BACKGROUND: 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). METHODS: Positive (PA) and negative (NA) aspects of these different designs are discussed, pointing to alternatives, according to Resolution CNS n masculine 196/96. RESULTS: 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. CONCLUSION: The choice of study designs must take into account arguments for ethical investigation and consensus on the use of new technology.
BACKGROUND: 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). METHODS: Positive (PA) and negative (NA) aspects of these different designs are discussed, pointing to alternatives, according to Resolution CNS n masculine 196/96. RESULTS: 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. CONCLUSION: The choice of study designs must take into account arguments for ethical investigation and consensus on the use of new technology.
Authors: Corinna Klingler; Diego Steven Silva; Christopher Schuermann; Andreas Alois Reis; Abha Saxena; Daniel Strech Journal: BMC Public Health Date: 2017-04-04 Impact factor: 3.295