[Knowledge, use and opinion about written informed consent in primary healthcare nurses: CONOSER pilot project]

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[Knowledge, use and opinion about written informed consent in primary healthcare nurses: CONOSER pilot project]
Cabrera-Rodríguez A, Rico-Blázquez M, Sanz-Álvarez EJ, Schmidt-RioValle J
Atencion Primaria, 3 December 2022; 55(2)
Abstract
To know the knowledge, implementation and opinion on informed consent of generalist nurses, specialists and primary care residents. Descriptive cross-sectional study using an online self-administered ‘ad hoc’ questionnaire. Primary care nurses in Madrid, from November 2020 to March 2021. Sample of 114 nurses: 91 generalist, 20 specialists and 3 residents. Sociodemographics, knowledge, implementation and opinion. The response rate was 27.7%. As a general rule, 48.2% indicated that informed consent was collected verbally, as established by law, with differences being found between categories, this percentage being higher in specialists and residents (P=0.004), and within specialists in those who had obtained their speciality by internal resident nurse (IRN) (P<0.0001). In addition, specialists and residents were those who most identified the legal norm regulating informed consent (P<0.0001). In terms of implementation and opinion, all groups obtained similar results. There are no previous studies that have analysed these aspects of informed consent comparing the different categories. Studies from other healthcare and geographical areas show that nurses have greater knowledge, although the demand for specific training in bioethics and biolaw is greater in the nurses participating in this study. Nurses have adequate knowledge about informed consent, use it in clinical practice and have an appropriate conception of it, being higher in some items in specialist nurses IRN and in residents.

Editor’s note: Atencion Primaria is a Spanish language publication that publishes works relative to the field of Primary Healthcare

Informed Consent in Anesthesiology: An exploratory Study

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Informed Consent in Anesthesiology: An exploratory Study
Bárbara Fontes, Sílvia Marina, Diana Andrade, Sofia Dias, Miguel Ricou
Acta Bioethica, November 2022; 28(2) pp 281-289
Open Access
Abstract
In the literature Informed consent (IC) assumptions is well established. However, the different stages and the conditions under which the IC for anesthetic practices is obtained, is scarce. The aim of the present study is to explore the phases and conditions of IC in anesthesiology. Anonymized clinical records of 325 patients submitted to anesthetic procedures at the Institute of Oncology of Porto were analyzed. A total agreement between the anesthetic techniques established in the IC and those performed, was reach with 270 patients. The importance of IC in clinical practice is discussed and an ideal process for IC is argued.

Editor’s note: Acta Bioethica is publication of the University of Chile

The Inconsistencies of Consent

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The Inconsistencies of Consent
Chunlin Leonhard
Catholic University Law Review, 2 December 2022; 71(4)
Open Access
Abstract
    U.S. legal scholars have devoted a lot of attention to the role that consent has played in laws and judicial consent jurisprudence. This essay contributes to the discussion on consent by examining judicial approaches to determining the existence of consent in three selected areas – contracts, tort claims involving medical treatment, and criminal cases involving admissibility of confessions, from the late nineteenth century until the present. This article examines how courts have approached the basic factual question of finding consent and how judicial approaches in those areas have evolved over time. The review shows that the late 19th century saw courts adopting a similar approach for finding consent across the three areas. Courts focused on observable signs of consent, verbal or nonverbal communications, to determine existence of consent. They found consent unless circumstances suggested that the consenting party lacked the power to use their will. However, courts began to diverge in the early and mid-twentieth century in their approaches to ascertaining consent. In contract disputes, courts’ consent approach has remained static, focusing on observable signs of consent or, in contract law parlance, “manifestations of assent.” In tort cases involving medical treatment, courts began requiring more than observable signs of consent; instead, courts focused on the consenting party’s access to information and comprehension, described by scholars as the informed consent doctrine. The judicial consent approach undertook the most dramatic change in criminal cases involving admissibility of confessions with judicial adoption of presumption of non-consent in custodial interrogation without the required warnings.

This article suggests that multiple factors appear to have contributed to divergent consent approaches across the three areas. Consent plays a different role in contract disputes from that in medical treatment and criminal confession cases. Courts have adopted a heightened consent inquiry in medical treatment and criminal confession cases as responses to significant social changes and increased public awareness of individual rights and the need to protect individuals from potential abuses and arbitrary government power. In addition, human cognitive biases—our flawed decision-making process, may have also contributed to the divergence.

Autonomy and Consent

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Autonomy and Consent
Book Chapter
Neil C. Manson
The Routledge Handbook of Autonomy, 2022 [Routledge]
Abstract
In the philosophy of consent, the notion of autonomy is widely appealed to for a number of reasons. The philosophy of consent has tended to focus on certain types of consent, in certain domains where consent plays an important normative role. But consent is also a key part of everyday social interactions beyond the special domains of interest of the philosophy of consent. Because the relationship between autonomy and consent in the philosophy of consent has been discussed by others (Dworkin 1988; Beauchamp and Childress 2001; O’Neill 2002; Beauchamp 2010; Walker 2018), the aim here is to take a slightly different approach and to consider what kinds of autonomy might be relevant to a proper characterization of everyday consent. We will then briefly return to consider the significance of autonomy in the philosophy of consent.

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Informed Consent: A Monthly Review
_________________

December 2022 :: Issue 48

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: GE2P2 Global_Informed Consent – A Monthly Review_December 2022

Informed Consent for Risk of COVID-19 in Preoperative Trauma Patients

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Informed Consent for Risk of COVID-19 in Preoperative Trauma Patients
Harvey, A. Sheokand, R. Rambani
Orthopaedic Proceedings, 14 November 2022; 104
Open Access
Abstract
Introduction
The risk of Covid-19 community and hospital acquired infection (HAI) on patient outcomes in trauma is still relevant. Patient’s should be routinely consented for this risk to ensure informed consent for perioperative contraction.
Method
A prospective audit was completed from December-March 2022 examining a consecutive series of patient admissions with capacity to consent. The standards for compliance was RCOS Toolkit 5#3 stating the importance of enhanced consent for risk of contraction, in operating and changes to care pathways. The target was 95% compliance. 2/2 contingency tables were generated to determine odds ratio for compliance versus Covid+ rate.
Results
This audit generated 80 consecutive patients from which 28 were excluded as non-operative or lacking capacity. It was found that 25% (13/52) had been specifically consented for risks of Covid-19. The rate of PCR-positive results was 15% (8/52) with a mortality of 25%. Approximately 2% of patients in this series were informed of the risk and had a positive Covid-PCR. An odds ratio of 0.38 indicates that being informed of the risk is not associated with rate of infection e.g by adopting enhanced personal protective measures.
Conclusions
The pandemic recovery has not removed this substantial community and nosocomial risk. Our results demonstrate poor compliance with RCS guidance despite ongoing relevance to care. Consent includes the counselling of a patient to specific Covid-related risks including thrombosis & death. Dissemination of these results will be followed by completion of the audit cycle to look for improvements in compliance.

 

Informed Consent in Mass Vaccination against COVID-19 in Romania: Implications of Bad Management

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Informed Consent in Mass Vaccination against COVID-19 in Romania: Implications of Bad Management
Sînziana-Elena Bîrsanu, Maria Cristina Plaiasu, Codrut Andrei Nanu
Vaccines, 5 November 2022; 10(11)
Abstract
Informing patients and obtaining valid informed consent were significant challenges for the COVID-19 immunization program. In Romania, the authorities issued a strategy for activities regarding vaccination against COVID-19, including the informed consent procedure. The lack of legal preparedness was evident when the medical personnel at the vaccination centers were provided with informed consent forms that did not respect the existing legal requirements. In addition, the protocol for persons seeking vaccination stated that the patient was supposed to receive the informed consent form from the receptionist in order to read and sign it. We analyzed the legal implications and the malpractice litigation risk associated with this practice. Due to essential deficiencies and in the absence of an official enactment of new regulations, we conclude that the vaccination consent process did not comply with the legal requirements. Implications include medical personnel’s legal liability, loss of malpractice insurance coverage, and public mistrust that may have contributed to a low vaccination rate. Given the potential of future pandemics or other health crises, this may be a valuable lesson for developing better legal strategies.

The approach to informed consent in acute care research

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The approach to informed consent in acute care research
Correspondence
Rafael Dal-Ré, Arthur L Caplan
Lancet Respiratory Medicine, 3 November 2022
Open Access
Excerpt
In their discussion of the contrasting responses of the UK and the USA to the unprecedented situation posed by the COVID-19 pandemic—and the urgent need for randomised controlled trials to guide clinical practice—Jonathan D Casey and colleagues state that the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial was approved “with an alteration of informed consent” to facilitate enrolment. We are concerned that this statement could confuse clinical investigators and research ethics committee members…

Editor’s note: The article referenced in this correspondence is Casey JD Beskow LM Brown J et al. Use of pragmatic and explanatory trial designs in acute care research: lessons from COVID-19. Lancet Respir Med. 2022; 10: 700-714.

Co-creation of information materials within the assent process: From theory to practice

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Co-creation of information materials within the assent process: From theory to practice
Jaime Fons-Martinez, Cristina Ferrer-Albero, Javier Diez-Domingo
Health expectations : an international journal of public participation in health care and health policy, 23 November 2022
Open Access
Abstract
Introduction
The informed consent process is key to safeguarding the autonomy of the participant in medical research. For this process to be valid, the information presented to the potential participant should meet their needs and be understood by them. The i-CONSENT project has developed ‘Guidelines for adapting the informed consent process in clinical trials’ which aim to improve informed consent so that they are easier to understand and better adapted to the needs and preferences of the target population. The best way to tailor information to the characteristics and preferences of the target population is to involve the community itself.
Methods
Following guidelines developed by i-CONSENT, assent materials were co-created for a mock clinical trial of the human papillomavirus vaccine in adolescents. During the process, two design thinking sessions were conducted involving a total of 10 children and 5 parents. The objectives of the sessions were to find out the children’s opinion of the informed consent (assent in their case) process in clinical trials, identify the parts that were most difficult to understand and alternatives for their presentation and wording, identify the preferred formats for receiving the information and the main characteristics of these formats, design a video explaining the clinical trial and evaluate a tool for assessing comprehension.
Results
Assent materials were co-created in three formats: a web-based material following a layered approach; a video in story format; a pdf document with an innovative way of presenting information compared to traditional assent documents. In addition, the Comprehension of Assent Questionnaire was co-designed, based on the Quality of Informed Consent questionnaire.
Conclusion
The design thinking methodology has proven to be an easy and useful tool for involving children in designing information tailored to their needs and preferences.
Patient or public contribution
A sample of the target population participated in the design and piloting of the materials created using design thinking methodology. In addition, patient representatives participated in the design and evaluation of the guidelines developed by the i-CONSENT project that were followed for the development of the materials in this study.

Using provocative design to foster electronic informed consent innovation

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Using provocative design to foster electronic informed consent innovation
Research
Evelien De Sutter, Stef Verreydt, Koen Yskout, David Geerts, Pascal Borry, An Outtier, Marc Ferrante, Corinne Vandermeulen, Nele Vanmechelen, Bart Van der Schueren, Isabelle Huys
BMC Medical Informatics and Decision Making, 17 November 2022; 22(296)
Open Access
Abstract
Background
The development of technological applications in clinical research, such as electronic informed consent (eIC), is on the rise. The involvement of end users throughout the design process of eIC is of utmost importance to improve the current informed consent process.
Methods
Using a provocative design, we conducted interviews with 30 clinical research participants. Provotypes were used as a starting base to discuss various aspects relevant to eIC. By providing a medium to encourage divergent thinking, participants’ views and concerns were solicited. Thematic analysis was undertaken using NVivo.
Results
The majority of participants placed trust in the principal investigator or the hospital to perform the role of eIC hosting party. Differing opinions were reported on the amount of information required related to stakeholders’ access to an eIC system, and thus, to participants’ personal data, to enable trust in an eIC system. Nevertheless, this study indicates a general willingness of participants to share personal data with physicians and pharmaceutical companies on an international level, and to receive requests for new research studies via an eIC system. Participants suggested to tailor an eIC system based upon their preferences, for example, regarding whom they want to share their personal data with. Moreover, they expressed a desire to choose how they can contact the research team, and to indicate which study-related information they would like to receive electronically. In addition, positive opinions were voiced on the integration of a test to assess participants’ understanding before providing their eIC.
Conclusions
Following a research through design approach, insights have been generated which inform the design of eIC. Provotypes were designed to help participants think beyond what is familiar to them. Study findings revealed that not all situations were perceived as provocative, because of participants’ motivation to advance scientific research and the trust they place in the research team. Nevertheless, the use of provocative design resulted in additional insights, generated by clinical research participants, which could be considered in the further design of eIC.