Infrastructuring Readability: Framing and Overflowing in Writing Assistant Software for Biomedical Research Informed Consent Forms
Research article
Loïc Riom, Solène Gouilhers, Claudine Burton-Jeangros
Science, Technology, & Human Values, 8 October 2024
Open access
Abstract
This article analyzes the development process of a software solution designed to assist researchers in writing biomedical research–informed consent forms. Funded by a Swiss ethics committee, the purpose of the software is to enhance the readability of such documents to improve biomedical research participants’ understanding of the information disclosed therein and to reduce the editing work of research ethics committees. Drawing on an embedded ethnographic research, we show how concerns that emerge in ethics reviews shape ethics committee IT infrastructure and how, in turn, this infrastructure contributes to redefining research ethics. We demonstrate that while the software reinforces the biomedical framing of research ethics, it also generates unexpected overflows. By forming new collectives, this infrastructuring process furthers expertise on informed consent forms while giving rise to new areas of inquiry and redefining the issue of readability in biomedical research. Thus, we provide insights into the complex entanglements between research ethic, computer programs, and writing practices. We conclude by reflecting on the role played by our research team during the software’s development and outline proposals on how ethnographic methods can contribute to make research ethics review accountable.
Data professionals’ attitudes on data privacy, sharing, and consent in healthcare and research
Data professionals’ attitudes on data privacy, sharing, and consent in healthcare and research
Research Article
Katya Kaplow,Max Downey, Darren Stewart, Allan B. Massie, Jennifer D. Motter, Lauren Taylor, John Massarelli, Taylor Matalon, Carolyn Sidoti, Macey L. Levan, Brendan Parent
Digital Health, 22 October 2024
Open Access
Abstract
Objective
Individuals who work on health data systems and services are uniquely positioned to understand the risks of health data collection and use. We designed and conducted a survey assessing the perceptions of those who work with health data around health data consent, sharing, and privacy practices in healthcare and clinical research.
Methods
A 43-item online survey was distributed via a market research firm to individuals (18+) who work with health data in the United States from March to April 2023. Descriptive statistics were calculated for all variables. Associations with demographic variables were assessed using Pearson’s X2 tests and ordinal logistic regression.
Results
Most of our respondents (61.7%) reported that they would trust people to use their health data across various sectors, but more respondents trusted those working in academic medical research (86.5%) and healthcare offices (89.9%) compared to those working in industry (68.2%). Despite this reported trust, a strong majority believed that individuals should have complete control over their health data (97.3%), specific consent should be obtained for each use of their health data (92.0%), and that there should be higher standards of consent and privacy for health records data than other types of data (93.7%).
Conclusions
Based on our findings, we might infer that people who work with health data generally trust institutions across sectors to protect their health data. However, many would prefer to have complete control over who has access to their health data and how it is used. These insights should be explored further through qualitative studies.
Considerations for the Design of Informed Consent in Digital Health Research: Participant Perspectives
Considerations for the Design of Informed Consent in Digital Health Research: Participant Perspectives
Research article
Brian J. McInnis, Ramona Pindus, Daniah Kareem, Camille Nebeker
Journal of Empirical Research on Human Research Ethics, 14 October 2024
Abstract
The research team, prospective participants, and written materials all influence the success of the informed consent process. As digital health research becomes more prevalent, new challenges for successful informed consent are introduced. This exploratory research utilized a human centered design process in which 19 people were enrolled to participate in one of four online focus-groups. Participants discussed their experiences with informed consent, preferences for receiving study information and ideas about alternative consent approaches. Data were analyzed using qualitative methods. Six major themes and sixteen sub-themes were identified that included study information that prospective participants would like to receive, preferences for accessing information and a desire to connect with research team members. Specific to digital health, participants expressed a need to understand how the technologies worked and how the volume of granular personal information would be collected, stored, and shared.
Trust and Inclusion in Digital Health: The Need to Transform Consent
Trust and Inclusion in Digital Health: The Need to Transform Consent
Brief Communication
Celia Brightwell, Stefanie Brückner, Orit Halpern, Stephen Gilbert
Digital Society, October 2024
Open Access
Abstract
As health systems increasingly adopt digital solutions, such as remote monitoring and telemedicine, the use of health apps is becoming increasingly widespread. Meanwhile, data protection regulations and digital transformation initiatives are making the individual responsible for protecting their health data. In this brief communication, we focus on how the consent interface in a health app can impact trust and inclusion in digital health for privacy-sensitive people. As the consent interface determines how an individual’s health data can be used in medical research, it represents a critical point between the citizen’s right to informational self-determination and the potential public benefit of advances in medical science. We find that app developers’ interests in controlling access to health data may influence the design of the consent interface and undermine an individual’s ability to understand what they are consenting to. We describe how a standardized consent interface applied to health apps could foster a trusting relationship between individuals and the digital transformation of healthcare.
Biobank consent under the GDPR: are potential sample donors informed about all lawful uses of biobank data?
Biobank consent under the GDPR: are potential sample donors informed about all lawful uses of biobank data?
Emmi Kaaya
Medicine, Health Care and Philosophy, 8 October 2024
Abstract
This paper analyses the information disclosures in two biobank consent documents used by biobanks operating under the General Data Protection Regulation (GDPR). The aim of the analysis is to investigate how these documents inform potential sample donors about possible future uses of biobank data. The findings suggest that the consent documents provide potentially misleading information regarding the range of possible future uses of biobank data. Based on these information disclosures, potential sample donors may reasonably believe that the data can only be used for a narrowly defined range of research purposes. However, the range of lawful uses of the data is much broader and less clearly defined. Consent provided based on misleading information is not morally transformative, even if it were legally valid. To facilitate morally transformative biobank consent, this paper provides two recommendations for information disclosure to potential sample donors regarding future uses of biobank data: first, potential sample donors should be informed about the legal scope of consent; and second, they should be informed about the full range of lawful uses of biobank data.
Biobanking, digital health and privacy: the choices of 1410 volunteers and neurological patients regarding limitations on use of data and biological samples, return of results and sharing
Biobanking, digital health and privacy: the choices of 1410 volunteers and neurological patients regarding limitations on use of data and biological samples, return of results and sharing
Emilia Giannella, Josep Miquel Bauça, Simona Gabriella Di Santo, Stefano Brunelli, Elisabetta Costa, Sergio Di Fonzo, Francesca Romana Fusco, Antonio Perre, Valerio Pisani, Giorgia Presicce, Francesca Spanedda, Giorgio Scivoletto, Rita Formisano, Maria Grazia Grasso, Stefano Paolucci, Domenico De Angelis, Giulia Sancesario
BMC Medical Ethics, 27 September 2024
Open access
Abstract
Background
The growing diffusion of artificial intelligence, data science and digital health has highlighted the role of collection of data and biological samples, thus raising legal and ethical concerns regarding its use and dissemination. Further, the expansion of biobanking, from the basic collection of frozen specimens to the virtual biobanks of specimens and associated data that exist today, has given a revolutionary potential on healthcare systems, particularly in the field of neurological diseases, due to the inaccessibility of central nervous system and the need of non-invasive investigation approaches. Informed Consent (IC) is considered mandatory in all research studies and specimen collections, and must specifically take into account the ethical respect to the individuals to whom the used biological material and data belong.
Methods
We evaluated the attitudes of patients with neurological diseases (NP) and healthy volunteers (HV) towards the donation of biological samples to a biobank for future research studies on neurological diseases, and limitations on the use of data, related to the requirements set by the General Data Protection Regulation (GDPR). The study involved a total of 1454 subjects, including 502 HVs and 952 NPs, recruited at Santa Lucia Foundation IRCCS, Rome, from 2020 to 2024.
Results
We found that (i) almost all subjects agreed with the participation in biobanking (ii) and authorization to genetic studies (HV = 99.1%; NP = 98.3%); Regarding the return of results, (iii) we found a statistically significant difference between NP and HV, the latter preferring not to be informed of potential results (HV = 43%; NP = 11.3%; p < 0.0001); (iv) a small number limited the sharing inside European Union (EU) (HV = 4.6%; NP = 6.6%), whereas patients were more likely to refuse transfer outside EU (HV = 7.4%; NP = 10.7% p = 0.05); (v) nearly all patients agreed with the use of additional health data from EMR for research purposes (98.9%).
Conclusions
Consent for the donation of material for research purposes is crucial for biobanking and biomedical research studies that use biological material of human origin. Here, we have shown that choices regarding participation in a neurological biobank can be different between HVs and NPs, even if the benefit for research and scientific progress is recognized. NP have a strong interest in being informed of possible results but limit sharing of samples, highlighting a perception of greater individual or relative benefit, while HV prefer a wide dissemination and sharing of data but not to have the return of the results, favoring a possible benefit for society and knowledge. The results underline the need to carefully manage biological material and data collected in biobanks, in compliance with the GDPR and the specific requests of donors.
Public Perspectives on Consent for and Governance of Biobanking in Japan
Public Perspectives on Consent for and Governance of Biobanking in Japan
Research Article
Masanori Oikawa, Yoshiyuki Takimoto
Journal of Empirical Research on Human Research Ethics, 27 September 2024
Abstract
Through strengthened biobank governance, broad consent has been widely accepted as a means to replace donors’ discretion based on the information of individual research protocols. Trust and other ethical and social notions, such as reciprocity and solidarity, are key concepts that support biobank governance. The types of allowed broad consent are several; however, they remain unclear, and whether these ethical and social notions are associated with public attitudes toward the consent model is not fully understood. This quantitative study examined two hypotheses: narrower and limited broad consent are more accepted by the public, and acceptance rates for broad consent increase with established measures related to biobank governance. This analysis supported both hypotheses, implying that the limited type of broad consent should be considered an important option, and that a specific type of governance is critical in promoting trust, reciprocity, and solidarity between biobanks and the public.
On the exercise of the right to withdraw consent by human genetic resources providers
On the exercise of the right to withdraw consent by human genetic resources providers
Qi Su, Jing Zhang, Ping Wang`
Chinese Medical Ethics, 2024; 37(8) pp 896-902
Abstract
To fully respect the true meaning and self-determination of human genetic resources providers, the Regulation on the Administration of Human Genetic Resources gives the providers the right to withdraw unconditionally at any time, that is, the right to withdraw consent. “Withdraw unconditionally at any time” means that the providers have the right to withdraw their consent at any stage without any adverse consequences. To ensure that the right to withdraw the consent of human genetic resources providers can be realized under the rule of law, adequate information should be provided to ensure the provider’s right to know, institutional management systems and withdrawal mechanisms should be established, and ethical reviews should be strengthened, which will ultimately produce legal effects, such as providers’ termination of participation, the destruction or deletion of genetic resources and no further use.
Editor’s note: This is a Chinese language publication from Xi’an Jiaotong University.
Comparing comprehension of consent document between adolescent girls and caregivers of adolescents in Siaya County, Kenya: implications for research with adolescents
Comparing comprehension of consent document between adolescent girls and caregivers of adolescents in Siaya County, Kenya: implications for research with adolescents
Research article
Jacob Onyango, Gift-Noelle Wango, Nicky Okeyo, Lennah Oluoch, Harsha Thirumurthy, Millicent Omoya, Nancy Ounda, Dickens Omondi, Kawango Agot
Research Ethics, 16 October 2024
Open access
Abstract
Despite their vulnerability, adolescents are often excluded from health research due to ethical concerns about research with minors, especially in low-income regions like Sub-Saharan Africa. We enrolled adolescent girls aged 15–17 years and caregivers of girls of the same age. Using a 25-question Comprehension Score Sheet, we applied a quantitative approach to compare the comprehension of informed consent of 33 adolescent girls and 41 caregivers of adolescent girls aged 15–17 years. The assessments were audio-recorded and reviewed for quality check. The results showed that adolescent girls were significantly better than caregivers in comprehending informed consent information overall and specifically on study procedures, voluntarism and study purpose. This suggests that adolescents can understand informed consent information at the same level as or better than caregivers who are entrusted with providing permission for adolescents to participate in research.
Developing best practice guidance for educational psychologists gaining consent across the 0-25 age range
Developing best practice guidance for educational psychologists gaining consent across the 0-25 age range
Althea Lyons, George Thomas, Sean Octigan, Joe Orme
Educational Psychology in Practice, 26 September 2024
Open access
Abstract
Consent is essential for legal and ethical psychological practice. EPs in the UK work with children and young people from ages 0 to 25, meaning that consent gaining practices must take account of the complexities of different professional guidelines, legislation, and case law depending on the age and competence of individual service users. This study used participatory action research to develop consent gaining guidance specific to EPs, considering issues related to children’s rights, parental responsibility, Gillick competence, mental capacity, and data protection. Findings from a preliminary study were used by a stakeholder group of EPs to create draft guidance. The project was guided by a working party comprising a trainee educational psychologist, a main grade EP, a professional body representative and a solicitor specialising in education law. Implications for professional practice and future research are discussed.
Center for Informed Consent Integrity 