Renata Axler

Citizens’ Values Regarding Research With Stored Samples From Newborn Screening in Canada

OBJECTIVES: Newborn screening (NBS) programs may store bloodspot samples and use them for secondary purposes. Recent public controversies and lawsuits over storage and secondary uses underscore the need to engage the public on these issues. We explored Canadian values regarding storage and use of NBS samples for various purposes and the forms of parental choice for anonymous research with NBS samples. METHODS: We conducted a mixed-methods, public engagement study comprising 8 focus groups (n = 60), an educational component, deliberative discussion, and pre- and post-questionnaires assessing knowledge and values toward storage and parental choice. RESULTS: Canadian citizens supported the storage of NBS samples for quality control, confirmatory diagnosis, and future anonymous research (>90%). There was broad support for use of NBS samples for anonymous research; however, opinions were split about the extent of parental decision-making. Support for a “routinized” approach rested on trust in authorities, lack of concern for harms, and an assertion that the population’s interest took priority over the interests of individuals. Discomfort stemmed from distrust in authorities, concern for harms, and prioritizing individual interests, which supported more substantive parental choice. Consensus emerged regarding the need for greater transparency about the storage and secondary use of samples. CONCLUSIONS: Our study provides novel insights into the values that underpin citizens’ acceptance and discomfort with routine storage of NBS samples for research, and supports the need to develop well-designed methods of public education and civic discourse on the risks and benefits of the retention and secondary use of NBS samples.

Why might people donate tissue for cancer research? Insights from organ/tissue/blood donation and clinical research.

Little is known about why patients with cancer do or do not donate their biopsied/cancerous tissue to research. A review of the literature on motivations to participate in clinical research and to donate tissues/organs for therapeutic use may provide some insights relevant to tumour banking research. While more research is necessary, a better understanding of the factors that motivate patients to give or refuse consent to tumour banking may ultimately improve consent practices, public trust and donation rates.

Cancer as Rubbish: Donation of Tumor Tissue for Research

Tissue banking (or biobanking), thought by many to be an essential form of medical research, has raised a number of ethical issues that highlight a need to understand the beliefs and values of tissue donors, including the motivations underlying consent or refusal to donate. Data from our qualitative study of the legal, social, and ethical issues surrounding tumor banking in New South Wales, Australia, show that participants’ attitudes to donation of tumor tissue for research are partially captured by theories of weak altruism and social exchange. However, we argue that the psychological rewards of value transformation described by Thompson’s rubbish theory provide additional insights into participants’ attitudes to tumor donation. We believe our data provides sufficient justification for an approach to regulation of tumor banking that is aimed at fostering a relationship based on the notions of virtuous reassignment and social exchange.

Expectations and values about expanded newborn screening: a public engagement study

Newborn bloodspot screening (NBS) panels have expanded to include conditions for which treatment effects are less certain, creating debate about population‐based screening criteria. We investigated Canadian public expectations and values regarding the types of conditions that should be included in NBS and whether parents should provide consent.

Do Canadian Researchers and the Lay Public Prioritize Biomedical Research Outcomes Equally? A Choice Experiment

Purpose To quantify and compare the preferences of researchers and laypeople in Canada regarding the outcomes of basic biomedical research. Method In autumn 2010, the authors conducted a cross-sectional, national survey of basic biomedical researchers funded by Canada’s national health research agency and a representative sample of Canadian citizens to assess preferences for research outcomes across five attributes using a discrete choice experiment. Attributes included advancing scientific knowledge (assessed by published papers); building research capacity (assessed by trainees); informing decisions in the health products industry (assessed by patents); targeting economic, health, or scientific priorities; and cost. The authors reduced a fractional factorial design (18 pairwise choices plus an opt-out option) to three blocks of six. They also computed part worth utilities, differences in predicted probabilities, and willingness-to-pay values using nested logit models. Results Of 3,260 potential researchers, 1,749 (53.65% response rate) completed the questionnaire, along with 1,002 citizens. Researchers and citizens prioritized high-quality scientific outcomes (papers, trainees) over other attributes. Both groups disvalued research targeted at economic priorities relative to health priorities. Researchers granted a premium to proposals targeting scientific priorities. Conclusions Citizens and researchers fundamentally prioritized the same outcomes for basic biomedical research. Notably, they prioritized traditional scientific outcomes and disvalued the pursuit of economic returns. These findings have implications for how academic medicine assigns incentives and value to basic health research and how biomedical researchers and the public may jointly contribute to setting the future research agenda.

Towards a bioethics of innovation

In recent years, it has become almost axiomatic that biomedical research and clinical practice should be ‘innovative’—that is, that they should be always evolving and directed towards the production, translation and implementation of new technologies and practices. While this drive towards innovation in biomedicine might be beneficial, it also raises serious moral, legal, economic and sociopolitical questions that require further scrutiny. In this article, we argue that biomedical innovation needs to be accompanied by a dedicated ‘bioethics of innovation’ that attends systematically to the goals, process and outcomes of biomedical innovation as objects of critical inquiry. Using the example of personalised or precision medicine, we then suggest a preliminary framework for a bioethics of innovation, based on the research policy initiative of ‘Responsible Innovation’. We invite and encourage critiques of this framework and hope that this will provoke a challenging and enriching new bioethical discourse.

Citizen expectations of 'academic entrepreneurship' in health research: public science, practical benefit.

Responsiveness to citizens as users of technological innovation helps motivate translational research and commercial engagement among academics. Yet, retaining citizen trust and support for research encourages caution in pursuit of commercial science.

The institutional workers of biomedical science: Legitimizing academic entrepreneurship and obscuring conflicts of interest

Abstract Given growing initiatives incentivizing academic researchers to engage in ‘entrepreneurial’ activities, this article examines how these academic entrepreneurs claim value in their entrepreneurial engagements, and navigate concerns related to conflicts of interest. Using data from qualitative interviews with twenty-four academic entrepreneurs in Canada, we show how these scientists value entrepreneurial activities for providing financial and intellectual resources to academic science, as well as for their potential to create impact through translation. Simultaneously, these scientists claimed to maintain academic norms of disinterested science and avoid conflicts of interest. Using theories of institutional work, we demonstrate how entrepreneurial scientists engage in processes of institutional change-through-maintenance, drawing on the maintenance of academic norms as institutional resources to legitimize entrepreneurial activities. As entrepreneurial scientists work to legitimize new zones of academic scientific practice, there is a need to carefully regulate and scrutinize these activities so that their potential harms do not become obscured.

Transparency of Biobank Access in Canada: An Assessment of Industry Access and the Availability of Information on Access Policies and Resulting Research

A key issue impacting public trust in biobanks is how these resources are utilized, including who is given access to biobank data and samples. To assess the conditions under which researchers are given access to Canadian biobanks, we reviewed websites and contacted Canadian biobanks to determine the availability of information on access policies and procedures; research resulting from access biobank data and samples; and conditions on private industry access to biobanks. We also conducted expert interviews with key Canadian stakeholders (n = 11) to obtain their perspectives on biobank transparency and access policies. Among 21 Canadian biobanks, there was wide variation in the access information made publicly available, and the majority of these allowed access by industry applicants. Biobanks should be governed by the principles of transparency, accountability, and accessibility, and attention must be given to the conditions around the commercialization of biobank-based research.