Permissions

It is the responsibility of the head of any register-based research project to ensure that required permissions have been obtained from relevant authorities. Below is a rough guide to application procedures.

!! Note that each authority has a processing time of several weeks to a few months, so it may take several months before you can access data.

Please contact the CIRRAU data management team if you are unsure of the correct application procedure.

Allan Timmermann (ati(at)econ.au.dk)

Ane Marie Closter (amcl(at)econ.au.dk)

Anna Huus Eriksson (aner(at)econ.au.dk)

REGISTER DATA ONLY

Every time you want to initiate a register-based research project, you need to register the project at your institution.

Aarhus University holds a record of all ongoing research projects that include personally sensitive data. You therefore notify AU of new projects, project extensions, data transfer etc. Register here (In Danish and for AU staff only). The form will include information on e.g.

- Name of the person responsible for the study

- Title and purpose of the study

- Persons whose data are included in the study

- Type of data

- etc.  

Project notifications are required in order to 1) keep control of data analyses carried out and 2) ensure openness regarding ongoing studies.

It is your responsibility to ensure that your proposed study is in accordance with Danish law, and in case of uncertainties or queries, make sure to contact the University (link for more information).

 

 

 

PROJECT NOTIFICATION FORMAT

All Aarhus University research projects that include personally sensitive data need to be registered by the University.

 

 

BIOLOGICAL MATERIAL

The National Committee on Health Research Ethics needs to be notified of any health research projects and give their permission before the study may be initiated. This means that if you plan to carry out a research project based on both register data and data from biological samples (e.g. genetic data), you have to notify the committees on health research ethics.

In short, a health research project is one that includes studies on

- Live-born human individuals

- Human gametes intended for fertilization, fertilized human eggs, zygotes and fetuses

- Tissue, cells and gametes from humans, fetuses etc.

- Deceased individuals

Also included are clinical experiments on medications and clinical experiments on medical equipment. Note that health research projects include studies within traditional health-related research as well as research concerned with social medicine and epidemiology. In addition, health research projects also include studies on psychiatric and clinical-psychiatric disorders, odontological and pharmaceutical research projects.

 

 

ETHICS COMMITTEE APPL. FORMAT

Guidelines for applications to the Committees on Health Research Ethics are presented on their homepage.

 

Notifications of projects to be administered at Aarhus University, Aarhus, should normally be submitted to the committees on health research ethics in the Central Denmark Region. If you plan to use genomic data, you may have to apply to the National Committee on Health Research Ethics.

HEALTH-RELATED DATA

If you want to include data from the Family Relations Database in your study, you need to submit an application to the research support unit at Sundhedsdatastyrelsen (SDS). You need to apply, whether you need 1) permission to receive an extraction of relevant data from the Family Relations Database to be placed in your project folder at Statistics Denmark, or 2) to purchase data extracts directly from SDS and have them sent to Statistics Denmark to be placed in your project folder. There, you may combine the data extracts with data from other sources, e.g. socioeconomic data from Statistics Denmark or cohort data collected by your own research group.

With the application form, you need to upload the following items:

- Project description

- Description of the data you need for your study

You can apply here: SDS (in Danish).

 

Prescription data 

A version of the Register of Medicinal Product Statistics is managed by Statistics Denmark on behalf of Sundhedsdatastyrelsen. Part of the data are included in 'Projektdatabase NCRR / CIRRAU', and they will be available to you on the condition that you obtain permission from Sundhedsdatastyrelsen to use them in your study. An application for such a permission should be combined with your project request to Statistics Denmark.

SDS APPLICATION FORMAT

Applications for use of health-related data from Sundhedsdatastyrelsen are comprised by two documents – a project description and a data extract description.

In addition, you need to supply an abstract and payment information etc. when you upload the application using the electronic form on the homepage of Sundhedsdatastyrelsen.

If you apply for extracts from the Family Relations Database, please use the form for "Data til Danmark Statistik" and check the "familiedatabasen" box in the form. Please also follow the format for variable lists also used for project requests to Statistics Denmark.