Epidemiology and Informed Consent

2021 ◽  
pp. 27-43
Author(s):  
Anna C. Mastroianni ◽  
Jeffrey P. Kahn

This chapter focuses on informed consent, which is a central concept and practice in the protection of the rights and interests of both patients receiving clinical care and individuals participating in research. It addresses the commitment to the ethical principles underlying informed consent that dates back to the early twentieth century, as reflected in many countries' laws governing the physician–patient relationship. It also recounts how informed consent was codified into national policies and international guidelines and standards for research on human subjects. The chapter explores the parallel origins of informed consent and its applications, which are based on distinctions between clinical practice and research and do not naturally apply to or readily translate to epidemiology. It outlines the requirements for consent that have been and are treated differently in epidemiology depending on the type of activity and sometimes the practicability of seeking consent from participants.

1987 ◽  
Vol 12 (1) ◽  
pp. 55-97 ◽  
Author(s):  
Fran Carnerie

AbstractMany individuals develop a temporary state of cognitive and emotional impairment after being diagnosed with catastrophic illness. Thus, when crucial decisions about medical treatment are required, they are unable to assimilate information; or worse, the legal need to be informed can rival a psychological desire to not be informed. The Canadian informed consent doctrine is unresponsive to crisis and clinically impracticable, and so paradoxically compromises the integrity and autonomy it was designed to protect. Many aspects of the physician-patient relationship and clinical setting also undermine the philosophical values enshrined in this doctrine. This further jeopardizes the individual's integrity. The Article explores proposals for change such as delaying the informing and consenting, improving the concept of consent, and improving the role of the physician.


Thomas Szasz ◽  
2019 ◽  
pp. 139-154
Author(s):  
Mantosh J. Dewan ◽  
Eugene A. Kaplan

Besides Szasz’s controversial views are brilliant contributions to clinical practice, including the following examples: (1) He elaborated the physician-patient relationship with three models—“activity-passivity,” “guidance-cooperation,” and “mutual participation.” (2) In The Ethics of Psychoanalysis (1965), he promoted “autonomous psychotherapy,” which involved noncoercive dialogue between therapist and patient that would lead to education and growth for the latter. (3) He argued that transference is part of the analyst’s judgment and the patient’s experience, and that there is a relationship between transference and learning. (4) He used principles of “object relations” theory to explicate deeply the signs and symptoms of schizophrenia. Contrary to popular belief, he was not “antipsychiatry” simpliciter. As a theorist, he clarified language and tried to understand pain. As a practicing clinician, he advocated ways to help people in distress, urged embracing the freedom and autonomy of patients, and treated them as persons with abilities to help themselves.


2021 ◽  
Vol 7 (1) ◽  
pp. 37-41
Author(s):  
Hossein Khoshrang ◽  
◽  
Morteza Rahbar Taramsari ◽  
Cyrus Emir Alavi3 ◽  
Robabeh Soleimani ◽  
...  

Background: In patients undergoing Electroconvulsive Therapy (ECT), obtaining written Informed Consent (IC) must be the standard measure before the procedure. The patient must be informed about the risks and benefits of the treatment and alternatives. Objectives: We aimed to investigate the quality of IC obtaining before the ECT course in an academic hospital in the North of Iran. Materials & Methods: This study was conducted at an academic center in the north of Iran during 2018-2019. Firstly the patients’ mental capacity was assessed, and if it was not adequate for giving informed consent, a patient’s relative was interviewed. The collected data were analyzed by SPSS V. 22. The Kolmogorov-Smirnov test was used to evaluate the normality assumption. To compare the mean scores in subgroups, we applied t-test. Results: A total of 259 people enrolled in the survey and were interviewed. Schizophrenia was the main cause of receiving ECT. The Mean±SD score of receiving information was 8.22±3.68 (0-16), understandability of IC 3.03±1.76 (0-6), patients’ voluntary acceptance of the treatment 1.38±0.68 (0-4) and physician-patient relationship 6.11±2.16 (0-12). The total Mean±SD score was 18.05±3.16 (0-38). Conclusion: IC process was not optimal in our center; however, great trust in the physicians was noticeable. The physician-patient relationship had the highest score while the intentional obtaining of informed consent achieved the lowest.


Author(s):  
Jianguang WANG

LANGUAGE NOTE | Document text in Chinese; abstract also in English.扁鵲是中國先秦時期著名的醫生,同時也是中國傳統醫學和醫學倫理的奠基者和實踐者之一。他在與蔡桓公的幾次會面中作出的對話,有著豐富的道德內涵,展示了傳統醫患之間的一種具有特色的醫學倫理。中國傳統的醫學倫理和職業精神並不把醫生僅僅看成是一個純粹的技術性職業,而是賦與其中豐富的人生道德內涵和家國天下的思想,所以在西方醫患關係中被認為是十分重要的知情同意問題,在中國傳統的醫患關係中雖然也存在,但並沒有成為中國傳統醫患關係的主體。與之相反,中國傳統的醫患關係因為是建立在“上醫醫國”的文化土壤中的,醫患之間的關係也是在綱常倫理的維度中加以調適的,所以這種關係不僅僅是今天意義上的權利和義務、知情和同意等法律屬性的關係。Bian Que is the earliest known Chinese physician of the Pre-Qin era (ca. 700 B.C.E), whose name is often associated with physicians of the highest medical caliber. One legend tells of how when Bian Que was in the feudal state of Cai, he visited the Lord Huan and told him that he had a serious disease. The Lord Huan thought Bian Que was trying to profit from the fears of his patients and declined the offer for treatment. Eventually, Lord Huan’s condition got worse. The last time Bian Que went to see Lord Huan, he knew that the lord would soon die and escaped from the state. This essay considers the ethical implications of the legend, such as the moral duty of the physician and the nature of the physician-patient relationship. Did Bian Que violate informed consent when he failed to tell the lord he would die of the disease if not treated immediately? The author concludes that the role of physician in ancient China was quite different from what one sees today. Thus, modern ideas and concepts such as informed consent and the language of rights cannot be applied to the case of Bian Que.DOWNLOAD HISTORY | This article has been downloaded 182 times in Digital Commons before migrating into this platform.


2021 ◽  
Vol 31 (1) ◽  
pp. 1-8
Author(s):  
Shadi Sabetghadam ◽  

Introduction: Nowadays, about 50-65% of births in Iran occur by Cesarean Section (CS). Informed consent (IC) is one of the most important ethical, legal and professional requirements of a surgical procedure. Objectives: This study aims to assess the quality of obtaining surgical IC from women underwent CS in public hospitals of Iran. Materials and Methods: In this analytical study with cross-sectional design, 300 postpartum women who had CS referred to two public hospitals in Rasht, Iran were participated through stratified random sampling method in 2016. Data were collected using a two-part researcher-made questionnaire. Collected data were analyzed by using descriptive statistics, Kruskal-Wallis test, Mann-Whitney U test, and Spearman’s correlation test. Results: The mean age of participants was 29.84 ± 5.9 years. The majority of them (45.3%) had education lower than high school. The overall mean score for the quality of obtained IC was 62.23±23.38, out of 150 points. Regarding its dimensions, quality of acquiring IC form (20.21±7.12, out of 40 points), provision of CS-related information (15.67±11.10, out of 45 points), voluntariness (7.53±6.95, out of 25), and the physician–patient relationship (18.81±8.87, out of 40 points) were perceived poor. Women’s educational level had a significant correlation with the IC quality dimensions of voluntariness (P=0.0001) and physician–patient relationship (P=0.043). The number of deliveries (P=0.008), live births (P=0.031), and stillbirth (P=0.0001) had a significant correlation with acquiring the IC form. The voluntariness was significantly associated with the number of live births (P=0.023) and stillbirth (P=0.001). The physician-patient relationship dimension was significantly associated with the number of pregnancies (P=0.023) and abortions (P=0.0001). The overall quality of obtained IC was significantly correlated with the women’ age (r= 0.162, P= 0.005). Conclusion: Most of women in Iran are not informed enough about the CS and its consequences. Health care providers should pay more attention to the women’s characteristics when obtaining IC for the CS. We recommend essential changes in the process of obtaining surgical IC for the CS in public hospitals of Iran. Obtaining IC during pregnancy may reduce unnecessary CSs.


2021 ◽  
pp. 161-178
Author(s):  
Abraham Fuks

Health care takes place in the relationship between patient and physician that is crafted mutually and relies crucially on the words and behaviors of the participants. The physician has a duty of care to the person who is ill and must therefore engage fully to respond to the needs of the patient. A language of alliance and shared goals that are clearly communicated shifts the doctor’s attention from the disease to the patient. This chapter examines schemas that have been put forward to characterize the clinical relationship and critiques the dual discourses that separate science and art, and posit technical skills and humane attentiveness as competing frames. It reviews phenomenological analyses of the clinical interaction and cautions against a form of autonomy and empowerment that permits clinicians to shed their responsibilities. The chapter explores clinical presence and relational understanding as necessary features of responsive and responsible clinical care.


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