Contents
- Tasks can be delegated, but responsibilities cannot.
- Tasks than can be delegated in UiO’s quality system for medical and health research:
- 1. Running overview of all medical and health research projects that involve humans, human biological material or health information
- 2. Proper handling of research data
- 3. Necessary insurance of research participants must be in place for the projects where this is a requirement
- 4. Human biological material must be handled properly, a manager must be appointed for all research biobanks and a register must be kept of biobanks linked to the unit
- 5. Deviation management
- 6. Training. Researchers and technical-administrative staff with research-related tasks must be fully conversant with the quality system
- 7. Internal submission before application to REC
- Deviation typology
Tasks can be delegated, but responsibilities cannot
Delegation is discussed in various parts of Deloitte’s audit report. In Procedure 1 – Responsibilities and delegation of tasks at UiO pursuant to the Health Research Act (.pdf) in the quality system, the University Director is responsible for the research pursuant to the Health Research Act as follows:
- The University Director has delegated the task of following up the procedures of the quality system to the Dean.
- As the head of faculty, the Dean always acts as the University Director’s (person responsible for the research) representative.
- The Dean can delegate tasks to the head of department, who in turn can delegate tasks to underlying units.
The person responsible for the research will facilitate the proper planning, organization, initiation, implementation, dissemination, completion and management of research projects in accordance with current legislation.
No administrative roles or functions at the Faculty or department are discussed in UiO’s overview of the roles and responsibilities in medical and health research at UiO. The administration’s function in the quality system is to serve as the secretariat for the academic management at units with delegated tasks.
Tasks that can be delegated in UiO’s quality system for medical and health research
1. Running overview of all medical and health research projects that involve humans, human biological material or health information
Starting in 2017, an overview of research projects will be held in a new research administration system.
The Faculty of Medicine’s procedure:
The Dean delegates the task of maintaining an overview of research projects to the head of department, who in turn can delegate the task to the administrative manager, head of research, head of research group and head of section or centre director (Centres of Excellence/KGJebsen) where such roles exist.
Research administration staff perform the task of maintaining the overview in the individual units on behalf of management.
Research administration staff report on the work of maintaining an overview of research projects to the administrative manager, head of research, head of research group and head of section or centre director (Centres of Excellence/KGJebsen), where such roles exist.
An annual report on the overview of research projects must be submitted to the Management Forum.
2. Proper handling of research data
The University Director has delegated the responsibility for UiO’s computer systems, internal control, information security and operation of TSD to the Director of Information Technology.
The Faculty of Medicine’s procedure:
The Dean delegates the task of ensuring that research data is properly handled and in accordance with procedure 6 and other IT regulations to the head of department, who in turn can delegate the task to the administrative manager, head of research, head of research group and head of section or centre director (Centres of Excellence/KGJebsen), where such roles exist.
In cases where the head of department, administrative manager, head of research, head of research group, head of section or centre director is a project manager, the management level above project manager will ensure that research data is properly handled.
3. Necessary insurance of research participants must be in place for the projects where this is a requirement
The Faculty of Medicine’s procedure:
The Dean delegates the task of ensuring that the necessary insurance is in place for research participants to the head of department, who in turn can delegate the task to the administrative manager, head of research, head of research group and head of section or centre director (Centres of Excellence/KGJebsen), where such roles exist.
4. Human biological material must be handled properly, a manager must be appointed for all research biobanks and a register must be kept of biobanks linked to the unit
The Faculty of Medicine’s procedure:
The Dean delegates the task of appointing a manager for the individual research biobanks and keeping a register of the unit’s biobanks to the head of department, who in turn can delegate the task to the administrative manager, head of research, head of research group and head of section or centre director (Centres of Excellence/KGJebsen), where such roles exist.
Research administration staff perform the task of maintaining the register of biobanks in the individual units on behalf of management. Research administration staff report on the work of maintaining an overview of research projects to the administrative manager, head of research, head of research group and head of section or centre director (Centres of Excellence/KGJebsen), where such roles exist.
5. Deviation management
The Faculty of Medicine’s procedure:
- Deviations in a research project must always be reported to an employee’s immediate superior, who will report the deviation to the administrative manager, head of research, head of research group and head of section or centre director (Centres of Excellence/KGJebsen), where such roles exist.
- Where such roles exist, the administrative manager, head of research, head of research group and head of section or centre director (Centres of Excellence/KGJebsen) must always report deviations in a research project to the head of department. The head of department must always report serious deviations to the Dean.
- The head of department must assess whether the research project should be suspended while the deviation is being dealt with. REC must be contacted to give an assessment of the deviation report if it is unclear whether the research project is safe and whether the risk is acceptable.
- An annual report of all deviations must be submitted to the Management Forum.
6. Training. Researchers and technical-administrative staff with research-related tasks must be fully conversant with the quality system
The Faculty of Medicine’s procedure:
- The Faculty has overarching responsibility for training in the use of the quality system.
- Courses must be jointly organized by the Faculty and departments.
- Training initiatives must be evaluated every six months until 2020.
- An evaluation report must be dealt with as a separate item in the Management Forum every six months.
- The Faculty’s research administration serves as the secretariat for courses on quality system procedures.
7. Internal submission before application to REK
The Faculty of Medicine’s procedure:
The Dean delegates the task of ensuring internal submission to the head of department, who in turn can delegate the task to the administrative manager, head of research, head of research group and head of section or centre director (Centres of Excellence/KGJebsen), where such roles exist.
In cases where the head of department, administrative manager, head of research, head of research group, head of section or centre director is a project manager, the management level above project manager will perform internal submissions.
Reports on the status of delegated tasks in the quality system
Reports as described above can be collated into one report. The exceptions are the twice-yearly evaluation of training up to 2020 and the deviation report, which is to be treated as a separate item in the Management Forum. Proposed resolution: The case is approved for consultation.
Deviation typology
What constitutes a deviation from the requirements in the Health Research Act and regulations, and the Personal Data Act and regulations?
- Unwanted and unexpected medical incidents (to be reported to the Norwegian Board of Health Supervision = Health Research Act, Section 23 and the duty to inform research participants of injuries and similar = Health Research Act, Section 24).
- Injury to the research participants (to be reported to the Norwegian Board of Health Supervision = Health Research Act, Section 23 and duty to inform research participants of any injuries or similar = Health Research Act, Section 24).
- Failure to obtain approval from REC or other approval bodies.
- Failure to obtain/invalid consent from research participants.
- Incorrect handling of research data.
- Incorrect or inadequate handling of human biological material.
- Incorrect or inadequate trials of a pharmaceutical drug.
- Incorrect or inadequate use of medical equipment in research projects.
- Research that is not described in the research protocol.
- Injuries to employees (HSE at UiO).
Procedure for deviation management
- Serious deviations as described above must always be reported to an employee’s immediate superior, who will report the deviation to the administrative manager, head of research, head of research group and head of section or centre director (Centres of Excellence/KGJebsen), where such roles exist.
- Where such roles exist, the administrative manager, head of research, head of research group and head of section or centre director (Centres of Excellence/KGJebsen) must always report deviations in a research project to the head of department.
- The head of department must always report serious deviations to the Dean. The head of department must assess whether the research project should be suspended while the deviation is being dealt with.
- REC must be contacted to give an assessment of the deviation report if it is unclear whether the research project is safe and whether the risk is acceptable.
- The head of department must make an assessment of who should have information on the deviation.
Measures to be initiated by project manager in the event of a deviation
- The project manager must stop all activities in the project and consider with the person responsible for the research whether the deviation has resulted in injury to research participants, and initiate measures to limit the damage.
- The project manager must inform the research participants of the deviation.
Deviations must be documented
The documentation must contain:
- Description of the deviation.
- Assumed reason.
- Time and place of the incident.
- Unwanted and unexpected medical incidents must be reported on the form in procedure 2 of the quality system.
- Details of the parties involved (including collaborating institutions).
- Measures initiated to limit any damage incurred.
Deviation closed
- The management’s assessment of whether all measures have worked as intended must be documented.
- The project can only be re-started if measures work as intended and the safety and risk in the project are acceptable.
Processing deviations
Once the system for overviews of research projects is in operation, deviations will be processed in this system. Until then, however, deviations must be documented as follows:
- All correspondence on the deviation must be archived in ePhorte (the case number is the deviation’s ID).
- A report detailing the deviation must be drawn up and archived with the correspondence.
- The deviation’s ID will be used in the Faculty’s annual processing of deviation reports.
Legal basis
Health Research Act, Section 6
Regulations to the Health Research Act, Section 4
Regulations to the Personal Data Act, Section 2-6