Refugee Attitudes Towards Patient Autonomy-Based Ethics of Informed Consent

Refugee Attitudes Towards Patient Autonomy-Based Ethics of Informed Consent
Book Chapter
Sukran Sevimli
Practices, Challenges, and Prospects of Digital Ethnography as a Multidisciplinary Method, 2022 [IGIG Global]
Abstract
The objective of this study was to identify refugees’ attitudes concerning the autonomy-based ethics of informed consent and to determine whether these attitudes varied by gender. A quantitative methodology was adopted for this study. Questions were scored using a Likert-type scale and face-to-face interviews were conducted with 610 refugees who had migrated to Turkey from MENA and Caucasia countries. Refugees from eleven countries participated in the survey, of whom the majority were men (62.5% male versus 37.5% female). Autonomy is a fundamental principle of human rights and medical ethics. Refugees from MENA countries, where the concept of autonomy is contrary to the deeply-held traditional religious views of much of the population, in general, have a poor grasp of informed consent as a patient right. Traditional values steeped in patriarchy constitute an obstacle to women making decisions regarding their own lives in MENA and Caucasia countries. Therefore, the practice of informed consent is of critical importance in helping to reduce gender differentials in healthcare.

Informed consent for surgical case reports

Informed consent for surgical case reports
Mohamed Onyango, Brian Kariuki
The Annals of African Surgery, 30 June 2022
Open Access
Excerpt
Informed consent is one of the most essential pillars of medical research ethics (1). It encompasses the medical ethical principle of autonomy which enables the participants to decide on whether or not to partake in a study without any coercion (2). It also enables patients to make informed decisions after critically analyzing the implications of the facts presented by the surgeon (3). It is of great importance that surgeons apply specific informed consent rules for specific study designs they undertake. The majority of studies submitted to surgical journals are case reports, but the process for obtaining quality informed consent is still insufficient. In addition, some journals do not have well-defined informed consent protocols for case report studies. This editorial thus aims to highlight case report specific rules for informed consent for surgeons to employ prior to commencement of their research…

Are Consent Forms Used in Cardiology Clinics Easy to Read?

Are Consent Forms Used in Cardiology Clinics Easy to Read?
İbrahim Etem Dural
Archives of the Turkish Society of Cardiology, 30 June 2022
Open Access
Abstract
Objective
Informed consent forms are a contract between the patient and the doctor before the medical diagnosis and treatment. It is extremely important that the patient can read and understand such forms. The purpose of the present study was to investigate the readability levels of consent forms recommended by the Turkish Society of Cardiology used in cardiology clinics.
Methods
The number of words, syllables, letters, and characters of 20 consent forms that are used in cardiology clinics were calculated. The readability scores were calculated by using the formulas of Ateşman and Bezirci–Yılmaz.
Results
It was found that the cardiology consent forms were readable at the 11th or 12th grade according to the Ateşman Index and at the high school level according to the Bezirci–Yılmaz Index.
Conclusion
We suggest that the informed consent forms recommended by the Turkish Society of Cardiology must be simplified from the level that requires high school education to the level that requires 6 years of education, which is the average schooling year in Turkey.

Informed consent: who are we informing?

Informed consent: who are we informing?
Michele O’Shea
Rural Remote Health, 26 July 2022; 22(3)
Open Access
Abstract
Communication is the foundation of informed consent in research. This article relays the reflections of an American urogynecology fellow and researcher in Kenya on the topic of informed consent. After learning of how a previous foreign researcher’s presence in the community had violated the trust that women placed in women’s health research, she reflects on how the standard eurocentric approach to obtaining written informed consent in research may sow breakdowns in communication and also perpetuate distrust in research. Particularly for settings in which the language is primarily spoken, or where there are varying literacy levels, the standard research consent should be reimagined to make the informed consent process more equitable and less of an exercise in documentation. Communication of research study information to patients must take into account the diverse and evolving ways in which patients best consume information, and in such a way that it ultimately enhances their autonomy.

Disparities in Comprehension of the Obstetric Consent According to Language Preference Among Hispanic/Latinx Pregnant Patients

Disparities in Comprehension of the Obstetric Consent According to Language Preference Among Hispanic/Latinx Pregnant Patients
Rose L. Molina, Emily Adams, Ricardo Aguayo, Samantha Truong, Michele R. Hacker
Cureus, 21 July 2022; 14(7)
Open Access
Abstract
Background
We assessed understanding of the obstetric consent form between patients with English and Spanish language preference.
Methods
This observational study included pregnant patients who identified as Hispanic/Latinx with English or Spanish language preference (defined as what language the patient prefers to receive healthcare information) and prenatal care providers at a large academic medical center from 2018 to 2021. Patient demographics, language preference, literacy, numeracy, acculturation, comprehension of the obstetric consent, and provider explanations were collected.
Results
We report descriptive statistics and thematic analysis with an inductive approach from 30 patients with English preference, 10 with Spanish preference, and 23 providers. The English group demonstrated 72% median correct responses about the consent form; the Spanish group demonstrated 61% median correct responses. Regardless of language, the participants demonstrated limited understanding of certain topics, such as risks of cesarean birth.
Discussion
Overall comprehension of key information in an obstetric consent form was low, with differences in language groups, which highlights opportunities for improvements in communication across language barriers. Innovations in the communication of critical pregnancy information for patients with limited English proficiency need to be developed and tested.

The Need to Adjust the Informed Consent for Jewish Patients for Treatments Involving Porcine Medical Constituents

The Need to Adjust the Informed Consent for Jewish Patients for Treatments Involving Porcine Medical Constituents
Original Paper
Ya’arit Bokek-Cohen
Journal of Immigrant and Minority Health, 18 July 2022
Abstract
In order to obtain full informed consent for medical treatments, it is imperative to provide patients of diverse ethnic backgrounds with all relevant information. Since the pig is considered an impure animal in Judaism, Jewish patients may wish to be informed of porcine-derived substances used in treating. The present study is the first to explore the level of knowledge of Jewish participants as to whether the medical use of pig is permitted by their religion, and the extent to which they believe it should be permitted. 714 Jewish participants completed a study questionnaire that included 15 medical uses of pigs. Findings indicated that the knowledge of Jewish law regarding these uses is a significant mediator in predicting the attitude toward the permissibility of these uses. I conclude with practical recommendations as to how to enhance cultural competence and improve the informed consent process when treating Jewish patients with porcine-derived constituents.

Patient Perception of Informed Consent and Its Associated Factors among Surgical Patients Attending Public Hospitals in Dessie City Administration, Northeast Ethiopia

Patient Perception of Informed Consent and Its Associated Factors among Surgical Patients Attending Public Hospitals in Dessie City Administration, Northeast Ethiopia
Research Article
Hana Gebrehiwot, Nathan Estifanos, Yosef Zenebe, Tamrat Anbesaw
Critical Care Research and Practice, 1 July 2022
Open Access
Abstract
Background
Poor perception of informed consent compromises patients’ autonomy and self-determination; as a result, they feel powerless and unaccountable for their treatment. This study aimed to assess patients’ perception of informed consent and its associated factors among surgical patients attending public hospitals in Dessie City Administration, Northeast Ethiopia.
Methods
Facility-based cross-sectional study was conducted on 422 surgical patients. A systematic sampling technique was used to select the study participants. Data were collected using a pretested structured interviewer-administered questionnaire. EpiData version 3.1 was used for data entry, and then data were exported to SPSS version 25 for analysis. Multivariable logistic regression analysis was done to identify factors associated with the outcome variable among the participants. Variables with  value less than 0.05 were considered statistically significant factors.
Results
The prevalence of poor perception of informed consent for surgical procedures was found to be 33.2% (95% CI: 28.8–37.8). In multivariable analysis, educational status with inability to read and write (AOR = 5.71; 95% CI: 2.76–11.80) and basic ability to read and write (AOR = 6.03; 95% CI: 2.57–14.16), rural residence (AOR = 3.71; 95% CI: 1.94–7.07), marital status being widowed and divorced (AOR = 3.85; 95% CI: 1.83–8.08), language of written informed consent different from mother tongue (AOR = 4.196; 95% CI: 1.12–15.78), poor patient-physician relationship (AOR = 2.35; 95% CI: 1.31–4.24), and poor knowledge of surgical informed consent (AOR = 3.05; 95% CI: 1.56–5.97) were significantly associated with poor perception of surgical informed consent.
Conclusion
In this study, one-third of surgical patients appear to have poor perceptions of informed consent for surgical procedures. Educational status, being rural residents, being widowed/divorced, language of written informed consent, poor patient-physician relationship, and poor knowledge of surgical informed consent were variables that are independent predictors of poor perception of informed consent for surgical procedures. The ministry of health and healthcare providers should develop a plan to raise patients’ awareness about the informed consent process for surgical procedures.

Family-oriented informed consent in China’s clinical settings: A sociological and ethical study

Family-oriented informed consent in China’s clinical settings: A sociological and ethical study
PhD Thesis
Jingru Li
University of Otago, 2022
Abstract
   In China’s clinical settings, it is common for families to make decisions about the information and treatments that a patient will receive. This practice or model is referred to as ‘family-oriented informed consent’. It differs from the ‘individual model’ practiced in many Western countries. A standard explanation for this difference is based on perceived differences between Chinese and Western cultures. On this view it is argued that family-oriented informed consent is most compatible with the strong familial culture in China, while patient-centred informed consent reflects Western individualism.

This study aims to understand how and why families are involved in informed consent in China, and to critically assess the arguments for and against this involvement. It does this through a sociological investigation and an ethical analysis. Semi-structured, in-depth interviews were conducted with 13 patients, 14 family caregivers, and nine health professionals in Tianjin and Beijing, two mega cities in China. A thematic analysis approach was used to analyse the empirical material. The findings confirm the prevalence of the family-oriented practice. For family participants, two reasons were most often mentioned to support family-oriented informed consent: “reducing harms” and “increasing benefits”. Most patient participants preferred to make decisions on their own. Only a small number of patient participants indicated a preference for family-oriented model. They mainly referred to their reliance on the family for funding and care. As for medical professional participants, most of them disapproved of the family-oriented model but felt too powerless to act on the side of patients in face of family’s requirement as the decision makers.

On the basis of these findings, I argue that family-oriented informed consent is empirically groundless and ethically wrong, and that ‘patient-oriented informed consent’ should be adopted instead. Besides familial culture, the findings indicated at least four other factors explaining the family-oriented model, including doctor-patient mistrust, insufficient public funding to healthcare, the conflicting legal stipulations, and poor communication. Moreover, the argument that the practice benefits patients is specious, as in many ways it can be more harmful to patients. Argument based on cultural differences is also dubious because it incorrectly assumes that family-oriented pattern only exists in China, and that Chinese people do not support individual autonomy. Having shown the problems with family-oriented pattern, I move to argue in support of ‘patient-centred model’. On this model, patients should have the authority in informed consent, and doctors should be sensitive to patients’ requirement about family involvement. This model is both contextually sensitive and morally justifiable to China’s clinical context because it is in line with most Chinese patients’ preference for self-determination and is beneficial to patients. To make this possible, it is important to specify patient’s individual right to informed consent in law and to stipulate medical professionals’ legal duty to respect patient’s autonomy. Improvement in doctor-patient communication and more government funding in the healthcare sector are equally important means for a better implementation.

How Informed is Informed Consent? Experiences of Research Participants at the KAVI-Institute of Clinical Research, Kenya

How Informed is Informed Consent? Experiences of Research Participants at the KAVI-Institute of Clinical Research, Kenya
Emily Nyariki, Robert R. Lorway, Omu Anzala, Joyce M. Olenja
African Journal of Health Sciences, 20 June 2022; 35(2)
Abstract
Introduction
Informed consent (IC) is a key yardstick for the ethical and legal conduct of clinical research involving human subjects. However, the extent to which it meets its obligations in low-income settings remains under-examined. This study explored the views and experiences of informed consent among research participants at the KAVI-Institute for Clinical Research, Nairobi, Kenya.
Materials and Methods
A mixed-methods study was conducted between March and June 2014. Participants were drawn from six selected KAVI-ICR studies. Data collection involved a survey questionnaire with 164 participants and in-depth interviews with 44 participants purposively selected from the survey questionnaire respondents. Descriptive statistics via SPSS and thematic analysis via Atlas Ti were used, for quantitative and qualitative data analysis respectively.
Results
The majority of participants had learnt about the KAVI studies from friends (41%) and community mobilisers/ peer educators (47%). The information relayed by these relations regarding participation had led some participants to reach their decisions before undergoing the informed consent process. All participants reported attending information meetings, passed the assessment of understanding tests, and autonomously gave their written consent. Incomplete understanding of research concepts such as randomization and associated terminologies, placebo, and vaccine-induced positivity were expressed.
Conclusion
Beyond understanding the information received before enrolment, participants’ decisions are shaped by individual and community factors as well as trust relations with trial staff and own friends. There is, therefore, a need for innovative approaches to implementing and evaluating informed consent in low-resource settings.

Informed consent: an empty promise? A comparative analysis between Italy and England, Wales, and Scotland

Informed consent: an empty promise? A comparative analysis between Italy and England, Wales, and Scotland
Research Article
Caterina Milo
Medical Law International, 16 June 2022
Open Access
Abstract
Informed consent (IC), as the process of sharing information between patients and clinicians before undertaking a medical treatment, signals a number of ‘good intentions’. IC, in its theoretical formulation, can be seen as valuing the expertise and contributions of both clinicians and patients, giving expression to the aspirations of both promoting patient autonomy and facilitating doctors to work in partnership with their patients. The Supreme Court judgement in Montgomery v Lanarkshire Health Board1 and the Italian legislation on IC2 are, in this respect, worthy of analysis as both provide valid examples of these ‘good intentions’. However, the reality of how IC has been translated in courtrooms does not always match the expectations. This article, through a comparative reflection, will claim that a gap between the ‘law in theory’ and the ‘law in practice’ is common to both legal systems. The article ultimately claims that changes in both legal and policy approach are needed in order to better safeguard IC.