Research Policy with Human Beings

The Critical Patient Journal (RDC) demands strict compliance with the ethical, legal and regulatory standards applicable to research involving human participants, ensuring respect for the dignity, rights, safety, privacy, confidentiality and well-being of the people involved in the published studies.

The authors are responsible for ensuring that the research was conducted in accordance with internationally recognized ethical principles, namely the Declaration of Helsinki of  the World Medical Association, the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals of  the International Committee of Medical Journal Editors (ICMJE), the guidelines of the Committee on Publication Ethics (COPE) and the applicable legislation in the context in which the study was developed.

 

⮚      Ethical Approval

Manuscripts describing research involving human participants should indicate, where applicable:

●        The name of the ethics committee or competent entity that assessed the study;

●        the number, reference or code of the approval obtained;

●        The date of ethical approval, which shall, where required, be prior to the commencement of the investigation.

When the nature of the study does not require formal approval by an ethics committee, or when such approval is not applicable, the authors must present a reasoned justification, which may be assessed by the Editorial Team.

RDC may request, at any stage of the editorial process, documentation proving ethical approval or other elements it deems necessary to verify compliance with the applicable ethical requirements.

The absence of ethical approval, when legally or ethically required, may determine the rejection of the manuscript.

 

⮚      Informed Consent

Authors must expressly declare that they have obtained informed consent from the participants or their legally authorized representatives, whenever required by applicable law and the ethical principles of the research.

The informed consent process should ensure that participants have received clear and adequate information about the objectives, procedures, potential risks and benefits of the study, as well as about the confidentiality of the data, the protection of their privacy and the right to refuse or withdraw participation, without any prejudice.

Where the research involves minors, incapacitated adults or other particularly vulnerable groups, the specific ethical and legal requirements applicable must be complied with.

 

⮚      Clinical Cases and Identifiable Information

In clinical reports or case series, authors must obtain specific permission for the publication of clinical information, images, records or any other elements that may allow the direct or indirect identification of participants.

Whenever possible, personal data and images should be properly anonymized. Anonymisation should not be achieved by altering or manipulating relevant clinical data that could compromise the authenticity of scientific information.

When anonymization is not sufficient to prevent the identification of the participant, there must be explicit consent for publication, obtained from the participant or his legal representative.

RDC reserves the right to request documentary proof of the consent obtained and to refuse the publication of manuscripts that do not demonstrate adequate compliance with the applicable ethical requirements.