ELSI-Brazil fulfils all the ethical criteria applied to scientific studies involving human subjects, such as voluntary participation, informed consent, privacy and data confidentiality.
The research procedures include: (1) an interview about general household characteristics and socioeconomic conditions of all residents; (2) an individual interview about physical and mental health and other relevant aspects; (3) blood pressure measurements, anthropometric measures and physical functioning assessment and (4) blood collection. The household interview i.e. procedure (1) is conducted with an adult member of each household. All residents aged 50 and older are eligible for the individual interview and objective physical measurements (2 and 3). A sub-sample was selected for blood collection (4).
Participants signed separate informed consent forms for each research procedure mentioned above. This consent fully clarifies and ensures all the rights and obligations of the participant. All interviewers are trained to answer and explain any potential doubts or queries raised by the participant who is entitle to consult a third party before signing the consent.
All interviewers are trained and accredited before the start of the fieldwork. All physical measurements fulfil very strict rules to protect participants’ health adopted in Brazil and in accordance with existing protocols. The results from blood pressure readings are reported to the participant. In an event of any problem during the physical assessment, demanding an urgent or emergency treatment, the participant is informed and referred to a health service unit accredited in the municipality where he/she lives. The same procedures are adopted for blood tests results.
Data confidentiality is ensured throughout all the phases of the study. The archived data are anonymized and used only for scientific purposes.
Regarding regulatory and legal aspects, ELSI-Brazil fulfils all the resolutions from the Brazilian National Ethics Council (resolution number 196/1996 and its amendments 292/1999, 340/2004, 346/2005, 347/2005 and 466/2012). ELSI-Brazil was approved by the ethics committee of the Rene Rachou Research Centre of the Oswald Cruz Foundation and it is registered in the national database of research involving human subjects, called Plataforma Brasil (protocol number 886.754).