Publication ethics


To ensure scientific publications are of the highest quality, the Committee on Publication Ethics (COPE) have established a series of international ethical standards and guidelines. These guidelines provide advice to editors and publishers on all aspects of publication ethics and, in particular, how to handle cases of research and publication misconduct. COPE also acts as a forum for editors and publishers of peer-reviewed journals to discuss all aspects of publication ethics.

Dove Medical Press is a member of COPE and subscribes to COPE’s Core Practices and Best Practice Guidelines to ensure the highest standards in publication ethics are upheld. All manuscripts submitted to Dove Medical Press undergo thorough pre-publication screening for issues relating to patient consent, patient identity protection and animal ethical approval. Authors must be aware of several important publication ethical issues when submitting an article to Dove Medical Press for publication. These issues are outlined below:

Patient identity/Informed consent
Dove Medical Press requires authors to confirm that all patients or participants (or that person’s parent or legal guardian, if the study participant is under 18 years of age) of any research, clinical trials or case studies have provided written informed consent for their details to be used in the manuscript. Similarly, any manuscript containing data, images or videos relating to an individual or group of individuals must have written patient consent for the publication of these details. Authors must also ensure all identifying patient data is anonymized and any nonessential identifying information should be omitted from the article. This includes but is not limited to the patient’s name, address, place of employment, date of birth, telephone number, email address, medical records and patient ID, account numbers, license number, IP address and full or comparable photographic image or video. Dove Medical Press instructs all authors to read and follow the ICMJE guidelines for the Protection of Research Participants.

Where informed consent has been obtained, it must be indicated in the published article and authors must be able to provide details of this if requested by the editor. The forms must contain all the elements generally expected to be included in a patient consent form. The WHO provides useful informed consent form templates which can be adapted by investigators to suit the needs of their specific studies. It is also the responsibility of the authors to ensure they have adequately archived patient consent forms and inform the journal of this. If any doubt exists about patient identification the Publisher at Dove Medical Press will be the final arbiter.

Ethical approval of human research
All planning conduct and reporting of human research must be in accordance with the Declaration of Helsinki. This includes any study involving human subjects, medical records and human tissues. Authors should also seek the approval to conduct research from an independent local, regional or national review board (e.g. Institutional Review Board (IRB) or ethics committee). Any considerations or approvals made by this committee must not reduce or eliminate the protections for research subjects set out by the Declaration of Helsinki. If doubt remains whether the research was conducted in accordance with the Declaration of Helsinki, the author must demonstrate the rationale for the independent local, regional or national review boards decision. A statement declaring review board approval must be included in the manuscript.

Ethical approval for use of human cell lines and tissues
Human cell lines and tissues are considered forms of human biospecimens. For this reason, we please ask authors to include a statement in their manuscripts detailing the relevant ethical approval and patient consent for the use of human cell lines or tissues in their studies. This is an essential requirement especially where the human material used is potentially identifiable, such as material contained in biobanks or similar repositories. If the cell lines or tissues were purchased through an accredited commercial provider, please provide details of this. If ethical approval or patient consent was not sought or provided, please provide an explanation for this.

Clinical Trial Registration
To be considered for publication, all authors submitting clinical trials involving human subjects must have registered the trial in a public trials registry. This is in accordance with the Declaration of Helsinki. Ideally, the clinical trial should be prospectively registered in an acceptable registry that is accessible to the public at no charge, open to prospective registrants, allows for the validity of the registration data to be checked and is electronically searchable. Authors must include the Clinical Trial Registration number in the manuscript.

Dove Medical Press defines a clinical trial as:

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may or may not include a placebo or control group) to evaluate the effects of those interventions on a health-related biomedical or behavioural outcome.

Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.

Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.

Full details of clinical trial registration and the necessary requirements can be found on the ICJME website.

Please note: The Clinical Trial Registration guidelines were adapted from information provided by the International Committee of Medical Journal Editors (ICMJE) and the World Health Organization (WHO).

Case reports/Case series/Clinical datasets
Dove Medical Press considers a case report to be the diagnosis, treatment and post-treatment follow-up of a single patient. In comparison, a case series is considered a group of case reports involving patients who were all given similar treatment. A clinical dataset is a list of well-defined variables collected during the course of ongoing patient care or as part of a clinical trial program. It includes electronic health records, administrative data, patient registries, and clinical trial data.

In some instances, a case report or case series containing information on less than three patients may not require IRB approval. This is because a case series of less than three subjects may not be considered generalized knowledge or research. However, this requirement is dependant on the institution, country or region implementing it and authors must ensure they have followed the correct regulatory requirements of their respective institution or country. Outside this requirement, all case reports, case series or clinical datasets must have IRB approval and authors must be aware that IRB approval cannot be given retroactively. A statement declaring IRB approval must be included in the manuscript. Details of Journals’ Best Practices for Ensuring Consent for Publishing Medical Case Reports can be found on COPEs website.

Ethical approval of animal research
All manuscripts involving animal research must show the work followed international, national and institutional guidelines for the ethical and legal treatment of animals. Authors must show the study was approved by an ethics review committee from the same institution at which the study was conducted. For non-human primate studies and veterinary studies using client-owned animals, it must be demonstrated the work meets the standards set out in NC3Rs primates guidelines and follows veterinary care best practices guidelines. For veterinary studies informed client consent must also be provided. Dove Medical Press advises all authors conducting animal research to read and follow NC3Rs ARRIVE guidelines. The guidelines set out the currently accepted procedures for the reporting of research using animals and are available in various translations including Chinese Mandarin. A statement declaring the ethical review committee’s approval must be included in the manuscript. 

Ethics FAQ for authors
Q: Do I need ethics approval for retrospective patient data?
A: Yes. Approval from a formally constituted review board (Institutional Review Board or Ethics committee) is required for all studies involving people, medical records, and human samples.
Q: Do I need patient consent for the use of retrospective data?
A: Informed consent by participants should always be sought. If not possible, an institutional review board must decide if this is ethically acceptable. A statement should be included in the Materials and Methods section of your manuscript, regarding the IRB decision.
Q: Do I need ethics approval for a review article or meta-analysis article?
A: No. This will have been obtained by the original authors.
Q: Do I need ethics approval for using samples sourced from commercial providers?
A: Yes. Approval from a formally constituted review board (Institutional Review Board or Ethics committee) is required for all studies involving people, medical records, and human samples.
Q: If ethics approval was not required, what statement should I include in my manuscript?
A: For those investigators who do not have access to formal ethics review committees, the principles outlined in the Declaration of Helsinki should be followed. If the study is judged exempt, a statement from the ethics committee is required. A statement should be included in the Materials and Methods section of your manuscript, regarding the decision.
Q: Do I need ethical approval when reporting on veterinary clinical cases?
A: No. For studies using client-owned animals, a high standard (best practice) of veterinary care and involves informed client consent statement should be included in the Materials and Methods section.
Q: Do I need ethics approval for studies involving live animals?
A: Yes. You must specify in the Materials and Methods section of your manuscript, the ethical review committee approval, and the international, national, and/or institutional guidelines followed regarding the animals welfare.
Q: Do I need approval for cells that have been sourced from an accredited commercial provider?
A: No. However, if cells have been gifted, or not sourced from an accredited commercial provider, we require confirmation that the research has been approved by a named institutional review board or ethics committee.

Updated 14 January 2020