The Impact of Artistic Representation on Patient Consent and Autonomy
Alberta Jeanne N.
Eurasian Experiment Journal of Scientific and Applied Research, 2024; 6(2)
Open Access
Abstract
Informed consent is fundamental to respecting patient autonomy in healthcare, ensuring that patients make voluntary, well-informed decisions about their treatment. However, consent processes can be hindered by communication barriers, time constraints, and differences in understanding complex medical information. Artistic representations in healthcare ranging from visual arts and music to theater—have emerged as potential tools to enhance patient comprehension and emotional engagement with medical procedures. This paper examines how various forms of art in healthcare environments may influence patient consent and autonomy. It considers the psychological, communicative, and therapeutic impacts of art, proposing that art can support consent by fostering deeper understanding and empathy between patients and healthcare providers. Four theoretical frameworks psychological impact, communicative theory, therapeutic influence, and autonomy in healthcare are analyzed to assess the efficacy of artistic representations in supporting patient-centered consent. By synthesizing empirical studies on artistic strategies in clinical settings, this article highlights the importance of interdisciplinary approaches to patient autonomy and explores the ethical implications of integrating art into consent processes.
Month: December 2024
Smart contract empowered dynamic consent: decentralized storage and access control for healthcare applications
Smart contract empowered dynamic consent: decentralized storage and access control for healthcare applications
Aparna Singh, Geetanjali Rathee
Peer-to-Peer Networking and Applications, 10 December 2024
Abstract
The ability to share Electronic Health Records (EHRs) with the right people plays a crucial role in providing on-time diagnosis. The outsourcing of private health data on the cloud, with negligible control in the hands of the data owners, poses a significant challenge for e-healthcare applications. Obtaining the owner’s consent is not just essential for data sharing but also to protect the privacy of the data being shared. With the help of Blockchain and Interplanetary File System (IPFS), this research paper proposes a purpose-based framework for obtaining dynamic consent before sharing data among healthcare providers, academicians, etc. The study develops a blockchain system on the Ethereum network to store encrypted EHRs on IPFS. This architecture allows for secure and privacy-enhanced data sharing. The proposed model demonstrates effectiveness in enhancing data security, privacy, scalability, ownership, and integrity of medical records. The cost analysis shows a negligible contract deployment cost of 0.00174363 ETH, equivalent to $2.78. The framework presents a viable solution for securing EHRs and obtaining dynamic consent, ensuring improved healthcare data management. The use of blockchain and IPFS offers a promising avenue for enhancing data security and privacy in e-healthcare applications.
Stakeholder Perspectives on Research Consent and Reconsent for Procedures Involving Biological Samples and Biobanking of Children and Adolescents Living With HIV in Kenya
Stakeholder Perspectives on Research Consent and Reconsent for Procedures Involving Biological Samples and Biobanking of Children and Adolescents Living With HIV in Kenya
Research article
Josephine Aluoch, Ashley Chory, Michael Scanlon, Emma Gillette, Hillary Koros, Dennis Munyoro, Celestine Ashimosi, Whitney Beigon, Janet Lidweye, Jack Nyagaya, Allison DeLong, Rami Kantor, Rachel Christine Vreeman, Violet Naanyu, Winstone M. Nyandiko
Journal of the International Association of Providers of AIDS Care, 13 December 2024
Open Access
Abstract
Objective
To explore the perspectives of stakeholders on consenting and reconsenting children and adolescents living with HIV (CALWH) to participate in research involving biological sampling and biobanking. Stakeholders included CALWH, their caregivers, subject matter experts (SMEs) such as Institutional Review Board (IRB) members, Community Advisory Board (CAB) members, Healthcare Providers, researchers, and community leaders.
Study design
This qualitative study was conducted at the Academic Model Providing Access to Healthcare (AMPATH) in Kenya. Semi-structured interviews were conducted with CALWH, their caregivers, and SMEs. Audio recordings were transcribed, thematically analyzed, and emerging themes derived.
Results
In total, 99 participants were interviewed, of which the majority (52%) were female; 50% of CALWH were female with a median age of 17.5 years (range 11-24); 70% of caregivers and 44% of SMEs were female. All SMEs, CALWH, and caregivers emphasized that recontacting and reconsenting were their strong preferences for the use of biospecimens and also an essential procedure to address legal and ethical considerations and confidentiality. All CALWH wanted consent to detail how they will be informed about research findings and emphasized making their results available to them. Caregivers highlighted the importance of trust in the use of the stored samples to be maintained as per the consents.
Conclusion
Our findings revealed that CALWH and their caregivers want researchers to go beyond the typical information provided about biospecimen storage and use. They desire to be recontacted and reconsented as well as maintain ongoing communication with the research team about the research findings.
Patient Reflections on the Consent Process for Donating Extra Bone Marrow Research Samples to a Hematology Biobank: A Qualitative Interview Study
Patient Reflections on the Consent Process for Donating Extra Bone Marrow Research Samples to a Hematology Biobank: A Qualitative Interview Study
Madeleine Gordon, Oksana Motalo, Erika Camilleri, Taryn Chesser, Gary Davis, Grace Fox, Katya Godard, Caryn Y Ito, Jocelyn Lepage, Krystina B. Lewis, Wendy Nuttall, Craig Peloshok, Stuart Nicholls, Mitchell Sabloff
Blood, 5 November 2024
Abstract
Background
Bone marrow samples taken at the time of diagnosis are essential for early diagnosis and treatment of acute leukemia (AL) and additionally can be used to understand the underlying biology. This requires bone marrow samples to be taken for clinical purposes as well as for research. Due to the rapid onset and progression of AL, there is a narrow time frame from initial disease suspicion to diagnosis confirmation and treatment initiation. This can present challenges with consenting patients for additional, research-specific bone marrow samples to be obtained during the diagnostic procedure. While patients with cancer are generally positive towards contributing to medical research, recruitment rates for bone marrow samples are low, hindering translational research aimed at improving patients’ outcomes in AL. Little is known about patient perspectives with respect to the informed consent process under these time-sensitive circumstances, or how these processes can improve research sample provision while also maintaining respect for patient autonomy and supporting their decision-making during a stressful time. The current study is aimed to better understand the experiences of patients with AL in relation to consenting to provide extra bone marrow samples for research during the diagnostic procedure.
Methods
Semi-structured interviews were conducted with patients treated for AL between January 1, 2017 and December 31, 2021 at The Ottawa Hospital. Patients were eligible if they were admitted to hospital urgently to confirm AL diagnosis, received intensive induction chemotherapy and spoke English or French. Interviews proceeded until data saturation was reached.
Results
Seventeen patients were interviewed. Patient experiences centred on three key areas within the consent process: Preparation and awareness of research, logistical challenges related to obtaining consent within the limited time frame and having emotional and psychological support. Patients were supportive of increasing public knowledge about research and noted the important roles that friends and family members played in providing support and retaining information. Despite the time pressure and anxiety that came with a diagnosis of AL, the decision to give a research sample did not in itself require much deliberation. Decisions were informed by proximal factors such as impact on patient health and family, the anticipated pain associated with the bone marrow procedure and its duration, as well as distal factors such as altruism and trust in the healthcare team. Patients valued as much time as possible between the consent process and the bone marrow extraction. Further, they valued information about the level of anticipated procedure-associated pain, the purpose of ongoing research and its use of samples, and details regarding the privacy and security of the research samples.
Conclusion
Our findings suggest that the success of consenting for additional bone marrow samples for research may be optimised through multiple changes, such as those pertaining to the environment where the consent discussion takes place as well as a period of time for reflection on the discussion prior to the procedure, in addition to the type of information provided, the recognition of patient concerns surrounding discomfort and how it will be mitigated and, finally, the value of current and future research.
What does a consent conversation for whole genome sequencing look like in the NHS Genomic Medicine Service? An observational study
What does a consent conversation for whole genome sequencing look like in the NHS Genomic Medicine Service? An observational study
Holly Ellard, Huda Alfardus, Saskia Sanderson, Celine Lewis
European Journal Of Human Genetics, 26 November 2024
Open Access
Abstract
Patient choice consent for whole genome sequencing (WGS) through the Genomic Medicine Service in England covers consent to diagnostic testing and an invitation to the National Genomic Research Library (NGRL). Little is known about what consent conversations for WGS look like in practice. We audio-recorded and analysed the content and structure of consent appointments (n = 26) between healthcare professionals (HCPs) and parents of children with rare disease across seven NHS Trusts. Appointments frequently covered the potential findings from testing, implications for family members, and DNA storage, but often omitted that data may be reanalysed in the future if a diagnosis is not made. Consent to the NGRL was typically sought during the same appointment; these discussions varied in content, but frequently included a background to the NGRL and data security. HCPs often tempered expectations around what WGS can achieve and asked questions to clarify parents’ understanding, but less commonly elicited parents’ values and concerns. Administrative tasks were time-consuming, but took less time when consent was recorded digitally. Future training should emphasise how to elicit patients’ values and concerns. Digital infrastructure and hiring roles such as genomic associates to support consent may be important strategies to meet the workload demands of WGS.
Variance of Consent for Genetic Return of Results Across Sociodemographic Traits
Variance of Consent for Genetic Return of Results Across Sociodemographic Traits
Christine Jovanovic, Brynn Mayer
University of Illinois Library, 25 November 2024
Abstract
There is a gap in the literature assessing whether demographic variables are associated with uptake of genetic testing in the absence of identified barriers of referral and cost. Because the All of Us Research Program offers genetic testing and counseling at no cost, we propose to address this gap using data from the University of Illinois Chicago All of Us Research Program, which includes over 16,000 individuals. This study will aim to assess whether consent to receive genetic return of results (GRoR) varies significantly across relevant sociodemographic factors among the diverse participants in the University of Illinois Chicago (UIC) All of Us cohort.
Obtaining Informed Consent From People With Dyslexia: The Role Of Easy Language
Obtaining Informed Consent From People With Dyslexia: The Role Of Easy Language
Marija Jozipović, Mirjana Lenček
Croatian Journal of Rehabilitation Research, 19 December 2024
Open Access
Abstract
Obtaining informed consent is a standard procedure in research practice. However, it is not sufficient, even if an individual chooses to participate voluntarily in research process, for the researchers to be able to claim that they have obtained informed consent. The consent must be of sufficiently ‘high quality’: it must not only be informed, but also valid, i.e., it must contain the following three elements: adequate information, voluntariness, and competence. Although preparing informed consent is a difficult process in general, it is particularly challenging when working with certain populations, such as clinical groups who have language and literacy difficulties, e.g., dyslexia. A lack of understanding of the basis and specific characteristics of this disorder can have negative effects on people with dyslexia (PwD) such as in the form of unwanted misunderstandings, psychological stress, negative effects on their learning processes, as well as unethical treatment in the research process. Studies have shown that PwD can be particularly vulnerable to research that might exploit, imply, or attribute unsafe practices to them and their difficulties, especially in connection with research recommendations that require written informed consent. Easy language refers to the language adaptation of a text to facilitate both reading and comprehension, particularly for PwD. Therefore, the use of the easy language guidelines for language adaptation and graphical adjustment is important when obtaining informed consent from PwD.
What Is Truly Informed Consent in Medical Practice and What Has the Perception of Risk Got to Do with It?
What Is Truly Informed Consent in Medical Practice and What Has the Perception of Risk Got to Do with It?
Catherine Jane Calderwood, Geir Sverre Braut, Siri Wiig
Healthcare, 24 December 2024
Abstract
Making decisions about risk, describing and appropriately explaining risk in medical practice is complex for patients and professionals. In this paper, we investigate how the concept of consent is practiced differently in the UK and Norway and discuss pros and cons of the chosen approaches from a patient safety culture perspective. We argue that consent is a fundamental part of the safety culture and influence on health system functioning and patient and staff safety. Examples from the UK and Norway are used and discussed in terms of how risk perception influences consent processes and practices.
‘Some parts of the consent form are written using complex scientific language’: community perspectives on informed consent for research with pregnant and lactating mothers in Uganda
‘Some parts of the consent form are written using complex scientific language’: community perspectives on informed consent for research with pregnant and lactating mothers in Uganda
Research
Adelline Twimukye, Sylvia Nabukenya, Aida N. Kawuma, Josephine Bayigga, Ritah Nakijoba, Simon Peter Asiimwe, Fredrick Byenume, Francis Williams Ojara, Catriona Waitt
BMC Medical Ethics, 21 December 2024
Open Access
Abstract
Background
Appropriate language use is essential to ensure inclusion of diverse populations in research. We aimed to identify possible language-related barriers regarding the informed consent process and propose interventions to improve clarity and understanding of pregnant and breastfeeding women participating in research.
Methods
A cross-sectional qualitative study employing focus group discussions (FGD) was conducted in Uganda from August 2023 to September 2023, involving a diverse group of stakeholders from the community, including community members, research participants, and Community Advisory Board members. 19 FGD comprised adult participants representing at least six different mother tongues (Luganda, Acholi, Runyankole, Runyoro, Lugbara and English). An inductive thematic approach was utilized for data analysis using NVivo version 12 software to identify language factors that influence informed consent. A series of community validation workshops ensured concurrence.
Results
At the individual level, language barriers, and low levels of literacy contributed to poor comprehension, thus hindering ability to achieve genuine informed consent. At the health facility level, participants reported that there was use of inappropriate, unclear language including inaccurate translations, with poor and complicated grammar in some consent forms. Participants reported that complex medical terminologies are difficult to translate to local languages. Community members highlighted that social/cultural norms in language use affected cultural perceptions of informed consent. To enhance understanding for individuals without education in science, participants suggested simplification of terminologies and avoidance of complex medical jargon. Researchers should identify participants’ preferred languages and communicate in those languages whenever possible. If researchers are not fluent, trained interpreters should be identified. Informed consent documents must be translated into local languages to ensure participants comprehend the study’s purpose, procedures, risks, and benefits. Involving community members during development and translation of these documents can provide valuable insights into local dialects and culturally specific concepts, ensuring that study tools like surveys and consent forms are accurate and respectful.
Conclusion
Language barriers influence the informed consent process within communities in Uganda. These can potentially be resolved at individual, health system and community levels. Consideration of locally understandable terms in community-facing study documentation is likely to enhance understanding and could improve research participation, although further studies are needed to assess these. The use of appropriate language ensures that informed consent is genuine in keeping with principles of Good Clinical Practice, and developing a research communication strategy should be part of inclusive research design.
Patients’ satisfaction with the preoperative informed consent in elective gynecological surgery in a tertiary hospital, BMA
Patients’ satisfaction with the preoperative informed consent in elective gynecological surgery in a tertiary hospital, BMA
Thossaporn Chuaysatit, Apichaya Pradyachaipimol, Jiraporn Luengmettakul
Thai Journal of Obstetrics and Gynaecology, 18 December 2024
Abstract
Objectives
This study aimed to evaluate patients’ satisfaction with the preoperative informed consent process in elective gynecological surgery.
Materials and Methods
This cross-sectional study was conducted at Charoenkrung Pracharak Hospital, Bangkok, Thailand, from October 2023 to May 2024. Personal data and satisfaction with the preoperative informed consent process were collected on the second postoperative day. The Thai version of the Decisional Satisfaction Scale (DSS) was used to measure the satisfaction and the Informed Consent Process Questionnaire was used to assess knowledge of surgery and perception of informed consent process. Bivariate associations between highly satisfied and not highly satisfied groups were tested using Fisher’s exact test.
Results
A total of 178 participants were enrolled, with mean age of 42.48 years. Most participants agreed or strongly agreed with the statements on the DSS, a mean total score was 27.87, indicating high overall satisfaction. 135 patients (75.8%) were highly satisfied with the informed consent process. There were several factors with significant differences between the highly satisfied group and not highly satisfied group. These included being informed about the consequences of not undergoing the procedure, knowing enough about the procedure to explain it, being informed about the reasons for prolonged urine catheterization and being given the opportunity to refuse the procedure.
Conclusion
This study highlights the critical role of an effective informed consent process in elective gynecological surgery. High patient satisfaction is achieved when communication and patient participation are prioritized. Future research should explore these dynamics in different settings and diverse populations.
Center for Informed Consent Integrity 