Year: 2024

Informed Consent and Adolescents with Cancer: Challenges and Tools in Online Studies

~ paigefitzsimmons ~ Leave a comment

Informed Consent and Adolescents with Cancer: Challenges and Tools in Online Studies
Research Article
Maria Carolina Neves, Sara Monteiro, Judith B. Prins, Célia
Journal of Adolescent and Young Adult Oncology, 3 July 2024
Introduction
   Adolescents and young adults (AYAs) with cancer are defined as those diagnosed between 15 and 39 years. Estimates suggest 1,335,100 new AYAs were diagnosed in 2019, but this population is still underrepresented in research. Some challenges to investigating this population are the differences in cancer types between younger and older AYAs; they are difficult to track and easily lost at follow-up; and they are difficult to find at the hospital since they are divided between the pediatric and adult clinics. This article will focus on adolescents 15–17 years old since these are the ones who might need parental consent to participate in research.

Online research has increased in popularity in the last decades, and in 2017, it was the primary way of collecting quantitative data worldwide. Recruiting minors through online methods was shown to be more efficient and cost-effective than offline methods while still allowing researchers to have representative sample. Research shows that adolescents use the internet frequently, making it a good place when investigating adolescents. Regarding cancer research, some studies have used online methods to recruit adolescents. However, there are additional challenges when using online methods with adolescents compared with offline methods. One of them is obtaining parental consent.

This article describes the challenges and alternatives to obtaining informed consent in online quantitative studies of adolescents with cancer and good practices. This may provide tools for researchers to define how they will obtain informed consent in online studies of adolescents with cancer and help lower barriers in research, encouraging more quantitative studies with this population.

From vulnerable subjects to research partners: a critical policy analysis of biomedical research ethics guidelines and regulations

~ paigefitzsimmons ~ Leave a comment

From vulnerable subjects to research partners: a critical policy analysis of biomedical research ethics guidelines and regulations
Research Article
Maria Cristina Murano
Research Ethics, 29 March 2024
Open Access
Abstract
Over the last three quarters of a century, international guidelines and regulations have undergone significant changes in how children are problematised as participants in biomedical research. While early guidelines enacted children as vulnerable subjects with diminished autonomy and in need of special protection, beginning in the early 2000s, international regulatory frameworks defined the paediatric population as vulnerable due to unaddressed public health needs. More recently, ethical recommendations have promoted the active engagement of minors as research partners. In this paper, I adopt a post-structuralist approach to policy analysis to examine deep-seated assumptions and presuppositions underlying the changes in the problematisation of children as biomedical research participants over time. While biomedical research ethics focuses on the autonomy and vulnerability of minors, ethical guidelines are situated in specific sociocultural contexts, shaped, among other things, by contingent public health needs and changing conceptions of the value of research and science for society. In the process, I demonstrate the challenge of moving away from an approach that in taking adults as the model overshadows the complexity of children’s lived experiences as well as their personal, cultural, and social lives. The lack of acknowledgement of this complexity makes children vulnerable to epistemic injustice, which is particularly crucial to address in public involvement initiatives.

Research Article

Maria Cristina Murano

Research Ethics, 29 March 2024

Open Access

Abstract

Over the last three quarters of a century, international guidelines and regulations have undergone significant changes in how children are problematised as participants in biomedical research. While early guidelines enacted children as vulnerable subjects with diminished autonomy and in need of special protection, beginning in the early 2000s, international regulatory frameworks defined the paediatric population as vulnerable due to unaddressed public health needs. More recently, ethical recommendations have promoted the active engagement of minors as research partners. In this paper, I adopt a post-structuralist approach to policy analysis to examine deep-seated assumptions and presuppositions underlying the changes in the problematisation of children as biomedical research participants over time. While biomedical research ethics focuses on the autonomy and vulnerability of minors, ethical guidelines are situated in specific sociocultural contexts, shaped, among other things, by contingent public health needs and changing conceptions of the value of research and science for society. In the process, I demonstrate the challenge of moving away from an approach that in taking adults as the model overshadows the complexity of children’s lived experiences as well as their personal, cultural, and social lives. The lack of acknowledgement of this complexity makes children vulnerable to epistemic injustice, which is particularly crucial to address in public involvement initiatives.

It’s a spiral staircase, not just two steps: An iterative approach to assessing patient capacity for medical decision-making

~ paigefitzsimmons ~ Leave a comment

It’s a spiral staircase, not just two steps: An iterative approach to assessing patient capacity for medical decision-making
Marc Tunzi, Philip G. Day, David J. Satin
Patient Education and Counseling, October 2024
Abstract
The assessment of medical decision-making capacity as part of the process of clinical informed consent has been considered a bioethical housekeeping matter for decades. Yet in practice, the reality bears little resemblance to what is described in the medical literature and professed in medical education. Most literature on informed consent refers to medical decision-making capacity as a precondition to the consent process. That is, a clinician must first determine if a patient has capacity, and only then may the clinician engage with the patient for the rest of informed consent. The problem with this two-step approach is that it makes no sense in actual practice. We see the assessment of medical decision-making capacity within the process of informed consent as a spiral staircase, not just two steps, requiring clinicians to keep circling up and around, making progress, until they get to where they need to be: 1. Clinicians start with a general presumption of capacity for most adults, sometimes having a provisional appraisal of capacity based on prior patient contact. 2. Then, they begin performing informed consent for the current situation and intervention options. 3. Next, they must reassess capacity during this process. 4. After that, they continue with informed consent. 5. If capacity is not yet clear, they repeat 1–4.

Modifications to consent documentation with adults with communication disorders following brain injury: An exploratory study

~ paigefitzsimmons ~ Leave a comment

Modifications to consent documentation with adults with communication disorders following brain injury: An exploratory study
Original Article
Jennifer Watermeyer, Chiara Aylward
Developing World Bioethics, 14 July 2024
Open Access
Abstract
Consent documentation for research studies is often inaccessible to people with neurogenic communication disorders following brain injury and there is limited literature on specific modifications for informed consent. This exploratory study aimed to identify effective strategies and modifications to consent processes for adults with brain injury. Using a fictitious research study, we developed a set of Participant Information Sheets (PISs) varying in complexity, presentation format, and communication modality. Evaluations were conducted with eight participants. Findings indicated diverse participant preferences for PIS modifications, suggesting simplified vocabulary, reduced text, carefully selected images, and an interactive presentation modality as helpful strategies. Building on previous literature, we present refined guidelines for consent modifications for adults with neurogenic communication disorder after brain injury. These guidelines can promote more appropriate inclusion of communicatively impaired populations in research and assist ethics committees and researchers in preparing modified consent documents.

Measuring Cognition in Clinical Trials in Parkinson’s Disease, Dementia with Lewy Bodies, and Related Disorders

~ paigefitzsimmons ~ Leave a comment

Measuring Cognition in Clinical Trials in Parkinson’s Disease, Dementia with Lewy Bodies, and Related Disorders
Roundtable Proceedings and Roadmap for Research
Shannon D. Donofry, Claire E. O’Hanlon
Rand, 8 July 2024
Excerpt
   Emerging research suggests that Parkinson’s disease (PD) and dementia with Lewy bodies (DLB) share underlying pathology and may represent a single, biologically defined disease spectrum. Cognitive changes are among the most worrisome symptoms for patients with PD, and are the core feature of DLB. While the cognitive changes experienced by individuals with PD and mild cognitive impairment share some clinical characteristics with patients who have undiagnosed or prodromal DLB, these changes are distinct from other types of dementias, such as Alzheimer’s disease.

To spur the adaptation of existing cognition-focused measures and the development of new ones to underlie clinical trial endpoints in PD and DLB, the PD/DLB Cognition Roundtable was held on January 10 and 11, 2024, in Washington, D.C. The roundtable brought together representatives from academia and industry, as well as with representatives of regulatory agencies, community partners, patient advocates, and research funders, to build consensus and collaborate on the outcome assessment and trial design methods that will support the development of new treatments for early or mild cognitive changes in disorders on the PD/DLB spectrum.

The authors of this document summarize the roundtable, discussing the state of the field for clinical trial design and cognition measures in PD and DLB, promising avenues of research, and perspectives of regulatory agencies…

Important legal principles of consent and mental capacity

~ paigefitzsimmons ~ Leave a comment

Important legal principles of consent and mental capacity
Iwan Dowie
British Journal of Community Nursing, 4 July 2024
Abstract
Consent is an essential part of healthcare practice, allowing patients to make autonomous decisions. However, this changes when a patient has mental incapacity or is unable to make decisions for themselves for a duration of time. This month’s Policy column looks at some of the key principles of the Mental Capacity Act 2005, and how this can be applied in community nursing practice.

Informed Consent and Surrogate Interference at the Initiation of Community-Based Palliative Care Services

~ paigefitzsimmons ~ Leave a comment

Informed Consent and Surrogate Interference at the Initiation of Community-Based Palliative Care Services
John C. Stys
Palliative Medicine Reports, 22 April 2024
Open Access
Abstract
Community-based palliative care (CBPC) clinicians sometimes contend with an ethically charged scenario when they encounter patients for the first time: The patient’s spouse, or other loved one or caregiver, revokes the patient’s valid informed consent to initiate care. While surrogates are usually motivated by protective instincts, there are other situations where surrogates act out of self-interest. This article considers whether it is ever ethically justified for an adult to revoke another adult’s valid informed consent to initiate palliative care services. The article examines this scenario from three perspectives: the patient’s capacity to give or relinquish informed consent, the surrogate’s intent and use of substituted judgment or best interest, and the clinician’s duty to provide clinical care. This ethical analysis argues that CBPC clinicians have an ethical responsibility to provide palliative care services for patients who have given valid informed consent for those services even when a surrogate acts as an interfering or oppositional force.

Qualitative Content and Discourse Analysis Comparing the Current Consent Systems for Deceased Organ Donation in Spain and England

~ paigefitzsimmons ~ Leave a comment

Qualitative Content and Discourse Analysis Comparing the Current Consent Systems for Deceased Organ Donation in Spain and England
Original Research
Kate Rees, Leah Mclaughlin, David Paredes-Zapata, Cathy Miller, Nicholas Mays, Jane Noyes
Transplant International, 4 July 2024
Abstract
England switched to an opt-out system of consent in 2020 aiming to increase the number of organs available. Spain also operates an opt-out system yet has almost twice the organ donations per million population compared with England. We aimed to identify both differences and similarities in the consent policies, documents and procedures in deceased donation between the two countries using comparative qualitative content and discourse analysis. Spain had simpler, locally tailored documents, the time taken for families to review and process information may be shorter, there were more pathways leading to organ donation in Spain, and more robust legal protections for the decisions individuals made in life. The language in the Spanish documents was one of support and reassurance. Documents in England by comparison appeared confusing, since additions were designed to protect the NHS against risk and made to previous document versions to reflect the law change rather than being entirely recast. If England’s ambition is to achieve consent rates similar to Spain this analysis has highlighted opportunities that could strengthen the English system-by giving individuals’ decisions recorded on the organ donor register legal weight, alongside unifying and simplifying consent policies and procedures to support families and healthcare professionals.

Self-Rated Competence of Ugandan Healthcare Workers to Obtain Informed Consent for Autopsy

~ paigefitzsimmons ~ Leave a comment

Self-Rated Competence of Ugandan Healthcare Workers to Obtain Informed Consent for Autopsy
Felix Bongomin, Winnie Kibone, Ritah Nantale, Robert Lukande, Ruth Bromley, Conrad Muzoora, Davidson H Hamer
American Journal of Tropical Medicine and Hygiene, 25 June 2024
Abstract
We examined the self-rated competence of Ugandan healthcare workers (HCWs) in obtaining informed consent for autopsies, considering the challenges of low autopsy acceptance rates globally. In September and October 2023, we conducted a nationwide cross-sectional study of HCWs, who provided informed consent to participate and completed an online, self-administered questionnaire. Participants’ self-rated competence in obtaining informed consent for autopsy was assessed through Likert scale questions. Knowledge and practices were also assessed. All scores were converted to percentages, with scores ≥80% indicating higher competence. We enrolled 216 HCWs (including 145 [67.1%] doctors), with a mean age of 31.6 ± 7.2 years. Overall, 55.6% (n = 120) had ever assisted in obtaining consent for autopsy, 43.6% (n = 100) had ever obtained consent for autopsy themselves, and 13.4% (n = 29) had ever attended training on obtaining consent for autopsy. The mean competency score was 59.8 ± 17.0% (perfect score, 100%), with 29 (13.4%) participants demonstrating high competence. Healthcare workers with adequate knowledge had higher competence scores (odds ratio [OR]: 15.0, 95% CI: 6.17-36.58, P <0.001). Compared with nurses/midwives, doctors had 73% lower odds of having a high competence score (adjusted OR: 0.27, 95% CI: 0.08-0.94, P = 0.040). Fewer than one in five Ugandan HCWs demonstrated high self-rated competence or possessed adequate knowledge regarding informed consent for autopsies, and only a few had received specialized training on how to obtain consent for an autopsy. Therefore, there is a pressing need for enhanced training and increased awareness among Ugandan HCWs in obtaining informed consent for autopsies.

Translating informed consent in Scottish maternity services: Perspectives from providers and researchers of both maternity care and translation/interpreting services

~ paigefitzsimmons ~ Leave a comment

Translating informed consent in Scottish maternity services: Perspectives from providers and researchers of both maternity care and translation/interpreting services
Jenny Patterson, Sebnem Susam-Saraeva
Language and Health, 22 June 2024
Abstract / Description of output
Background
Failing to meet the communication and information needs of childbearing women leaves them unable to provide true informed consent. Lack of control or lack of involvement in decision making contribute to birth trauma. For those with Limited English Proficiency (LEP) receiving information requires use of interpreters often hindered within pressurised maternity services and urgent situations. Women with LEP are often of ethnicities at risk of poorer maternity outcomes and from cultures where maternity service practices differ from Scottish maternity services.
Question
How do maternity care professionals (MCPs) and translation & interpreting (T&I) providers experience their role around informed consent when caring for women with LEP in Scotland; what do they identify as barriers or facilitators?
Methods
Data were collected using qualitative methodology through online focus groups and interactive workshops including a mix of MCPs and T&I providers. Recruitment used a snowball approach via word of mouth and email. Focus groups were audio recorded and transcribed verbatim, workshops were audio-visually recorded and closely examined. Data were analysed using Framework analysis.
Results
Four themes emerged from the study: 1) Limited resources; 2) Inter-professional concerns; 3) Cultural heritage; and 4) Power.
Discussion
Limited resources affect women, MCPs and interpreting services. A lack of cultural awareness and power differentials create pressure for everyone within the process.
Conclusion
LEP increases complexity around informed consent. Challenges are multifaceted compounded by lack of time and resources alongside power differentials. Trust, respect and continuity are key facilitators.