual researchers who fulfill the first criterion should be given the opportunity to fulfill all criteria, then groups should also be given this opportunity. In such cases, the group should (in some way) be given the opportunity to participate in the critical revision of the article and to approve the final version. But can a group of 2,000 volunteer bird watchers take responsibility for a research study being carried out properly? Perhaps the group can at least answer for the accuracy of its own observation efforts. Being credited for one’s contribution to a study through authorship and taking responsibility for the contribution are two sides of the same coin, according to the publication ethicists. That citizen scientists must accept responsibility in order to be counted as co-authors is perhaps also an opportunity to convey something about the nature of science, one could add.

The article concludes by proposing seven heuristic rules regarding who can be included as an author. For example, one should, as far as possible, respect existing guidelines (such as the Vancouver rules), apply a wide conception of contributions, and be open to new forms of authorship. Perhaps a group can sometimes be credited through authorship? The seventh and final heuristic rule is to be generous to citizen scientists in unclear cases by including rather than excluding.

Read the article on citizen scientists as authors here: Authorship and Citizen Science: Seven Heuristic Rules.

Pär Segerdahl

Written by…

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

Sandin, P., Baard, P., Bülow, W., Helgesson, G. Authorship and Citizen Science: Seven Heuristic Rules. Science and Engineering Ethics 30, 53 (2024). https://doi.org/10.1007/s11948-024-00516-x

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Debate on responsibility and academic authorship

Dictionary "Collaborate", Image by Dianne Hope from Pixabay
8 October, 2024 / / 2 Comments

Who can be listed as an author of a research paper? There seems to be some confusion about the so-called Vancouver rules for academic authorship, which serve as publication ethical guidelines in primarily medicine and the natural sciences (but sometimes also in the humanities and social sciences). According to these rules, an academic author must have contributed intellectually to the study, participated in the writing process, and approved the final version of the paper. However, the deepest confusion seems to concern the fourth rule, which requires that an academic author must take responsibility for the accuracy and integrity of the published research. The confusion is not lessened by the fact that artificial intelligences such as ChatGPT have started to be used in the research and writing process. Researchers sometimes ask the AI ​​to generate objections to the researchers’ reasoning, which of course can make a significant contribution to the research process. The AI ​​can also generate text that contributes to the process of writing the article. Should such an AI count as a co-author?

No, says the Committee on Publication Ethics (COPE) with reference to the last requirement of the Vancouver rules: an AI cannot be an author of an academic publication, because it cannot take responsibility for the published research. The committee’s dismissal of AI authorship has sparked a small but instructive debate in the Journal of Medical Ethics. The first to write was Neil Levy who argued that responsibility (for entire studies) is not a reasonable requirement for academic authorship, and that an AI could already count as an author (if the requirement is dropped). This prompted a response from Gert Helgesson and William Bülow, who argued that responsibility (realistically interpreted) is a reasonable requirement, and that an AI cannot be counted as an author, as it cannot take responsibility.

What is this debate about? What does the rule that gave rise to it say? It states that, to be considered an author of a scientific article, you must agree to be accountable for all aspects of the work. You must ensure that questions about the accuracy and integrity of the published research are satisfactorily investigated and resolved. In short, an academic writer must be able to answer for the work. According to Neil Levy, this requirement is too strong. In medicine and the natural sciences, it is often the case that almost none of the researchers listed as co-authors can answer for the entire published study. The collaborations can be huge and the researchers are specialists in their own narrow fields. They lack the overview and competence to assess and answer for the study in its entirety. In many cases, not even the first author can do this, says Neil Levy. If we do not want to make it almost impossible to be listed as an author in many scientific disciplines, responsibility must be abolished as a requirement for authorship, he argues. Then we have to accept that AI can already today be counted as co-author of many scientific studies, if the AI made a significant intellectual contribution to the research.

However, Neil Levy opens up for a third possibility. The responsibility criterion could be reinterpreted so that it can be fulfilled by the researchers who today are usually listed as authors. What is the alternative interpretation? A researcher who has made a significant intellectual contribution to a research article must, in order to be listed as an author, accept responsibility for their “local” contribution to the study, not for the study as a whole. An AI cannot, according to this interpretation, count as an academic author, because it cannot answer or be held responsible even for its “local” contribution to the study.

According to Gert Helgesson and William Bülow, this third possibility is the obviously correct interpretation of the fourth Vancouver rule. The reasonable interpretation, they argue, is that anyone listed as an author of an academic publication has a responsibility to facilitate an investigation, if irregularities or mistakes can be suspected in the study. Not only after the study is published, but throughout the research process. However, no one can be held responsible for an entire study, sometimes not even the first author. You can only be held responsible for your own contribution, for the part of the study that you have insight into and competence to judge. However, if you suspect irregularities in other parts of the study, then as an academic author you still have a responsibility to call attention to this, and to act so that the suspicions are investigated if they cannot be immediately dismissed.

The confusion about the fourth criterion of academic authorship is natural, it is actually not that easy to understand, and should therefore be specified. The debate in the Journal of Medical Ethics provides an instructive picture of how differently the criterion can be interpreted, and it can thus motivate proposals on how the criterion should be specified. You can read Neil Levy’s article here: Responsibility is not required for authorship. The response from Gert Helgesson and William Bülow can be found here: Responsibility is an adequate requirement for authorship: a reply to Levy.

Personally, I want to ask whether an AI, which cannot take responsibility for research work, can be said to make significant intellectual contributions to scientific studies. In academia, we are expected to be open to criticism from others and not least from ourselves. We are expected to be able to critically assess our ideas, theories, and methods: judge whether objections are valid and then defend ourselves or change our minds. This is an important part of the doctoral education and the research seminar. We cannot therefore be said to contribute intellectually to research, I suppose, if we do not have the ability to self-critically assess the accuracy of our contributions. ChatGPT can therefore hardly be said to make significant intellectual contributions to research, I am inclined to say. Not even when it generates self-critical or self-defending text on the basis of statistical calculations in huge language databases. It is the researchers who judge whether generated text inspires good reasons to either change their mind or defend themselves. If so, it would be a misunderstanding to acknowledge the contribution of a ChatGPT in a research paper, as is usually done with research colleagues who contributed intellectually to the study without meeting the other requirements for academic authorship. Rather, the authors of the study should indicate how the ChatGPT was used as a tool in the study, similar to how they describe the use of other tools and methods. How should this be done? In the debate, it is argued that this also needs to be specified.

Pär Segerdahl

Written by…

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

Levy N. Responsibility is not required for authorship. Journal of Medical Ethics. Published Online First: 15 May 2024. doi: 10.1136/jme-2024-109912

Helgesson G, Bülow W. Responsibility is an adequate requirement for authorship: a reply to Levy. Journal of Medical Ethics. Published Online First: 04 July 2024. doi: 10.1136/jme-2024-110245

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What is hidden behind the concept of research integrity?

14 May, 2024 / / 1 Comment

In order to counteract scientific misconduct and harmful research, one often talks about protecting and supporting research integrity. The term seems to cover three different aspects of research, although the differences may not always be fully in mind. The term can refer to the character traits of individual researchers, for example, that the researcher values truth and precision and has good intentions. But the term can also refer to the research process, for example, that the method, data and results are correctly chosen, well executed and faithfully reproduced in scientific publications. Third, the term can refer to research-related institutions and systems, such as universities, ethical review, legislation and scientific journals. In the latter case, it is usually emphasized that research integrity presupposes institutional conditions beyond the moral character of individual researchers.

Does such a varied concept have to be problematic? Of course not, but possibly the concept of research integrity is less suitable, argue Gert Helgesson and William Bülow in an article that you can read here: Research Integrity and Hidden Value Conflicts.

In the article, they first discuss some ambiguities in the three uses of the concept of research integrity. Which personal traits are desirable in researchers and which values should they endorse? Does the integrity of the research process cover all ethically relevant aspects of research, including the application process, for example? Are research-related institutions actors with research integrity, or are they rather means that support research integrity?

Mentioning these ambiguities is not, as I understand it, intended as a decisive objection. Nor do the authors think that it is generally a shortcoming if concepts have a wide and varied use. But the concept of research integrity risks hiding value conflicts through its varying use, they argue. Suppose someone claims that, in order to protect and support research integrity, we should criminalize serious forms of scientific misconduct. This is perhaps true if by research integrity we refer to aspects of the research process, for example, that results are accurate and reliable. But the stricter regulation of research that this entails risks reducing the responsibility of individual researchers, which can undermine research integrity in the first sense. How should we compare the value of research integrity in the different senses? What does it mean to “increase research integrity”?

The concept of research integrity is not useless, the authors point out. But if we want to make value conflicts visible, if we want to clarify what we mean by research integrity and which forms of integrity are most important, as well as clear up the ambiguities mentioned above, then we will examine issues that are appropriately described as issues of research ethics.

If I understand the authors correctly, they mean that ethical questions about research should be characterized as research ethics. It is unfortunate that “research integrity” has come to function as an alternative designation for ethical questions about research. Everything becomes clearer if any questions about “research integrity,” if we want to use the concept, fall under research ethics.

Pär Segerdahl

Written by…

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

Helgesson, G., Bülow, W. Research Integrity and Hidden Value Conflicts. Journal of Academic Ethics 21, 113–123 (2023). https://doi.org/10.1007/s10805-021-09442-0

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Research nurses on ethical challenges in recruiting participants for clinical research

Nurse talking to patient, Photo by RDNE Stock project on pexels
16 January, 2024 / / 1 Comment

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

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

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

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

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

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

Pär Segerdahl

Written by…

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

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

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Ethics needs empirical input

Medical ethics conference in Uppsala, 10–11 June 2024

19 December, 2023 / / 1 Comment

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

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

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

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

Pär Segerdahl

Written by…

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

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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

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

Written by…

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

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

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Ethics needs empirical input

Using artificial intelligence with academic integrity

Phone with ChatGPT open
6 June, 2023 / / 1 Comment

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

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

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

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

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

Pär Segerdahl

Written by…

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

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

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We care about education

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