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.

WHAT'S KNOWN ON THIS SUBJECT: Newborn screening (NBS) programs may store bloodspot samples and use them for secondary purposes, such as research. Recent public controversies and lawsuits over storage and secondary uses underscore the need to engage the public on these issues. WHAT THIS STUDY ADDS:This public engagement study identifies values underlying citizens' acceptance of and discomfort with research from NBS samples. Well-designed methods of public education and civic discourse on the risks and benefits of storage and secondary uses of NBS samples are required. abstract 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.

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 ª

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, shows 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.

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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.

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.

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