Case #18: Access to patient record data

 
Cases are examples of questions and inquiries we receive in the Guidance Function, which we would like to share for inspiration.

A researcher contacted the Guidance Function with an inquiry about how to get access to data from patient records.
In general there are four ways of obtaining permission to gain access to patient record data:

  1. Patient consent
  2. Approval from a scientific ethics committee
  3. Approval from the Regional Council
  4. Quality assurance or quality development projects


1.
You can get permission to access patient records by obtaining written consent from the patient. However, you should be aware that consent lapses no later than 1 year after it has been given, and must be obtained once again.

2.
If the research project requires the approval of a scientific ethics committee, e.g. if the project contains human biological material or sensitive bioinformatic data, etc., then you can also be approved to obtain patient record information through this. Read more about what must be reported to the Scientific Ethics Committee on the following website (in Danish): Hvad skal jeg anmelde? | Nationalt Center for Etik
It must be emphasized that permission is only given for the disclosure of patient record information, i.e. the researcher must contact the department in question, which must hand over the patient record information and make a further agreement about the record extract.

3.
If the research project does not require scientific ethics approval, the regional council in the region where the researcher works can grant approval for obtaining patient record information. Below you will find links to guidance and applications from the regional councils.
Again, it must be emphasized that permission is only given for the disclosure of patient record information, i.e. the researcher must contact the department in question, which must hand over the patient record information and make a further agreement about the record extract.

4.
The management at the treatment facility, cf. section 42 d, subsection of the Health Act 2, can only approve the acquisition of patient record information for use in quality assurance or quality development projects.
In some cases, it can be difficult to define whether one’s project is a research or quality project. In case of doubt, it is recommended to contact the local hospital management for clarification.
 

In this case, we helped the researcher clarify the different authorization options available for obtaining patient record information. We also sent information about the regional council in question, for the region in which the researcher worked.
 
Please feel free to contact us if you need guidance in your research project. Our services are free, and we aim to reply to any inquiries within 2-4 working days.
The Guidance Function offers first-level support for Danish and international researchers in need of help to navigate the requirements and processes surrounding research projects.

 
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