Toward Meeting the Obligation of Respect for Persons in Pragmatic Clinical Trials

Toward Meeting the Obligation of Respect for Persons in Pragmatic Clinical Trials
Morain SR, Kraft SA, Wilfond BS, Mcguire A, Dickert NW, Garland A, Sugarman J
The Hastings Center Report, 1 May 2022; 52(3) pp 9-17
Research ethics oversight systems have traditionally emphasized the informed consent process as the primary means by which to demonstrate respect for prospective subjects. Yet how researchers can best fulfill the ethical obligations of respect for persons in pragmatic clinical trials (PCTs)-particularly those that may alter or waive informed consent-remains unknown. We propose eight dimensions of demonstrating respect in PCTs: (1) engaging patients and communities in research design and execution, (2) promoting transparency and open communication, (3) maximizing agency, (4) minimizing burdens and promoting accessibility, (5) protecting privacy and confidentiality, (6) valuing interpersonal interactions with clinicians and study team members, (7) providing compensation, and (8) maximizing social value. While what respect requires in the context of PCTs will vary based on the nature of the PCT in question, the breadth of these dimensions demonstrates that respect obligations extend beyond informed consent processes.

When is public private? Tweets, privacy and consent in health research

When is public private? Tweets, privacy and consent in health research
Sabitra Kaphle, Rachel Kornhaber, Susan Hunt, Roger Watson, Michelle Cleary
Nurse Education in Practice, August 2022; 63
Online social media platforms provide opportunities for the global community to share and express their views, opinions, reactions, and feelings openly. The use of social media for the purpose of information sharing surged during the COVID-19 pandemic due to mandated physical distancing requirements. This is a seemingly consensual catharsis at a time of heightened need for alternative social activity and critical information sharing. Communication on open social media platforms has created opportunities for researchers to access and analyse rich, publicly available data to study a range of topics and issues. The creation of this abundant public data has also led to fundamental methodological and ethical challenges for social science researchers. Namely, is the use of this public data for research a breach of privacy and confidentiality? Are social media users becoming involuntary research participants as their communications and personal information are mined and published on without participant insight and informed consent? In this discussion, we aim to highlight some of the critical methodological and ethical issues that researchers must consider while using Twitter as a data source to publish from.

Assessment of Social Trust in Relatives of Discharged Patients With Personal Consent and Other Relatives of Patients

Assessment of Social Trust in Relatives of Discharged Patients With Personal Consent and Other Relatives of Patients
Research Article
Hamid Reza Moretza Bagi, Zhila Khamnian, Forough Hatami, Samad Shams Vahdati, Reza Yazdani, Sama Rahnemayan
Journal of Patient Experience, 6 July 2022
Lack of social trust in the physician–patient relationship will disrupt health. Since social trust has not been sufficiently studied in patients’ companions, this study investigates and compares social trust and its dimensions in companions of patients discharged against medical advice with total patients’ companions in the emergency room. In this cross-sectional descriptive-comparative study, 385 patients’ companions were enrolled. This study was done by a questionnaire with five subscales: honesty, frankness, cooperative tendency, confidence, and trust. Data were analyzed using descriptive statistics and analytical statistics methods. In this study, there was no significant difference between the mean score of social trust between companions of patients discharged against medical advice (61.11 ± 9.01) and patients discharged after treatment (62.27 ± 6.97). There was a significant relationship between the mean score of the 2 groups only in the frankness domain (P-value = .001). The level of social trust in the patients’ companions was moderate in both groups. Companions of discharged patients after completing the treatment process are more explicit than the companions of patients discharged against medical advice.

Co-creation with research participants to inform the design of electronic informed consent

Co-creation with research participants to inform the design of electronic informed consent
Evelien De Sutter, David Geerts, Pascal Borry, Kristien Coteur, Dorien Bamps, Heleen Marynissen, Els Ampe, Els Geenens, Marleen Depré, Isabelle Huys
Digital Health, 6 June 2022; 8 pp 1–11
Open Access
This study aimed to provide recommendations for a personalized electronic informed consent interface that is adapted to research participants’ needs and could enable a longitudinal interaction between the participants and the research team.
The co-creation process consisted of three co-creation workshops, one focus group discussion, and four semi-structured interviews. In total, 24 participants, who had taken part in four disparate clinical studies in Belgium, were involved. Descriptive statistics and qualitative content analysis were applied to analyze the survey data and audio recordings.
Varying perceptions on the type and amount of information described in an informed consent form were reported. Other findings were related to the structure and presentation of information, setting preferences for data sharing, and electronically signing new informed consent versions. Regarding the long-term interaction, most of the participants wanted to receive progress updates, including the results, of the study in which they had taken part. They proposed to receive a notification, preferably via email, in case new information is made available on the electronic informed consent interface.
To optimally support the design of an electronic informed consent interface, it is key to understand the research participants’ needs. Study findings suggest that an electronic informed consent interface may be a promising technological application to interactively provide study-related information and to keep participants informed during and after the clinical study.

Perspectives from a Predominantly African American Community about Biobank Research and a Biobank Consent Form

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
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.

(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
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
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.
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.
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.
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
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.
Multi-language digital animations explaining laparoscopic cholecystectomy were introduced at The Royal London Hospital for patients who attended for elective surgery ( 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.
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.
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
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.
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.
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]
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.