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KMID : 0878220110230030318
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Journal of Sasang Constitutional Medicine
2011 Volume.23 No. 3 p.318 ~ p.329
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Attitude and awareness of Sasang Constitution Investigators on the Informed Consent
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Yoo Jong-Hyang
Kim Yun-Young
Kwon Ji-Hye
Park Ki-Hyun
Lee Si-Woo
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Abstract
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Objectives: We surveyed the attitude and awareness of Sasang Constitution investigators on informed consent in clinical study. This study was performed in order to improve the quality of ethical aspects in clinical study by surveying the process of obtaining informed consent.
Methods: We sent the questionnaire by email to Sasang Constitution investigators who had the experience in clinical study. The question was about the necessity of informed consent and the process of obtaining it.
Results: Twenty-two out of 24 questionnaires were collected. All of investigators recognized that informed consent is needed for clinical study. Sixty-four percent of the respondents ’fully’ or ’mostly’ explained the informed consent but they added only 41% of participants ’fully’ or ’mostly’ understood. Fifty-four point five percent of respondents provided participants enough time and opportunity to inquire the study in details to decide whether or not to participate in the study, the rest of respondents obtained informed consent without providing enough time for decision.
Conslusions: Sasang Constitution investigators had high awareness of necessity for informed consent in clinical study. But participants’ understanding was low despite of the degree of investigators’ explanation. A various strategies should be designed for improving consent forms and process. Most of all, investigators should make sure that informed consent intends to protect participants and promote ethical research conduct.
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KEYWORD
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Informed Consent, Clinical Study, Constitution Investigator
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