The University Board c/o the Rector
Responsibilities and tasks according to UiO procedures
Has overall responsibility for, and for the management of, the activities of the institution, and monitoring those activities
Delegating tasks
Delegation to the University Director of daily responsibilities in order to have in place systems for health research and protection of personal information
The University Director
Role
- Person with overall responsibility for research under the Health Research Act
- Sponsor for clinical trials of medicinal products and medical devices
- Data controller for personal data in accordance with the Personal Data Act
Responsibilities and tasks according to UiO procedures
- Delegated responsibility for all health research at UiO
- UiO’s responsible person for multicentre studies
- Responsible for ensuring justification assessment of health science research projects
- Responsible for UiO’s research biobanks
- Responsible for the protection of personal information when processing personal data
- Responsible for conducting internal control of research projects
- Liability officer in the event of injuries incurred to humans during medical trials or as a result of biological material or health information being handled in violation of the regulations
- Facilitate medical and health science research, including clinical trials of medicinal products and medical devices, safeguarding ethical, medical, health related, scientific, concerns regarding privacy protection and information security
Delegating tasks
- Permanent delegation to individual faculty deans and museum/centre directors subject to the University Board
- Delegation to the IT Director of tasks subject to the University Director’s responsibility for privacy protection
Department Director, Department of Research and Innovation Administration
Responsibilities and tasks according to UiO procedures
Establishing and maintaining a quality assurance system for medical and health science research, including document management
Delegating tasks
Can delegate tasks within the department
IT - Director (USIT)
Role
Performance of tasks subject to the University Director’s privacy protection responsibilities
Responsibilities and tasks according to UiO procedures
- Establishing and maintaining procedures for processing personal data
- Operating UiO’s data systems
- Internal control system for data security
- Exercising data processor/privacy protection responsibility
- Assessment of the lawfulness of data processing under privacy protection legislation
Delegating tasks
Can delegate tasks within the department
Chief Auditor
Responsibilities and tasks according to UiO procedures
Responsible for conducting internal audits, monitoring external supervision and reporting to University management
Delegating tasks
Can delegate tasks within the department
Individual deans at faculties, museum directors and directors at centres under the University Board
Role
Research manager and data controller’s permanent representative in their unit
Responsibilities and tasks according to UiO procedures
- Facilitating the organisation, planning, initiation, implementation, dissemination, conclusion and post-management of research projects
- Responsible for an overview at their individual unit of all medical and health science research projects which involve humans, human biological material, or health information
- Responsible for justifiably processing research data and human biological material
- Responsible for biobanks and for the designation of biobank officers
- Responsible for handling deviation reports
Delegating tasks
Can delegate further to heads of department
Head of the department and corresponding organisational levels
Role
Research manager’s representative in the event of a documented delegation from
the research manager’s permanent representative in their unit
Responsibilities and tasks according to UiO procedures
- Responsible for ensuring that the unit’s research projects are planned, organised, initiated, implemented, disseminated, concluded and finalised in accordance with all applicable legislation
- Responsible for assessing the justifiability in collaboration with project managers, and for ensuring the availability of necessary expertise and relevant evaluations from the EU or other external actors for the justifiability assessment.
- Responsible for ensuring that the department’s staff are familiar with the quality assurance system
- Responsible for notifying superiors and Chief Auditor upon notice of external supervision
- Establishing and maintaining department-specific procedures
- Tasks that are delegated from the research manager’s permanent representative in their faculty, such as the ongoing overview of research projects, safeguarding internal presentation prior to application to REK, designating those responsible for individual research biobanks and keeping a register of biobanks affiliated with their own department
Delegating tasks
May delegate further to the underlying level
Underlying level to the Head of Department or equivalent
Role
The research manager’s representative upon documented delegation from the Head of Department or equivalent
Responsibilities and tasks according to UiO procedures
Tasks delegated from Head of Department
Delegating tasks
Cannot further delegate the research manager’s tasks. Delegation is decided by the Head of Department or equivalent
Researcher at UiO
Role
Project Manager
Responsibilities and tasks according to UiO procedures
- Independent assessment of the project’s justifiability
- Internal presentation of the project for the research manager’s representative
- Daily operation of the research project
- Registering and updating the project in Forskpro, UiO’s ongoing overview of health science research projects
- Communicating with the research manager’s representative (head of the faculty/department/group leader) and UiO’s manager of data processing responsibilities
- Obtaining necessary internal and external approvals, ensuring their availability to the research manager’s representative and implementing them in accordance with approved conditions
- Handling and storage of research data
- Project documentation and follow-up of the project’s finances
Delegating tasks
As a project manager, practical project tasks may be delegated to colleagues, including students, who are qualified for the specific task.
Independent assessment of project justifiability cannot be delegated.
Medical Doctors or dentists employed by UiO
Role
Principal investigator
Responsibilities and tasks according to UiO procedures
Responsible for carrying out clinical trials of medicinal products and/or medical devices
Delegating tasks
Can delegate tasks to qualified colleagues with written documentation
Project team members appointed by the project manager
Role
Project team member
Responsibilities and tasks according to UiO procedures
According to the delegation from the project manager
Delegating tasks
Cannot delegate tasks further. The project manager must decide the delegation
Project team members appointed by the Faculty Head or museum director/centre director under the University Board
Role
Biobank manager
Responsibilities and tasks according to UiO procedures
Responsible for ensuring that material in research biobanks is stored
and handled appropriately
Delegating tasks
Can delegate tasks to colleagues who are qualified for the specific task. The delegation must be documented
Student
Role
Project team member. Cannot be a project manager
Responsibilities and tasks according to UiO procedures
According to the agreement with the supervisor, who is the project manager for the student project
Delegating tasks
Cannot delegate tasks further. Delegation is decided by the project manager
Data protection officer
Role
Data protection officer
Responsibilities and tasks according to UiO procedures
Should give advice as to how the data controller (see University Director) can best safeguard the privacy protection interests of employees and research participants
Delegating tasks
Cannot be delegated
Sikt (comprises the former NSD, Norwegian Centre for Research Data)
Role
Provider of personal data services under the agreement with UiO
Responsibilities and tasks according to UiO procedures
Conducts advance assessment of the lawfulness of processing and any privacy protection implications of research projects
See UiO’s procedure for research using personal data
Delegating tasks
Cannot be delegated