Case Study: Innovation Procurement for a Cardiac Program.

This case describes a competitive dialogue strategy to procure a cardiac program solution to strengthen performance, outcomes and value in an Ontario hospital. All major contracts for the cardiac program were expiring, offering a unique opportunity for procurement of innovation. Procurement was completed in two phases, with an additional request for proposals issued for the unique specialty products not included in the initial procurement. The implementation of contracts was monitored to ensure that outcomes and deliverables were achieved. The procurement for the entire cardiac program was complex; however, it resulted in substantial cost savings and value-added services for the cardiac program.

Case Study: Innovation Procurement for a "Smart" Privacy Solution.

This case describes an initiative to procure a "smart" privacy solution with machine learning capabilities that could eliminate false-positive alerts of privacy risks for an Ontario hospital. A competitive dialogue procurement strategy proceeded over a two-year period and involved two stages of competitive dialogue and a pilot phase to test the procured privacy solution. Discussions and sharing feedback on solutions with vendors, followed by dialogue on solution pricing and service offerings, resulted in a vendor contract that allowed other hospitals to benefit from the established agreement. This approach supported scalability of the procured privacy solution.

Innovation Procurement in Health Systems: Exploring Practice and Lessons Learned.

As rising healthcare costs continue to challenge the sustainability of global health systems, there has been a strategic shift toward a focus on value, which considers the outcomes and value of healthcare delivery relative to the costs of care delivery. A unique feature of this focus on value has influenced a shift in procurement whereby health organizations are advancing the procurement of innovative solutions to achieve defined outcomes that overcome challenges such as the quality, safety and cost of care delivery. In this paper, we report on the implementation of three innovation procurement models in four Ontario healthcare organizations. These case studies provide evidence of the value and impact of innovation procurement approaches emerging from the four healthcare organizations. Three models of innovation procurement are described in the four cases, along with qualitative analysis of experiences and outcomes for both the organizations and the participating vendors. Evidence of the value and impact of procuring innovative solutions to address health organization challenges offers insights and new approaches to leveraging public procurement methodologies to achieve value and impact for health systems.

Case Study: Innovation Procurement for a Digital Services Platform.

This case describes a design contest strategy to procure a solution to coordination of care transitions across healthcare programs to strengthen patient outcomes. The fit of the vendors' approach with the organization and the potential for building a strong relationship with the vendor teams were evaluated. A consortium of small Canadian companies was selected to proceed to a proof-of-concept phase and full implementation of the digital solution across the region. This design contest approach resulted in a successful vendor partnership for the organization to co-design, develop, implement and scale an innovative solution to support care transitions across the region.

Case Study: Innovation Procurement for a Patient and Caregiver Support Solution in the Home.

This case describes an innovation partnership procurement strategy by a community care health organization to procure a digital solution able to support both caregivers and older adults receiving homecare services. Vendor submissions proposed both existing technologies and new solutions that were challenging to evaluate. An existing technology was procured and first pilot tested in a laboratory setting prior to a field trial with seniors and their caregivers in the home. Recruitment of seniors to participate was unsuccessful. The importance of early engagement of seniors and greater clarity in partnership expectations were key learning outcomes of this case.

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.

PUBLIC AND PATIENT INVOLVEMENT IN HEALTH TECHNOLOGY ASSESSMENT: A FRAMEWORK FOR ACTION.

OBJECTIVE: As health technology assessment (HTA) organizations in Canada and around the world seek to involve the public and patients in their activities, frameworks to guide decisions about whom to involve, through which mechanisms, and at what stages of the HTA process have been lacking. The aim of this study was to describe the development and outputs of a comprehensive framework for involving the public and patients in a government agency's HTA process. METHODS: The framework was informed by a synthesis of international practice and published literature, a dialogue with local, national and international stakeholders, and the deliberations of a government agency's public engagement subcommittee in Ontario, Canada. RESULTS: The practice and literature synthesis failed to identify a single, optimal approach to involving the public and patients in HTA. Choice of methods should be considered in the context of each HTA stage, goals for incorporating societal and/or patient perspectives into the process, and relevant societal and/or patient values at stake. The resulting framework is structured around four actionable elements: (i) guiding principles and goals for public and patient involvement (PPI) in HTA, (ii) the establishment of a common language to support PPI efforts, (iii) a flexible array of PPI approaches, and (iv) on-going evaluation of PPI to inform adjustments over time. CONCLUSIONS: A public and patient involvement framework has been developed for implementation in a government agency's HTA process. Core elements of this framework may apply to other organizations responsible for HTA and health system quality improvement.

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

BACKGROUND: 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. OBJECTIVES: We explore citizen expectations of the specifically academic nature of commercial science [i.e. academic entrepreneurship (AE)] and the influence of conflict of interest concerns, hopes about practical benefits and general beliefs. DESIGN, SETTING AND PARTICIPANTS: We conducted a cross-sectional national opinion survey of 1002 Canadians online in 2010. RESULTS: Approval of AE was moderate (mean 3.2/5, SD 0.84), but varied by entrepreneurial activity. Concern about conflict of interests (COI) was moderate (mean 2.9/5, SD 0.86) and varied by type of concern. An ordinary least-squares regression showed that expectations of practical benefits informed support for AE, specifically that academic-industry collaboration can better address real-world problems; conflict of interest concerns were insignificant. CONCLUSIONS: These findings suggest that citizens support AE for its potential to produce practical benefits, but enthusiasm varies and is reduced for activities that may prioritize private over public interests. Further, support exists despite concern about COI, perhaps due to trust in the academic research context. For user engagement in research priority setting, these findings suggest the need to attend to the commercial nature of translational science. For research policy, they suggest the need for governance arrangements for responsible innovation, which can sustain public trust in academic research, and realize the practical benefits that inform public support for AE.

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

OBJECTIVES: 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. METHODS: Eight focus groups (FG; n = 60) included education, deliberative discussion and pre-/post-questionnaires. Data were analysed quantitatively and qualitatively. RESULTS: Quantitatively, the majority supported NBS for serious disorders for which treatment is not available (95-98, 82%). A majority endorsed screening without explicit consent (77-88%) for treatable disorders, but 62% supported unpressured choice for screening for untreatable disorders. Qualitatively, participants valued treatment-related benefits for infants and informational benefits for families. Concern for anxiety, stigma and unwanted knowledge depended upon disease context and strength of countervailing benefits. CONCLUSIONS: Anticipated benefits of expanded infant screening were prioritized over harms, with information provision perceived as a mechanism for mitigating harms and enabling choice. However, we urge caution around the potential for public enthusiasm to foster unlimited uptake of infant screening technologies.

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.

Transparency About Governance Contributes to Biobanks' Trustworthiness: Call for Action.

This article examines biobank transparency mechanisms vis-à-vis their public information, as found on the public biobank webpages. Two independent studies about biobank governance in Europe and Canada identified a lack of governance-related information provided by biobanks on their public webpages. This lack of transparency stands in contrast to governance best practice guidelines highlighting the importance of transparency as a principle of good governance. Transparency is especially important as many biobanks are publicly funded, and it contributes to accountability and supports the development of donor trust in biobanks. Empirical evidence shows that the public supports greater transparency about biobank governance. It will be important that information provided online is relevant and accessible for a variety of different stakeholders (e.g. public and private sector scientists and institutions, donors and potential donors, members of the public). Transparency standards, however, need to be proportionate to avoid the situation that only large-scale biobanks can allocate appropriate resources to fulfil them. Implementing adequate standards of transparency about biobanks' governance will increase accountability but also allow current and future participants to make more informed decisions about their participation in biobank activities.

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.

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

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.

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.

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.