Background
DAC was established as a means for upholding the Health Research Act's requirement of internal control (§ 4) and the guidelines of Article 30th of the General Data Protection Regulation (GDPR).
All medical and healthcare research is required to abide by the guidelines of the Health Research Act. Both project leaders and associated organizations are responsible for upholding these regulations.
The requirement of internal control applies to all types of research projects, e.g. internal projects at HMR, multicenter studies, and external projects that seeks to use data/patient information from HMR.
What does DAC review?
DAC reviews and approves a project's privacy and data protection measures on behalf of the HMR administration.
DAC does not usually review the scientific quality and value of research projects. The project leader is responsible for assuring that the project is of high scientific quality, feasibility and value. This needs to be formulated in a clear and concise manner when applying for approval from DAC.
DAC may nonetheless review the aforementioned and similar areas (e.g, the project's ethical and scientific aspects) that is related to the quality and value of the research project. DAC may, based on this, propose changes to the application before the project can be approved.
DAC competence
The DAC members have broad knowledge of topics related to privacy and data protection and conducting research projects at the theoretical and practical level.
DAC shall
- assure privacy and data protection in research
- by ensuring that all research projects are formally approved and in accordance with the privacy and data protection guidelines.
- when retrieving sensitive information from patient journals and quality registries.
- when storing and retrieving biological materials.
- assure privacy and data protection in medical and healthcare research, including
- quality assurance projects.
- innovation projects.
- research projects.
DAC may also assess:
- the overall quality and use of the project, including...
- its ethical, professional and scientific aspects
- the project leader's professional and scientific competence
DAC is not required to assess:
- continuous internal quality assurance in relation to § 26 of The Health Personnel Act that is recorded in accordance to Article 30 of GDPR. This does not require approval from DAC.
Meetings
DAC arranges meetings approx. every third week. All applications need to be submitted half a week in advance to the scheduled meeting.
All relevant documents need to be attached to the application before it may be reviewed by DAC. Each meeting typically assesses five applications but the number may vary depending on how comprehensive each application is.
Decisions and complaints on decisions
Decisions by DAC is done on behalf of HMR. Decisions that reject an application need to be properly reasoned. The applicant may appeal the decision within three weeks after the decision has been given.
All appeals are submitted to DAC, which arranges a new review of the application in question. The decision may either be maintained or changed depending on the final verdict by DAC.
If the decision is still maintained: DAC prepares and forwards the appeal case to the Director of Medical Strategy and Development, who functions as the main appellate instance. The Director's decision is final. The regulations of the Public Administration Act apply.
