Ethical issues when submitting to the Journal of Sports Sciences

In previous editorials, we have considered some of the ethical issues that arise when experimental work on human participants is undertaken in a research context (Nevill, 2002; Maughan, 2003). The first concern in all human experimentation must surely be to ensure that no harm comes to the volunteers who participate in our studies. In most cases, there is a clear line that few would cross, but some experimental work imposes particular challenges. As the disciplines evolve, and as the Journal itself grows and matures, so new challenges arise that cause us all to ask questions.

All of us, as editors of a busy and expanding Journal, see far more manuscripts than our readers see in print. Manuscripts fail to survive the review process for different reasons, but in some cases, papers fall at the first hurdle because the design is fundamentally flawed, and no amount of rewriting can remedy the deficiencies in the study design. In such cases, it is inevitable that questions are asked about how the study managed to clear the ethical review process that all – or at least almost all – Institutions require. If there is no prospect of the question that was addressed being answered, then it is surely unethical to subject the participants to whatever procedures are involved.

More serious concerns are raised occasionally, and the Journal's editors and the referees need to think how to respond when questions do arise. In one paper submitted to the Journal recently, the authors stated that they had used aspartame as a placebo treatment in a supplementation study. Nothing wrong with that; aspartame is a sweetener that is found in many food products, including especially low-energy soft drinks. Concerns have been expressed about the safety of aspartame, and an Acceptable Daily Intake (ADI) has been identified and set at 40 mg/kg body mass (EU Scientific Committee on Food, 2002). In this case, however, the authors stated that the placebo consisted of 6 grams of aspartame, administered four times per day for six days, giving a total daily dose of 24 grams. For the average subject, this is about 10 times the ADI. Even the active treatment, which consisted of 5 grams of the substance under investigation plus 1 gram of aspartame four times daily, was substantially in excess of the ADI for aspartame. When questioned about this, the corresponding author gave an assurance that the research project received approval from the institution where the data were collected and that he did not violate the terms of the approved protocol. What is the editor to make of this? Is it the function of reviewers and editors to police the world of science and to challenge what may be seen as unethical practices? If not, whose function is it? Notwithstanding the author's assurance, how do we know that the institutional review board was fully informed? Were they just told that a placebo would be used? If they were told that such a large dose of aspartame was to be used, was the committee aware that this was far in excess of the ADI?

This is only one of several examples that have caused the editorial board to consider how they should respond in such cases. In other cases, the integrity of the data themselves have been called into question. We believe that there is a responsibility on the Journal's referees/reviewers to draw the attention of Editors to possible unethical practice, and a responsibility on the Editors to consider whether action is required. We have therefore resolved to put in place a procedure for dealing with such instances. This extends current practice where Section Editors verify that manuscripts contain a statement to confirm that appropriate ethics approval has been granted.

Referees will be asked to inform Section Editors if there is a suspicion that a study does not conform, in all respects, to accepted ethical standards. The Section Editor will, in turn, raise this with the Editor-in-Chief. Together they will review the evidence and decide whether there is a case for asking the author to clarify what was done and to confirm that all procedures were approved by an Institutional Review Board (IRB) and were carried out as specified. If the Section Editor and the Editor-in-Chief are not satisfied, the evidence will be placed before the next Editorial Board meeting. Possible actions to be taken if it is agreed that there has been a breach of good ethical practice would include a move to seek clarification from the author's IRB that the study as detailed in the manuscript had actually received approval.

The Editors are not seeking to act as arbiters of what is acceptable and what is not, but are seeking simply to ensure that all papers published in the Journal do conform to accepted ethical standards. Authors submitting manuscripts to the Journal, and reviewers acting on behalf of the Journal, should be aware of the importance that the Journal of Sports Sciences attaches to such ethical issues.