Encouraging greater empowerment for adolescents in consent procedures in social science research and policy projects
Oddrun Samdal, Isabelle Budin-Ljøsne, Ellen Haug, Trond Helland, Lina Kjostarova‐Unkovska, Claire Bouillon, Christian Bröer, Maria Corell, Alina Cosma, Dorothy Currie, Charli Eriksson, Rosemarie Felder‐Puig, Tania Gaspar, Curt Hagquist, Janetta Harbron, Atle Jaastad, Colette Norena Kelly, Cécile Knai, Dorota Kleszczewska, Bjarte Birkeland Kysnes, Nanna Lien, Aleksandra Luszczynska, Gerben Moerman, Concepción Moreno-Maldonado, Saoirse NicGabhainn, Iveta Pudule, Jelena Gudelj Rakic, Ana Rito, Alfred Mestad Rønnestad, Madeleine Ulstein, Harry Rutter, Knut-Inge Klepp
Obesity Reviews, September 2023
Open Access
Abstract
The United Nations Convention on the Rights of the Child emphasizes the importance of allowing children and adolescents to influence decisions that are important to them following their age and maturity. This paper explores the principles, practices, and implications around using parental versus child/adolescent consent when participating in social science research and policy development. Experiences from two studies are presented: The Confronting Obesity: Co‐creating policy with youth (CO‐CREATE) and the Health Behaviour in School‐aged Children (HBSC) study, a World Health Organization (WHO) Collaborative Cross‐National study. Although parental consent may be an important gatekeeper for protecting children and adolescents from potentially harmful research participation, it may also be considered an obstacle to the empowerment of children and adolescents in case they want to share their views and experiences directly. This paper argues that evaluation of possible harm should be left to ethics committees and that, if no harm related to the research participation processes is identified and the project has a clear perspective on collaborating with the target group, adolescents from the age of 12 years should be granted the legal capacity to give consent to participate in the research project. Collaboration with adolescents in the development of the research project is encouraged.
‘It’s a nightmare’: informed consent in paediatric genome-wide sequencing. A qualitative expert interview study from Germany and Switzerland
‘It’s a nightmare’: informed consent in paediatric genome-wide sequencing. A qualitative expert interview study from Germany and Switzerland
Johanna Eichinger, Bettina Zimmermann, Bernice Elger, Stuart McLennan, Isabel Filges, Insa Koné
European Journal of Human Genetics, 29 September 2023
Open Access
Abstract
The use of genome-wide sequencing (GWS) in paediatrics has added complexity to informed consent (IC) and pretest counselling because of the vast number and interpretation of potential findings, and their implications. However, empirical data from continental Europe on these issues remains limited. This study therefore aimed to explore the experiences and views of medical geneticists working with children in Germany and Switzerland regarding the challenges of obtaining valid IC in paediatric GWS. Qualitative interviews with 20 medical geneticists were analysed employing reflexive thematic analysis. In the interviews, many medical geneticists questioned the validity of parents’ IC due to the enormous amount of relevant information given and the variety and complexity of the possible test outcomes. Key barriers identified included familial implications, administrative challenges and struggles with non-directiveness. Medical geneticists’ suggestions for improvement included increasing the number of genetics professionals and better information material, which is crucial as GWS becomes a diagnostic standard in the early care pathways of children. An adjustment of aspirations from still existing ideal of traditional fully IC to appropriate IC seems to be needed. Such a more realistic and ethically sound adaptation of the requirements for IC can lead to better ‘informedness’ and improve the validity of the consent. This might also help reduce the moral distress for the medical geneticists involved.
The Social Contract for Health and Wellness Data Sharing Needs a Trusted Standardized Consent
The Social Contract for Health and Wellness Data Sharing Needs a Trusted Standardized Consent
Brief Report
Stefanie Brückner, Toralf Kirsten, Peter Schwarz, Fabienne Cotte, Michael Tsesis, Stephen Gilbert
Mayo Clinic Proceedings: Digital Health, December 2023; 1(4) pp 527-533
Open Access
Abstract
The rise of health and wellness applications has led to a new category of citizen-generated health data, which are collected through sensors and user inputs. As more parameters are measured over longer time periods, these data will gradually become more important for disease prediction, care, and research than classical clinic-generated health data. Policymakers now recognize the potential of both data types in initiatives such as the European Health Data Space, which aims to enable data sharing for patient care and research at scale. Although it could be argued that clinic-generated data come from public-funded health systems and should therefore be sharable, after depersonalization, for public service, this argument extends poorly to data from wearables and applications. We propose a new approach for standardized health consent, both broad and dynamic, to overcome consent fatigue and engage citizens in data sharing.
Specific measures for data-intensive health research without consent: a systematic review of soft law instruments and academic literature
Specific measures for data-intensive health research without consent: a systematic review of soft law instruments and academic literature
Review Article
Julie-Anne R. Smit, Menno Mostert, Rieke van der Graaf, Diederick E. Grobbee, Johannes J. M. van Delden
European Journal of Human Genetics, 17 October 2023
Open Access
Abstract
It is a common misunderstanding of current European data protection law that when consent is not being used as lawful basis, the processing of personal data is prohibited. Article 9(2)(j) of the European General Data Protection Regulation (GDPR) permits Member States to establish a legal basis in national law that allows for the processing of personal data for scientific research purposes without consent. However, the European legislator has formulated this “research exemption” as an opening clause, rendering the GDPR not specific as to what measures exactly are required to comply with the research exemption. This may have significant implications for both the protection of personal data and the advancement of data-intensive health research. We performed a systematic review of relevant soft law instruments and academic literature to identify what measures are mentioned in those documents. Our analysis resulted in the identification of four overarching themes of suggested measures: organizational measures; technical measures; oversight and review mechanisms; and public engagement and participation. Some of the suggested measures do not substantially contribute to the clarification of the GDPR’s “suitable and specific measures” requirement because they remain vague or broad in nature and encompass all types of data processing. However, the themes oversight and review mechanisms and public engagement and participation provide valuable insights which can be put to practice. Nevertheless, further clarification of the measures and safeguards that should be installed when invoking the research exemption remains necessary.
Toward Consent in Molecular HIV Surveillance? Perspectives of Critical Stakeholders
Toward Consent in Molecular HIV Surveillance? Perspectives of Critical Stakeholders
Research Article
Stephen Molldrem, Anthony K J Smith, Vishnu Subrahmanyam
AJOB Empirical Bioethics, 28 September 2023
Abstract
Background
The emergence of molecular HIV surveillance (MHS) and cluster detection and response (CDR) programs as key features of the United States (US) HIV strategy since 2018 has caused major controversies. HIV surveillance programs that re-use individuals’ routinely collected clinical HIV data do not require consent on the basis that the public benefit of these programs outweighs individuals’ rights to opt out. However, criticisms of MHS/CDR have questioned whether expanded uses of HIV genetic sequence data for prevention reach beyond traditional public health ethics frameworks. This study aimed to explore views on consent within MHS/CDR among critical stakeholders.
Methods
In 2021 we interviewed 26 US HIV stakeholders who identified as being critical or concerned about the rollout of MHS/CDR. Stakeholders included participants belonging to networks of people living with HIV, other advocates, academics, and public health professionals. This analysis focused on identifying the range of positions among critical and concerned stakeholders on consent affordances, opt-outs, how to best inform people living with HIV about how data about them are used in public health programs, and related ethical issues.
Results
Participants were broadly supportive of introducing some forms of consent into MHS/CDR. However, they differed on the specifics of implementing consent. While some participants did not support introducing consent affordances, all supported the idea that people living with HIV should be informed about how HIV surveillance and prevention is conducted and how individuals’ data are used.
Conclusions
MHS/CDR has caused sustained controversy. Among critical stakeholders, consent is generally desirable but contested, although the right for people living with HIV to be informed was centrally supported. In an era of big data-driven public health interventions and routine uses of HIV genetic sequence data in surveillance and prevention, CDC and other agencies should revisit public health ethics frameworks and consider the possibility of consent processes.
Informed consent practices for acute stroke therapy: principles, challenges and emerging opportunities
Informed consent practices for acute stroke therapy: principles, challenges and emerging opportunities
Review
Amir Mbonde, Michael J. Young, Adam A. Dmytriw, Quentin J. Moyer, Joshua A. Hirsch, Thabele M. Leslie-Mazwi, Natalia S. Rost, Aman B. Patel, Robert W. Regenhardt
Journal of Neurology, 10 October 2023
Abstract
Importance
Informed consent (IC) plays a crucial yet underexplored role in acute stroke treatment, particularly in the context of intravenous thrombolysis (IVT) and endovascular thrombectomy (EVT). This narrative review examines data on current IC practices in acute ischemic stroke management, specifically for patients treated with IVT or EVT, with the aim of identifying areas for improvement and strategies to enhance the IC process.
Observations
IC practices for IVT vary significantly among hospitals and physicians with the frequency of always requiring consent ranging from 21 to 37%. Factors influencing IC for IVT include patient decision-making capacity, standard of care, time sensitive nature of treatments, legal and moral obligations, risk of complications, physician age and speciality, treatment delays, and hospital size. Consent requirements tend to be stricter for patients presenting within the 3–4.5-h window. The content and style of information shared as part of the IC process revealed discrepancies in the disclosure of stroke diagnosis, IVT mechanism, benefits, and risks. Research on IC practices for EVT is scarce, highlighting a concerning gap in the available evidence base.
Conclusions and relevance
This review underscores the significant variability and knowledge gaps in IC for EVT and IVT. Challenges related to decision-making capacity assessment and the absence of standardised guidance substantially contributes to these gaps. Future initiatives should focus on simplifying information delivery to patients, developing formal tools for assessing capacity, standardising ethical frameworks to guide physicians when patients lack capacity and harmonizing IC standards across sites. The ultimate goal is to enhance IC practices and uphold patient autonomy, while ensuring timely treatment initiation.
[Proposal for participation in intensive care and emergency medicine studies for patients unable to give informed consent (Cologne Model)]
[Proposal for participation in intensive care and emergency medicine studies for patients unable to give informed consent (Cologne Model)]
Kochanek M, Grass G, Böll B, Eichenauer DA , Shimabukuro-Vornhagen A , Hallek M, Zander T, Mertens J, Voltz R
Medizinische Klinik, Intensivmedizin und Notfallmedizin, 29 September 2023
Abstract
When conducting clinical trials in intensive care and emergency medicine, physicians, ethics committees, and legal experts have differing views regarding the inclusion of patients who are incapable of giving consent. These different views on the participation of patients who are not capable of giving consent also complicate how clinical trials are prepared and conducted. Based on the results of a literature search, a consensus model (Cologne Model) was developed by physicians performing clinical research, ethics committees, and lawyers in order to provide patients, those scientifically responsible for the study, ethics committees, and probate (guardianship) judges with a maximum of patient safety and legal certainty, while simultaneously enabling scientific research.
Editor’s note: This is a German language publication.
Developing a dementia friendly approach to consent in dementia research
Developing a dementia friendly approach to consent in dementia research
Michelle Pyer, Alison Ward
Aging and Mental Health, 11 September 2023
Abstract
Objectives
This paper explores the process of gaining consent from the perspectives of people living with dementia, their relatives/carers, and service providers. This is developed based on new primary qualitative research and addresses a gap in critical reflection on the practice and ethical process of research consent.
Methods
A qualitative approach was used to conduct this research through the implementation of four focus groups run with people living with dementia (n=12), two focus groups with family members (n=6), two focus groups with service staff (n=5).
Results
Data was analysed thematically, to identify two core themes: consent as a journey and the flexible consent approach. These identified concerns with autonomy, decision making and placing people living with dementia at the centre of the consent process. The journey of consent emerged as central to supporting participation and enhancing the consent process.
Conclusion
The paper presents new evidence about the lived experience of research consent in the field of dementia, presenting the process of collecting consent in research as a flexible process that is best supported through a growing knowledge of participants and participation sites.
Capacity Assessment in Emergency Surgery
Capacity Assessment in Emergency Surgery
Selwyn O. Rogers, Darren S. Bryan
Journal of Clinical Ethics, Fall 2023; 34(3) pp 270-272
Abstract
Informed consent is a necessary component of the ethical practice of surgery. Ideally, consent is performed in a setting conducive to a robust patient-provider conversation, with careful consideration of risks, benefits, and outcomes. For patients with medical or surgical emergencies, navigating the consent process can be complicated and requires both careful and expedited assessment of decision-making capacity. We present a recent case in which a patient in need of emergency care refused intervention, requiring urgent capacity assessment and a modification to usual care.
Why we have duties of autonomy towards marginal agents
Why we have duties of autonomy towards marginal agents
Book Chapter
Anna Hirsch
Theoretical Medicine and Bioethics, 12 May 2023 [Springer]
Open Access
Abstract
Patients are usually granted autonomy rights, including the right to consent to or refuse treatment. These rights are commonly attributed to patients if they fulfil certain conditions. For example, a patient must sufficiently understand the information given to them before making a treatment decision. On the one hand, there is a large group of patients who meet these conditions. On the other hand, there is a group that clearly does not meet these conditions, including comatose patients or patients in the late stages of Alzheimer’s disease. Then there is a group of patients who fall into the range in between. At the lower end of this range are so-called ‘marginal agents,’ which include young children and patients in the middle stages of Alzheimer’s disease. They also do not meet the typical requirements for autonomy, which is why they are usually granted fewer autonomy rights. However, some of them are capable of ‘pre-forms’ of autonomy that express what is important to them. These pre-forms differ from mere desires and reflect the identification/authenticity condition of autonomy. They have something in common with autonomous attitudes, choices, and actions – namely, they express the value of autonomy. As I will argue, autonomy is a value worthy of protection and promotion – even in its non-reflexive forms. Against this background, it becomes clear why we have autonomy duties, more precisely positive, autonomy-enabling duties, towards marginal agents and why we should give them as much attention as autonomy duties towards competent patients.
Center for Informed Consent Integrity 