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. However, it does require understanding of the specific contexts arising in implementation research related to both study design and the intervention being implemented. Second, implementation research involves many different types of people in research, including patients, clinicians, administrators, the social networks of any of these, and the general population. These individuals play different roles that may entail different ethical considerations, obligations, and vulnerabilities. Third, the appropriateness of and need for informed consent in implementation research is connected to the role of the subject/participant, the nature of the intervention, and the design of the study. Even where traditional "full" consent processes are unnecessary or inappropriate, communication and engagement are critical. Similarly, even when research is exempt and informed consent unnecessary, Data Safety and Monitoring Board oversight of implementation studies may be advisable to ensure quality, address unexpected consequences, and identify overwhelming evidence of benefit. Fourth, implementation science is often explicitly designed to encourage specific behaviors and discourage others. There is a need for clarity regarding when efforts at behavioral change enhance or threaten autonomy and how to protect participants whose autonomy is threatened. Fifth, there is significant overlap between implementation science and quality improvement, and the ideal regulatory oversight structure for implementation science remains unclear. It is critical to encourage learning and growth while assuring appropriate protections. Sixth, implementation research takes place across a range of social and cultural contexts. Engagement and collaboration with stakeholders in designing and executing implementation trials and studies- especially when vulnerabilities exist- is essential. Attention to these themes will help ensure that implementation science fulfills its goal of advancing the practice of health care within a sound ethical framework.