Opportunities and challenges of a dynamic consent-based application: personalized options for personal health data sharing and utilization
Research
Ah Ra Lee, Dongjun Koo, Il Kon Kim, Eunjoo Lee, Sooyoung Yoo, Ho-Young Lee
BMC Medical Ethics, 31 August 2024
Open Access
Abstract
Background
The principles of dynamic consent are based on the idea of safeguarding the autonomy of individuals by providing them with personalized options to choose from regarding the sharing and utilization of personal health data. To facilitate the widespread introduction of dynamic consent concepts in practice, individuals must perceive these procedures as useful and easy to use. This study examines the user experience of a dynamic consent-based application, in particular focusing on personalized options, and explores whether this approach may be useful in terms of ensuring the autonomy of data subjects in personal health data usage.
Methods
This study investigated the user experience of MyHealthHub, a dynamic consent-based application, among adults aged 18 years or older living in South Korea. Eight tasks exploring the primary aspects of dynamic consent principles–including providing consent, monitoring consent history, and managing personalized options were provided to participants. Feedback on the experiences of testing MyHealthHub was gathered via multiple-choice and open-ended questionnaire items.
Results
A total of 30 participants provided dynamic consent through the MyHealthHub application. Most participants successfully completed all the provided tasks without assistance and regarded the personalized options favourably. Concerns about the security and reliability of the digital-based consent system were raised, in contrast to positive responses elicited in other aspects, such as perceived usefulness and ease of use.
Conclusions
Dynamic consent is an ethically advantageous approach for the sharing and utilization of personal health data. Personalized options have the potential to serve as pragmatic safeguards for the autonomy of individuals in the sharing and utilization of personal health data. Incorporating the principles of dynamic consent into real-world scenarios requires remaining issues, such as the need for powerful authentication mechanisms that bolster privacy and security, to be addressed. This would enhance the trustworthiness of dynamic consent-based applications while preserving their ethical advantages.
Data Altruism, Personal Health Data and the Consent Challenge in Scientific Research: A Difficult Interplay between EU Acts
Gauthier Chassang, Lisa Feriol
European Data Protection Law Review, 2024
Abstract
The article explores the challenges in implementing data altruism, focusing on personal health data altruism for scientific research purposes. The analysis highlights conceptual gaps and lack of clarity of the Data Governance Act (DGA) provisions and their unclear interplay with the General Data Protection Regulation (GDPR). Ethical considerations regarding the relationship between altruism and solidarity-based systems are discussed, along with legal issues surrounding the scope of data altruism and consent requirements in different scenarios of personal health data altruism for scientific research. The discussion extends to existing opt-out practices in scientific research and their recognition, pointing out potential drawbacks of an overly restrictive emphasis on consent in the context of data altruism. The conclusion highlights the conceptual and ethical shortcomings of data altruism, advocates for the development of an integrative approach to altruism within the regulatory sphere and within health data-sharing organisations for encouraging collaboration and recognition of contributors to not-for-profit research in the public interest. Ultimately, the article supports the development of new approaches to participation in research through dynamic opt-out mechanisms in health systems and emphasises the need for clearer regulatory guidance to unlock the full potential of health data altruism.
Addressing the ethical challenges to informed consent for brain tissue donation
Addressing the ethical challenges to informed consent for brain tissue donation
Amitabha Palmer
Medicine & Ethics, 10 September 2024
Abstract
The tremendous medical promise of human organoids has led large research institutions and national agencies to create brain tissue banks. In response, regulatory agencies have created regulations that guide consent processes for collecting tissue samples from donors. These regulations are, in part, intended to ensure that donors’ samples are not used in ways that conflict with their moral values, beliefs, and goals. While these regulations frequently serve this purpose well, we argue that they are insufficient in the case of brain tissue donation because of unique ethical concerns that arise from technologies and applications that use brain tissue samples. After considering the inadequacies, we suggest how consent policies can be improved. We focus on US policy specifically because some Caribbean and Latin American countries reference US regulatory frameworks in developing their own.
Ethical, legal, and social implications in research biobanking: A checklist for navigating complexity
Ethical, legal, and social implications in research biobanking: A checklist for navigating complexity
Original Article
Olga Tzortzatou-Nanopoulou, Kaya Akyüz, Melanie Goisauf, Łukasz Kozera, Signe Mežinska, Michaela Th. Mayrhofer, Santa Slokenberga, Jane Reichel, Talishiea Croxton, Alexandra Ziaka, Marina Makri
Developing World Bioethics, 10 July 2023
Open Access
Abstract
Biobanks’ activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first–hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four-step checklist aiming to facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU.
Implications of genetic testing and informed consent before and after genetic testing in individuals with cancer
Implications of genetic testing and informed consent before and after genetic testing in individuals with cancer
Priyanka Kumar, David J Benjamin, Sourat Darabi, Goetz Kloecker, Arash Rezazadeh Kalebasty
World Journal of Clinical Oncology, 24 August 2024; 15(8) pp 975-981
Abstract
Recent advancements in next generation sequencing have allowed for genetic information to become more readily available in the clinical setting for those affected by cancer and by treating clinicians. Given the lack of access to geneticists, medical oncologists and other treating physicians have begun ordering and interpreting genetic tests for individuals with cancer through the process of “mainstreaming”. While this process has allowed for quicker access to genetic tests, the process of “mainstreaming” has also brought several challenges including the dissemination of variants of unknown significance results, ordering of appropriate tests, and accurate interpretation of genetic results with appropriate follow-up testing and interventions. In this editorial, we seek to explore the process of informed consent of individuals before obtaining genetic testing and offer potential solutions to optimize the informed consent process including categorization of results as well as a layered consent model.
Adolescent Self-Consent for the HPV Vaccine and the Effects on Vaccine Rates
Adolescent Self-Consent for the HPV Vaccine and the Effects on Vaccine Rates
Health Policy
Alexa D. Thompson, Regena Spratling
Journal of Pediatric Health Care, 22 September 2024
Abstract
The adolescent development age is the period between 10 and 19 years when a child becomes a young adult and learns to make important health decisions independently. Adolescents consenting to receive a vaccine without parental or legal guardian consent is adolescent self-consent. Adolescent self-consent for the human papillomavirus (HPV) vaccine is a health policy issue that could increase vaccine uptake rates. Adolescent self-consent for the vaccine may increase adolescents’ autonomy with their healthcare decisions. Pediatric advanced practice nurses and other healthcare providers should advocate for adolescents and encourage parents to allow adolescents to be more active regarding the HPV vaccine.
Research Ethics of Involving Adolescents in Health Research Studies: Perspectives From Australia
Research Ethics of Involving Adolescents in Health Research Studies: Perspectives From Australia
Neha Faruqui, Angus Dawson, Katharine Steinbeck, Elizabeth Fine, Julie Mooney-Somers
Journal of Adolescent Health, September 2024
Open Access
Abstract
Purpose
Adolescent participation in health research studies is critical yet complex given the lack of clarity around issues such as consent. This study aimed to understand how those conducting research in Australia navigate research ethics in health research involving adolescents, through qualitative interviews.
Methods
Purposive sampling was used to recruit 23 researchers involved in adolescent health research using semi-structured in-depth interviews. Interviews were conducted via Zoom and audio-recorded after obtaining informed consent. Thematic analysis was used to construct themes and data were organised using NVivo.
Results
Two contrasting positions emerged from the data: (1) framing of adolescents as inherently vulnerable, their participation in research understood in terms of risk and protection and (2) adolescent engagement in research is understood in terms of empowerment, emphasising their capacity to make decisions about research participation. We traced these positions through three key themes, particularly in relation to the role of ethics committees: (1) competing positions as a result of inferior or superior knowledge about adolescent lives, (2) competing positions resulting in a risk averse or an empowerment approach, and (3) reflections on processes of obtaining consent which involves gatekeeping and tokenism.
Discussion
Our study highlights the contentious topic of navigating ethics committee requirements for the needs of adolescents. Majority of participants felt the current research ethics establishment is not favourable for researchers or adolescents themselves. While it is imperative that perceptions of ethics committees also be studied in the future, our study provides preliminary understanding of how experiences and perceptions shape how researchers interact with the research ethics establishment.
Consent in Pediatric Critical Care Trials: Duty or Burden?
Consent in Pediatric Critical Care Trials: Duty or Burden?
Editorial
Mark J. Peters, Kate Plant
Pediatric Critical Care Medicine, September 2024
Excerpt
Clinical practice is highly variable. Some of our colleagues use more maintenance fluids than we would choose for our patients. Or we might continue antibiotics beyond when they would stop them. We suspect any reader could think of similar examples in their own teams.
We currently accept this variability as commonplace in a complex setting such as a PICU. After all, there are tens, if not hundreds, of minor management decisions for each patient each day (1). If there were no differences between clinicians, our job could be replicated by robots or at least protocolized. There is a reasonable argument that this variability brings an additional level of safety. Practice regresses toward a mean such that over the duration of an admission any more extreme requests by one clinician will tend to be moderated by the colleague who takes over on the following shift.
Although we share our decision-making and plans with parents and patients where appropriate, we do not typically seek consent for these small variations in practice between staff…
Assessment of decision-making autonomy in chronic pain patients: a pilot study
Assessment of decision-making autonomy in chronic pain patients: a pilot study
Research
Marguerite d’Ussel, Emmanuelle Sacco, Nathan Moreau, Julien Nizard, Guillaume Durand
BMC Medical Ethics, 18 September 2024
Open Access
Abstract
Background
Patient decision-making autonomy refers to the patients’ ability to freely exert their own choices and make their own decisions, given sufficient resources and information to do so. In pain medicine, it is accepted that appropriate beneficial management aims to propose an individualized treatment plan shared with the patients, as agents, to help them live as autonomously as possible with their pain. However, are patients in chronic pain centers sufficiently autonomous to participate in the therapeutic decisions that concern them? As this question still remains unanswered, a pilot study was set up to that aim.
Methods
Over a 2-month period, first-time patients within a tertiary multidisciplinary pain center underwent a systematic evaluation of their autonomy using the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), considered the benchmark tool for measuring a patient’s ability to consent to treatment. Demographic data and pain characteristics of the patients were collected and their respective attending pain physicians were asked to clinically assess their patients’ degree of autonomy. Another physician, who had not participated in the initial patient evaluation, subsequently administered the MacCAT-T questionnaire to the same patients.
Results
Twenty-seven patients were included during the study period (21 women and 6 men), with an average age of 50 years. The average duration of pain was 8 years. Based on their clinical experience, the 4 different pain physicians in charge of these patients considered that out of 25 assessed patients, 22 of them (89%) had full decision-making capacity, with no deficit in autonomy. According to the MacCAT-T results, only 13 of these 25 patients (48%) had no deficit, while 7 (26%) had a major deficit in autonomy. The only patient characteristic that appeared to be related to autonomy was pain type, specifically nociplastic pain. The average time taken to complete the test was 20 min, and patients were very satisfied with the interview.
Conclusion
Results from the present pilot study suggest that patients suffering from chronic pain do not appear to be entirely autonomous in their decision to consent to the proposed treatment plan according to the MacCAT-T questionnaire, and physicians seem to find it difficult to properly assess this competence in a clinical setting. Further studies with larger samples are needed to better evaluate this concept to improve the complex management of these patients.
Consent to voluntary antipsychotic drug treatment-Is it free and informed?
Consent to voluntary antipsychotic drug treatment-Is it free and informed?
Refael Yonatan-Leus, Nili Karako-Eyal
Psychiatric Rehabilitation Journal, 16 September 2024
Abstract
Objective
The present research investigates the dynamics of consent in the context of antipsychotic drug therapy, with a particular emphasis on the essential attributes that constitute free and informed consent within medical treatment scenarios.
Method
Twenty individuals treated with antipsychotic drugs with consent underwent semistructured interviews.
Results
The following major themes were identified: (a) lack or total absence of information regarding the treatment, emphasizing side effects, risks, chances of success, and treatment alternatives. (b) A subjective experience of the lack of free choice that was sometimes also accompanied by the conditioning of psychiatric rehabilitation services or receiving treatment in an open ward by taking antipsychotic medication.
Conclusions and implications for practice
The research findings may indicate a problem in obtaining informed consent for antipsychotic treatment that should be addressed. The themes highlight the need to examine the interface between rehabilitation services and psychiatric treatment from the legal and ethical perspective of the autonomy of individuals receiving care.
Center for Informed Consent Integrity 