General Ethical Aspects
RPMESP emphasizes that all research must be carried out respecting the rights of the participants, of those individuals related to the participants and of the members of the communities in which the research is conducted. Likewise, respect for the rights of other living beings, respect for natural resources, the environment and the cultural environment of societies must be ensured.
In this context, it is essential to ensure compliance with the ethical principles of respect of persons, beneficence and justice, which are part of the international guidelines governing ethical conduct in research, such as the Declaration of Helsinki and the Belmont Report. Articles submitted to RPMESP must ensure compliance with these principles in order to minimize any risks that may arise during the research. This aspect will be considered during the evaluation of each manuscript.
When necessary, the Editorial Board will request proof of approval by an ethics committee and of the informed consent as a prerequisite prior to publication.
Manuscripts are evaluated individually and impartially by the RPMESP Editorial Board, which makes decisions based on the aforementioned guidelines, in addition to the following: the World Health Organization (WHO) 2017 Code of Ethics and Professional Conduct, the 2016 International Ethical Guidelines for Health-Related Research Involving Human Subjects of the Council for International Organization of Medical Science (CIOMS), the American College of Epidemiology (ACE) 2000 Ethics Guidelines, and the Health Research Ethics Authority (HREA).
All research involving human subjects must have been carried out in strict compliance with the guidelines of the Declaration of Helsinki. The name of the ethics committee that approved the research and the code of the study approval document must be included in the manuscript. If the study did not require ethical approval due to its design or characteristics, the institution or committee that granted the exception must be identified. When appropriate, it should be mentioned in the article that informed consent was obtained from the participants.
If a study categorizes human beings according to race, ethnicity, social origin, sex, gender identity, sexual orientation, religion, political inclination, age, diagnosis, disability, socioeconomic status, among others, the authors should describe and justify the method used for such categorization, in addition to describing in detail the definition of the categories. We recommend following the SAGER guidelines when it is necessary to use categories related to sex, gender and/or sexual orientation. All terms should be used carefully to avoid confusion.
The language used in the manuscript must be respectful and inclusive, as well as non-stigmatizing. The article should be free of stereotypes or cultural assumptions.
Photographs showing patients’ faces should be edited to prevent identification of the individual. Anonymity of individuals should be ensured. Authors should state in the manuscript that consent for publication of the photographs was obtained from the patients or their legal representative. The Editorial Board may request evidence of informed consent if necessary. Images that do not comply with these requirements will not be published.
All Peruvian clinical trials must be registered in the Peruvian Clinical Trials Registry (REPEC) platform. International clinical trials must be in one of the primary registries of the World Health Organization Registry Network or in registries approved by the International Committee of Medical Journal Editors (ICMJE). The registry code must be included in the manuscript. We recommend following the CONSORT recommendations in order to guarantee transparency in the reporting of results.
Studies involving transplantation of human organs, tissues, embryos, stem cells or gametes must indicate that the specific guidelines and regulations in force for each case were followed. Details should be provided about the entities that provided the samples, in addition to specifying the institutional committee that approved the study. It must be stated that informed consent was obtained in all cases.
Approval by an ethics committee is required for all research conducted on human subjects including, but not limited to:
- Clinical trials and observational studies.
- Genetic research.
- Socio-anthropological research on vulnerable and non-vulnerable populations.
- Research on indigenous populations.
- Research on medical records or other personal information.
- Research that directly uses human biological material or non-anonymized samples stored in biobanks, among others.
The RPMESP Editorial Board does not request the approval of an institutional ethics committee in the following cases:
- Systematic reviews with or without meta-analysis.
- Bibliometric studies.
- Studies with secondary databases: these databases can have three sources:
- National survey databases, research or repositories (includes public health surveillance data) that are public or open access. Authors should include the link to access the database.
- Databases of primary research that were approved by an ethics committee, in these cases authors must comply with the following:
- Guarantee that the database used was completely anonymized.
- Submit evidence of authorization by of the institution/researcher responsible for the use of the database.
- Databases that come from public health surveillance* or outbreak studies**, in these cases authors must comply with the following:
- Ensure that the database used was completely anonymized.
- In the case that the database is not public, authors must submit evidence of the authorization by the entity that generates the data stating their consent to the publication.
*Public health surveillance: Defined as the continuous and systematic collection, analysis, and interpretation of health-related data essential to the planning, implementation, and evaluation of public health practice by the Centers for Disease Control and Prevention. This refers to health interventions that, due their nature, are required for the prevention and control of diseases in the population.
**Outbreak: A greater than expected increase in the number of cases of a disease. It may also be a single case in a new area. If not controlled quickly, an outbreak can become an epidemic, as stated by the Centers for Disease Control and Prevention. This refers to a timely intervention aimed at describing and controlling the progression of such an occurrence.
Both cases do not require the use of research methodology in order to be executed, but during the process they generate relevant scientific information to be disseminated.
Animal studies include research in vertebrate and invertebrate animals. In these cases, the manuscript must include a section clearly stating that the corresponding guidelines and regulations have been complied with. This section must include the identification of the institution or committee that approved the procedures. Likewise, the manuscript should include the characteristics of the animals that are relevant to the study.
We suggest reviewing the ARRIVE guidelines for animal research.
The following types of articles require approval by an animal research ethics committee:
- Experimental animal studies (testing of drugs, plants, foods, devices, and development of experimental models).
- Studies using animal baits
- Studies of venom extraction from animals in captivity (snakes) or in natural conditions (hunting).
The RPMESP Editorial Board will not request the approval of an animal research ethics committee in the following cases:
- Studies using secondary animal databases.
- Studies on insects or invertebrates that do not affect human health.
Studies in plants (in vitro studies)
Approval by an ethics committee will not be requested. Test specimens of all wild plants described in the manuscript must be deposited in a public herbarium or other public collection that provides access to the deposited material. Information about the voucher specimen and who identified it should be included in the manuscript. It is recommended to include georeferencing data of the plant.