Frequency and reasons that parents decline genetic testing for critically ill neonates.

Purpose: Current literature reports strong support among parents for genetic testing for ill neonates; yet, some parents decline this testing for unknown reasons. We aimed to document the proportion of parents who decline, describe their clinical and demographic characteristics, and categorize their rationales.

Methods: We reviewed medical records to collect and compare clinical and demographic information for patients whose parents consented to and declined recommended genetic testing.

Engaging children and adolescents in the design and conduct of paediatric research.

The importance of patient engagement in product development and clinical research is widely acknowledged. In pediatrics, parents and guardians are often vocal advocates for their children in the process, but investigators and sponsors rarely directly solicit children's or adolescents' perspectives in clinical research planning or as patient partners during the conduct of research. Here, we provide compelling reasons and recommendations for investigators and sponsors to systematically engage young people in the design, conduct, and review of research, and the premise that input will be incorporated as a routine expectation.

Ethical issues in implementation science: perspectives from a National Heart, Lung, and Blood Institute workshop.

Ethical issues arise in the context of implementation science that may differ from those encountered in other research settings. This report, developed out of a workshop convened by the Center for Translation Research and Implementation Science within the United States National Heart, Lung, and Blood Institute, identifies six key themes that are important to the assessment of ethical dimensions of implementation science. First, addressing ethical challenges in implementation science does not require new ethical principles, commitments, or regulations.

Managing institutional conflicts: Stakeholder accounts of communication between conflict of interest and technology transfer offices.

There have been repeated calls for academic institutions to develop policies and procedures to manage institutional conflicts of interest (ICOI) arising from technology transfer activities. While prior research has examined adoption of ICOI policies by medical schools and universities, little is known about how these institutions handle ICOI in practice, hindering the development of evidence-based recommendations to improve ICOI management. To address this gap, we conducted semi-structured interviews with 25 senior administrators responsible for research integrity and conflict of interest issues at academic institutions.

The ethical value of consulting community members in non-emergency trials conducted with waivers of informed consent for research.

There is growing interest in using embedded research methods, particularly pragmatic clinical trials, to address well-known evidentiary shortcomings afflicting the health care system. Reviews of pragmatic clinical trials published between 2014 and 2019 found that 8.8% were conducted with waivers of informed consent; furthermore, the number of trials where consent is obtained is increasing with time.