‘I haven’t met them, I don’t have any trust in them. It just feels like a big unknown’: a qualitative study exploring the determinants of consent to use Human Fertilisation and Embryology Authority registry data in research
Qualitative research
Claire Carson, Lisa Hinton, Jenny Kurinczuk, Maria Quigley
BMJ, 30 May 2019; 9(5)
Abstract
Objectives 
To explore why and how fertility patients decide to allow (or deny) the use of personal data held in the Human Fertilisation and Embryology Authority registry for linkage and research.
Design 
A qualitative study was conducted using in-depth face-to-face interviews and an online survey to garner information on experience and opinions from fertility clinic patients and staff. Verbatim transcripts were analysed using the ‘one sheet of paper’ method to identify themes.
Setting 
Women and men were recruited between September 2015 and December 2017, via fertility clinics across England and online advertising, then interviewed at a location convenient to them.
Participants
20 patients and 9 staff were interviewed, 40 patients completed the online survey.
Results 
Consent for disclosure (CD) forms are completed at a stressful time, when patients often feel overwhelmed; these forms were considered a low priority. Perceptions of benefit (to individuals, to wider society) and harm (misuse of data, impact of disclosure on child) influenced consent. Important themes included: understanding of the forms; trust in those asking, in researchers, in the Human Fertilisation and Embryology Authority (HFEA); and wider attitudes to data use. Issues influencing response, and thus the representativeness of the HFEA data set, were highlighted.
Conclusions 
Understanding what is being asked, and trust in those organisations keeping and using personal data, affects individual decisions to consent to disclosure. Patients were influenced by the wider context of infertility, as well as general concerns about data sharing and security. Low consent rates, which vary by clinic and likely also by patients’ characteristics, have adverse implications for research conducted using HFEA data collected after 2008. Public understanding of data use and security is relatively poor; increased public trust in, and awareness of, research based on routine data could improve consent to data use and reduce the risk of bias.

Can dynamic consent facilitate the protection of biomedical big data in biobanking in Malaysia?
Original Paper
Mohammad Firdaus Abdul Aziz, Aimi Nadia Mohd Yusof
Asian Bioethics Review, 25 May 2019; pp 1–14
Abstract
As with many other countries, Malaysia is also developing and promoting biomedical research to increase the understanding of human diseases and possible interventions. To facilitate this development, there is a significant growth of biobanks in the country to ensure continuous collection of biological samples for future research, which contain extremely important personal information and health data of the participants involved. Given the vast amount of samples and data accumulated by biobanks, they can be considered as reservoirs of precious biomedical big data. It is therefore imperative for biobanks to have in place regulatory measures to ensure ethical use of the biomedical big data. Malaysia has yet to introduce specific legislation for the field of biobanking. However, it can be argued that its existing Personal Data Protection Act 2010 (PDPA) has laid down legal principles that can be enforced to protect biomedical big data generated by the biobanks. Consent is a mechanism to enable data subjects to exercise their autonomy by determining how their data can be used and ensure compliance with legal principles. However, there are two main concerns surrounding the current practice of consent in biomedical big data in Malaysia. First, it is uncertain that the current practice would be able to respect the underlying notion of autonomy, and second, it is not in accordance with the legal principles of the PDPA. Scholars have deliberated on different strategies of informed consent, and a more interactive approach has recently been introduced: dynamic consent. It is argued that a dynamic consent approach would be able to address these concerns.

Biobanking and the consent problem [BOOK CHAPTER]
Timothy Caulfield, Blake Murdoch
Law 2019 – Chapter 10, 26 April 2019; pp 173–184
Abstract
From a research perspective, interest in biobanking continues to intensify. Governments and industry have invested heavily in biobanks, as exemplified by initiatives such as the UK Biobank and the United States’ Precision Medicine Initiative. But despite this enthusiasm, many profound legal and ethical challenges remain unresolved. Indeed, there continue to be disagreements about how best to obtain consent and the degree and nature of control that research participants retain over donated samples and health information. Emerging social trends – including concerns about commercialization and perceived rights of continuing control (“biorights”) – seem likely to intensify these issues.

Dynamic Consent and biobanking: a means of fostering sustainability? [BOOK CHAPTER]
Jane Kaye, Megan Prictor
Law 2019 – Chapter 7, 26 April 2019; pp 117-129
Abstract
Biobanks are rich repositories of biological materials (such as DNA) and other health and demographic data, often collected over a long period, that can be used for a variety of research purposes to improve the health of individuals and populations. It is important that the value of biobanks is maximized, but at this point in time, there are a number of challenges to achieving this. There are continued debates over the most appropriate mode of gaining consent from people who contribute tissue samples and data to biobanks, that will uphold high ethical standards and enable autonomous decisionmaking. As in other fields, there are changing legal and regulatory frameworks that can have significant implications for biobank management. There are also increasing concerns as to whether biobanks are achieving maximum usage and what the longer-term sustainability plans of maintaining these repositories should be. In this chapter, we outline some of the risks facing biobanks, using examples drawn from a range of international settings. We suggest that the concept of “Dynamic Consent,” a digital platform for engaging research participants, has the capacity to ensure a more engaged and informed cohort of participants, that might in turn address many of the legal and sustainability challenges currently facing biobanks. In this chapter, current uses of Dynamic Consent platforms in biobanking research in the UK, continental Europe, and the USA, and outline considerations for future application and evaluation of this tool to help enhance the relevance, ethical operation, sustainability, and interoperability of biobanks, are examined.

The biobank consent debate: why ‘meta-consent’ is still the solution!
Thomas Ploug, Soren Holm
Journal of Medical Ethics, 14 March 2019
Abstract
In a recent article in the Journal of Medical Ethics, Neil Manson sets out to show that the meta-consent model of informed consent is not the solution to perennial debate on the ethics of biobank participation. In this response, we shall argue that (i) Manson’s considerations on the costs of a meta-consent model are incomplete and therefore misleading; (ii) his view that a model of broad consent passes a threshold of moral acceptability rests on an analogy that misconstrues how biobank research is actually conducted and (iii) a model of meta-consent is more in tune with the nature of biobank research and enables autonomous choice.

Participants’ understanding of informed consent for biobanking: a systematic review
Elizabeth R. Eisenhauer, Alan R. Tait, Soo Young Rieh, Cynthia M. Arslanian-Engoren,
Clinical Nursing Research, Vol 28, Issue 1, 2019
Articles
Abstract
Nurses are increasingly asked to obtain consent from participants for biobanking studies. Biobanking has added unique complexities to informed consent. The purpose of this systematic review was to evaluate participants’ level of understanding of the information presented during the informed consent process unique to the donation of biological specimens for research. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were utilized to conduct the review. PubMed, EMBASE, CINAHL, PsycINFO, Scopus, Web of Science, and ProQuest bibliographic databases were searched. Results indicated that elements of informed consent unique to biobanking were poorly understood. Most studies had authors or funding associated with a biobank. Only one study disclosed and assessed participants’ understanding of moral risks. Increased disclosures, values-clarification, and presenting information via multiple modalities may facilitate understanding. There is a need to improve the quality of informed consent for biobanking studies by utilizing standardized instruments, definitions, and encouraging research about informed choice outside the biobanking industry.