Primary caregivers’ experience with the informed consent process in the paediatric emergency department: An interview-based qualitative study
Adonis Wazir, Ibrahim Sandokji, Morten Greaves, Rasha D Sawaya
Paediatrics & Child Health, 3 April 2021
Abstract
Objective
This study aims to understand primary caregivers’ (PCG) experience with the informed consent (IC) process.
Methods
We conducted in-depth interviews with PCGs of paediatric patients who underwent a procedure requiring IC in the paediatric emergency department (PED) of a tertiary care paediatric centre in the USA, between January and March 2013 and between September 2013 and January 2014. We triangulated the qualitative findings from the PCG interviews with Likert-scale responses from the PCGs and with results from surveyed physicians.
Results
We included 14 PCG–physician dyads. Our results show that PCGs understand the importance of the IC process. They appreciated the calm demeanor of providers, and the clarity of their wording. PCGs felt that IC can add to the stress, and that it could be made simpler and timelier. PCGs also had varying extents of retention of the information provided.
Conclusion
This exploratory study suggests an overall positive IC experience of the PCGs while highlighting areas for improvement including a more thorough discussion of alternatives, a better assessment of knowledge transmission and retention by the PCG, and recognition of the PCG’s discomfort during decision making in a stressful environment.
Forms to capture child consent to surgical procedures: Time to focus on function rather than form
Forms to capture child consent to surgical procedures: Time to focus on function rather than form
A Strode, C Badul
South African Journal of Bioethics and Law, April 2021; 14(1)
Open Access
Abstract
It is uncontroversial that no form of treatment, including a surgical operation, can be undertaken without the consent of the patient/proxy. The Children’s Act deals expressly with consent to ‘surgical operations’ on children. Section 12 creates a framework based on the principles of child participation and protection. Nevertheless, obtaining consent from children remains complex: firstly, children are legal minors and have limited capacity to act independently. Secondly, there may be risks or longer-term consequences of surgery that distinguish it from medical treatment. Third, a child’s capacity to understand risks is not static: it evolves with age, and limited tools exist to access capacity. Fourth, there are at least three parties to the consent procedure – the child, the parent/guardian and the medical practitioner, all of whom may have different interests. Fifth, in some instances there is the added complication of child parents who need to provide consent for their own child. This article aims to provide guidance to surgeons and other medical practitioners performing surgery on children. It does this through setting out the legal norms relating to child consent to an operation. It critically examines the pro forma consent forms (forms 34 and 35) found in the regulations issued in terms of the Children’s Act that are to be used to document the consent process, and identifies key gaps and weaknesses. It concludes with recommendations for the adaptation of these forms through the use of a checklist to ensure that all the requirements for valid consent are documented, protecting children and medical practitioners.
‘Informed consent’ in consensual child welfare: some reflections on its controversial nature
‘Informed consent’ in consensual child welfare: some reflections on its controversial nature
Rosi Enroos, Johanna Korpinen, Tarja Pösö
European Journal of Social Work, 28 March 2021
Open Access
Abstract
The article examines the nature of consent in the context of Finnish care order decision-making as described by social workers, parents and young people, all personally involved in care order decision-making, albeit in different roles: on the one hand, an authority asking for the view about a child removal, and on the other, a party expressing a view which has huge legal, social and moral implications for their family relations. Based on qualitative data, the analysis examines two criteria for informed consent: adequate information and freedom from undue influence. The findings highlight the messy and blurred nature of consent that is found in other fields of practice as well. There are, however, some distinctive features relevant to consensual services in child welfare which need to be further elaborated. In particular, family relationality shapes the nature of consent through intra-familial power and emotions, differently for parents and children. Critical awareness of the nature of consent is also important for an understanding of service-user participation and self-determination.
Informed Consent From Children
Informed Consent From Children
Tim Moore
Sage Research Methods, 17 September 2019
Abstract
Children’s informed consent in participatory research is an essential component to ethical research practice. Although there has been significant attention from researchers about the importance of seeking children’s informed consent prior to their participation in data collection, some commentators see consent as an ongoing process rather than a hurdle to be overcome prior to data collection. After discussing the participation of children in research, this entry presents five steps that may help researchers consider how to embed informed consent in research activities as well as examples to show how researchers can assist children to understand, indicate, utilize, and reflect on their consent.
Beyond Montgomery – decision making, consent and the GMC
Beyond Montgomery – decision making, consent and the GMC
Anastasia Georgiou, Helen Bolton
Obstetrics, Gynaecology & Reproductive Medicine, 17 April 2021
Abstract
In November 2020 the General Medical Council (GMC) updated its guidance on decision making and consent. This new document reflects significant legal and ethical developments that have occurred in recent years. It is helpful to understand the context from which this guidance has arisen, and imperative to understand the implications it will have on clinical practice. As such, this article will (i) outline the evolution of consent (ii) briefly explain the landmark case of Montgomery and (iii) highlight the key updates in the GMC’s 2020 guidance.
Changing FDA Approval Standards: Ethical Implications for Patient Consent
Changing FDA Approval Standards: Ethical Implications for Patient Consent
Viewpoint
Jonathan J. Darrow, Sanket S. Dhruva, Rita F. Redberg
Journal of General Internal Medicine, 8 April 2021
Open Access
Excerpt
The pace of new drug and medical device introductions has accelerated in recent years. In 2018, 59 novel drugs were approved in the USA, the most since 1996. A rising proportion of drugs and devices qualify for one of the US Food and Drug Administration’s (FDA) expedited programs, which allow approval based on less rigorous clinical trials. Expanded access and emergency use authorization allow access to products—such as remdesivir (Veklury) and COVID-19 vaccines—even before they are approved.
The growing array of products made available with limited evidence poses important challenges for patients and physicians. Ethical principles require that patients consent to treatment after being informed of the benefits and harms of each alternative. In routine practice, however, the consent process is often truncated, with limited presentation of alternatives, risks, and outcome data. As regulatory processes have evolved, the consent process—already criticized by some as inadequate—has changed little. We review the evolution of drug and device evidence requirements and consider the implications for informed consent…
Knowledge and practices of seeking informed consent for medical examinations and procedures by health workers in the Democratic Republic of Congo
Knowledge and practices of seeking informed consent for medical examinations and procedures by health workers in the Democratic Republic of Congo
Doudou Nzaumvila, Patrick Ntotolo, Indiran Govender, Philip lukanu, JD Landu Niati, Didier Sanduku, Tombo Bongongo
African Journals Online, 16 April 2021; 21(1)
Open Access
Abstract
Background
Informed consent (IC) is linked to the ethical principle of respecting patient autonomy, respect for human rights and ethical practice, while in many countries it is a standard procedure. Anecdotally, it should be noted that in the Democratic Republic of Congo (DRC) in many instances ICs are not obtained systematically. To date, no research appears to have been conducted on this matter. This study aimed to assess the knowledge and practice of obtaining IC from patients among health care providers (HCP) in the DRC.
Methods
This was a cross-sectional study, with a convenient sampling of 422 participants. Data from the questions were collected on an imported Microsoft Excel spreadsheet for review at INSTAT.TM The authors set IC’s accurate knowledge and practice at 80% or higher. The Fisher Exact test was used to compare categorical association results, and a p-value < 0.05 was considered statistically significant.
Results
Results showed that giving information in detail to patients on their medical condition was associated with formal training on medical ethics and IC (p: 0.0028; OR: 1.894; CI: 1.246 to 2.881), which was also associated with answering the patient’s questions in detail (p: 0.0035; OR: 1.852; CI: 1.236 to 2.774). About 127(30.09 %) of participants scored 80% or higher. Extracurricular training was associated with withholding information from patients, up to 27 times more than other factors (p< 0.0001; OR: 27.042; CI: 13.628 to 53.657). when it comes to get IC, HCP with many years of practice scored better than others, in one of the question the odd ratio was closer to 7 ( p< 0.0001; OR: 6.713; CI: 4.352 to 10.356). Only 47(11.14%) of the participants scored 80% or more of the questions about practice of IC.
Conclusion
For a variety of reasons, knowledge and practice of IC among HCPs was very low. A common programme for the country as part of formal training might lead to an improvement. In addition, patients’ education on IC should be displayed in waiting areas at all medical centres.
Validation of the factors influencing family consent for organ donation in the UK
Validation of the factors influencing family consent for organ donation in the UK
Original Article
M. K. Curtis A. R. Manara S. Madden C. Brown S. Duncalf D. Harvey A. Tridente D. Gardiner
Anaesthesia, 16 April 2021
Summary
Between 2013 and 2019, there was an increase in the consent rate for organ donation in the UK from 61% to 67%, but this remains lower than many European countries. Data on all family approaches (16,896) for donation in UK intensive care units or emergency departments between April 2014 and March 2019 were extracted from the referral records and the national potential donor audit held by NHS Blood and Transplant. Complete data were available for 15,465 approaches. Consent for donation after brain death was significantly higher than for donation after circulatory death, 70% (4260/6060) vs. 60% (5645/9405), (OR 1.58, 95%CI 1.47–1.69). Patient ethnicity, religious beliefs, sex and socio‐economic status, and knowledge of a patient’s donation decision were strongly associated with consent (p < 0.001). These factors should be addressed by medium‐ to long‐term strategies to increase community interventions, encouraging family discussions regarding donation decisions and increasing registration on the organ donor register. The most readily modifiable factor was the involvement of an organ donation specialist nurse at all stages leading up to the approach and the approach itself. If no organ donation specialist nurse was present, the consent rates were significantly lower for donation after brain death (OR 0.31, 95%CI 0.23–0.42) and donation after cardiac death (OR 0.26, 95%CI 0.22–0.31) compared with if a collaborative approach was employed. Other modifiable factors that significantly improved consent rates included less than six relatives present during the formal approach; the time from intensive care unit admission to the approach (less for donation after brain death, more for donation after cardiac death); family not witnessing neurological death tests; and the relationship of the primary consenter to the patient. These modifiable factors should be taken into consideration when planning the best bespoke approach to an individual family to discuss the option of organ donation as an end‐of‐life care choice for the patient.
Obstacles to Obtaining Informed Consent from the Perspective of Transplant Coordinators: A Qualitative Study
Obstacles to Obtaining Informed Consent from the Perspective of Transplant Coordinators: A Qualitative Study
Research Article
Alireza Shamsaeefar, Nasrin Motazedian, Fatemeh Rahmanian, Saman Nikeghbalian, Seyed Ali Malek-Hosseini
Hepatitis Monthly, 5 April 2021; 21(2)
Abstract
Background
The lack of consent to donate body organs leads to an increase in the death rate of patients on the waiting list for transplantation. Unwillingness of families is known as the main obstacle to organ donation, and the media has an essential role in motivating organ donation.
Objectives
This study aimed to explore obstacles to obtaining consent for organ donation from transplant coordinators’ perspective throughout Iran.
Methods
In this qualitative study, 13 in-depth semi-structured face-to-face interviews were conducted with transplant coordinators from November 2018 to March 2019. The participants were investigated using a purposive sampling method. The participants’ age and work experience ranged between 32 – 49 years and 6 – 25 years, respectively. Open-ended questions were asked from the participants in a private room. An experienced interviewer explained the study’s objectives to the coordinators, and each interview lasted on average 50 minutes. The interview scripts were analyzed using a content analysis method.
Results
The findings highlighted the difficulty of obtaining consent from brain-dead patients’ families. The obstacles could be internal or external. External determinants were healthcare providers’ lack of empathy, inadequate consultation from doctors outside the hospital, media content, and uninformed comments from relatives. Internal determinants were hoping for recovery, denial, and disagreement among family members.
Conclusions
The healthcare team should have a better connection with families to obtain organ donation consent from them. Therefore, a training program must be developed for the treatment team so that they show more supportive behavior and improve quality of care in hospitals before and after brain death.
Health workers’ perspectives on informed consent for caesarean section in Southern Malawi
Health workers’ perspectives on informed consent for caesarean section in Southern Malawi
Research Article
Wouter Bakker, Siem Zethof, Felix Nansongole, Kelvin Kilowe, Jos van Roosmalen, Thomas van den Akker
BMC Medical Ethics, 29 March 2021; 22(33)
Open Access
Abstract
Objective
Informed consent is a prerequisite for caesarean section, the commonest surgical procedure in low- and middle-income settings, but not always acquired to an appropriate extent. Exploring perceptions of health care workers may aid in improving clinical practice around informed consent. We aim to explore health workers’ beliefs and experiences related to principles and practice of informed consent.
Methods
Qualitative study conducted between January and June 2018 in a rural 150-bed mission hospital in Southern Malawi. Clinical observations, semi-structured interviews and a focus group discussion were used to collect data. Participants were 22 clinical officers, nurse-midwives and midwifery students involved in maternity care. Data were analysed to identify themes and construct an analytical framework.
Results
Definition and purpose of informed consent revolved around providing information, respecting women’s autonomy and achieving legal protection. Due to fear of blame and litigation, health workers preferred written consent. Written consent requires active participation by the consenting individual and was perceived to transfer liability to that person. A woman’s refusal to provide written informed consent may pose a dilemma for the health worker between doing good and respecting autonomy. To prevent such refusal, health workers said to only partially disclose surgical risks in order to minimize women’s anxiety. Commonly perceived barriers to obtain a fully informed consent were labour pains, language barriers, women’s lack of education and their dependency on others to make decisions.
Conclusions
Health workers are familiar with the principles around informed consent and aware of its advantages, but fear of blame and litigation, partial disclosure of risks and barriers to communication hamper the process of obtaining informed consent. Findings can be used to develop interventions to improve the informed consent process.
Center for Informed Consent Integrity 