Table 1 Definitions
Term | Definition |
|---|---|
Evaluative empirical research | Empirical research evaluating how ethical recommendations are applied in practice. The publication was assigned to this category if it included a collection of either qualitative and/or quantitative data to evaluate the effectiveness (intended and unintended effects), efficiency or validity of the implementation of an ethical recommendation This may include studies that • Evaluate the extent to which an ethical recommendation is implemented in the current practice (e.g. status quo studies on how often results of completed clinical studies are published or to what extent informed consent forms follow the FDA recommendations on presenting risks and benefits) • Evaluate obstacles and opportunities that are associated with the implementation of the ethical recommendation (e.g. interview research with sponsors and principal investigators on experienced challenges and opportunities for implementing post-trial-access to drugs used in clinical trials) • Evaluate whether the ethical recommendation is implemented in a way that reflects the validity requirements of the respective recommendation. (e.g. a study investigating whether the concrete informed consent procedures of a specific study or in a specific context allow voluntary and informed consent decisions) |
Non-evaluative empirical research | The publication was assigned to this category only if it includes a collection of either qualitative and/or quantitative data that is not used to assess the worth or merit of the implementation of an ethical recommendation This may include studies that • Assess the attitudes of stakeholders towards a medical procedure (e.g. interview research to assess the attitudes of lay people in Germany towards oocyt donation) • Aim to understand the expectations of stakeholders of medical procedures (e.g. interview animal researchers about their viewpoints on whether and how future animal studies should be registered or not) |
Borderline cases | We expect that our categories are not absolutely distinct and there will be articles that cannot be clearly categorized. These borderline cases are valuable to further refine our concept This may include studies that • Provide a conceptual (armchair) evaluation of the effectiveness, efficiency or validity of ethical recommendations • Develop tools to evaluate the implementation of ethical recommendations (e.g. development of a scale to assess the understanding in an informed consent procedure) |