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Quality Assurance System for Health Research

Here you can read about the requirements for health research, how to comply with them, and the procedures we must have in place to ensure that requirements are adhered to. These requirements apply to all health research at USN. They cover health research in a broad sense, not just projects requiring approval from a Regional Ethics Committee (REK).

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About the Quality Assurance System 

The objective of the requirements and routines laid out on the following pages is to ensure that health research conducted at USN complies with legislation and ethical guidelines. The quality assurance system refers to health research in a broader sense. It assures the quality of projects that fall under the Health Research Act and those that do not. 

All research in Norway is subject to the Research Ethics Act  and must adhere to recognised ethical research norms. This responsibility is specified in Norwegian and international guidelines, such as the ALLEA Code of Conduct for Research Integrity and the guidelines from the National Research Ethics Committees. 

With some exceptions, the Health Research Act governs health research in Norway. The act is a legal framework aiming to protect research participants. The purpose of the Health Research Act is "to promote good and ethically responsible medical and health-related research" (Section 1). The act applies to health research at USN, and provides information about the requirements for health research, how to adhere to them, and the procedures USN has in place to ensure compliance. You can also find relevant links and resources under theme covered by USN’s quality assurance guide. All research covered by the Health Research Act must seek prior approval from a Regional Ethics Committee (REK). All medical and health-related research projects must follow the guidelines outlined in this document. 

Not all research related to health, however, falls under the Health Research Act. Even in research not governed by this law, it is necessary to protect research participants, clarify who is responsible for what, and ensure proper processing of research data. Additionally, there is other legislation that all research in Norway must follow, such as the Research Ethics Act and the Personal Data Act. 

When Should the Health Research Guidelines at USN be Used? 

  • All research projects covered by the Health Research Act must apply to the REK and comply with relevant laws and regulations. This is specified in USN’s guide on quality assurance in health research.   
  • All projects that broadly involve health, engage human participants through research intervention, pose a potential risk to research participants, and/or process health-related data must also follow USN’s guide on quality assurance. 
  • All research projects at USN can use USN’s quality assurance guidelines as part of their own quality system for responsible research. 

Resources 

Questions About the Quality Assurance System for Health Research?

The Department of Research, Innovation, and Library Services manages the Quality Assurance System for Health Research at USN. The quality assurance system is reviewed and updated as needed. If you have suggestions for improvements or notice that content is missing, feel free to report it to forskningsetikk@usn.no. We will reply to your email.

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