Value-based Consent Model: A Design Thinking Approach for Enabling Informed Consent in Medical Data Research
Simon Geller, Sebastian Müller, Simon Scheider, Christiane Woopen, Sven Meister
Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies – HEALTHINF, 2022; pp 81-92
Due to new technological innovations, the increase in lifestyle products, and the digitalisation of healthcare the volume of personal health data is constantly growing. However, in order to use, re-use, and link personalised health data and, thus, unlock their potential benefits in health research, the authors of the data need to voluntarily give their informed consent. That is a major challenge to health data research, because the classic informed consent process requires the immense administrative burden to ask for consent, every time personal health data is accessed. In this paper we argue that all alternative consent models that have been developed to tackle this problem, either do not reduce administrative burdens significantly or do not conform to the informed consent ideal. That is why we used the design thinking approach to develop an alternative consent model that we call the value-based consent model. This model has the potential to reduce administrative burdens while empowering research subjects to autonomously translate their values into consent decisions.
Personalized medicine and research biobanking: From traditional to new informed consent generating a need for participatory governance [BOOK CHAPTER]
Personalized Medicine in the Making, 8 March 2022; pp 249-267 [Springer]
Emerging personalized medicine necessitates the collection, storage and processing of an increasing number and type of human biological samples and associated data within research biobanks throughout the world, materials and data which will be used in future large-scale health-related studies. Hence, ethical concerns regarding biobanks have increased. Here, issues pertaining to autonomy and privacy will be considered, as well the related debate mainly focused on whether or not maintaining the informed consent model used in traditional health research sufficiently guarantees the dignity and rights of subjects, while at the same time serving as a good tool to obtain an appropriate balance between the research subjects’ interests and the public interest. The present paper aims to illustrate the evolutionary path of ethical reflection in this regard towards new models of informed consent, such as broad consent, dynamic consent, and meta consent. At the same time, this path generates the need for new types of governance that take into account the necessity of involving subjects in the decision-making process, especially in light of advancements in data mining and big data technologies.
Inclusion of people living with Alzheimer’s disease or related dementias who lack a study partner in social research: Ethical considerations from a qualitative evidence synthesis
Kate de Medeiros, Laura M. Girling, Nancy Berlinger
Dementia, 1 March 2022
Because use of a study partner (proxy decision-maker) to give informed consent on behalf of someone living with Alzheimer’s disease or related dementias (ADRD) is common in nearly all clinical research, people living with ADRD who lack a study partner are regularly excluded from participation. Social research presents different opportunities and risks than clinical research. We argue that guidelines developed for the latter may be unduly restrictive for social research and, further, that the automatic exclusion of people living with ADRD presents separate ethical challenges by failing to support extant decision-making capacity and by contributing to underrepresentation in research.
The study objective was to identify key components related to including cognitively vulnerable participants who lack a study partner in social research.
Research design/Study sample
We conducted an adaptive qualitative evidence synthesis (QES) and subsequent content analysis on 49 articles addressing capacity and research consent for potentially cognitively compromised individuals, to include people living with ADRD, who lack a study partner.
We identified four major topic areas: defining competency, capacity, and consent; aspects of informed consent; strategies to assess comprehension of risks associated with social research; and risks versus benefits.
Based on findings, we suggest new and ethically appropriate ways to determine capacity to consent to social research, make consent processes accessible to a population experiencing cognitive challenges, and consider the risks of excluding a growing population from research that could benefit millions.
The Capacity to be an Expert: Considerations of decision-making assessment for geriatric psychiatrists
Greg Sullivan, Greg Lannuzzi, Joel Kamper
The American Journal of Geriatric Psychiatry, April 2022; 30(4) pp S13-S14
Obtaining valid consent for treatment is predicated on a patient’s ability to make an informed decision, and capacity decisions involve a balance between respecting patients’ autonomy with protecting those with cognitive (and other) impairments. Given the importance of informed consent and the low rates with which clinical teams identify incapacity, it is critically important for geriatric mental health providers to competently identify and evaluate patients with capacity concerns. This need is particularly acute for complex cases, where the presence of medical and cognitive comorbidities can make capacity determination challenging.
Furthermore, while statutes often provide physicians with a legal means for civil commitment of patients lacking decisionmaking capacity, these mechanisms typically mandate the presence of a contributory mental illness. However not all conditions which affect medical decision-making capacity are psychiatric. Hospitalized medically ill patients frequently request discharge prior to being medically appropriate to do so, placing themselves at risk. To proceed with discharge respects a patient’s right to autonomy at the expense of patient safety and provider liability. To detain the patient against their wishes may be medically justifiable, but can be detrimental. State statutes provide little guidance about how to proceed in this situation, and geriatric providers should be aware of the pertinent legal and practical considerations for clinicians facing this arduous decision.
An additional challenge to geriatric mental health involves sexual decision-making and questions of incapacity. Supporting the need for intimacy remains a vital element of long-term care, and great responsibility rests upon the care team to ensure that autonomy, the right to sexual expression, and freedom of intimacy are allowed. However while these principles must be respected, they may present unique challenges in settings where one or more of the participants are diagnosed with a neurocognitive disorder and in long-term care settings. In these instances the traditional elements of informed consent required to demonstrate decision-making capacity must be expanded and adapted.
Negotiating Research Participant Consent With, for and by Adults With Developmental Disabilities in Interaction With Their Third-Party Consent Providers
Nick Boettcher, Camille Duque, Bonnie M. Lashewicz
International Journal of Qualitative Methods, 13 March 2022
We illuminate third-party research participant consent with, for, and by adults with developmental disabilities by examining consent as an iterative, ongoing process. We use an instrumental case study of three adults with developmental disabilities who, together with their third-party consent providing parents, participated in a broader conversation and video analysis study of how family members are part of decision-making by adults with developmental disabilities. Adults with developmental disabilities comprising our case demonstrated discomfort that left us with questions about the relational nature of third-party consent. We performed a directed content analysis of transcripts and video data corresponding to moments of discomfort, resulting in categories of one- distress, two- non-disclosure, and three- evasion. Our findings illustrate ambiguities where consent was at stake and where there appeared to be no ultimate “Yes” or “No” interpretation. We conclude that expressions of resistance to research participation by adults with developmental disabilities displayed in our data were assertions of autonomy that occurred in relation, yet ran counter to, the agendas of researchers and third-party consent providing parents. We offer recommendations for researchers in the developmental disability field and for qualitative researchers more broadly who might encounter similar ambiguities amidst the relational workings of consent. Greater analytic attention to the relational dynamics of consent has potential to expand ethical commitments of qualitative researchers beyond the limited range of meanings offered in ethics board approvals and signed consent forms.
New injectable antiretroviral therapy for HIV facilitates novel treatment pathways for persons without capacity to consent to medical treatment
Kirbie Storrier, Calina Ouliaris, Duncan George
Australasian Psychiatry, 13 March 2022
The development of new injectable antiretroviral therapy facilitates treatment for Human immunodeficiency virus (HIV) positive individuals who lack capacity to consent, posing a safety risk to both themselves and the wider community. We consider pathways to enforce treatment and propose an algorithm to determine the most appropriate legal instrument for application.
Legislative safeguards in mental health and guardianship legislation provide oversight and protection for those who suffer from illness and require coercive treatment. These frameworks have utility in the treatment of HIV patients who lack capacity to consent to treatment.
Reconsidering Informed Consent for Trans-Identified Children, Adolescents, and Young Adults
Stephen B Levine, E Abbruzzese, Julia M Mason
Journal of Sex and Marital Therapy, 17 March 2022
In less than a decade, the western world has witnessed an unprecedented rise in the numbers of children and adolescents seeking gender transition. Despite the precedent of years of gender-affirmative care, the social, medical and surgical interventions are still based on very low-quality evidence. The many risks of these interventions, including medicalizing a temporary adolescent identity, have come into a clearer focus through an awareness of detransitioners. The risks of gender-affirmative care are ethically managed through a properly conducted informed consent process. Its elements deliberate sharing of the hoped for benefits, known risks and long-term outcomes, and alternative treatments must be delivered in a manner that promotes comprehension. The process is limited by: erroneous professional assumptions; poor quality of the initial evaluations; and inaccurate and incomplete information shared with patients and their parents. We discuss data on suicide and present the limitations of the Dutch studies that have been the basis for interventions. Beliefs about gender-affirmative care need to be separated from the established facts. A proper informed consent processes can both prepare parents and patients for the difficult choices that they must make and can ease professionals’ ethical tensions. Even when properly accomplished, however, some clinical circumstances exist that remain quite uncertain.
Children’s informed signified and voluntary consent to heart surgery: Professionals’ practical perspectives
Priscilla Alderson, Hannah Bellsham-Revell, Joe Brierley, Nathalie Dedieu, Joanna Heath, Mae Johnson, Samantha Johnson, Alexia Katsatis, Romana Kazmi, Liz King, Rosa Mendizabal, Katy Sutcliffe, Judith Trowell
Nursing Ethics, 25 February 2022
The law and literature about children’s consent generally assume that patients aged under-18 cannot consent until around 12 years, and cannot refuse recommended surgery. Children deemed pre-competent do not have automatic rights to information or to protection from unwanted interventions. However, the observed practitioners tend to inform young children, respect their consent or refusal, and help them to “want” to have the surgery. Refusal of heart transplantation by 6-year-olds is accepted.
What are possible reasons to explain the differences between theories and practices about the ages when children begin to be informed about elective heart surgery, and when their consent or refusal begins to be respected?
Research design, participants and context
Research methods included reviews of related healthcare, law and ethics literature; observations and conversations with staff and families in two London hospitals; audio-recorded semi-structured interviews with a purposive sample of 45 healthcare professionals and related experts; interviews and a survey with parents and children aged 6- to 15-years having elective surgery (not reported in this paper); meetings with an interdisciplinary advisory group; thematic analysis of qualitative data and co-authorship of papers with participants.
Approval was granted by four research ethics committees/authorities. All interviewees gave their informed written consent.
Interviewees explained their views and experiences about children’s ages of competence to understand and consent or refuse, analysed by their differing emphases on informed, signified or voluntary consent.
Differing views about children’s competence to understand and consent are associated with emphases on consent as an intellectual, practical and/or emotional process.
“Greater respect for children’s practical signified, emotional voluntary and intellectual informed consent can increase respectful understanding of children’s consent. Nurses play a vital part in children’s practitioner-patient relationships and physical care and therefore in all three elements of consent.”
Tele-consent using mixed reality glasses (NREAL) in pediatric inguinal herniorrhaphy: a preliminary study
Won-Gun Yun, Joong Kee Youn, Dayoung Ko, Inhwa Yeom, Hyun-Jin Joo, Hyoun-Joong Kong, Hyun-Young Kim
Nature – Scientific Reports, 24 February 2022; 12(3105)
There is an increasing demand and need for patients and caregivers to actively participate in the treatment process. However, when there are unexpected findings during pediatrics surgery, access restrictions in the operating room may lead to a lack of understanding of the medical condition, as the caregivers are forced to indirectly hear about it. To overcome this, we designed a tele-consent system that operates through a specially constructed mixed reality (MR) environment during surgery. We enrolled 11 patients with unilateral inguinal hernia and their caregivers among the patients undergoing laparoscopic inguinal herniorrhaphy between January through February 2021. The caregivers were informed of the intraoperative findings in real-time through MR glasses outside the operating room. After surgery, we conducted questionnaire surveys to evaluate the satisfaction and usefulness of tele-consent. We identified contralateral patent processus vaginalis in seven out of 11 patients, and then additionally performed surgery on the contralateral side with tele-consent from their caregivers. Most caregivers and surgeons answered positively about the satisfaction and usefulness of tele-consent. This study found that tele-consent with caregivers using MR glasses not only increased the satisfaction of caregivers and surgeons, but also helped to accommodate real-time findings by adapting surgical plan through the tele-consent.
Ages of Consent and Majority [BOOK CHAPTER]
Dana Lee Baker, Raquel Lisette Baker
Neuroethical Policy Design, 1 January 2022; pp 89-100 [Springer]
Most contemporary humans distinguish adulthood from childhood. Historical conceptions of these two states have varied across time and place. Understanding past approaches to majority takes in the reality that for much of human history, a large proportion of children did not survive until adulthood. Cultures around the world once created definite transitions into adulthood for children fortunate enough to survive childhood. Once the fragility of children weighed less heavily on the collective human consciousness, consideration of the distinction between child and adult became more nuanced. Many cultural traditions surrounding transition to adulthood remain in contemporary practice. However, as adult life became more complicated, access to adult privileges and assumption of adult responsibilities became more staggered. Furthermore, determining whether or not a particular individual has transitioned to adulthood became less clear and absolute in most contemporary societies.