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Bioethics and Protection of Personal Information in Experimental Studies.
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Ock Joo Kim
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Korean J Epidemiol. 2007;29(1):1-12.
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 Abstract
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Abstract
Experimental studies involve intervention and manipulation of study elements such as randomization of the participating groups. In general, experimental studies involving human are riskier than observational studies, demanding robust ethical vigilance and compliance among such stakeholders as investigators, sponsors, IRBs and health authorities. Social values of research should be counted as a primary ethical consideration in experimental research. It is unethical to put human subjects into uncertain and risky conditions if the study does not pursue valuable knowledge. Sound scientific design is prerequisite for good ethics.
Risk-benefit ratio of the study must be carefully evaluated study. Not only risks from physical harms but also socio-economical and psychological harms from the study should be considered as risk of the study. Risks from the design of the study such as randomization and placebo must be carefully examined. Voluntary informed consent is essential in experimental studies involving human. Human subjects, before they decide to participate in the study, must be informed the followings: risks, benefits, experimental procedures, alternative treatment, compensation for injury, and participants' voluntariness and right to withdraw at anytime. Experimental studies are usually required written consent documentation and full institutional review board (IRB) review. Other elements of experimental research ethics includes special protection for high risk groups and various vulnerable groups, and protection of privacy and confidentiality.
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Bioethics and Protection of Personal Information in Observational Studies.
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Ock Joo Kim, Eun Kyung Choi
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Korean J Epidemiol. 2006;28(2):129-137.
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Abstract
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Abstract
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.
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