Research ethics policies
Regarding the ethical aspects involved in the conduct of the study, the following should be considered:
Research involving human subjects:
All research conducted on human subjects require approval by an ethics committee, 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 Committee will not request the approval by 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:
a) Databases from national surveys, research or repositories (includes public health surveillance data) that are publicly available. Authors should include the link to access the database.
b) Databases of primary research that were approved by an Ethics Committee, in these cases the authors must comply with the following:
- Guarantee that the used database was completely anonymized.
- Present the permission of the institution/researcher responsible for the use of the database.
c) Databases that come from public health surveillance* or outbreaks**, in these cases the authors must comply with the following:
- Guarantee that the database used was completely anonymized.
- In the case that the database is not public, they must present the authorization of the responsible entity that generates the data to express their agreement with the publication.
*Public health surveillance: “The ongoing, systematic collection, analysis, and interpretation of health-related data essential to planning, implementation, and evaluation of public health practice” (Centers for Disease Control and Prevention). This is understood as health actions that, by their nature, are required for the prevention and control of disease in the population.
**Outbreak: “A greater-than-anticipated increase in the number of endemic cases. It can also be a single case in a new area. If it’s not quickly controlled, an outbreak can become an epidemic” (Centers for Disease Control and Prevention). This is understood as a timely intervention aimed at describing and controlling the progression of such occurrences.
In both cases, the research methodology is not used to be executed, however, during the process it generates relevant scientific information to be disseminated.
The following 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
- Poison extraction studies on animals in captivity (snakes) or in natural conditions (hunting).
The RPMESP Editorial Board will not request the approval by 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.
Research with plants (in vitro studies):
Approval by an ethics committee will not be requested. Test specimens of all wild plants described in a manuscript should 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 the georeferencing of the plant.
In case of doubts or controversies in this regard, the RPMESP Editorial Committee will be the one to evaluate and solve them, as previously established. All this, in compliance with international organizations such as the Declaration of Helsinki 2013, the World Health Organization (WHO), The Council for International Organization of Medical Science (CIOMS) 2016, American College of Epidemiology Ethics Guidelines, Health Research Ethics Authority (Canada).
If the Editorial Committee deems it necessary, it will request the study database and complementary information in order to corroborate its results.