If significant changes are made to a research activity that has already been approved by the Research Ethics Committee, the changes must be reported.

 

It is only necessary to report changes that are relevant to the research-ethical assessment.

This may include, for example:

• changes to the target group of research participants (e.g. new inclusion or exclusion criteria)
• changes to methods or interventions
• new types of data, including new or more sensitive personal data
• changes to the consent basis or information materials provided to research participants

The email should briefly describe the proposed changes or additions in relation to the originally approved research activity.
The AAU Research Ethics Committee will then assess whether the changes can be accommodated within the existing approval or whether they constitute a new research activity requiring a new application.