Principle Of Informed Consent Research Articles

Application of the Informed Consent Principle in Civil Law: A Case Study of Reduction Operations and Internal Fixation


 
 
 This article describes the application of the principle of informed consent in civil law, focusing on case studies of internal reduction and fixation operations (ORIF). The research method uses a normative legal approach by analyzing related laws and regulations, related court decisions, and relevant legal literature. Interviews with medical legal practitioners and experienced physicians were conducted to gain practical insight into doctor-patient agreements in ORIF actions. The importance of a holistic and adaptive approach in implementing the principle of informed consent in Indonesia not only covers legal aspects, but also considers cultural, social, and economic factors. This requires active involvement from all relevant parties, as well as increased awareness of patient rights and physician responsibilities. By understanding these challenges, we can improve informed consent systems in the context of ORIF, create a more transparent healthcare environment, and safeguard the principles of patient well-being in medical practice. The results of this study are expected to contribute to a further understanding of the complexities of civil law in the context of informed consent, strengthen ethical principles in medical practice, and provide guidance for stakeholders, including physicians and medical law practitioners with a focus on ORIF actions.
 
 

The evolution and development of the principle of free, prior and informed consent in South Africa

This article traces the evolution of the principle of free, prior and informed consent within the South African developmental context. Internationally, free prior and informed consent presupposes that communities have the right to give or withhold consent to proposed development projects on the lands that they own, occupy or otherwise use. Specific to South Africa, research reveals that although the country has not formally adopted the free, prior and informed consent principle within its development system, the spirit of the principle has permeated the development discourse in the country through development policies, legislation and case law. All major development policies in South Africa embody the public participation element, which is a precursor to free, prior and informed consent. Several Acts of parliament specifically require that communities’ consent must be sought and obtained before any development may take place in their territories. This sentiment has recently been augmented by court cases, both at High Court and Constitutional Court levels.

From knowledge to a gendered event and trustful ties: HPV vaccine framings of eligible Finnish girls and school nurses.

In the present study, we examine socio-cultural and practical aspects of human papillomavirus vaccination (HPVV) through a multi-sited study of framings. We ask how HPVV is framed in the daily lives of vaccination-aged Finnish girls and in school nurses' everyday work. We then mirror these framings against both each other and Finland's official vaccination campaign. Based on analysis of interviews with 24 nurses and 12 girls and the campaign materials, we argue first that the campaign frames vaccination as an individual, knowledge-based decision reflecting the informed consent principle. Second, however, the vaccination is framed in the everyday lives of eligible girls through gendered social ties and as a gendered and cohort-specific event pivoting around the needle prick. Third, HPVV is not primarily framed in the school nurses' work as preparing the girls for the vaccination decision by sharing official information but through trust-based social relationships with the girls and their parents. We conclude that, as the vaccination is not an issue of individually reflected and knowledge-based decision-making for the two interviewed key groups, the official Finnish HPVV campaign and the undergirding informed consent principle drift into problems in their practical implementation.

Intestinal parasitic infections in a population ofBaAka Pygmies inhabiting the Congo Basin inthe Central African Republic.

Pygmy tribes inhabit tropical environment of Central Africa. After expulsion from their original habitat by the Bantu people, they settled in a local forest ecosystem where they live with very low sanitary standards. Their actual morbidity remains unknown. The aim of the study was to analyze the prevalence of intestinal parasitic infections in BaAka Pygmies inhabiting the Congo Basin in the Central African Republic. The study was conducted in 2015, and involved a group of 950 Pygmies living inthe Sangha-Mbaere and Lobaye prefectures. Single stool samples were collected from study participants, fixed in 10% formalin, transported from Africa to Europe, and analyzed by light microscopy using 5 different diagnostic methods (direct smear, decantation with distilled water, Fülleborne's flotation, Kato-Miura thick smear, DiaSyS/PARASYS system sedimentation) at the Military Institute of Medicine in Warsaw, Poland. Microscopic examination revealed infections with 14 different species of intestinal nematodes, cestodes, trematodes and protozoa. According to the study findings, 90.5% of BaAka Pygmies were found to be infected with intestinal parasites, and 70.8% had mixed infections. Most of the pathogenic intestinal parasites were nematodes (85.0%), with Asrcaris lumbricoides (29.8%), hookworm (29.4%) and Trichuris trichiura (10.7%) being predominant. Poor sanitation, limited the high prevalence of intestinal parasitic infections in the community of Pygmies. The negative test results may prove the effectiveness of periodic deworming campaigns chich, implemented by non-governmental organizations, are voluntary with respect to the informed consent principle.

Chinese Localization of the Right to Be Forgotten

The right to be forgotten is a new trending right that originated from the European Union and is transferring to China. To break down the Bentham’s panopticon of comprehensive digital memory, it is necessary for China to adopt the right to be forgotten. While the Chinese legal framework of personal information has not been completed yet, the Draft of Personal Information Law implies a focus on duties of controllers and interests of minors. By analysing possible legal attributes of the right to be forgotten, it can be noted that typifying the right to be forgotten is essential, but the problem of exercising limitation and of the asymmetric information market have not been solved. To tackle these problems, one solution is to specify the requirements of the government, the organization and the information subject with balance; the other is to perfect the right to be forgotten referring to the Informed Consent Principle and complement other principles to support the entire personal information protection system.

Intravitreal injection of conbercept after operation in the treatment of proliferatived diabetic retinophathy complicated with vitreous hemorrhage

Objective To observe the efficacy and safety of intravitreal injection of conbercept in the treatment of proliferatived diabetic retinophathy (PDR) complicated with vitreous hemorrhage by minimally invasive vitreoretinal surgery. Methods Prospective clinical study. A total of 50 patients with PDR complicated with vitreous hemorrhage clinically diagnosed in Tianjin Medical University Eye Hospital who needed vitrectomy were recruited in this study. According to the principle of informed consent, the patients were divided into two groups: postoperative injection group and the control group. Twenty-five eyes of 25 patients in each group were examined before operation. No significant proliferative changes in the posterior pole and traction retinal detachment were observed. There was significant difference of age between two groups (t=-24.697, P=0.030), but no significant difference of sex (χ2=0.330, P=0.564), duration of diabetes (t=-1.144, P=0.258), logMAR BCVA (t=-0.148, P=0.883), lens state (χ2=0.397, P=0.529), panretinal laser photocoagulation (χ2=1.333, P=0.248). The postoperative injection group was treated with intravitreous injection of 0.05 ml conbercept (10 mg/ml) immediately after 27G minimally invasive vitrectomy. The other treatment and follow-up were the same as those in the postoperative injection group except for conbercept injection. All patients underwent routine slit-lamp examination, indirect ophthalmoscope and B-ultrasound examination before operation. The main outcome measure included the time of operation, the incidence rate of iatrogenic retinal holes and silicone oil filling. The recurrence of vitreous hemorrhage, BCVA, intraocular pressure, central retinal thickness (CRT), postoperative complications and progression were recorded 1 week, 1 month, 3 months and 6 months after operation. Results At 1 week and 1, 3, 6 months after operation, there was significant difference of logMAR BCVA between the two groups (t=-4.980, -4.840, -4.892, -5.439; P<0.001). At 3 and 6 months after operation, the recurrence of vitreous hemorrhage in the postoperative injection group was lower than that in the control group, but there was no statistical difference between two groups (χ2=3.030, 4.153; P=0.192, 0.103). At 1 week and 1, 3, 6 months after operation, the CRT in the postoperative injection group was lower than that in the control group, the difference was significant (t=-2.622, -2.638, -3.613, -3.037; P=0.012, 0.010, 0.001, 0.004, 0.005). There was no complications such as choroid detachment, proliferative vitreoretinopathy, retinal detachment, iris redness and neovascular glaucoma in all the eyes after operation. Conclusions Intravitreal injection of conbercept in the treatment of PDR after operation is safe and effective. It can reduce the recurrence of vitreous hemorrhage after vitrectomy, improve the BCVA. Key words: Diabetic retinopathy/complications; Vitreous hemorrhage; Angiogenesis inhibitors/therapeutic use; Vitrectomy

The Waxing &amp;amp; Waning of Informed Consent: Medical Assistance in Dying and the Question of Advance Requests

This paper traces the impact of the principle of informed consent on Canadian legal developments in the area of advance directives, medical assistance in dying (MAID), and (where the two converge) advance requests in the context of MAID. I show how recognition of the principle of informed consent has not only served to justify developments in the law facilitating advance directives; it has also played an important role in justifying the legalization, under specific circumstances, of MAID. The paradigmatic case of informed consent is where a clearly competent, fully informed adult effectively communicates with their physician, contemporaneously to the administration of treatment. Deviation from these conditions raises questions about how to apply the principle. I examine the claim that the ascendance of the informed consent principle has eclipsed other principles while obscuring the role that the professional judgment of physicians plays in the provision of medical treatment. I analyse this claim in relation to conflicts over prolongation of so-called futile treatment and access to MAID. I then argue why the present capacity requirement, barring advance requests for MAID, is justified.

Audit of informed consent document for major surgical procedures at a tertiary care hospital

Background: Consent is being regarded as the cornerstone of a doctor patient relationship. No patient can be forced, directly or indirectly, to accept treatment which it may refuse, even if it is painless, beneficial to him and without any risk including the fact that refusal may have life threatening consequences. Lack of an informed consent is an area that can win legal suits for the patient even when the claim for any negligence is weak. Aim: To review the informed consent documents in cases of major surgical procedures conforming the accepted principles of informed consent and to prepare a checklist for help in future audit of informed consent documents. Methods: Authors compiled a list of desirable and essential content areas in informed consent document based on commonly accepted professional standards. Informed consent forms of planned major surgical procedures for department of surgery, obstetrics and gynecology and orthopedics were included. 100 informed consent forms, selected randomly by computer at medical records department, for each department were studied for 23 attributes. Descriptive statistics and exploratory data analysis techniques were used to analyze the data. Result: The consent documents lacked a third of essential elements in totality for all the departments [08/ 23] while few partially. Conclusion: There is ample room for training of treating registered medical practitioner on how an informed consent should be documented so as to be safe ethically as well as legally. Consent is never a defense in an allegation of medical negligence.

ABOUT THERAPEUTIC RELATIVISM IN ADDICTOLOGY

The problem of off-label therapy of addictive disorders is analyzed in the article. It has been noted that such a practice became widespread due to the position of narcologists called "therapeutic relativism" according to which establishing a "nosological" diagnosis on ISD or DSM was not basic and significant for making a therapeutic decision. Significant is a determination of a psychopathologic syndrome / phenomenon level and existence of the patient's subjective inquiry. It is estimated that the doctor has the right to prescribe a therapy depending on "inquiry" of the person seeking for a medical attention not only in case of disorders detection, but also in cases of the preclinical states. The discussion history on the limits of addictive norm and pathology has counted more than thirty years when there was an opinion that addictive disorders represented the continuum built as disorders increase and excluded existence of differential criteria between the norm and pathology. The problem of diagnostics and therapy intensified with the introduction of ICD-10 which besides the dependence contained nosologically undetermined heading "harmful (with harmful consequences) use of surfactant" (F1x.1). The article makes a conclusion that off-label therapy in a modern addictology can be considered as justified, but only concerning drugs with the proved safe action profile and in case of unfailing adherence to the informed consent principle.

Consentimiento informado en la prestación de servicios de salud

El presente ensayo es de tipo explicativo, descriptivo y argumentativo cuyo objeto principal es evidenciar la importancia del consentimiento informado, que actúa como garantía para el ejercicio del derecho a la salud. Los métodos utilizados son el exegético para demostrar y comprender la importancia del principio de autonomía y su principio derivado del consentimiento informado en el ordenamiento jurídico y en lo específico en la relación médico paciente. Así mismo se utiliza el método de derecho comparado y de análisis del caso para examinar dos sentencias una de la Corte IDH y otro del TEDH con el objetivo de evidenciar como en la realidad material o práctica se desnaturaliza y descontextualiza el consentimiento informado de los pacientes violentando sus derechos.

Mining industry perspectives on indigenous rights: Corporate complacency and political uncertainty

Over the last decade or so, there has been a global shift towards attempts to recognise the rights of indigenous peoples, particularly in regards to extractive activities on their traditional territories. At the same time, however, the extraction of natural resources in breach of indigenous rights, continues to take place at ever increasing rates. Using a case study of Swedish mining industry attitudes to indigenous rights, and specifically that of the principle of Free Prior and Informed Consent (FPIC), the article explores this paradox. Mining companies operating in Sweden do not currently respect or implement the principle of FPIC, and the article illustrates how mining representatives justify and reconcile this. It elucidates how the Swedish mining industry mobilises various, and at times contradictory, discourses, including on the one hand, the complacent rationale that human rights protections are superfluous in Sweden, and on the other hand, the idea that a respect for FPIC would create uncertainty and thereby threaten the existence of the mining industry.

Will the Eu Data Protection Regulation 2016/679 Inhibit Critical Care Research?

There is an inherent tension between critical care research and data protection. Because of their condition it is not possible to ask for the patients' informed consent to be enrolled in observational research at the point of admission to the hospital. Often this is not possible at a later moment either. Yet informed consent is the baseline to be enrolled in research with personal data and exceptions must be allowed for by national legislation. This was the case under Directive 95/96/EC and will be the case under the General Data Protection Regulation (GDPR, Regulation 2016/679 EU) which will replace the Directive from 25 May 2018 onwards. Though being a Regulation and therefore directly applicable in the Member States, the long debate about the research exceptions in the GDPR left many aspects of observational research including the exception to the informed consent principle, mainly to the Member States. It may be assumed that most Member States will leave their present state of the law intact in this respect as that was part of the political compromise. We compared existing national privacy legislation from the perspective of critical care research and found great variation. Although this may not impede the collection of emergency and critical care research with data without prior informed consent in countries which are more responsive to such research, it might be a challenge to exchange such data from the national nodes in European wide research collaboration. We make a case that countries which are not responsive to such research should adapt their legislation in the interests of future critical care patients.

Environmental Law Politics and Malind Anim Indigenous People Rights Protection based on Free and Prior Informed Consent Principles

Indigenous peoples and the environment are two things that are difficult to separate, because they are interdependent. The regulation of environmental law in Indonesia and in the world generally regulates the protection of indigenous peoples’ rights of the environment. Over time, conflicts over the environment often occur due to the needs of development that exploit the indigenous peoples’ environment. The problem in this paper is to protect the rights of indigenous peoples and their customary environment based on the Principles of Free and Prior Informed Consent (FPIC). Based on FPIC principles, indigenous peoples' rights of their environment can be protected and it will not cause harm to the indigenous peoples. When governments and investors use the customary environment of the indigenous people for both public and economic development interests, they must pay respect and appreciation to the indigenous peoples in the using the environment based on FPIC principles. This research was conducted by analyzing the rules of law and the principles of law, and examining the relationship of environmental law issues and the regulations that exist. The conclusion of this paper is that the principles of FPIC is the concept of environmental protection on the rights of indigenous peoples which must be applied in the existing laws of environmental law in Indonesia to maintain legal certainty in protecting indigenous peoples' customary environment.

Present situation and influencing factors on classroom mobile phone dependence syndrome in college students

Objective: To explore the current situation and influencing factors on Classroom Mobile Phone Dependence Syndrome (CMPDS) among college students, and to provide scientific basis for guiding college students to use mobile phones reasonably and healthily. Methods: Stratified cluster sampling method was used. Students from different majors and different grades in Lanzhou University were included as the research objects. Classes were recognized as a unit in receiving basic field investigation in this questionnaire related study. Informed consent principles were followed and process of survey was anonymously carried out. Results: The overall rate of CMPDS in college students was 8.7%, including 'mild rate' as 6.6% and 'seriously mild rate' as 2.1%. No significant differences were found on genders or grades. Factors as shopping in the classroom shopping (OR=3.720), being bored on courses (OR=1.740), WiFi coverage (OR=1.787), time of practice in the classrooms (OR=1.514), and the total time of daily mobile phone use (OR=1.513) etc, appeared as risk factors related to CMPDS among the college students. However. shooting courseware (OR=0.579) appeared as a protective factor. Conclusions: Rate of CMPDS was high in college students and we suggested to form a joint task force among the college authority, teachers and students to work on the related problems. Hopefully, the serious CMPDS condition will be minimized and both physical and mental health of the college students be improved.

Некоторые аспекты реализации принципа добровольного информированного согласия на медицинское вмешательство в отношении детей

Некоторые аспекты реализации принципа добровольного информированного согласия на медицинское вмешательство в отношении детей

Included or Excluded: An Analysis of the Application of the Free, Prior and Informed Consent Principle in Land Grabbing Cases in Cameroon

Even though the principle of free, prior and informed consent (FPIC) is soft law, the need to respect, protect and fulfil the rights to be informed and to be involved in development projects is strongly backed in international legal instruments including inter alia the ILO Convention 169 Concerning Indigenous and Tribal People in Independent Countries (1998) and the UN Declaration on the Rights of Indigenous and Tribal People (2007). These instruments do not only appear to be the most comprehensive and advanced international legal instruments that deal with indigenous peoples' rights in terms of the FPIC, but also signal an addition to the growing body of international human rights law that serves to ensure the realisation and protection of the substantive environmental and other human rights of indigenous people, particularly in the context of land grabbing activities that have the potential to negatively impact on their rights. Such rights include, for example, the rights to be informed and to participate in decision-making processes with respect to development projects, including land grabbing activities. This implies an obligation on states party to such international agreements to ensure that indigenous people are informed about and are actively involved in both the negotiation and the implementation of land grabbing deals. However, because the latter often takes place against the background of non-transparent transactions which are inimical to the rights and interests of indigenous people, one may wonder why the principle of FPIC is not applicable during land grabbing transactions.&#x0D; Focusing on Cameroon, this article examines instances of land grabbing in the country in order to support this hypothesis. This is done by focusing specifically on the application of the principle of FPIC. The arguments in the article are inspired by international law in which the application of the principle in the context of land grabbing serves not only to protect the rights and interests of indigenous people but is also conducive to fostering and reinforcing the land governance regime of host countries involved in such deals. To this end, the article concludes that because the principle embodies aspects of procedural rights such as the rights to information and participation, which are often conspicuously lacking during land grabbing contracts, its application in and during land grabbing might be useful to set the basis for the recognition, promotion, and enforcement of local communities' rights in Cameroon.&#x0D;  &#x0D;    

Analysis on Several Violations of the Informed Consent Principle in the Process of Human Body Test—Taking Protection to the Rights and Interests of the Subjects as the Core

Human testing is the basis and prerequisite for the development of medical science. Informed consent worked as an important principle which protect people’s rights and interests, is very important in theory and practice, however, in the process of actual operation, subject to the influence of many factors, the actual implementation effect of this principle is still unsatisfactory. This paper focuses on the discussion of some cases which violated the rights of subjects because of derogate from principle of informed consent, in order to put forward some methods to solve those problems. With the development of medical science, no matter in terms of the scope, means or influences and intervention on human bodies, modern human trial has been applied more widely and more deeply. Moreover, general attention has been paid to by patients and the ethics circle. Informed consent, the principle of life ethics which is regarded as the most basic principle of human trials, has been attached great importance to.

Analysis of nursing ethics and practice of physical constraints in the intensive care unit

Patients in intensive care unit were more critically ill, and often accompanied by dottiness and restless. In order to avoid the adverse events and self-injury, body constraints were often used on the patients. Therefore, this paper would discuss the ethics of body constraints and give the suggestions. According to the literature review and the analysis of the clinical nursing experience of relevant ethical principles, data was collected. The principle of informed consent, respect, and harmless was hard to decide on the issue of body constraints for patients in ICU. Nurses might pay attention to the application of ethical principles, and strengthen the humanistic care. On the issue of body constraints for ICU patients, nurses might pay special attention to the application of possible ethics principles in nursing process and reduce the application of the body constraints, and promote the physical and mental comfort of patients. It reflected the progress of the humanistic solicitude in the current clinical nursing and important value. Key words: Ethical analysis; Intensive care unit; Body constraint

A contrast study on mild hypothermia treatment of neonatal hypoxic-ischemic encephalopathy at different time windows

Objective To study the clinical effects of mild hypothermia treatment of neonatal hypoxic-ischemic encephalopathy(HIE) at different time windows by observing neonatal amplitude integrated electroencephalography(aEEG) and neuron-specific enolase(NSE) level changes before and after therapy. Methods There were 152 cases of newborns with HIE, according to the principle of informed consent with the mild hypothermia and regular treatment.According to the starting time of treatments the cases were divided into 6 h group and 6 to 12 hours group.And accor-ding to the conditions the cases were divided into mild, moderate and severe groups.The control group was treated by classical solutions, while mild hypothermia group received conventional treatment combined with head mild hypothermia therapy.All the newborns had aEEG monitoring and NSE measuring 3 days before and after treatment. Results Whe-ther it was within 6 h or 6 to 12 h starting mild hypothermia therapy for mild HIE newborns, it had no obvious change for aEEG and NSE scroes compared with the control group.However, it was only within 6 h starting hypothermia therapy for moderate group and severe group in the 3 days of treatment with aEEG score changes(moderate: 1.8±0.7, 4.7±1.7, F=5.67, P 0.05). Conclusions Determination of aEEG and NSE can help determine the recent curative effect after cryogenic treatment of children with HIE.Children with mild HIE even without low temperature treatment, their prognosis was good.Children with moderate HIE, both within the time window of 6 h and line between 6 and 12 h head low temperature treatment, also had curative effect, and the earlier treatment begins, the better the curative effect.And for children with severe HIE, hypothermia therapy had curative effect only within 6 h. Key words: Mild hypothermia; Time-window; Hypoxic ischemic encephalopathy; Neonatal amplitude integrated electroencephalography; Neuron-specific enolase

Effect of comprehensive nursing intervention on laryngeal cancer patients' depression and coping modes

Objective To investigate the effect of comprehensive nursing intervention on the depression and coping modes of laryngeal cancer patients. Methods A total of 106 laryngeal cancer patients in compliance with the principle of informed consent were randomly divided into experimental group (56 cases) and control group (50 cases).The patients' depression and their coping modes were investigated by adopting Self-rating Depression Scale (SDS) and Medical Coping Modes Questionnaire (MCMQ), and comprehensive nursing intervention were given to the experimental group. Results After the implementation of comprehensive nursing intervention, the depression score of experimental group apparently was decreased, and the difference was statistically significant (P 0.05). Conclusions Comprehensive nursing intervention can change the patients' cognition of the disease and improve their condition of depression.Meanwhile it teaches them the positive and correct coping modes so as to enhance their confidence in fighting with the disease and to promote the rehabilitation of the disease. Key words: Comprehensive nursing intervention; Laryngeal cancer; Depression; Coping modes