[Ethical issues about seroprevalence studies on viral hepatitis]

Epidemiological studies on viral hepatitis (VH) using new technologies raise ethical issues especially concerning community-based studies on seroprevalence (CSS), sentinel surveillance-based studies (SBS) the use of blood-bank registers (BBR) and serum stocks (SS).

Positive (PA) and negative (NA) aspects of these different designs are discussed, pointing to alternatives, according to Resolution CNS n masculine 196/96.

Priority for research is justified by VH magnitude, severity, and vulnerability, and need for development of diagnosis/therapy protocols and prevention/control strategies. With respect to CSS, PA was identified as: subject autonomy; adequate samples and as NA: costs override benefits, and availability of information from other sources. In relation to SBS, PA are: VH monitoring has lower operational costs than CSS; absence of additional injuries to subject; while NA is: relative restriction of representativeness. For BBR, PA is: the low cost of monitoring of HBV/HCV in blood donors and with no additional risk. PA has limited representativeness. SS studies present as PA: benefits higher than risks/costs; possibility of identification of new morbidity and offering of adequate diagnosis and treatment. NA is: biological material and research data can be used for other researches.

The choice of study designs must take into account arguments for ethical investigation and consensus on the use of new technology.