Ethical considerations
The authors must ensure that the study submitted complies with the ethical and legal principles in both the research and publication phases, including the guidelines of the World Medical Association Declaration of Helsinki revised in 2013 (https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/), the ICMJE (www.icmje.org) and the Committee on Publication Ethics (COPE) (http://publicationethics.org/resources/guidelines).
Ethical Committee Approval
When applicable, the authors must provide evidence of approval by the ethics committee(s) of the involved institution(s). This information must be included in the appropriate section of the manuscript.
Informed Consent
Before publication, written informed consent should be obtained from the participants (or parent/guardian) in the studies involving patients or volunteers. The authors are responsible for obtaining patients’ informed consent for any reported clinical and biological data, published photographs, and videos. This information must be stated in the appropriate section of the manuscript.
Privacy
RPO follows the General Data Protection Regulation (Law No. 58/2019 of 8 August). Accordingly, any non-consented information related to patients, including photographs, identification, or hospital record numbers, is not accepted, even after taking appropriate measures to preserve anonymity. Furthermore, names, initials, or other forms of identification must be removed from photos or other images.
Studies involving animals
Studies involving animal experiments must be conducted following the guidelines defined in the “Guide for the Care and Use of Laboratory Animals” by the National Institute of Health. All animal studies should also comply with the ARRIVE (Animal Research: Reporting of In Vivo Experiments) guidelines. The authors should also comply with the national legislation that regulates this type of study (Decree-Law No. 113/2013 of 7 August 2013). The manuscript should clearly include a declaration of compliance with the above-mentioned guidelines. RPO holds the right to reject any manuscript based on ethical misconduct in human or animal studies.
CONFLICTS OF INTEREST AND FUNDING SOURCES
Public trust in the scientific process and the credibility of published articles depends partly on how conflicts of interest are handled during the planning, implementation, writing, peer review, editing, and publication of scientific work.
A conflict of interest exists when professional judgment concerning a primary interest (such as patients’ welfare or the validity of research) may be influenced by a secondary interest (financial gain). Financial relationships are the most easily identifiable type of conflicts of interest and are the most likely to undermine the credibility of the journal, the authors, and science itself. However, conflicts can occur for other reasons, such as personal relationships or rivalries, academic competition, and intellectual beliefs. Authors should avoid entering into agreements with study sponsors, both for-profit and nonprofit, that interfere with authors’ access to all of the study’s data or with their ability to analyze and interpret the data and to prepare and publish manuscripts independently when and where they choose. All participants in the peer-review and publication process must consider their potential conflicts of interest when fulfilling their roles and must disclose all relationships that could be perceived as potential conflicts of interest.
Therefore, all authors must complete and submit the ICMJE Form for Disclosure of Potential Conflicts of Interest available at: http://www.icmje.org/disclosure-of-interest/. This information will not influence the editorial decision; it will be kept confidential during the manuscript review and published if the article is accepted. If there are no conflicts of interest, the authors must state this. This information should be provided in the section entitled “Declaration of Conflicts of Interest”, which follows the “Acknowledgements” section and precedes the “References”. The absence of any conflict of interest must also be declared as well.
Authorship
Everyone listed as an author should meet our criteria for authorship. Everyone who meets our criteria for authorship must be listed as an author.
The journal follows the criteria established by the International Committee of Medical Journal Editors (ICMJE) Uniform Requirements for Manuscripts Submitted to Biomedical Journals. The requirements for authorship are:
– Substantial contributions to the conception and design, acquisition of data, or analysis and interpretation of the study data that has resulted in the manuscript.
– Drafting the article or revising it critically.
– Final approval of the version to be published.
– Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Authors must meet all four conditions in order to be listed. The correspondence author is responsible for ensuring that all co-authors meet the requirements for authorship. Each author agrees that the corresponding author will be responsible for submitting the manuscript to the journal. By submitting this manuscript, each of the authors indicates that they have had full access to all the data in this study and assume full and public responsibility for the integrity and accuracy of the data analysis.
Once the manuscript is submitted, it will not be possible to make changes in the order and number of authors, so all issues related to authorship must be solved before sending the manuscript for the first time.
In case of collective authorship, the names of the writers or the ones responsible for the work followed by “and the Group …” will be included when all the members of the group consider themselves co-authors of the work. If the name of the group is to be included, even if not all of its members are considered co-authors, the responsible authors will be mentioned followed by “on behalf of the Group …” or “by the Group …”. In any case, the names and institutions of the members of the group will be included in an attachment at the end of the manuscript.
Contributors who do not meet the criteria for authorship should be mentioned in the Acknowledgments. It is expected that those being acknowledged have given their permission to be named.
The journal declines any responsibility on possible conflicts derived from the authorship of the works that are published in it.
Editors, members of the Editorial Board, and journal staff as authors
The RPO considers original papers submitted by editors, Editorial Board members, and journal staff, but they are not involved in editorial decisions about their scholarly work. After submission, an editorial assistant verifies if any member of the RPO team is an author. In this case, the members are excluded from publication decisions. The RPO has two Editors-in-Chief, and one of them (without authorship responsibility) is assigned to coordinate and oversee the review process.
CLINICAL TRIALS
RPO supports initiatives that contribute to better disclosure of clinical trial results. This includes prospective registration of clinical trials in public databases. Following the ICMJE recommendations, the RPO requires the registration of all clinical trials included in manuscripts submitted for publication in this journal.
ICMJE adopts the World Health Organization’s definition of the clinical trial: “any study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes”. This definition includes Phase I to Phase IV trials. In addition, ICMJE defines health-related interventions as “any intervention used to modify a biomedical or health-related outcome” and health-related outcomes as “any biomedical or health-related measures obtained in patients or participants”.
Moreover, registration in a public clinical trials database is mandatory for the data obtained from clinical trials, following the recommendations of the ICMJE. The trials must be registered before or at the start of the patient recruitment period. The trial registration number (TRN) and date should be included in the last line of the manuscript abstract.
Purely observational studies (those in which the assignment of the medical intervention is not at the investigator’s discretion) do not require registration.
