Resources to aid ethical review of clinical studies: an exploratory scoping review identifying gaps and opportunities.

Abstract

Background: Research Ethics Committees (RECs) review the ethical, legal, and methodological standards of clinical research. Complying with all requirements and professional expectations while maintaining the necessary scientific and ethical standards can be challenging for applicants and members of the REC alike. There is a need for accessible guidelines and resources to help medical researchers and REC members navigate the legal and ethical requirements and the process of their review.

Methods: We employed an explorative search for resources on the websites of a purposively selected sample of relevant stakeholders, including 12 national umbrella organizations (six German-language and six English-language), three English-language international umbrella organizations, and 16 national RECs of major university hospitals (eight German- and eight English-language). We qualitatively mapped the identified resources onto the guiding principles of ethical clinical research and 35 related checkpoints. To describe the content of the resources, we conducted a thematic analysis.

Results: We extracted a total of 233 resources, including templates (n = 134, 58.5%), guidelines/recommendations (n = 62, 26.6%), checklists (n = 23, 9.9%), tools (n = 5, 2.2%), flowcharts (n = 5, 2.2%), glossaries (n = 3, 1.3%), and one (0.4%) software program. We extracted 101 German and 132 English resources created between 2004 and 2023. The majority (n = 204; 87.6%) could be assigned to one checkpoint. The remaining 29 (12.5%) resources were considered unspecific (e.g., a checklist which documents to be submitted for a German drug trial). The specific resources are discussed per checkpoint.

Conclusion: While much support is available for some aspects, such as participant information and informed consent forms, it is lacking in other areas, such as study design, analysis, and biometrics. More support should be provided in these areas to ensure that research projects are methodologically sound. A more detailed analysis of the quality of available resources could help identify other areas of need.