Ethical Issues
ELSI-Brazil fulfills all the ethical criteria applied to scientific studies involving human subjects, such as voluntary participation, informed consent, participants’ privacy, and data confidentiality.
The research procedures on each occasion 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, anthropometric, and physical measurements. An adult resident of each household is invited to respond to the above-mentioned household interview. All residents aged 50 years or older are invited to respond to the individual interview and complete the physical measurements. Blood tests and sample storage were performed in a subsample of participants in wave 1. Saliva collection was performed among participants who authorize this procedure in wave 2.
Those who agreed to participate in the study signed separate informed consent forms for each procedure mentioned above. This consent fully clarifies and ensures all the rights and obligations of the participants. All interviewers are trained to answer and explain any potential doubts or queries raised by the participants who are entitled to consult a third party before signing the consent.
In each wave, the interviewers are trained and accredited before the start of the fieldwork. All physical measurements fulfill very strict rules to protect participants’ health adopted in Brazil and in accordance with existing protocols. The results from blood pressure measurements and anthropometric measures are reported to the participant. In an event of any problem detected 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 procedure is adopted with reference to laboratory tests.
The confidentiality of data obtained in interviews and other procedures is ensured throughout all the phases of the study. The information is archived without nominal identification and is used only for scientific research purposes.
Regarding regulatory and legal aspects, ELSI-Brazil fulfills 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). The approval by the institutional ethics committee is described below.
How to cite :
The ELSI-Brazil was approved by the Ethics Committee of the Oswaldo Cruz Foundation - Minas Gerais and the process is registered on Plataforma Brasil (CAAE: 34649814.3.0000.5091). Participants signed separate informed consent forms for each of the research procedures and authorized access to corresponding secondary databases.