Research on informed consent of biological sample biobank
Jun Zheng, Yiting Li, Xin Li
Chinese Medical Ethics, 2025; 38(1) pp 72-77
Abstract
As biological sample biobanks progressively demonstrate their significant value in the field of biomedical research,they also pose challenges to existing social norms and ethical rules,making the normative issue of informed consent of participants highly concerned. The current research has insufficient exploration of informed consent in the collection, preservation,utilization,and other links of the sample. In response to the complexity and diversity of each link,it is advocated to refine informed consent strategies to ensure comprehensive protection of participants’ rights and interests. Given the continuity and dynamism of informed consent,it is recommended to establish a flexible review mechanism to address changes in research content,increased risks,and changes in participant capabilities,ensuring the ethical legitimacy of the research and the autonomy in making decisions of participants. Meanwhile,it is emphasized to fully confirm informed consent before sample entry into the bank, adopt suitable consent forms for outbound utilization and waste disposal,and pay special attention to ethical and legal issues related to human genetic resources.

Editor’s note: This is a Chinese language publication supervised by the Chinese Ministry of Education and sponsored by Xi’an Jiaotong University.

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
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.

Enabling Demonstrated Consent for Biobanking with Blockchain and Generative AI
Caspar Barnes, Mateo Riobo Aboy, Timo Minssen, Jemima Winifred Allen, Brian D. Earp, Julian Savulescu
The American Journal of Bioethics, 5 November 2024
Abstract
Participation in research is supposed to be voluntary and informed. Yet it is difficult to ensure people are adequately informed about the potential uses of their biological materials when they donate samples for future research. We propose a novel consent framework which we call “demonstrated consent” that leverages blockchain technology and generative AI to address this problem. In a demonstrated consent model, each donated sample is associated with a unique non-fungible token (NFT) on a blockchain, which records in its metadata information about the planned and past uses of the sample in research, and is updated with each use of the sample. This information is accessible to a large language model (LLM) customized to present this information in an understandable and interactive manner. Thus, our model uses blockchain and generative AI technologies to track, make available, and explain information regarding planned and past uses of donated samples.

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
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
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.

Addressing the ethical challenges to informed consent for brain tissue donation
Amitabha Palmer
Medicine & Ethics, 10 September 2024
Abstract
The tremendous medical promise of human organoids has led large research institutions and national agencies to create brain tissue banks. In response, regulatory agencies have created regulations that guide consent processes for collecting tissue samples from donors. These regulations are, in part, intended to ensure that donors’ samples are not used in ways that conflict with their moral values, beliefs, and goals. While these regulations frequently serve this purpose well, we argue that they are insufficient in the case of brain tissue donation because of unique ethical concerns that arise from technologies and applications that use brain tissue samples. After considering the inadequacies, we suggest how consent policies can be improved. We focus on US policy specifically because some Caribbean and Latin American countries reference US regulatory frameworks in developing their own.

Ethical, legal, and social implications in research biobanking: A checklist for navigating complexity
Original Article
Olga Tzortzatou-Nanopoulou, Kaya Akyüz, Melanie Goisauf, Łukasz Kozera, Signe Mežinska, Michaela Th. Mayrhofer, Santa Slokenberga, Jane Reichel, Talishiea Croxton, Alexandra Ziaka, Marina Makri
Developing World Bioethics, 10 July 2023
Open Access
Abstract
Biobanks’ activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first–hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four-step checklist aiming to facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU.

Dynamic governance: A new era for consent for stem cell research
Perspective
Rosario Isasi, Heidi B. Bentzen, Morris Fabbri, Antonie Fuhr, Joel C. Glover, Nancy Mah, Deborah Mascalzoni, Sabine Mueller, Stefanie Seltmann, Andreas Kurtz
Stem Cell Reports, 15 August 2024
Open Access
Summary
Governance infrastructures streamline scientific and ethical provenance verification of human pluripotent stem cell (SC) lines. Yet, scientific developments (e.g., SC-derived embryo models, organoids) challenge research governance approaches to stored biospecimens, questioning the validity of informed consent (IC) models. Likewise, e-health platforms are driving major transformations in data processing, prompting a reappraisal of IC. Given these developments, participatory research platforms are identified as effective tools to promote longitudinal engagement, interactive decision-making, and dynamic governance. Learning from European initiatives piloting dynamic IC for biobanking and SC research, this Perspective explores the benefits and challenges of implementing dynamic IC and governance for SC.