Internal investigation of research misconduct often fails

May 30, 2017

Pär SegerdahlWhat characterizes a research scandal? In a short article in Hastings Center Report, Carl Elliott uses as an example the case of Paolo Macchiarini at the Swedish Karolinska Institutet.

Macchiarini’s deadly experiments with stem cell-covered artificial trachea, transplanted to patients who did not have life-threatening diseases, have unique features linked to the personality and charisma of the researcher. However, the scandal resembles other scandals on one point, Elliott says. Whistle-blowers who use internal channels at the home university to handle research misconduct often fail. Justice is not done until the press reveals the scandal. In this case, a Swedish documentary film, The Experiments, exposed the scandal.

If Elliott is right, I personally draw two conclusions. The first is that investigative journalism is important. It reveals misconduct that would otherwise not be exposed. My second conclusion is that we cannot be satisfied with this.

Angry customers who want to force the shop assistant to correct what they think went wrong can threaten: “If you don’t fix this, I’ll contact the local newspaper.” A responsible person who suspects research misconduct should not have to act in a way that others can interpret as partial exercise of power. It poisons the situation and increases the risk for the whistle-blower.

If internal channels often fail to handle research misconduct, as Elliott claims, a system of external management is required. Therefore, it is good that a Swedish public inquiry recently suggested that an independent agency should investigate suspected research misconduct.

Contacting the media should not have to be “the way” of effectively exposing research misconduct; it is a way out if the standard way fails. If the way out often is required, something is wrong with the way.

Pär Segerdahl

This post in Swedish

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Where to publish and not to publish in bioethics – the 2017 list

May 9, 2017

Stefan Eriksson, Associate Professor of Research Ethics, Uppsala University

Allegedly, there are over 8.000 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.

Gert Helgesson, Professor of Medical Ethics, Karolinska InstitutetThus we published this blog post in 2016. This is our first annual update (the previous version can be found here). At first, we relied heavily on the work of Jeffrey Beall, a librarian at the University of Colorado, who runs 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. These lists were not, however, the final say on the matter, as it is impossible for one person 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 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. Last year, 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 36 of them (up with eleven from last year) alphabetically 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).

WHERE NOT TO PUBLISH IN BIOETHICS – THE 2017 LIST

UPDATE! New journal added: Advance Humanities and Social Sciences (Consortium Publisher). 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. The publisher is listed on SPJ.

UPDATE II: New journal added: The Recent Advances in Academic Science Journal (Swedish Scientific Publications). Despite the name it seems based in India. The only Swedish editor’s existence cannot be verified. Website quality is lacking. Listed on SPJ.

In light of recent legal action taken against people trying to warn others about dubious publishers and journals – see here and here – 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

Read more about Stefan’s work at CRB here

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

We like ethics : www.ethicsblog.crb.uu.se


More biobank ethics and law

March 13, 2017

Biobank and registry research comes with particular sets of legal and ethical issues. We explore some of them in our Biobank Perspectives newsletter.

In this issue, you can read about some of the challenges that arise when biobanking stem cells in relation to a new project on the legal and ethical aspects of using stem cells to treat type 1 diabetes. We also offer a progress update from the B3Africa project and present the new Swedish legal officer BBMRI-ERIC ELSI helpdesk.  You can also read about the Swedish Government Inquiry  that was presented recently, proposing a new legal framework for handling and investigating research misconduct, with a new act suggested to enter into force on 1st of January 2019.

Josepine Fernow & Anna-Sara Lind

We recommend readings - the Ethics Blog


Ethics and law of stem cell treatment of diabetes

December 21, 2016

Pär SegerdahlMany people support in various ways medical research, which they perceive as urgent in view of the needs of various patient groups. But patients typically won’t benefit from research unless the results are translated into development of medical products.

Type 1 diabetes is an incurable disease that requires daily life-sustaining treatment and strict dietary rules. Disease onset usually occurs at an early age.

In Sweden, about 50 000 people have this form of diabetes and of these around 8 000 are children. In type 1 diabetes, the immune system attacks the insulin-producing cells. Without insulin the body cells cannot use glucose for energy, and the sugar level in the blood rises. Energy is recovered instead from fat and protein, which causes waste products that can cause diabetic coma and attacks on vital organs.

Today, diabetes is treated with daily insulin injections, or by using an insulin pump. This requires continuous measurement of blood sugar levels, as incorrect doses of insulin entails risks and can be life-threatening. It is not easy to live with diabetes.

An alternative treatment, which is still at the research stage, is to generate new insulin-producing cells using human embryonic stem cells. The insulin-producing cells detect blood sugar levels and regulate the secretion of insulin. In order not to be attacked by the immune system, the transplanted cells are encapsulated in a protective material. It may become easier to live with diabetes.

But research alone doesn’t treat diabetes. Encapsulated insulin-producing cells need to be produced and made available also to patients; not only to research participants. But this is a big step and a host of ethical and legal issues, including embryo donation, patentability and consent, need to be examined and discussed.

The Swedish Research Council recently granted funding for a project to examine these issues. The project is led by Mats G. Hansson at CRB and is a collaboration with Olle Korsgren, professor of transplantation immunology, as well as with lawyers Anna-Sara Lind and Bengt Domeij, and philosophers and ethicists Jessica Nihlén Fahlquist and Pär Segerdahl.

The step from stem cell research to available treatments requires reflection. I look forward to start thinking about the ethical and philosophical questions.

Pär Segerdahl

This post in Swedish

Approaching future issues - the Ethics Blog


The apparent academy

November 29, 2016

Pär SegerdahlWhat can we believe in? The question acquires new urgency when the IT revolution makes it easier to spread information through channels that obey other laws than those hitherto characterizing journalism and academic publishing.

The free flow of information online requires a critical stance. That critical stance, however, requires a certain division of labor. It requires access to reliable sources: knowledge institutions like the academy and probing institutions like journalism.

But what happens to the trustworthiness of these institutions if they drown in the sea of impressively designed websites? What if IT entrepreneurs start what appear to be academic journals, but publish manuscripts without serious peer review as long as the researchers are paying for the service?

This false (or apparent) academy is already here. In fact, just as I write this, I get by email an offer from one of these new actors. The email begins, “Hello Professor,” and then promises unlikely quick review of manuscripts and friendly, responsive staff.

What can we do? Countermeasures are needed if what we call critical reflection and knowledge should retain their meaning, rather than serve as masks for something utterly different.

One action was taken on The Ethics Blog. Stefan Eriksson and Gert Helgesson published a post where they tried to make researchers more aware of the false academy. Apart from discussing the phenomenon, they listed deceptive academic journals to which unsuspecting bioethicists may submit papers (deceived by appearances). They also listed journals that take academic publishing seriously. The lists will be updated annually.

In an article in Medicine, Health Care and Philosophy (published by Springer), Eriksson and Helgesson deepen their examination of the false academy. Several committed researchers have studied the phenomenon and the article describes and discusses what we know about these questionable activities. It also proposes a list of characteristics of problematic journals, like unspecified editorial board, non-academic advertisement on the website, and spamming researchers with offers to submit manuscripts (like the email I received).

Another worrying trend, discussed in the article, is that even some traditional publishers begin to embrace some of the apparent academy’s practices (for they are profitable). Such as publishing limited editions of very expensive anthologies (which libraries must buy), or issuing journals that appear to be peer reviewed medical journals, but which (secretly) are sponsored by drug companies.

The article concludes with tentative suggestions on countermeasures, ranging from the formation of committees that keep track of these actors to stricter legislation and development of software that quickly identifies questionable publications in researchers’ publication lists.

The Internet is not just a fast information channel, but also a place where digital appearance gets followers and becomes social reality.

Pär Segerdahl

Eriksson, S. & Helgesson, G. 2016. “The false academy: predatory publishing in science and bioethics.” Medicine, Health Care and Philosophy, DOI 10.1007/s11019-016-9740-3

This post in Swedish

Approaching future issues - the Ethics Blog


Identifying individuals while protecting privacy

August 24, 2016

Pär SegerdahlResearch ethics is complex and requires considering issues from several perspectives simultaneously. I’ve written about the temptation to reduce research ethics to pure protection ethics. Then not as much needs to be kept in mind. Protection is the sole aim, and thinking begins to resemble the plot of an adventure film where the hero finally sets the hostages free.

Protection is of course central to research ethics and there are cases where one is tempted to say that research participants are taken hostage by unscrupulous scientists. Like when a group of African-American men with syphilis were recruited to a research study, but weren’t treated because the researchers wanted to study the natural course of the disease.

Everyday life is not one big hostage drama, however, which immediately makes the issues more complex. The researcher is typically not the villain, the participant is not the victim, and the ethicist is not the hero who saves the victim from the villain. What is research ethics in everyday situations?

There is currently a growing concern that coding of personal data and biospecimens doesn’t sufficiently protect research participants from privacy invasions. Hackers hired to test the security of research databases have in some cases been able to identify the individuals who provided their personal data to research (in the belief that the link to them had been made inaccessible to outsiders through advanced coding procedures). Such re-identified information can obviously harm participants, if it falls into the wrong hands.

What is the task of research ethics here? Suddenly we can begin to discern the outlines of a drama in which the participant risks becoming the victim, the researcher risks becoming the villain’s accomplice, and the ethicist rushes onto the scene and rescues the victim by making personal data in research databases completely anonymous, impossible to identify even for researchers.

But everyday life hasn’t collapsed yet. Perhaps we should keep a cool head and ask: Why are personal data and biological samples not fully anonymized, but coded so that researchers can identify individual patients/research participants? The answer is that it’s necessary to achieve scientific results (and to provide individual patients the right care). Discovering relationships between genetics, lifestyle and disease requires running several registries together. Genetic data from the biobank may need to be linked to patient records in healthcare. The link is the individual, who therefore must be identifiable to the research, through the use of advanced code keys.

The need to identify participants is particularly evident in research on rare diseases. Obviously, there is only scant data on these diseases. The data needs to be shared between research groups, often in different countries, in order to collect enough data for patterns to appear, which can lead to diagnoses and treatments.

An overly dramatic heroic effort to protect privacy would have its own victims.

In an article in the European Journal of Human Genetics, Mats G. Hansson and co-authors develop a different, more sustainable ethical response to the risk of re-identification.

Respecting and protecting participants’ privacy is, of course, a central concern in the article. But protection isn’t the only perspective, since science and health care are ethical values too. And here you need to be able to identify participants. The task the authors assume, then, is that of discussing the risks of re-identification, while simultaneously considering the needs for identifiable data.

The authors are, in other words, looking for a balance between different values: simply because identifiable data are associated with both risks and benefits.

You can read a summary of the article on the CRB website. What I focus on in this post is the authors’ overall approach to research ethics, which doesn’t emphasize the hero/villain/victim opposition of certain dramatic situations.

The public image of research ethics is very much shaped by its function in response to research scandals. But research ethics is usually, and less dramatically, about making everyday life function ethically in a society which contains research. Making everyday life run smoothly is a more complex and important task than playing the hero when everyday life breaks down. In this work, more values and challenges need to be taken into account simultaneously than in emergency scenarios where ethicists, very naturally, focus on protection.

Everyday life may not be as exciting as a research scandal, but if we don’t first and foremost take responsibility for making everyday life work smoothly, as a complex whole, then we can expect more drama.

Keep a cool head and consider the issues from a variety of perspectives!

Pär Segerdahl

Hansson, M. G. et al. The risk of re-identification versus the need to identify individuals in rare disease research. European Journal of Human Genetics, advance online publication, 25 May 2016; doi: 10.1038/ejhg.2016.52

This post in Swedish

Approaching future issues - the Ethics Blog


Research ethics is not only protection ethics

June 6, 2016

Pär SegerdahlSystems for ethical review of research would never have been developed if it were not for the need to protect research participants from being exploited, exposed to excessive risks, or injured.

Considering how several research scandals strengthened this protection motive, it is easy to believe that protection is the sole aim of research ethics. This is not the case.

The starting point has always been that research is something worthwhile; something ethically important. Medical research provides knowledge that can lead to better diagnoses and more effective treatments. The humanities and social sciences can provide knowledge that supports more informed debates and more thoughtful political decisions.

Ethics review is about striking a balance between ethical values. Are the risks in proportion to the value of the research? Are the risks minimized, or can the research questions be examined more safely? Are research participants properly informed about the research purpose and the risks that participation might entail? Do they get the opportunity to freely decide whether to participate or not?

The “novelty” of research ethics is thus the balancing of ethical values. It’s not that ethical values are turned against research, for research itself is regarded as an ethical value. Also researchers are learning to balance values when they plan their research. The balancing is done not only in the review system, then, but pervades research itself more and more.

Doing the balancing is rarely easy. Moreover, as already mentioned, it is easy to overlook the starting point: that research is regarded as a value. This invites interpreting research ethics as pure protection ethics, which threatens to make ethics review one-sided.

For these reasons, well-written manuals are needed for members of ethical review boards, and for researchers. Manuals that not only inform about regulations and legislation, but also discuss the difficulties of balancing ethical values, and highlight how research ethics is “balance ethics” and not just protection ethics (except when protection law applies).

A new book, Balanced Ethics Review (Springer 2016), by Simon N. Whitney, is such a manual. It is written from within the American review system. But by openly discussing the difficulties of balancing ethical values, and by bringing to the fore how research ethics functions as “balance ethics,” the book has greater universality. – Perhaps precisely where the need for guidance is greatest.

Pär Segerdahl

This post in Swedish

We recommend readings - the Ethics Blog


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