System Owner
The overall system responsibility for research is assigned to OUS's management by the CEO and is exercised by the Director of Research, Innovation and Education. System responsibility includes overall responsibility for strategy, policy, framework management and follow-up of the research activities at OUS. The system responsible must also establish and maintain the hospital’s system for internal control in research, and facilitate systematic measures for the implementation of internal control for research in the hospital’s divisions.
Line Managers
Research is part of the ordinary operation at OUS. The line manager shall ensure that research activities in his/her unit are properly planned, organised and conducted in accordance with applicable laws, requirements and recognised research ethics norms, and within the limits of allocated resources. The manager also decides whether research projects should be carried out, including:
- Assess whether a research project is medically and ethically sound to carry out, including safeguarding of privacy and information security in accordance with requirements and regulations.
- Assess whether necessary advice regarding privacy has been obtained, where this is required in accordance with the Research Procedure, including ensuring that data protection impact assessments are carried out in accordance with the Data Protection Impact Assessment Procedure - DPIA (id. 131979).
- Evaluate whether projects are satisfactorily professionally, financially and administratively organised and planned, including that the project manager has sufficient expertise.
- Ensure proper processing of research data and human biological material in research (information security and privacy).
- Ensure that there is sufficient legal basis for processing personal and health related information in accordance with governing documents.
- Ensure that projects do not start until all necessary statutory approvals (e.g. REK and SLV) are obtained, including feedback on treatment basis in accordance with governing documents.
- Ensure that technical data collection and storage solutions are security-approved according to procedure (id. 11791)
- Designate the person responsible for the research biobank if relevant (see Responsible Person below).
For more information on the implementation of health research projects, see the Research Procedure.
The line manager’s responsibility to ensure proper organisation and conduct of research in own unit also includes:
- Keeping track of research activities in own unit and make systematic reviews, e.g. to ensure that ongoing projects have the necessary approval(s) and treatment basis in accordance with GDPR.
- Facilitating that employees become familiar with and receive training in relevant research regulations, including relevant governing documents and routines for "Notification to Data Protection Officer and Chief Information Security Officer" (id. 110411).
- Ensuring that satisfactory internal routines are established in own and underlying units. This will ensure a sound professional and administrative foundation, implementation and reporting of research projects, according to the hospital's governing documents.
- Assess whether the department has sufficient resources, patient base, infrastructure and support staff to conduct planned studies.
Division Research Manager (Forskningsleder)
The research manager holds an advisory staff function and assists the division manager in the overall follow-up of all research in the division. The research manager helps the division manager with implementing internal control systems for research and is also responsible for following up nonconformities and conflicts that are reported to the division manager, including those related to doctoral work.
Project Manager
The project manager is responsible for the day-to-day running of his/her research projects and for ensuring that the projects are planned, conducted and completed in accordance with the Research Procedure and other relevant governing documents, including:
- Ensuring that ethical, medical, health related, privacy and information security issues are taken care of at all stages of the project
- Obtaining necessary advice on privacy and data protection, related to the processing of personal and health information in his/her own projects, including ensuring that the necessary data protection impact assessment has been carried out, when this is required in accordance with governing documents (id. 131979).
- That the project is internally anchored and approved in accordance with the Research Procedure and internal routines in the department, including collaborating departments.
- That necessary approvals (e.g. REK, SLV) and feedback on the treatment basis for the processing of personal and health information are available before starting a project.
- That the project is carried out according to formal approvals and feedback on treatment basis, and in accordance with other requirements of the Research Procedure and other relevant governing documents
- Provide change notification when required by governing documents (id. 110411 and id. 13300).
- Ensure that all project staff members have sufficient competence to carry out assigned tasks in the project.
- Provide necessary agreements for research collaboration with external partners, including formalisation of the agreement in accordance with the OUS mandate structure.
- Prepare required reports etc. to relevant bodies.
For more information on planning and conducting health research projects, click here.
Responsible Person for Research Biobank
Every research biobank must have a responsible person with higher medical or biological education. For projects conducted under the auspices of OUS, the responsible person must be employed at the hospital.
The responsible person has the day-to-day operational responsibility of the research biobank, and shall ensure that the collection, registration, storage, processing and destruction of material are conducted in an ethically sound manner and in accordance with relevant regulations and internal guidelines. Usually the project manager also has the role of responsible person.
For more information, see Biobank.
Project Staff Members
Project staff members must be specified by the project manager and stated in the research protocol and application to REK when relevant. Each project staff member has an independent responsibility to familiarise themselves with relevant regulations and internal governing documents (eHåndboken).
External project staff members who will be given access to information systems at OUS shall be subject to the hospital's instructional authority.
Special Responsibility for Doctoral Work
Employees with supervisory responsibility for PhD candidates employed by OUS must ensure that the agreement between the relevant doctoral program and OUS is followed, including familiarising themselves with and following up their supervisory responsibilities in accordance with PhD regulations at the relevant institution.
Supervisors employed by OUS are also responsible for keeping the department head and research manager in the division informed of nonconformities and any conflict cases as part of the completion of a PhD programme.
For candidates employed by OUS, the Research Instruction and responsibilities as a project staff member apply. The candidate is also responsible for familiarising himself with, and following up on, his own obligations in accordance with the PhD regulations at the institution concerned.
