Biobanking and consenting to research: a qualitative thematic analysis of young people’s perspectives

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

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

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

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.

Perspectives from a Predominantly African American Community about Biobank Research and a Biobank Consent Form

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 and Human Research, 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.

Personalized medicine and research biobanking: From traditional to new informed consent generating a need for participatory governance [BOOK CHAPTER]

Personalized medicine and research biobanking: From traditional to new informed consent generating a need for participatory governance [BOOK CHAPTER]
Antonella Ficorilli
Personalized Medicine in the Making, 8 March 2022; pp 249-267 [Springer]
Abstract
Emerging personalized medicine necessitates the collection, storage and processing of an increasing number and type of human biological samples and associated data within research biobanks throughout the world, materials and data which will be used in future large-scale health-related studies. Hence, ethical concerns regarding biobanks have increased. Here, issues pertaining to autonomy and privacy will be considered, as well the related debate mainly focused on whether or not maintaining the informed consent model used in traditional health research sufficiently guarantees the dignity and rights of subjects, while at the same time serving as a good tool to obtain an appropriate balance between the research subjects’ interests and the public interest. The present paper aims to illustrate the evolutionary path of ethical reflection in this regard towards new models of informed consent, such as broad consent, dynamic consent, and meta consent. At the same time, this path generates the need for new types of governance that take into account the necessity of involving subjects in the decision-making process, especially in light of advancements in data mining and big data technologies.

Biobank Participants’ Attitudes toward Requiring Understanding for Biobank Consent

Biobank Participants’ Attitudes toward Requiring Understanding for Biobank Consent
T.J. Kasperbauer, Colin Halverson, Abigail Garcia, Karen K. Schmidt, Peter H. Schwartz
Ethics & Human Research, 22 December 2021
Abstract
Biobank participants often do not understand the information they are provided during the informed consent process. Ethicists and other stakeholders have disagreed, however, on the appropriate response to these failures in understanding. This paper describes an attempt to address this issue by conducting knowledge tests with 22 recent biobank enrollees, followed by in-depth, semistructured interviews about the goal of understanding in biobank consent. The interviews revealed that while biobank enrollees thought the information on the knowledge test was important, they did not think that performance on the test should affect whether individuals are permitted to enroll in a biobank. Three main themes emerged from the interviews: helping others by contributing to research is more important than understanding consent forms, less understanding is required because biobank-based research is low risk, and only a small amount of information in the consent form is really essential. These perspectives should be considered in discussing the ethics and governance of biobank consent processes.

Harmonising the human biobanking consent process: an Irish experience

Harmonising the human biobanking consent process: an Irish experience
Open Letter
Lydia O’Sullivan, Tomás Carroll, Niamh Clarke, Sarah Cooper, Ann Cullen, Laura Gorman, Billy McCann, Blánaid Mee, Nicola Miller, Verena Murphy, Máiréad Murray, Jackie O’Leary, Sharon O’Toole, Emma Snapes, Suzanne Bracken
HRB Open Research, 17 September 2021; 4(96)
Open Access
Abstract
Biobanks are repositories of human biological samples and data. They are an important component of clinical research in many disease areas and often represent the first step toward innovative treatments. For biobanks to operate, researchers need human participants to give their samples and associated health data. In Ireland, research participants must provide their freely given informed consent for their samples and data to be taken and used for research purposes. Biobank staff are responsible for communicating the relevant information to participants prior to obtaining their consent, and this communication process is supported by documentation in the form of Participant Information Leaflets and Informed Consent Forms (PILs/ICFs). PILs/ICFs should be concise, intelligible, and contain relevant information. While not a substitute for layperson and research staff discussions, PILs and ICFs ensure that a layperson has enough information to make an informed choice to participate or not. However, PILs/ICFs are often lengthy, contain technical language and can be complicated and onerous for a layperson to read. The introduction of the General Data Protection Regulation (GDPR) and the related Irish Health Research Regulation (HRR) presented additional challenges to the Irish biobank community. In May 2019, the National Biobanking Working Group (NBWG) was established in Ireland. It consists of members from diverse research backgrounds located in universities, hospitals and research centres across Ireland and a public/patient partner. The NBWG aimed to develop a suite of resources for health research biobanks via robust and meaningful patient engagement, which are accessible, GDPR/HRR-compliant and could be used nationally, including a PIL/ICF template. This open letter describes the process whereby this national biobank PIL/ICF template was produced. The development of this template included review by the Patient Voice in Cancer Research, led by Professor Amanda McCann at University College Dublin and the Health Research Data Protection Network.

Collecting Biospecimens and Obtaining Biobank Consent From Patients in an Academic Health Care Setting

Collecting Biospecimens and Obtaining Biobank Consent From Patients in an Academic Health Care Setting
T.J. Kasperbauer, Amy Waltz, Brenda Hudson, Bridget Hawryluk, Courtney Moore, Karen Schmidt,
Peter H. Schwartz
Academic Medicine, 14 September 2021
Abstract
Academic health centers and health systems increasingly ask patients to enroll in research biobanks as part of standard care, raising important practical and ethical questions for integrating biobank consent processes into health care settings. This article aims to assist academic health centers and health systems considering implementing these integrated consent processes by outlining the 5 main issues—and the key practical and ethical considerations for each issue—that Indiana University Health and the Indiana Biobank faced when integrating biobank consent into their health system, as well as the key obstacles encountered. The 5 main issues to consider include the specimen to collect (leftover, new collection, or add-ons to clinical tests), whether to use opt-in or opt-out consent, where to approach patients, how to effectively use digital tools for consent, and how to appropriately simplify consent information.

The value of consent for biobanking

The value of consent for biobanking
News & Views
Elizabeth Bromley, Dmitry Khodyakov
Nature Human Behaviour, 23 August 2021
Excerpt
Biobanks facilitate large-scale tests of hypotheses that may advance health, but whether biobanking participants adequately comprehend the potential uses of their data should concern researchers and the public. Consent matters because it provides a singular safeguard and a participatory mechanism to influence science’s production of new forms of power…