Perspectives from a Predominantly African American Community about Biobank Research and a Biobank Consent Form
Laura K Sedig, E Hill De Loney, Sarah B Bailey, Kayte Spector-Bagdady, Bianca Ghita, Lydia Koh Krienke, Raymond Hutchinson
Ethics and Human Research, July 2022; 44(4) pp 26-33
Abstract
Minority populations have been underrepresented in clinical trials, as well as in research biobanks that are created to conduct research with participants’ biospecimens and related medical and research data. Biobank research raises issues about informed consent and privacy and the confidentiality of participants’ personal data. Our study involved three focus groups of 10 adults each that were conducted in a medically underserved, predominantly African American community to elucidate questions and concerns regarding an institutional biobank. Transcripts from the discussion were qualitatively analyzed. Three main themes that arose from the focus groups included the importance of trust, the importance of the community in research, and suggestions to improve trust. The concerns identified in this study provide a starting point for future research to help research institutions become more trustworthy to the communities they serve.
Year: 2022
(Re)Conceptualising ‘good’ proxy decision-making for research: the implications for proxy consent decision quality
(Re)Conceptualising ‘good’ proxy decision-making for research: the implications for proxy consent decision quality
Victoria Shepherd
BMC Medical Ethics, 18 July 2022; 23(75)
Open Access
Abstract
People who are unable to make decisions about participating in research rely on proxies to make a decision based on their wishes and preferences. However, patients rarely discuss their preferences about research and proxies find it challenging to determine what their wishes would be. While the process of informed consent has traditionally been the focus of research to improve consent decisions, the more conceptually complex area of what constitutes ‘good’ proxy decision-making for research has remained unexplored. Interventions are needed to improve and support proxy decision-making for research but are hampered by a lack of understanding about what constitutes decision quality in this context. A global increase in conditions associated with cognitive impairment such as dementia has led to an urgent need for more research into these conditions. The COVID-19 pandemic and subsequent necessity to conduct research with large numbers of critically ill patients has made this need even more pressing. Much of the empirical research centres on the desire to improve decision accuracy, despite growing evidence that authenticity is more reflective of the aim of proxy decisions and concerns about the methodological flaws in authenticity-focused studies. Such studies also fail to take account of the impact of decision-making on proxies, or the considerable body of research on improving the quality of healthcare decisions. This paper reports a concept synthesis of the literature that was conducted to develop the first conceptualisation of ‘good’ proxy decisions about research participation. Elements of decision quality were identified across three stages of decision-making: proxy preparedness for decision-making which includes knowledge and understanding, and values clarification and preference elicitation; the role of uncertainty, decisional conflict, satisfaction and regret in the decision-making process; and preference linked outcomes and their effect. This conceptualisation provides an essential first step towards the future development of interventions to enhance the quality of proxy decision-making and ensure proxy decisions represent patients’ values and preferences.
Autonomous patient consent for anaesthesia without preoperative consultation: a qualitative feasibility study including low-risk procedures
Autonomous patient consent for anaesthesia without preoperative consultation: a qualitative feasibility study including low-risk procedures
Original Research Article
MarijeMarsman, Wisse M.F. van den Beuken, Wilton A. van Klei, Teus H.Kappen
BJA Open, September 2022
Abstract
Background
Informed consent for anaesthesia is mandatory and requires provision of information and subsequent consent during consultation between anaesthesiologist and patient. Although information can be provided in an electronic format, it is unknown whether this a valid substitute for a consultation. We explored whether provision of digital information is equivalent to oral consultation and whether it enables patients to give electronic informed consent (e-consent) for anaesthesia.
Methods
Qualitative feasibility study using semi-structured interviews in 20 low-risk adults scheduled for minor surgery under general anaesthesia or procedural sedation at a university hospital. Data were analysed using a thematic content analysis approach. During the interviews, patients followed an application that provides information and subsequent e-consenting.
Results
The mean age was 50 yr and patients had good digital skills. Fifteen patients (75%) had previous experience of anaesthesia. The digital application provided enough information for all patients, but eight (40%) preferred consultation with an anaesthesiologist, mainly for personal contact. Patients had different information needs, with previous experiences leading to lower information needs. Nineteen patients had sufficient information to consent autonomously. Most patients considered separate anaesthesia consent superfluous to the surgical consent.
Conclusion
The digital application provided sufficient information and patients valued the information offered and the advantage of processing information at their own pace. This information made patients feel empowered to autonomously consent to anaesthesia without consultation. Remarkably, consent for anaesthesia was considered unimportant, because patients felt they had ‘no choice’ if they wanted to undergo surgery.
Animation Supported Consent Before Elective Laparoscopic Cholecystectomy
Animation Supported Consent Before Elective Laparoscopic Cholecystectomy
Original Scientific Report
Emre Doganay, David S. Wald, Sam Parker & Frances Hughes
World Journal of Surgery, 28 June 2022
Open Access
Abstract
Background
Patient understanding of surgical procedures is often incomplete at the time they are performed, invalidating consent, and exposing healthcare providers to complaints and claims of failure to inform. Remote consultations, language barriers and patient factors can hinder an effective consent pathway. New approaches are needed to support communication and shared decision-making.
Methods
Multi-language digital animations explaining laparoscopic cholecystectomy were introduced at The Royal London Hospital for patients who attended for elective surgery (www.explainmyprocedure.com/lapchole). Patients completed questionnaires on the day of their procedure both before and after introduction of the animations. We assessed patient-reported understanding of the procedure, its intended benefits, the possible risks, and alternatives to treatment in 72 consecutive patients, 37 before (no animation group) and after 35 after introducing the animations into the consent pathway (animation group). Patient understanding in the two groups was compared.
Results
The two groups were well matched in respect of age, sex and whether English was their first spoken language. The proportions of patients who reported they completely understood the procedure, its benefits, risks, and alternatives in the no animation group were 54, 57, 38 and 24% and in the animation group, 91, 91, 74 and 77%, respectively; p < 0.01 for each comparison.
Conclusion
The integration of multi-language laparoscopic cholecystectomy video animations into the patient consent pathway was associated with substantial improvement in reported understanding of the procedure, benefits, risks, and alternatives to treatment. This approach can be applied across all surgical disciplines in a standardised manner in an era of accelerated elective work and remote consultations.
Enhancing informed consent through use of patient-specific 3D printing in skull base neurosurgery: 3D printing in skull base neurosurgery
Enhancing informed consent through use of patient-specific 3D printing in skull base neurosurgery: 3D printing in skull base neurosurgery
Shan Yasin Mian, Shubash Jayasangaran, Aishah Qureshi, Mark Hughes
Journal of Neurological Surgery, 27 June 2022
Abstract
Objectives
Informed consent is fundamental to good practise. We hypothesised that a personalised 3D printed model of skull base pathology would enhance informed consent and reduce patient anxiety. Design Imaging (DICOM) files were 3D printed. After a standard pre-surgery consent clinic, patients completed part-1 of a structured questionnaire. They then interacted with their personalised 3D printed model. They then completed part-2 seeking to explore perceived involvement in decision-making, anxiety, concerns (emotional) and lesion anatomical location, surgical risks (factual). Descriptive statistics were used to report responses and text classification tools were used to analyse free text responses.
Setting and participants
14 patients undergoing elective skull base surgery (with pathologies including skull base meningioma, craniopharyngioma, pituitary adenoma, Rathke cleft cyst, and olfactory neuroblastoma) were prospectively identified at a single unit.
Results
After model exposure, there was a net trend towards reduced patient-reported anxiety and enhanced patient-perceived involvement in treatment. 13/14 patients (93%) felt better about their operation and 13/14 patients (93%) thought all patients should have access to personalised 3D models. After exposure, there was a net trend towards improved patient-reported understanding of surgical risks, lesion location, and degree of feeling informed. 13/14 patients (93%) felt the model helped them understand the surgical anatomy better. Analysis of free text responses, after exposure found 47% positive sentiment, 35% neutral, and 18% negative.
Conclusions
In the context of skull base neurosurgery, personalised 3D printed models of skull base pathology can improve surgical consent and reduce patient anxiety.
The Legal Requirements for—and Limits to—the Donor’s and the Patient’s Consent
The Legal Requirements for—and Limits to—the Donor’s and the Patient’s Consent
Book Chapter
Silvia Deuring
Brain Organoids in Research and Therapy, 10 July 2022; pp 131-190 [Springer]
Abstract
Research with and on brain organoids implicates well-known problems of consent: under which circumstances is consent required, when is it valid, and how far does it reach? In some cases, these problems are exacerbated by the applicability and complex interplay of specific statutes such as the Transplantation Act, the Transfusion Act, and the regulations on medicinal products. For that reason, this article seeks to provide an overview of the problems of consent within the various contexts of brain organoid use.
Consent and Deidentification of Patient Images in Dermatology Journals: Observational Study
Consent and Deidentification of Patient Images in Dermatology Journals: Observational Study
Japbani K Nanda, Michael Armando Marchetti
JMIR dermatology, 6 July 2022; 5(3)
Excerpt
Publication of patient images contributes to research and education in dermatology. However, it is important to protect patients’ privacy and rights. The Committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE) have provided best practices and recommendations, respectively, for the protection of patients’ rights in scholarly publications [1,2]. Nonetheless, requirements for the deidentification of patient images and for the acquisition of consent to publish such images vary across governing bodies and journals. Our objective was to describe leading dermatology journals’ instructions regarding deidentification and consent to publish patient images as well as the content and readability of consent forms…
Consent in organ transplantation: putting legal obligations and guidelines into practice
Consent in organ transplantation: putting legal obligations and guidelines into practice
Research
Farrah Raza, James Neuberger
BMC Medical Ethics volume, 5 July 2022; 23(69)
Open Access
Abstract
Consent in medical practice is a process riddled with layers of complexities. To some extent, this is inevitable given that different medical conditions raise different sets of issues for doctors and patients. Informed consent and risk assessment are highly significant public health issues that have become even more prominent during the course of the Covid-19 pandemic. In this article we identity relevant factors for clinicians to consider when ensuring consent for solid organ transplantation. Consent to undergo solid organ transplantation is more complex than most surgical and other clinical interventions because of the many factors involved, the complexity of the options and the need to balance competing risks. We first outline the context in which consent is given by the patient. We then outline the legal principles pertaining to consent in medical practice as it applies in the UK and the implication of recent legal judgments. The third section highlights specific complexities of consent in organ transplantation and identifies relevant factors in determining consent for organ transplantation. The fourth section offers practical recommendations. We propose a novel ‘multi-factor approach’ to informed consent in transplantation which includes understanding risk, effective communication, and robust review processes. Whilst understanding risk and communication are a given, our suggestion is that including review processes into the consent process is essential. By this we specifically mean identifying and creating room for discretion in decision-making to better ensure that informed consent is given in practice. Discretion implies that health care professionals use their judgement to use the legal judgements as guidance rather than prescriptive. Discretion is further defined by identifying the relevant options and scope of clinical and personal factors in specified transplantation decisions. In particular, we also highlight the need to pay attention to the institutional dimension in the consent process. To that end, our recommendations identify a gap in the current approaches to consent. The identification of areas of discretion in decision-making processes is essential for determining when patients need to be involved. In other words, clinicians and healthcare professionals need to consider carefully when there is room for direction and where there is little or no room for exercising discretion. In sum, our proposed approach is a modest contribution to the on-going debate about consent in medicine.
Sufficient informed consent to medical treatment of adults: legal and ethical perspectives from Malawi
Sufficient informed consent to medical treatment of adults: legal and ethical perspectives from Malawi
Eva Maria Mfutso Bengo, Adamson Muula, Joseph Mfutso Bengo
Malawi Medical Journal, June 2022; 34(2) pp 143-150
Open Access
Abstract
This special communication discusses the current legal and ethical requirements for informed consent to medical treatment of adults in Malawi. It analyzes the scope of the laws and code of ethics on professional discipline, including criminal privilege for surgeries and clarifies when insufficient disclosures entitle patients to compensation under civil law. Inconsistencies and uncertainties in the law are made apparent. It evaluates to which degree disclosure standards of other Commonwealth jurisdictions (e.g. the case of Montgomery) would be suitable for the health care setting of a country like Malawi that is characterized by shortages of resources, high illiteracy rates and a communitarian cultural context. Doctor-patient communication is not alien to African culture and part of sufficient informed consent. In order to balance the need for efficiency in health care delivery, accountability for quality care, fairness and effective patient-doctor communication the authors suggest to adopt the reasonable patient test only, if a defence of heavy workload on case-to-case basis is introduced at the same time. This does not dispense the need for organisational diligence on part of the institutional health care provider within its capacity.
The evolution and development of the principle of free, prior and informed consent in South Africa
The evolution and development of the principle of free, prior and informed consent in South Africa
Original Article
Naledzani Mukwevho
South African Journal on Human Rights, 27 June 2022
Abstract
This article traces the evolution of the principle of free, prior and informed consent within the South African developmental context. Internationally, free prior and informed consent presupposes that communities have the right to give or withhold consent to proposed development projects on the lands that they own, occupy or otherwise use. Specific to South Africa, research reveals that although the country has not formally adopted the free, prior and informed consent principle within its development system, the spirit of the principle has permeated the development discourse in the country through development policies, legislation and case law. All major development policies in South Africa embody the public participation element, which is a precursor to free, prior and informed consent. Several Acts of parliament specifically require that communities’ consent must be sought and obtained before any development may take place in their territories. This sentiment has recently been augmented by court cases, both at High Court and Constitutional Court levels.
Center for Informed Consent Integrity 