Korean J Epidemiol.  2006 Dec;28(2):129-137.

Bioethics and Protection of Personal Information in Observational Studies

  • 1Department of History of Medicine and Medical Humanities, College of Medicine Seoul National University, Korea. okim9646@snu.ac.kr


Observational studies constitute an important part of epidemiologic research. Researchers need to recognize that some of the observational studies may result in serious damage to the participants, and it is very important to understand that which aspect of such studies may pose a risk to the participant. The key element of an observational study that may raise an important ethical issue is specific information itself. Researchers need to make sure who has the right to make decision on the information, and by what pathways the information flows. Informed consent is an essential component involved in handling the information associated with participants' interest. Institutional review board (IRB) should oversee the study design and procedures to ensure the study procedures respect the rights of the participants and communities they belong to and protect them from any harm. Modern technologies add new dimensions to observational studies because of genetic information and large scale database systems that are linked with the study. Data security need to be assured by various procedures and legal protections. As the value of information becomes greater in the modern society, the importance of bioethics and personal information protection also becomes greater in the observational studies.


Observation; Bioethics; Personal; Record

MeSH Terms

Computer Security
Ethics Committees, Research
Human Rights
Informed Consent
Observational Study
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