Control routines and supervision - health research - Kunnskapsbasen
Control routines and supervision - health research
The person responsible for research ( Head of Department / Dean / Head of the Unit) must monitor their own project portfolio.
The person responsible for research (RR) must also take systematic measures to ensure that the project is conducted in accordance with the guidelines for medical and health research, that the necessary approvals have been received and processing of personal data complies with laws, regulations and the institution’s own guidelines.
If the RR discovers non-conformances, the procedure for handling non-conformances must be followed.
A sample of 10% of all the research projects must be checked each year, and the sample must be selected from different phases of implementation: start-up, implementation and completion.
Review of implementation
Every year, the RR checks that medical and health research projects have obtained the necessary approvals and that they comply with the law and the information specified in the approved application or change notification.
Review at project completion
The RR checks whether the procedures related to completion have been followed and that research data that have been stored electronically or in other archival systems have been deleted or anonymized.
In the communications with his or her manager, the RR must report on the level of compliance with laws and procedures, the measures that have been taken and whether the quality tool has been used.
The internal control system
The university must carry out internal control adapted to the size, nature, activities and risk factors of the research. The person or body responsible for research must see to the preparation and documentation of procedures that enable the project manager and project team members to comply with the requirements in effect for medical and health research.
Responsibility and authority relationships are shown in the list of authorizations. The role descriptions specify the duties of the person or body responsible for research, the project manager and the project team members.
The internal control system describes the process from planning of the research project until its completion. The system emphasizes the requirements that must be satisfied so that the research complies with the regulations for medical and health research.
The project manager must involve the research manager (RR) before the project starts, and the RR must assess whether the project is consistent with the unit’s strategy and whether the necessary resources are available.
The internal control system describes the requirements for risk assessments and procedures for dealing with non-conformances, who must be notified of non-conformances and who is responsible for ensuring that non-conformances are rectified.
The person or body responsible for research must monitor the project portfolio. To ensure that research projects are carried out in accordance with the protocol, procedures and legislation, the person or body responsible for research must conduct an annual check of a sample of projects in different phases (start-up, implementation and completion). Non-conformances must be corrected. If research violates the permissions that have been granted and it is not possible to rectify the situation, the research must be stopped.
In the management communications with their line manager, the person or body responsible for research must report on the research activities at the unit, compliance with legislation and procedures, and the quality system used.
External audits (supervision)
External audits may be conducted by the Norwegian Board of Health Supervision (Statens helsetilsyn) and the Norwegian Data Inspectorate (Datatilsynet). For projects involving administration of medicines to human subjects, the Norwegian Medicines Agency (Statens legemiddelverk) may also provide supervision. For projects that involve the use of medical equipment, the Directorate of Health (Helsedirektoratet) or the Directorate for Civil Protection and Emergency Planning (Direktoratet for samfunnssikkerhet og beredskap) may provide supervision.