"The Stakes Are Higher"- Patient and Caregiver Perspectives on Cystic Fibrosis Research and Personalized Medicine.

Introduction: Making bench to bedside advances in cystic fibrosis (CF) care requires the sustained engagement and trust of people living with CF. However, there is a scarcity of studies exploring their concerns and priorities regarding research and its end products. The aim of this qualitative study was to generate empirical evidence regarding patient and caregiver perspectives on cystic fibrosis research and personalized medicine to foster developments in translational research in Canada. Methods: A total of 15 focus groups were conducted, engaging 22 adults with CF and 18 caregivers (e.g., parents, siblings and partners) living in Canada. Inductive thematic analysis relied on an iterative process involving themes derived from both participant meaning-making and existing scientific literature. Participant perspectives were considered along intrapersonal, intracommunity, interpersonal, and structural lines. Results: Overall, participants described a relationship to CF research inextricable from the lived experience of CF as a lifelong progressive and terminal disease and from the goal of advancing medical science. They were enthusiastic and excited about the emergence of CFTR modulators, although they had some knowledge gaps regarding the associated research. They largely spoke to positive experiences with researcher communication but had feedback regarding informed consent processes and the return of study results. Participants also voiced concerns about structural access barriers to research and to its end products. Extensive histories of research participation, a relatively small and intercommunicative CF community, and structural overlap between research and care settings contributed to their perspectives and priorities. Conclusion: Study findings are valuable for researchers and policy-makers in CF and rare or progressive diseases more broadly. Continuing to solicit and listen to the voices of patients and caregivers is crucial for research ethics and the translation of new therapies in the area of personalized medicine.

Pandemics, privacy, and public health research.

Sharing data expediently for pandemic response purposes exposes healthcare providers in Canada to significant regulatory uncertainty. Duplicative and contradictory ethical and legal duties flowing from overlapping sources can stifle flows of medical data among clinicians, researchers, and institutions. Authorities should support caregivers and accelerate research by providing clear guidance to the health sector. Institutions should foster robust data stewardship and standardize their practices to those recognized among the international health informatics community. Reform is critical to ensuring Canadian healthcare providers can deliver efficient health responses that are integrated with dispersed and disparate national and international approaches.

Coming Out to Play: Privacy, Data Protection, Children's Health, and COVID-19 Research.

The COVID-19 pandemic has underscored the need for new ways of thinking about data protection. This is especially so in the case of health research with children. The responsible use of children's data plays a key role in promoting children's well-being and securing their right to health and to privacy. In this article, we contend that a contextual approach that appropriately balances children's legal and moral rights and interests is needed when thinking about data protection issues with children. We examine three issues in health research through a child-focused lens: consent to data processing, data retention, and data protection impact assessments. We show that these issues present distinctive concerns for children and that the General Data Protection Regulation provides few bright-line rules. We contend that there is an opportunity for creative approaches to children's data protection when child-specific principles, such as the best interests of the child and the child's right to be heard, are put into dialogue with the structure and logic of data protection law.

Modeling consent in the time of COVID-19.

Effective responses to the COVID-19 pandemic require novel solutions for research and responsible data sharing. Biobanking presents itself as a key priority in furthering our understanding of COVID-19. In this article, we propose a tripartite approach to consent to create resources for research relating to COVID-19. The approach aims to link three levels of participation: COVID-19 patients, respiratory/infectious disease patients, and longitudinal study participants. We explore the potential approaches that can be taken to consent processes with these three participant groups. We furthermore describe an access model for both single-site and multi-site data and sample storage. Through dealing with these topics at a high level, the model may be adapted to local legal and ethical requirements while still pursuing its ultimate goal: the creation of a research infrastructure that supports transparent, strong, and open science.