Background and purpose

The purpose of the guidelines is to safeguard privacy for participants in research projects that process personal data and health research data, in line with the Personal Data Processing Act (Personal Data Act implementing the Privacy Regulation (EU) 2016/679) and the Medical and Health Research Act (Health Research Act). The guidelines shall also cover general research ethics considerations in line with the Act on the Organization of Research Ethics Work (the Research Ethics Act). The privacy regulations shall contribute to personal data processing following basic privacy considerations and ensuring personal integrity, privacy, and sufficient quality of personal data. The Research Ethics Act emphasizes that all research must take place following recognized research ethics norms. Both the Personal Data Act and the Research Ethics Act emphasize the institution's responsibility, in addition to the fact that someone who processes personal data (in this case, researchers and students) has an independent responsibility to comply with laws, guidelines and norms. The institution shall implement appropriate technical and organizational measures to ensure and demonstrate that treatment is carried out correctly and possible deviations are discovered and corrected. In all processing of personal data, privacy consequences must be assessed, and protocols processed. The guidelines with routines are HVL's tool to ensure this.

The guidelines represent a standard collection of routines for research projects that include the processing of both personal data and health research data. While the Personal Data Act applies to all research that handles personal data, there are additional special routines that must meet the requirements of the Health Research Act.

More information on privacy can be found at the Norwegian Centre for Research Data (NSD) and the Norwegian Data Protection Authority and subject-specific research ethics guidelines from the National Research Ethics Committees.

Legal basis (in Norwegian only)