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.
Ethics of Informed Consent in Medical settings: A qualitative study of clinicians managing patients presenting with self-harm in Pakistan
Ethics of Informed Consent in Medical settings: A qualitative study of clinicians managing patients presenting with self-harm in Pakistan
Rakhshi Memon, Muqaddas Asif, Bushra Ali Shah, Tayyeba Kiran, Ameer B Khoso, Sehrish Toque, Jahanara Miah, Ayesha Ahmad, Imran B Chaudhry, Nasim Chaudhry , Nusrat Husain, Sarah JL Edwards
BMC Medical Ethics [under review], 24 January 2024
Abstract
Background
informed consent is considered to be the standard method for respecting the autonomy of individual participants in research and is thought to be based on several conditions: 1) providing information on the purpose of the research or a specific treatment, what it will entail, 2) the participants being mentally competent to understand the information and weigh it in the balance, and 3) the participants to be free from coercion. While there are studies of informed consent in other countries, especially Low and Middle Income Countries (LMICs), this study explored the role of cultural norms in the process of obtaining informed consent by clinicians in healthcare settings in general and mental health in particular, specifically focusing on the tension between contexts of Western autonomy and collectivist values in cultures such as Pakistan.
Methods
Qualitative interviews with 20 clinicians in Pakistan to explore consent processes in participant recruitment in Randomised Controlled Trials (RCTs), using a topic guide to gain an understanding of the consent process in Pakistan when recruiting participants in RCTs and decision-making regarding treatments and the influence of cultural norms’ impact on attitudes and beliefs in the collectivist culture.
Results
The interviews revealed that shared decision making was more morally important than individual autonomy, the role of the family played a dominant part in the consent-taking procedure, the decision of the elder and/or family patriarch took prominence, and that clinicians and researchers encountered significant challenges in consent process in Pakistan. Four distinct themes emerged which were 1) Family deciding for patients, 2) Benefits of involving family in consent process, 3) Gender disparity in consent process, 4) Challenges experienced by clinicians during consent process in Pakistan.
Conclusions
The concept of consent is generally considered important in many cultures, however, there are two strands of understanding. There seems to be consensus that participant agreement is necessary to protect the participant but with regards to autonomy there are significant cultural differences whether it is the right for autonomy of the individual (western) or family, community, or expert authority in other cultures, in Pakistan clinician-researchers sometimes preferred one approach and sometimes the other as they appreciated the interests of the patient to be.
Upcoming Calls For Public Consultation
We will selectively include calls for public consultation from multilateral agencies, governments, INGOs and other sources where there is a clear intersection with consent/assent. This might be obvious from the title of the draft guidance, regulations, etc., but more often, it will be a thematic area or topic – if properly addressed at all. If you would like to explore participation with our working group developing submissions for these calls, please contact us [david.r.curry@ge2p2global.org].
Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability
Food and Drug Administration, HHS.
Scheduled Pub. Date: 12/22/2023 FR Document: 2023-28210 PDF: https://downloads.regulations.gov/FDA-2023-D-5259-0002/attachment_1.pdf 8 Pages (109 KB)
Submit either electronic or written comments on the draft guidance by February 20, 2024
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Master Protocols for Drug and Biological Product Development.” The draft guidance addresses the design and analysis of trials conducted under a master protocol as well as the submission of documentation to support regulatory review. The primary focus is on randomized umbrella and platform trials that are intended to contribute to a demonstration of safety and substantial evidence of effectiveness. The considerations in this guidance apply to a range of therapeutic areas. The draft guidance is intended to clarify the Agency’s thinking on the use of master protocols in drug and biological product development, which was previously addressed in FDA’s guidance entitled “COVID–19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention.” FDA is also announcing the withdrawal of the guidance entitled “COVID–19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention.
Excerpt
250 C. Informed Consent
252 The informed consent process should cover all treatment arms in the trial to which the subject
252 could be randomized.13,14 In a platform trial allowing drugs to enter and leave the trial over time,
253 the consent form should be modified over time to reflect the drugs currently under evaluation…
256 The informed consent process should occur prior to a subject’s randomization and avoid
256 substudy-specific consent. Consent that occurs after subjects have been randomized to one of the
257 substudies may result in subjects with different prognostic characteristics across substudies,
258 raising concern about the comparability of each drug group with the shared control group
259 (comprised of control subjects from different substudies). To illustrate the concern, consider a
260 master protocol with two drugs (drug A and drug B) in which the subject consents to screening
261 and randomization to a substudy as part of the master protocol, with a substudy-specific
262 informed consent process to occur after randomization to that substudy; after the substudy-
263 specific consent, the subject is then randomized to the drug or its matched control. With this
264 process, comparing drug A against the shared control arm (including subjects who received
265 either control for drug A or control for drug B) may result in noncomparable groups if subjects
266 who would consent to participating in the drug A substudy differ from subjects who would
267 consent to participating in the drug B substudy.
13 Some consent processes allow a subject to be randomized in the trial even if the subject only consents to a subset of the drugs under evaluation; under such a process, subjects should not have the potential to be randomized to drugs for which they do not consent.
14 See the guidance for IRBs, Clinical Investigators, and Sponsors Informed Consent (August 2023).
Informed Consent: A Monthly Review
_________________
January 2024 :: Issue 61
This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.
Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:
Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: Center for Informed Consent Integrity – A Monthly Review_January 2024
Center for Informed Consent Integrity 