Research on humans
- Justify why you are using adults
- If you are using vulnerable adults, such as elderly with illness, justify this and explain exactly what procedures you will undertake
- Specify exactly what information you will collect and do with this information
- Specify how informed consent will be obtained.
- State any expected harm and benefit to the adults
- Confirm you have insurance to protect staff and adults in the study
- Discuss if any incidental findings may be found and your strategy to addressing these
- Confirm you have read national and EU regulations on studies with adults and related these in your application to the specifics of your study
- Justify how many adults will be used by clear sample size calculations (under recruitment or over- recruitment can be unethical) and give inclusion and exclusion criteria
- Confirm if it’s a clinical trial you will follow good clinical practice and all EU regulations.
- Specify exactly your data protection approach and practices
- If these are vulnerable adults (e.g. elderly patients in a residential center with advanced Alzheimer’s) particular attention should be given to how you will get informed consent, and provide support if needed.
