From “Informed” to “Engaged” Consent: Risks and Obligations in Consent for Participation in a Health Data Repository

From “Informed” to “Engaged” Consent: Risks and Obligations in Consent for Participation in a Health Data Repository
Research Article
Elizabeth Bromley, Alexandra Mendoza-Graf, Sandra Berry, Camille Nebeker, Dmitry Khodyakov
The Journal of Law, Medicine & Ethics, 28 April 2020
Abstract
The development and use of large and dynamic health data repositories designed to support research pose challenges to traditional informed consent models. We used semi-structured interviewing (n=44) to elicit diverse research stakeholders’ views of a model of consent appropriate to participation in initiatives that entail collection, long-term storage, and undetermined future research use of multiple types of health data. We demonstrate that, when considering health data repositories, research stakeholders replace a concept of consent as informed with one in which consent is engaged. In engaged consent, a participant’s ongoing relationship with a repository serves as a substitute or adjunct to information exchange at enrollment. We detail research stakeholders’ views of the risks of engaged consent and suggest questions for further study about engagement and consent procedures in initiatives that aim to store data for future unspecified research purposes.

Evidence‐Based Communication in Clinical, Mass Media, and Social Media Contexts to Enhance Informed Consent for Participation in Clinical Trials and Precision Medicine Initiatives [BOOK CHAPTER]

Evidence‐Based Communication in Clinical, Mass Media, and Social Media Contexts to Enhance Informed Consent for Participation in Clinical Trials and Precision Medicine Initiatives [BOOK CHAPTER]
Susan E. Morgan, Aurora Occa, Wei Peng, Soroya J. McFarlane
The Handbook of Applied Communication Research
John Wiley & Sons, 17 April 2020; Chapter 49
Summary
This chapter explains that improved clinical trial communication will result in better informed patients who demonstrate greater willingness to participate in a system that is intended to produce significant advances in medical treatment. It centers on the factors where communication scholars and practitioners can best apply their energy and insights. These include clinical communication interventions, including training of physicians, study nurses, and clinical research staff; public communication messages designed to inform a broad audience about scientific concepts that are central to meaningful and informed consent; and the use of social media platforms for participant recruitment and retention. The chapter discusses the implications of these findings for the development of new interventions designed to enroll members of the public in emerging precision medicine (PM) initiatives, particularly among minority populations. It also reviews communication‐based interventions, including interpersonal communication trainings, public communication campaigns, persuasive message design, and targeted message delivery.

A randomized controlled trial comparing video-assisted informed consent with standard consent for Mohs micrographic surgery

A randomized controlled trial comparing video-assisted informed consent with standard consent for Mohs micrographic surgery
Original Article
Yueyue Miao, Victoria L. Venning, Kylie-Ann Mallitt, Julia E. J. Rhodes, Noah J. Isserman, Gilberto Moreno, Simon Lee, William Ryman, Gayle Fischer, Rebecca B. Saunderson
Journal of the American Academy of Dermatology International, July 2020; 1(1) pp 13-20
Open Access
Abstract
Background
There is a need for improvement in informed medical consent to address the lack of standardization and to increase patient engagement.
Objective
To investigate the use of a video to aid informed consent for Mohs micrographic surgery and evaluate patient understanding, satisfaction, anxiety, and time savings relative to verbal consent.
Methods
A 2-armed randomized controlled trial involving 102 patients compared video-assisted consent with a control group who underwent consent in the standard verbal manner. All participants underwent questionnaire-based testing of knowledge, satisfaction, and anxiety, and the time of each consultation was measured.
Results
Patients who watched the video performed significantly better in the knowledge questionnaire compared with the control group (P = .02), were more satisfied with their understanding of the risks of Mohs micrographic surgery (P = .013), and spent less time with their physician (P = .008). Additionally, 78.4% of video group patients reported that they preferred seeing the video before speaking with their physician.
Limitations
The study design may not replicate day-to-day clinical practice.
Conclusion
Video-assisted consent for Mohs micrographic surgery improves patient knowledge, leads to a better understanding of the risks, and saves physicians time without compromising patient satisfaction and anxiety levels in this study setting.

Developing model biobanking consent language: what matters to prospective participants?

Developing model biobanking consent language: what matters to prospective participants?
Research Article
Laura M. Beskow, Catherine M. Hammack-Aviran, Kathleen M. Brelsford
BMC Medical Research Methodology, 15 May 2020; 20(119)
Open Access
Abstract
Background
Efforts to improve informed consent have led to calls for providing information a reasonable person would want to have, in a way that facilitates understanding of the reasons why one might or might not want to participate. At the same time, advances in large-scale genomic research have expanded both the opportunities and the risks for participants, families, and communities. To advance the use of effective consent materials that reflect this landscape, we used empirical data to develop model consent language, as well as brief questions to assist people in thinking about their own values relative to participation.
Methods
We conducted in-person interviews to gather preliminary input on these materials from a diverse sample (n = 32) of the general population in Nashville, Tennessee. We asked them to highlight information they found especially reassuring or concerning, their hypothetical willingness to participate, and their opinions about the values questions.
Results
Consent information most often highlighted as reassuring included the purpose of the biobank, the existence and composition of a multidisciplinary oversight committee, the importance of participants’ privacy and efforts to protect it, and controlled access to a scientific database. Information most often highlighted as concerning included the deposition of data in a publicly accessible database, the risk of unintended access to data, the potential for non-research use of data, and use of medical record information in general. Seventy-five percent of participants indicated initial willingness to participate in the hypothetical biobank; this decreased to 66% as participants more closely considered the information over the course of the interview. A large majority rated the values questions as helpful.
Conclusions
These results are consistent with other research on public perspectives on biobanking and genomic cohort studies, suggesting that our model language effectively captures commonly expressed reasons for and against participation. Our study enriches this literature by connecting specific consent form disclosures with qualitative data regarding what participants found especially reassuring or concerning and why. Interventions that facilitate individuals’ closer engagement with consent information may result in participation decisions more closely aligned with their values.

Informed Consent in Patients With Frailty Syndrome

Informed Consent in Patients With Frailty Syndrome
Brendan Silbert, David Scott
Anesthesia & Analgesia, June 2020; 130(6) pp 1474–1481
Abstract
Frailty is present in more than 30% of individuals older than 65 years of age presenting for anesthesia and surgery, and poses a number of unique issues in the informed consent process. Much attention has been directed at the increased incidence of poor outcomes in these individuals, including postoperative mortality, complications, and prolonged length of stay. These material risks are not generally factored into conventional risk predictors, so it is likely that individuals with frailty are never fully informed of the true risk for procedures undertaken in the hospital setting. While the term “frailty” has the advantage of alerting to risk and allowing appropriate care and interventions, the term has the social disadvantage of encouraging objectivity to ageism. This may encourage paternalistic behavior from carers and family encroaching on self-determination and, in extreme cases, manifesting as coercion and compromising autonomy. There is a high prevalence of neurocognitive disorder in frail elderly patients, and care must be taken to identify those without capacity to provide informed consent; equally important is to not exclude those with capacity from providing consent. Obtaining consent for research adds an extra onus to that of clinical consent. The informed consent process in the frail elderly poses unique challenges to the busy clinical anesthesiologist. At the very least, an increased time commitment should be recognized. The gap between theoretical goals and actual practice of informed consent should be acknowledged.

The Importance of Engaging Children in Research Decision‐Making: A Preliminary Mixed‐Methods Study

The Importance of Engaging Children in Research Decision‐Making: A Preliminary Mixed‐Methods Study
Erin Talati Paquette, Hannah Palac, Elizabeth Bair, Blake Schultz, Nicole Stenquist, Steven Joffe, Avani Shukla
Ethics & Human Research, 18 May 2020
Abstract
Studies demonstrate deficiencies in parents’ and children’s comprehension of research and lack of child engagement in research decision‐making. We conducted a cross‐sectional and interview‐based study of 31 parent‐child dyads to describe decision‐making preferences, experiences, and comprehension of parents and children participating in research. Parents and children reported that parents played a greater role in decisions about research participation than either parents or children preferred. The likelihood of child participation was associated with the extent of input the parent permitted the child to have in the decision‐making process, the child’s comprehension, whether the study team asked the child about participation, whether the child read study‐related materials, the parent’s marital status, and the child’s race. Children had lower comprehension than adults. Comprehension was related to age, education, verbal intelligence, and reading of study‐related information. Parent understanding was associated with prospect for benefit and illness severity. Child participation may be improved by increasing parent‐child communication, emphasizing important relational roles between parent and child, respecting the developing autonomy of the child, increasing engagement with the study team, providing appropriate reading materials, and assessing comprehension.

‘It’s never okay to say no to teachers’: children’s research consent and dissent in conforming schools contexts

‘It’s never okay to say no to teachers’: children’s research consent and dissent in conforming schools contexts
Perpetua Kirby
British Educational Research Journal, 5 May 2020
Abstract
This paper examines the limits to children giving research consent in everyday school contexts that emphasises their conformity to comply with adult expectations, and highlights children’s competence and agency in navigating this conformity through different practices of dissent. It draws on research into children’s agency, using a multimodal ethnography of Year One classrooms in two English primary schools. The paper includes a reflexive methodological focus, exploring the extent to which I counter the schools’ emphasis on conformity. This includes creating visuals for children to practice consent; positioning myself as the researcher in a non-teacher role, as ‘least adult’, and the one who ‘least knows’; and designing interview spaces markedly different from classrooms. The paper examines how children navigate conforming discourses by finding different ways to dissent in the research. Firstly, children demonstrate a sophisticated awareness of the cultural norms of indicating refusals beyond saying the word ‘No’. Secondly, children achieve unnoticeablity, by which they absent themselves from the ‘on-task’ classroom culture, and by extension, the research process. Thirdly, they engage in playful dissent demonstrating their political knowingness of the classroom social order. The paper discusses the implications for educational research when the values of consent are in conflict with a schooling focused on conformity. This includes emphasising the limits of consent procedures, paying closer attention to how researchers recognise and respond ethically to children’s multiple practices of dissent, and using research to disrupt problematic power structures in education settings that limit possibilities for children’s consent.

Case for persuasion in parental informed consent to promote rational vaccine choices

Case for persuasion in parental informed consent to promote rational vaccine choices
Original Research
Jennifer O’Neill
Journal of Medical Ethics, 4 May 2020
Abstract
There have been calls for mandatory vaccination legislation to be introduced into the UK in order to tackle the national and international rise of vaccine-preventable disease. While some countries have had some success associated with mandatory vaccination programmes, the Royal College of Paediatrics and Child Health (RCPCH) insist this is not a suitable option for the UK, a country which has seen historical opposition to vaccine mandates. There is a lack of comprehensive data to demonstrate a direct link between mandatory vaccination legislation and increased uptake. While there are examples whereby there has been an improvement, some studies suggest that comparable results can be obtained by strongly recommending vaccinations instead. The RCPCH insist that healthcare workers are ideally placed to engage and inform parents to make every interaction a ‘vaccine opportunity’. This paper calls for a principled, rational approach to interpretations of autonomy which underpin parental informed consent. MacLean’s concept of mutual persuasion could be a vehicle to ensuring parents are suitably informed of both the material risks associated with vaccine choices and to consider the rationality of their decisions, while ultimately upholding parental autonomy. It is argued that this, alongside infrastructural improvement, could create a more sustainable, long-term improvement in childhood vaccination rates in the UK than mandatory vaccination.

Literacy as a Distinct Developmental Domain in Children

Literacy as a Distinct Developmental Domain in Children
Viewpoint
Perri Klass, John S. Hutton, Thomas G. DeWitt
JAMA Pediatrics, 30 March 2020; 174(5) pp 407-408
Abstract
The acquisition of literacy, from earliest emergent stages to full fluency with understanding and self-expression in written language, represents a distinct developmental trajectory. Unlike other developmental arenas, achieving literacy combines environmental stimulation and informal interaction in the preschool years with formal school-based instruction in decoding print and reflects the integration of multiple neuronal networks. Skills children acquire along this literacy trajectory powerfully influence life course, from early school achievement to earning potential to lifelong self-expression and civic engagement. Recognizing this, many pediatric health care professionals have incorporated literacy promotion into primary care, often through Reach Out and Read, an evidence-based model (supported by a national network) that provides parental guidance and children’s books at health supervision visits.

Providing Incentives to Youth Participants in Research: A Literature Review

Providing Incentives to Youth Participants in Research: A Literature Review
Research Article
Jenny L. Afkinich, Dara R. Blachman-Demner
Journal of Empirical Research on Human Research Ethics, 19 December 2019
Abstract
The provision of financial incentives to youth involved in research remains an understudied and contentious issue. Although the practice is common and often accepted, a comprehensive understanding of the current status of the literature regarding the potential benefits and limitations is lacking. The primary question this article seeks to answer is as follows: “What are the concerns and best practices identified in the literature for the appropriate and ethical provision of incentives to children and adolescents?” Following a thorough review and screening process, 25 articles were selected and central themes were identified within them. Themes include the following: the wage-payment model, effectiveness for recruitment, effectiveness for retention, financial versus alternative incentives, coerciveness, influence on validity of results, and other ethical dilemmas. Gaps in the literature are discussed. Overall, the literature suggests financial incentives can be provided appropriately to children as long as necessary precautions are taken.