1. Purpose
The purpose of this procedure is to ensure that the duties ascribed to the person with overall responsibility for research, including those of the data controller, are fulfilled at UiO, and that delegation of tasks from the person with overall responsibility for research is documented.
2. Scope
This procedure applies to all research at UiO covered by the Health Research Act.
3. Responsibilities
The University Director
- holds the role of the person with overall responsibility for research under the Health Research Act, and the role of the data controller under the Personal Data Act
- shall ensure that medical and health science research is carried out in such a way that ethical, medical, health related, scientific, privacy protection and information security are safeguarded while keeping sound and feasible project execution
- is responsible for establishing internal control
- shall facilitate sound research through the establishment of a quality assurance system for medical and health science research and a distinct organisational structure
- is responsible for establishing procedures for handling personal data during research
- is responsible for ensuring that the duties of the Research Manager and Data Controller are fulfilled, but may delegate duties and tasks to faculties, museums, independent centres or support units in Management and Support Units
- is responsible for research biobanks directed by UiO
- is a liability officer by law
Individual deans at faculties, museum directors and directors at centres under the University Board
- is the representative of the person with overall responsibility for research at their units
- facilitates the proper organisation, planning, initiation, implementation and conduct, dissemination, conclusion and post-management of research projects
- shall ensure that each individual health science research project undergoes an internal review, including justifiability assessment, prior to initiation, during and at the conclusion of the research project
- is responsible for the development and implementation of necessary unit-specific procedures
Individual Head of Department or equivalent
is, in their department/unit, responsible for:
- ensuring that the unit’s research projects are planned, organised, initiated, implemented and conducted, disseminated, concluded and finalized correctly and in accordance with all applicable legislation
- tasks delegated from the Dean or equivalent; such as managing continuous overviews, safeguarding internal presentation, including privacy, prior to applications to REK and notifications to Sikt (formerly NSD, Norwegian Centre for Research Data), as well as designating responsibility for individual research biobanks and keeping a register of the biobanks affiliated with their own department
- delegation of duties and tasks to the level below when appropriate
UiO employees who at all times hold the role of project manager
- shall have an overview of the requirements and regulations applicable to the research, UiO’s quality assurance system for medical and health science research, and UiO’s procedure for research using personal data
- conduct an independent evaluation of the project’s justifiability, including the protection of privacy
- ensure the internal presentation of the project before its starting date, during the project and upon completion, see Procedure 2
- ensure that project staff are trained and informed
- ensure that test subjects, materials and data are processed properly
- report deviations according to Procedure 8
UiO employees who at any time hold the role of the person responsible for the research biobank
- shall have an overview of requirements and regulations applicable to research biobanks, and of UiO’s quality assurance system for medical and health science research, as well as UiO’s procedure for research using personal data
- ensure that staff are trained and informed
- ensure that material in research biobanks is stored and handled properly
- report deviations according to Procedure 8
4. Description of tasks
Delegation of duties and tasks
The Faculty Head (Dean) or equivalent will always be the University Director’s (person with overall responsibility for research) representative in the individual faculty, museum or centre under the University Board, and will be delegated the duties and tasks of the person with overall responsibility for research as specified under chapter 3 of this procedure. This delegation will not be separately documented by UiO. The faculty leader or equivalent may delegate the duties and tasks of the person with overall responsibility for research to the Heads of the Department. Such delegation must be documented, see Attachment 1.1 Form for permanent delegation of tasks.
The Head of Department or equivalent may delegate the duties and tasks of the person with overall responsibility for research to the underlying level where appropriate. Such delegation must be documented.
The delegation of duties and tasks from the person with overall responsibility for research to Management and support units (LOS), the IT Director, the director of the Department for Research and Innovation Administration and the director of the Internal Auditing Unit is described in UiO’s Quality assurance policy for medical and health science research.
5. Legal basis
- LOV 2008-06-20 no 44 Health Research Act
- FOR-2009-07-01-955 Regulations on Organisation of Medical Research
- LOV-2018-06-15-38 Act on the Processing of Personal Data
6. Appendices
Attachment 1.1 Form for permanent delegation of tasks (word)
Local routines
Procedure descriptions and forms for the Faculty of Medicine