Medical Ethics and Informed Consent to Treatment: Past, Present and Future

Medical Ethics and Informed Consent to Treatment: Past, Present and Future
Alan Mordue, Elizabeth A Evans, James T Royle, Clare Craig
Cureus, 9 December 2024; 16(12)
Open Access
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.

Consent to medical student teaching: an observational, cross-sectional study exploring the patient view

Consent to medical student teaching: an observational, cross-sectional study exploring the patient view
Research
Niki Newman, Fraser McKenzie, Jonathan M. Wells, Tim Wilkinson, John Dean, Matthew Doogue, Lutz Beckert
BMC Medical Education, 24 December 2024
Open Access
Abstract
Background
New Zealand guidelines stipulate that patient consent is obtained for medical student involvement in clinical care, however, patients’ preferences regarding consent for medical student teaching have not been widely explored. This study examined patient preferences for consent for medical student teaching with the aim to increase patient empowerment, to optimise care and to reflect societal expectations more accurately.
Method
Observational, semi-qualitative, cross-sectional study of in-patients. Each participant was presented with a series of nine hypothetical clinical scenarios and were allowed a limited number of responses. For each scenario the participants completed a short questionnaire about their preferences for consent. These included their preferred mode of consent (implicit, verbal or written), timing of consent, and who should take their consent. The analysis used descriptive statistics and ordinal logistic regression mixed models to investigate associations between patient characteristics and chosen mode of consent.
Results
There were 123 participants (50% male), median age was 64 years. Patients were admitted to either medical (69%), surgical (22%) or women’s health (9%). Increasing age was statistically significantly associated with a preference for verbal and implicit rather than written consent with the exception of ‘breaking bad news’ and ‘bedside teaching’. The majority of patients preferred verbal consent across all nine clinical scenarios (57–82%), including two surgical scenarios where verbal consent was preferred by 59%. Most patients preferred the supervising doctor to take consent, with no clear preference about the timing.
Conclusions
This study identifies the patient voice in the consent process for the involvement of medical students in clinical care. Although the patients’ views generally align with an existing national consensus statement, there is variability in the expectations of the patients suggesting flexibility in the consent process is still needed. The preference for older patients for verbal or implicit consent compared with younger patients for more invasive scenarios highlights the need for consideration of inter-generational differences. Most patients in this study were willing to contribute to student learning in all scenarios.

The German Medical Informatics Initiative Broad Consent in the Emergency Department: A Single Centre Prospective Observational Study to Assess Consenting Mode Dependent Success Rates

The German Medical Informatics Initiative Broad Consent in the Emergency Department: A Single Centre Prospective Observational Study to Assess Consenting Mode Dependent Success Rates
Felix Patricius Hans, Jan Kleinekort, Melanie Boerries, Alexandra Nieters, Gerhard Kindle, Micha Rautenberg, Laura Bühler, Gerda Weiser, Michael Clemens Röttger, Carolin Neufischer, Matthias Kühn, Julius Wehrle, Anna Christine Slagman, Antje Fischer-Rosinsky, Larissa Eienbröker, Frank Hanses, Gisbert Wilhelm Teepe, Hans-Jörg Busch, Leo Benning
JMIR Medical Informatics, 19 November 2024
Abstract
Background
The Broad Consent (BC) by the German Medical Informatics Initiative (MII) was developed to serve as a national blueprint for consenting patients for the use of routinely collected medical-, insurance- and contact data and biomaterials for research purposes, ensuring compliance with European General Data Protection Regulation (GDPR). Emergency departments (EDs) are characterized by a broad and unselected patient population that provides the opportunity to include patients from different demographic and socioeconomic groups, as well as from different disease groups. While also posing regulatory and ethical challenges, obtaining BC in an ED environment presents a promising opportunity to increase the availability of ED data for research.
Objective
This study aimed to evaluate the success rate of obtaining BC through different consenting approaches in a tertiary ED. The study also explored factors influencing consent and dropout rates.
Methods
A single-center prospective observational study was conducted in a German tertiary ED from September to December 2022. Patients were randomly selected (every 30th patient) and screened for eligibility to be informed about BC. Eligible patients were informed through one of three modalities: (a) directly in the ED, (b) during inpatient stay on the ward, or (c) via telephone after discharge. The primary outcome was the success rate of obtaining BC within 30 days of ED presentation. Secondary outcomes included analysis of potential influences on the success- and dropout rate concerning patient characteristics, information mode, and the interaction time applied for the information.
Results
Out of 11,842 ED visits in the study period, 419 patients were randomly screened for BC eligibility, with 151 meeting the inclusion criteria. Of these, 68 patients (45.0 %) consented to at least one BC module, while 24 (15.9 %) refused participation. The overall dropout rate was 39.1 %, with the highest dropout occurring in the telephone-based group (52.3 %) and lowest in the ED group (7.1 %). Patients who were informed face-to-face during the inpatient stay following their ED treatment had the highest consent rate (85.2 %), while those approached in the ED or by telephone consented in 69.2 %. Logistic regression analysis indicated that longer interaction time was significantly associated with higher consent rates, whereas female gender was associated with increased dropout rates. No significant differences were found between consenting and non-consenting groups concerning age, triage category, billing details (inpatient treatment), or diagnosis distribution.
Conclusions
Obtaining BC in an ED environment is feasible, and showed representative inclusion of the ED-population. However, discharge from the ED and female gender negatively influenced the odds of obtaining consent to the BC. Face-to-face interaction significantly improves consent rates and seems to be the most promising approach for consenting inpatients. Telephone-based approaches, conversely, resulted in higher dropout rates but equal consent rates as the direct consenting in the ED. The study highlights the need for tailored consent strategies, indicating a benefit to maintain staff in EDs and on wards to provide information on BC and obtain consent from eligible patients.

Consent under Duress

Consent under Duress
Book
Tom Dougherty
Oxford Academic, 31 December 2024
Abstract
Consent can make actions morally permissible. But consent can lose its moral force when it is given under duress. Understanding how this happens requires answering the question of which types of duress undermine consent. Uncontroversially, severe coercion, like threats of violence, can prevent consent from creating moral permissions. But what about minor duress? Duress from natural causes? Duress from social norms? Duress that is merely apparent to the consent-giver with no objective basis in reality? To answer these questions, Consent under Duress defends an account that follows two key approaches. First, it adopts an expansive approach that broadens the class of misconduct that is constituted by acting on someone’s consent that is given under duress. Second, it adopts a scalar approach that allows that consent can be invalidated to varying degrees, which in turn can track the degrees of the severity of the duress to which the consent-giver is subject. The expansive and scalar approaches work in tandem. Once there is an expansion of the aforementioned class of misconduct, additional theoretical resources are needed to draw moral distinctions within this heterogeneous class. By providing these resources, the scalar approach supplements the expansive approach. Meanwhile, once it is recognized that consent can be partially invalidated by minor duress, it is necessary to expand the class of what constitutes misconduct that is constituted by acting on someone’s consent that is given under duress. By arguing independently for these mutually reinforcing approaches, Consent Under Duress offers a robust defense of their combination.

Scaffolding Informed Consent

Scaffolding Informed Consent
Extended Essay
Dominic Wilkinson, Neil Levy
Journal of Medical Ethics, 20 December 2024
Abstract
    The principle of respecting patient autonomy underpins the concept and practice of informed consent. Yet current approaches to consent often ignore the ways in which the exercise of autonomy is deeply epistemically dependent.

In this paper, we draw on philosophical descriptions of autonomy ‘scaffolding’ and apply them to informed consent in medicine. We examine how this relates to other models of the doctor–patient relationship and other theories (eg, the notion of relational autonomy). A focus on scaffolding autonomy reframes the justification for existing ways of supporting decisions. In other cases, it suggests a need to rethink how, when and where professionals obtain consent. It may highlight the benefit of technology for supporting decisions.

Finally, we consider the implications for some high-stakes decisions where autonomy is thought to be critical, for example, termination of pregnancy. We argue that such decisions should not be free from all sources of influence—rather they should be protected from undesired influence.

Excerpt
…In what we might call a socially supported model of decision making, individuals make their decisions with input from others. They seek opinions and advice from family and friends, and information from medical professionals, and then attempt to weigh that information in coming to a decision that reflects their own values and outlook. Such socially supported decisions are very plausibly better for the input of others: a broader range of considerations are brought to bear than the individual could marshal on their own. But the final decision-making reflects cognition that is fully the individual’s own. Properly scaffolded models, however, go beyond socially supported models. On the latter, decision-making reflects cognition that is distributed across agents and across the environment. Scaffolded autonomy draws its inspiration from distributed models of cognition…

“Informed” consent? Ethical considerations for clinicians using therapy-matching platforms

“Informed” consent? Ethical considerations for clinicians using therapy-matching platforms
Colette N. Delawalla, Lorenzo Lorenzo-Luaces
Journal of Consulting and Clinical Psychology, 2024; 92(12)
Abstract
Mental health care in the United States is prohibitively difficult to access. Barriers of entry include a shortage of providers, high cost of services, insufficient insurance coverage, and layers of bureaucracy. This problem of low supply and high demand created a unique environment for capitalist problem solvers to enter the therapeutic market, via “therapy-matching platforms.” Several ethically related Federal Trade Commission (FTC) complaints and independent investigations into these platforms highlight that the forward progress is not without growing pains. This commentary focuses on ensuring proper informed consent when providing services on therapy-matching platforms (e.g., BetterHelp, TalkSpace).

Empowering Patients for Disease Diagnosis and Clinical Treatment: A Smart Contract-Enabled Informed Consent Strategy

Empowering Patients for Disease Diagnosis and Clinical Treatment: A Smart Contract-Enabled Informed Consent Strategy
Md Al Amin, Hemanth Tummala, Rushabh Shah, Indrajit Ray
arXiv, 13 December 2024
Open Access
Abstract
Digital healthcare systems have revolutionized medical services, facilitating provider collaboration, enhancing diagnosis, and optimizing and improving treatments. They deliver superior quality, faster, reliable, and cost-effective services. Researchers are addressing pressing health challenges by integrating information technology, computing resources, and digital health records. However, digitizing healthcare introduces significant risks to patient data privacy and security, with the potential for unauthorized access to protected health information. Although patients can authorize data access through consent, there is a pressing need for mechanisms to ensure such given consent is informed and executed properly and timely. Patients deserve transparency and accountability regarding the access to their data: who access it, when, and under what circumstances. Current healthcare systems, often centralized, leave much to be desired in managing these concerns, leading to numerous security incidents. To address these issues, we propose a system based on blockchain and smart contracts for managing informed consent for accessing health records by the treatment team members, incorporating safeguards to verify that consent processes are correctly executed. Blockchain’s inherent immutability ensures the integrity of consent. Smart contracts automatically execute agreements, enhancing accountability. They provide a robust framework for protecting patient privacy in the digital age. Experimental evaluations show that the proposed approach can be integrated easily with the existing healthcare systems without incurring financial and technological challenges.

Current Calls For Public Consultation          

Ethical Guidelines for Research Using Pervasive Data
A Notice by the U.S. National Telecommunications and Information Administration on 12/11/2024
Public comment period that ends 01/15/2025.
SUMMARY:
The National Telecommunications and Information Administration (NTIA) is seeking public input on the potential writing of ethical guidelines for the use of “pervasive data” in research. “Pervasive data” refers to data about people gathered through online services. NTIA will rely on these comments, along with stakeholder engagements, in considering whether to draft and issue non-binding guidelines to assist researchers working with pervasive data. Such guidelines, if warranted, would detail how independent third-party researchers [3] can work with pervasive data while meeting ethical expectations of research and protecting individuals’ privacy and other rights…

The goal of ethical guidelines would be to outline principles and best practices that researchers, research institutions, data intermediaries,[4] and online service providers can choose to follow when involved in research with pervasive data…

Pervasive data can be drawn from global networks and may be analyzed by an international community of researchers. Therefore, it is increasingly important to use a global lens to address ethical issues in pervasive data. Advancements in research using pervasive data may benefit from international collaboration and agreed-upon norms for ethical research and the protection of privacy and other rights…

Risks to data subjects presented by research with pervasive data include reidentification of anonymous user accounts; release or inference of information that can be used to perpetuate a range of privacy and other individual-level harms, including fraud, impersonation, discrimination, reputational harms, and emotional distress; and decreased willingness to post and access information online and engage in the digital economy…

Sample Questions:

  1. Consent and autonomy are key principles in human subjects research ethics. However, users of online services may be required to divulge certain personal information and/or have no ability to freely make decisions about its use.[44] How should researchers working with pervasive data consider consent and autonomy?
  2. What, if any, would be an appropriate consent model for research with pervasive data? How and how often should consent occur?
  3. Are there alternative models to traditional consent that either support autonomy or provide protections for data subjects in cases where autonomy is limited?
  4. How, if at all, is user autonomy influenced by context, such as the need to use online services for school, work,[45] or socializing?
  5. What existing ethical frameworks, such as those from professional organizations [64] or government agencies,[65] should be considered when drafting national-level ethical guidelines for research with pervasive data?
  6. To what extent do existing frameworks apply to the collection and use of pervasive data?
  7. What modifications of existing frameworks might be necessary to ensure that those frameworks are applicable to the needs of research with pervasive data?