Although research on drugs and medical devices for human is well regulated and scrutinized through the existing IRB system, there is a need for a careful review of the current process for approving surgical procedures involving new medical devices. In particular, the clinical application of innovative surgical procedures with new or existing devices should be examined from an ethical point of view. There are, at this point, no formal ethical rules concerning innovative surgical procedures, and important terms are in need of clarification and definition. This article argues that while the adequacy of IRB process for surgical innovation has to be reviewed, there are needs to debate on some reasonable and valid definitions and ethical regulations of surgical innovation. In addition to, while the potential of professional surgical organizations for self-regulation has to be respected, the debates concerning the ethical issues associated with innovative surgical procedures should be opened up to the academic medical sector and those outside of the medical community.
Purpose: The purposes of this study were to identify future changes that may affect medical decision-making and to suggest future directions for the medical decision-making system in Korea.
Methods: This study conducted Delphi surveys and in-depth group interviews with physicians and nurses working in two different university hospitals in Daegu and Busan.
Results: The collected data suggest that the current medical decision-making system needs to be more clearly defined in accordance with clinical applications. The findings from professional group interviews suggest that the Korean government may need to regulate economic conditions in order to facilitate medical decision-making in the near future as hospital environments change and grow.
Conclusion: The results of this study may help healthcare professionals working at various crisis settings to understand and apply decision-making systems in the context of end-of-life medical care. The future directions were proposed that national standard setting and financial support, hospital ethics committee constitution, nationwide information for social consensus, strengthening the education of health professionals.
Almost all countries in the world experience a scarcity of health care resources and the need to ration health care services. Each medical system is faced with difficult decisions concerning treatment coverage and priorities. Current methods of allocation are based on (1) substantial principles of justice, (2) cost-effectiveness analysis, (3) cost-value analysis, and (4) market mechanisms. Given these methods of allocating health care services, the question of legitimacy is rightfully raised. The question of legitimacy needs to be approached in an orderly manner. In the first place, the concept of democratic legitimacy needs to be articulated. Secondly, current methods of allocation must be evaluated. Thirdly, a legitimate method of allocation is needed. This article concentrates on the first and the second step. I argue that current methods of allocation fail to satisfy a democratic conception of legitimacy. However, this conclusion does not mean that these methods of allocating should be totally rejected. Each of these methods has an important element that at least contributes to democratic legitimacy. Based upon the evaluation provided in this article, I introduce a very promising method of allocating health care services, one developed by N. Daniels and J. Sabin.
In order to understand fully the issues involved in end-of-life care decisions, it is important to know the genuine wishes and thoughts of terminal patients themselves. This article reports on a narrative analysis of the data drawn from structured interviews with a number of terminal patients suffering from critical diseases such as cancer. Most patients approve of the withdrawal of life support treatment in irreversible and extremely painful conditions. They also admit the necessity of “advance directives” and even active euthanasia. However, their attitudes toward disease and death are emotionally complex. In facing their own death, patients need more emotional/medical support and pain control. Their relationships with family members or friends are also critical in this regard. Terminal patients are not entirely satisfied with current methods of communication with care givers, although they appreciate their concerns and goodwill. This analysis concludes that it is necessary to approach end-of-life care decisions in a more subtle and humane way that should be customized to the demand of each individual patient these decisions should be treated as part of the overall medical care given to terminal patients.
본 연구는 한국의 중환자 혹은 말기환자의 생애말기 결정의 하나로 널리 선택되고 있는 심폐소생술 금지(Do-Not-Resuscitate, DNR) 결정에 대하여 출간된 연구논문의 특성을 규명하고 심폐소생술 금지 결정과 관련된 특성을 고찰하고자 시도되었다.
연구방법으로는 통합적 문헌고찰을 적용하였고 연구대상으로는 1998년부터 2010년까지 3개의 한국 의료 데이터베이스에서 한국어로 쓰여진 심폐소생술 금지와 관련된 논문 20개를 찾아 분석하였다.
연구결과는 다음과 같다. 첫째, 한국에서 수행된 대부분의 심폐소생술 금지와 관련된 연구는 의료인들을 대상으로하여 서술적 조사연구로 이루어지거나 의무기록의 후향적 고찰을 통해 진행되어 왔다. 둘째, 연구논문의 결과를 통해 확인된 심폐소생술 금지와 관련된 주요 특성은 다음과 같다. 심폐소생술 금지 결정은 환자보다는 가족이나 의사에 의해 따라 결정되는 것으로 나타났고, 한국의 의료상황에서 심폐소생술 금지 결정에 영향을 미치는 요인으로는 의학적 무용성, 연령, 품위 있는 죽음, 및 경제적인 어려움을 포함하는 것으로 조사되었다.
본 연구의 결과가 의료분야에 시사하는 바는 다음과 같다. 첫째, 가족 중심의 한국 사회 문화에서 가족들이 환자의 심폐소생술 금지와 관련된 결정을 할 때, 환자의 소망과 선호도를 잘 파악하고 이를 따른 결정을 할 수 있도록 돕는 것이 필요하겠다. 둘째, 생애 말기에 처한 환자를 돌보는 여러 관련 의료인 중에 간호사는 환자의 가족과 의사 사이에서의 중간자 역할을 잘 수행할 책임이 있겠다. 셋째, 환자의 소망과 선호도에 관해 보다 적극적으로 의사소통을 하는 것은 현 상황에서의 의사결정 주체인 가족의 부담감을 줄이고 의료진의 도덕적 고뇌를 감소시키는 데에 도움이 될 것이다. 마지막으로 이러한 내용이 실무에서 잘 반영되기 위해서, 심폐소생술 금지와 관련된 추후 연구들은 환자를 포함한 연구대상, 다양한 연구방법론을 적용하여 더욱 활발히 이루어져야 하겠다.
This article examines the four principles of biomedical ethics introduced by Beauchamp and Childress for possible use in deliberating ethical issues that arise in the context of physician-pharmaceutical industry interactions (PPII). PPII is regarded as a threat to the ideal physician-patient relationship because it blurs the scientific, objective, and altruistic ideals of professional medical practice. Several guidelines have been proposed to redress the undesirable effects of PPII, but few have provided any ethical justification or mechanism to resolve possible internal conflicts. The principle-based approach is a good starting point because it focuses on practical solutions for decision-making as well as on theoretical justifications. This article shows how the four ethical principles can be specified and applied in three hypothetical cases of PPII, and how two practical rules, the rule of transparency and avoidance, can be assimilated.
The relationship between the medical profession and the pharmaceutical industry has received considerable attention in recent years in Korea. In this article we examine the impact of physicianpharmaceutical industry interaction (PPII) on physician prescriptions. While physicians’ decisions concerning prescriptions are influenced by many factors, two of the most influential are the visits of sales representatives from pharmaceutical companies and the gifts and other enticements that pharmaceutical companies provide for physicians. Patients regard gifts from pharmaceutical companies as less appropriate and more influential than do physicians. Inappropriate relations between physicians and pharmaceutical companies can damage physician-patient relationships and harm the medical profession as a whole. Recent investigations in the United States and Korea have found many illegalities in physician-pharmaceutical industry interaction. The article argues for the urgent need to develop clear ethical codes and compliance mechanisms concerning PPII.
The pharmaceutical industry interacts with the medical profession by supporting clinical research and assisting in medical education activities in academic medical centers. Medical students and residents spend years establishing patterns of prescribing and making relationships with pharmaceutical companies. The pharmaceutical industry has a significant presence during residency training, gaining the overall acceptance of trainees, and appears to influence prescribing behavior. Contact with pharmaceutical representatives is common among medical students and residents. Residents acknowledge the potential for industry influence in others, but generally not in themselves, despite evidence that they themselves are influenced as well. The prescriptions written by residents are associated with pharmaceutical representative visits and the availability of samples. A variety of policy and educational guidelines appear to influence residents’ attitudes toward interactions with industry representatives, although data on the long-term effects of these interventions are limited. This article contends that medical training programs can benefit from policies and curricula that teach medical students and residents about the influence of marketing and how to critically evaluate the information they receive from industry representatives.
Clinical practice guidelines are systematically developed statements to assist practitioners and patients in making appropriate health care decisions in specific clinical circumstances. The potential influence of industry in the development or dissemination of clinical practice guidelines raises ethical concerns. A review of the development and dissemination of the Surviving Sepsis Campaign guidelines shows that the interaction between the pharmaceutical industry and academic societies can undermine clinical guidelines and harm the industry’s reputation. Thus, it is argued here that the process of developing and disseminating clinical practice guidelines should not be tainted by problems of corporate support and transparency. Furthermore, the process should identify and manage any conflicts of interest and ensure the patient-centeredness of the evaluation of emerging medical evidence.