• Journal of Preventive Medicine and Public Health
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• 제41권5호
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• pp.339-344
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• 2008

Objectives : The objective of this paper is to discuss the importance of obtaining informed consent for conducting epidemiological studies and public health activities, based on the Report of the UNESCO's Working Group on Informed Consent. Methods : The Report of the UNESCO's Working Group on Informed Consent was reviewed and discussed in connection with the ethical considerations of public health activities and epidemiological research. Results : It was at the Nuremberg Trial for the German war criminals of the Second World War that the principle of 'consent' was first stated as a consequence of the medical abuses carried out during the War. As a result of the Trial, the Nuremberg Code came out in 1947. Since then, various international declarations or ethical principles on 'informed consent' have been developed and published. These ethical principles on 'informed consent' have mostly to do with the clinical research that involves human subjects, and not with epidemiological studies and public health activities. However, UNESCO recently issued a comprehensive Report on Informed Consent based on the Universal Declaration on Bioethics and Human Rights adopted in 2005, and this included detailed guidelines on informed consent in epidemiological studies and public health activities. Conclusions : Universal Declaration on Bioethics and Human Rights emphasizes the principle of autonomy to protect the human rights of the human subjects involved in any public health activities and epidemiological research. As a practical guideline, obtaining informed consent is strongly recommended.

• 사상체질의학회지
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• 제23권3호
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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.

• 대한기관윤리심의기구협의회지
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• 제1권2호
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• pp.30-42
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• 2019

In pharmaceutical clinical trials as human material research, the collection, use, storage and provision of human materials must be in accordance with the criteria stipulated in 「Bioethics and Safety Act」, except in the case that some criteria about it is in the law related to clinical trials such as 「Pharmaceutical Affairs Act」 and 「Enforcement Rule on Safety of Drugs, etc.」 so these take precedence over. Under 「Bioethics and Safety Act」, the core aspect of the legal standard for obtaining informed consent is the use of statutory form . The use of statutory form ensure that both those who obtain informed consent and those who give it can know the contents contained this form as well as recognize its importance. Thus, the person who has the right to informed consent can sign the statutory form after correct understanding of the contents. In reality, however, some researchers and IRB members determine that only the main informed consent form is to be used because most of contents on statutory from are included in the main informed consent form. Some other researchers and IRB members judge that the use of statutory form is not needed if human materials may only be used for laboratory testing and the rest will not be stored and provided for future use. Most of these determination and judgement is based on the interpretation of the Korea National Institute for Bioethics Policy(hereafter, KoNIBP) on IRB Information Portal Site. But, it is questionable whether the KoNIBP's interpretation is legally valid and the KoNIBP is the legal entity having authority to interpret existing statute. In some cased not only using the main informed consent form including enough information about the collection, use, storage and provision of human materials but also collecting necessary minimum human materials, and discarding the rest, unusing the statutory form may not cause the problem to respect and protect the research participant's rights. Therefore, the provision stipulating the criteria about the use of statutory form as the legal standard of obtaining informed consent that applies all human material research without exception should review to revise. At least, straighten out the confusion surrounding whether or not the statutory form is to be used, before the revision of related provision, considering the logical opinions of some researchers and IRB Members, the Ministry of Health and Welfare as the legal entity having authority to interpret existing statute should represent its opinion about permission of the acceptable exceptions.

• 대한기관윤리심의기구협의회지
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• 제5권2호
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• pp.51-58
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• 2023

Purpose: To validate the effectiveness of obtaining consent education on errors in the consent process and to develop the education program for researchers. Methods: From February 2019 to February 2022, a 30-minute, 1:1 face-to-face consent education developed using the ADDIE model was conducted on 78 nurses as principal investigators. An informed consent audit tool, which includes 6 items developed by Asan Medical Center Human Research Protection Center, was used to analyze errors in obtaining informed consent process. Data analysis was performed using the SPSS ver. 25.0, and the Mann-Whitney U-test and χ²-test were utilized to verify the difference in errors between the experimental and control groups. Results: The participants consisted of 42 in the experimental group and 36 in the control group, with no statistically significant difference between the 2 groups. Both 2 groups showed the highest frequency of documentation errors, followed by format errors, errors related to a suitability of investigator, participant, or participant's legally acceptable representative, witness and confidentiality issues. After education, there was a significant decrease in both format errors (p=0.002) and documentation errors (p<0.001) in the experimental group. The proportion of participants without any errors in all items was higher in the experimental group (35.7%) compared to the control group (5.6%), and this difference was statistically significant (p=0.001). Conclusion: The obtaining consent education program was found to be effective in reducing informed consent errors. This study emphasizes the importance of education, suggesting the need for its expansion and accessibility, as well as the necessity for all researchers conducting clinical studies to receive the obtaining consent education.

• 성인간호학회지
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• 제19권4호
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• pp.556-566
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• 2007

Purpose: This study attempted to analyze problems of informed consent in the clinical setting and appraise ethical aspects inherent in such issues in order to boost awareness of informed consent and its implementation among healthcare professionals. Methods: Study methods included identifying ethical meanings of informed consent in the clinical setting based on the principal ethics, and exploring the process of informed consent utilizing communicative ethics and feminine care ethics Results: The ethical basis of informed consent encompasses not only respect for autonomy but also prohibiting malice, practicing beneficience, and establishing justice. These principles, however, are limited in illustrating the ethical aspects of communicative ethics and care ethics that are entailed in informed consent within clinical settings. The ethical meaning of informed consent involves a communicative and caring process between healthcare professionals, patients, and family built on mutual respect. Conclusion: Healthcare professionals must fully understand the ethical meanings of informed consent and in turn respect and protect the clients' right to know and making decisions. Nurses especially, must take on the role of mediator and advocate throughout the process of obtaining informed consent, and practice ethical caring by facilitating communication grounded in mutual understanding among the physician, patient, and family members.

• Archives of Plastic Surgery
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• 제43권5호
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• pp.402-410
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• 2016

Background In an increasing number of lawsuits doctors lose, despite providing preoperative patient education, because of failure to prove informed consent. We analyzed judicial precedents associated with insufficient informed consent to identify judicial factors and trends related to aesthetic surgery medical litigation. Methods We collected data from civil trials between 1995 and 2015 that were related to aesthetic surgery and resulted in findings of insufficient informed consent. Based on these data, we analyzed the lawsuits, including the distribution of surgeries, dissatisfactions, litigation expenses, and relationship to informed consent. Results Cases were found involving the following types of surgery: facial rejuvenation (38 cases), facial contouring surgery (27 cases), mammoplasty (16 cases), blepharoplasty (29 cases), rhinoplasty (21 cases), body-contouring surgery (15 cases), and breast reconstruction (2 cases). Common reasons for postoperative dissatisfaction were deformities (22%), scars (17%), asymmetry (14%), and infections (6%). Most of the malpractice lawsuits occurred in Seoul (population 10 million people; 54% of total plastic surgeons) and in primary-level local clinics (113 cases, 82.5%). In cases in which only invalid informed consent was recognized, the average amount of consolation money was KRW 9,107,143 (USD 8438). In cases in which both violation of non-malfeasance and invalid informed consent were recognized, the average amount of consolation money was KRW 12,741,857 (USD 11,806), corresponding to 38.6% of the amount of the judgment. Conclusions Surgeons should pay special attention to obtaining informed consent, because it is a double-edged sword; it has clinical purposes for doctors and patients but may also be a litigation strategy for lawyers.

• 동의생리병리학회지
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• 제25권6호
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• pp.1089-1094
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• 2011

We examined the decision-making capacity of seniors of consent to oriental clinical research. This study was performed in order to improve the quality of ethical aspects before obtaining informed consent. Oriental investigators interviewed 251 seniors who participated in Sasang clinical research. The questionnaire was about the capacity of consent and the subjective awareness of informed consent. Two hundred fifteen out of 250 questionnaires were collected. One hundred thirty four(62.3%) seniors had the capacity of consent to research and 81(37.7%) seniors did not pass. The subjective awareness of informed consent in having the capacity group is $78.02{\pm}12.92$ and not having group is $72.17{\pm}9.17$. The investigation of senior capacity of consent was aimed at protecting seniors' interests and completing investigators' ethical responsibilities. This study found that only 62.3% of senior participants had the capacity of consent. This investigation will be expected to raise the importance of seniors' capacity of consent. Also we expect methods and procedures for capacity assessment of informed consent to be followed for increasing quality of clinical research.

• 의료법학
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• 제16권2호
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• pp.3-26
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• 2015

수술행위는 신체에 대한 침습을 포함하는 것이므로 의료인은 수술주체와 수술행위의 내용을 충분히 설명하여 환자가 그 수술을 받을 것인지의 여부를 선택하도록 하여야 하고, 이는 헌법 제10조에서 규정한 개인의 인격권과 행복추구권에 의하여 보호되는 환자의 자기결정권에 해당한다. 미국에서는 '대리수술'의 경우 폭행에 해당한다고 판단한 사례가 있으나, 국내에서는 아직까지 수술의사에 대한 상해죄 등을 인정한 사례가 없고, 수술행위는 환자의 신체에 대한 적대적인 손상행위가 아니므로 상해죄로 처벌하기 어려운 면이 있다. 또한 환자의 '가정적 승낙'을 폭넓게 인정하는 판례의 입장에 따르면 의사의 전단적 의료행위에 대하여 업무상과실치사상죄로 처벌하기도 어려우므로, 환자의 자기결정권 강화를 위하여 의사의 설명의무를 의료법 등에 명문화하고, 대리수술 등 전단적 의료행위에 대하여 별도의 처벌규정을 입법화할 필요가 있다.

• Clinical and Experimental Pediatrics
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• 제46권7호
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• pp.647-654
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• 2003

목 적 : 소아에서 예방접종시 예방접종 예진표(동의서) 사용에 관한 보호자들의 반응과 예진표 사용의 문제점을 알아보기 위하여 연구를 시행하였다. 방 법 : 2002년 7월 1개월 동안 예방접종을 위해 삼성제일병원 소아과에 내원한 환아 2,820명 중 무작위로 추출한 112명의 보호자를 대상으로 예방접종 예진표 사용에 대한 설문조사를 실시하였다. 결 과 : 설문응답자는 어머니가 90명(80.4%)으로 가장 많았고, 응답자의 연령별 분포는 30-39세가 71명(63.4%)으로 가장 많았다. 학력분포는 대졸이 61명(54.6%)으로 가장 많았고 고졸이 35명(31.3%)이었다. 자녀의 예방접종을 주로 하는 곳은 종합병원 87명(77.7%), 대학병원 13명(11.6%), 보건소 5명(4.5%), 개인의원 2명(1.8%)순이었다. 응답자 중 예진표를 처음 작성해본 사람은 42명(37.5%), 2회와 3회 이상 작성해본 사람은 각각 28명(25%)과 40명(35.7%)이었다. 예진표를 받은 후의 반응에 대해서는 73명(65.2%)이 매번 잘 읽어본다고 답했고, 형식적으로 읽어본다고 답한 경우도 16명(14.3%) 있었다. 예진표 작성에 대해서는 좋다고 대답한 경우가 62명(55.4%), 귀찮지만 필요하다고 생각한다가 40명(35.7%)으로 91.1%에서 긍정적인 반응을 보였고, 그외 그저 그렇다가 7명(6.3%), 불편하고 귀찮아서 안 했으면 한다가 3명(2.7%)이었다. 예진표 작성을 하기 싫은 이유로는 아이를 안고 예진표를 작성하는 것이 힘들다고 답한 경우가 55명 중 33명(60%)이었고, 그밖에 답해야 할 문항이 많아 읽기 귀찮다고 답한 경우가 13명(23.6%)이었다. 예진표를 읽고 이상반응의 이해에 도움이 된다고 대답한 경우는 80명(71.4%), 별로 도움이 되지 않는다고 한 경우는 10명(8.9%), 읽어도 내용을 모르거나 의사의 추가 설명이 필요하다고 대답한 경우는 21명(18.8%)이었다. 예방접종 후 나타날 수 있는 이상반응에 대한 질문 결과, 이전에 이상반응에 대해 66명(58.9%)은 막연히 알고 있었다고 하였고 43명(38.4%)은 잘 몰랐다고 하였으며, 이상반응에 대한 보호자의 질문에, 걱정이 되지만 예방접종을 하겠다고 대답한 경우가 105명(93.8%)이었다. 이상반응이 생겼을 때 대처방법에 대한 질문에, 가벼운 증상이라도 병원에 연락하거나 찾아온다고 대답한 경우가 77명(68.8%), 집에서 경과를 관찰한다는 대답도 32명(28.6%)이었다. 결 론 : 보다 안전한 예방접종을 위하여 예진표 사용은 꼭 필요하지만 우리나라에서는 지금까지 예방접종시 예진표의 사용이 저조하였던 것이 사실이다. 예방접종 예진표에 대한 보호자 호응도는 좋은 편이었으나, 적절한 교육과 설명으로 그 취지를 좀 더 잘 이해시키고, 우리 실정에 맞는 예진표를 개발하여 이의 사용을 앞으로 적극 확대하여야 할 것이라 생각된다.

• 의료법학
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• 제20권2호
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• pp.111-140
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• 2019

생명윤리 및 안전에 관한 법률은 인체유래물연구와 인체유래물은행에 관하여 일련의 규율을 가하고 있다. 같은 법은 인체유래물연구에 대하여는 연구목적을 정하여 설명 후 동의를 받게 하는 반면, 인체유래물은행의 경우 연구목적을 정하지 아니한 채 기증받게 한다. 나아가 보건복지부령으로 정하는 인체유래물 연구 동의서식을 보면 연구목적을 정하는 경우에도 '포괄적으로 연구에 대하여' 동의하는 개방동의·백지동의가 허용된다. 덧붙여 2019. 4. 23. 개정된 제42조의2는 진단·치료과정에서 채취된 인체유래물의 잔여검체에 대하여 본인이 거부의사를 명시하지 아니하는 한 목적도 정하지 아니한 채 인체유래물은행에 제공하는 것을 허용한다. 이러한 입법은 과도하다고 보인다. 국제적으로 인체유래물기증자의 자율성과 인체유래물은행 및 인체유래물연구의 특성을 고려할 때 포괄동의를 수용할 필요가 있음은 부정하기 어렵다. 그러나 인체유래물연구에는 생명윤리 및 안전에 관한 법률 이외에 종종 개인정보 보호법도 적용되고 국내·외적으로 이 영역에서는 개방동의·백지동의는 물론, 포괄동의의 허용성도 논란의 대상이었음을 염두에 둘 필요가 있다. 또 근래의 발전된 정보통신기술에 비추어볼 때 완전한 동적동의는 아니라 하더라도 특히 위험한 경우에는 동적동의를 통한 특정동의요건의 충족이 필요하고 가능한 사안도 있다. 이는 인체유래물의 제2차적 사용 내지 인체유래물은행의 운영에 관한 거버넌스 설계와 그에 대한 설명 후 동의 및 인체유래물기증자에 대한 투명성, 인체유래물기증자의 참여권 보장을 포함한다.