Responsibilities and delegation of tasks
Introduction
The University of Oslo is Norway’s oldest university, anchored in European scientific tradition. UiO’s strategic ambitions up to 2030 are central in planning, implementing and reporting UiO’s research, and can be summed up as follows:
- Promote independent, ground-breaking and long-term research
- Intensify efforts related to research ethics and research integrity
- Contribute to a strong and positive research culture founded on high academic standards and ideals for all research activities
- Knowledge and awareness of research ethic norms must be safeguarded by all academic communities and by all levels of the organisation through systematic training and continuous awareness
Medical and health science research can take place in all faculties at UiO. This means that the research covers a considerable range and that a central quality assurance system can only provide general guidelines. Furthermore, faculty-specific systems must be available and adapted to the scope and character of the health research at the individual faculty.
Parts of UiO’s research are integrated into other institutions, and the quality assurance system must consider this. Oslo University Hospital and Akershus University Hospital have a special responsibility for research and education in collaboration with UiO. This arrangement of combined positions with employment at both the University and the University Hospital is a well-established scheme for safeguarding this statutory interaction.
All parts of the quality assurance system will contribute to ensuring that medical and health science research, including clinical trials of medicinal products and medical devices, is planned, implemented and reported in such a way that ethical, medical, health, science and privacy conditions are safeguarded while keeping sound and feasible project execution.
UiO, UiO’s employees, PhD candidates and students must comply with the following guidelines in all research activities:
Main principles
Authorities and regulations
UiO’s research activities shall be in compliance with relevant laws and external guidelines, as well as the institution’s internal guidelines. UiO shall ensure as far as possible that its clients, subcontractors and partners also comply with current regulations and guidelines. Applications and other documents submitted to the Regional Committees for Medical and Health Research Ethics (REK), the Norwegian Medicines Agency, and other authorities, shall be complete and thoroughly worked through in accordance with regulatory requirements and standards. The same applies to submissions to SIKT (Norwegian Agency for Shared Services in Education and Research, formerly the NSD – Norwegian Centre for Research Data), which is UiO’s service provider for privacy protection assessment.
Confidentiality and security
Anyone with authorised access to health information and other personal data processed in a research project shall ensure that unauthorised personnel is not able to gain access to or knowledge of that information. Documents and other information relating to research projects shall be kept secure so that unauthorised persons are not able to access them. Electronic systems and premises used for research activities must meet requirements for storing personally identifiable information set out in the Personal Data Act and UiO’s guidelines. Research data shall not be extracted from these systems without a written data disclosure agreement. Documents may be shredded and/or deleted if this is in accordance with REK decisions as well as relevant legislation. TSD (Services for Sensitive Data) shall be used for the collection, processing and storage of data.
Expertise
UiO’s project staff must have adequate education and experience for the research tasks for which they are responsible and shall be given ongoing supervision and follow-up. Limited experience can be compensated by extended supervision and follow-up. UiO’s researchers are encouraged to participate in academic forums, interest groups and associations where UiO research can be promoted and presented, while also being subject to evaluation and criticism.
Working environment
UiO’s leadership will develop and maintain a good research environment with open communication.
Agreements with partners
Research cooperation with other institutions must not take place without a written agreement between UiO and its partners. In addition to financial conditions, this agreement must describe which of the collaborating institutions’ quality assurance systems will be used in the project, and where the data generated during the project will be retained. If a project includes the collection and/or use of human biological material, this must be specified in the agreement or its appendices. For projects of longer durations, agreements should be reviewed annually to make necessary changes or additions.
Internal control
Internal reviews involve systematic work, including training, to ensure that UiO complies with laws and regulations, as well as targeted and efficient operation and reliable reporting.
UiO must have a quality assurance system for compliance with legislation relevant to UiO’s health research, including data protection legislation. The quality assurance system must be kept up to date, with routine reviews being carried out every three years by the Department of Research and Innovation Administration. Employees must be trained on the quality assurance system as needed, based on their research project tasks, and in the event of any changes. UiO must have a system and a plan to carry out internal quality checks of its systems and of research projects carried out by UiO as responsible for the research or in collaboration with other research responsible institutions or organisations. Projects for which UiO is responsible for the research, or where UiO is one of several collaborating institutions, must be registered in Forskpro. Forskpro is UiO’s ongoing overview of research projects.
Responsibilities and delegation of tasks
See the overview of Roles and responsibilities within UiO’s medical and health science research.