Research involving human subjects

Last updated: 05/22/2025

REGEPE understands that ethics govern the standards of conduct for scientific researchers. Therefore, we emphasize the importance of adhering to ethical principles to protect the dignity, rights, and well-being of research participants. REGEPE also acknowledges that, due to its publication scope—Entrepreneurship and Small Business Management—submitted studies will exclusively involve individuals as research participants, excluding, for instance, clinical patients and studies involving animals and/or plants.

Based on the above and in accordance with the principles of the Declaration of Helsinki, REGEPE requires its researchers to comply with ethical research standards. All studies involving people—whether representative individuals of a sample or interviewees, for example—must be evaluated by a legitimate research ethics committee before being conducted.

Regarding participant consent, authors must indicate whether participants provided written consent. The documentation of participant consent should include, for example, all potential risks associated with participation in the research, as well as clear communication regarding the participant’s right to refuse participation at any point during data collection and the measures taken to ensure the anonymity of participating individuals.

  • For Brazilian authors, we recommend that the issuance and certification of supporting documents for the above guidelines be carried out through the Plataforma Brasil. Thus, documents such as the Free and Informed Consent Form (TCLE), the Data Usage Commitment Form (TCUD), and the Project Submission Receipt in Plataforma Brasil—where the project registration number (Certificate of Ethical Appreciation Submission - CAAE) in the CEP-Conep system is listed—should be submitted.
  • In the case of international researchers who do not have models for the aforementioned terms directed by their respective Ethics Committees, we strongly recommend completing the consent training provided by the U.S. Department of Health and Human Services and making cautious use of the models suggested by the World Health Organization.

For studies where participant consent is waived, authors must submit a declaration such as the example below:

"The Ethics Committee [TO BE COMPLETED] waived the need for ethical approval and participant consent for the collection, analysis, and publication of retrospectively obtained and anonymized data for this study."

REGEPE recommends that authors of any research study pay close attention to the rules (laws and policies) established by their respective national regulatory bodies, as well as their institutions, regarding the necessity of compliance with ethical guidelines when conducting research involving human subjects.

For research conducted in other locations, authors must adhere to the procedures outlined by their respective countries and competent authorities.