Medical Research and Personal-data Protection ⎯Take Japanese Epidemiology Research as the Basis

 

Title
Medical Research and Personal-data Protection ⎯Take Japanese Epidemiology Research as the Basis
Author
Chen-Mei Fan Chiang
Keywords
Medical Research, Ethical Principles for Epidemiology Research, Ethical Committee, Informed Consent, Human Material or Data Ethical Principle Personal-Data Protection
Abstract
Medical progress is based on research that ultimately must include studies involving
human subjects. For medical research using identifiable human material or
data, it is the duty of physicians who participate in medical research to protect life,
health, right to self-determination, privacy, and confidentiality of personal information
of research subjects.
This article provides an overview of ethical principles for epidemiology research
which enacted by Japan in 2008. The ethical principles set forth three important
subjects, the first how to get the informed consent from potential research
subject, the second is the construct, function and duty of research ethical Committee,
and the third protect personal information of research subjects. In Accordance
with this ethical principles, the individual research subject should be provided appropriate
access to participation in research, can constitute an adequate regulatory framework for protection in epidemiology research.
On the other hand, Taiwan have, in the past enacted Human Research Act,
Human Biobank Management Act, Medical Care Act, in order to regulate medical
research and protect research subjects. Yet the scope of the existing regulations are
restricted and there is considerable confusion about how the rules would be applied,
they are insufficient to personal-data protection. Therefore to study ethical principles
for epidemiology about Japan, we believe that can get some available reference
to engage in constructive debate on the issue about personal information protection
of research subjects.
Abstract Article

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