The FDA considers study advertisements to be the beginning of the informed consent process. The IRB will make sure you get it right from the get go. Required information for study advertisements includes:
- Name and address of investigator/ research facility;
- Purpose of the study;
- Summarized inclusion/exclusion criteria;
- List of any procedures involved;
- Time (or other) commitment required;
- Location of research;
- Who to contact for further information.
