Ethical obligation and legal requirements: On informed consent practices in Bangladesh
Sonia Mannan, Jobair Alam, K. M. Ashbarul Bari, S. M. A. A. Mamun, Rehnuma Mehzabin Orin
Developing World Bioethics, 19 May 2022
Informed consent to medical intervention is fundamental in both ethics and law. But in practice it is often not taken seriously in developing countries. This paper provides an appraisal of informed consent practices in Bangladesh. Following a review of the ethical and legal principles of informed consent, it assesses the degree to which doctors adhere to it in Bangladesh. Based on findings of non-compliance, it then investigates the reasons for such non-compliance through an appraisal of informed consent practices in Bangladesh and provides recommendations aimed at improving such practices. The significance of this paper lies in unveiling the interdependence between the ethical and legal traits of informed consent and their ramifications on strengthening the patient-oriented approach of duty to care.
Understanding of Critical Elements of Informed Consent in Genomic Research: A Case of a Paediatric HIV-TB Research Project in Uganda
Francis Anyaka Amayoa, Frederick Nelson Nakwagala, John Barugahare, Ian Guyton Munabi, Erisa Sabakaki Mwaka
Journal of Empirical Research on Human Research Ethics, 12 May 2022
Several studies have reported inadequate comprehension of informed consent for genomic research. This study aimed to assess research participants’ understanding of critical elements of informed consent for genomic research. A cross-sectional survey involving 123 parents/caregivers of children participating in a paediatric genomic TB/HIV study was conducted. Only 47.2% of the participants had adequate understanding of consent information. The mean objective (actual) and subjective (perceived) understanding scores were 78.7% and 91.7% respectively. Participants adequately understood most elements of consent however, some elements were poorly understood including foreseeable risks, protection of confidentiality and compensation for research related injury. Overall there was inadequate comprehension of critical elements of informed consent and there was dissonance between actual and perceived comprehension of informed consent.
Awareness of Knowledge, Attitude and Practices of Medical Students and Surgical Trainees Regarding Surgical Informed Consent: A Cross-sectional Multicentric Study from Northern India
Nishtha Singh, Sudhir Kumar Jain, Tariq Hameed, Kanwal Preet Kochhar, Param Jit, Chandra Bhushan Singh
Asian Journal of Medicine and Health, 22 March 2022; 20(3) pp 25-31
Informed Consent is the cornerstone of modern medical and surgical care. All patients have the right to be involved in decisions about their treatment and care. Obtaining SIC (surgical informed consent) is an important and essential skill that one must acquire in medical training, yet many residents receive very little formal education.
Multiple choice questionnaire designed and after pretesting circulated on Google formsTM having questions pertaining to knowledge, attitude and practice. Total 463 responses obtained and appropriate statistical tests applied in Microsoft Excel and StataSE.
Knowledge-score remained constant for medical students and trainees, Attitude-score (18.59 to 18.93) and Practice-score (2.30 to 3.62) statistically significant increase in score with clinical exposure was noted. Gender wise difference were in A-score, females scored higher 18.87 and males scored 18.49. For trainee doctors unlike P scores, K and A scores did not increase with experience.
Early intervention in undergraduate years and continuous upskilling is the need tobridge the hiatus of doctor-patient relationship. This necessitates scenario and role play based teaching, student teaching patient based learning regarding the SIC.
There is a Knowledge attitude practice gap present not only in undergraduate students but postgraduates residents regarding SIC, for which the current curriculum and the ongoing practical training is insufficient to bridge. Indian curriculum must make amendments to bridge it.
Tips for Managing Ethical Challenges in Advance Care Planning: A Qualitative Analysis of Japanese Practical Textbooks for Clinicians
Environmental Research and Public Health, 9 April 2022
Yoshihisa Hirakawa, Kaoruko Aita, Mitsunori Nishikawa, Hidenori Arai, Hisayuki Miura
While advance care planning (ACP) provides healthcare professionals with valuable tools to meet patients’ needs in a person-centered manner, several potential ethical challenges are inherent to the process. However, recent studies have largely focused on ACP practicalities such as implementation, execution, and completion rather than on the ethical challenges that clinicians routinely encounter in ACP practices.
This study aimed to identify tips for clinicians managing ethical challenges in ACP practices.
It performed a brief search for all Japanese published books pertaining to ACP practice available as of January 2021 using the keywords “advance care planning (ACP)” and “autonomy” and analyze the content of nine practical ACP textbooks for clinicians.
Two major themes capturing the essential recommendations for managing ethical challenges in ACP were ultimately identified, namely interprofessional ethics and informed consent.
The findings suggested tips for managing ethical challenges in ACP: refer to ethical frameworks for interprofessional collaboration and ethical decision making, assess decision-making capacity of family substitute decision makers and one’s eligibility for the role, understand the standard process of informed consent and how to handle situations when the patient are not well informed about the diagnosis and prognosis of non-cancer illness.
Study about Informed Consent for Surgical Care in East Africa
New Horizons in Medicine and Medical Research, 6 April 2022; 3 pp 210-215
In the developed world, informed surgical consent is one of the pillars of ethical conduct in surgical practise. Only a few researchers in low-income developing countries have investigated the practise of pre-operative surgical consent. During the informed consent process, the patient has the right to make an autonomous and independent decision about his or her surgical treatment after the surgeon caring for the patient has provided the necessary information. The World Medical Association (WMA) Declaration of Lisbon encourages patient autonomy and independent decision-making. Informed consent in surgical practise may be influenced by factors such as family and cultural background, education, religion, and socioeconomic status. Few studies have reviewed consent practises among surgeons in East Africa to document best surgical practises and identify areas for improvement in the East African setting. The purpose of this review was to report on the authors’ personal experiences with surgical consent among Ugandan surgeons, as well as to discuss the specific challenges faced in East Africa. In Uganda, informed consent administration and documentation remain deficient. In medical schools, better medical ethics education and communication skills training are required. For fully trained surgeons, refresher courses in medical ethics and communication skills may also be required.
Examining Informed Consent Processes for Indigenous families in Research: A Scoping Review Protocol
Cindy Peltier, Lorrilee McGregor, Mia Bourque, Irina Oltean, Nancy Young
Open Science Forum, 4 April 2022
Though numerous research pursuits in Indigenous communities have been undertaken, very few have consistently addressed community priorities, or collaborated with Indigenous peoples throughout the research process. This scoping review protocol proposes to explore the existing wise consent processes that respect the rights of Indigenous families (parents, children), and Indigenous community protocols.
Methods and analysis
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for conducting scoping reviews will be followed closely. All primary and theoretical studies of any design written in English from January 1st 2000 to March 31st 2022 examining Indigenous approaches to obtaining informed consent among parents or families and/or children and youth, will be included. Two reviewers will independently review the literature in order to apply the inclusion and exclusion criteria. Data from studies will be extracted and charted in NVivo, following the Arksey and O’Malley’s (2005) framework. The Critical Appraisal Skills Programme (CASP) checklists, depending on the study design of each included study, and the original and modified Aboriginal and Torres Strait Islander Quality Appraisal Tool (ATSI) versions, will be used to assess study quality. A narrative synthesis of the informed consent literature will be reported.
This scoping review will evaluate the existing informed consent processes, barriers to consent, and alternative consent processes in the literature. Results will be shared via conferences, reports and social media with our Indigenous communities, and disseminated through a peer-reviewed publication. This scoping review may prove useful to others who are investigating informed consent processes among Indigenous families in research.
Comparative analysis of informed consent for spine surgery in patients in Ethiopia and Poland and the importance of verbal contact with patients based on the medical mission “Polish Medical Team Helping Hand”
Zygmunt Siedlecki, Abat Sahlu, Adu Sileshy, Surafel Mekonnen Mendere, Amanuel Firew Dilnesaw, Yemisirach Bizuneh, Sebastian Grzyb, Bizuayehu Mengesha Tegene, Abenezer Tirsit, Maciej Śniegocki
Journal of Education, Health and Sport, 3 April 2022; 12(2)
The authors present a comparative analysis of the issue of legal consents for surgical procedures between Ethiopia and Poland. The analysis is based on the procedures performed as part of the Polish medical mission “Polish Medical Team Helping Hand”. As part of this project, the authors performed ten surgical procedures for percutaneous spine stabilization in soldiers injured during the war with gunshots of the spine and after falling from a height. All soldiers signed informed written consent to the procedure. However, the authors noticed a significant role of additional oral/ verbal (not written) information in discussing the details of the procedure, which in Polish hospitals must be in writing for formal and legal reasons. The authors conclude that while the written consent for surgical treatment is key and necessary both in Poland and in Ethiopia, in the case of medical procedures performed in Ethiopia, oral communication between the doctor and patients and oral explanations are more binding even regardless of the language barrier.
Informed consent in dentistry and medicine in Spain: Practical considerations and legality
M Otero, N Oishi, F Martínez, M-T Ballester, J Basterra
Medicina oral, patología oral y cirugía buccal, 3 April 2022
The healthcare practice of dentistry, as well as medicine, is framed within a legal environment. Patients have the right to know all the information related to any action performed on them and dental or medical doctors are obliged to obtain their patient’s prior written informed consent (IC) before undertaking any healthcare procedures.
Material and methods
Here we reviewed the legality and jurisprudence in Spain regarding IC. We also used INFLESZ text readability analysis software to analyse a sample of official Spanish informed consent documents (ICDs) from different surgical and interventional procedures related to dentistry and oral cavity interventions.
It is a mistake to confound IC with ICDs. This error prevents physicians from considering the former as a care process in which the patient’s authorisation signature is the last link in a chain formed, almost in its entirety, by the informative process and deliberation alongside the patient. Multiple factors can influence communication between practitioners and their patients. Importantly, treatment adherence is greater when patients feel involved and autonomous in shared decision-making and when the circumstances of their lives are adequately considered. We concluded that although the ICDs we analysed conformed to the requirements set out in international law, they were somewhat difficult to read according to the reading habits of the general Spanish population.
Knowledge about the legality of IC helps professionals to understand the problems that may arise from their non-compliance. This is because the omission or defective fulfilment of IC obligations is the origin of legal responsibility for medical practitioners. In this sense, to date, there have been more convictions for defective ICs than for malpractice. The information provided in ICs should include the risks, benefits, and treatment alternatives and must be tailored to the needs and capabilities of the patient to enable autonomous decision-making.
Factors affecting willingness to participate in vaccine clinical trials in an underdeveloped country: perspective from Nepal
Ram Hari Chapagain, Santosh Adhikari, Bishnu Rath Giri, Pankaj Ray, Nisha Jyoti Shrestha, Bina Prajapati, Prakash Joshi, Sunita Pokharel, Suresh Man Tamang, Birendra Prasad Gupta, T. Anh Wartel, Sushant Sahastrabuddhe, Ganesh Kumar Rai, Tarun Saluja
Human Vaccines & Immunotherapeutics, 6 March 2022
Due to the inherent complex nature of clinical trials, individual’s willingness to participate and hence, enrollment in a clinical trial maybe challenging. When it comes to vaccine clinical trial in children, informed consent needs to be secured from the parents or legally acceptable representatives (LARs). Some of the factors which contribute to hesitancy in taking part in clinical trials are based on the level of education, living standards, part of the world they live, associated burden of disease, fear of different procedures in clinical trial, side effects, limited understanding, limited time, and mistrust with Investigational product. This study included 201 parents/LARs, who approached Kanti Children Hospital site in Kathmandu with the interest to get their children enrolled in a vaccine clinical trial with objectives of describing the reasons for agreeing or disagreeing to participate in the vaccine clinical trial, factors affecting decision making, and finding the major concerns of parents/LARs. The acceptance for the study vaccine was 136 (67.7%) whereas denial was 65 (32.3%). This study showed that age, education level, family structure, advice from family and friends, and medical guidance play important roles in willingness of parents to get their child enrolled in the trial. If a proper counseling is done, fear of blood sampling is not a big factor which is contrary to the belief among clinical researchers. Safety of vaccine, frequency of injections, and cost of vaccine were the main concerns of the parents, which need to be addressed extensively while planning for any clinical trial in children.
Informed consent forms for gynecologic cancer surgery: recommendations from the Korean Society of Gynecologic Oncology
장하균, 심승혁, 이마리아, Won Moo Lee 오경진, 유헌종, 김미경, 김민규, 이광범, 소경아, 김영태, 이대우, Doo-Yoon Hyun 이종민
Obstetrics & Gynecology Science, March 2022; 65(2) pp 105 – 112
The sociomedical environment is changing. In the traditional physician-patient relationship, the physician was authoritative and the patient was obedient. The contractual relationship featured patient consent to the physician’s decision. Today, the physician must explain fully the planned medical treatment, and any alternative, to the patient, who has the right to choose her treatment after considering the benefits and side-effects. The Korean Society of Gynecologic Oncology thus decided to standardize the surgical consent forms to meet the legal requirements of modern medicine, improve patient understanding of the surgical details, and protect medical staff from legal disputes. To determine the format and content, subcommittees for each cancer type collected and reviewed all relevant articles and the current consent forms of domestic medical institutions. After several meetings, 16 basic items to be included for each type of gynecologic cancer were selected. Also, to help patients understand the surgical details, figures were included. The revised forms were legally reviewed in terms of the appropriateness of the format and content. We also developed English versions to provide adequate information for foreign patients. We hope that these efforts will promote trust between patients and physicians, and contribute to effective treatment by laying a foundation of mutual respect.