Informed Consent


The research proposal must include an informed consent form to be signed by the persons participating as subjects in the study. This form should be prepared according to the following rules:

  • Explain the reasons for the research, individual or collective benefits of it and clearly state the actual or potential risks that intervention involves.
  • It must be explicit, in simple language, if the subject is a child or a person who has no ability to discern the contents of the letter, it must be signed by the parent, guardian or legal guardian to be identified.
  • In the case of studies:

vAt the individual level: The researcher must obtain informed consent from the subject or, if the person is not capable to give informed consent (e.g. children), the proxy consent of a duly authorized representative. In the case of children, he must obtain the consent of the child to the extent that their mental development capacity allows

vAt the family level, the letter must be addressed to the responsible head of the family, who must sign as legally responsible.

vTargeting the population: If the population is captive (children's nurseries, school population, prisoners, etc.), as well as the letter of individual consent, a letter of consent from the highest level of the institution authorities should be included in the research proposal.

vAimed at community level: In addition to individual consent letters, include a cover letter bearing the consent and support for the implementation of the study of civil authorities of higher hierarchical level of the community.

vStudies at the national or Sub regional level involving sectoral interventions at the regional or national level should consider aspects of consent, as well as include communications to address the technical units of the sectors (research committees if there were, as well as to the sectoral authorities at the highest level) so that, in addition to being informed about technical and scientific aspects of the research, the authorities know that research is respecting the ethical aspects for the protection of the participating.

vIncentives for participation:

-          Inconveniences suffered   

-          time lost

-        Reimbursement of expenses incurred regarding their participation in research. Free medical services can be offered as well. However, the payments should not be so large or the medical services so extensive as to induce people to accept and participate. All payments, reimbursements and medical services to be provided to research subjects must be approved by the ethical review committee.



Essential information for research subjects


Research involving children


Research with subjects with mental or behavioral disorders


Research involving subjects in developing communities




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