Table 2 Compliance level for three selected issues of ethical review (n = 832 RECs)

Information on the right to seek compensation is verified to be present in the consent forms

(Item 16 – Appendix)

The presence of this information is crucial to remind research participants of their human rights and legal guarantees. It is not the responsibility of the CEP/Conep System to judge or determine that anyone should provide financial compensation to a research participant. This is a matter for the legal system. However, as part of its mission to protect research participants, the CEP/Conep System must ensure that participants are informed of their right to turn to the justice system and seek compensation for any damage resulting from the study, at any point, if they so wish.

15.74% (n = 131)

No specification of the CEP/Conep standards based on which ethical issues were raised

(Item 5 – Appendix)

Significant heterogeneity was observed in the way ethical issues were raised in research protocols in the CEP/Conep System. While variability is not a problem in itself, the fact that many reports do not reference the CEP/Conep regulations when discussing ethical issues weakens the legitimacy of the ethical review process and any requests for adjustments and clarifications. To ensure that any issues requiring further attention by researchers are adequately reported and addressed, their description must refer to the specific legislation on which the concerns are based.

19.33% (n = 161)

Adequate review of informed consent forms to ensure immediate, free, and comprehensive assistance to research participants

(Item 19 – Appendix)

Information on these rights is of crucial importance, since individuals who agree to take part in a study must be explicitly told through the informed consent form that those responsible for the study will ensure they receive the necessary treatment for any harm or damage to their wellbeing directly or indirectly related to their participation in the study.

34.78% (n = 289)