Editorial practices
SPANISH JOURNAL OF CLINICAL CASES IN INTERNAL MEDICINE (Revista Española de Casos Clínicos en Medicina Interna or RECCMI, according to the Spanish acronym)
Sociedad Española de Medicina Interna (SEMI, according to the Spanish acronym)
Ethical aspects of RECCMI
Even at the risk of being repetitive, the Spanish Journal of Clinical Cases in Internal Medicine (RECCMI) Management, its sponsor, the Sociedad Española de Medicina Interna (SEMI), and the technical editors (CTO editorial) wish to clearly state their commitment to the ethical standards of scientific publication currently deemed to be of application.
For this reason, RECCMI has gathered from the literature the primary published statements highlighting a commitment to ethics as one of their most obvious values.
Any research conducted by authors, whatever its nature, must be carried out according to the Declaration of Helsinki guidelines and the standards of good clinical practice, in addition to the legislation in force.
Informed consent
In any clinical study, the authors must confirm authorisation from the corresponding ethics committee as well as written informed consent (or exemption of such requirement from said ethics committee).
When publishing clinical cases, authors obtain patient authorisation to publish the case and must ensure no identifiable data is included. Photographs must be non-identifying (if the patient's face is included, the eyes must be covered with opaque black tape) and written authorisation must also be obtained from the patient for the publication of such photographs.
One of the defining characteristics of clinical cases, in general, is their particularity. While their reproducibility makes them useful for forming and drawing conclusions that enable the identification of clinical behaviours and their application to new patients, therein lies the social and scientific benefit of their discovery and their application to diagnosis and therapeutic correspondence.
However, this particularity, as well as the local vulnerability of computerised file storage systems, means that clinical cases, and their protagonists, are more easily identifiable than those included in larger series.
These characteristics make it necessary, from the perspective of potential identification and in the interest of ideal bioethical conduct, to make a significant effort to guarantee the protection of any individual data that could possibly identify individuals.
For this reason, RECCMI requires the following conditions of the authors of the cases it publishes:
- If there exists any possibility to directly identify a patient or patients (photographs, videos, etc.), express authorisation for participation must accompany the final version submitted to RECCMI.
- In all cases and for all articles, the authors must have and maintain possession of the corresponding informed consent for publication.
Conflicts of interest
Authors must declare all possible conflicts of interest in the form of familial, personal or financial relationships related to the results of the article. If there are no conflicts of interest, authors are still required to include this in their manuscript under the corresponding section, stating "No conflict of interest". In addition, sources of funding for the article are to be included in the acknowledgements section.
The editors may require authors to expand or elaborate on the conflicts of interest statement as they deem appropriate.
RECCMI adheres to the latest version of the rules of the International Committee of Medical Journal Editors, which extends conflicts of interest to the authors' family members and persons living with them.
Submitted articles must not have been published previously (except in the form of communication at a scientific conference or as a PhD thesis) or be under review by another journal at the time of submission to RECCMI or during the peer review period.
All authors contributing to the article must comply with the authorship requirements described by the ICMJE, available at http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html.
As mentioned above, all papers involving patients must explicitly state that written informed consent for their participation has been obtained.
Experimentation on human subjects
Scientific research and experimentation involving human subjects is a right and duty of the scientific and biomedical community. Scientific experimentation is an important means of advancing knowledge about human nature. This knowledge must be used to improve human well-being, health and quality of life.
Regarding papers involving human subject research, the following items must be made explicitly stated in a separate document to be attached to the article:
- In human subject research, the interests of science and society may never prevail over the well-being of the subject. The subject's right to protect his or her integrity must always be respected. Every precaution should be taken to preserve the physical and psychological integrity of individuals participating as experimental subjects.
- Experimentation on human subjects which may involve risk or discomfort to the subjects should only be conducted when there are no alternative procedures of comparable efficacy.
- Biomedical research involving human subjects must conform to generally accepted scientific and ethical standards. It shall be grounded in the assessment of risks based on prior, adequately performed laboratory and animal experimentation and on a thorough knowledge of the possible consequences of the research. No experiments may be performed on human subjects unless there is no comparably effective alternative method to human experimentation.
- Risk-benefit ratio of research. The risks or discomfort involved in experimentation on human subjects shall not be disproportionate nor shall it impair moral conscience or dignity. In the case of biomedical research, the importance of the objective shall in proportion to the inherent risk to the subject.
- Any biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others.
- Concern for the interests of the subject must always prevail over the interests of science and society. Any research or experiment must be discontinued if the risks are found to outweigh the calculated benefits.
- Participation in any research or experiment shall involve the free and informed consent of the subject after being adequately informed of the nature and purpose of the investigation, the aims, methods, anticipated benefits, and potential risks or discomforts it may entail. Subjects shall be free to withdraw their consent at any time, without any detriment to themselves. In the case of participation in research or experiments in minors or disabled persons with impaired competence or autonomy, consent shall always be given in writing by their legal guardian, relative, the person who has the duty of care.
- In the event that researchers offer subjects financial incentives or rewards, or incentives of any other kind, for their participation in the research or experiment, in no case this shall be so high that the subject cannot reasonably refuse it.
- Researchers must ensure the subjects' right to privacy. In teamwork, each investigator is responsible for maintaining complete confidentiality. All participants in human subject research shall maintain the strictest confidentiality such that the subjects' personal and family privacy is not violated.
- In any scientific experiment or research, experimental subjects or participants must be treated with the utmost respect for their dignity, beliefs, privacy, and modesty, with special protection for the most vulnerable.
- In all scientific research or experiments, the identity of the researcher(s) responsible for the investigation or analysis must be clearly stated as well as that of the rest of the research team collaborating on the experiment or research.
- The responsibility for the research must always rest with the investigator, and never on the research subject, even though subject has given their consent. Approval from an ethics committee of the experimental protocols does not exempt investigators from their direct responsibility.
Author contributions. In this section of the manuscript, a paragraph specifying the contributions of each of the authors listed on the first page shall be included, regarding both the work and the preparation of the manuscript.
The standardised requirements for manuscript submission to scholarly journals state that authorship should be based on substantial contribution, which should simultaneously include:
- The conception and design of the work, or the acquisition, analysis or interpretation of the data.
- Drafting the work or revising it critically for important intellectual content.
- Final approval of the version to the published.
- Taking responsibility for and ensuring that all aspects of the manuscript have been reviewed and discussed among the authors to ensure that they are presented with the utmost accuracy and integrity. These criteria can be checked and expanded upon in different information sources available at the following links, among others:
- http://www.icmje.org/recommendations/browse/rolesand-responsibilities/defining-the-role-of-authors-andcontributors.html
- http://www.editorialmanager.com/jvs/ACCOUNT/CriteriaforAuthorship.pdf
All these conditions must be met, as exclusive participation in acquisition of funding, data collection, or statistical analysis, for example, does not justify authorship, nor does general supervision of the work. The responsible author must ensure that all included individuals meet the authorship criteria and that no one is excluded who also meets the criteria. Examples for the wording of authorship contributions can be found at the end of the main body of text of original papers published in recent issues of RECCMI. Including this information is a prerequisite for consideration of the manuscript by the editorial board. Therefore, authorship contribution statements must be made for all the types of articles described above. In addition, authors will be asked to sign a transparency declaration using the text below:
The corresponding author, on behalf of the other signatories, affirms the accuracy, transparency, and honesty of the data and information contained in the study, that no important aspects have been omitted, and that any discrepancies between authors have been adequately resolved and described.
Funding. Financial and material support for the study should also be acknowledged on the second page, indicating the organisation, agency, institution, or company and the project, agreement, or contract number. If no external funding was obtained, "No funding" should be stated. This information is required for all the types of articles described above.
Acknowledgements. The second page should also include an acknowledgements paragraph, if appropriate, where individuals who do not fulfil all the criteria for authorship, but have aided the study or manuscript in some way, should be listed. This is also an acceptable place to cite individuals or institutions that have supported the study or manuscript, either with work or funds. RECCMI adheres to the International Committee of Medical Journal Editors (http://www.icmje.org/) international acknowledgements standards. All individuals mentioned explicitly in the acknowledgements section must be aware of this and approve their inclusion in said section.