Table 1 Ethical considerations comparison between biomedical and dissemination and implementation research
Ethical considerations | Biomedical research | Dissemination and implementation research |
|---|---|---|
Is it human subjects’ research? | Individuals often serve as subjects, with focus on safety and individual outcomes | Subjects can be individuals, groups, or entire health systems. Ethical review may be needed for interventions affecting broader systems |
Ethical review often focuses on individual participant rights and well-being | Ethical review boards may need to assess impact on communities, organizations, and health delivery systems. Waiving review for quality improvement should be carefully considered | |
Who should provide informed consent? | Consent typically obtained from individual participants | Consent considerations extend to healthcare providers, administrators, and patients. Scope includes potential impact on systems and practices in implementation |
Consent form outlines study purpose, procedures, risks, and benefits for individuals | Consent may cover changes at the system level, understanding potential effects on multiple stakeholders | |
Is equipoise necessary? | Control groups often used to compare new interventions | Balancing equipoise can involve changes in practices, necessitating ethical reasoning for control groups. Uncertainty in scientific merit is important, but implementation context adds complexity |
Equipoise considers balancing risks and benefits for individual participants | Risk-benefit assessment includes potential system-level and societal impact, as well as individual well-being | |
How can scientific rigor be protected in routine care settings? | Rigor focuses on experimental design, data collection, and analysis | Rigor includes evaluating how interventions integrate into real-world contexts. Added challenge of assessing system-level outcomes |
Focus on addressing potential biases from study design and analysis | Consideration of biases extends to the impact of biases on healthcare delivery and system-level outcomes. Balancing scientific rigor with the practical considerations of diverse stakeholders is challenging. |