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.
Month: June 2019
Dynamic Consent and biobanking: a means of fostering sustainability? [BOOK CHAPTER]
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.
Consent and Autonomy in the Genomics Era
Consent and Autonomy in the Genomics Era
Review
Rachel Horton, Anneke Lucassen
Current Genetic Medicine Reports, 2 May 2019; Cancer Genomics, pp 1–7
Abstract
Purpose of Review
Genomic tests offer increased opportunity for diagnosis, but their outputs are often uncertain and complex; results may need to be revised and/or may not be relevant until some future time. We discuss the challenges that this presents for consent and autonomy.
Recent Findings
Popular discourse around genomic testing tends to be strongly deterministic and optimistic, yet many findings from genomic tests are uncertain or unclear. Clinical conversations need to anticipate and potentially challenge unrealistic expectations of what a genomic test can deliver in order to enhance autonomy and ensure that consent to genomic testing is valid.
Summary
We conclude that ‘fully informed’ consent is often not possible in the context of genomic testing, but that an open-ended approach is appropriate. We consider that such broad consent can only work if located within systems or organisations that are trustworthy and that have measures in place to ensure that such open-ended agreements are not abused. We suggest that a relational concept of autonomy has benefits in encouraging focus on the networks and relationships that allow decision making to flourish.
NGS-Based genetic testing for heritable cardiovascular diseases. Specific requirements for obtaining informed consent
NGS-Based genetic testing for heritable cardiovascular diseases. Specific requirements for obtaining informed consent
JörgSchmidtke, KathrinWittkowski, RalfGlaubitz
Molecular and Cellular Probes, 3 May 2019
Abstract
Clinical genetic testing in cardiovascular genetic medicine has undergone rapid changes. Next generation sequencing allows simultaneous testing of all genes associated with any cardiovascular phenotype, and molecular genetic testing for multiple genes has become the standard of practice for cardiovascular medicine. While technical and clinical advantages of multigenic approaches are evident, informed consent procedures have become more complex and challenging to the physician ordering such a test, particularly due to the increased potential for unsolicited findings. Based on the EuroGentest “Guidelines for diagnostic next-generation sequencing” we here propose a set of disease-specific requirements for obtaining informed consent for NGS-based genetic testing in a cardiogenetic clinic. We can show that it is often not feasible to obtain informed consent for every detail and suggest, in such cases, to reach general consent beforehand and discuss specific implications of unsolicited findings after the test results are available.
Informed consent and community engagement in genomic research [PhD THESIS]
Informed consent and community engagement in genomic research [PhD THESIS]
Ogunrin, O. A.
University of Liverpool, 2019
Abstract
The introduction of genomic research to, and emergence of biobanks in, sub-Saharan African countries raise ethical issues that require urgent attention. Firstly, there are concerns about whether individuals and communities would agree to participate in this type of research especially considering how communitarianism may affect their decision-making process. Secondly, there are controversies over whether the informed consent process as it is applied to other biomedical researches would be appropriate for genomic research in sub-Saharan Africa. And thirdly, the components of engagement of culturally distinct communities in genomic research are not yet clarified… There was consensus between the adult research participants and the biomedical researchers on the appropriateness of blanket consent type for genomic research but the community leaders, health workers and the youths prefer either reconsenting or delegated consent…
The concise argument: the importance of consent and choice
The concise argument: the importance of consent and choice
The concise argument
John McMillan
BMJ Journal of Medical Ethics, 13 May 2019; 45 pp 285-286
When Beauchamp and Childress articulated the necessary and sufficient conditions for informed consent, they might have thought that would be the final word on what informed consent is.1 It’s emphasis in the Belmont Report,2 the Nuremberg Code,3the Helsinki Declaration4 and numerous codes of professional ethics seems more than sufficient for emphasising its importance. Nonetheless, its place as the central issue for medical ethics appears undiminished and Pubmed lists 6192 publications with ‘Informed Consent’ in the title since 1979.
One view of this is that medical ethics has channelled too much intellectual effort into consent, perhaps at the expense of other important ethical issues. Papers in this issue of the Journal of Medical Ethics suggest that the discussion of consent continues because of the need to consider what it means in new contexts, how it can be a challenge in some contexts, how it is related to tough theoretical issues about the value of choice and autonomy and how it can blend into other debates…
The notion of free will and its ethical relevance for decision-making capacity
The notion of free will and its ethical relevance for decision-making capacity
Tobias Zürcher, Bernice Elger, Manuel Trachsel
BMC Medical Ethics, 8 May 2019; 20(31)
Abstract
Background
Obtaining informed consent from patients is a moral and legal duty and, thus, a key legitimation for medical treatment. The pivotal prerequisite for valid informed consent is decision-making capacity of the patient. Related to the question of whether and when consent should be morally and legally valid, there has been a long-lasting philosophical debate about freedom of will and the connection of freedom and responsibility.
Main text
The scholarly discussion on decision-making capacity and its clinical evaluation does not sufficiently take into account this fundamental debate. It is contended that the notion of free will must be reflected when evaluating decision-making capacity. Namely, it should be included as a part of the appreciation-criterion for decision-making capacity. The argumentation is mainly drawn on the compatibilism of Harry Frankfurt.
Conclusions
A solution is proposed which at the same time takes the notion of free will seriously and enriches the traditional understanding of decision-making capacity, strengthening its justificatory force while remaining clinically applicable.
Consent in pregnancy: a qualitative study of the views and experiences of women and their healthcare professionals
Consent in pregnancy: a qualitative study of the views and experiences of women and their healthcare professionals
Jacqueline Nicholls, Anna L David, Joseph Iskaros, Anne Lanceley
European Journal of Obstetrics & Gynecology and Reproductive Biology, 11 May 2019
Abstract
Objective
Consent in antenatal settings is contentious, poorly understood and recognised as problematic for pregnant women. This study aimed to investigate participants’ views and experiences of the consent process.
Design
Qualitative research performed in a large urban teaching hospital in London. Sixteen pregnant women and fifteen healthcare professionals (obstetricians and midwives) participated. Consent consultations were observed and in-depth interviews carried out with healthcare professionals and pregnant women using semi-structured interview guides. Data were collectively analysed to identify themes in the experiences of the consent process.
Results
Four themes were identified: 1) Choice and shared decision-making. Pregnant women do not always experience consent in a choice-making way and often do not understand information provided to them. 2) Contextualising information disclosure. What is important to women is not only the information but the relational context in which consent is obtained. 3) Quality of HCP-woman relationship. Trust in their healthcare professional sometimes makes women seek less information and conversely. Individualised information is desired by women but professionals found it difficult to ensure that women receive this in practice. 4) Law and professional practice. Doctors are more aware of legal developments in consent related to the Montgomery case than their midwifery colleagues, but they are not always certain of the implications.
Conclusion
Results suggest that an effective antenatal consent process which empowers pregnant women requires their understanding of provided information to be elicited. There is a delicate balance to be struck between the trust of a patient in their professional and information-based consent, rather than a simple focus on improving information provision. Whilst recognising women’s desire for bespoke consent professionals acknowledged the difficulty of ensuring this in practice. If consent is to remain the legal yardstick of autonomous choice-making, women’s understanding and that shared with their healthcare professional needs to be more explicitly addressed.
Revamping the Privacy Policy: A Study on Informed Consent and User Interactions [PhD THESIS]
Revamping the Privacy Policy: A Study on Informed Consent and User Interactions [PhD THESIS]
Denton Wood
Baylor University, Department of Computer Science, May 2019
Abstract
Privacy is an abstract concept that has very real repercussions for users of technology in the twenty-first century. Recent large-scale controversies such as the Facebook and Cambridge Analytica scandal bring into question users’ understandings of what companies are allowed to do with their data. The primary method of communicating privacy rights to users is the privacy policy; however, these policies are not always effective at gaining users’ informed consent regarding their rights. This thesis will attempt the show the effectiveness of privacy policies at gaining informed consent through an experiment showing the impact of different display factors on users’ understanding.
Getting the Gist Across Is Enough for Informed Consent for Acute Stroke Thrombolytics
Getting the Gist Across Is Enough for Informed Consent for Acute Stroke Thrombolytics
Comments and Opinions
Skolarus LE, O’Brien A, Meurer WJ , Zikmund Fisher BJ
Stroke, 14 May 2019
Acute stroke thrombolytics greatly reduce poststroke disability, both in clinical trails and in clinical practice. Too few patients, however, take advantage of these life-improving and cost-saving treatments. In fact, in the United States, up to 7.5% of tPA (tissue-type plasminogen activoator) eligible patients refuse this time limites stroke treatment , and even among stroke patients who receive tPA, up to 20% experience delayed treatment due to patient and family consent…
Center for Informed Consent Integrity 