Opt-out

Clinical research is normally conducted after explaining the study to participants and obtaining their signed consent (informed consent).

However, under national guidelines, research that uses only existing information or records—without placing new burdens on participants such as blood draws or additional tests—does not always require direct individual consent.

Instead, the following is required:

• Publicly disclosing the purpose and content of the research, such as on a website
• Providing a way for anyone who does not want their data used to opt out at any time

This method is called “opt-out.”