Anchoring in Own Department

Before the research can be initiated, the project manager must conduct a risk assessment, ensure that the study is anchored in a research group, and that it is approved by the responsible line manager for research.

Together with the research group and line manager, the researcher must clarify the following:

Is the project medically and ethically sound? This will usually be a so-called risk- benefit assessment.
Are privacy protection and the research participants' rights safeguarded in a reassuring manner?
Is there any reason to consider the need for a separate privacy impact assessment?
Is the project satisfactorily professionally, financially and administratively organized?

If several departments at the hospital are involved, the project manager or responsible researcher must ensure that the collaborating department (s) are informed and have approved their own contributions in the project.

If the project is a multicenter study, the project manager must ensure that collaborating institutions (research managers) are informed and that necessary binding agreements are in place.