The Fiduciary Duties of Doctor in Clinical Trials (임상시험에서 의사의 선량한 관리자의 주의의무)
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- The Korean Society of Law and Medicine
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- v.21 no.2
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- pp.163-207
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- 2020
Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.
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.
This paper empirically investigates the factors that influence the consumer choice of an app market based on the rational choice theory. The app market is the only channel where a consumer can buy smartphone apps, which give various functional convenience and are considered to be a major contributor to the proliferation of smartphones. Analyses of 281 questionnaires show that usability and structural guarantees as benefit factors significantly influence the app market choice. From the cost perspectives, both monetary and non-monetary conversion costs are found to significantly influence the app market choice. On the other hand, customer trust, information quality, and market image were found to have no significant effect on app market selection. In particular, Korean app market platform providers (KT, LG U +) seem to be superior in terms of structural guarantees, such as customer center operation and damage compensation regulations, compared to overseas app market platform operators (Google). However, in the case of the Google App Market, it is pre-installed on all Android phones, so it is not inconvenient to install additional apps to use other app market. This is disadvantageous to domestic app market platform operators, and it is necessary to establish a policy solution point. In terms of operator costs, both monetary and non-monetary conversion costs have a significant impact on app market choice. In particular, non-monetary conversion costs have a negative impact on Korean app market platform operators. It can be explained that the service expectation level of the domestic app market is low and it is recognized that the time cost factor such as membership is large for new users to use. It seems to be necessary to improve the domestic app market business. Meanwhile, extant research on smartphone apps focuses on the purchase of apps themselves, but not on the selection of the app market itself. In order to fill in this gap, this study focuses on the determinants of app market selection, including the characteristics of an app market and the switching costs.
The idea of establishing an International Court of Air and Space Law (hereinafter referred to ICASL) is only my academic and practical opinion as first proposal in the global community. The establishment of the International Court of Air and Space Law can promote the speed and promote fairness of the trial in air and space law cases. The creation of an ICASL would lead to strengthening of the international cooperation deemed essential by the global community towards joint settlement in the transnational air and space cases, claims and would act as a catalyst for the efforts and solution on aircraft, satellite and space shuttle's accidents and cases and all manpower, information, trial and lawsuit to be centrally managed in an independent fashion to the benefit of global community. The aircraft, satellite and spacecraft's accidents attributes to the particular and different features between the road, railway and maritime's accidents. These aircraft, satellite and spacecraft's accidents have incurred many disputes between the victims and the air and space carriers in deciding on the limited or unlimited liability for compensation and the appraisal of damages caused by the aircraft's accidents, terror attack, satellite, space shuttle's accidents and space debris. This International Court of Air and Space Law could hear any claim growing out of both international air and space crash accidents and transnational accidents in which plaintiffs and defendants are from different nations. This alternative would eliminate the lack of uniformity of decisions under the air and space conventions, protocols and agreements. In addition, national courts would no longer have to apply their own choice of law analysis in choosing the applicable liability limits or un-limit for cases that do not fall under the air and space system. Thus, creation of an International Court of Air and Space Law would eliminate any disparity of damage awards among similarly situated passengers and shippers in nonmembers of air and space conventions, protocols, agreements and cases. Furthermore, I would like to explain the main items of the abovementioned Draft for the Convention or Statute of the International Court of Air and Space Law framed in comparison with the Statute of the International Court of Justice, the Statue of the International Tribunal for the Law of the Sea and the Statute of the International Criminal Court. First of all, in order to create the International Court of Air and Space Law, it is necessary for us to legislate a Draft for the Convention on the Establishment of the International Court of Air and Space Law. This Draft for the Convention must include the elected method of judges, term, duty and competence of judge, chambers, jurisdiction, hearing and judgment of the ICASL. The members of the Court shall be elected by the General Assembly and Council of the ICAO and by the General Assembly and Legal Committee of the UNCOPUOS from a list of persons nominated by the national groups in the six continent (the North American, South American, African, Oceania and Asian Continent) and two international organization such as ICAO and UNCOPUOS. The members of the Court shall be elected for nine years and may be re-elected as one time. However, I would like to propose a creation an International Court of Air and Space Law in extending jurisdiction to the International Court of Justice at the Hague to in order to decide the air and space convention‘s cases. My personal opinion is that if an International Court on Air and Space Law will be created in future, it will be settled quickly and reasonably the difficulty and complicated disputes, cases or lawsuit between the wrongdoer and victims and the injured person caused by aircraft, satellite, spacecraft's accidents or hijacker and terrorists etc. on account of deciding the standard of judgment by judges of that’s court. It is indeed a great necessary and desirable for us to make a new Draft for the Convention on a creation of the International Court of Air and Space Law to handle international air and space crash litigation. I shall propose to make a new brief Draft for the Convention on the Creation of an International Court of Air and Space Law in the near future.
Land was originally communized by a community in the primitive society of Korea, and in the age of the ancient society SAM KUK-SILLA, KOKURYOE and PAEK JE-it was distributed under the principle of land-nationalization. But by the occupation of the lands which were permitted to transmit from generation to generation as Royal Grant Lands and newly cleared lands, the private occupation had already begun to be formed. Thus the private ownership of land originated by chiefs of the tribes had a trend to be gradually pervaded to the communal members. After the, SILLA Kingdom unified SAM KUK in 668 A.D., JEONG JEON System and KWAN RYO JEON System, which were the distribution systems of farmlands originated from the TANG Dynasty in China, were enforced to established the basis of an absolute monarchy. Even in this age the forest area was jointly controlled and commonly used by village communities because of the abundance of area and stocked volume, and the private ownership of the forest land was prohibited by law under the influence of the TANG Dynasty system. Toward the end of the SILLA Dynasty, however, as its centralism become weak, the tendency of the private occupancy of farmland by influential persons was expanded, and at the same time the occupancy of the forest land by the aristocrats and Buddhist temples began to come out. In the ensuing KORYO Dynasty (519 to 1391 A.D.) JEON SI KWA System under the principle of land-nationalization was strengthened and the privilege of tax collection was transferred to the bureaucrats and the aristocrats as a means of material compensation for them. Taking this opportunity the influential persons began to expand their lands for the tax collection on a large scale. Therefore, about in the middle of 11th century the farmlands and the forest lands were annexed not only around the vicinity of the capital but also in the border area by influential persons. Toward the end of the KORYO Dynasty the royal families, the bureaucrats and the local lords all possessed manors and occupied the forest lands on a large scale as a part of their farmlands. In the KORYO Dynasty, where national economic foundation was based upon the lands, the disorder of the land system threatened the fall of the Dynasty and so the land reform carried out by General YI SEONG-GYE had led to the creation of ensuing YI Dynasty. All systems of the YI Dynasty were substantially adopted from those of the KORYO Dynasty and thereby KWA JEON System was enforced under the principle of land-nationalization, while the occupancy or the forest land was strictly prohibited, except the national or royal uses, by the forbidden item in KYEONG JE YUK JEON SOK JEON, one of codes provided by the successive kings in the YI Dynasty. Thus the basis of the forest land system through the YI Dynasty had been established, while the private forest area possessed by influential persons since the previous KORYO Dynasty was preserved continuously under the influence of their authorities. Therefore, this principle of the prohibition was nothing but a legal fiction for the security of sovereign powers. Consequently the private occupancy of the forest area was gradually enlarged and finally toward the end of YI Dynasty the privately possessed forest lands were to be officially authorized. The forest administration systems in the YI Dynasty are summarized as follows: a) KEUM SAN and BONG SAN. Under the principle of land-nationalization by a powerful centralism KWA JEON System was established at the beginning of the YI Dynasty and its government expropriated all the forests and prohibited strictly the private occupation. In order to maintain the dignity of the royal capital, the forests surounding capital areas were instituted as KEUM SAN (the reserved forests) and the well-stocked natural forest lands were chosen throughout the nation by the government as BONG SAN(national forests for timber production), where the government nominated SAN JIK(forest rangers) and gave them duties to protect and afforest the forests. This forest reservation system exacted statute labors from the people of mountainious districts and yet their commons of the forest were restricted rigidly. This consequently aroused their strong aversion against such forest reservation, therefore those forest lands were radically spoiled by them. To settle this difficult problem successive kings emphasized the preservation of the forests repeatedly, and in KYEONG KUK DAI JOEN, the written constitution of the YI Dynasty, a regulation for the forest preservation was provided but the desired results could not be obtained. Subsequently the split of bureaucrats with incessant feuds among politicians and scholars weakened the centralism and moreover, the foreign invasions since 1592 made the national land devasted and the rural communities impoverished. It happned that many wandering peasants from rural areas moved into the deep forest lands, where they cultivated burnt fields recklessly in the reserved forest resulting in the severe damage of the national forests. And it was inevitable for the government to increase the number of BONG SAN in order to solve the problem of the timber shortage. The increase of its number accelerated illegal and reckless cutting inevitably by the people living mountainuos districts and so the government issued excessive laws and ordinances to reserve the forests. In the middle of the 18th century the severe feuds among the politicians being brought under control, the excessive laws and ordinances were put in good order and the political situation became temporarily stabilized. But in spite of those endeavors evil habitudes of forest devastation, which had been inveterate since the KORYO Dynasty, continued to become greater in degree. After the conclusion of "the Treaty of KANG WHA with Japan" in 1876 western administration system began to be adopted, and thereafter through the promulgation of the Forest Law in 1908 the Imperial Forests were separated from the National Forests and the modern forest ownership system was fixed. b) KANG MU JANG. After the reorganization of the military system, attaching importance to the Royal Guard Corps, the founder of the YI Dynasty, TAI JO (1392 to 1398 A.D.) instituted the royal preserves-KANG MU JANG-to attain the purposes for military training and royal hunting, prohibiting strictly private hunting, felling and clearing by the rural inhabitants. Moreover, the tyrant, YEON SAN (1495 to 1506 A.D.), expanded widely the preserves at random and strengthened its prohibition, so KANG MU JANG had become the focus of the public antipathy. Since the invasion of Japanese in 1592, however, the innovation of military training methods had to be made because of the changes of arms and tactics, and the royal preserves were laid aside consequently and finally they had become the private forests of influential persons since 17th century. c) Forests for official use. All the forests for official use occupied by government officies since the KORYO Dynasty were expropriated by the YI Dynasty in 1392, and afterwards the forests were allotted on a fixed standard area to the government officies in need of firewoods, and as the forest resources became exhausted due to the depredated forest yield, each office gradually enlarged the allotted area. In the 17th century the national land had been almost devastated by the Japanese invasion and therefore each office was in the difficulty with severe deficit in revenue, thereafter waste lands and forest lands were allotted to government offices inorder to promote the land clearing and the increase in the collections of taxes. And an abuse of wide occupation of the forests by them was derived and there appeared a cause of disorder in the forest land system. So a provision prohibiting to allot the forests newly official use was enacted in 1672, nevertheless the government offices were trying to enlarge their occupied area by encroaching the boundary and this abuse continued up to the end of the YI Dynasty. d) Private forests. The government, at the bigninning of the YI Dynasty, expropriated the forests all over the country under the principle of prohibition of private occupancy of forest lands except for the national uses, while it could not expropriate completely all of the forest lands privately occupied and inherited successively by bureaucrats, and even local governors could not control them because of their strong influences. Accordingly the King, TAI JONG (1401 to 1418 A.D.), legislated the prohibition of private forest occupancy in his code, KYEONG JE YUK JEON (1413), and furthermore he repeatedly emphasized to observe the law. But The private occupancy of forest lands was not yet ceased up at the age of the King, SE JO (1455 to 1468 A.D.), so he prescribed the provision in KYEONG KUK DAI JEON (1474), an immutable law as a written constitution in the YI Dynasty: "Anyone who privately occupy the forest land shall be inflicted 80 floggings" and he prohibited the private possession of forest area even by princes and princesses. But, it seemed to be almost impossible for only one provsion in a code to obstruct the historical growing tendecy of private forest occupancy, for example, the King, SEONG JONG (1470 to 1494 A.D.), himself granted the forests to his royal families in defiance of the prohibition and thereafter such precedents were successively expanded, and besides, taking advantage of these facts, the influential persons openly acquired their private forest lands. After tyrannical rule of the King, YEON SAN (1945 to 1506 A.D.), the political disorder due to the splits to bureaucrats with successional feuds and the usurpations of thrones accelerated the private forest occupancy in all parts of the country, thus the forbidden clause on the private forest occupancy in the law had become merely a legal fiction since the establishment of the Dynasty. As above mentioned, after the invasion of Japanese in 1592, the courts of princes (KUNG BANGG) fell into the financial difficulties, and successive kings transferred the right of tax collection from fisherys and saltfarms to each KUNG BANG and at the same time they allotted the forest areas in attempt to promote the clearing. Availing themselves of this opportunity, royal families and bureaucrats intended to occupy the forests on large scale. Besides a privilege of free selection of grave yard, which had been conventionalized from the era of the KORYO Dynasty, created an abuse of occuping too wide area for grave yards in any forest at their random, so the King, TAI JONG, restricted the area of grave yard and homestead of each family. Under the policy of suppresion of Buddhism in the YI Dynasty a privilege of taxexemption for Buddhist temples was deprived and temple forests had to follow the same course as private forests did. In the middle of 18th century the King, YEONG JO (1725 to 1776 A.D.), took an impartial policy for political parties and promoted the spirit of observing laws by putting royal orders and regulations in good order excessively issued before, thus the confused political situation was saved, meanwhile the government officially permittd the private forest ownership which substantially had already been permitted tacitly and at the same time the private afforestation areas around the grave yards was authorized as private forests at least within YONG HO (a boundary of grave yard). Consequently by the enforcement of above mentioned policies the forbidden clause of private forest ownership which had been a basic principle of forest system in the YI Dynasty entireely remained as only a historical document. Under the rule of the King, SUN JO (1801 to 1834 A.D.), the political situation again got into confusion and as the result of the exploitation from farmers by bureaucrats, the extremely impoverished rural communities created successively wandering peasants who cleared burnt fields and deforested recklessly. In this way the devastation of forests come to the peak regardless of being private forests or national forests, moreover, the influential persons extorted private forests or reserved forests and their expansion of grave yards became also excessive. In 1894 a regulation was issued that the extorted private forests shall be returned to the initial propriators and besides taking wide area of the grave yards was prohibited. And after a reform of the administrative structure following western style, a modern forest possession system was prepared in 1908 by the forest law including a regulation of the return system of forest land ownership. At this point a forbidden clause of private occupancy of forest land got abolished which had been kept even in fictitious state since the foundation of the YI Dynasty. e) Common forests. As above mentioned, the forest system in the YI Dynasty was on the ground of public ownership principle but there was a high restriction to the forest profits of farmers according to the progressive private possession of forest area. And the farmers realized the necessity of possessing common forest. They organized village associations, SONGE or KEUM SONGE, to take the ownerless forests remained around the village as the common forest in opposition to influential persons and on the other hand, they prepared the self-punishment system for the common management of their forests. They made a contribution to the forest protection by preserving the common forests in the late YI Dynasty. It is generally known that the absolute monarchy expr opriates the widespread common forests all over the country in the process of chainging from thefeudal society to the capitalistic one. At this turning point in Korea, Japanese colonialists made public that the ratio of national and private forest lands was 8 to 2 in the late YI Dynasty, but this was merely a distorted statistics with the intention of rationalizing of their dispossession of forests from Korean owners, and they took advantage of dead forbidden clause on the private occupancy of forests for their colonization. They were pretending as if all forests had been in ownerless state, but, in truth, almost all the forest lands in the late YI Dynasty except national forests were in the state of private ownership or private occupancy regardless of their lawfulness.