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About the Quality Assurance System

Roles and Responsibilities

Outline of roles and responsibilities for research projects at USN.

The Project Manager will

  • Assess whether alternatives to conducting research on humans exist, evaluate and describe risks, and, if necessary, stop or modify the project
  • Apply for REK approval, submit the notification form to Sikt, and obtain other necessary approvals
  • Obtain supervisory endorsement before the start of a project, present the notification form and REK approval when requested, and inform the supervisor of major changes in the project
  • Prepare a research protocol and ensure that the research is conducted in accordance with this protocol
  • Ensure that essential documentation is stored in accordance with documentation requirements
  • Follow the conditions set out in the REK approval, the Sikt assessment, and any other approval
  • Notify REK and Sikt of major changes to the project
  • Ensure information security, data protection, and adherence to recognised research ethics standards
  • Safeguard the rights of the project’s research participants
  • Ensure that freely given, informed, and documented consent is obtained from research participants
  • Ensure that all individuals working on the project have the necessary competence and knowledge to carry out their tasks in accordance with the health research guidelines
  • Create a Data Management Plan (DMP) and ensure secure storage of research data
  • Assess which research data can be shared and facilitate sharing in USN’s research data repository
  • Ensure deletion/anonymisation of health data, secure long-term storage and/or destruction of biological material when REK approval expires
  • Submit a final report to REK and Sikt after the project is completed
  • Provide requested information in connection with internal audits and supervisory activities
  • Report unexpected outcomes and irregularities in cases where breaches of law, regulation, or guidelines have occurred.

Note: For health research projects subject to the Health Research Act and requiring REK approval, the project manager must hold a doctoral degree or equivalent qualifications.

Students and Employees Involved in Health Research will

  • Notify their supervisor or academic advisor if they need training related to the guidelines and/or regulations applicable to health research
  • Follow relevant guidelines and regulations
  • Have a duty to prevent and report irregularities
  • Prepare the Sikt notification form in consultation with their supervisor
  • Assist the project manager in applying to REK

The type of responsibility a student may assume, with supervision, will vary depending on the level/degree of responsibility. For more detailed information about the division of responsibilities between supervisor and student in student projects, see the dedicated section on Student Projects.

Heads of Department* will

  • Ensure that a project manager has the competence required
  • Assess whether research projects align with the unit’s strategy and have the necessary resources to be carried out
  • Ensure that responsibilities between any external parties are clarified in writing
  • Assist the Department for Research, Innovation and Library Services with internal audits of health research projects
  • Follow up on irregularities that have been reported
  • Ensure that employees in the unit are familiar with and use the quality assurance system
  • In cases where project managers change jobs during an ongoing research project, ensure that a new project manager is appointed

* Some research at USN is conducted within dedicated centres or units, such as eDU (Unit for Digitalisation and Educational Quality). In such cases, the centre or unit head assumes these responsibilities.

The person responsible for the Research Biobank will

  • Ensure that the research biobank is established and managed in accordance with relevant legislation
  • Ensure proper storage and handling of the material in the research biobank
  • Follow up on the right to opt out of the use of biological material in research

USN’s Institutional Responsibility as Endorsing Research Institution

  • The University Board has the overarching responsibility for ensuring that research projects at USN comply with applicable laws and regulations for research, a responsibility which it further delegates to the Principal. The Principal may then delegate tasks, but not the responsibility itself, to others within the organisation.

  • The Vice-Principal for Research, Sustainability and Innovation has overarching academic and strategic leadership responsibility for research.

  • The Director of Shared Administrative Services has the overarching responsibility for ensuring that USN’s shared services have the necessary resources and collaboration to support the systematic quality assurance system for health research.

  • The Director of Research has operational responsibility for the shared services’ follow-up of health research projects.

The Director of Research will

  • Maintain the quality assurance system for health research and ensure it is regularly updated in accordance with new legislation and emerging research ethical challenges

  • Ensure that guidance and training in the health research quality system are offered
  • Conduct internal audits of health research projects
  • Annually review the status of the quality assurance system and the internal control system together with the Deans and the Vice-Principal for Research, Sustainability and Innovation
  • Facilitate the proper processing of research data and human biological material
  • Be responsible for maintaining an ongoing overview of medical and health-related research involving humans, human biological material, or health data in USN’s project database
  • Ensure that USN has procedures for handling deviations in health research, that deviations are followed up, and that the reporting obligation to the Norwegian Board of Health Supervision is fulfilled
  • Ensure that necessary insurance coverage for research participants is in place, in accordance with § 50 of the Health Research Act

Deans will:

  • Be administratively responsible for ensuring that research at USN complies with the Health Research Act, the Personal Data Act, the Research Ethics Act, and other relevant regulations
  • Ensure that employees and students at USN receive necessary training in the Health Research Act, data protection regulations, and research ethics
  • Ensure that research is conducted as regulated and that irregularities are followed up on
  • Appoint a person with the necessary competence to be responsible for the research biobank

Subject-Matter Expert in Data Protection / Data Protection Advisor will

  • Provide advice when research requires personal data

  • Assist the Department for Research, Innovation and Library Services with internal audits of health research projects

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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