0000-0002-4592-9214As we celebrate PLOS ONE’s ten year anniversary, we continue our commitment to uphold rigorous standards for publications across all scientific disciplines. This is not a small goal. Several years ago, the staff editors at
Emphasizing the fact that clinical trials can influence treatment decisions, the recent AllTrials campaign has called for all trials past and present to be registered, and the results reported. As one of the initiating organisations behind this initiative, PLOS is committed to continuously developing and adopting policies that might help rectify publication bias in the trials literature. Following in the footsteps of PLOS Medicine, this campaign has led the editorial staff at PLOS ONE to re-evaluate how we handle unregistered trials.
Previously, in line with the International Committee of Medical Journal Editors (ICMJE) policy and like several other journals, we required all clinical trials that began after July 1, 2005 to be registered prospectively (before patient recruitment) in a publicly available registry approved by the World Health Organization (WHO). To stress the need for prospective registration, papers that did not fulfill these criteria were rejected, but this potentially prevented the results of some trials from being published. Thus while we still expect prospective registration to be standard practice, as of today, we will also consider retrospectively registered clinical trials to help ensure the medical community has access to the results of these trials.
These retrospectively registered clinical trials must however meet the following criteria:
1) The trial must be registered in a WHO-approved registry before submission to the journal
2) The authors must explain the reason for late registration within the methods section of the manuscript
3) They must include a statement confirming that all ongoing or future related trials are registered
As a reminder, when determining what constitutes a clinical trial, PLOS ONE follows the WHO’s definition: “a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” The ICMJE further clarifies that “health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events”.
The ICMJE also recommends that if scientists are unsure whether their trial meets the above definition, they should err on the side of registration.
We believe that while prospective trial registration remains the gold standard, this change in policy will be a positive step towards increased transparency and accountability and is in line with another recent initiative supported by PLOS ONE, the RIAT (Restoring Invisible and Abandoned Trials) initiative. This is also in accordance with the core values of the journal to publish all papers, including studies reporting negative results, provided they are technically sound and done to high scientific and ethical standards.
Image: by NHS Confederation on Flickr
Most readers are by now familiar with the core principle behind PLOS ONE: to publish all papers that are scientifically and technically sound, regardless of their perceived impact or importance. Another publication criterion that has received far less attention until recently is our commitment to the quality and completeness of reporting.
PLOS ONE considers reporting quality to be of importance in two main areas: first in relation to completeness of authors’ descriptions of study methods and results, and second in assuring readers of the ethical basis underlying the work. The rationale for ensuring high standards of reporting and ethical oversight is aligned with our core mission to facilitate the re-use of open-access research; if studies aren’t reported appropriately, or don’t have the necessary ethical oversight, it is much more difficult for others to replicate the work or incorporate the data as part of a larger study.
The natural follow-up question might be: how do we as a journal maintain these standards? Here, we’d like to outline briefly our standards, the reasons for them, and the process for ensuring that authors adhere to them. By doing this, we hope to shed light on some of our internal processes, both for the journal’s community, as well as for interested readers that appreciate sound, well-done science as much as we do.
PLOS ONE is a large, international, open-access scientific journal that considers all manuscripts reporting the results of primary scientific research. Day to day, the journal receives many types of studies, including experimental and observational work on animal and human populations, as well as a range of computational and theoretical work. These are submitted by researchers around the world who are not necessarily bound by common standards of reporting or ethical oversight.
As an international journal, however, PLOS ONE has a responsibility to establish and maintain consistent and high standards for publication. Therefore, we require that authors assure us on submission of appropriate ethical review and approval for experimental work involving animals and human participants; relevant permissions for field studies or observational work; and adherence to appropriate discipline-specific guidelines for the reporting of taxonomic, paleontological, or archaeological specimens. In some areas, there are also more prescriptive guidelines to ensure the full description of study methods and results—including CONSORT for reporting randomized clinical trials and PRISMA for reporting systematic reviews in relation to human participants—and we provide links to many more in our manuscript guidelines.
How do journal staff check for these standards when we receive so many submissions each day? At PLOS ONE, we’ve found that the most effective way to ensure papers meet our requirements is to perform a series of checks at submission. This ensures that by the time articles are assigned to Academic Editors for detailed review, crucial information about ethical oversight and study conduct will be available for their consideration. By screening papers before the formal peer-review process, we provide support to our Editorial Board and reviewers, who volunteer their time and offer an invaluable service to the journal and the scientific community as a whole. Equipping our Academic Editors with additional, important details when they agree to handle a manuscript allows them to focus their specialized expertise where it is most valued: on the scientific and technical quality of the paper.
That said, we consider our Academic Editors as partners in our goal of maintaining high standards for reporting, research ethics, and integrity. We ask our Editorial Board members for advice in difficult situations, and greatly appreciate the expert input that they provide. In certain situations we seek the advice of additional experts in reporting or ethics to provide oversight on specific papers, and are currently setting up dedicated advisory boards to assist us. We also consult Editorial Board members when developing new internal policies, or when robust community guidelines (such as CONSORT for randomized clinical trials or the proposed ARRIVE for experimental animal research) are not yet available for specific study types.
We appreciate the support of PLOS ONE authors, editors, and reviewers in helping us maintain the highest standards possible.
Posted on behalf of the in-house editors at PLOS ONE:
Associate Editors Gina Alvino, Sarah Bangs, Meghan Byrne, Christna Chap, Michelle Dohm, Matt Hodgkinson, Anna Schmidt, and Elizabeth Silva; Senior Editors Eric Martens and Emma Veitch; Consulting Editors Catriona MacCallum and Iratxe Puebla; and Editorial Director Damian Pattinson