| Medical and health research: activity conducted using scientific methods to generate new knowledge about health and disease |
| Person or body responsible for the research: institution or some other legal or physical person who has the overall responsibility for the research project and who has the necessary capabilities to be able to fulfil the duties ascribed to the person or body responsible for the research pursuant to this Act |
| Internal control: systematic measures to promote research that is planned, organised, implemented and finalised in accordance with the requirements pursuant to the Health Research Act. Procedures for deviation handling shall be a part of the internal control system. |
| Deviation: an act of deviating from requirements and procedures, i.e. something that has not been carried out as described in UiO’s current procedures. The most important aspect of deviation management is finding out why something went wrong, and taking measures to prevent it from happening again. |
1. Purpose
This procedure aims to ensure that the responsibility of the person with overall responsibility for research to establish procedures for reporting, handling and following up on deviations in accordance with the Health Research Act is fulfilled at UiO.
2. Scope
This procedure applies to deviations that arise in connection with research at UiO which is covered by the Health Research Act, and which is a deviation from the requirements of this law or from UiO’s corresponding procedures in UiO’s quality assurance system for medical and health science research. This procedure does not apply to deviations that are reported in separate systems, even if related to health research; this can, for example, include
- Personal data violation
- HSE non-conformities
- Whistleblowing
- Research ethics misconduct
Adverse medical events/ occurring as part of the interaction/intervention with study subjects/informants in the conduct of individual health research projects are not classified as deviation, but as adverse medical events/incidents to be reported in accordance with the prescription of procedure 2, chapter 4.16.
3. Responsibilities
The person with overall responsibility for research
- shall establish a quality assurance system for medical and health science research, suitable to the size, scope, activities as well as possible risk factors of the institution. The quality assurance system will include procedures for receiving deviation reports and will ensure that non-conformance is corrected.
- shall regularly, and at least annually, receive overviews of deviations from individual faculties and equivalents, and give feedback on desired measures for improvement.
Individual deans at faculties/centres under the University Board
are, in their own faculty/unit, responsible for:
- receiving and dealing with deviation reports in their unit
- further reporting to the University Director as the person with overall responsibility for research
- feedback to the individual department or equivalent
- contributing to the work of deviation rectifying and the initiation of preventative measures to ensure continuous improvement
- preparation of procedures for reporting and handling of deviations in their unit
Individual heads of department/unit or equivalent
are, in their own department/unit, responsible for:
- receiving and dealing with deviation reports from project managers in their unit
- reporting to the dean or equivalent
- giving feedback to individual project managers
- contributing to the work of deviation rectifying and the initiation of preventative measures to ensure continuous improvement
- preparation of procedures for reporting and handling deviations in their unit
UiO employees who at any time hold the role of managers of health research projects
are, within their project, responsible for:
- having an overview of deviations in their project
- receiving and dealing with deviation reports from project team members
- reporting to the head of department or equivalent
- feedback to project team members
- regular reviews of reported deviations with the project’s team members
- rectifying deviations and initiating preventative measures for improvement
Project team members in UiO’s health research projects
are responsible for:
- reporting deviations to the project manager of their project(s)
- contribute to rectifying deviations and initiating preventative measures for improvement
4. Description of tasks
4.1.Reporting and follow-up to deviations in individual projects
Deviations from the requirements of the Health Research Act, and/or from the requirements of UiO’s corresponding procedures for medical and health science research, must be reported using the stipulated form (see Attachment 1 to this procedure) and submitted to the head of the department or equivalent. A review of reported deviations, with follow-up improvement measures, is regularly conducted with the project group e.g. in connection with regular project meetings.
Reports and documentation of submissions and reviews, as well as documentation of corrective and preventative improvement measures, are archived in the project archive, together with feedback from higher levels.
4.2. Reporting and follow-up to deviations at the department level
Deviation reports from individual health research projects are assessed once received to identify any urgent cases. Urgent matters are handled quickly and sent on to the faculty level. Summarising reports are regularly prepared and forwarded to the faculty level and to individual projects, and are followed up across projects. Reports and related correspondence, as well as documentation of improvement measures and other follow-ups, are archived.
4.3. Reporting and follow-up to deviations at the faculty level
Deviation reports received from the department level as urgent matters should be handled quickly. Critical deviation (see Attachment 1 to this procedure) is immediately forwarded to the University Director as the person with overall responsibility for research. Summarising reports are regularly prepared and sent to the person with overall responsibility for research and to individual departments, for follow-up and improvement measures across projects. Reports and related correspondence, as well as documentation of measures and other follow-ups, are archived.
4.4. Reporting and follow-up to deviations by the person with overall responsibility for research
Deviation reports received from the faculty level as critical deviations (see Attachment 1 to this procedure) are forwarded immediately to the person with overall responsibility for research. Summarising reports are regularly prepared and sent to the person with overall responsibility for research and to individual departments, for follow-up and improvement measures across projects. Reports and related correspondence, as well as documentation of measures and other follow-ups, are archived. Presentation and discussion of reported deviations are regularly carried out with the representatives of the person with overall responsibility for research at a faculty level, possibly in already established meetings and preferably in the context of discussions of other types of deviations (see Chapter 2). Decisions regarding measures are conveyed to the department level and project manager level as part of continuous improvement efforts.
5. Legal basis
- LOV 2008-06-20 nr 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
Form for reporting deviations from UiO's quality assurance system for health science research (Word)