From waste product to blood, brains and narratives : developing a pluralist sociology of contributions to health research

Funded by National Institute for Health Research (NIHR) Oxford Biomedical Research CentrePeer reviewedPublisher PD

Public views on the donation and use of human biological samples in biomedical research: a mixed methods study

Objective A mixed methods study exploring the UK general public's willingness to donate human biosamples (HBSs) for biomedical research.<p></p> Setting Cross-sectional focus groups followed by an online survey.<p></p> Participants Twelve focus groups (81 participants) selectively sampled to reflect a range of demographic groups; 1110 survey responders recruited through a stratified sampling method with quotas set on sex, age, geographical location, socioeconomic group and ethnicity.<p></p> Main outcome measures (1) Identify participants’ willingness to donate HBSs for biomedical research, (2) explore acceptability towards donating different types of HBSs in various settings and (3) explore preferences regarding use and access to HBSs.<p></p> Results 87% of survey participants thought donation of HBSs was important and 75% wanted to be asked to donate in general. Responders who self-reported having some or good knowledge of the medical research process were significantly more likely to want to donate (p<0.001). Reasons why focus group participants saw donation as important included: it was a good way of reciprocating for the medical treatment received; it was an important way of developing drugs and treatments; residual tissue would otherwise go to waste and they or their family members might benefit. The most controversial types of HBSs to donate included: brain post mortem (29% would donate), eyes post mortem (35%), embryos (44%), spare eggs (48%) and sperm (58%). Regarding the use of samples, there were concerns over animal research (34%), research conducted outside the UK (35%), and research conducted by pharmaceutical companies (56%), although education and discussion were found to alleviate such concerns.<p></p> Conclusions There is a high level of public support and willingness to donate HBSs for biomedical research. Underlying concerns exist regarding the use of certain types of HBSs and conditions under which they are used. Improved education and more controlled forms of consent for sensitive samples may mitigate such concerns.<p></p&gt

Consent for the use of human biological samples for biomedical research: a mixed methods study exploring the UK public’s preferences

OBJECTIVE: A mixed-methods study exploring the UK general public's views towards consent for the use of biosamples for biomedical research.<p></p> SETTING: Cross-sectional population-based focus groups followed by an online survey.<p></p> PARTICIPANTS: 12 focus groups (81 participants) selectively sampled to reflect a range of demographic groups; 1110 survey responders recruited through a stratified sampling method with quotas set on sex, age, geographical location, socioeconomic group and ethnicity.<p></p> MAIN OUTCOME MEASURES: (1) Views on the importance of consent when donating residual biosamples for medical research; (2) preferences for opt-in or opt-out consent approaches and (3) preferences for different consent models.<p></p> RESULTS: Participants believed obtaining consent for use of residual biosamples was important as it was 'morally correct' to ask, and enabled people to make an active choice and retain control over their biosamples. Survey responders preferred opt-in consent (55%); the strongest predictor was being from a low socioeconomic group (OR 2.22, 95% CI 1.41 to 3.57, p=0.001) and having a religious affiliation (OR 1.36, 95% CI 1.01 to 1.81, p=0.04). Focus group participants had a slight preference for opt-out consent because by using this approach more biosamples would be available and facilitate research. Concerning preferred models of consent for research use of biosamples, survey responders preferred specific consent with recontact for each study for which their biosamples are eligible. Focus group participants preferred generic consent as it provided 'flexibility for researchers' and reduced the likelihood that biosamples would be wasted. The strongest predictor for preferring specific consent was preferring opt-in consent (OR 4.58, 95% CI 3.30 to 6.35, p=0.015) followed by non-'White' ethnicity (OR 2.94, 95% CI 1.23 to 7.14, p<0.001).<p></p> CONCLUSIONS: There is a preference among the UK public for ongoing choice and control over donated biosamples; however, increased knowledge and opportunity for discussion is associated with acceptance of less restrictive consent models for some people.<p></p&gt

Gay and bisexual men’s perceptions of the donation and use of human biological samples for research: a qualitative study

Human biological samples (biosamples) are increasingly important in diagnosing, treating and measuring the prevalence of illnesses. For the gay and bisexual population, biosample research is particularly important for measuring the prevalence of human immunodeficiency virus (HIV). By determining people’s understandings of, and attitudes towards, the donation and use of biosamples, researchers can design studies to maximise acceptability and participation. In this study we examine gay and bisexual men’s attitudes towards donating biosamples for HIV research. Semi-structured telephone interviews were conducted with 46 gay and bisexual men aged between 18 and 63 recruited in commercial gay scene venues in two Scottish cities. Interview transcripts were analysed thematically using the framework approach. Most men interviewed seemed to have given little prior consideration to the issues. Participants were largely supportive of donating tissue for medical research purposes, and often favourable towards samples being stored, reused and shared. Support was often conditional, with common concerns related to: informed consent; the protection of anonymity and confidentiality; the right to withdraw from research; and ownership of samples. Many participants were in favour of the storage and reuse of samples, but expressed concerns related to data security and potential misuse of samples, particularly by commercial organisations. The sensitivity of tissue collection varied between tissue types and collection contexts. Blood, urine, semen and bowel tissue were commonly identified as sensitive, and donating saliva and as unlikely to cause discomfort. To our knowledge, this is the first in-depth study of gay and bisexual men’s attitudes towards donating biosamples for HIV research. While most men in this study were supportive of donating tissue for research, some clear areas of concern were identified. We suggest that these minority concerns should be accounted for to develop inclusive, evidence-informed research protocols that balance collective benefits with individual concerns

Biobank participation of persons with epilepsy in South Wales

Introduction: The Swansea Neurology Biobank (SNB) has collected thousands of DNA bio-samples from people with epilepsy in South Wales. Analysis of biobank participation is important to optimise future recruitment for epilepsy research, meta-data analysis and gene / biomarker discovery. This will lead to a high-quality platform for the collection of biological specimens and data. Method: Participation data was extracted from over 2,500 patient records during SNB screening between 2016 and 2018. Biobank participation rates were calculated and linked to epilepsy prevalence using linked, anonymised primary care within the Secure Anonymised Information Linkage databank. Demographics, epilepsy characteristics and social deprivation status (measured using the Welsh Index of Multiple Deprivation – WIMD) were combined at a small geographical (Lower Super Output Area) scale. Factors hypothesised to influence biobank participation were analysed using bivariate and multivariate statistics. A proportion of biobank participants completed a questionnaire assessing attitudes to biobank consent. Results: 12.5% of people with epilepsy seen at epilepsy clinics within the Swansea area were represented in the SNB in 2018. Epilepsy prevalence in the study area (0.92%) was higher than the all Wales epilepsy prevalence (0.85%) and was highest in the most deprived areas. Older patients were more likely to donate compared to the youngest age grouping. Generalised onset epilepsy was underrepresented in the SNB with only 19% having generalised epilepsy. Nearly 20% of patients did not attend their appointment with the majority (59%) coming from the most deprived areas. A large proportion of non-attenders who had generalised epilepsy were diagnosed with Juvenile Myoclonic Epilepsy. Participation rates were lower in more deprived areas when compared to less deprived areas (36% WIMD quintile 1 compared to 41% quintile 4 and 5). Biobank participants were generally positive about biobank donation but there were uncertainties related to the broad reach of the consent process. Conclusion: Our results highlight the difficulty in encouraging research participation at levels representative of the local epilepsy population. Despite higher epilepsy prevalence in more deprived areas, participation rates are lower and non-attendance rates are higher. Mapping of epilepsy participation enables the identification of these low participation areas enabling focused recruitment strategies. Working with primary care and bringing services to the community may improve recruitment when compared to hospital clinic based recruitment

Public awareness of and attitudes towards research biobanks in Latvia

Background: Public awareness and engagement are among the main prerequisites for protecting the rights of research participants and for successful and sustainable functioning of research biobanks. The aim of our study was to analyse public awareness and attitudes towards research biobanks in Latvia, and to compare these data with the results of the 2010 Eurobarometer study. We also analysed the influence of awareness and attitudes towards biobanks on willingness to participate in biobank studies and on preferred type of informed consent. Methods: We developed a 12-question survey repeating seven questions about biobanks from the 2010 Eurobarometer questionnaire and adding five others. After describing the study variables, we performed a two-stage analysis of the results. In the first stage we analysed differences between the answers from 2010 and 2019 and conducted univariate analyses of relationships among particular variables, and between those variables and the socio-demographic characteristics of participants. In the second stage we investigated multivariable associations of willingness to participate and type of consent with awareness, trust and the socio-economic characteristics of participants. Results: According to our study, the general public in Latvia is still not well informed about research biobanks. Fewer respondents have heard about research biobanks than in 2010. At the same time, the number of respondents who are willing to donate biological samples and personal data to a biobank has increased, e.g. the number of respondents who would definitely or probably be willing to provide information about themselves has increased from 25.8.% to 40.7 since 2010. Overall, concerns about the donation of different types of biological samples and data to a biobank have slightly decreased. Conclusions: Public awareness about biobanks is important for their sustainability. It needs to be increased not only by traditional methods of informing the public, but also by more innovative and participatory approaches, e.g. by citizen science projects. There is a need to strengthen the public visibility and trustworthiness of ethics committees in Latvia in the field of biobanking

Socio-legal perspectives on biobanking: the case of Taiwan

This thesis investigates in depth the phenomenon of biobanking from an anthropological and socio-legal approach. In recent years there has been an evertighter alliance formed between discoveries in life sciences and capital accumulation. The rapid advances in genomics introduce a new form of capital in the development of technoscience. In order to find biomarkers for genetic association studies in the susceptibility of common complex diseases, the generation of large-scale population resources is deemed to be an important step to support the development of genomics which now transforms its imagery from informatics to therapeutics. Biobanks - collections of human biological materials linked through genetic information - have attracted considerable attention across the globe. These global assemblages of capital and vital politics have led to innovative institutions and arrangements in fields of technoscience and ethics. Though biobanking is an apparently global phenomenon, diverse political innovations and ethical configurations emerge from the specific social and cultural milieux, in which its establishment and operation are situated. This thesis uses recent developments of a longitudinal population-based research resource in Taiwan as a specific instance to analyse the delicate entanglement between politics, capital and life sciences. It explores not only the legal and ethical issues posed by biobanks, such as consent, privacy and property, but also the political and economic aspects of the biobanks that are embedded in the broader global bio-economies. This emphasis, focusing on the way in which biovalue is produced, politico-scientific decisions are made and ethical configurations are framed, allows an opportunity to reassess law and ethics, capital and politics, as well as the role of the state and its populations in this new form of biotechnology

Harmonized and Quality Sample Handling in Biobank-Supported Multicenter Prospective Studies

In the frame of multicenter research studies, biobanks ensure the harmonization and traceability of the prospective collection of quality samples. This is significant because pre-analytical variables must be carefully considered to guarantee the integrity of biomarkers to be tested and to avoid bias affecting the validity of the analytical results. According to a quality management system, biobanks contribute with documents and records; consumable preparation for collection, processing, and conservation; sample quality controls; and centralized management of sample handling, storage, and distribution. Traceability of samples is based on unique standard codes and the use of pre-assigned, pre-coded, and pre-labeled materials for sample collection, processing, and conservation. By using these supporting tools, quality derivatives are obtained based on common and evidence-based standard operating procedures (SOPs), with associated traceability information in relation with their collection, processing, conservation, and distribution. The biobank-supported workflow, specifically designed and implemented for each project, allows obtaining harmonized quality samples contributing to the quality of large and complex research projects and the corresponding validity of the analyses

Dwarna : a blockchain solution for dynamic consent in biobanking

Dynamic consent aims to empower research partners and facilitate active participation in the research process. Used within the context of biobanking, it gives individuals access to information and control to determine how and where their biospecimens and data should be used. We present Dwarna—a web portal for ‘dynamic consent’ that acts as a hub connecting the different stakeholders of the Malta Biobank: biobank managers, researchers, research partners, and the general public. The portal stores research partners’ consent in a blockchain to create an immutable audit trail of research partners’ consent changes. Dwarna’s structure also presents a solution to the European Union’s General Data Protection Regulation’s right to erasure—a right that is seemingly incompatible with the blockchain model. Dwarna’s transparent structure increases trustworthiness in the biobanking process by giving research partners more control over which research studies they participate in, by facilitating the withdrawal of consent and by making it possible to request that the biospecimen and associated data are destroyed.peer-reviewe