• Journal of Sasang Constitutional Medicine
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• v.23 no.3
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• pp.318-329
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• 2011

1. 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. 2. 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. 3. 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. 4. Conclusions: 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.

• The Korean Society of Law and Medicine
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• v.5 no.2
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• pp.294-319
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• 2004

Because the treatment of a physician generally pertains to the intrusion into body of a patient, his/her consent is a must in order for such conduct to be justifiable. To ensure effective consent of a patient, the physician should fully inform him/her of kind and details of the disease and way of treatment and risks associated with it. The patient can, then, make a decision whether he/she should accept any treatment or operation, if necessary, on the basis of such information. The obligation of physicians to explain has since long been recognized as important in view of guaranteeing the rights of patients for self-decision and protecting them from arbitrary assessment of physicians for treatment. Progress has been made in this respect even to the extent that physicians treat patients on equal terms and think first of all much of establishing trustworthy relationships with patients. Lots of studies in Korea and foreign countries have tried to explore the issues concerning the obligation of physicians to explain in the meantime but seem to have failed to make concrete and versatile approaches from the standpoint of protecting the rights of patients. Wouldn't it be really possible for patients to perceive their own rights and cope actively with the medical treatments? If physicians have full understanding to the rights of patients, they will be put in a better situation to protect themselves and patients, in turn, can identify their own responsibility correctly, which will eventually contribute to fulfilling the goal of treatment. With this background, the present paper examines briefly the obligations of physicians for explanation based mainly on the preceding theories and judicial precedents in the first place and then deals with the status quo and contents of the German medical laws, with a focus on the treaty of European Law 1997 and its working document on the applications of genetics for health purposes that stipulate the detailed criteria on the medical treatment and rights of patients and Germany's $\ulcorner$Charter of Rights for Patients$\lrcorner$ promulgated in 2003.

• The Korean Society of Law and Medicine
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• v.18 no.1
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• pp.3-35
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• 2017

The Supreme Court of Korea first admitted compensation for damages caused by breach of informed consent in 1979. From then on, specific details of informed consent are shaping up and developing through court precedents. The duty of informed consent of doctor is based on article 10 of the Constitution and medical contract, and is expressly prescribed Article 12 of Framework Act on Health and Medical Services and other acts and regulations. By the way, the regulations about duty of informed consent of doctor have been established in Medical Law revised on December 20, 2016, and the revised Medical Law will be implemented on June 21, 2017. According to the revised Medical Law, medical practices subject to description and consent are operation, blood transfusion and general anesthesia that threaten to cause serious harm to human life or to the body. When performing these medical activities, the written consent must be explained and agreed upon in advance. If a doctor violates the law, he will incur fines of less than 3 million won. Comparing and viewing the revised Medical Law and existing legal principles about the duty of informed consent, we can confirm that there is a substantial difference between the two parties. Accordingly, despite the implementation of the revised medical law, the existing legal principles are unlikely to be affected. However, from the perspective of legal uniformity and stability, it is undesirable that legal judgments on the same issues differ from each other. The revised Medical Law about informed consent needs to be reformed according to existing legal principles. And, as in the case of Germany, it is desirable to include the matters concerning informed consent in the civil code.

• The Korean Society of Law and Medicine
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• v.24 no.2
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• pp.147-196
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• 2023

Advances in brain science have made it possible to stimulate the brain to treat brain disorder or to connect directly between the neuron activity and an external devices. Non-invasive neurotechnologies already exist, but invasive neurotechnologies can provide more precise stimulation or measure brainwaves more precisely. Nowadays deep brain stimulation (DBS) is recognized as an accepted treatment for Parkinson's disease and essential tremor. In addition DBS has shown a certain positive effect in patients with Alzheimer's disease and depression. Brain-computer interfaces (BCI) are in the clinical stage but help patients in vegetative state can communicate or support rehabilitation for nerve-damaged people. The issue is that the people who need these invasive neurotechnologies are those whose capacity to consent is impaired or who are unable to communicate due to disease or nerve damage, while DBS and BCI operations are highly invasive and require informed consent of patients. Especially in areas where neurotechnology is still in clinical trials, the risks are greater and the benefits are uncertain, so more explanation should be provided to let patients make an informed decision. If the patient is under guardianship, the guardian is able to substitute for the patient's consent, if necessary with the authorization of court. If the patient is not under guardianship and the patient's capacity to consent is impaired or he is unable to express the consent, korean healthcare institution tend to rely on the patient's near relative guardian(de facto guardian) to give consent. But the concept of a de facto guardian is not provided by our civil law system. In the long run, it would be more appropriate to provide that a patient's spouse or next of kin may be authorized to give consent for the patient, if he or she is neither under guardianship nor appointed enduring power of attorney. If the patient was not properly informed of the risks involved in the neurosurgery, he or she may be entitled to compensation of intangible damages. If there is a causal relation between the malpractice and the side effects, the patient may also be able to recover damages for those side effects. In addition, both BCI and DBS involve the implantation of electrodes or microchips in the brain, which are controlled by an external devices. Since implantable medical devices are subject to product liability laws, the patient may be able to sue the manufacturer for damages if the defect caused the adverse effects. Recently, Korea's medical device regulation mandated liability insurance system for implantable medical devices to strengthen consumer protection.

• The Korean Society of Law and Medicine
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• v.24 no.4
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• pp.37-63
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• 2023

In medical litigation, there are various cases where a doctor's 'explanation' of a patient becomes problematic. Medical explanations and guidance are required from the doctor, starting from the beginning of diagnosis, through treatment processes such as surgery, when hospitalization is necessary for treatment, during hospitalization, upon discharge, and after discharge. Furthermore, notification from the doctor or medical institution may be requested regarding the economic costs that will be incurred due to medical treatment. South Korea's judiciary has been developing legal principles regarding such doctor's explanations by distinguishing between explanations for obtaining consent for medical treatment and medical explanations related to guidance on patient treatment methods, taking into account related laws such as the stage of treatment and the Medical Service Act. Additionally, the Constitutional Court recently ruled on the non-benefit cost notification system linked to the explanation of economic costs. However, holding a doctor accountable solely because the doctor's explanation was insufficient has aspects that do not correspond to the actual situation in clinical reality, and may have a reflexive disadvantage that results in a decline in legal rights. Therefore, the doctor's explanation needs to be examined from both perspectives: guaranteeing the patient's right to self-determination and protecting his or her right to decision.

• Proceedings of the Korea Contents Association Conference
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• 2012.05a
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• pp.173-174
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• 2012

To determine whether position affects measured lung capacity of spinal cord injury patients. The study subjects were 45 patients with spinal cord injury (cervical level 15, thoracic level 15, lumbar level 15). Subjects were provided with a full explanation of the experimental procedures and all provided written consent signifying their voluntary participation. We used a spirometer (Spirometer, Micromedical Ltd, UK) to measure pulmonary function in the supine and sitting positions (straightened upper body at an angle of $90^{\circ}$). Forced vital capacity (FVC), forced expiratory volume during the first second (FEV1), tidal volume (TV), and maximum insufflation capacity (MIC) were also measured. FVC, FEV1, TV, MIC (%) were greater in the supine than in the sitting position for those with injury at the cervical or thoracic injury level. On the other hand, FVC, FEV1, TV, MIC (%) were lower in the supine position for those with an injury at the lumbar level. More attention should be paid to the effect of injury level on measured lung capacity.

• The Korean Journal of Pain
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• v.25 no.4
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• pp.254-257
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• 2012

Background: Elderly patients visiting pain clinic may be at greater risk of misunderstanding the explanation because of age-related cognitive decline. Video instruction may provide a consistent from of teaching in a visual and realistic manner. We evaluated the effect of educational video on the patient understanding and satisfaction in a group of geriatric patients visiting pain clinic. Methods: Ninety two patients aged more than 60 years old who were scheduled for transforaminal epidural block were recruited. After exposure to either video or paper instruction process, each patient was asked 5-item comprehension questions, overall satisfaction and preference question. During follow-up period, number of outpatient referral-line call for further explanation was counted. Results: We observed significantly better comprehension in the video education compared with paper instruction (P < 0.001). Patient satisfaction was also higher in the video group (P = 0.015), and patients visiting pain clinic were more preferred video instruction (P < 0.001). Proportion of referral-line call for further explanation were similar (P = 0.302). Conclusions: Video approach to instruction process before consent improves treatment comprehension in geriatric patient visiting pain clinic.

• Journal of Korean Dental Science
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• v.2 no.1
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• pp.4-10
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• 2009

Though implant treatment is considered as a common treatment option for edentulous patients, there have been few studies on the temporomandibular disorder (TMD) related with implant treatment. The purposes of this study were to evaluate the relevance of TMD to the implant patients and to evaluate the risk factors of TMD in relation with implant treatment. For the evaluation of various risk factors of TMD in relation with implant therapy, clinical evaluation focused on patient factors and implant factors. From a group of 694 patients, 25 patients (3.6 %) were included in this study. The majority of the patients were included in the asymptomatic 'adaptive' group. Parafunction was detected in 11 patients, 8 patients were male. Four patients having parafunction showed complications such as implant failure or fracture of the suprastructure. From the results, it is possible that TMJ related symptoms are developed or aggravated after implant therapy, which requires relatively more chair time; so TMJ examination should be included in the pre-operative evaluation for dental implant patients. Also, it is important to treat patients after they sign an informed consent that includes a detailed explanation on the possibility of TMD during treatment.

• Journal of Korean Academy of Nursing Administration
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• v.11 no.3
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• pp.255-264
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• 2005

This study is a descriptive research in investigating the perception of doctors and nurses with regard to DNR, and data were collected through survey questionnaires. The period of collecting data was between July 15 and October 30, 2004, distributing 128 questionnaires to 128 participants, and a total of 110 questionnaires from 55 doctors and 55 nurses were collected (86%)among 70 different hospitals. The collected data were analyzed using SAS program to get real number and percentage, and were also analyzed with $X^2$-test. The Study Results are as follows: 1. Respondents who agreed with the necessity of DNR was 97.27%, the reasons of DNR necessity were 59.20% of 'impossibility of recovery in spite of lots of efforts,' and 35.20% of 'for the purpose of choosing a comfortable and dignified death,' and 97.2% of respondents answered that it was necessary to give explanation of DNR to serious case patients, terminal patients and their family. 2. Problems derived from DNR decisions were 44.44% of 'lack of treatment and nursing,' 21.11% of 'guilty conscience about failing to do best efforts,' and 71.57% of CPR implementation right after DNR decision. 3. Reasons of implementing CRP for patients with DNR decision were 50.94% of 'for the presence of family and relatives at the point of patient's death,' 20.76% of 'guardian's change of DNR decision,' and 16.98% of 'no communication for the consent after DNR decision.' 4. With regard to who was to make DNR decision? there was a difference in the opinion between doctors' and nurses' group while the group of doctors chose 'by the consent of the family and the doctor in charge,' and the group of nurses chose 'patient's intension,' and with regard to Have you received DNR related education? and Will people who want DNR increase if there is explanation given? there was a difference between the two groups. 5. In the catholic institutions, respondents of 71.7% said that it was necessary to take DNR depending upon the situation, and 73% said that they had performed DNR before. 6. In the institutions with over 500 beds, 91.92% of respondents said that there should be an establishment of guideline book as a written format to implement DNR. From the results of this study, it was found that DNR was implemented and executed broadly in clinical fields in the absence of necessary instructions and/or guideline, and that DNR order was placed to the group of doctors who got less opportunity for proper education than did that of nurses.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.16 no.4
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• pp.2691-2703
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• 2015

This research aims to provide basic materials for assisting DNR patient cares by understanding ICU nurses' awareness and ethical attitude regarding DNR. A total of 154 results were analyzed which were collected from Aug. 1st to Sep. 5th in 2014 by surveying nurses working in ICU (from 1 advanced general hospital in G metropolitan city and other general hospitals of more than 700 beds in Cheolla provinces). (1) For the decision attitudes of DNR, there were both consent and objection. Consent for the patient's opinion of rejecting further treatment and life extension despite of bad prognosis. And objection for no conducting DNR in the case of the patient's wish, treatment requested by the guardian, and CPR for the patient who has no chance. (2) Objection for artificial respirator and other treatment requested by the patient's family and the entrance of guardians into ICU. Consent for the passive use of artificial respirator by the doctor and the decrease of basic care to stabilize patients physically and mentally. No specific opinion for treatment not following aseptic techniques. Objection for frequent reports to primary care physician requested by the family. (3) Acknowledging less interest by the doctor, while supporting the health care team in the case of the guardian's complaint, objection for the DNR decision mede by the primary care physician. Objection for the DNR decision by the guideline. Objection or neutrality for straightforward explanation to the patient of bad prognosis. Objection for straightforward explanation of the patient's status (even near to death) to the patient him/herself or the guardian. In conclusion, the subject of DNR is the patient and the patient's opinion should be fully reflected. The conflict arising from the scope of medical practice and decision processes should be minimized. The standard and guideline for DNR decision is required for the ethical decision making for the patient along with agreements based on full explanations.