pp. 293-295 in Bioethics in Asia

Editors: Norio Fujiki and Darryl R. J. Macer, Ph.D.
Eubios Ethics Institute

Copyright 2000, Eubios Ethics Institute All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.

C2. Ethical Concerns Facing Biomedical Journals

Dr. Adrian J. Ivinson.

Editor, Nature Medicine, New York, USA

Introduction

Research is finally presented to the community when it is published. Whereas for the reader this work is presented as a fait accompli, for journal editors and the expert referees called in to help assess the merits of the work, each manuscript is seen to evolve over a period of several months from submission, through revisions, editing and finally to publication. This process unearths details of the process from which the research grew: Who instigated the work; Why and what was the rationale for the approach taken; Did the study design change through the course of the project; Who funded it and what was their motive; Is there a precedent for this sort of work; Who are the authors (and who is not an author) and how was the final list and order of authors arrived at; Are all the authors fully aware of all the above and of the detailed contents and claims of the final paper? These and many other issues may give rise to ethical concerns and it is often the case that by publishing the work the authors are seeking from the editors an implicit approval of all of their procedures and claims. In parallel, expert referees called upon to help the editors select appropriate work for publication, look toward the editors to clarify and resolve concerns that they might have with the work.

How should journals respond to these challenges?

The issues journal editors are expected to consider and resolve

(i) Fraud

When we start considering the issues that journal editors are often expected to address and resolve, one of the first things to become apparent is how little we know about the incidence of problems that might be considered as raising ethical questions.

Looking at, for example, inappropriate research activities, one gets the impression that fraud and scientific misconduct are on the rise \ but really we have no idea. A few celebrated cases in recent years have raised the communityfs awareness of fraud and misconduct, but we donft know if this has been going on at a similar rate for decades and is only now being discussed more openly, or if indeed it is rising. Perhaps it is in decline! Are we seeing the tip of the iceberg or is the system of research - peer review - publication - scrutiny - and confirmation, by and large secure and rigorous enough to catch most cases? Sadly, we can not answer even this basic question (and in fact it is difficult to even consider how we might go about answering it.)

It does however seem reasonable to suggest that largely due to advances in recombinant DNA technologies over the past ten years or so, biomedical research has grown tremendously and with this growth it has become more competitive and aggressive. With much more at stake, the pressure to produce results is now quite extreme. The gpublish or perishh mentality is dominant and many younger investigators seem to respond inappropriately (although understandably) by being more secretive, selective in how they report their work and more likely to aim for short-term goals rather than better long-term understanding and knowledge growth.

Although we do not know how prevalent inappropriate scientific conduct is, we do know what the perception is: In 1993, Swazey and colleagues questioned 4,000 scientists and found that many thought that they had actually witnessed or heard directly of scientific misconduct. We also know that many governments, research agencies and universities think that the problem is sufficient to warrant the establishment of education programmes and investigative bodies.

From the editors perspective, in many ways, scientific misconduct \ a deliberate action \ is the easiest to deal with. If the fraud is good (that is, thorough and convincing) and well executed, editors and expert referees will not notice it and therefore there is nothing really to be done. An often forgotten but logical extension of this is that the editors of journals do not verify any of the work that they publish. The rationale behind the research, its presentation and the interpretation of the work, are examined and checked, but the actual raw data is rarely seen and even if it were, this would do nothing to verify the integrity and origin of the research.

Science is based on trust and as with all endeavours based on trust, it is not difficult to cheat if that is your intention.

(ii) Not fraud and not new

Editors are often asked to resolve recurrent issues that for many of those involved, challenge their ethical expectations: It is, for example, unethical for the head of a department to be added as an author on all papers emanating from that department purely because of his/her position. And who should the first, last and middle authors be; Are the results presented in the paper, truly illustrative of all the results achieved and is all the negative data also apparent; Is it clear who funded the work and are the financial or other commercial interests of the authors and their sponsors known and relevant to the work? Issues such as these often arise only when work is submitted for publication and examined by editors and referees during the peer review process. Perhaps the referees have a prior knowledge of the work and have discussed it with one or other of the authors or with a jilted collaborator. Perhaps they heard the work presented at a conference but find that then it was presented in a very different light (all those troublesome failures of six months ago have been dropped and the work has taken on great significance, statistical or otherwise.) Perhaps the referee is a competitor. How, for example, should the editor react when a junior author calls to complain that the order in which the authorsf names appear on the paper has been changed since the project began and that they feel hard done to; or when a referee declares that, as presented, the work represents a fine paper but that they are aware of other unreported aspects of the work, and suggesting that you, as editor, should look into the matter. Can the editor really contact an author and ask gAre you being entirely honest?h or gIfd like you to reconsider whether what you have done was entirely ethical?h or perhaps gDid you really let all those patients and other subjects know precisely what you were doing with their samples and test results?h This is not a question or sensibilities (editors know how to tackle unsavoury issues and are used to giving authors disappointing and unwelcome news). It is a question of authority. Editors have no authority and no mandate to confirm basic claims in a paper and there is no way that editors can start trying to confirm all those claims. Nor can they confirm ethical behaviour or sanction what might be less than ethical. Science is based upon trust and biology in particular is still a discipline that relies upon many small contributions from many individuals and they all have to trust each other.

(iii) New ethical concerns

So far, I have been considering only recurrent and well established problems with bioethics -- sadly, there is nothing new about scientific fraud or authorship disputes. However, perhaps the more demanding ethical issues are those involving new paradigms and applications of technology. We have heard a lot about these \ xenotransplantation, genetic testing, embryo research c cloning! How should journals react to work that actually satisfies that over-used clich_, and does gpush back frontiersh?

Here more than ever we find ourselves considering questions, the answers to which can in a very real and immediate sense, shape and influence society. And here also we must face the frailty resulting from our ignorance. How will allowing (or banning) human embryo research affect tomorrowfs society. Does a broad ban on mammalian cloning research mean that potentially important discoveries are sacrificed in order to offer some temporary (and in all probability untenable) technological, emotional security? Should a radical new HIV vaccine be tried today or should it wait for five years and tens of thousands of deaths before being trialed?

If someone submits a research paper in which it is quite clear that a norm of research ethics has been ignored, we can refrain from publishing it, citing our specific concerns. However, how should we react when the paper takes a bold step in a new direction but simply does not make mention of appropriate protocols or ethical practice or policies? Do we question the authors of all such articles? If the answer is gyesh then we must prepare ourselves for a lot of questioning because the simple truth is that most authors do not address such issues, formally, specifically and in writing, at the time of submission. And more often than not, those that do address these issues, simply regurgitate a standard sentence that to all purposes is a formality and on which little significance can be placed. And do we take into account the geographical (and therefore cultural) origin of the paper? Some institutions will not fund human embryo research, whereas others will \ are editors supposed to know all these occasions and act accordingly?

The point is two-fold (and they are connected): First, the time for addressing ethical concerns with biomedical research is not when the work is completed and submitted for publication, but before it is begun. Secondly, journal editors should not be the gatekeepers or judges, deciding what does and does not fulfill their ethical criteria. The New England Journal of Medicine and the Journal of the American Medical Association have said that they will not publish work that does not comply with US Federal Government requirements for such work. That is clearly a sensible position to take when considering legal ramifications of ignoring those federal requirements (and in the U.S., a publisher can be sued along with the author and the editor) \ but in practice, I think their policy accomplishes very little. I also think it is flawed -- How are they going to check that all submitted work complies with the requirements; and will they reject work presented by authors of another country in which the rules are slightly different? Implicit in their policy is the assumption that all the work they publish , does in fact comply \ yet how can they know that for certain and do the journals therefore share responsibility if non-compliant work sneaks through the system and is published? Finally, how should those journals react when procedures not covered by the governmentfs regulations, are submitted?

Journal editors do have to be informed and active in the arena of bioethics and they should be prepared to contribute to the debate and to support commonly agreed standards - but they cannot police these rules or stand as gatekeepers. Perhaps where we can help is by providing more space for a thoughtful and practical discourse on ethics and by doing our best to ensure that this debate is presented in a truly accessible format such that it encourages the interest and participation of as many as possible \ scientists, religious leaders, the lay public, journalists, bioethicists c. and even editors.

We can also encourage debate and consensus ahead of time. Many ethical issues cannot be predicted, but others can and we should be ready for them rather than reacting to them. Germ line gene therapy and other germ line modification, for example, are just around the corner. We should not be waiting for submission of the first manuscript reporting such an advance, to formulate our thoughts on the moral and ethical arguments for and against such work. Publishing or not publishing that paper will not make it right or wrong.

Conclusion

It has been suggested that editors should decide not to publish work regardless of how important or interesting it seems, if that work was not performed in an ethical fashion. Such a policy suggests that editors are the best group to maintain the moral high ground (a very dubious suggestion!) In fact, those of you that study these points are much better placed to examine the issues. If you leave it to editors, you are choosing a system that at best can eclose the barn door after the horse has boltedf. If the work is not ethical, it should have been stopped long before submission for publication. We must find a longer-term approach to educating scientists and medics of their ethical obligations, such that publication is never the issue.


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