Tag: research ethics (Page 4 of 8)

Pragmatic trials without informed consent?

8 April, 2019 / Pär Segerdahl / 0 Comments

Randomized controlled trials (RCTs) are considered to be the gold standard for determining a causal effect of medical interventions. To achieve this aim, possible confounding factors must be avoided. This implies excluding many patients from participating in the trial, for example, patients with concomitant conditions. A negative consequence of these exclusions, however, is limited generalizability. Studying the artificially uniform participant group, you will be able to determine a causal effect, but you will know much less about real-life treatment outcomes in the population where the intervention actually will be used.

Further artificiality is created by the written informed consent procedure, which excludes even further patients from participating in the trial. Moreover, because they know they participate in a clinical trial, participants may change their behavior.

All this points to the importance of so-called pragmatic randomized controlled trials. In such trials, the effectiveness of two approved and routinely prescribed medicines are compared in normal clinical practice. This avoids most of the artificiality of RCTs and significantly improves generalizability and practical clinical relevance. Randomization is still required for scientific purposes, however, and written informed consent is an ethical obligation.

The demand for written informed consent is an obstacle to pragmatic trials. By creating, once again, artificial selection of patients, results continue to be less generalizable, which detracts from the whole point of conducting pragmatic trials. In a recent paper in the BMJ, twelve authors, among them, Stefan Eriksson at CRB, therefore argue that “EU clinical trial regulations should be revised to allow the waiver or modification of informed consent in low risk pragmatic trials.”

Some would consider this suggestion to be controversial. We need to keep in mind, however, the extremely low risks of studies that compare standardly prescribed medicines in normal clinical practice. We need to balance that low risk against the enormous social value of generalizable findings in evidence-based medicine.

Pär Segerdahl

Dal-Ré, R. et al. Low risk pragmatic trials do not always require participants’ informed consent. BMJ 2019;364:l1092

Patients find misleading information on the internet

30 October, 2018 / Pär Segerdahl / 0 Comments

In phase 1 clinical studies of substances that might possibly be used to treat cancer in the future, cancer patients are recruited as research participants. These patients almost always have advanced cancer that no longer responds to the standard treatment.

That research participation would affect the cancer is unlikely. The purpose of a phase 1 study is to determine safe dosage range and to investigate side effects and other safety issues. This will then enable proceeding to investigating the effectiveness of the substance on specific forms of cancer, but with other research participants.

Given that patients often seek online information on clinical trials, Tove Godskesen, Josepine Fernow and Stefan Eriksson wanted to investigate the quality of the information that currently is available on the internet about phase 1 clinical cancer trials in Sweden, Denmark and Norway.

The results they report in the European Journal of Cancer Care are quite alarming. The most serious problem, as I understand it, is that the information conceals risks of serious side effects, and in various ways suggests possible positive treatment outcomes. This lack of accurate language is serious. We are dealing with severely ill patients who easily entertain unrealistic hopes for new treatment options.

To give a picture of the problem, I would like to give a few examples of typical phrases that Godskesen, Fernow and Eriksson found in the information on the internet, as well as their suggestions for more adequate wordings. Noticing the contrast between the linguistic usages is instructive.

One problem is that the information speaks of treatment, even though it is about research participation. Instead of writing “If you are interested in the treatment,” you could write “If you want to participate in the research.” Rather than writing “Patients will be treated with X,” you could write “Participants will be given X.”

The substance being tested is sometimes described as a medicine or therapy. Instead, you can write “You will get a substance called X.”

Another problem is that research participation is described as an advantage and opportunity for the cancer patient. Instead of writing “An advantage of study participation is that…,” one could write “The study might lead to better cancer treatments for future patients.” Rather than writing “This treatment could be an opportunity for you,” which is extremely misleading in phase 1 clinical cancer trials, one could more accurately say, “You can participate in this study.”

The authors also tested the readability of the texts they found on the internet. The Danish website skaccd.org had the best readability scores, followed by the Norwegian site helsenorge.no. The Swedish website cancercenter.se got the worst readability scores. The information was very brief and deemed to require a PhD to be understandable.

It is, of course, intelligible that it is hard to speak intelligibly about such difficult things as cancer trials. Not only do the patients recruited as study participants hope for effective treatment. The whole point of the research is effective cancer treatment. This is the ultimate perspective of the research; the horizon towards which the gaze is turned.

The fact, however, is that this horizon is far removed, far away in the future, and is about other cancer patients than those who participate in phase 1 trials. Therefore, it is important not to let this perspective characterize information to patients in whom hope would be unrealistic.

Do not talk about treatments and opportunities. Just say “You can participate in this study.”

Pär Segerdahl

Godskesen, TE, Fernow J, Eriksson S. Quality of online information about phase I clinical cancer trials in Sweden, Denmark and Norway. Eur J Cancer Care. 2018;e12937. https://doi.org/10.1111/ecc.12937

This post in Swedish

Genetic risk: Should researchers let people know?

24 September, 2018 / Anna Holm Bodin / 0 Comments

Should researchers inform research participants if they happen to discover individual genetic risks of disease? Yes, many would say, if the information is helpful to the participants. However, the value of complex genetic risk information for individuals is uncertain. Jennifer Viberg Johansson suggests that this uncertainty needs to be acknowledged by both geneticists and ethicists.

One reason people want to participate in large genetic studies is the comprehensive health checks researchers often offer to collect data. In the future, people could also be offered information about genetic risks. According to Jennifer Viberg Johansson, there are some factors researchers should consider before offering these kinds of results.

Providing genetic risk information may not be as helpful to individuals as one may think. Knowing your genetic make-up is not the same as knowing your own probability for disease. In addition, the genetic risk information from research is not based on symptoms or personal concerns, as it would be in the healthcare system. It is thus less “personalised” and not connected to any symptoms.

Genetic risk information is complex and can be difficult to understand. To the research participants interviewed by Jennifer Viberg Johansson, risk information is something that offers them an explanation of who they are, where they are from, and where they may be heading. To them, learning about their genetic risk is an opportunity to plan their lives and take precautions to prevent disease.

Whether research participants want genetic risk information or not is more complex. Research participants themselves may change their answer depending on the way the question is asked. Risk research shows that we interpret probabilities differently, depending on the outcome and consequences. Jennifer Viberg Johansson’s work points in the same direction: probability is not an essential component of people’s decision-making when there are ways to prevent disease.

People have difficulties making sense of genetic risk when it is presented in the traditional numeric sense. It is hard to interpret what it means to have a 10 per cent or 50 per cent risk of disease. Instead, we interpret genetic risk as a binary concept: you either have risk, or you don’t. Based on her results, Jennifer Viberg Johansson suggests we keep this in mind for genetic counselling. We need to tailor counselling to people’s often binary perceptions of risk.

Communicating risk is difficult, and requires genetic counsellors to understand how different people understand the same figures in different ways.

Jennifer Viberg Johansson defended her dissertation September 21, 2018.

Anna Holm

Viberg Johansson J., (2018), INDIVIDUAL GENETIC RESEARCH RESULTS – Uncertainties, Conceptions, and Preferences, Uppsala: Acta Universitatis Upsaliensis

This post in Swedish

What does the order of authors mean?

19 September, 2018 / Pär Segerdahl / 1 Comment

How should we interpret the sequence of author names in academic publications? Does it inform us about how much each author contributed to the publication?

After reading an article on the topic by Gert Helgesson and Stefan Eriksson, I realize that authorship order is a very disorderly matter. The first and last positions are often counted as the most important. But not always. To my surprise, not even a first position necessarily signifies first authorship. Sometimes, the asterisk after the author whose contact details are given is interpreted as a sign of first authorship. Sometimes the asterisk means that this author is subordinate and handles all practicalities associated with the publication.

Sometimes the second position is of particular importance. Sometimes not. Sometimes the next to last position has a particular interpretation. Sometimes another. Helgesson and Eriksson talk about group traditions and describe conventions in different scientific fields. Are there really no guidelines to follow? No, actually not. Author guidelines at most recommend authors to agree well in advance on the order of authors. However, since the guidelines do not specify what the order signifies, the meaning of the agreed upon authorship order is unclear!

Considering how meritorious authorship is in academic competition for positions and grants, this lack of order is surprising. Is the question too sensitive? Will an overly clear order lead to time-consuming quarrels between authors about who should stand first, last, second place, second to last, with asterisk, without asterisk, and so forth?

Helgesson and Eriksson discuss different proposals for clarifying authorship order. One proposal they encountered is that the first and last positions each render 40% of the total value of the paper. The remaining 20% is shared equally by the authors in the intermediate positions. For five authors, authorship value would thus be divided: 40, 6.7, 6.7, 6.7 and 40%. This type of proposal is dismissed, because fixed values would be fair only if work efforts actually happened to be distributed just that way (which is unlikely).

A more flexible system could be to provide actual percentages, on a case-by-case basis. But how are actual percentages determined? Different authors contribute qualitatively differently: by designing the study; by analyzing data; by drafting the paper. What kind of contribution has most weight?

Another suggestion is not to assign a relative value to the authors’ contributions. Instead, one specifies what each one contributed. Contributorship instead of authorship, where the contribution is described in absolute terms rather than relative. For example: “contributed to designing the study,” “contributed to data analysis,” “contributed to drafting the paper.” A problem with this proposal, Helgesson and Eriksson point out, is that it in fact says very little about absolute contributions. “Contributed to designing the study” can mean both substantial and lightweight contributions.

The article ends by taking a step back. For perhaps we took a step in the wrong direction when we required a more orderly authorship order? The problem about the meaning of the sequence of author names presupposes an individualistic and competitive outlook on science. Today, there are also other tendencies, which may be more worthwhile, such as striving to make science open and socially responsive. Perhaps we should avoid attaching too much importance to authorship order?

Should our focus be on collective contributions to science, with and for society, rather than on individual merit in the competition for employment and funding?

Thus the article ends, with a question calling for more contemplation.

Pär Segerdahl

Helgesson, G. & Eriksson, S. Authorship order. Learned Publishing, 2018, doi: 10.1002/leap1191

This post in Swedish

Nurses’ vulnerable position when care and research coincide

10 September, 2018 / Pär Segerdahl / 0 Comments

A new article highlights ethical challenges that nurses face in their profession when more and more clinical trials are conducted on cancer patients.

Nursing alone is stressful. Studies have shown how heavy workload and being pressed for time can cause moral blindness and emotional immunization among nurses. In clinical trials, the situation is even more complicated, due to dual professional roles. The nurses have to accommodate both the values of care and the values of research. Caring for cancer patients coincides with recruiting patients as research participants and coordinating clinical trials on them according to detailed research protocols.

The article by Tove Godskesen et al. describes challenges faced by nurses burdened with this dual professional identity. The most difficult challenges concern cancer patients near the end of life, who no longer respond to the standard therapy. They often hope desperately that research participation will give them access to the next generation of cancer drugs, which may work more efficiently on them. This unrealistic hope creates difficulties for the nurses. They must recruit cancer patients to clinical trials, while the patients often are so terminally ill that they, from a perspective of caring, perhaps rather should be allowed to end their lives in peace and quiet.

An additional complication, next to the heavy workload in nursing and the dual identity as a nurse in the service of research, is that the number of clinical trials increases. There is a political ambition to accelerate the development, to support the Nordic pharmaceutical industry. This means that more and more nurses are engaged to coordinate trials: a task for which they rarely were trained, for which they hardly have time to prepare, and over which they lack power, given their position in the hierarchy of healthcare.

In view of the political ambition to increase the number of clinical trials, there should be a corresponding ambition to support the increasing number of nurses who will have to assume dual professional roles. Godskesen’s study indicates that there is a lack of systematic strategies to handle the situation. Nurses who coordinate trials on patients support each other, to the best of their abilities, over a quick cup of coffee.

Godskesen recommends more strategic training and better support for nurses working with clinical trials. For the nurses’ sake, and not least for the sake of patient safety.

Pär Segerdahl

Tove E. Godskesen, Suzanne Petri, Stefan Eriksson, Arja Halkoaho, Margrete Mangset, Merja Pirinen, Zandra Engelbak Nielsen. 2018. When Nursing Care and Clinical Trials Coincide: A Qualitative Study of the Views of Nordic Oncology and Hematology Nurses on Ethical Work Challenges. Journal of Empirical Research on Human Research Ethics. doi.org/10.1177/1556264618783555

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Where to publish and not to publish in bioethics – the 2018 list

2 May, 2018 / Stefan Eriksson / 1 Comment

Stefan Eriksson, Associate Professor of Research Ethics, Uppsala University

Update: The 2019 list is now available!

Allegedly, there are over 12.000 so called predatory journals out there. Instead of supporting readers and science, these journals serve their own economic interests first and at best offer dubious merits for scholars. We believe that scholars working in any academic discipline have a professional interest and a responsibility to keep track of these journals. It is our job to warn the young or inexperienced of journals where a publication or editorship could be detrimental to their career and science is not served. 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 third 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 although they live on in new form (anonymous) at the Stop predatory journals site (SPJ) and they can also be found archived. The latest effort to create a thorough blacklist 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. Moreover, since only questionable journals are listed, the good journals must be found elsewhere.

A response of gate keeping 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:

– Top 50 Bioethics Journals and Top 250 Most Cited Bioethics Articles Published 2011-2015 (Mark Hakkarinen, Georgetown)
– Top 100 Bioethics Journals in the World (same author)
– The CODEX list of journals in the field
– List from Google Scholar
– Key Journals in The Philosopher’s Index
– Core Bioethics Journals in PubMed (Georgetown)

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 (eleven new entries for 2019, two have 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:

– 8 Ways to Identify a Questionable Open Access Journal (Chrissy Prater)
– How to avoid predatory journals—a five point plan (Jocalyn Clark)
– The false academy: predatory publishing in science and bioethics (article by us, includes the 25 defining characteristics of a “predatory” journal)

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).

WHERE NOT TO PUBLISH IN BIOETHICS – THE 2019 LIST

Advance Humanities and Social Sciences (Consortium Publisher)
Critical remark (2018): Behind this journal you’ll 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.
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.
American Open Ethics Journal (Research and Knowledge Publication)
Critical remark (2019): Listed on Cabells with 7 violations.
Annals of Bioethics & Clinical Applications (Medwin Publishers)
Criticism 1 │ Criticism 2
Critical remark: 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.
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 review concludes the journal is not suitable to publish in.
Critical remark (2019): Listed by Cabells with 10 violations.
British Open Journal of Ethics (British Open Research Publications)
Critical remark (2019): Listed by Cabells with 6 violations.
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.
East 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. Thorough reviews November 2018 and February 2019 conclude that it exhibits at least 13 or 14 of the 25 criteria for “predatory” journals.
Ethics Today Journal (Franklin Publishing)
Critical remark (2019): Listed by Cabells with 9 violations.
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.
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.
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
Criticism
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.
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?
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. A thorough review in May 2019 concludes that it exhibits at least 12 of the 25 criteria for “predatory journals”.
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. A thorough review February 2018 concludes that it exhibits at least 16 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 1 │ Criticism 2 │ Criticism 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
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. 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; Claims an IF of 5.22 (by “Research Journal Impact Factor“); Despite title from India; Alternative indexing; 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 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”.
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. 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.
International Journal of Philosophy and Theology (American Research Institute for Policy Development)
Criticism 1 │ Criticism 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.”
International Journal of Public Health and Human Rights (Bioinfo Publications)
Criticism
Critical remark (2017): Listed on SPJ; On many other blacklists and IF from Index Copernicus.
International Journal of Research in Humanities and Social Studies (Sryahwa Publications)
Critical remark (2017): 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.
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.
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; 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.
Jacobs Journal of Clinical Trials
Critical remark (2018): Spamming with invitation to special issue on ‘Ethical Issues in Health Care Research’. Have been severely criticized here and also in this scholarly article. Publisher listed on SPJ. A randomly chosen article from issue 1 is markedly flawed in execution.
Critical remark (2019): Web page is presently down when trying to access.
Journal of Academic and Business Ethics (Academic and Business Research Institute)
Critical remark (2017): Listed on SPJ as well as several other blacklists; Journal seems uncertain about it’s own name, the header curiously says “Journal of ethical and legal issues”.
Journal of Bioethics and Applications (Sci Forschen)
Critical remark (2018): Brand new journal with no articles yet. Publisher has been criticized for spamming more than once, have a bad record at Scam Analyz e, and is listed on SPJ.
Journal of Clinical Research & Bioethics (OMICS)
Criticism 1 │ Criticism 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 l ost). They are listed by Cabells for 8 violations.
Journal of International Ethical Theory and Practice (MedCrave)
Criticism 1 │ Criticism 2 │ Criticism 3 │ Criticism 4 │ Criticism 5 │ Criticism 6 │ Criticism 7
Critical remark (May 2018): New journal with no articles or issues yet – but still is in need of so many editors that spam emails are sent. They kindly allow for scientific articles: “The research articles can include the findings and the methodology you used.” MedCrave uses many alternative indexing services. They are listed by SPJ. They also spam the Internet with claims for all criticism to be a hoax or fake news.
Update 2019: Have ceased operations, apparently.
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.
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…
Journal of Social Sciences and Humanities (AASCIT)
Criticism 1 │ Criticism 2 │ Criticism 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.
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.
Medical Ethics and Communication (Avid Science)
Criticism
Critical remarks (2017): Listed on SPJ; Spamming researchers with offer of eBook publication for $350.
Nova Journal of Humanities and Social Sciences
Criticism
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 2019: Web pass alert on entering the site.
Open Journal of Philosophy (Scientific Research Publishing – SCIRP)
Criticism 1 │ Criticism 2 │ Criticism 3 │
Philosophical Papers and Review (Academic Journals)
Critical remark (2017): Listed on SPJ and blacklisted by the Ministry of Higher Education of Malaysia; Although it claims to be a peer-review journal, it states that manuscripts “are reviewed by editorial board members or other qualified persons”.
Philosophy Study (David Publishing Company)
Criticism 1 │ Criticism 2
Critical remark (2017): Listed on SPJ.
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.
Universal Open Ethics Journal (Adyan Academic Press)
Critical remark (2019): listed by Cabells for 7 violations.
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 blacklists.

End remark:

In light of recent legal action taken 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.

Stefan Eriksson & Gert Helgesson

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

Open access – the rise and fall of a community-driven model of scientific communication, by J Schöpfel.
Predatory Publishing, Questionable Peer Review, and Fraudulent Conferences, by John D Bowman.
Predatory and Fake Scientific Journals/Publishers – A Global Outbreak with Rising Trend: A Review, by Tin et al.
Rise of the predators: Business is booming in the murky global market of suspect and sham publishers and journals, by Bryn Nelson.
‘Predatory’ open access: a longitudinal study of article volumes and market characteristics, by Cenyu Shen and Bo-Christer Björk.
Spurious alternative impact factors: The scale of the problem from an academic perspective, by Gutierrez et al.
The Writing Style of Predatory Publishers, by Markowitz et al.
How should we treat those taken in by predatory journals?, by Dalmeet Singh Chawla.
Time to stop talking about ‘predatory journals’, by Eriksson & Helgesson.
All publishers are predatory – some are bigger than others, by Olavo B. Amaral
Why Open Research, a nice site advocating open access publishing for research

Rules for authorship must be clarified

11 April, 2018 / Pär Segerdahl / 0 Comments

Recently, I wrote a post on honorary authorships in the academia. When I in that post tried to render the ICMJE criteria for academic authorship, I felt dull since I could not figure out how to express in my own words the fourth criterion:

”Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.”

To count as an author of an academic publication, it is not sufficient to contribute to the research, to drafting or revising the intellectual content of the text, and to approve the final version. You must also satisfy this fourth criterion, which has to do with responsibility for research misconduct.

What does the criterion actually say? After reading an opinion piece by Gert Helgesson and Stefan Eriksson in Learned Publishing, I realize that it was not just my stupidity that caused my difficulties to summarize the fourth criterion. The formulation is ambiguous, which may be due to disagreement among the authors of the authorship criteria!

Helgesson and Eriksson find three possible interpretations of the fourth criterion:

Emphasizing the initial ten words (until the first instance of “work”), the criterion seems to say that all authors are responsible, or should be held responsible, for all parts of the article. If the work was fraudulent in some way, all authors should be held responsible, even if they were unaware of what was going on.
Continuing to read the whole criterion, its meaning changes. The criterion then seems to say that if fraudulence is suspected, then all authors have the responsibility to facilitate the investigation of the suspicions (regardless of what part of the work the suspicions concern).
A third interpretation goes further than the second interpretation. It says that an author should support investigations of fraudulence not only after the article was sent to a journal. An author should initiate such investigations him- or herself already during the research and drafting phase, if he or she suspects fraudulence.

It is impossible to determine which interpretation holds. Helgesson and Eriksson consider the third interpretation most reasonable from a research ethical point of view. If this is the intended interpretation, it should be made linguistically unmistakable in the next revision of the authorship criteria, the opinion piece concludes.

Pär Segerdahl

Helgesson, G. and Eriksson, S. Revise the ICMJE Recommendations regarding authorship responsibility! Learned Publishing 2018. doi: 10.1002/leap.1161

This post in Swedish

Risks of discrimination in population-based biobanks

4 April, 2018 / Pär Segerdahl / 0 Comments

Even good intentions can cause harm. Considerately treating certain groups as “vulnerable,” such as pregnant women and children, can cause discrimination against them. If we protect them from participation in clinical research, we know less about how they respond to medical treatments. They are therefore exposed to greater risks when they are patients in need of medical treatment. Thanks for your concern.

Deborah Mascalzoni points out possible discrimination patterns in population-based biobank research. She particularly highlights people with psychiatric conditions, who often are excluded from such studies. However, she also mentions children, who rarely are included in population-based biobanks, as well as people with early forms of dementia or addiction problems.

Mascalzoni thus asks how representative population-based biobanks really are. This is important, as results from such research are increasingly used in the planning of care. We need to see these potential discrimination patterns more clearly, so that people suffering from psychiatric conditions, for example, have similar opportunities to benefit from research as others.

However, the patterns are caused not only by how we think of certain groups as “vulnerable.” Even practical difficulties, to which you may not give much thought, can cause discrimination. It is ethically and legally cumbersome to recruit children as research participants. People suffering from depression may have suicidal thoughts, which requires special efforts. People with early symptoms of dementia may have difficulty understanding complex information, which complicates the process of informed consent.

Some groups are in practice more difficult to recruit to population-based biobanks. Not only our consideration of certain groups as “vulnerable,” then, but also practical obstacles to which we do not pay attention, may cause biased research results, which may lead to poorer care for certain groups. There is therefore reason to ask about representativeness.

Pär Segerdahl

Mascalzoni, D. 2017. Reverse discrimination for psychiatric genetic studies in population-based biobanks. European Neuropsychopharmacology 27: 475-476

This post in Swedish

Two measures against the culture of honorary authorships

13 March, 2018 / Pär Segerdahl / 0 Comments

It is important in the academia to know who actually contributed as author to scientific publications. Partly because authorship is meritorious when researchers seek positions and funding. Partly to facilitate investigations of suspected research misconduct.

These are two important reasons why there are guidelines for academic authorship. These guidelines state that an author should not only contribute to design, data collection, or analysis behind the publication. An author should also contribute to writing and revising the text. An author should moreover approve the final version of the text, and agree to be accountable if there are issues of accuracy or integrity.

The number of authors listed on academic publications tends to increase. As an extreme example, I might mention that in 2011, 140 scientific articles were published listing more than 1,000 authors!

One reason for the larger numbers of listed authors is, of course, that research is becoming increasingly complex and requires collaborations that are more extensive. However, much suggests that the number of undeserving authors increases. One could speak of a culture of honorary authorships within the academia.

There are strong driving forces behind the culture of honorary authorships. It can be about supporting cohesion in a research group by avoiding the uncomfortable decision to exclude team members who contributed minimally to the work being published. It can be about creating good relationships with influential people in the research community by giving them authorship; which they sometimes demand. It can be about increasing the chances of being published by having a famous researcher’s name in the author list. And since big research projects are prestigious, a long author list looks good. It creates pressure on the journals to publish what apparently required the contribution of so many skilled researchers – one thinks.

What can we do about it? In a recent article with the, nowadays, modest number of four authors, it is emphasized that guidelines for academic authorship, which have been around for a long time and are well known, obviously do not suffice. In the journal Insights, Stefan Eriksson, Tove Godskesen, Lars Andersson and Gert Helgesson write that we probably need to create psychological incentives against the culture of honorary authorships.

More specifically, two simple measures are suggested that can reduce undeserving authorships within the academia:

When researchers seek positions, interview them about their contributions to publications that they include in the list of qualifications. If they are only honorary authors, they may not be able to account for the articles or how they contributed to them. Knowing that this is part of the recruitment process can create a psychological pressure to avoid undeserving honorary authorships.
Divide authorship and citations scores with the number of authors. Awareness that scores are calculated in this way creates a psychological pressure not to include undeserving authors in the author list.

One might object that this proposal instead risks excluding collaborators from contributing as authors, although they could very well be invited to function as well-deserved co-authors. This objection is addressed in the article. Instead of explaining the authors’ defense, I hope that my silence on this point will motivate readers of the Ethics Blog to read the important article. So that I do not lure you into some sort of honorary readership! How often do we not intimate that we have read something very interesting, which we in fact only skimmed through or heard summarized?

The academic culture of honorary authorships will not disappear easily. Ethical guidelines are obviously not enough. Of course, the best thing would be if we all became saints. While waiting for it to happen, psychological incentives may be needed to behave well.

Pär Segerdahl

Eriksson, S., Godskesen, T., Andersson, L., Helgesson, G. (2018). How to counter undeserving authorship. Insights. 31(1), p.1. DOI: http://doi.org/10.1629/uksg.395

This post in Swedish

Hoping when there is no hope

27 November, 2017 / Pär Segerdahl / 0 Comments

Patients participating in phase I oncology trials have terminal cancer and are near the end of life. Participating in research cannot cure them or even extend their lives. Not only because they have terminal cancer, but also because in phase I trials one tests the safety profile of the treatment, not effectiveness against cancer.

Nevertheless, many patients state that hope is an important reason for them to participate in phase I oncology trials. This is worrying from an ethical perspective. Do they understand what they agree to when they enroll as research participants? Have they been properly informed?

In an article in the Journal of Oncology Practice, Tove Godskesen discusses the issue, together with Ulrik Kihlbom. They argue that it is a norm in cancer care to provide hope to patients, and that this norm may support a tendency in personnel who recruit research participants to not always discourage hope, but rather reinforce it.

Since supporting hope in cancer patients is humanly important, it is not entirely easy to find a solution to the problem. Godskesen and Kihlbom proceed cautiously by distinguishing three kinds of hope that cancer patients may have concerning their participation in phase I trials.

The first is independent hope: patients hope for something that is independent of cure, such as receiving more attention by participating in research. The second kind of hope is realistic hope: patients understand that there is really no hope of cure or prolonged life, but they still hope against hope. The third kind is unrealistic hope: patients misunderstand the situation and think they are offered a treatment that doctors/researchers believe can help.

It is reasonable to support independent and realistic hope in phase I trials, according to Godskesen and Kihlbom. However, unrealistic hope is ethically worrying. It should be discouraged when patients enroll as research participants.

Discouraging unrealistic hope requires awareness of the norm to provide hope to cancer patients. The authors describe how a hopeful attitude is activated simultaneously with the cancer diagnosis. Words like treatment, hope and cure are immediately emphasized in the conversations with patients. The risk is that these words are used in the same hopeful spirit also when participation in a phase I trial is discussed.

Another problem in this context is that patients participating in phase I trials rarely receive palliative care, which would be reasonable given their terminal cancer. This may create the false appearance that research participation means being offered a new treatment. Perhaps the norm to provide hope creates this reluctance to mention palliative care. Staff is afraid that they may discourage hope. That fear is problematic, the authors claim.

What measures do Godskesen and Kihlbom propose? First of all, we need to put extra high demands on the information to participants in phase I oncology trials so that this vulnerable patient group is not exploited. Secondly, the information should contain palliative options. Thirdly, patients should receive palliative counseling throughout the trial.

Integrating research participation with palliative care reduces the risk of encouraging unrealistic hope in this patient group. The fact that trial participation is research and not treatment becomes clearer.

Pär Segerdahl

Godskesen T. and Kihlbom, U. (2017), “I have a lot of pills in my bag, you know”: institutional norms in the provision of hope in phase I clinical cancer trials. Journal of Oncology Practice 13(10): 679-682. DOI: 10.1200/JOP.2017.021832

This post in Swedish

Tag: research ethics (Page 4 of 8)

Genetic risk: Should researchers let people know?

What does the order of authors mean?

Nurses’ vulnerable position when care and research coincide

Where to publish and not to publish in bioethics – the 2018 list

Rules for authorship must be clarified

Two measures against the culture of honorary authorships

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