Ethical considerations for genetic research in low-income countries: perceptions of informed consent, data sharing, and expectations in Nicaragua
Iris S. Delgado, Abigail Outterson, Vaishnavi Ramesh, Alda Gabriela Amador Sanchez, Alfonso César Boza, Damaris Lopez-Pilarte, Juan José Amador Velázquez, David J. Friedman, Daniel R. Brooks, Madeleine K. Scammell, Catharine Wang
European Journal of Human Genetics, 5 December 2023
Open Access
Abstract
Genetic research presents numerous ethical, legal, and social implications (ELSI), particularly when the research involves collaborations between investigators in high and low-income countries. Some ELSI issues are universal, and others are specific to context and culture. This study investigates perceptions of genetic research in Nicaragua, Central America, where local and U.S. based researchers have collaborated for over a decade. A total of 43 residents from northwestern Nicaragua, a region with high mortality rates attributed to chronic kidney disease of non-traditional causes (CKDnt), were interviewed, including research participants in ongoing studies (n = 36), health professionals (n = 3), labor leaders (n = 2), and family members of research participants (n = 2). Questions focused on informed consent, data-sharing, and post-study expectations. Audio recordings of interviews conducted in Spanish were transcribed and translated into English. English transcripts were coded and analyzed using NVivo 12 software. The lack of familiarity with terms in the consent form presented a barrier to participant comprehension of key elements of the genetic research study, raising concerns about the validity of informed consent. Research participants often viewed their participation as access to health care. Health professionals emphasized the importance of long-term partnerships between foreign-based researchers and local health institutions. Leaders and family members recommended that they be informed of research studies and allowed the opportunity to consent, as they felt the benefits and risks of research also apply to them. Our findings identified genetic research practices to be improved upon in order to be more responsive to the contextual realities of collaborators living in low-resource settings.
Month: December 2023
GDPR Requirements for Biobanking Activities Across Europe
GDPR Requirements for Biobanking Activities Across Europe
Book
Editors: Valentina Colcelli, Roberto Cippitani, Christoph Brochhausen-Delius, Rainer Arnold
2023 [Springer]
About this book
The book deals with the effective operation of the rules related to biomedical research and pays attention to the activities of the national legislatures of the 27 Member States in the field of scientific research. This multilevel system has an impact on biobanking activity. The book answers questions realized by operators on the main biobanks around the EU in the field of GDPR. The authors and editors used the questions born from brainstorming among members of the Association European, Middle East & Africa for Biopreservation and Biobanking (ESBB) to offer to the operators in biobanking activity and researchers quickly answer to their daily questions, but with authors highest quality. Further the book provides a comprehensive review of the rapidly expanding field of biobanking. It provides researchers and scholars working on biobanking and bio-sharing and more in general in the university hospitals and clinical trial consortiums, and companies, biomedical researchers, but also jurists and the professionals (in particular judges, lawyers, officers) an instrument rigorous but easy to use of the GDPR in the case of biobanking activities. The book identifies a methodological path to tackle the legal or ethical problem on a specific scientific-technological to verify existing solutions and give ideas for future applications. The importance of the legal solution influences the implementation of the development of the biobanking activity service itself.
How to Design Consent for Health Data Research? An Analysis of Arguments of Solidarity
How to Design Consent for Health Data Research? An Analysis of Arguments of Solidarity
Original Article
Svenja Wiertz
Public Health Ethics, 12 December 2023
Excerpt
…Informed consent has been set down as a core ethical requirement for medical research in the Declaration of Helsinki and the Nuremberg Code but was traditionally understood to apply to research with direct involvement of patients. As research without direct involvement of patients—based solely on collected data or biospecimen—becomes more relevant and prevalent, another set of normative requirements, also operating under the name of consent, comes into play: Gefenas et al. have employed the terms of ‘interventional consent’ and ‘informational consent’ to mark this difference. Informational consent, governed in the European Union today mainly under the General Data Protection Regulation (GDPR) sets the legal standards for processing personal data…
In safe hands: child health data storage, linkage and consent for use
In safe hands: child health data storage, linkage and consent for use
Cervantée E K Wild, Ngauru T Rawiri, Ken Taiapa, Yvonne C Anderson
Health Promotion International, 6 December 2023; 38(6)
Abstract
While there is potential for societal benefit from linkage and integration of large datasets, there are gaps in our understanding of the implications for children and young people, and limited inclusion of their views within this discourse. We aimed to understand the views and expectations of children, young people and their parents/caregivers in Aotearoa New Zealand regarding child health data storage, linkage and consent for use. This qualitative study included 24 Māori and non-Māori children, young people and their families across five focus groups, recruited from a community-based health service. A mixed Māori and non-Māori research team facilitated participant recruitment and data collection. Child, adolescent and parent/caregiver groups were held separately. Sessions were audio-recorded and the verbatim transcripts were analysed thematically. We identified three themes: (i) I am more than a number: seeing patients as people; (ii) In safe hands: data as power; and (iii) What are your intentions with my data? Consent as an active relationship. A key challenge was the reductive and stigmatizing potential of data integration for minoritised groups. Hypothetical discussions of data sharing and linkage were contingent on trust between the participant and the health professional, with negotiated data ownership. Consent was conceived as an active relationship needing renewal and renegotiation as children reached adulthood. Current consent processes for ongoing use of child data require further deliberation. Without a strong ethical and child rights-based approach to issues of child health data management, consent and linkage, we risk exacerbating health inequities and experiences of breach of trust.
A systematic review exploring challenges of informed consent processes in antipsychotic prescribing
A systematic review exploring challenges of informed consent processes in antipsychotic prescribing
Review Article
Jemima Thompson, Lisa M. Grünwald
Psychosis, 19 December 2023
Abstract
Introduction
Informed consent is the process whereby individuals make decisions about their medical care. Information provision, presumption of capability and absence of coercion are three fundamental assumptions required to provide informed consent. Informed consent may be complex to achieve in the context of antipsychotic prescribing. This systematic review aimed to explore challenges relating to informed consent processes in antipsychotic prescribing in the UK.
Method
This was a systematic review of the literature relating to informed consent in antipsychotic prescribing in community settings. Data were analysed using Framework analysis.
Results
Twenty-eight articles were included. Information provision has been perceived as lacking for a long time. Capacity has often not been assumed and loss of capacity has sometimes been viewed as permanent. Power imbalances associated with prescriber status and legal framework surrounding the Mental Health Act can blur lines between coercion and persuasion.
Discussion
Challenges relating to process of informed consent in antipsychotic prescribing have persisted throughout the last few decades. People prescribed antipsychotics need to be made aware of their effects in line with current research. Further research is required to develop models for best practices for informed consent.
Equitable and accessible informed healthcare consent process for people with intellectual disability: a systematic literature review
Equitable and accessible informed healthcare consent process for people with intellectual disability: a systematic literature review
Systematic Review
Manjekah Dunn, Iva Strnadová, Jackie Leach Scully, Jennifer Hansen, Julie Loblinzk, Skie Sarfaraz, Chloe Molnar, Elizabeth Emma Palmer
BMJ Quality & Safety, 9 December 2023
Abstract
Objective
To identify factors acting as barriers or enablers to the process of healthcare consent for people with intellectual disability and to understand how to make this process equitable and accessible.
Data sources
Databases: Embase, MEDLINE, PsychINFO, PubMed, SCOPUS, Web of Science and CINAHL. Additional articles were obtained from an ancestral search and hand-searching three journals.
Eligibility criteria
Peer-reviewed original research about the consent process for healthcare interventions, published after 1990, involving adult participants with intellectual disability.
Synthesis of results
Inductive thematic analysis was used to identify factors affecting informed consent. The findings were reviewed by co-researchers with intellectual disability to ensure they reflected lived experiences, and an easy read summary was created.
Results
Twenty-three studies were included (1999 to 2020), with a mix of qualitative (n=14), quantitative (n=6) and mixed-methods (n=3) studies. Participant numbers ranged from 9 to 604 people (median 21) and included people with intellectual disability, health professionals, carers and support people, and others working with people with intellectual disability. Six themes were identified: (1) health professionals’ attitudes and lack of education, (2) inadequate accessible health information, (3) involvement of support people, (4) systemic constraints, (5) person-centred informed consent and (6) effective communication between health professionals and patients. Themes were barriers (themes 1, 2 and 4), enablers (themes 5 and 6) or both (theme 3).
Conclusions
Multiple reasons contribute to poor consent practices for people with intellectual disability in current health systems. Recommendations include addressing health professionals’ attitudes and lack of education in informed consent with clinician training, the co-production of accessible information resources and further inclusive research into informed consent for people with intellectual disability.
A survey of informed consent in patients with dementia in the US and Japan
A survey of informed consent in patients with dementia in the US and Japan
Iijima Yoshihiko
Nagoya Journal of Medical Science, 31 October 2023;
Open Access
Abstract
This study aimed to confirm the reality of family-focused medical treatment of dementia in Japan and the US. It conducted a questionnaire survey on informed consent from patients with dementia among neurologists and psychiatrists in four prefectures in the Tokai Region (Aichi, Gifu, Mie, and Shizuoka) and dementia specialists in the US. Of the responses, 120 (39.7% response rate) and 20 (5.9% response rate) were obtained, respectively. In obtaining informed consent from patients with dementia, 75 Japanese specialists (62.5%) and 16 US specialists (80.0%) regularly assessed patients’ decision-making abilities. The majority of specialists in both Japan and the US used the Mini–Mental State Examination and Hierarchic Dementia Scale-Revised, which are widely used for cognitive function assessment. In the survey, 27 Japanese specialists (22.5%) and 10 US specialists (50.0%) had different considerations when obtaining informed consent for participation in research, compared to their medical practice. The majority of Japanese and US specialists obtained informed consent from both the patient and their family.
‘But, what is a researcher?’ Developing a novel ethics resource to support informed consent with young children
‘But, what is a researcher?’ Developing a novel ethics resource to support informed consent with young children
Julia Truscott, Laura Benton
Children’s Geographies, 12 December 2023
Abstract
Young children are generally unfamiliar with the notion of research, which can generate ethical discomfort when seeking their consent to participate in it. Taking informed consent with young children as a focus, in this viewpoint article we reflect on what it means for young children (aged approximately 3–8 years) to be ‘informed’ in the context of research participation. We then share the process of developing an interdisciplinary, innovative ethics video resource to enhance children’s understanding of research, the researcher role and children’s participation in research. To ensure the resource was understandable and engaging for young children, we drew on existing research literature and other supplementary resources as well as creative storytelling and consultation with children and parents. The animated video, which is freely available online, builds from young children’s own experiences and questions with the aim of better supporting their understandings and upholding their rights through the informed consent process.
Evaluating the Decisional Capacity for Informed Consent of Transition age Children to Adolescence in Human Subject Research
Evaluating the Decisional Capacity for Informed Consent of Transition age Children to Adolescence in Human Subject Research
Research Article
Kamran Salayev, Ulviyya Aslanova, Kerim Munir
Journal of Empirical Research on Human Research Ethics, 10 December 2023
Abstract
This study aimed to evaluate children’s capacity for informed consent. We translated into Azerbaijani language and adapted the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC). We enrolled four healthy groups: children aged 11, 12, and 13 years and adults. We provided the participants with information about the simulated research proposal and a related informed consent form. Subsequently, they were administered the UBACC. The mean total UBACC scores were 11.9 (11-year-olds), 12.7 (12-year-olds), 14.0 (13-year-olds), and 16.0 (adults). The gradual increase in the mean UBACC scores with age suggests the continuous maturation of the capacity to comprehend the informed consent process. There was no specific cutoff age to decide whether the children were competent enough to provide informed consent.
American LGBTIQ+ youth using waived or parent/guardian informed consent: investigating social support and life satisfaction
American LGBTIQ+ youth using waived or parent/guardian informed consent: investigating social support and life satisfaction
Research Article
Sarah Kiperman, Emily Srisarajivakul, Carrie E. Lorig, Carla Kevern
Journal of LGBT Youth, 4 December 2023
Abstract
Minimal research in the United States has investigated how LGBTIQ+ youth who use waived consent– an ethical research method that facilitates inclusion for minors when informed consent poses a barrier– differ from LGBTIQ+ youth who can acquire consent from their parent(s)/guardian(s). The current study surveyed N = 313 American LGBTIQ+ youth, where n = 173 used waived consent and n = 92 used parent consent to participate. Researchers explored how these youth compared regarding their life satisfaction and support experiences across parents/guardians, teachers, close friends, classmates, and people at school. Differences were also investigated using MANOVAs and t-tests among n = 149 cisgender and n = 164 gender diverse (e.g., transgender, genderqueer, gender-nonconforming) LGBTIQ+ youth. While overall life satisfaction was similar among youth with waived and parent consent as well as among youth identifying as cisgender and gender diverse, youth who used parent consent perceived having greater support from their parents/guardians, people at school, and classmates compared to youth who used waived consent. Gender diverse youth reported significantly lower levels of support from parents, classmates, and people at school compared to their cisgender peers. Implications for research and practice are discussed.
Center for Informed Consent Integrity 