Consideraciones bioéticas en estudios experimentales de evaluación de impacto de programas

Ethical considerations must be taken into account in studies involving people. The evaluation of programmes using randomised designs requires careful consideration regarding their enrolment, intervention allocation and follow/up phases. From the outset, special emphasis must be placed on equity during the enrolment phase concerning the inclusion of subjects participating in such studies, gaining/giving their informed consent and confidentiality. The allocation intervention phase should consider the control group's deprivation of benefits, their assignation by random draw and equity regarding the distribution of benefits. Special consideration should be paid to adverse events during the follow-up phase and participants' remuneration. The ethical implications of randomising individuals benefitting from programmes require extensive analysis, the organisation of consensus and ethical guidelines being disseminated for researchers and evaluators.