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FAQ

A collection of some of the frequently asked questions regarding submitting a health research project in Denmark

by subject in alphabetical order

Other authorities could be:

Danish Medicines Agency
Danish Data Protection Agency
Danish Patient Safety Authority

Get help in English >>

The purpose of these guidelines is to provide an overview of the requirements that apply to research into biological material as imposed by the Committee Act. The guidelines describe when research involving biological material must be notified and how to handle biological material if a project subject to notification collects, stores and/or uses biological material.

Read the guide on the webpage from the Danish National Committee on Health Research Ethic >>

New projects decided at a committee meeting

Statutory case processing time for these is 60 days of a proper submission being recieved.

Changes submited as a amendment

Statutory case processing time for these is 35 days of a proper submission being recieved.

The purpose of these guidelines is to ensure that genomics research takes place according to the provisions of the Committee Act in relation to research participants’ autonomy, safety and well-being, which come before scientific interests to acquire new knowledge.

Read the guide on the webpage from the Danish National Committee on Health Research Ethic >>

 

 

A decision taken by a regional committee can be taken before the national committee. Complaints procedures >>

The Regional Committees on Health Research Ethics for Southern Denmark consists of two committees with each 11 members.

The regional research committees are set up by the Regional Council in Southern Denmark. 5 members in each committee are active within health research and 6 are politically appointed of the Regional Council.

See the members of the committees (only in Danish) >>

When talking about adverse reactions in research projects, a distinction is usually made between adverse reactions in clinical trials on medicinal products and adverse reactions in trials not involving medicinal products.

Here you can find out when you must report adverse reactions in either of these trials>>

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