Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road
Scientific Contribution
Eugenijus Gefenas, J. Lekstutiene, V. Lukaseviciene, M. Hartlev, M. Mourby, K.Ó Cathaoir
Medicine, Health Care and Philosophy, 17 November 2021
Abstract
This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: (a) the data protection regime which follows the application of the European Union General Data Protection Regulation (GDPR), and (b) the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore has challenged the concept of ‘broad consent’, which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR ‘research condition’ provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper.
Month: December 2021
Supported Decision-Making in Persons With Dementia: Development of an Enhanced Consent Procedure for Lumbar Puncture
Supported Decision-Making in Persons With Dementia: Development of an Enhanced Consent Procedure for Lumbar Puncture
Original Article
Theresa S. Wied, Julia Haberstroh, Jakov Gather, Tarik Karakaya, Frank Oswald, Mishal Qubad, Matthé Scholten, Jochen Vollmann, Johannes Pantel, the ENSURE Consortium
Frontiers in Psychiatry, 16 November 2021
Abstract
The right to make autonomous decisions is enshrined in law. However, the question how persons with cognitive deficits can be enabled to make autonomous decisions has not been satisfactorily addressed. In particular, the concept of supported decision-making and its implementation into practice has been poorly explored for persons with dementia (PwD).This article describes the empirical development and implementation of support tools to enhance informed consent processes (so called enhanced consent procedures/ECP) for PwD on whether to undergo lumbar puncture. In the end of the process of pilot testing and further development of the tools, the following tools were defined: (1) Standardized Interview Structure, (2) Elaborated Plain Language, (3) Ambience and Room Design, (4) Keyword Lists, (5) Priority Cards, (6) Visualization, and (7) Simplified Written Informed Consent (Patient Information), as well as the general attitude (8) Person-Centered Attitude of the facilitator. As the development, implementation and evaluation of ECP tools is one objective of the transnational ENSURE project, we also include an overview of future empirical procedures. So far, our findings can serve as a selection of possibilities to support PwD in decision-making and help practitioners achieve an appropriate balance between the autonomy and protection of PwD in complex decision-making situation. Future studies should address the question if the proposed set of tools is effective to enhance informed consent processes in PwD.
The Narrative Approach to Informed Consent: Empowering Young Children’s Rights and Meaningful Participation
The Narrative Approach to Informed Consent: Empowering Young Children’s Rights and Meaningful Participation
Practial Guide
Fiona Mayne, Christine Howitt
Routledge, 2022
Open Access
Excerpt
The Narrative Approach to Informed Consent: Empowering Young Children’s Rights and Meaningful Participation is a practical guide for researchers who want to engage young children in rights-based, participatory research. This book presents the Narrative Approach, an original and innovative method to help children understand their participation in research. This approach moves away from traditional paper-based consent to tailor the informed consent process to the specific needs of young children. Through the Informing Story, which employs a combination of interaction, information and narrative, this method enables children to comprehend concepts through storytelling. Researchers are stepped through the development of an Informing Story so that they can deliver accurate information to young children about what their participation in research is likely to involve. To further inform practice, the book documents the implementation of the Narrative Approach in four case studies demonstrating the variety of settings in which the method can be applied…
Deferred Consent in Pediatric Drug Trials: Moving from Why to How
Deferred Consent in Pediatric Drug Trials: Moving from Why to How
Commentary
Martin Offringa, Terry P. Klassen
Pediatric Drugs, 28 October 2021; 23 pp 533–535
Excerpt
Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe and effective treatment. There is an ongoing need for clinical trials investigating emergency drug treatments of children with life-threatening conditions as there are still relatively few clinical trials in this setting and severely ill children are under-represented in research. A main challenge of such trials is seeking parents’ consent for including their critically ill child in a research study. The reasons are obvious: there is not always someone with parental responsibility present when a child enters a hospital’s emergency department, newly delivered mothers may be unable to give consent to emergency investigations or treatment of their baby because of general anesthetic or post-delivery sedation, or parents may be highly stressed in an emergency and struggle to make an informed decision about research in the limited time available…
Consent, privacy and confidentiality: Babies, children and young people’s experience of healthcare
Consent, privacy and confidentiality: Babies, children and young people’s experience of healthcare
Review
National Guideline Alliance (UK)
NICE Evidence Reviews Collection, August 2021
Excerpt
Babies, children and young people accessing healthcare have the right to consent to treatment, and rights to privacy and confidentiality. These rights are outlined both in the United Nations Convention on the Rights of the Child (UNCRC) and the NHS Constitution, and this review did not aim to assess the validity of these rights.
The provision of consent is covered by professional frameworks and international human rights laws, and young people over 16 have the right to consent to their own treatment. Those under the age of 16 can consent if they have the competence to do so, otherwise someone with parental responsibility can consent on their behalf.
The right to privacy includes privacy and dignity during discussions, examination, treatment and care, and the right to confidentiality includes the restricted use and sharing of personal and identifiable data and access to health records.
The aim of this review was to determine how children and young people, and the parents or carers of babies and young children prefer discussions about their privacy and confidentiality to be addressed by healthcare services and healthcare providers, as well as their views and preferences on discussions about consent…
Consent and confidentiality: exploring the ethical challenges of working with young people [CONFERENCE PAPER]
Consent and confidentiality: exploring the ethical challenges of working with young people [CONFERENCE PAPER]
Zoe Morris, Nicholas Gamble
International School Psychology Association Annual Conference 2021, 13-16 July 2021
Abstract
Working with young people, particularly within schools, is complex work for psychologists and counsellors, both ethically and legally. Little is known about the process by which psychologists and counsellors determine the capacity for young people to provide their own consent for services – yet this process is undertaken everyday by school psychologists. This paper aimed to explore role that context and client characteristics may play in assessing a young person’s capacity. This paper presents findings from a study of 108 practitioners working in Australia. Participants responded to questions related to how they undertake an assessment of capacity in a young person and what factors are considered to support or negate capacity to consent. Responses provided insight into practitioner reasoning and decision-making processes when facing ethical dilemmas with young people as clients. This paper will explore current practice, highlight common challenges for school psychologists, and integrate with current guidelines and policy.
Understanding the legal considerations of consent in nursing practice
Understanding the legal considerations of consent in nursing practice
Iwan Dowie
Nursing Standard, 22 November 2021
Abstract
Consent to treatment is a common, albeit complex, aspect of nursing practice. Over the past few years, laws have been strengthened to provide increased recognition of patient autonomy. This has meant that there is a greater onus placed on nurses to understand how consent is obtained from patients, the elements required to ensure any consent is valid, and how to proceed when it has been determined that a patient does not have the mental capacity to consent to treatment. This article explores some of the legal considerations that nurses should keep in mind when seeking consent from a patient.
Obtaining informed consent from patients hospitalized in the surgical wards as a major legal challenge
Obtaining informed consent from patients hospitalized in the surgical wards as a major legal challenge
Seyed Khosro Ghasempouri, Masoud Shayesteh Azar, Mohammad Hosein Kariminasab, Zakaria Zakariaei, Mohammad Khademloo, Hesamoddin Raeeis Danaei, Ashkan Zakariaei
Annals of Medicine and Surgery, 17 November 2021
Open Access
Abstract
Background and objectives
Informed consent (IC) is the process of establishing communication between the physician and the patient or an alternative decision that leads to the agreement or rejection of the patient and/or their legal representative to perform specific medical procedures. In this study, we evaluated the level of awareness and patient participation in IC in the surgical wards of the general hospital in northern Iran in the 2019–2020 years.
Patients and methods
This study is cross-sectional research that was performed during the 2019–2020 years. The statistical population includes patients admitted to the surgical wards of the general hospital in northern Iran in 2019–2020. The Cochran’s formula was used to determine the sample size and the statistical sample size was 385 patients. The sampling method is stratified random. The method of data collection was through questionnaire tools. The software used was SPSS 21 with an independent t-test and one-way ANOVA.
Results
Our data showed that the frequency of men was significantly higher (P < 0.001). Individuals with a higher education group have a significantly higher level of awareness (P < 0.001). The Pearson’s Correlation (PC) test showed that there was no significant correlation between age and patients’ awareness score (PC = -0.007, P = 0.887).
Conclusion
The current study showed that individuals with higher education had a significantly higher level of awareness, and there was no significant correlation between age and patients’ awareness score. Therefore, senior university administrators are suggested to improve IC processes in accordance with the patients’ rights charter and internationally accredited standards, and assist health care providers with legal implications in the courts.
Informed consent: Legalities, perspectives of physicians and patients, and practices in OECD/non-OECD countries
Informed consent: Legalities, perspectives of physicians and patients, and practices in OECD/non-OECD countries
Original Article
Amrita Shenoy, Gopinath N. Shenoy, Gayatri G. Shenoy
Médecine Palliative, 30 October 2021
Summary
In the medico-legal context, obtaining informed consent is described as the process in which the doctor apraises the patient of the intricacies of the proposed treatment, its alternatives, benefits and risks presented, therein, the right to refuse or withdraw consent at any point, and the risks of not undergoing treatment at all. As segments of disciplined inquiry, we, hereby, present a synthesis of the legalities, perspectives of physicians and patients, and practices in two cohorts of countries. We, specifically, analyze the above segments in the context of formative informed consent codes prevalent in France, United States, United Kingdom, Brazil, and India. In this process, we place focus on landmark judgments that conceived the frameworks of informed consent to its present stage. The present study, additionally, elaborates on the past practice of modulating the volume/intensity of medical details conveyed to the patient or, in other words, how informed the informed consent should be. We illustrate the above concept with an example of the once conservative English medical approach that has now shifted to a collaborative American one. An eminent Scottish judgment ruled in 2017 was instrumental in enacting the same. Conclusively, we explore how illiterate or semi-literate, financially constrained patients are withdrawn and passive in medical decision-making. The process of obtaining informed consent from the above stratum of poverty-stricken fiscally restrained patients is known to be potentially cumbersome. In this context, we, nevertheless, propose to expand on the ways of obtaining informed consent contextual to the above patient qualities.
Should we criminalize a deliberate failure to obtain properly informed consent?
Should we criminalize a deliberate failure to obtain properly informed consent?
Clark Hobson, José Miola
Medical Law International, 25 October 2021
Open Access
Abstract
This paper takes the form of a polemic and thought experiment. The starting point is that, if medical law’s claims to place autonomy at the heart of the enterprise are to be taken seriously, then autonomy either needs to be considered a recoverable harm, or the most egregious infringements should be subject to the criminal law. This might particularly be the case where a doctor deliberately attempts to modify the patient’s decision by failing to disclose information that they know that the patient would find significant. The article considers medical law’s relationship with autonomy, before applying the criminal law – in the form of the analogous situation of defendants who deliberately fail to disclose HIV+status to their sexual partners. What we find is a distinct difference in the way that autonomy is seen by medical and criminal law, although both are equally unsatisfactory.
Center for Informed Consent Integrity 