The challenges and potential solutions of achieving meaningful consent amongst research participants in northern Thailand: a qualitative study
Research
Rachel C Greer, Nipaphan Kanthawang, Jennifer Roest, Carlo Perrone, Tri Wangrangsimakul, Michael Parker, Maureen Kelley, Phaik Yeong Cheah
BMC Medical Ethics, 19 December 2023
Open Access
Abstract
Background
Achieving meaningful consent can be challenging, particularly in contexts of diminished literacy, yet is a vital part of participant protection in global health research.
Method
We explored the challenges and potential solutions of achieving meaningful consent through a qualitative study in a predominantly hill tribe ethnic minority population in northern Thailand, a culturally distinctive population with low literacy. Semi-structured interviews were conducted with 37 respondents who had participated in scrub typhus clinical research, their family members, researchers and other key informants. A thematic analysis was conducted.
Results
Our analysis identified four interrelated themes surrounding participants’ ability to give consent: varying degrees of research understanding, limitations of using informal translators, issues impacting decisions to join research, and voluntariness of consent. Suggestions for achieving more meaningful consent included the use of formal translators and community engagement with research populations.
Conclusions
Participant’s agency in decision making to join research should be supported, but research information needs to be communicated to potential participants in a way that they can understand. We found that improved understanding about the study and its potential benefits and harms goes beyond literacy or translation and requires attention to social and cultural factors.
Year: 2024
Clinical Informed Consent and ABA
Clinical Informed Consent and ABA
Abraham Graber, Allison Maguire
Behavior Analysis in Practice, 8 January 2024
Open Access
Abstract
The practice of clinical informed consent in America is governed by over 100 years of case law. Although predominant ethics resources for behavior analysts offer some guidance regarding the provision of clinical informed consent, such guidance remains limited. The goal of this article is thus to expand the contemporary literature on clinical informed consent in behavior analysis by providing a historical and contemporary guide to relevant case law. The article will highlight seminal moments in the history of case law regarding clinical informed consent, discuss their applicability to the process of clinical informed consent in behavior analysis, and provide an enhanced understanding of the ethical and legal obligations related to informed consent in the therapeutic context.
Editor’s note: ABA stands for applied behavior analysis.
Towards the implementation of law n. 219/2017 on informed consent and advance directives for patients with psychiatric disorders and dementia. Physicians’ knowledge, attitudes and practices in four northern Italian health care facilities
Towards the implementation of law n. 219/2017 on informed consent and advance directives for patients with psychiatric disorders and dementia. Physicians’ knowledge, attitudes and practices in four northern Italian health care facilities
Research
Corinna Porteri, Giulia Ienco, Mariassunta Piccinni, Patrizio Pasqualetti
BMC Medical Ethics, 6 January 2024
Open Access
Abstract
Background
On December 2017 the Italian Parliament approved law n. 219/2017 “Provisions for informed consent and advance directives” regarding challenging legal and bioethical issues related to healthcare decisions and end-of life choices. The law promotes the person’s autonomy as a right and provides for the centrality of the individual in every scenario of health care by mean of three tools: informed consent, shared care planning and advance directives. Few years after the approval of the law, we conducted a survey among physicians working in four health care facilities specific for the care of people suffering from psychiatric disorders, cognitive disorders and dementia located in the North of Italy aiming to investigate their perceived knowledge and training need, attitudes regarding law n. 219/2017 provisions, and practices of implementation of the law.
Methods
A semi-structured questionnaire was developed on an online platform. The invitation to participate in the survey was sent by email to the potential participants. Information was collected by means of the online platform (Google Forms) which allows to export data in a spreadsheet (Windows Excel) to perform basic statistical analysis (frequency distributions, bar chart representation).
Results
Twenty-five out of sixty physicians participated in the survey. None of the respondents value their knowledge of the law as very good, 10 good, 13 neither poor nor good, 1 poor and 1 very poor. All the respondents want to learn more about the law (21 yes and 4 absolutely yes). The majority of respondents agrees with the content of the law as a whole (3 absolutely agree, 13 agree), and on each provision. The question on the clarity of the concept of capacity in the law received mixed answers and this impacted on the physicians’ opinion regarding the legitimacy in principle for our groups of patients to realize shared care planning and write advance directives. Thirteen physicians neither introduced the theme of shared care planning nor arranged for shared care planning and the main reason for this was that no patient was in a clinical situation to require it. When shared care planning is realized, a variability in terms of type and number of meetings, mode of tracking and communication is registered.
Conclusions
Our survey results indicate a need for more clarity regarding the interpretation and implementation of the law in the patient groups under study. There are in particular two related areas that deserve further discussion: (1) the question of whether these patient groups are in principle legitimized by the law to realize shared care planning or write advance directives; (2) the notion of capacity required by the law and how this notion can be declined in real-life situations.
Informed consent – Ethical doctrine and a legal mandate
Informed consent – Ethical doctrine and a legal mandate
Review Article
Anjali Gera, Jayashree Sood
Current Medicine Research and Practice, November – December 2023; 13(6) pp 286-291
Open Access
Abstract
Informed consent is not only an ethical doctrine but also a legal mandate in medical practice and clinical research. The concept of consent has changed over the last few decades from doctor-focused to patient-focused. This provides adequate knowledge to the patient about disease and treatment options so that the patient and doctor can make shared decisions. Respecting the patient’s autonomy, disclosure of material risks and solicitation of the patient’s preferences are very important in the process of informed consent. The relationship between doctor and patient should be one of trust and communication. An honest and ethically obtained consent can prevent litigations and medicolegal repercussions.
Nursing Roles in the Quality of Information in Informed Consent Forms of a Spanish County Hospital
Nursing Roles in the Quality of Information in Informed Consent Forms of a Spanish County Hospital
José Manuel García-Álvarez, Alfonso García-Sánchez
Nursing Reports, 4 January 2024; 14(1) pp 89-98
Abstract
Background
Because of their direct and continuous contact with the patient, nurses play a relevant role in ensuring that informed consent forms are complete and easy to read and comprehend. The objective of this study was to analyze the legibility and formal quality of informed consent forms for non-surgical procedures in a county hospital.
Methods
The readability of these forms was analyzed using the INFLESZ scale and the information they provided according to the formal quality criteria established for these forms.
Results
Readability was difficult in 78.08% of the forms analyzed. No form fulfilled all the criteria, the most non-compliant being the non-appearance of the verification of delivery of a copy to the patient (100%), the contraindications (94.59%), and the alternatives (83.78%) of the procedure. Statistically significant differences were observed between disciplines with respect to the INFLESZ readability score and the formal quality score, but no statistically significant correlation was found between the two scores.
Conclusions
The informed consent forms for non-surgical procedures analyzed presented mostly difficult readability and poor formal quality, making it difficult for patients to have understandable and complete information. Nursing professionals should be actively involved in their improvement to facilitate patient decision making.
A Pilot Study On The Global Practice On Informed Consent In Paediatric Dentistry
A Pilot Study On The Global Practice On Informed Consent In Paediatric Dentistry
Original Research
Nicoline Potgieter, Gemma Bridge, Marlies Elfrink, Morenike O. Folayan, Sherry Shiqian Gao, Sonia Groisman, Ashwin Jawdekar, Arthur M. Kemoli, David Lim, Phuong Ly, Shani Mani, Ray M. Masumo, Joana Monteiro, Majorie K. Muasya, Ambrina Qureshi, Norman Tinanoff
Frontiers in Oral Health, 2024
Abstract
Background
Conducting oral treatment early in the disease course is encouraged for better health outcomes. Obtaining informed consent is an essential part of medical practice, protecting the legal rights of patients and guiding the ethical practice of medicine. In practice, consent means different things in different contexts. Silver Diamine Fluoride (SDF) and Silver Fluoride (SF) are becoming popular and cost-effective methods to manage carious lesions, however, cause black discolouration of lesions treated. Obtaining informed consent and assent is crucial for any dental treatment and has specific relevance with SDF/ SF treatments.
Methods
The aim of this paper is to describe informed consent regulations for dental care in a selection of countries, focusing on children and patients with special healthcare needs. An online survey was shared with a convenience sample of dental professionals from 13 countries. The information was explored and the processes of consent were compared.
Results
Findings suggest that there are variations in terms of informed consent for medical practice. In Tanzania, South Africa, India, Kenya, Malaysia and Brazil age is the determining factor for competence and the ability to give self-consent. In other countries, other factors are considered alongside age. For example, in Singapore, the United Kingdom, and the United States the principle of Gillick Competence is applied. Many countries’ laws and regulations do not specify when a dentist may overrule general consent to act in the “best interest” of the patient.
Conclusion
It is recommended that it is clarified globally when a dentist may act in the “best interest” of the patient, and that guidance is produced to indicate what constitutes a dental emergency. The insights gathered provide insights on international practice of obtaining informed consent and to identify areas for change, to more efficient and ethical treatment for children and patients with special needs. A larger follow up study is recommended to include more or all countries.
Implementing co-production to enhance patient safety: the introduction of the Patient Safety Consent tool, an example of a simple local solution to a common challenge
Implementing co-production to enhance patient safety: the introduction of the Patient Safety Consent tool, an example of a simple local solution to a common challenge
Abdulelah Alhawsawi, David Greenfield
International Journal for Quality in Health Care, 28 December 2023
Abstract
Zero harm is one of the priorities that all healthcare systems are aspiring for. However, more than two decades after ‘To Err is Human’ report, many systems are struggling to identify or implement strategies to achieve this important goal. One of the very powerful, yet underutilized strategies towards transforming patient safety and achieving Zero Harm is ‘co–production’. Co-production of health is defined as ‘the interdependent work of users and professionals who are creating, designing, producing, delivering, assessing, and evaluating the relationships and actions that contribute to the health of individuals and populations’. Simply put, co-production means that patients contribute alongside professionals to the provision of health services. While we know the importance and potential value of co-production, many health systems are underutilizing the approach. Actions to effectively implement and sustain changes to service provision to use co-production are elusive. To realize improvements, a key requirement for health professionals is addressing the question: how can we implement and sustain co-production in efficient, effective ways? To address this challenge, and thereby improve patient safety and work towards zero harm, we introduce the ‘Patient Safety Consent’ (PSC) tool, a simple co-production tool to empower patients and families to become more active members in their own healthcare. Implementing the co-production of care, requires a shift in the traditional attitudes and power dynamics between healthcare professionals and patients. Professionals explicitly share service information, diagnosis assessments, treatment options, decision-making and involve patients and their families in determining the direction and actions for their care; conversely, patients and families take on an active role in engaging in discussions, potential care pathways, and ongoing decisions about their treatment and care. Hence, the PSC tool is a direct, engaging, comprehensive and, where used effectively, a powerful strategy for changing the dynamics and outcomes of care…
Probability and informed consent
Probability and informed consent
Book Chapter
Nir Ben-Moshe, Benjamin A. Levinstein, Jonathan Livengood
Theoretical Medicine and Bioethics, 8 August 2023 [Springer]
Abstract
In this paper, we illustrate some serious difficulties involved in conveying information about uncertain risks and securing informed consent for risky interventions in a clinical setting. We argue that in order to secure informed consent for a medical intervention, physicians often need to do more than report a bare, numerical probability value. When probabilities are given, securing informed consent generally requires communicating how probability expressions are to be interpreted and communicating something about the quality and quantity of the evidence for the probabilities reported. Patients may also require guidance on how probability claims may or may not be relevant to their decisions, and physicians should be ready to help patients understand these issues.
Blockchain-Based Dynamic Consent for Healthcare and Research
Blockchain-Based Dynamic Consent for Healthcare and Research
Book Chapter
Wendy M. Charles
Blockchain in Healthcare, 30 December 2023 [Springer]
Abstract
As individuals gain greater access control over their health information, dynamic consent solutions are increasingly offered to allow individuals to make informed choices about their permissions over time. Blockchain-based tools and technologies are emerging to enhance the capabilities of dynamic consent solutions to offer individuals more engagement. While blockchain-based systems cannot replace all human interactions, blockchain features can increase granularity, transparency, and trust. This chapter describes the benefits and drawbacks of dynamic, informed consent and proposes several design and feature considerations to optimize blockchain-based features.
From informed to empowered consent
From informed to empowered consent
Original Article
Chelsea O. P. Hagopian
Nursing Philosophy, 29 December 2023
Abstract
Informed consent is ethically incomplete and should be redefined as empowered consent. This essay challenges theoretical assumptions of the value of informed consent in light of substantial evidence of its failure in clinical practice and questions the continued emphasis on autonomy as the primary ethical justification for the practice of consent in health care. Human dignity—rather than autonomy—is advanced from a nursing ethics perspective as a preferred justification for consent practices in health care. The adequacy of an ethic of obligation (namely, principlism) as the dominant theoretical lens for recognising and responding to persistent problems in consent practices is also reconsidered. A feminist empowerment framework is adopted as an alternative ethical theory to principlism and is advanced as a more practical and complete lens for examining the concept and context of consent in health care. To accomplish this, the three leading conceptions of informed consent are overviewed, followed by a feminist critique to reveal practical problems with each of them. The need for a language change from informed to empowered consent is strongly considered. Implications for consent activities in clinical practice are reviewed with focused discussion on the need for greater role clarity for all involved in consent—beyond and inclusive of the patient-physician dyad, as the practice and improvement of consent is necessarily a transdisciplinary endeavour. Specific concrete and practical recommendations for leveraging nursing expertise in this space are presented. Perhaps what is most needed in the discourse and practice of consent in health care is nursing.