“A question of trust” and “a leap of faith”: A qualitative study of participants’ perspectives on consent, privacy and trust in smart home research
Mari-Rose Kennedy, Richard Huxtable, Giles M Birchley, Jonathan C S Ives, Ian J Craddock
JMIR mHealth and uHealth, 1 August 2021
Abstract
Background
‘Ubiquitous’, ‘smart’ computing technology has the potential to assist humans in numerous ways, including health and social care. Covid-19 has notably hastened the move to remote delivery of many health services. Development of technology involves a variety of stakeholders in the process of testing, refinement, and evaluation. Where stakeholders are research participants, this poses practical and ethical challenges, particularly if the research is situated in people’s homes. Researchers must observe prima facie ethical obligations linked to participants’ interests in having their autonomy and privacy respected.
Objective
This research explores ethical considerations around consent, privacy, anonymisation and data-sharing with participants involved in SPHERE, a project developing smart technology for monitoring people’s health behaviours at home. Their unique insights from being part of this unusual experiment offers valuable perspectives on how to properly approach informed consent for similar smart home research in the future.
Methods
Semi-structured qualitative interviews (with adults and children) were conducted with 7 households/16 participants recruited from SPHERE. Purposive sampling was used to invite participants from a range of household types and ages. Interviews were conducted in participants’ homes or on-site at the University of Bristol. Interviews were digitally recorded, transcribed verbatim and analysed using an inductive thematic approach.
Results
Four themes were identified: (1) motivations for participating; (2) transparency, understanding and consent; (3) privacy, anonymity, and data use; and (4) trust in research. Motivations to participate in SPHERE stemmed from an altruistic desire to support research directed towards the public good. Participants were satisfied with the SPHERE consent process despite reporting some difficulties: recalling and understanding information received; the timing and amount of information provision; and sometimes finding the information to be abstract. Participants were also satisfied that privacy was assured and judged that reasons for conducting the research compensated for threats to privacy. Participants trusted the project and the team. Factors relevant to developing and maintaining this trust were the trustworthiness of the research team, provision of necessary information, the control participants had over participation, and positive prior experiences of research involvement.
Conclusions
This small study offers valuable insights into the perspectives of participants in smart home research on important ethical considerations around consent and privacy. The findings might have practical implications for future research regarding the types of information researchers should convey, the extent to which anonymity can be assured, and the long-term duty of care owed to participants who place trust in researchers not only on the basis of this information, but also because of their institutional affiliation. This study highlights important ethical implications: although autonomy matters, trust appears to matter most. Researchers should therefore be alert to the need to foster and maintain trust, particularly as failing to do so might have deleterious effects on future research.
Month: September 2021
Parents’ experiences of decision making for rapid genomic sequencing in intensive care
Parents’ experiences of decision making for rapid genomic sequencing in intensive care
Fiona Lynch, Amy Nisselle, Zornitza Stark, Clara L. Gaff, Belinda McClaren
European Journal of Human Genetics, 23 August 2021
Abstract
The clinical utility of rapid genomic sequencing (rGS) for critically unwell infants and children has been well demonstrated. Parental capacity for informed consent has been questioned, yet limited empirical data exists to guide clinical service delivery. In an Australian nationwide clinical implementation project offering rGS for critically unwell infants and children, parents made a decision about testing in under a day on average. This study reports parents’ experiences of decision making for rGS within this rapid timeframe to inform pre-test counselling procedures for future practice. A nationwide sample of 30 parents, whose children were amongst the first to receive rGS, were interviewed. We found that framing and delivery of rGS require careful consideration to support autonomous decision making and avoid implicit coercion in a stressful intensive care setting. Many parents described feeling ‘special’ and ‘lucky’ that they were receiving access to expensive and typically time-consuming genomic sequencing. Thematic analysis revealed a spectrum of complexity for decision making about rGS. Some parents consented quickly and were resistant to pre-test counselling. Others had a range of concerns and described deliberating about their decision, which they felt rushed to make. This research identifies tensions between the medical imperative of rGS and parents’ decision making, which need to be addressed as rGS becomes routine clinical care.
The value of consent for biobanking
The value of consent for biobanking
News & Views
Elizabeth Bromley, Dmitry Khodyakov
Nature Human Behaviour, 23 August 2021
Excerpt
Biobanks facilitate large-scale tests of hypotheses that may advance health, but whether biobanking participants adequately comprehend the potential uses of their data should concern researchers and the public. Consent matters because it provides a singular safeguard and a participatory mechanism to influence science’s production of new forms of power…
Communicating With Diverse Patients About Participating in a Biobank: A Randomized Multisite Study Comparing Electronic and Face-to-Face Informed Consent Processes
Communicating With Diverse Patients About Participating in a Biobank: A Randomized Multisite Study Comparing Electronic and Face-to-Face Informed Consent Processes
Research Article
Christian M. Simon, Kai Wang, Laura A. Shinkunas, Daniel T. Stein, Paul Meissner, Maureen Smith, Rebecca Pentz, David W. Klein
Journal of Empirical Research on Human Research Ethics, 19 August 2021
Abstract
Some individuals’ understanding of informed consent (IC) information may improve with electronic delivery, but others may benefit from face-to-face (F2F). This randomized, multisite study explores how individuals from diverse backgrounds understand electronic IC documents versus F2F, their confidence in understanding, and enrollment in research. A total of 501 patients at two U.S. biobanks with diverse populations participated. There were no overall differences between electronic and F2F understanding, but F2F predicted higher confidence in understanding and enrollment. Ethnicity and a higher educational level predicted higher understanding and confidence. Study findings suggest that electronic consent may lead to better understanding for non-Hispanic patients of higher socioeconomic status. F2F processes may lead to better understanding and higher enrollment of patients from Hispanic and lower socioeconomic levels. Researchers should carefully consider how they implement electronic IC processes and whether to maintain an F2F process to better address the needs and limitations of some populations.
Vulnerabilities of Cancer Patients and Their Effects on Informed Consent for Biobanking
Vulnerabilities of Cancer Patients and Their Effects on Informed Consent for Biobanking
Mason Kyle, Diana Cortez, Blaze Carbonell, Edgar Masmila, Alfredo Molinolo, and Sharmeela Kaushal
Biopreservation and Biobanking, 4 August 2021
Introduction
The biorepository (BR) at the Moores Cancer Center (MCC) of the University of California, San Diego is a College of American Pathologists (CAP)-accredited biobanking core that performs informed patient consent, tissue collection, characterisation, storage, and distributiom under Institutional Review Board (IRB)-approved protocol. The informed consent process is the key element that allows the BR to procure and distribute human biospecimens and associated patient information for research…
Rebooting consent in the digital age: a governance framework for health data exchange
Rebooting consent in the digital age: a governance framework for health data exchange
Analysis
Nivedita Saksena, Rahul Matthan, Anant Bhan, Satchit Balsari
BMJ Global Health, 22 July 2021; 6(5)
Abstract
In August 2020, India announced its vision for the National Digital Health Mission (NDHM), a federated national digital health exchange where digitised data generated by healthcare providers will be exported via application programme interfaces to the patient’s electronic personal health record. The NDHM architecture is initially expected to be a claims platform for the national health insurance programme ‘Ayushman Bharat’ that serves 500 million people. Such large-scale digitisation and mobility of health data will have significant ramifications on care delivery, population health planning, as well as on the rights and privacy of individuals. Traditional mechanisms that seek to protect individual autonomy through patient consent will be inadequate in a digitised ecosystem where processed data can travel near instantaneously across various nodes in the system and be combined, aggregated, or even re-identified.
In this paper we explore the limitations of ‘informed’ consent that is sought either when data are collected or when they are ported across the system. We examine the merits and limitations of proposed alternatives like the fiduciary framework that imposes accountability on those that use the data; privacy by design principles that rely on technological safeguards against abuse; or regulations. Our recommendations combine complementary approaches in light of the evolving jurisprudence in India and provide a generalisable framework for health data exchange that balances individual rights with advances in data science.
Divergent Human Rights Approaches to Capacity and Consent [BOOK CHAPTER]
Divergent Human Rights Approaches to Capacity and Consent [BOOK CHAPTER]
Gerald Neuman
Mental Health, Legal Capacity, and Human Rights, 2021 [Cambridge University Press]
Abstract
The institutional dialogue among the Committee on the Rights of Persons with Disabilities and other human rights tribunals has led to greater protection of rights. But not all courts and treaty bodies have accepted the Committee’s absolutist position on legal capacity. The chapter illustrates the multiple human rights-based approaches to capacity and decision-making, and describes how the Committee’s absolutism endangers many of the people living with moderate or severe dementia whom it supposedly benefits.
Impact of animation-supported consent on complaints and serious incidents due to failure to inform
Impact of animation-supported consent on complaints and serious incidents due to failure to inform
D S Wald, L Arrol
QJM: An International Journal of Medicine, 17 August 2021
Summary
Background
Introduction of digital animations to explain medical procedures before consent to treatment (animation-supported consent) has been shown to improve patient-reported understanding of a procedure’s benefits, risks and alternatives.
Aim
We examined whether introduction of animation-supported consent is associated with a change in the incidence of complaints and serious incidents due to failure to inform.
Methods
Multi-language animations explaining 10 cardiac procedures, in coronary intervention, electrophysiology and cardiac surgery, (www.explainmyprocedure.com) were introduced at a London cardiac centre from April 2019. Complaints and serious incidents due to failure to inform were identified from the hospital Datix database for the two years before introducing animation-supported consent (no animation group) and the two years afterwards (animation group), together with the total number of procedures and major complications recorded during these periods. We compared the incidence of complaints and serious incidents, expressed as a proportion of the number of major complications, recorded during each period.
Results
There were 580 complications among 21 855 procedures performed in the no animation group and 411 complications among 18 254 procedures in the animation group. There were 14 complaints or serious incidents due to failure to inform in the no animation group and 3 in the animation group; rates of 2.41% (14/580) and 0.73% (3/411), respectively (P < 0.001 for difference).
Conclusion
In this observational comparison, introduction of animation-supported consent was associated with a 70% reduction in complaints or serious incidents due to failure to inform before consent. This has significant quality and cost implications for improving consent pathways in clinical practice.
Graphic narrative based informed consent for bronchoscopy improves satisfaction in patients after lung-transplantation: A randomized controlled trial
Graphic narrative based informed consent for bronchoscopy improves satisfaction in patients after lung-transplantation: A randomized controlled trial
Benjamin Seeliger, Moritz Z. Kayser, Nora Drick, Jan Fuge, Christina Valtin, Mark Greer, Jens Gottlieb
Patient Education and Counseling, 13 August 2021
Abstract
Objective
This study investigated the effects of supplementing standard informed consent (IC) with a graphic narrative on patient satisfaction, periprocedural anxiety and experience.
Methods
Patients due to undergo first conscious surveillance bronchoscopy following lung transplantation were randomized to receive IC with (intervention group) or without (control group) a graphic narrative illustrating the procedure. The primary endpoint was overall patient satisfaction with the IC. Key secondary endpoints were change in state anxiety level, as measured by State Trait Anxiety Inventory, and a questionnaire assessing satisfaction with IC and adverse experience during bronchoscopy (judged by patient and examiners).
Results
Sixty patients were randomized, and 59 patients were included in the analysis (30 intervention-group; 29 control-group). Overall patient satisfaction was higher in the intervention group 9.5 (25Q–75Q: 8.6–9.8) vs. 8.6 (25Q–75Q: 8.1–9.2), p = 0.028). Change in state anxiety level (before vs after informed consent) was similar between the groups. There were no significant differences in adverse experience during bronchoscopy.
Conclusion
Addition of a graphic narrative illustrating bronchoscopy improved patient satisfaction with IC but did not influence anxiety before and adverse experience during the procedure.
Practice implications
Supplementing the IC process with a procedure-specific graphic narrative may be a simple tool to improve patient satisfaction.
Transparent reporting of recruitment and informed consent approaches in clinical trials recruiting children with minor parents in sub-Saharan Africa: a secondary analysis based on a systematic review
Transparent reporting of recruitment and informed consent approaches in clinical trials recruiting children with minor parents in sub-Saharan Africa: a secondary analysis based on a systematic review
Research Article
Angela De Pretto-Lazarova, Domnita Oana Brancati-Badarau, Christian Burri
BMC Public Health, 28 July 2021; 21(1473)
Open Access
Abstract
Background
Standardised checklists of items to be addressed in clinical study protocols and publications are promoting transparency in research. However, particular specifications for exceptional cases, such as children with minor parents are missing. This study aimed to examine the level of transparency regarding recruitment and informed consent approaches in publications of clinical trials recruiting children with minor parents in sub-Saharan Africa. We thereby focused particularly on the transparency about consenting persons (i.e. proxy decision-makers) and assessed the need to expand reporting guidelines for such exceptional cases.
Methods
We conducted a secondary analysis of clinical trial publications previously identified through a systematic review. Multiple scientific databases were searched up to March 2019. Clinical trial publications addressing consent and potentially recruiting children with minor parents in sub-Saharan Africa were included. 44 of the in total 4382 screened articles met our inclusion criteria. A descriptive analysis was performed.
Results
None of the included articles provided full evidence on whether any recruited children had minor parents and how consent was obtained for them. Four proxy decision-maker types were identified (parents; parents or guardians; guardians; or caregivers), with further descriptions provided rarely and mostly in referenced clinical trial registrations or protocols. Also, terminology describing proxy decision-makers was often used inconsistently.
Conclusions
Reporting the minimum maternal age alongside maternal data provided in baseline demographics can increase transparency on the recruitment of children with minor mothers. The CONSORT checklist should require clinical trial publications to state or reference exceptional informed consent procedures applied for special population groups. A standardized definition of proxy decision-maker types in international clinical trial guidelines would facilitate correct and transparent informed consent for children and children with minor parents.
Center for Informed Consent Integrity 