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

Tag: research ethics (Page 1 of 7)

Research nurses on ethical challenges in recruiting participants for clinical research

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

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

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

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

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

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

Pär Segerdahl

Written by…

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

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

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Ethics needs empirical input

Medical ethics conference in Uppsala, 10–11 June 2024

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

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

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

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

Pär Segerdahl

Written by…

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

This post in Swedish

We recommend conferences

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

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

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

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

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

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

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

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

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

Pär Segerdahl

Written by…

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

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

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Thinking about authorship

The importance of ethical review in research with severely ill children

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

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

Misuse of co-authorship remains a problem despite educational measures

In science, correctly stated co-authorship is essential. Being transparent about who did what can be said to belong to the documentation of the research. Incorrectly stated co-authorship does not only give a distorted picture of the research, however. It also creates injustice between researchers and unfairly affects who gets employment or research grants. This also affects which research will be conducted and by whom.

There are internationally recommended rules for what counts as co-authorship, for example the Vancouver rules for medical publications. Despite the importance of correctly stated co-authorship, and despite international guidelines, several studies show that deviant practices are common. One way to deal with the problem is, of course, educational efforts. Doctoral students at medical faculties in Scandinavia increasingly receive instruction in publication ethics, and thus in these rules. Are the efforts effective?

Recently, results were published from an online survey aimed at people who have recently obtained a doctorate at medical faculties in Denmark, Norway and Sweden. The aim of the study was to explore experiences of and attitudes towards handling of authorship. Almost half of the respondents stated that the Vancouver rules were not fully respected in at least one of the studies included in the thesis. About a quarter of the respondents reported inappropriate handling of authorship order in at least one study. Nevertheless, the majority (96.7%) stated that it is important that the Vancouver rules are followed.

The study’s conclusion is that despite increased educational efforts in publication ethics at Scandinavian universities, the handling of co-authorship continues to be a problem in medical research. One can ask why the problem persists despite the efforts, and despite the positive attitude towards the authorship rules among the vast majority of respondents in the study.

In the discussion of the results, the authors suggest that it is probably not the doctoral students themselves who transgress the authorship rules, but supervisors and other more senior researchers, to whom the doctoral student is subordinate. The educational efforts thus miss a very relevant target group. The authors therefore mention a new trend at medical faculties in Sweden to introduce compulsory teaching in research ethics for supervisors of doctoral students. At the same time, they doubt the effectiveness of increased educational efforts alone, since authorship can be considered an academic currency. As long as authorship functions as a kind of career capital for researchers, deviant practices will remain common.

If you want to know more, read the study here: Misuse of co-authorship in Medical PhD Theses in Scandinavia: A Questionnaire Survey.

Then you can also read about another important result. A larger proportion of women responded that authorship order did not correctly reflect contribution in their thesis. A greater proportion of women also emphasized the importance of following the authorship rules. This may indicate that women are treated worse than men in matters of authorship and therefore place more importance on fair action, the authors suggest.

Pär Segerdahl

Written by…

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

Helgesson, G., Holm, S., Bredahl, L., Hofmann, B., Juth, N. Misuse of co-authorship in Medical PhD Theses in Scandinavia: A Questionnaire Survey. Journal of Academic Ethics (2022). https://doi.org/10.1007/s10805-022-09465-1

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We want to be just

Predatory conferences

If you are an academic, you have probably noticed that you are getting more and more unexpected invitations via e-mail to participate as a speaker in what are presented as scientific conferences. The invitations can be confusing, as they are often not even in your subject area. But sometimes they get it right and maybe even mention your latest publication, which is praised in general terms. What is happening?

Publication ethics is one of many research areas at CRB. In recent years, we have researched (and blogged about) so-called predatory journals, which can lure academics to publish their studies in them for a considerable fee, which will make the article openly available to readers. Open access is an important trend in science, but here it is exploited for profit without regard for academic values. Predatory journals are often generously multidisciplinary and the promised “effective” peer review is just as generous, in order to capture as many paying authors as possible.

The steady stream of conference invitations to academics reflects the same dubious type of activity, but here the profit comes from conference fees and sometimes also from arranging accommodation. Within publication ethics, one therefore also speaks of predatory conferences. What do we know about these conferences? Is there any research on the phenomenon?

The first systematic scoping review of scholarly peer-reviewed literature on predatory conferences was recently published in BMJ Open. The overview was made by four researchers, Tove Godskesen and Stefan Eriksson at CRB, together with Marilyn H Oermann and Sebastian Gabrielsson.

The review showed that the literature on predatory conferences is small but growing, 20 publications could be included. Almost all of the literature in the review described characteristics that may define predatory conferences. The most cited characteristic was the spam email invitations, with flattering language that could contain grammatical errors and be non-scientific. Another distinguishing feature described was that the organization hosting the conference was unknown and used copied pictures without permission. Finally, high fees, lack of peer review, and multidisciplinary scope were also mentioned.

Why do researchers sometimes attend predatory conferences? Possible reasons cited in the literature were the focus on quantity in academic research dissemination, falling victim to misleading information, or the attractive and exotic locations where these conferences are sometimes held. The easy submission and review process and the opportunity to participate as a chair or invited speaker were also mentioned as possible attractions. Personal characteristics such as inexperience, naivety, ignorance, vanity and indifference were also mentioned.

Consequences of attending predatory conferences were described in only one of the publications, an interview study with conference participants. Their stories were marked by disappointments of various kinds. Small overcrowded conference rooms, poorly organized conference facilities, deviations from the conference program that could be reduced by a whole day, reputable keynote speakers announced in the program were absent, and the organizers were hard to reach as if the whole event was remote controlled. Participants were sometimes forced to book their accommodation through the organizers at double cost, and they could also experience that the organizers stole their identities by using their pictures and personal information as if they were part of the conference team. Many participants were so disappointed that they left the conferences early, feeling like they never wanted to attend any conferences again.

The literature also suggested various countermeasures. Among other things, education for all researchers and mentoring of junior academics, published lists of predatory conferences and their organizers, accreditation systems for conferences, and checklists to help identifying predatory conferences. It was also stated that universities and research funders should review their ways of assessing the qualifications of researchers seeking employment, promotion or funding. Attending predatory conferences should not be an asset.

For more details and discussion, read the systematic review here: Predatory conferences: a systematic scoping review.

Another countermeasure mentioned in the literature was more research on predatory conferences. This is also a conclusion of the overview: both empirical and analytical research should be encouraged by funders, journals and research institutions.

Hopefully, these staged conference rooms will soon be empty.

Pär Segerdahl

Written by…

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

Godskesen T, Eriksson S, Oermann MH, et al. Predatory conferences: a systematic scoping review. BMJ Open 2022;12:e062425. doi: 10.1136/bmjopen-2022-062425

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We want solid foundations

Where to publish and where not to publish in bioethics – the 2022 list

We have seen “predatory” publishing take off in a big way and noticed how colleagues start to turn up in the pages of some of these journals. While many have assumed that this phenomenon mainly is a problem for low-status universities, there are strong indications that predatory publishing is a part of a major trend towards the industrialization of misconduct and that it affects many top-flight research institutions (see Priyanka Pulla: “In India, elite institutes in shady journals”, Science 354(6319): 1511-1512).

This trend, referred to by some as the dark side of publishing, needs to be reversed. Thus we published this blog post in 2016. This is our fifth annual update (the first version can be found here). At first, we relied heavily on the work of Jeffrey Beall, a librarian at the University of Colorado, who run blacklists of “potential, possible, or probable” predatory publishers and journals. His lists have since been removed but are kept by others and they can also be found archived.

The latest effort to create a thorough list of predatory outlets comes from Cabells, who distinguish around 70 different unacceptable violations and employs a whole team reviewing journals. These lists are not, however, the final say on the matter, as it is impossible for one person or a limited group to judge reliably actors in every academic discipline.

A response of gatekeeping needs to be anchored in each discipline and the scholars who make up that discipline. As a suitable response in bioethics, we have chosen to, first, collect a few authoritative lists of recommended bioethics journals that can be consulted by anyone in bioethics to find good journals to publish with.

For our first post, we recommended a list of journals ourselves, which brought on some well-deserved questions and criticism about criteria for inclusion. Unfortunately then, our list ultimately drew attention from other parts of the message that we were more concerned to get across. Besides, there are many other parties making such lists. We, therefore, have dropped this feature. Instead, we have enlarged the collection of good journal lists to the service of our readers. They are all of great use when further exploring the reputable journals available:

It is of prime importance to list the journals that are potentially or possibly predatory or of such a low quality that it might be dishonoring to engage with them. We have listed all 50 of them alphabetically (one new entry for 2022, one has ceased operation and been removed), and provided both the homepage URL and links to any professional discussion of these journals that we have found (which most often alerted us to their existence in the first place).

Each of these journals asks scholars for manuscripts from, or claims to publish papers in bioethics or related areas (such as practical philosophy). They have been reviewed by the authors of this blog post as well as by a group of reference scholars that we have asked for advice on the list. Those journals listed have unanimously been agreed are journals that – in light of the criticism put forth and the quality we see – we would not deem acceptable for us to publish in. Typical signs as to why a journal could fall in this category, such as extensive spamming, publishing in almost any subject, or fake data being included on the website etc., are listed here:

We have started to more systematically evaluate the journals against the 25 defining characteristics we outlined in the article linked to above (with the help of science and technology PhD students). The results will be added when they exist.

We would love to hear about your views on this blog post, and be especially grateful for pointers to journals engaging in sloppy or bad publishing practices. The list is not meant as a check-list but as a starting point for any bioethics scholar to ponder for him- or herself where to publish.

Also, anyone thinking that a journal in our list should be given due reconsideration might post their reasons for this as a comment to the blog post or send an email to us. Journals might start out with some sloppy practices but shape up over time and we will be happy to hear about it. You can make an appeal against the inclusion of a journal and we will deal with it promptly and publicly.

Please spread the content of this blog as much as you can and check back for updates (we will do a major update annually and continually add any further information found).

Note to readers: The list contained on Stop Predatory Journals referred to below has been down for while. From 2022 any reference to journals/publishers being included on SPJ refers to their previous inclusion. We will gradually check for inclusion in the most prominent list presently available, Cabells’ Predatory Reports, as a alternative.

WHERE NOT TO PUBLISH IN BIOETHICS – THE 2022 LIST

  • Advanced Humanities & Social Sciences (Consortium Publisher)
    Critical remark (2018): It has been claimed that behind this journal you find OMICS, the most-ever discussed publisher of this kind, see http://ottawacitizen.com/news/local-news/predatory-publisher-expanding-empire-in-canada. The only article published in 2016 is very badly edited, all the references are lost in the text and the paper would not pass an exam at our departments.  2017 volume is again only one article. The publisher is listed on SPJ.
    Critical remark (2022). After a complaint from the publisher, we have checked the latest volume. An article like this one shows no evident editorial work on the paper at all, so we still regard the journal to be a low quality outlet for research.
  • Advances In Medical Ethics  (Longdom Publishing)
    Critical remark (2019): When asked, one editor attest to the fact that his editorship was forged. Publisher was on Beall’s list and is now listed at Cabells with 5 violations. A thorough review December 2019 concludes that it exhibits at least 7 of the 25 criteria for “predatory” journals.
    Update: A more recent review (2022) concludes that it exhibits about 17 such criteria. How an e-mail exchange with this publisher can turn out is shown here.
    Update (2023): A thorough review in August concludes that it exhibits at least 10 of the 25 criteria for “predatory” journals
  • American Open Ethics Journal (Research and Knowledge Publication)
    Critical remark (2019): Listed on Cabells with 7 violations.
    Update: A thorough review February 2020 concludes that it exhibits at least 11 of the 25 criteria for “predatory” journals.
    Update: Another thorough review December 2023 concludes that it exhibits at least 11 of the 25 criteria for “predatory” journals.
  • Annals of Bioethics & Clinical Applications (Medwin Publishers)
    Criticism 1 
    Critical remark (2019): Publisher was on Beall’s list and is on many other lists of these journals. They say that they are “accepting all type of original works that is related to the disciplines of the journal” and indeed the flow chart of manuscript handling does not have a reject route. Indexed by alternative indexes.
    Critical remark (2020): Listed on Cabells with 5 violations. A thorough review October 2020 concludes that it exhibits at least 9 of the 25 criteria for “predatory” journals.
  • Austin Journal of Genetics and Genomic Research (Austin Publishing Group)
    Criticism 1 │Criticism 2 │Criticism 3
    Critical remark (2017): Spam e-mail about special issue on bioethics; Listed by SPJ; Romanian editorial member is said to be from a university in “Europe”; Another editorial board member is just called “Michael”; APG has been sued by International Association for Dental Research and The American Association of Neurological Surgeons for infringing on their IP rights. Student reviews concludes the journal is not suitable to publish in, one finding that the journal exhibits at least 16 of the 25 criteria for “predatory” journals.
    Critical remark (2019): Listed by Cabells with 10 violations.
    Critical remark (2021): A thorough review concludes that the journals exhibits at least 13 of the 25 criteria for “predatory” journals.
  • British Open Journal of Ethics (British Open Research Publications)
    Critical remark (2019): Listed by Cabells with 6 violations.
    Critical remark (2022): A thorough review concludes that the journal exhibit many criteria for “predatory” journals, for example that no editorial board exists and the journal is not indexed, and that it is strongly recommended to avoid “publishing” with this journal.
  • Creative Education (Scientific Research Publishing – SCIRP)
    Criticism 1 │ Criticism 2
    Critical remark (2017): Listed by SPJ; They claim misleadingly to be indexed by ISI but this relates to be among cited articles only – they are not indexed. A thorough review May 2017 concludes that it exhibits at least 5 of the 25 criteria for “predatory” journals.
    Update (2022): Listed on Cabells with 3 violations.
    Update (2023): A new review in 2023 concludes that it exhibits 11 of the 25 criteria for “predatory” journals.
  • Eastern European Scientific Journal (East European Research Alliance)
    Critical remark (2017): Listed by SPJ; Criticised by Beall for having a bogus editorial board; Claims to be indexed by ISI but that is not the well-known Institute for Scientific Information (now Thompson Reuters), but rather the so-called International Scientific Indexing.
    Update: Thorough reviews November 2018 and February 2019  conclude that it exhibits at least 13 or 14 of the 25 criteria for “predatory” journals.
    Update (2022): Listed on Cabells under its old name (“East”) with 11 violations.
  • Ethics Today Journal (Franklin Publishing)
    Critical remark (2019): Listed by Cabells with 9 violations.
    Update: “www.franklinpublishing.net expired on 06/21/2022 and is pending renewal or deletion”
  • European Academic Research (Kogaion Publishing Center, formerly Bridge Center)
    Critical remark (2017): Listed by SPJ; Uses impact factor from Universal Impact Factor (now defunct); A thorough review May 2017 concludes that it exhibits at least 15 of the 25 criteria for “predatory” journals.
    Update: A thorough review October 2022 concludes that it exhibits at least 14 of the 25 criteria for “predatory” journals.
  • European Scientific Journal (European Scientific Institute)
    Critical remark (2017): Listed by SPJ; Use of alternative indexes. A thorough review May 2017 concludes that it exhibits at least 9 of the 25 criteria for “predatory” journals.
    Update: A thorough review November 2022 concludes that it exhibits at least 6 of the 25 criteria for “predatory” journals. Another review in May 2023 concludes that it exhibits at least 6 of the 25 criteria.
  • International Journal of Advances in Social Science and Humanities
    Critical remark (2017): Listed by SPJ; Impact factor given by  Global Impact Factor. A thorough review March 2019 concludes that it exhibits at least 10 of the 25 criteria for “predatory” journals.
  • International Journal of Contemporary Research & Review
    Critical remark (2017): Listed by SPJ; Indexed by Index Copernicus; Despite claims they seem not to be indexed by either Chemical Abstracts or DOAJ. 
    A thorough review June 2017 concludes that it exhibits at least 9 of the 25 criteria for “predatory” journals.
  • International Journal of Current Research
    Critical remark (2017): Listed by SPJ; Uses IF from SJIF and Index Copernicus and more. It wrongly claims to be indexed by Thomson Reuters, ORCID and having a DOI among other things. A thorough review January 2018 concludes that it exhibits at least 12 of the 25 criteria for “predatory” journals.
    Update (2023): A thorough review October 2023 concludes that it exhibits at least 11 of the 25 criteria for “predatory” journals.
  • International Journal of Current Research and Academic Review (Excellent Publishers)
    Critical remark (June 2018): Listed by SPJ and Cabells because of misleading claims about credentials, metrics, and too quick review; alternative indexing; publishes in almost any field imaginable; the editor -in-chief is head of the “Excellent Education and Researh Institute” (sic) which does not seem to exist even when spelled right?
    Update: A thorough review in December 2019 concludes that it exhibits at least 12 of the 25 criteria for “predatory journals”.
    Update (2022): A thorough review in July concludes that it exhibits at least 13 of the 25 criteria for “predatory journals”.
  • International Journal of Ethics (Nova Science Publishers)
    Criticism 1
    Critical remark (2022): The article on Nova at Wikipedia notes that librarians have been critical of this publisher; A Ms. Alexandra Columbus is both the owner of, business manager and customer contact for Nova.
    Update (2023): A thorough review in May concludes that it exhibits at least 9 of the 25 criteria for “predatory journals”.
  • International Journal of Ethics & Moral Philosophy (Journal Network)
    Critical remark (2017): Listed by SPJ; Publisher was criticized by Beall when launching 350 journals at once; After several years not one associate editor has signed up and no article has been published; No editorial or contact details available. Thorough reviews in May 2019 and February 2020 conclude that it exhibits at least 10 to 12 of the 25 criteria for “predatory journals”.
    Update (2022): Does not seem to be online.
  • International Journal of Ethics in Engineering & Management Education
    Critical remark (2019): Papers from almost any field; Claims to have a 5.4 Impact factor (from IJEEE); Indexed by GJIF etc. A non-existent address in “Varginia”, US (sic!); Open access but asks for the copyright; Claims to be indexed in Scopus can’t be verified.
    Update (2020): Thorough reviews February 2018 and February 2020 conclude that it exhibits at least 16-17 of the 25 criteria for “predatory” journals. Listed by Cabells with 11 violations found.
  • International Journal of Humanities and Social Science (Centre for Promoting Ideas)
    Criticism 1Criticism 2Criticism 3 │ Criticism 4
    Critical remark (2019): The chief editor listed in April 2014  is a deceased person (2018). A thorough review in April 2019 concludes that it exhibits at least 9 of the 25 criteria for “predatory” journals.
  • International Journal of Humanities and Social Science Invention
    Criticism 1 
    Critical remark (2017): Listed by SPJ and is on many other lists of blacklisted journals; An IF of 4.5 given by African Quality Centre for Journals; Open access but asks for the copyright; Publishes any subject; Says that the journal is indexed in DOAJ which it does not seem to be. 
    Update: A thorough review February 2018 concludes that it exhibits at least 13 of the 25 criteria for “predatory” journals.
  • International Journal of Humanities and Social Science Research
    Critical remark (2017): Listed by SPJ and Cabells; Claims an IF of 5.22 (by “Research Journal Impact Factor“); Despite title from India; Alternative indexing; Thorough reviews in February 2018 and February 2020 conclude that it exhibits at least 10-13 of the 25 criteria for “predatory” journals.
  • International Journal of Humanities and Social Sciences
    Critical remark (2017): Listed by SPJ; Has an amazing fast-track review option for $100 that guarantees “the review, editorial decision, author notification and publication” to take place “within 2 weeks”. “Editors” claim that repeated requests to be removed from the list of editors result in nothing. Thorough reviews in  February and June 2018 conclude that it seems to exhibit at least 7 to 10 of the 25 criteria for “predatory” journals.
  • International Journal of Humanities & Social Studies
    Critical remark (2017): Listed by SPJ; IF from International Impact Factor Services; States that there “is no scope of correction after the paper publication”.
    Critical remark (2018): They write that the “review process will be completed expectedly within 3-4 days”.
    Critical remark (2020): A thorough review in October 2020 concludes that it seems to exhibit at least 7-8 of the 25 criteria for “predatory” journals.
    Update (2024): A thorough review concludes that it seems to exhibit at least 10 of the 25 criteria for “predatory” journals.
  • International Journal of Legal, Ethical and Regulatory Issues (Jacobs Publishers)
    Criticism 1
    Critical remark (2019): Spamming with invitation to publish. They are unsure of their own name; in the e-mail they call the journal “International Journal of Legal, Ethical and Regulatory Affairs“! Publisher listed on SPJ. Editor-in-chief and editorial board are missing. Claims that material is “written by leading scholars” which is obviously false.
    Update (2022): Publisher cannot be found any longer.
  • International Journal of Philosophy (SciencePG)
    Criticism 1 │ Criticism 2
    Critical remark (2017): Listed by SPJ; Alternative indexing and also IF from Universal Impact Factor (now defunct); Promises a two-week peer review.
    Update: Thorough reviews in April and November 2018 conclude that it seems to exhibit at least 10 or 8 of the 25 criteria for “predatory” journals and also find obvious examples of pseudo-science among the published articles.
    Update (2023): A thorough review in October concludes that it seems to exhibit at least 6 of the 25 criteria for “predatory” journals.
  • International Journal of Philosophy and Theology (American Research Institute for Policy Development) Criticism 1Criticism 2 │ Criticism 3
    Critical remark: A thorough review in June 2018 concludes that “there are grounds to believe that the American Research Institute never intended to create a serious scientific periodical and that, on the contrary, its publications are out-and-out predatory journals.”
    Update (2022): A thorough review in June concludes that it seems to exhibit at least 9 of the 25 criteria for “predatory” journals. However, the website could not be accessed on June 21.
  • International Journal of Public Health and Human Rights (Bioinfo Publications)
    Criticism 1
    Critical remark (2017): Listed on SPJ; On many other lists of predatory journals and have an IF from Index Copernicus.
    Update (2022): Not accessible in June.
  • International Journal of Research in Humanities and Social Studies (Sryahwa Publications)
    Critical remark (2018): Listed on SPJ; Open access but asks for the copyright. A thorough review in April 2018 concludes that it seems to exhibit at least 9 of the 25 criteria for “predatory” journals.
    Update (2022): A June review again confirmed that it seems to exhibit at least 9 of the 25 criteria for “predatory” journals.
  • International Journal of Social Science and Humanities Research (Research Publish Journals)
    Critical remark (2017): Listed on SPJ; On their homepage they state that in order to get a high IF their journals are “indexed in top class organisation around the world” although no major index is used.
    Update: A thorough review in 2020 concludes that it seems to exhibit at least 14 of the 25 criteria for “predatory” journals.
  • International Open Journal of Philosophy (Academic and Scientific Publishing)
    Critical remark (2017): Listed on SPJ and was heavily critized on Beall’s blog; The editorial board consists of one person from Iran; Although boosting 12 issues a year they have published only 1 article in the journal’s first four years.
    Update: A thorough review March 1 2017 concludes that it exhibits 17 of the 25 criteria for “predatory” journals and one in March 2019 that it exhibits at least 13 criteria.
  • International Researchers
    Critical remark (2017): Listed on SPJ; Indexed by e.g. Index Copernicus; Claims that it is “Monitor by Thomson Reuters” but is not part of the TR journal citation reports; Several pages are not working at time of review; A thorough review April 24 2017 concludes that it exhibits at least 6 of the 25 criteria for “predatory” journals.
  • Internet Journal of Law, Healthcare and Ethics (ISPUB)
    Criticism 1 │ Criticism 2
    Critical remark (2017): Formerly on Beall’s list.
  • Journal of Academic and Business Ethics (Academic and Business Research Institute)
    Critical remark (2017): Listed on SPJ as well as several other; Journal seems uncertain about it’s own name, the header curiously says “Journal of ethical and legal issues”.
    Update 2021: A thorough review May 2021 concludes that it exhibits at least 7 of the 25 criteria for “predatory” journals.
  • Journal of Bioethics and Applications (Sci Forschen)
    Critical remark (2018): Brand new journal with no articles yet. Publisher has been criticized for spamming , have a bad record at Scam Analyze, and is listed on SPJ.
    Critical remark (2022): A thorough review March 2022 concludes that it exhibits at least 7 of the 25 criteria for “predatory” journals.
  • Journal of Clinical Research & Bioethics (OMICS/Walsh MedicalMedia)
    Criticism 1Criticism 2 │ Criticism 3 │ Criticism 4 │ Criticism 5 │ Criticism 6
    Critical remark (2017): This publisher is listed on SPJ and was taken to court for possible fraud by the Federal Trade Commission in the US (and lost). They are listed by Cabells for 8 violations.
    Update (2022): They now have a new (?) publisher, but still the same Danish editor as before. A thorough review May 2022 concludes that it exhibits at least 7 of the 25 criteria for “predatory” journals.
  • Journal of Law and Ethics
    Critical remark (2017): Listed on SPJ; Claims to be on Ulrichs but is not; Claims to be in the Norwegian list and can actually be found there but under its former name (4 years earlier) and with 0 points.
    Update 2019: Seems to have moved to here. Security warnings and denied access makes it impossible to check whether it is the same journal or another one.
  • Journal of Philosophy and Ethics (Sryahwa Publications)
    Critical remark (2019): listed by Cabells for 7 violations.
    Critical remark 2020): A thorough review October 2020 concludes that it exhibits at least 11 of the 25 criteria for “predatory” journals.
  • Journal of Research in Philosophy and History (Scholink)
    Criticism 1 
    Critical remark (June 2018): Listed on several lists of predatory publishers. They only do “peer review” through their own editorial board, a flowchart states. They claim to check for plagiarism but the first 2018 article abstract run by us through a checker turned out to be self-plagiarized from a book and it looks to have been published many times over. Unfortunately, the next paper checked in the same issue was also published the previous year by another journal listed here…
    Critical remark (March 2021): A thorough review concludes that it exhibits at least 14 of the 25 criteria for “predatory” journals.
    Update 2023: A thorough review concludes that it exhibits at least 11 of the 25 criteria for “predatory” journals.
  • Journal of Social Sciences and Humanities (AASCIT)
    Criticism 1Criticism 2Criticism 3
    Critical remark (2019): From law to religion, this journal publishes it all. Though publisher claims to be “American”, it has only two editors, both from India. The list from Cabells includes 13 journals from this publisher. The AASCIT Code of Ethics apparently plagiarizes the INCOSE Code of Ethics.
  • Journal of Studies in Social Sciences and Humanities
    Critical remark (2017): Listed on SPJ; Alternative indexing; Uses several alternative IF providers. A thorough review October 2017 concludes that it exhibits at least 9 of the 25 criteria for “predatory” journals.
    Critical remark (2020): A thorough review October 2020 concludes that it exhibits at least 4 of the 25 criteria for “predatory” journals.
  • JSM Health Education and Primary Health Care
    Spamming with invitation to special issue on ‘Bioethics’. The publisher is listed on SPJ,  and criticized and exposed here. It is indexed by spoof indexer Directory of Research Journals Indexing among others (whose website is now gone, BTW).
    Update (2019): Access denied because of non-secure connection.
    Update (2022): Access now possible again.
  • Medical Ethics and Communication (Avid Science)
    Criticism 1
    Critical remarks (2017): Listed on SPJ; Spamming researchers with offer of eBook publication for $350.
    Update: In June 2022, the journal cannot be accessed online.
  • Nova Journal of Humanities and Social Sciences
    Criticism 1
    Critical remark (2018): This publisher was on Beall’s list; Uses alternative impact factors and indexing; Publishes in less than 30 days; Curiously, it says no fee is charged for publication.
    Update: In June 2022, the journal cannot be accessed online.
  • Open Journal of Philosophy (Scientific Research Publishing – SCIRP)
    Criticism 1 │ Criticism 2 │
    Critical remark (2021): A thorough review March 2021 concludes that it exhibits 6 of the 25 criteria for “predatory” journals.
  • Open Journal for Studies in Philosophy (Center for Open Access in Science)
    Critical remark (2020): Cabells found 8 violations.
    Update: Thorough reviews May-June 2022 concludes that it exhibits at least 8-9 of the 25 criteria for “predatory” journals.
  • Philosophical Papers and Review (Academic Journals)
    Critical remark (2017): Listed on SPJ and blacklisted by the Ministry of Higher Education of Malaysia.
    Update (2021): Latest article in press was accepted the same day it was sent in – and it happened back in 2018!
    Update: A thorough review April 2022 concludes that it exhibits at least 10 of the 25 criteria for “predatory” journals.
  • Philosophy Study  (David Publishing Company)
    Criticism 1Criticism 2
    Critical remark (2017): Listed on SPJ. A thorough review October 2019 concludes that it exhibits approx. 8 of the 25 criteria for “predatory” journals.
    Update: Another thorough review December 2023 concludes that it exhibits at least 9 of the 25 criteria for “predatory” journals.
  • The Recent Advances in Academic Science Journal (Swedish Scientific Publications)
    Critical remark (2018): Despite the publisher’s name it seems based in India. The only Swedish editor’s existence cannot be verified. Website quality is lacking. Listed on SPJ. A thorough review October 2017 concludes that it exhibits at least 15 of the 25 criteria for “predatory” journals.
    Update: Domain for sale in June 2022.
  • Universal Open Ethics Journal (Adyan Academic Press)
    Critical remark (2019): listed by Cabells for 7 violations.
    Update: Thorough reviews in May 2022 concludes that it exhibits 13 to 20 of the 25 criteria for “predatory” journals.
  • World Journal of Social Sciences and Humanities (Science and Education Publishing, SciEP)
    Criticism 1 │Criticism 2
    Critical remark (2017): Listed on SPJ as well as many other.
    Update: A thorough review in May 2019 concludes that it exhibits at least 7 of the 25 criteria for “predatory” journals.

End remark:

In light of legal action and threats against people trying to warn others about dubious publishers and journals – see here and here, for example – we want to stress that this blog post is about where we would like our articles to show up, it is about quality, and as such it is an expression of a professional judgement intended to help authors find good journals with which to publish.

Indirectly, this may also help readers to be more discerning about the articles they read. As such it is no different from other rankings that can be found for various products and services everywhere. Our list of where not to publish implies no accusation of deception or fraud but claims to identify journals that experienced bioethicists would usually not find to be of high quality. Those criticisms linked to might be more upfront or confrontational; us linking to them does not imply an endorsement of any objectionable statement made therein. We would also like to point out that individual papers published in these journals might of course nevertheless be perfectly acceptable contributions to the scholarly literature of bioethics.

Essential resources on so-called predatory publishing and open access:

Written by…

Stefan Eriksson, Associate Professor of Research Ethics at Uppsala University, read more about his work on publication, regulation and consent.

and…

Gert Helgesson, professor of Medical Ethics at Karolinska Institute.


We like ethics

Co-authorship when not everyone’s research is included in the paper

Questions about authorship are among the most sensitive professional issues for researchers. Apart from the fact that researchers live and make careers on their publications, it is important for scientific and research ethical reasons to know who is responsible for the content of the publications.

A feature of research that can create uncertainty about who should be counted as a co-author of a scientific publication is that such publications usually report research that has mainly already been carried out when the paper is being written. Many researchers may have contributed to the research work, but only a few of them may contribute to the writing of the paper. Should everyone still be counted as an author? Or just those who contribute to the writing of the paper?

The International Committee of Medical Journal Editors (ICMJE) has formulated a recommendation that creates greater clarity. Simplified, the recommendation is the following. Authorship can be given to researchers who clearly meet four criteria. You must: (1) have made substantial contributions to the research study (e.g., designing the study, or collecting, analysing and interpreting data); (2) have contributed to drafting the paper and revising its intellectual content; (3) have approved the final version of the article; (4) have agreed to be responsible for all aspects of the work by ensuring that issues of accuracy and integrity are investigated.

Furthermore, it is recommended that researchers who meet criterion (1) should be invited to participate in the writing process, so that they can also meet criteria (2)(4) and thus be counted as co-authors.

However, research does not always go according to plan. Sometimes the plans need to be adjusted during the research process. This may mean that one of the researchers has already made a significant research effort when the group decides not to include that research in the writing of the paper. How should co-authorship be handled in such a situation, when someone’s results fall out of the publication?

The issue is discussed by Gert Helgesson, Zubin Master and William Bülow in the journal Science and Engineering Ethics. Considering, among other things, how easily disagreement about authorship can disrupt the dynamics of a research group, it is important that there is an established order concerning authorship, which handles situations such as this.

The discussion in the article is based on an imaginary, concrete case: A research group includes three younger researchers, Ann, Bo and Choi. They have all been given individual responsibility for different parts of the planning and execution of the empirical work. They work many hours in the laboratory. When the research group sees the results, they agree on the content of the article to be written. It then turns out that Ann’s and Bo’s analyses are central to the idea in the article, while Choi’s analyses are not. Choi’s results are therefore not included in the article. Should Choi be included as a co-author?

We can easily imagine Choi contributing to the writing process, but what about criterion (1)? If Choi’s results are not described in the article, has she made a significant contribution to the published research study? Helgesson, Master and Bülow point out that the criterion is ambiguous. Of course, making a significant contribution to a research study can mean contributing to the results that are described in the article. But it can also mean contributing to the research process that leads up to the article. The former interpretation excludes Choi as co-author. The latter interpretation makes co-authorship possible for Choi.

The more inclusive interpretation is not unreasonable, as research is a partially uncertain exploratory process. But do any strong reasons support that interpretation? Yes, say Helgesson, Master and Bülow, who state two types of reasons. Firstly, it is about transparency and accountability: what happened and who was involved? Excluding Choi would be misleading. Secondly, it is a matter of proper recognition of merit and of fairness. Choi worked as hard in the laboratory as Ann and Bo and contributed as much to the research that led to the article. Of course, the purpose of the article changed during the process and Choi’s contribution became irrelevant to the content of the article. But her efforts were still relevant to the research process that led up to the article. She also did a good job as a researcher in the group: it seems unfair if her good work by chance should not be recognized in the same way as the other researchers’ work.

The proposal in the article is therefore that the first criterion for authorship should be interpreted as a significant contribution to the research process leading up to the article, and that this should be clarified in the recommendation.

The article also discusses possible counter-arguments to the more inclusive interpretation of the authorship recommendation. If you want to study the reasoning more closely and form your own opinion, read the article: How to Handle Co-authorship When Not Everyone’s Research Contributions Make It into the Paper.

Pär Segerdahl

Written by…

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

Helgesson, G., Master, Z. & Bülow, W. How to Handle Co-authorship When Not Everyone’s Research Contributions Make It into the Paper. Sci Eng Ethics 27, 27 (2021). https://doi.org/10.1007/s11948-021-00303-y

This post in Swedish

We recommend readings

When established treatments do not help

What should the healthcare team do when established treatments do not help the patient? Should one be allowed to test a so-called non-validated treatment on the patient, where efficacy and side effects have not yet been determined scientifically?

Gert Helgesson comments on this problem in Theoretical Medicine and Bioethics. His comment concerns suggestions from authors who in the same journal propose a specific restrictive policy. They argue that if you want to test a non-validated treatment, you should from the beginning plan this as a research project where the treatment is tested on several subjects. Only in this way do you get data that can form the basis for scientific conclusions about the treatment. Above all, the test will undergo ethical review, where the risks to the patient and the reasons for trying the treatment are carefully assessed.

Of course, it is important to be restrictive. At the same time, there are disadvantages with the specific proposal above. If the patient has a rare disease, for example, it can be difficult to gather enough patients to draw scientific conclusions from. Here it may be more reasonable to allow case reports and open storage of data, rather than requiring ethically approved clinical trials. Another problem is that clinical trials take place under conditions that differ from those of patient care. If the purpose is to treat an individual patient because established treatments do not work, then it becomes strange if the patient is included in a randomized study where the patient may end up in the control group which receives the standard treatment. A third problem is when the need for treatment is urgent and there is no time to approach an ethical review board and await their response. Moreover, is it reasonable that research ethical review boards make treatment decisions about individual patients?

Gert Helgesson is well aware of the complexity of the problem and the importance of being careful. Patients must not be used as if they were guinea pigs for clinicians who want to make quick, prestigious discoveries without undergoing proper research ethical review. At the same time, one can do a lot of good for patients by identifying new effective treatments when established treatments do not work. But who should make the decision to test a non-validated treatment if it is unreasonable to leave the decision to a research ethical board?

Gert Helgesson suggests that such decisions on non-validated treatments can reasonably be made by the head of the clinic, and that a procedure for such decisions at the clinic level should exist. For example, an advisory hospital board can be appointed, which supports discussions and decisions at the clinic level about new treatments. The fact that a treatment is non-validated does not mean that there are no empirical and theoretical reasons to believe that it might work. Making a careful assessment of these reasons is an important task in these discussions and decisions.

I hope I have done justice to Gert Helgesson’s balanced discussion of a complex question: What is a reasonable framework for new non-validated treatments? In some last-resort cases where the need for care is urgent, for example, or the disease is rare, decisions about non-validated treatments should be clinical rather than research ethical, concludes Gert Helgesson. The patient must, of course, consent and a careful assessment must be made of the available knowledge about the treatment.

Pär Segerdahl

Written by…

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

Helgesson, G. What is a reasonable framework for new non-validated treatments?. Theor Med Bioeth 41, 239–245 (2020). https://doi.org/10.1007/s11017-020-09537-6

This post in Swedish

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