Attitudes of the Public Toward Consent for Biobank Research in Japan
Masanori Oikawa, Yoshiyuki Takimoto, Akira Akabayashi
Biopreservation & Biobanking, 19 December 2022
Abstract
Background
Parallel to the rapid advancement of biological and information technologies, the role and forms of biobank research have been constantly changing. The ethical, legal, and social implications of consent in biobank research are in a state of flux. This study aimed to clarify current Japanese public preferences regarding the consent model and explore how public attitudes are determined.
Methods
We conducted an online, population-based quantitative survey among Japanese residents aged between 20 and 69 years. Statistical analyses consisted of univariate and multivariate logistic regression.
Results
Of the 1580 respondents, 60.9% preferred autonomy-based consent (specific or dynamic consent) and 23.9% preferred broad-type consent (opt-out or broad consent). Marital status, gender, and privacy concerns were significantly associated with the preference for a consent model.
Conclusions
Our results demonstrated the public’s current preference for autonomy-based consent, including dynamic consent. However, our findings also revealed that approximately half of the respondents considered broad consent as somewhat preferable.

A Preliminary Study to Explore the Informed Consent Approach and the Ethical Challenges in the Malaysian Biobanking for Research
Amnah Azahar, Aimi Nadia Mohd Yusof, Zahir Izuan Azhar
Asian Bioethics Review, 8 November 2022
Open Access
Abstract
Since 2005, Malaysia has established several biobanks to keep in line with the advancement of biomedical research and development of biobanks in other countries such as the UK and the USA. Despite the establishment of several biobanks in Malaysia, little is known about the informed consent approach in biobanking research and its ethical challenges. This study aims to identify the approach in obtaining informed consent in the Malaysian biobanking for research and explore its ethical challenges. Using non-probability purposive sampling, an in-depth interview with the key informants was conducted in Klang Valley. Based on the interviews, broad consent is the main approach used in obtaining informed consent in biobanking for research in Malaysia and five major ethical challenges were identified. These challenges include the informants’ opinion on the current informed consent approach, understanding participants’ rights, the role of the research ethics committee, biobanking governance in Malaysia, and informants’ knowledge and awareness. In summary, there is a lack of understanding among those involved in biobanking on the ethical, legal, and social aspects of biobanking for research in Malaysia.

Improving the Practice of Obtaining Informed Consent for Biobanking in Clinical Settings
Laura Arregui Egido, María Villalobos-Quesada
Biopreservation and Biobanking, 29 September 2022
Abstract
Background
Biobanks form key research support infrastructures that ensure the highest sample quality for scientific research. Their activity must align closely and proportionally to the interests of researchers, donors, and society. Informed consent (IC) is a central tool to guarantee the protection of donors’ rights and interests.
Aim
This study aimed to analyze the challenges of obtaining IC for biobanking in clinical settings and ways to improve this process.
Methods
Biobank Bellvitge University Hospital HUB-ICO-IDIBELL in Barcelona received 8671 IC forms between 2017 and 2020. The mistakes that caused IC forms to be rejected by the Biobank were analyzed. In addition, interventions aimed at physicians to improve the IC process were evaluated through a calculation of the relative risk (RR). Finally, physicians who submitted samples to the Biobank, most of whom are involved in research activities, were surveyed about the barriers to collecting IC and how to improve this process.
Results
During 2017–2020, 19.6% of IC forms were rejected. The most relevant cause of rejection was the use of outdated IC forms, followed by missing patient information or mistakes having been made by the physician. Evaluation of the rejection rates before and after interventions to improve the IC process suggests significant improvement (27.7% before interventions (January 2017–May 2018) compared to 9.6% after interventions (February–December 2020), RR 0.4 95% CI 0.34–0.47; p < 0.0001). According to the physicians, the most important barrier to collecting IC is the time constraint, and they consider digitalization as a viable solution.
Conclusions
Our research offers a view of the less well-understood practical challenges that physicians and biobanks face when collecting IC in clinical settings. It suggests that, despite multiple challenges, continuous monitoring, training, and information programs for physicians are key to optimizing the IC process in clinical settings.

Blanket Consent and Trust in the Biobanking Context
Original Research
Morten Ebbe Juul Nielsen, Nana Cecilie Halmsted Kongsholm
Journal of Bioethical Inquiry, 6 September 2022
Abstract
Obtaining human genetic samples is vital for many biobank research purposes, yet, the ethics of obtainment seems to many fraught with difficulties. One key issue is consent: it is by many considered ethically vital that consent must be fully informed (at least ideally speaking) in order to be legitimate. In this paper, we argue for a more liberal approach to consent: a donor need not know all the specifics of future uses of the sample. We argue that blanket consent is ethically defensible, and that this is buttressed by considerations of (justified) trust-relations. Given robust institutional oversight, blanket consent is a permissible form of consent in the bio-banking context.

Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process
Deborah Mascalzoni, Roberto Melotti, Cristian Pattaro, Peter Paul Pramstaller, Martin Gögele, Alessandro De Grandi, Roberta Biasiotto
European Journal of Human Genetics, 5 September 2022
Open Access
Abstract
The Cooperative Health Research in South Tyrol (CHRIS) is a longitudinal study in Northern Italy, using dynamic consent since its inception in 2011. The CHRIS study collects health data and biosamples for research, and foresees regular follow-ups over time. We describe the experience with the CHRIS study dynamic consent, providing an overview of its conceptualization and implementation, and of the participant-centered strategies used to assess and improve the process, directly linked to participation and communication. In order to comply with high ethical standards and to allow broadness in the areas of research, CHRIS dynamic consent was conceived as an interactive process: based on a strong governance and an ongoing tailored communication with participants, it aims to promote autonomy and to develop a trust-based engaged relationship with participants, also relevant for retention. Built within an online platform, the consent allows granular choices, which can be changed over time. In a process of co-production, participants views have been investigated and kept into account in policy development. Participants showed a high degree of participation, thus enabling the consolidation of the CHRIS resources. Even though a low change rate was reported in the baseline, participants valued the possibility of changing their informed consent choices. Communication (language-tailored, ongoing, multimedia) was important for participants, and for participation and retention. In our experience, dynamic consent was proven to be a flexible consent model, which allowed to meet ethical and legal standards for participation in research, and to accommodate participants’ and researchers’ needs.

Biobanking and consenting to research: a qualitative thematic analysis of young people’s perspectives
Fabian van der Velden, Lily Gills, Jasmin Broadey, Louise Hayes, Eve Roberts, Jack Courtney, Joanne Ball, Marieke Emonts, Emma Lim
BMJ Archives of Disease in Childhood, 17 August 2022
Abstract
Aims
Biobanking biological samples and consenting patients are common practice in paediatric infectious diseases research. We aimed to gain insight into young people’s knowledge, views and perspectives around current practices of biobanking and consent, in order to improve consent procedures.
Methods
We designed a structured electronic survey aimed at children and young people (CYP), 11-21 years of age, collecting demographic data, and views on biobanking and consent using four scenarios: 1) prospective consent, 2) deferred consent, 3) reconsent and assent age, and 4) animal studies. The survey was disseminated via Young Person’s Advisory Group North England (YPAGne) and other YPAGs social media channels and to the secondary schools of participating young people in this project. Data were analysed utilising a qualitative thematic approach by three independent data reviewers and common themes identified. Triangulation of data by a 4th reviewer occurred independently. Data were collected in two time waves. The second wave ensured data saturation.
Results
102 CYP completed the survey. All were ≥11 years old, the majority between 16-18 years (63.7%, n=65), female (66.7%, n=68), and from North East England and Cumbria (82.4%, n=84). 73 had no prior knowledge of biobanking (72.3%). Prospective consent acceptability for biobanking was high (91.2%, n=93), with main themes being ‘altruism’ and ‘potential benefits outweigh individual risks’. Main themes against were ‘increased risk of complications’ and ‘needle phobia’. Deferred consent acceptability was lower (84.3%, n= 86), common themes were: ‘altruism’, ‘body integrity’, and ‘sample frugality’. Participants state that prospective consent is preferable, but not always appropriate given the clinical situation. Communication is key and it is important to state why deferred consent is needed, and participation can still be declined. Those opposing deferred consent state it violated their integrity and takes away their control over their own body. Reconsent once children reach the age of informed assent was preferred by 76.5% of CYP (n=78), the majority stating an age >14 years as appropriate. 79.2% would want to be informed if their biobanked sample is used in future research (n=80). Just over half agrees with samples being used for animal testing (54.5%, n=55), which goes up to 80.2% (n=81) if explained as the last necessary step prior to human testing for medical research.
Conclusion
Acceptability of prospective and deferred consent for biobanking is high among CYP, with ‘altruism’, ‘frugality’ and ‘body integrity’ as important themes. Justification and clear communication are paramount and assent should be obtained from any CYP with capacity. CYP should be part of the consenting procedure, not just their parent/legal guardian.

Biobanks in the low-and middle-income countries of the Arab Middle East region: challenges, ethical issues, and governance arrangements—a qualitative study involving biobank managers
Research
Ahmed Samir Abdelhafiz, Mamoun Ahram, Maha Emad Ibrahim, Alya Elgamri, Ehsan Gamel, Rania Labib, Henry Silverman
BMC Medical Ethics volume, 14 August 2022; 23(83)
Open Access
Abstract
Background
Biobanks have recently been established in several low-and middle-income countries (LMICs) in the Arab region of the Middle East. We aimed to explore the views of biobank managers regarding the challenges, ethical issues, and governance arrangements of their biobanks.
Methods
In-depth semi-structured qualitative interviews were conducted with a purposive sample of eight biobank managers from Egypt (6), Jordan (1), and Sudan (1). Interviews were performed either face-to-face, by phone, or via Zoom and lasted approximately 45–75 min. After verbal consent, interviews were recorded and then transcribed. The authors performed a thematic analysis of the transcripts independently and then integrated the themes via a consensus process.
Results
Biobank managers discussed the main challenges in establishing their biobanks. These included the staff’s lack of experience and training, limited funds, deficit awareness of biobanks, obtaining funding from different sources. Only four reported they were active in distributing biospecimens and health data to researchers. Six biobanks used a broad consent model, one used tiered consent, and another allowed participants to opt-out of being recontacted. Five managers avoided partnerships with pharmaceutical companies due to concerns with unfavorable reactions from the community. Five managers did not have clear policies for returning research results to the donors. Five expressed challenges with sample and data sharing with international collaborators; all five used material transfer agreements. The biobank managers revealed variable governance arrangements and activities with community involving awareness and educational efforts rather than active engagement. Several expressed the importance of transparency with the operations of their biobanks and gaining the trust of their stakeholders.
Conclusion
Managers of biobanks in LMICs in the Arab Middle East encounter financial, operational, and social challenges toward their sustainability efforts. Discussions with key stakeholders are warranted to manage ethical issues involving informed consent, privacy, data sharing, and the return of results. We recommend that biobank managers in the Arab Middle East form collaborative networks within the region and internationally, develop trusting governance relationships with their stakeholders, and pursue engagement activities with their communities to enhance trust.

Biological sample donation and informed consent for neurobiobanking: Evidence from a community survey in Ghana and Nigeria
Research Article
Arti Singh, Oyedunni Arulogun, Joshua Akinyemi, Michelle Nichols, Benedict Calys-Tagoe, Babatunde Ojebuyi, Carolyn Jenkins, Reginald Obiako, Albert Akpalu, Fred Sarfo, Kolawole Wahab, Adeniyi Sunday, Lukman F. Owolabi, Muyiwa Adigun, Ibukun Afolami, Olorunyomi Olorunsogbon, Mayowa Ogunronbi, Ezinne Sylvia Melikam, Ruth Laryea, Shadrack Asibey, Wisdom Oguike, Lois Melikam, Abdullateef Sule, Musibau A. Titiloye, Isah Suleiman Yahaya, Abiodun Bello, Rajesh N. Kalaria,Ayodele Jegede,  Mayowa Owolabi, Bruce Ovbiagele, Rufus Akinyemi
PLOS One, 11 August 2022
Open Access
Abstract
Introduction
Genomic research and neurobiobanking are expanding globally. Empirical evidence on the level of awareness and willingness to donate/share biological samples towards the expansion of neurobiobanking in sub-Saharan Africa is lacking.
Aims
To ascertain the awareness, perspectives and predictors regarding biological sample donation, sharing and informed consent preferences among community members in Ghana and Nigeria.
Methods
A questionnaire cross-sectional survey was conducted among randomly selected community members from seven communities in Ghana and Nigeria.
Results
Of the 1015 respondents with mean age 39.3 years (SD 19.5), about a third had heard of blood donation (37.2%, M: 42.4%, F: 32.0%, p = 0.001) and a quarter were aware of blood sample storage for research (24.5%; M: 29.7%, F: 19.4%, p = 0.151). Two out of ten were willing to donate brain after death (18.8%, M: 22.6%, F: 15.0%, p<0.001). Main reasons for unwillingness to donate brain were; to go back to God complete (46.6%) and lack of knowledge related to brain donation (32.7%). Only a third of the participants were aware of informed consent (31.7%; M: 35.9%, F: 27.5%, p<0.001). Predictors of positive attitude towards biobanking and informed consent were being married, tertiary level education, student status, and belonging to select ethnic groups.
Conclusion
There is a greater need for research attention in the area of brain banking and informed consent. Improved context-sensitive public education on neurobiobanking and informed consent, in line with the sociocultural diversities, is recommended within the African sub region.

Perspectives from a Predominantly African American Community about Biobank Research and a Biobank Consent Form
Laura K. Sedig, E. Hill De Loney, Sarah B. Bailey, Kayte Spector-Bagdady, Bianca Ghita, Lydia Koh Krienke, Raymond Hutchinson
Ethics & Human Research, 8 July 2022; 44(4) pp 26-33
Abstract
Minority populations have been underrepresented in clinical trials, as well as in research biobanks that are created to conduct research with participants’ biospecimens and related medical and research data. Biobank research raises issues about informed consent and privacy and the confidentiality of participants’ personal data. Our study involved three focus groups of 10 adults each that were conducted in a medically underserved, predominantly African American community to elucidate questions and concerns regarding an institutional biobank. Transcripts from the discussion were qualitatively analyzed. Three main themes that arose from the focus groups included the importance of trust, the importance of the community in research, and suggestions to improve trust. The concerns identified in this study provide a starting point for future research to help research institutions become more trustworthy to the communities they serve.