Ethical guidance for applicants
The Ethical guidance for applicants outlines the key areas that Committee members consider when reviewing an application. This document was created as a resource for Sponsors and research teams in the preparation of applications to the Research Ethics Committees (NRECs). and include the following topics:
- Study design and procedures
- Dissemination of study results
- Anticipated benefits/risks for participants
- Site and staff suitability
- Recruitment and consent
- Study withdrawal
- Insurance and financial information
- Data protection
- Biological samples
- Genetic data and findings
- Future research
- Participant information leaflet / informed consent form (PIL/ICF)