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A growing number of individuals who are not professional scientists are working with professional scientists to contribute to scientific research through a broad spectrum of volunteer activities and roles. To guide the regulatory oversight of scientists carrying out citizen science projects, we draw distinctions among five categories of projects in which volunteer activities and roles vary based on the combination of setting (institutional or not), subject matter (human or not), and the norms and expectations of handling volunteers' personally identifiable information. Each category has potentially different ethical considerations and forms of institutional (or regulatory) oversight. We identify and assign numeric labels to these categories rather than names to avoid confusion and value-laden connotations regarding terminology. We hope the absence of terminology will initiate conversations and encourage rapid evolution of necessary vocabulary in this area. We focus on Type 4 research, projects led in academia and in which volunteers are not the subject of the research, but provide personally identifiable information with expectations of non-confidentiality. Our preliminary data show that current Type 4 projects generally lack informed consent, and most do not provide details about their handling of personally identifiable data. We identify areas where federal guidelines, as well as existing institutional ethics review protocols for protection of human subjects in research, might be applied to some forms of citizen science in ways that could either support, or inadvertently undermine, the Common Rule (the US regulation regarding protection of human subjects). We illustrate these areas with examples of projects from Cooper's lab. By highlighting the complex and distinct challenges of responsible conduct with each project type, we urge professional scientists, citizen scientists, regulators, and other stakeholders to jointly determine the type of institutional oversight that will best mitigate risks without stymying innovation and benefits. We hope that this essay will spark a lively discussion and refinement of concepts, research, and improved practices. [ABSTRACT FROM AUTHOR]

The article talks about informed consent of the participants in medical research and the disclosure of clinical results to the participants. Topics discussed include the field of genomic research, the patients undergoing genome sequencing and seeking information on the incidental findings, and the concept of the disclosure of results being a right of the patients.

Data sharing is a precondition of precision medicine. Numerous organizations have produced abundant guidance on data sharing. Despite such efforts, data are not being shared to a degree that can trigger the expected data-driven revolution in precision medicine. We set out to explore why. Here we report the results of a comprehensive analysis of data-sharing guidelines issued over the past two decades by multiple organizations. We found that the guidelines overlap on a restricted set of policy themes. However, we observed substantial fragmentation in the policy landscape across specific organizations and data types. This may have contributed to the current stalemate in data sharing. To move toward a more efficient data-sharing ecosystem for precision medicine, policy makers should explore innovative ways to cope with central policy themes such as privacy, consent, and data quality; focus guidance on interoperability, attribution, and public engagement; and promote data-sharing policies that can be adapted to multiple data types. [ABSTRACT FROM AUTHOR]

Paediatric decision-making is the art of respecting the interests of child and family with due regard for evidence, values and beliefs, reconciled using two important but potentially conflicting concepts: best interest standard (BIS) and shared decision-making (SD-M). We combine qualitative research, our own data and the normative framework of the United Nations Convention on the Rights of Children (UNCRC) to revisit current theoretical debate on the interrelationship of BIS and SD-M. Three cohorts of child, parent and health care professional interviewees (N total  = 47) from Switzerland and the United States considered SD-M an essential part of the BIS. Their responses combined with the UNCRC text to generate a coherent framework which we term the shared optimum approach (SOA) combining BIS and SD-M. The SOA separates different tasks (limiting harm, showing respect, defining choices and implementing plans) into distinct dimensions and steps, based on the principles of participation, provision and protection. The results of our empirical study call into question reductive approaches to the BIS, as well as other stand-alone decision-making concepts such as the harm principle or zone of parental discretion.Conclusion: Our empirical study shows that the BIS includes a well-founded harm threshold combined with contextual information based on SD-M. We propose reconciling BIS and SD-M within the SOA as we believe this will improve paediatric decision-making. What is Known: • Parents have wide discretion in deciding for their child in everyday life, while far-reaching treatment decisions should align with the child's best interest. • Shared decision-making harbours potential conflict between parental authority and a child's best interest. What is New: • The best interest standard should not be used narrowly as a way of saying "Yes" or "No" to a specific action, but rather in a coherent framework and process which we term the shared optimum approach. • By supporting this child-centred and family-oriented process, shared decision-making becomes crucial in implementing the best interest standard.

While genetic testing may be the gateway to the future of medicine, it also poses challenges for individuals, especially in terms of differentiated treatments on the basis of their genetic characteristics. The fear of unwanted disclosure to insurers and the possibility of genetic discrimination can hamper the recruitment of individuals for clinical research that involves genetic testing. Precision medicine initiatives, such as All of Us, are proliferating in the United States. In order to succeed, however, they must ensure that the millions of Americans recruited to share their genetic data are not penalized with regard to life, disability and long-term insurance coverage. In this Perspective, we discuss several initiatives adopted by countries around the world, such as the United Kingdom and France, that better balance the interests of insurers and research subjects, and explain how the United States might learn from them. We call for regulatory and industry leadership to come together to establish a voluntary moratorium on insurance pricing with the aim of protecting research participants.