Demonstrated Consent and the Common Good: On Withdrawal of Consent in Stem Cell Research
Open Peer Commentaries
Tijs Rosema, Martine de Vries, Hanna Lammertse, Roland Bertens, Nienke de Graeff
American Journal of Bioethics, 7 April 2025
Excerpt
Barnes et al. (Citation2025) argue that demonstrated consent enhances donor autonomy. This is because demonstrated consent offers donors “ongoing accessibility of information according to donor preferences” and so gives donors “actionable rights to reassess or withdraw consent” (Barnes et al. Citation2025, 99).
Since demonstrated consent uses broad consent as default, it allows researchers to conduct various research projects based on a single initial consent procedure, and so helps contribute to societal interests (Barnes et al. Citation2025). Therefore, demonstrated consent meets the so-called “balance criterion” which Barnes et al. (Citation2025) introduced to underline that informed consent frameworks should also balance donor autonomy with broader societal interests, including progress in science and medicine.
But what does the balance criterion imply for situations in which donor autonomy leads to significant negative consequences for societal interests? This question may arise when donors withdraw their consent. By taking stem cell research as an example, we reason that although demonstrated consent enhances donor autonomy, the exercise of donor autonomy by withdrawing consent should not always lead to the discontinuation of research.
We argue that the right of withdrawal can be limited in stem cell research if a donor is properly informed about limits of withdrawal when providing initial consent. Additionally, we see opportunities for demonstrated consent to compensate for this proposed limitation of donor autonomy. We thus provide a more detailed elaboration on demonstrated consent and the balance criterion in the context of stem cell research…
Month: May 2025
On the Complexities of Enabling Demonstrated Consent
On the Complexities of Enabling Demonstrated Consent
Open Peer Commentaries
Panagiotis Alexiou, Joel Azzopardi, Claude Julien Bajada, Jean-Paul Ebejer, Gillian M. Martin, Nikolai Paul Pace
American Journal of Bioethics, 7 April 2025
Excerpt
Barnes et al. (Citation2025) introduce a novel vision for biobanking consent in their article “Enabling Demonstrated Consent for Biobanking with Blockchain and Generative AI.” Their concept of “demonstrated consent” leverages blockchain technology and non fungible tokens, along with large language models to enhance transparency and participant engagement. We put this novel framework in context of existing approaches, and highlight some key questions that arise.
The central question that Barnes et al. seek to address is the inherent limitations of the following two traditional consent models in biobanking, namely:
- Study-specific consent: A type of consent where individuals give permission for the use of their bio-samples and data to be used in a single, well defined, research project. While ethically robust, it is often impractical in the context of long-term biobanking due to the increased administrative burden and inflexibility.
- Broad consent: A type of consent where individuals allow their bio-samples and data to be used in future, sometimes unspecified, research projects, with few or no specific restrictions. Importantly, without the need to be re-contacted or consulted. This approach is more efficient, but can undermine the autonomy of participants by failing to provide sufficient information about future research uses. Broad consent needs to be paired with strategies of risk mitigation, and continuous provision of information to participants.
In response to these challenges, various alternative models have been proposed, including tiered informed consent (Tiffin Citation2018), meta-consent (Ploug and Holm Citation2016), and dynamic consent (Kaye et al. Citation2015; Budin-Ljøsne et al. Citation2017) These models try to increase the involvement of participants, but are vulnerable to issues similar to study-specific consent. Dynamic consent in particular, has gained traction as a means of allowing participants to dynamically update their consent preferences in real time, thus tailoring their participation to studies based on their preferences. Individuals however, have to constantly manage their consent, leading to potential choice overload and consent fatigue. The “demonstrated consent” model proposed by Barnes et al. aims to circumvent these issues by providing a secure, transparent, and easily accessible source of information, without requiring participants to continuously manage their preferences. The central contribution of this manuscript is the proposed integration of non-fungible tokens (NFTs) and large language models (LLMs) to tackle these issues…
Challenges to Demonstrated Consent in Biobanking: Technical, Ethical, and Regulatory Considerations
Challenges to Demonstrated Consent in Biobanking: Technical, Ethical, and Regulatory Considerations
Open Peer Commentaries
Jasmine E. McNealy, Megan Doerr
American Journal of Bioethics, 7 April 2025
Excerpt
We read with interest Barnes and colleagues’ recent article, “Enabling Demonstrated Consent for Biobanking with Blockchain and Generative AI” (Barnes et al. 2025). We appreciate their efforts to succinctly ground their proposal within consent scholarship and their distillation of the ethical challenges of informed consent for repository contexts. Like many, we are vocal advocates for improving the informed consent process, especially within repository enabled research (Doerr et al. 2021). We also strongly support the creative use of technology to mitigate consent’s shortcomings (Moore et al. 2017; Kraft and Doerr 2018). However, we are concerned that Barnes et al.’s proposal faces several critical technical challenges to implementation, does not account for key features of repository enabled research, and adds novel regulatory concerns to the mix…
Narrative Transparency in AI-Driven Consent
Narrative Transparency in AI-Driven Consent
Open Peer Commentaries
Jarrel De Matas, Jiefei Wang, Vibhuti Gupta
American Journal of Bioethics, 7 April 2025
Excerpt
As artificial intelligence (AI) systems become more prevalent, ethical inquiry into transparency, trust, and patient autonomy must develop with similar pace. One area where such inquiry required is in the process of obtaining informed consent, particularly in a biobanking context, where participants are asked to share their biological data for research purposes. Although Barnes et al. (Citation2025) proposes using blockchain and AI to improve transparency and engagement in biobanking through demonstrated consent, their approach lacks a concrete framework: informed consent should not only be considered a transactional process, as Manson and O’Neill (Citation2007) argue, but more importantly a user-centered, communicative act that requires participants to understand complex information, balance risks and benefits, and make decisions that overlap with their values and preferences. To complement what we identify in Barnes et al. (Citation2025) as an overstatement of the transactional approach to informed consent, we suggest a Narrative Transparency Framework. This framework applies storytelling principles to drive AI-assisted consent processes and aims to improve decision-making, enhance understanding, and foster trust by enhancing personalized, ethically framed, and user-adaptive narratives. In this paper, we explore the theoretical basis of narrative transparency which is premised on the role of narrative structure in shaping participant understanding and decision-making. We also outline the components of the Narrative Transparency Framework and discuss practical strategies for utilizing narrative-driven AI consent interactions…
Consent Is Dead, Long Live Ethical Oversight: Integrating Ethically Sourced Data into Demonstrated Consent Models
Consent Is Dead, Long Live Ethical Oversight: Integrating Ethically Sourced Data into Demonstrated Consent Models
Open Peer Commentaries
Jean-Christophe Bélisle-Pipon, Vardit Ravitsky
American Journal of Bioethics, 7 April 2025
Excerpt
Barnes et al. (Citation2025) propose a demonstrated consent model that seeks to address challenges in modern biomedicine by transforming consent from a static, one-time transaction into a dynamic process. Their model integrates blockchain technology with generative artificial intelligence (AI) to allow donors to monitor the use of their biological samples in real time and adjust their preferences as research evolves. This approach helps to respond to the limitations of traditional consent frameworks—a concern echoed by Evans and Bihorac (Citation2024), who note that “informed consent for data use, as conceived in the 1970s, seems dead.” They argue that modern computational methods introduce privacy risks not only through direct data breaches but also via inferences drawn from aggregated data, affecting even those who have not directly consented. Barnes and colleagues’ model embeds increased transparency and user agency into consent processes. However, it also raises ethical questions: Does this approach truly empower donors, or might it overwhelm them with technical complexity? Can blockchain’s transparency and AI’s capacity to personalize consent overcome systemic inequities, or will they obscure deeper structural imbalances? These questions are essential to assessing whether demonstrated consent can adequately safeguard autonomy, privacy, and justice in biomedical research…
Informed Consent: An Essential Tool for Medical Practice and Research
Informed Consent: An Essential Tool for Medical Practice and Research
Review Article
Sukhvinder Singh Oberoi, Nilima Sharma, Sweta Rastogi, Sunil Kumar, Anand Suresh
Amrita Journal of Medicine, April-June 2025
Abstract
The concept of informed consent regulates the relationship between medical practice and patients, promoting human rights and dignity. It serves as both a legal and ethical mechanism for ensuring autonomy and self-determination. This review examines the concept of informed consent as it applies to both medical research and clinical practice, addressing its types, prerequisites, limitations, and challenges. Additionally, it explores waiver of consent and the concept of minimal risk in research. The review highlights the importance of shared decision-making (SDM), the barriers to informed consent, and the role of comprehension in the consent process. The discussion emphasizes the need for improvements in informed consent procedures, particularly in enhancing patient understanding and addressing legal and ethical gaps. Future research should focus on refining consent mechanisms to improve their effectiveness in modern healthcare.
Health system-led early consent and direct contact of at-risk relatives: Pilot study results
Health system-led early consent and direct contact of at-risk relatives: Pilot study results
Nora B Henrikson, Aaron Scrol, Jamilyn M Zepp, Melissa L Anderson, Paula R Blasi, John J Ewing, Jane Grafton, James D Ralston, Stephanie M Fullerton, Kathleen A Leppig
Public Health Genomics, 3 April 2025
Abstract
Introduction
At-risk relatives of probands with genetic variants associated with hereditary cancer risk should receive cascade genetic testing. In the U.S., probands are expected to notify their own at-risk relatives, but many relatives never learn of their risk, representing missed opportunity to reduce morbidity and mortality associated with hereditary cancers. Direct contact of relatives could reach relatives not contacted by the proband. We conducted a single-arm, prospective pilot evaluation of a direct contact intervention based on patient and family preferences. Here we report the study’s quantitative results, measured by proband and relative participation in the intervention follow-up survey.
Methods
We recruited adults receiving genetic counseling for inherited cancer risk at one U.S. integrated health system. A genetic counselor offered to contact at-risk relatives. We surveyed probands and relatives at study enrollment and 6-8 weeks and evaluated administrative data to assess the program’s outreach to probands and relatives, its acceptability, and its limited efficacy.
Results
We approached 148 probands before their genetic counseling appointment. 55 (37%) consented to study participation. Of these, 31 completed genetic testing, 29 of whom provided consent to contact 101 relatives. 44% (n=45) of relatives consented to be contacted by the study genetic counselor. Acceptability was high for both groups and no harms were reported. All relatives reached (n=43) received their proband’s test results, including 6 pathogenic/likely pathogenic findings.
Conclusion
A direct contact program was acceptable, reached at-risk relatives and communicated proband test results. Direct contact with early consent of relatives holds promise for future research.
Editor’s Note: Our Center is examining the nuanced underlying issues raised by this important article.
Challenges and Solutions in Implementing Informed Consent in Digital Environments: A Scoping Review
Challenges and Solutions in Implementing Informed Consent in Digital Environments: A Scoping Review
Ramona Schmidt, Ina Schiering, Harald Zwingelberg, Michael Friedewald
IEEE Access, 30 April 2025
Abstract
In times of ubiquitous data collection and processing, the need for privacy and control is stronger than ever. The implementation of informed consent is becoming increasingly important. The obligation to obtain informed consent and the user’s right to information and to refuse or withdraw consent is already defined in the GDPR. Particularly within the mHealth [mental health] sector, where the collection of particularly sensitive health data occurs, the realisation of informed consent presents an important challenge. However, many applications are still not compliant, and companies seem to struggle with the implementation of effective informed consent. This scoping review analyses how the technical implementation of informed consent has been addressed in the literature to date, what challenges need to be overcome when implementing informed consent, and what solutions are proposed and discussed in the current literature on the implementation of informed consent.
Toward Ethical Digital Practices: Guidelines for Consent, Accountability, and Transparency in Anthropology
Toward Ethical Digital Practices: Guidelines for Consent, Accountability, and Transparency in Anthropology
Amber M Plemons, Micayla C Spiros
American Journal of Biological Anthropology, April 2025
Abstract
Objectives
Digital tools and imaging are now common practice in biological anthropology research. Ethical concerns around the management, use, and display of digital human remains are a budding topic of discussion. Currently, there are no formalized discipline-wide guidelines or standards for digital ethics in biological anthropology. To bridge the gap between ethical standards and digital practices, we need to gauge current digital tools and resources used by professionals, as well as the state of ethical codes for professional organizations regarding digital media in biological anthropology.
Materials and methods
This study reviews ethical statements from five professional organizations and survey responses from biological anthropologists on their use and opinions of digital remains. Text analyses were performed on ethics statements to identify terms related to digital remains and on survey responses to identify key themes in opinions of digital ethics.
Results
Results demonstrated that only one organization mentions digital ethics while survey results indicate researchers are creating and using digital tools in their research. Thematic text analyses underline the need for consent, digital ethical guidelines, anonymity, data security, and cultural sensitivity and respect.
Discussion
These results highlight the gap in practice and guidelines for digital ethics. We propose immediate action items, including the development of a cross-cultural, disciplinary working group to generate cohesive digital ethics standards, explicit statements on digital human remains in donor forms, the addition of digital best practice standards into organizations’ ethics codes, and ethics statements added to current digital platforms. These proposed ethical guidelines and questions for donor forms are provided for these action items.
Editor’s Note: “Digital remains” refers to the digital data and information a person leaves behind after death, including online accounts, emails, social media posts, documents, and other digital assets.
Co-designing and pilot-testing an infographic to support the consent process in an adaptive platform trial for adults in ICU with community-acquired pneumonia or COVID-19: a mixed methods study within a trial (SWAT)
Co-designing and pilot-testing an infographic to support the consent process in an adaptive platform trial for adults in ICU with community-acquired pneumonia or COVID-19: a mixed methods study within a trial (SWAT)
Research
Heather K. O’Grady, Kathy Smith, Sandra Dalziel, Barbara Dolanjski, Gyan Sandhu, Marlene Santos, Jackie Bosch, Lyn S. Turkstra, Srinivas Murthy, John C. Marshall, Michelle E. Kho
Research Involvement and Engagement, 25 April 2025
Open Access
Abstract
Background
Informed consent documents educate patients and families about research participation and alternatives. However, given their length and complexity, consent documents can be challenging to understand, particularly in high-stress environments such as the Intensive Care Unit (ICU) and for complex study designs such as platform trials.
Methods
This is an exploratory sequential mixed methods study-within-a-trial (SWAT) of REMAP-CAP (Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia). Phase 1: We conducted focus groups with individuals with lived experience, including ICU survivors, substitute decision makers (SDMs) and research coordinators (RCs) to refine an infographic to augment a priori REMAP-CAP consent encounters. We analyzed data using inductive content analysis. Phase 2: We piloted the infographic with patients/SDMs approached a priori to participate in REMAP-CAP, who could communicate in English, at five sites in Ontario, Canada. We assessed implementation according to 1) eligible consent encounters (number of patients/SDMs eligible for SWAT / approached for REMAP-CAP), 2) receipt of infographic (number of patients/SDMs who received the infographic / eligible consent encounters), 3) consent to participation in this SWAT by patients/SDMs (number of patients/SDMs who consented / those approached), and 4) feedback questionnaire completion (number of patients/SDMs who completed the questionnaire / those who received it).
Results
Phase 1: We conducted two, two-hour focus groups with 5 participants (10 participants total). Participants identified important infographic design considerations (visual presentation, language) and content (study details, participation in research).
Integration: Results from Phase 1 were used to develop a final consent infographic.
Phase 2: Sixty-three patients were eligible for REMAP-CAP during the study period; 21 were eligible (33%) for the SWAT. Of these, 18 patients/SDMs (86%) received the infographic, 17 consented to the SWAT (94%) and 15 (88%) completed questionnaires. RCs completed case report forms for each consent encounter (n = 18, 100%).
Conclusions
We engaged individuals with lived experience to co-design a consent infographic. We achieved three of four pre-specified feasibility objectives during pilot testing of the infographic for a priori REMAP-CAP consent encounters. Although there were fewer eligible consent encounters than anticipated, we identified acceptable rates of infographic delivery, consent to SWAT participation and questionnaire completion.
Center for Informed Consent Integrity 