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@article{ART001427124},
author={송영민},
title={The Way to Secure Trial Subjects' Rights of the Self Determination on the Clinical Trials of Medical Supplies},
journal={DONG-A LAW REVIEW},
issn={1225-3405},
year={2010},
number={46},
pages={145-173}

TY - JOUR
AU - 송영민
TI - The Way to Secure Trial Subjects' Rights of the Self Determination on the Clinical Trials of Medical Supplies
JO - DONG-A LAW REVIEW
PY - 2010
VL - null
IS - 46
PB - The Institute for Legal Studies Dong-A University
SP - 145
EP - 173
SN - 1225-3405
AB - Owing to the experimental characteristic of clinical trials, it is not obvious how much the benefit and riskiness would affect to the trial subjects in the process of experiments, thus whether the intentions of trial subjects are reflected is more important issue than medical treatments in clinical services. The adults who have the consent abilities would be able to take part in clinical trials with their own decision as the rights of self determination to their bodies, however those who are not capable of consenting for themselves like the underage or serious dementia patients should not be admitted their eligibility as the trial subjects. Nevertheless it could be permitted exceptionally in case the result of clinical trials could come out only when those people take part in as the trial subjects to achieve the aims of clinical trials, but still in this case it should be allowed if it is only for treatment. In addition, the substituted determinations are made in accordance with custom in medical services in case of not having consent abilities, however the consents of agents should be considered as other's decision not his(her) own decision in the position of trial subjects. Thus, there need to be a couple of assessments in the designation of agents. those are as follows. ① the assessment whether there is the intention to take part in clinical trials of himself(herself) or the contract of guardianship in advance. ② the assessment whether there is the designation of a close relative who knows his(her) value systems although it is unclear to be his(her) own intention. Furthermore, the researchers should inform the trial subjects of the result of judgement that he(she) lacks the ability to consent before explaining the clinical trials to the agents and let the trial subjects know the intents in case the agents agreed with it. The reason additional procedures should be made is that the consent abilities of trial subjects are too obscure. I also suppose that the trial subjects should not refuse the procedures and the rights of refusal should be respected in case of his(her) refusal.
KW - Clinical Trial;Personal Rights;Right of Self Determination;Informed Consent;Substituted Judgement;Pharmaceutical Affairs Act;Korea Good Clinical Practice;Trial Subject
DO -
UR -
ER -

송영민. (2010). The Way to Secure Trial Subjects' Rights of the Self Determination on the Clinical Trials of Medical Supplies. DONG-A LAW REVIEW, 46, 145-173.

송영민. 2010, "The Way to Secure Trial Subjects' Rights of the Self Determination on the Clinical Trials of Medical Supplies", DONG-A LAW REVIEW, no.46, pp.145-173.

송영민 "The Way to Secure Trial Subjects' Rights of the Self Determination on the Clinical Trials of Medical Supplies" DONG-A LAW REVIEW 46 pp.145-173 (2010) : 145.

송영민. The Way to Secure Trial Subjects' Rights of the Self Determination on the Clinical Trials of Medical Supplies. 2010; 46 : 145-173.

송영민. "The Way to Secure Trial Subjects' Rights of the Self Determination on the Clinical Trials of Medical Supplies" DONG-A LAW REVIEW no.46(2010) : 145-173.

송영민. The Way to Secure Trial Subjects' Rights of the Self Determination on the Clinical Trials of Medical Supplies. DONG-A LAW REVIEW, 46, 145-173.

송영민. The Way to Secure Trial Subjects' Rights of the Self Determination on the Clinical Trials of Medical Supplies. DONG-A LAW REVIEW. 2010; 46 145-173.

송영민. The Way to Secure Trial Subjects' Rights of the Self Determination on the Clinical Trials of Medical Supplies. 2010; 46 : 145-173.

송영민. "The Way to Secure Trial Subjects' Rights of the Self Determination on the Clinical Trials of Medical Supplies" DONG-A LAW REVIEW no.46(2010) : 145-173.