Consent for publication

Our journal received a manuscript which was a report of an evaluation and enhancement of an online clinical decision support system (CDS) for a specific population at risk of a disease. The online CDS had been developed by a national agency with a mission to support health promotion and disease prevention activities. Evaluation of the CDS was supported through contracts and sub-contracts. The first author was an employee of a university that was a sub-contractor on the project; the second and third authors were employees of a business that describes itself as providers of innovative scientific and technical solutions for national agencies through a consortium of more than 100 universities. The first author’s university was part of this consortium.

The manuscript was submitted to our journal 3 months after the project was finished. Project reports were also submitted to the national agency through the sub-contractors. The second author was the primary conduit of communication between the sub-contractors and the national funding agency.

As a result of the project report and evaluation, the national agency made changes to the online CDS, which included taking down the online version that was reported in the manuscript. When the manuscript was revised, the first author decided to include screenshots from the national agency which described the CDS even though it was no longer available online. 

The revised manuscript was submitted, re-reviewed, and after a few small changes, accepted for publication. Shortly thereafter, the editorial associate for the journal contacted the first author to inquire about whether permission was needed to print the screenshots. The first author asked the second author to verify that the national agency was happy about the inclusion of the screenshots. She replied that the agency approved. During the proofing stage, when the second author did not respond to emails, the editorial assistant contacted the agency directly and was told that the programme officer was totally unaware of the existence of the manuscript. Questions surrounding the actions of the second author then emerged pertaining to the details of his communication with the national agency prior to the manuscript being submitted to our journal.

The first author contacted the journal and said the proofs had to be reviewed and approved by the primary funder. As editor, I replied that at the page proof stage, all edits/changes must be very minor. Substantial changes would require that the manuscript be taken out of the production process and depending on the nature of the changes, the entire submission and review process might have to begin anew.

During a telephone call with the first author she stated that she believed the second author had lied regarding eliciting input and obtaining permission from the national agency to submit and publish the manuscript in our journal. Further, the second author had been fired from his job for “ethical transgressions,” and was now doing work completely unrelated to his previous job for the sub-contractor. She believed he had contributed little to the original paper. The first author has been dealing with the fallout from this and the funding agency. She asked if she should withdraw the manuscript? Or if not, should the second author be listed as an author?

As editor, I am reluctant to have the second author remain on the manuscript, especially given the fact that he may have done less on the manuscript than he originally said and may not even qualify for authorship according to the ICMJE guidelines. The first author agrees with this, but she is concerned that he may take litigious action against her, the university where she works, or the journal.

Question(s) for the COPE Forum

• Should the journal reject the manuscript? Is it unsalvageable at this point?
• If the journal does not reject the manuscript, should the second author be removed? How could that be handled?

Journal A is dedicated to communication about practical treatments related directly to patient and personal experiences. These ongoing discussions have been part of this specific medical profession for the past 50 years and journal A is a platform for these discussions.

Regarding new treatments and new developments, permission from the local medical ethical commission is mandatory as well as patient written permission for publication. For all other cases concerning standard practise reports about practical treatment issues, only written informed consent from the patient is needed before publication. As expected, only successful practical treatment cases are submitted for publication to journal A.

The society related to the journal organizes a biannual complication meeting which is attended by a small audience of around 120 doctors at which participants present their complication cases. At this meeting, many basic complications are discussed, which can be related to lack of education, lack of knowledge of materials, lack of knowledge about patient disease, or insufficient training, some of which have devastating outcomes. Many of these complications are avoidable.

As an editor and a doctor, I would like to publish some of these cases to improve patient safety and healthcare in general. However, the authors are often afraid of legal repercussions and patients are often not willing to provide consent after bad experiences. My solution would be to publish a series of these case reports as one publication with all authors in alphabetic order. I would leave out specific patient demographics, such as age and gender, and I would do so without written patient informed consent.

Question(s) for the COPE Forum

• Would this publication violate COPE guidelines? If yes, how could this be resolved?
• Is there any other way to resolve these issues?

An editor received a query from an author: “Your guidelines are clear that presenting data at a society meeting does not preclude publication. But what if the society records the presentation, retains copyright of that recording, and posts it online? Is asking presenters to turn over copyright of a recording of data presented at a prepublication stage and disseminating the recording as they see fit crossing the "prior publication" line?”

Question(s) for the COPE Forum
• Are presentation audiotapes considered prior publication?
• If tapes are copyrighted, does that preclude publication?

We have received a number of manuscripts involving a published scale where the scale’s developer is known to comb the literature and ask those who used the scale for research to pay for a retroactive license, sometimes asking for very large sums of money.

We have started asking authors on all submissions where the scale is used to provide a copy of the license agreement with the scale’s developer. In most cases, the authors do not have the agreement and are not receiving prompt responses from the scale’s developer and his team when they contact him to ask about the license. We have had to withdraw these manuscripts from submission until authors can provide evidence to indicate that the scale’s developer has granted them a license.

In a more complicated case, we found an accepted (but not published) manuscript that used the scale. We asked the authors, after acceptance, to obtain the correct permissions (they had not done so initially). They subsequently acquired the correct license, but the scale’s developer came back with a number of comments on the paper that he was requiring the authors to make prior to publication. This included adding three of his own papers to the reference list (but not indicating where they should be cited in the text). He also added his name and contact information to a number of places in the paper, most notably in the acknowledgments section.

The scale’s license contract and copyright agreement include a number of ‘copyright requirements’ that the authors must agree to. One of these is that all manuscripts using the scale that are being considered for publication must be submitted to the developer first to check that all copyright requirements are included. We felt it would be editorially irresponsible to allow these changes to the manuscript after peer review and have had to withdraw the manuscript (the developer also indicated that he "will not allow" the authors to publish the version of the manuscript that was accepted). The authors were very understanding about withdrawing their paper as they had been having a difficult time dealing with the scale’s developer and his team.

We have another case where the authors are removing data from their manuscript relating to the published scale but adding a note to indicate why they have done this. As such, the reporting of results will be incomplete.

We disagree with the actions of the researcher and his enforcement of copyright on the tool. We are currently only publishing articles that have a license permitted by the scale’s developer because we do not want to be sued or have to retract the articles.

Question(s) for the COPE Forum

• How should we be handling cases where this scale is being used?

• Should we be taking any action relating to the developer’s conduct?

As editor of a psychology journal, I received a manuscript from a group of scholars. The authors describe a qualitative online study with adolescent girls, aged 15–18 years, who met in person with a stranger they first ‘met’ online. The girls describe their reasoning about the risks, the safety measures they used and reactions to discomfort they experienced in the meetings.

The authors noted on our required information form that they “Confirm that all the research meets the ethical guidelines, including adherence to the legal requirements of the study country.” They also note in their cover letter that the paper conforms to APA (American Psychological Association) standards.

In the paper, the authors note that “parental consent was not required” because “all of the participants were older than 15 at the time of the interview, which is the legal age in the country where the study was performed”.

Because they identified the source of a number of quotations from the interviews that they conducted as being from 15 year olds, I contacted the first author for clarification.  I also asked where the statute is listed that states 15 years as the age of consent in your country and also asked if the study was reviewed by an ethical review board.

The author confirmed that the legal age is 15 years and the sentence should have read “all the participants were 15 years old or older.” They agreed to correct the paper. They stated 15 years was set in the project as the age where they would not require parental consent, but the youths themselves were informed about the procedure as well as their rights and agreed to participate. They said the law does not require informed consent when personal data (ie, data that could directly connect the information collected to the specific person) are not being gathered and stored during the process (with the exception of biomedical research). Hence institutional review board approval was not required and the project was therefore not reviewed by an ethical board. However, the project proposal contained a detailed description of the procedure, including the ethical aspects. The project proposal was approved by a university, and evaluated, approved and funded by a grant agency.

My concern is about the age of the participants. Does the Forum have a recommendation regarding the requirements for parental approval for participants as young as 15 years, even if the legal age of consent is 15?

Question(s) for the COPE Forum
• What is COPE's position on research on 15–18 year olds without parental permission in a country where the legal age of consent is 15 years?

A paper was submitted to our journal. The managing editor was concerned about patient information in the paper and queried the authors. The authors responded that the data were collected from routine samples and so consent was never obtained. The patients were lost to follow-up, and there was no ethics committee approval as it involved the study of existing data, but they did discuss with the institutional review board who said it was exempt.

The cohort was 2500 patients, all with one syndrome, in one hospital. The paper contains two tables that display data from 12 patients: sex, age, presenting symptom, as well as laboratory parameters and outcome.

Question(s) for the COPE Forum
• Are these patients identifiable?
• If we remove, say, age and sex, would that be sufficient to render the data anonymous? Would we lose clinical significance by removing age and gender for those patients, although the paper does mention that of the 12 patients most were female and gives the median age group?
• Should we publish this without patient consent?
• The study also mentions controls who underwent biopsy, but what is not clear is whether those controls were also from the same cohort and perhaps underwent biopsy as part of routine screening. Would they need ethics approval for biopsy?

Author A was an overseas PhD student who successfully completed the PhD, and then returned home to a country with considerable political and civil unrest. It had been intended to submit a paper before author A left but time ran out. Subsequently, authors B, C, D and E, who were all involved in the work in one form or another (experimental design, performing preliminary experiments, data interpretation and reanalysis, writing), have written the paper. However, authors B, C, D and E cannot track down author A.

Authors B, D and E have  tried emailing author A using the email address that author A used before and during the stay in the UK. Authors B and E have tried contacting author A’s spouse (who also did a PhD under author E’s supervision) by email and Facebook, but the spouse is not responding. Author E has contacted a colleague of author A at the overseas university that author A worked in but that person does not know how to contact author A, nor does another student from that country who studied in author E’s laboratory at the same time. The university that author A worked in is not open due to hostilities, and their website gives no contact information

Authors B, C, D and E are very keen to publish this paper, because the science is good, and also it is important for some of the co-authors who are early career workers and who need publications on their CVs.

Clearly, authors B, C, D and E are unable to obtain permission to publish from author A, whom authors B, C, D and E would like to put as first author, as author A performed the experiments.

Question(s) for the COPE Forum
• As the publisher of the journal where authors B, C, D and E wish the article to be published, would it be acceptable to publish the paper with a full statement about the authors’ contributions to the article, and the fact that authors B, C, D and E have not been able to contact A? Thus there would be complete transparency.

Our journal publishes case reports describing the evaluation, diagnosis and treatment of unusual cases. Parents must provide written informed consent prior to manuscript submission. No cases are presented with unique identifiers and each is anonymised as much as possible.

A manuscript was submitted with written consent that was accepted for publication and assigned to an issue. Just before the issue was to be folioed, the parents contacted the authors and revoked consent. The journal was able to pull the article prior to publication. The editorial board is concerned about this happening again and what the course of action would be if consent is withdrawn from a case that has already been published.

Question(s) for the COPE Forum
• Once written consent is provided, can it be revoked?
• If the article was already published, what would be the reasonable course of action? Retraction?