Consent and Deidentification of Patient Images in Dermatology Journals: Observational Study
Japbani K Nanda, Michael Armando Marchetti
JMIR dermatology, 6 July 2022; 5(3)
Excerpt
Publication of patient images contributes to research and education in dermatology. However, it is important to protect patients’ privacy and rights. The Committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE) have provided best practices and recommendations, respectively, for the protection of patients’ rights in scholarly publications [1,2]. Nonetheless, requirements for the deidentification of patient images and for the acquisition of consent to publish such images vary across governing bodies and journals. Our objective was to describe leading dermatology journals’ instructions regarding deidentification and consent to publish patient images as well as the content and readability of consent forms…
Month: July 2022
Consent in organ transplantation: putting legal obligations and guidelines into practice
Consent in organ transplantation: putting legal obligations and guidelines into practice
Research
Farrah Raza, James Neuberger
BMC Medical Ethics volume, 5 July 2022; 23(69)
Open Access
Abstract
Consent in medical practice is a process riddled with layers of complexities. To some extent, this is inevitable given that different medical conditions raise different sets of issues for doctors and patients. Informed consent and risk assessment are highly significant public health issues that have become even more prominent during the course of the Covid-19 pandemic. In this article we identity relevant factors for clinicians to consider when ensuring consent for solid organ transplantation. Consent to undergo solid organ transplantation is more complex than most surgical and other clinical interventions because of the many factors involved, the complexity of the options and the need to balance competing risks. We first outline the context in which consent is given by the patient. We then outline the legal principles pertaining to consent in medical practice as it applies in the UK and the implication of recent legal judgments. The third section highlights specific complexities of consent in organ transplantation and identifies relevant factors in determining consent for organ transplantation. The fourth section offers practical recommendations. We propose a novel ‘multi-factor approach’ to informed consent in transplantation which includes understanding risk, effective communication, and robust review processes. Whilst understanding risk and communication are a given, our suggestion is that including review processes into the consent process is essential. By this we specifically mean identifying and creating room for discretion in decision-making to better ensure that informed consent is given in practice. Discretion implies that health care professionals use their judgement to use the legal judgements as guidance rather than prescriptive. Discretion is further defined by identifying the relevant options and scope of clinical and personal factors in specified transplantation decisions. In particular, we also highlight the need to pay attention to the institutional dimension in the consent process. To that end, our recommendations identify a gap in the current approaches to consent. The identification of areas of discretion in decision-making processes is essential for determining when patients need to be involved. In other words, clinicians and healthcare professionals need to consider carefully when there is room for direction and where there is little or no room for exercising discretion. In sum, our proposed approach is a modest contribution to the on-going debate about consent in medicine.
Sufficient informed consent to medical treatment of adults: legal and ethical perspectives from Malawi
Sufficient informed consent to medical treatment of adults: legal and ethical perspectives from Malawi
Eva Maria Mfutso Bengo, Adamson Muula, Joseph Mfutso Bengo
Malawi Medical Journal, June 2022; 34(2) pp 143-150
Open Access
Abstract
This special communication discusses the current legal and ethical requirements for informed consent to medical treatment of adults in Malawi. It analyzes the scope of the laws and code of ethics on professional discipline, including criminal privilege for surgeries and clarifies when insufficient disclosures entitle patients to compensation under civil law. Inconsistencies and uncertainties in the law are made apparent. It evaluates to which degree disclosure standards of other Commonwealth jurisdictions (e.g. the case of Montgomery) would be suitable for the health care setting of a country like Malawi that is characterized by shortages of resources, high illiteracy rates and a communitarian cultural context. Doctor-patient communication is not alien to African culture and part of sufficient informed consent. In order to balance the need for efficiency in health care delivery, accountability for quality care, fairness and effective patient-doctor communication the authors suggest to adopt the reasonable patient test only, if a defence of heavy workload on case-to-case basis is introduced at the same time. This does not dispense the need for organisational diligence on part of the institutional health care provider within its capacity.
The evolution and development of the principle of free, prior and informed consent in South Africa
The evolution and development of the principle of free, prior and informed consent in South Africa
Original Article
Naledzani Mukwevho
South African Journal on Human Rights, 27 June 2022
Abstract
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.
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.
Informed Consent before coronary angiography and percutaneous coronary intervention from the patient’s perspective: A picture is worth a thousand words
Informed Consent before coronary angiography and percutaneous coronary intervention from the patient’s perspective: A picture is worth a thousand words
Brand, C. Crayen, A. Hamann, S. Martineck, L. Gao, H. Brand, S.M. Squier, K. Stangl, F. Kendel, V. Stangl
IJC Heart & Vasculature, August 2022; 41
Abstract
Background
Patients scheduled for coronary angiography may feel insufficiently informed about the planned procedure. We aimed to evaluate the patient-rated quality of the Informed Consent (IC) process and to investigate the efficacy of medical graphics to assist and improve the IC procedure.
Methods
A graphic-based information broschure illustrating central steps of the procedure was created in collaboration with scientific illustrators. In a randomized, controlled, prospective trial, 121 patients undergoing coronary angiography/PCI were randomized to a group obtaining the usual IC (Control group) or to a group that additionally obtained a graphic-based IC (Comic group). The perceived quality of the IC was compared between groups using single items of the Client Satisfaction Questionnaire-8 and self-designed single items.
Results
Only 67.8% of patients stated to have completely read the standard written IC sheet. The quality of the IC was perceived to be very good in 45.0% of patients in the Comic group compared to 24.6% in the Control group (p =.023). 57.4% of the Control group compared to 76.7% of the Comic group stated that all of their questions were satisfactorily adressed (p =.015). 43.3% of the Comic group, in contrast to only 18.0% of the Control group, declared to feel „very satisfied“ with the obtained IC procedure (p =.002). The acceptance of this new IC approach was very high: no patient expressed feelings of not being taken seriously when reading medical graphics.
Conclusions
Our data confirm pronounced limitations of the usual IC practice. The use of medical graphics positively impacts on patient-evaluated endpoints and may significantly improve the IC procedure.