Moral Dilemmas Regarding Physical Restraints in Intensive Care Units: Understanding Autonomy, Beneficence, Non-Maleficence and Justice in the Use of Physical Restraints
Zhou J, Qin Q, Chen S, Zhang H
Journal of Multidisciplinary Healthcare, 28 March 2024
Abstract
In intensive care units, patients are often restrained to ensure their safety, with physical restraints being the most commonly used method. However, physical restraints compromises the patient’s freedom, health and comfort, and nurses often face moral dilemmas when deciding whether to use physical restraints. This article examines physical restraints through the four universal principles of autonomy, beneficence, non-maleficence and justice. Through these principles, the authors will critically explore whether the physical restraints of patients by nurses is ethical in practice and what moral issues exist. This paper also explores conflicts and moral dilemmas for nurses in this context. Finally, suggestions are made on changes to education and clinical practice.
Month: April 2024
Medical Ethics and Facilitating Fully Informed Consent to Treatment
Medical Ethics and Facilitating Fully Informed Consent to Treatment
Alan Mordue, Evans E A, Royle T J, Clare Craig
OSF Preprints, 24 April 2024
Abstract
It has been asserted that there was an erosion of medical ethics during the Covid-19 pandemic and a departure from the principle of obtaining fully informed consent from patients before treatment. In light of these assertions, this article reviews the historical development of medical ethics and the approach to obtaining informed consent, and critiques the consent practices before and during the pandemic. It then describes a new tool for displaying key statistics on the benefits and risks of interventions to help explain them to patients and suggests a more rigorous process for seeking fully informed consent in the future.
Editor’s note: OSF Preprints is published by the Center for Open Science.
Responsible Governance of Genomics Data and Biospecimens in the Context of Broad Consent: Experiences of a Pioneering Access Committee in Africa
Responsible Governance of Genomics Data and Biospecimens in the Context of Broad Consent: Experiences of a Pioneering Access Committee in Africa
Rebai A, Abayomi A, Andanda P, Bukini D, Kerr R, Herbst K, Mabuka J, Wamuyu R, Dandara C
Qeios, 24 April 2024
Abstract
International collaboration in genomic research is gaining momentum in African countries and is often supported by external funding. Over the last decade there has been an increased interest in African genomic data. The contribution of this rich data resource in understanding diseases predominant in both African and global populations has been limited to date. Although There has been some non-governmental funding dedicated to the advancement of genomic research and innovation by African-based and African-led research groups, but the impact of these initiatives is hard to quantify. However, there is now opportunity for the global research community to leverage decades of genomic data and biospecimens originating from African populations. The experience we describe in this paper is of an access governance framework established under the Human, Heredity, and Health in Africa (H3A) consortium, given the task of managing wider access to the data and biospecimen resources collected via its various projects. The function of the Data and Biospecimen Access Committee (DBAC) is to facilitate the advancement of medicine and health, whilst fostering the development bioinformatics capabilities at Africa-based institutions or regional hubs. Our collective experiences and lessons learned as a committee provide examples of nuanced considerations when evaluating access to African data. The committee was semi-autonomous in its establishment and has independence in decision-making. The DBAC continually advocates for responsible use of genomic data and biospecimens that were obtained from African research participants, under broad consent, by primary researchers who no longer have oversight over future use of these resources.
Advancing a Consent-Forward Paradigm for Digital Mental Health Data
Advancing a Consent-Forward Paradigm for Digital Mental Health Data
Sachin R. Pendse, Logan Stapleton, Neha Kumar, Munmun De Choudhury, Stevie Chancellor
arXiv, 22 April 2024
Abstract
The field of digital mental health is advancing at a rapid pace. Passively collected data from user engagements with digital tools and services continue to contribute new insights into mental health and illness. As the field of digital mental health grows, a concerning norm has been established — digital service users are given little say over how their data is collected, shared, or used to generate revenue for private companies. Given a long history of service user exclusion from data collection practices, we propose an alternative approach that is attentive to this history: the consent-forward paradigm. This paradigm embeds principles of affirmative consent in the design of digital mental health tools and services, strengthening trust through designing around individual choices and needs, and proactively protecting users from unexpected harm. In this perspective, we outline practical steps to implement this paradigm, toward ensuring that people searching for care have the safest experiences possible.
Editor’s note: arXiv is published by Cornell University.
An ethical analysis of human fetal and embryological collections and informed consent: a focus group study
An ethical analysis of human fetal and embryological collections and informed consent: a focus group study
Joyce El-Haddad, Nalini Pather
BMC Medical Ethics Preprint, 19 April 2024
Abstract
Background
Human fetal and embryological collections refer to repositories or archives that house remains of human fetuses and embryos at different stages of development. Previous studies have highlighted that most remains in these collections have been obtained without informed consent from the next of kin, thus reflecting a time in history where this may have been acceptable. Previous studies seeking stakeholder perceptions towards these collections suggest that there is misalignment with the values of society today, and the current guiding frameworks pertaining to these collections. The aim of this study was to explore and analyse the perceptions of key stakeholders regarding fetal collections with a particular focus on informed consent.
Methods
Through conducting focus group interviews of 25 participants, the study sought to provide an in-depth exploration of how stakeholders perceive the value of fetal and embryological collections, and the importance of informed consent.
Results
The mean age of participants was 29.1 years of age with a gender distribution of 40% men and 55.6% of women. Thematic analysis identified four themes: Consent; preparation for clinical practice; 3. equity and fairness; and 4 educational value, with several subthemes identified at macro, meso, and micro ethical levels. Macro subthemes included importance of informed consent, and equity and fairness, and genetic composition. Meso subthemes included respect and privacy, and legal and institutional considerations. Micro subthemes included emotional considerations, preparation for clinical practice, and educational value.
Conclusions
The study advocates for consideration of the ethical issues surround human fetal and embryological collections from the macro, meso, and micro ethical frameworks.
Editor’s note: This preprint is Under Review at BMC Medical Ethics.
Evolution of informed consent in research: From the Hippocratic Oath to the tailored consent
Evolution of informed consent in research: From the Hippocratic Oath to the tailored consent
Essay
Jaime Fons-Martinez, Carlos Murciano-Gamborino, Javier Diez-Domingo
Open Research Europe, 17 April 2024
Abstract
Background
Informed consent (IC) is essential in defending the autonomy of potential participants in clinical research. Despite the advances in research ethics, particularly in IC, the different guidelines and codes have not been fully implemented. Several studies have presented consent deficiencies that have resulted in unethical practices or poor understanding of the IC.
Main body
This article reviews the evolution of IC, from its philosophical origins and initial use in the Ottoman Empire (16th century) to its use in clinical research today. It also presents the vision of the European project i-CONSENT (Grant Agreement number: 741856), whose main purpose is to improve the understanding of ICs in research and identifies the key components of a new paradigm to develop patient-centred ICs.
Conclusions
In many cases, the IC has served to protect the investigator or sponsor from complaints. Different ethical guidelines have sought to make the IC a more useful tool, with little success. Today’s IC is mainly a bureaucratic and legal process that fails to consider the patient’s point of view. In this context, the Guidelines for Tailoring the Informed Consent Process in Clinical Studies provide alternatives to the current IC process, focusing on the patient’s opinions and making them part of the process, thereby improving clinical research quality.
Assessment of the knowledge, attitude and practices of the informed consent process in oral healthcare among dental students in Makerere University Dental Hospital, Uganda
Assessment of the knowledge, attitude and practices of the informed consent process in oral healthcare among dental students in Makerere University Dental Hospital, Uganda
Research Article
David Nono, Ernest Mwebesa, Godfrey Bagenda, Isaac Okullo, Charles Mugisha Rwenyonyi, Simon Williams, David Nono
BMC Medical Education Preprint, 11 April 2024
Abstract
Introduction
Informed consent is an ethical and legal component of healthcare. It ensures patient autonomy and allows patients to make decisions regarding their treatment. In dental care, informed consent is particularly important because most dental procedures are invasive. Since dental students are future dentists, they need to learn about their ethical obligations and accountability through the informed consent process as this is critical to the patient’s well-being. The present study aimed to determine dental students’ knowledge, attitudes, and practices of informed consent for oral health care in Makerere University Dental Hospital, Uganda.
Study Methodology
This was a descriptive cross-sectional quantitative study that was carried out at Makerere University Dental Hospital. Third, fourth, and fifth-year students (n = 102) pursuing a Bachelor of Dental Surgery programme took part in a survey. A self-administered structured questionnaire was used to assess their knowledge, attitudes, and practices of informed consent for oral health care. Collected data were entered into Epi-data version 3.1, where it was cleaned, coded, and imported to STATA version 14 software for statistical analysis.
Results
Of the 102 participants, 65.7% were males. The mean age was 25 (SD = 3.21) years. The majority (90%) of the students had a high level of knowledge of the informed consent process. About 80% had a positive attitude towards informed consent and 85% most often practiced the informed consent process. Based on bi-variate analysis, training on informed consent, year of study, age, and sex were significantly associated with the informed consent process. However, there was no significant risk factor associated with informed consent in multiple logistic regression analysis.
Conclusion
The study findings highlighted high levels of knowledge, positive attitude, and practice of the informed consent process among the clinical dental students. Continuous in-service training for dentists and other oral healthcare workers on the informed consent process is highly recommended.
Editor’s note: This preprint is Under Review at BMC Medical Education.
Considerations for the design of informed consent in digital health research: Participant perspectives
Considerations for the design of informed consent in digital health research: Participant perspectives
Research Methods & Evaluation
Brian McInnis, Ramona Pindus, Daniah Kareem, Camille Nebeker
Advance, 1 April 2024
Abstract
The research team, prospective participants, and written materials all influence the success of the informed consent process. As digital health research becomes more prevalent, new challenges for successful informed consent are introduced. This exploratory research utilized a human centered design process where 19 people were enrolled to participate in one of 4 online focus-groups. Participants discussed their experiences with informed consent, preferences for receiving study information and ideas about alternative consent approaches. Data were analyzed using qualitative methods. Six major themes and sixteen sub-themes were identified that included study information that prospective participants would like to receive, preferences for accessing information and a desire to connect with research team members. Specific to digital health, participants expressed a need to understand how the technologies worked and how the volume of granular personal information would be collected, stored, and shared.
Editor’s note: Advance is a sage preprint publication.
Mental capacity assessment in the multi-professional real world: a qualitative study of six areas of uncertainty
Mental capacity assessment in the multi-professional real world: a qualitative study of six areas of uncertainty
Research Article
Andrew McWilliams, Kevin Ariyo, Anthony S. David, Gareth S. Owen
Wellcome Open Research, 2024
Open Access
Abstract
Background
The Mental Capacity Act 2005 of England and Wales is a ground-breaking piece of legislation with reach into healthcare, social care and legal settings. Professionals have needed to develop skills to assess mental capacity and handle malign influence, but it is unclear how assessments are implemented in real world settings. Our previously reported survey found professionals juggling competing resources in complex systems, often struggling to stay up to date with law. The current follow-up study uses one-to-one interviews of professionals to characterise in detail six areas of uncertainty faced when assessing mental capacity, whilst suggesting ways to make improvements.
Methods
Forty-four healthcare, social care and legal professionals were interviewed, using a semi-structured topic guide. Transcripts were analysed using framework analysis: a qualitative technique built to investigate healthcare policy.
Results
Our topic guide generated 21 themes. In relation to the six areas of uncertainty: 1) Many participants stressed the importance of capturing a holistic view, adding that their own profession was best-placed for this – although a medical diagnosis was often needed. 2) The presumption of capacity was a laudable aim, though not always easy to operationalise and occasionally being open to abuse. 3) There was cautious interest in psychometric testing, providing a cognitive context for decisions. 4) Undue influence was infrequent, but remained under-emphasised in training. 5) Multi-professional assessments were common, despite doubts about fitting these within local resources and the law. 6) Remote assessment was generally acceptable, if inadequate for identifying coercion.
Conclusions
Practical constraints and competing demands were reported by professionals working within real world systems. Assessment processes must be versatile, equally applicable in routine and emergency settings, across diverse decisional types, for both generalist and specialist assessors, and able to handle coercion. Recognising these challenges will guide development of best practices in assessment and associated policy.
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].
Invitation for Public Comment: WHO principles for human genome access, use and sharing
8 April 2024 Consultation Period: 8th April 2024 – 3 May 2024
Background
For the potential of genomics to be realized, access to, use, and the sharing of human genome data is critical. Following the WHO’s Science Council 2022 Report on Accelerating access to genomics for global health: promotion, implementation, collaboration, and ethical, legal, and social issues, WHO is implementing a programme of activities to promote equitable and fair access to genomics technologies for the benefit of people worldwide. As part of this, WHO is developing guiding principles for human genome data access, use and sharing. To develop these principles, a virtual consultation was held in January 2024 with an interdisciplinary group of participants. This consultation discussed the diverse perspectives on issues related to human genome data access, use and sharing; how a global set of principles from WHO may enable data access, use and sharing; and proposed initial principles. This was followed by an in-person meeting in March 2024 that considered in detail the proposed principles. Following this meeting, a draft document was developed and comments on this document and the principles are now invited.
Feedback on the WHO Principles for human genome data access, use, and sharing
Public feedback on this document is being solicited through this public consultation using the comment form.
Center for Informed Consent Integrity 