Legal changes to informed consent and application to clinical practice in surgery
Research Article
Marco Dalle Carbonare, Elizabeth A Gruber
Medico-Legal Journal, 6 July 2023
Abstract
For consent to be fully informed, it must be tailored to each patient, who must be appraised of alternative treatments (including that of no treatment) and informed of the material risks which an individual would wish to know and consider significant. This also includes Covid-19 related risks. Whilst surgeons had at times to offer sub-optimal treatments due to pressures caused by the pandemic, patients should still be given the choice to delay their treatment. Consent obtained remotely via digital technology must comply with the same requirements as in a face-to-face setting.
Consent and Rights within human healthcare IT solutions for lawful basis processing
Consent and Rights within human healthcare IT solutions for lawful basis processing
Peter Barnsley, James Fleming
Francis Crick Institute, 27 June 2023
Abstract
This paper argues for ‘consent by design’ and ‘rights by design’ in IT systems through a framework of atomic consents. It highlights the value of improved openness for users and benefits from standardization that come from such an approach. It argues for a new IT design concept focused on the human at the heart of information systems: the creation of a set of ‘atomic consents’ and ‘atomic rights’, the latter derived from General Data Protection Rights, to help architect IT systems that maintain trust and engagement in IT systems that support human health, societal and people data use. Although this paper concentrates on, and refers in part to, a health context, it is believed that all (or much) of the framework can be applied to all realms of IT development and deployment. The application of a set of atomic consents, embedded within an IT system, can facilitate trusted systems such as research environments. By combining these atomic consents with the atomic rights (as per data protection laws), a way of expressing requirements and architecture for, and within, IT systems is simplified and standardised. This should save money, ensure extensibility and allow flexibility and transparency as social practice and legal frameworks evolve. By enabling both a more granular model of consent, and also by defining what parts of an IT system invoke these, IT systems should become more open (to regulation and audit), more flexible and so more trusted.
Free prior informed consent in the extractive industry: Approaches to involving Indigenous peoples in decision-making in Russia
Free prior informed consent in the extractive industry: Approaches to involving Indigenous peoples in decision-making in Russia
Research article
Yakovleva, T.N. Gavrilyeva, A.I. Makarov, N.A. Krasilnikova
Journal of Environmental Management, 15 October 2023
Abstract
Free prior informed consent is a principle for consulting, cooperating, and obtaining consent from Indigenous peoples through their representative institutions on matters affecting them. It is promoted by the United Nations Declaration on the Rights of Indigenous Peoples, which calls on nations to strengthen the civil, political, and economic rights of Indigenous peoples by securing their rights to land, minerals, and other natural resources. Extractive companies have been developing policies to address Indigenous peoples’ concerns as part of legal compliance and voluntary actions under corporate social responsibility. The lives and cultural heritage of Indigenous peoples are continuously affected by operations of extractive industries. This is notable in the Circumpolar North, where Indigenous peoples have developed sustainable resource use practices in fragile natural environments. In this paper, we examine corporate social responsibility approaches to implementing free prior informed consent in Russia. We investigate how public and civil institutions influence the policies of extractive companies and their impact on Indigenous peoples’ self-determination and participation in decision-making.
Why don’t we inform patients about the risk of diagnostic errors?
Why don’t we inform patients about the risk of diagnostic errors?
Ömer Kasalak, Jan P. Pennings, Jeroen W. Op den Akker, Derya Yakar, Thomas C. Kwee
European Journal of Radiology, August 2023
Abstract
The principles of autonomy and informed consent dictate that patients who undergo a radiological examination should actually be informed about the risk of diagnostic errors. Implementing such a policy could potentially increase the quality of care. However, due to the vast number of radiological examinations that are performed in each hospital each day, financial constraints, and the risk of losing trust, patients, and income if the requirement for informed consent is not imposed by law on a state or national level, it may be challenging to inform patients about the risk of diagnostic errors. Future research is necessary to determine if and how an informed consent procedure for diagnostic errors can be implemented in clinical practice.
The Two Pillars of Intensive Care Medicine (II): The Patient’s Wishes and Consent
The Two Pillars of Intensive Care Medicine (II): The Patient’s Wishes and Consent
Book Chapter
Aimee B. Milliken, Nicholas Sadovnikoff
Ethics in Intensive Care Medicine, 20 July 2023 [Springer]
Abstract
In this chapter, we review the second pillar of intensive care medicine: the patient’s wishes and informed consent. First, we review the concept of respect for autonomy and then address its corollary, the concept of informed consent. We discuss decision-making capacity and voluntariness as essential preconditions to a fully informed consent. Finally, we address the practice of shared decision-making.
How surgeons use risk calculators and non-clinical factors for informed consent and shared decision making: A qualitative study
How surgeons use risk calculators and non-clinical factors for informed consent and shared decision making: A qualitative study
Original Research Article
Jasmine Panton, Brendin R. Beaulieu-Jones, Jayson S. Marwaha, Alison P. Woods, Drashko Nakikj, Nils Gehlenborg, Gabriel A. Brat
American Journal of Surgery, 10 July 2023
Abstract
Background
The discussion of risks, benefits, and alternatives to surgery with patients is a defining component of informed consent. As shared-decision making has become central to surgeon-patient communication, risk calculators have emerged as a tool to aid communication and decision-making. To optimize informed consent, it is necessary to understand how surgeons assess and communicate risk, and the role of risk calculators in this process.
Methods
We conducted interviews with 13 surgeons from two institutions to understand how surgeons assess risk, the role of risk calculators in decision-making, and how surgeons approach risk communication during informed consent. We performed a qualitative analysis of interviews based on SRQR guidelines.
Results
Our analysis yielded insights regarding (a) the landscape and approach to obtaining surgical consent; (b) detailed perceptions regarding the value and design of assessing and communicating risk; and (c) practical considerations regarding the future of personalized risk communication in decision-making. Above all, we found that non-clinical factors such as health and risk literacy are changing how surgeons assess and communicate risk, which diverges from traditional risk calculators.
Conclusion
Principally, we found that surgeons incorporate a range of clinical and non-clinical factors to risk stratify patients and determine how to optimally frame and discuss risk with individual patients. We observed that surgeons’ perception of risk communication, and the importance of eliciting patient preferences to direct shared-decision making, did not consistently align with patient priorities. This study underscored criticisms of risk calculators and novel decision-aids – which must be addressed prior to greater adoption.
Informed Consent for Image-Guided Procedures: A Nationwide Survey of Perceptions and Current Practices
Informed Consent for Image-Guided Procedures: A Nationwide Survey of Perceptions and Current Practices
Forsman, S. Silberstein, E.D. Cyphers, E.J. Keller, M.S. Makary
Clinical Radiology, 29 June 2023
Abstract
Aim
To characterise the current landscape of informed consent practices for image-guided procedures, including location of consent, guideline availability, and utility of decision-aid resources.
Materials and methods
A survey of 159 interventional radiologists was conducted from April through June 2022. The survey evaluated participant demographics (gender, practice type, and level of training) and consent practices. Fifteen questions investigated discussion of benefits, risks, and alternatives, who obtained consent, location of consent conversations, how decision-making capacity is assessed, availability of formal guidance on consent discussions, and if and how decision-aids are used.
Results
Most respondents (93.7%) were “extremely” or “very” comfortable discussing the benefits and risks of image-guided procedures during informed consent. Most respondents were “very” comfortable discussing alternative treatments within radiology (86.8%) while fewer felt confident regarding alternatives outside radiology (46.5%). Most respondents indicated obtaining consent in a pre-procedure area (89.9%,), while 12.7% of respondents obtained consent in the procedure room. Of the respondents, 66.7% did not have formal education or documented guidance on what providers should disclose during consent. Ninety-two respondents (57.9%) reported using decision aids. The type of decision aid varied, with most reporting using illustrations or drawings (46.6%). Decision aid utility was more prevalent in non-teaching/academic (71.4%) versus academic (61%) institutions (p=0.02).
Conclusion
Regardless of demographics, interventionalists are confident in discussing benefits, risks, and alternative image-guided therapies, but are less confident discussing alternative treatment options outside of radiology. Formal education on informed consent is less common, and the use of decision aids varies between teaching and non-teaching institutions.
Perspectives on Current Attitudes, Enablers, and Barriers to Obtaining Surgical Informed Consent for Doctors-in-Training
Perspectives on Current Attitudes, Enablers, and Barriers to Obtaining Surgical Informed Consent for Doctors-in-Training
Mary Teoh, Daniel Jia Wei Lee, David Cooke, Munyaradzi G Nyandoro
Cureus, June 2023; 15(6)
Abstract
Background
Surgical informed consent (SIC) is paramount in modern-day litigious surgical practice, yet numerous complaints remain about the consenting process. This paper investigated current attitudes, enablers, and barriers to obtaining SIC in clinical practice for doctors-in-training (DiT).
Methodology
Self-reported SIC practice among DiT (N=1,652) across three metropolitan health service regions in Western Australia (WA) was surveyed using a de-identified 20-item multiple response ranking, dichotomous quantitative and qualitative online survey. Data were analyzed using Statistical Package for the Social Sciences (SPSS) version 27 (IBM Corp., Armonk, NY, USA).
Results
The response rate was 23% (n=380). There was an even distribution of key demographics across all three health regions; the median postgraduate year (PGY) was two. Only 57.4% of DiT strongly felt comfortable and confident obtaining a SIC. Of the responders, 67.4% correctly identified key SIC components. There were significant positive associations between comfort and confidence with obtaining SIC and the seniority level of the DiT (p<0.001), identification of SIC components (p<0.001), and prior training in SIC (p<0.001). Most DiTs highlighted the necessity for formal SIC training with a preference for interactive workshops supported by e-learning modules.
Conclusions
Most DiTs can identify the key factors that constitute a valid SIC; however, the practical conversion of this skill could be better. The key enablers to improved SIC techniques were well-supported departments, with further training and clear guidelines within the institutions. The identified barriers were time constraints, inexperience, and a lack of senior support. Future practices and interventions should address these key barriers while promoting the enablers of sustainable and efficient SIC practice.
Consent
Consent
Iain Mactier, Paul McConnell
Anaesthesia & Intensive Care Medicine, 13 July 2023
Abstract
Consent is a fundamental ethical and legal principle in good medical practice. A patient must have capacity to provide informed consent. There are four key principles that need to be satisfied when establishing if a patient has capacity. For consent to be valid, the patient must be made aware of all associated risks to which they would attach significance. Information provided to patients should be individualized, objective and include all reasonable alternatives. It should be made clear if a procedure is optional, for example, an analgesic regional nerve block. Questions should be encouraged and answered honestly. Patients need adequate time to consider all the information provided. The consent process should be documented but a separate signed consent form is not required for most anaesthetic interventions. Some patients may have an advance care directive or a legally appointed power of attorney and these must be respected. When a patient has not made such arrangements and does not have capacity, treatment should be provided in accordance with their best interests. This must be individualized and consider multiple factors. Specialist advice should be sought in circumstances where there is uncertainty.
Gaining Consent to Survey Respondents’ Partners: The Importance of Anchors’ Survey Experience in Self administered Modes
Gaining Consent to Survey Respondents’ Partners: The Importance of Anchors’ Survey Experience in Self administered Modes
Tobias Gummer, Pablo Christmann, Tanja Kunz
Comparative Population Studies, 6 July 2023; 48 pp 281-306
Open Access
Abstract
Dyadic surveys aim to interview pairs of respondents, such as partners in a relationship. In dyadic surveys, it is often necessary to obtain the anchors’ consent to contact their partners and invite them to a survey. If the survey is operated in self-administered modes, no interviewer is present to improve the consent rate, for example, by providing convincing arguments and additional information. To overcome the challenges posed by self-administered modes for dyadic surveys and to improve consent rates, it is important to identify aspects that positively influence the likelihood of anchors giving consent to contact their partners. Ideally, these aspects are in the hands of the researchers, such as the survey design and aspects of the questionnaire. Thus, in this study, we analyzed the relationship between anchors’ survey experience and their willingness to consent to surveying their partners in self-administered modes. Based on data from the German Family Demography Panel Study (FReDA), we found that the anchors’ perceptions of the questionnaire as “interesting” or “too personal” were related to consent rates. These relationships were consistent across different survey modes and devices. Effects of other aspects of the questionnaire, such as “important for science” and “diverse” varied between modes and devices. We concluded with practical recommendations for survey research and an outlook for future research.
Center for Informed Consent Integrity 