1. Purpose
The purpose of this procedure is to ensure that each research project is planned, organised, initiated, implemented and conducted, disseminated, concluded and finalized correctly and in accordance with all applicable legislation including a thorough internal justifiability assessment and evaluation of the applicable legislation. Furthermore, the procedure must ensure that the necessary agreements, notifications and approvals are in place before the project starts and that this is followed up throughout the project period up to reporting and in the event of any publication.
2. Scope
This procedure applies to all research at UiO which is covered by the Health Research Act and must be conducted in accordance with UiO’s quality assurance system for medical and health science research. It must be correlated to other legislation which may apply to medical and health science research, cf. Chapter 5 of this procedure and UiO’s Guidelines for processing personal data in research. Separate procedures apply to clinical trials of medical products and/or medical devices, see Procedure 3 and Procedure Procedure 4.
Health research conducted in partnership with other institutions may be undertaken in accordance with the partner institution’s quality system if this has been established in an agreement (e.g. framework agreement, collaboration agreement or project agreement).
3. Responsibilities
The Project manager is responsible for:
- preparing a project description in accordance with Attachment 2.2 to this procedure
- carrying out an independent assessment of the project’s soundness and feasibility including privacy protection, in accordance with Attachment 2.7 to this procedure
- presenting the project to the representative of the person with overall responsibility for research in accordance with Attachment 2.8 to this procedure, the unit-specific procedures and UiO’s procedures on presentation in the event of external funding, when relevant
- establishing research-specific biobanks
- ensuring the necessary descriptions for the use of general biobanks at UiO
- ensuring the necessary descriptions and agreements for the use of biobanks managed by other biobank owners
- establishing agreements with potential partners outside of UiO
- registering the project in the UiO’s system FORSKPRO for a continuous overview
- ensuring that necessary external approvals are obtained
- notifying Sikt of the project (formerly NSD, Norwegian Centre for Research Data)
- posting in Clinicaltrials.gov if required
- the daily operation of the research project
- communication with the representative of the person with overall responsibility for research at the unit and UiO’s data controller, including information about feedback from external and internal approvals and evaluations
- communication with public authorities
- ensuring that the research project is conducted in accordance with approved conditions
- ensuring that project participants provide informed consent
- ensuring that any changes in research protocol are approved before they are implemented
- appropriate delegation of duties within the project group
- ensuring that research data is managed and stored in accordance with UiO’s procedures
- archiving of project documentation in accordance with UiO’s procedures
- monitoring project finances in accordance with UiO’s procedures
- ensuring that the necessary insurance of research participants is in place[1]
- providing information to project participants in the event of injuries or complications
- notifying adverse medical events in accordance with UiO’s procedures
- submitting a final report and any other reports to REC
[1] Regulations relating to the organisation of medical and health research, Section 3 d) require the necessary insurance for research participants to be in place. See also Notes on the individual provisions in the regulations relating to the organisation of medical and health research, p. 2.
The representative of the person with overall responsibility for researchis responsible for:
- ensuring that justifiability assessment is conducted in collaboration with relevant healthcare professionals and other necessary expertise based on the content, scope and nature of the project
- appointing a person responsible for the biobank, if applicable
- ensuring that agreements are in place concerning any release of human biological material
- ensuring that the necessary evaluations and follow-up take place throughout the entire project until completion
- keeping an overview of external and internal approvals and assessments, including the necessary follow-up on these
Cf. Attachment 2.1 Project planning and implementation form
Attachment 2.2 Checklist for research protocol
Attachment 2.7 Checklist for assessment of justifiability for health research projects
Attachment 2.8 Checklist for internal presentation of health research projects
4. Description of tasks
4.1 Clarification of responsibilities in collaborative projects
In collaborative health projects with other institutions, the research responsibility shall be established and written agreements must be in place prior to the project starts. The institution responsible for research and project manager shall be named in the project agreement. The project manager must have the necessary research expertise and experience for the current project. Students at levels lower than doctoral degree level may not act as project managers.
A multicentre study has a single project manager, but may have several institutions responsible for research.
4.2 Clarification of responsibilities and origins when using biological materials
For health science research projects in which the use of human biological material is included, the relevant biobanks shall be described in accordance with Procedure 5. When using human biological material from external biobanks (managed by entities other than UiO), written agreements shall be in place before the project starts.
4.3 The project manager’s independent assessment of justifiability
Prior to the project’s presentation to the representative of the person with overall responsibility for research, the project manager shall conduct an independent assessment of whether ethical, medical, health related, research, privacy and information security aspects are safeguarded in the project. See Attachment 2.7 to this procedure. In the event that there are any assessments associated with applications to the EU or other external sources for funding, such assessments must be presented. Similar assessments must be conducted throughout the implementation of the project, particularly in the event of planned changes and when completing the project. Assessments of justifiability shall be reviewed with the representative of the person with overall responsibility for research and/or specialist representative appointed by the representative of the person with overall responsibility for research as part of the presentation of the health science research project.
4.4 Internal presentation of the project to the representative of the person with overall responsibility for research
The project manager must present the project to the representative of the person with overall responsibility for research in line with the procedures at the faculty/department/unit and the UiO’s procedures for presentation in connection with external funding when relevant.
The internal presentation may take place after funding has been established, but before the application for advance approval is submitted to REC and before the project is submitted for consideration at Sikt (formerly NSD, Norwegian Centre for Research Data). The person with overall responsibility for research must be kept up-to-date with all feedback from REC and Sikt.
In the event of significant changes to the project, a new presentation must be made in accordance with Attachment 2.8 to this procedure, including a new assessment of justifiability in accordance with Attachment 2.7. Presentations and assessments from the representative of the person with overall responsibility for research must be documented, cf.
- Attachment 2.1 Project planning and implementation form
- Attachment 2.7 Checklist for assessment of justifiability for health research projects
- Attachment 2.8 Checklist for internal presentation of health research projects
and must also be registered in FORSKPRO
4.5 The project manager’s delegation of tasks
The tasks to be performed in the project may be delegated from the project manager to project team members. Each project team member must hold qualifications relevant to the tasks she/he has been delegated. The project manager cannot delegate the responsibility for own independent assessment of justifiability of the project. Delegation of tasks must be documented. Documentation must be updated in the event of changes.
4.6 Preparation of research protocol
The research protocol with attachments must be prepared in accordance with Attachment 2.2 Checklist for research protocol. All elements of the checklist must be included in the protocol. If any individual elements are not relevant, these must be indicated using the phrase “Not relevant to this project”.
All documents must have version control, i.e. the version number and date.
4.7 Application for preliminary approval from the authorities
Prior to the project starts, necessary approvals must be obtained from REC. Approvals must also be obtained from the Norwegian Medical Products Agency if the project involves research on medicinal products products and/or medical devices. See Procedure 3 and Procedure 4 for medicinal products s and medical devices. Applications for approval must be complete and enclosed with the final, signed version of the research protocol and the final, dated version of other attachments.
4.8 Notification to Sikt (formerly NSD, Norwegian Centre for Research Data)
Prior to the start, the project must also be submitted to Sikt for an advance assessment of the legal basis for data processing and any privacy concerns associated with the project. Cf. UiO’s procedures for processing personal data in research. Sikt is a service provider that provides personal data services on agreement with UiO.
4.9 Registration in clinicaltrials.gov
After the project has been approved by REC and any other external agencies, it must be considered whether there is a requirement to register a project in the international database clinicaltrials.gov. Such registration may be a prerequisite for subsequent publication.
4.10 Information and obtaining consent
All research subjects must receive information about the research project and be asked to consent to participate in accordance with the approval from REC unless otherwise provided for by law. The information letter and declaration of consent must be drawn up in accordance with the template from REC, see Attachment 2.3 REC templates for information letters and declarations of consent. In cases where consent is required, such consent must be documented with the date and signature of the project participant, who must also receive a copy of the signed consent. In the event of changes to the implementation of the project or changes to the use of data, renewed consent must be considered. New consent must be obtained if the change could have an impact on the participants’ consent. The new declaration of consent must be submitted to REC together with the change request (cf. Item 4.11) and must be approved by REC before use.
In the event of research into human biological material or health data, consent for broader defined research purposes may be obtained subject to approval from REC.
Research subjects have the right of access to their own data. Research subjects that have given broad consent are entitled to regular information about the project from the project manager.
Application for approval of planned changes
In the event of planned changes in accordance with Attachment 2.4 REC procedures for project changes including checklist, it may be necessary to obtain new approval from the same agencies that granted preliminary approval. The changes must be approved before they can be implemented. The changes must also be presented to the representative of the person with overall responsibility for research, see attachments 2.7 and 2.8 to this procedure. An overview of the types of changes that require new approval can be found on the REC website.
4.11 Notification of changes in the processing of personal data
Changes to the processing of personal data during the project period must also be reported to Sikt using the notification form, cf. UiO’s procedures for research using personal data.
The project manager must create a link key for persons who have consented to participate in the research project. The link key will include a unique personal identifier linked to the serial number/participant number during the trial, see Procedure 6 Storage and management of research data, Attachment 6.2 Link key and overview of research subjects form.
Pursuant to Procedure 6 Storage and Management of Research Data, sensitive research data such as the link key and all other documents that include the research subjects’ names or other personal data, as well as consent forms and source documentation (raw data), must be stored in the University of Oslo’s Sensitive Data Services - TSD. Research subjects may be identified only using serial number/participant number in registration forms and any other documents issued by the project manager to internal or external data processors.
4.12 Submission of final report and other reports
The final report must be submitted to REC as soon as the results from the project are available.
4.13 Project documentation archives
Key project documents in accordance with Attachment 2.5 Checklist for the archiving of project documents must be archived in a manner appropriate to implementation during the project period. After completion of the project, documentation must be collated and stored on UiO’s servers with back-up, with formats and locations in accordance with the department procedures. For storage of research data, please see Description of Procedure 6 Storage and Management of research data (information security).
4.14 Reporting any adverse medical events
Adverse medical events must be documented by the project manager using Attachment 2.6 Notification form for the reporting of adverse medical events. If the project manager considers the event to be serious, the completed form must be submitted to the Norwegian Board of Health Supervision within five (5) working days. A copy of the submission must be sent to the representative of the person with overall responsibility for research.
4.15 Disclosure requirement relating to participants in the event of injuries
In the event that an injury or complication that could be the result of the research project is inflicted upon a research participant, the project manager must immediately inform the research participant of the injury and the research participant’s rights and access to claim compensation. Furthermore, the representative of the person with overall responsibility for research must also be informed without delay.
5. Legal basis
- LOV 2008-06-20 nr. 44 Medical and Health Research Act
- FOR-2009-07-01-955 Regulations relating to the organisation of medical and health research
- LOV-2018-06-15-38 Personal Data Act
- LOV-2003-12-05-100 Biotechnology Act
- LOV-2014-06-20-43 Personal Health Data Filing System Act
- LOV-2001-06-15-53 The Norwegian Patient Injuries Act
6. Appendices
- 2.1 Project planning and implementation form (Word)
- 2.2 Checklist for research protocol (Word)
- 2.3 REC templates for information letters and declarations of consent (rekportalen.no)
- 2.4 REC procedures for project changes including checklist (rekportalen.no)
- 2.5 Checklist for the archiving of project documents (Word)
- 2.6 Form for reporting adverse medical events (Word)
- 2.7 Checklist for assessment of justifiability for health research projects (in Norwegian, Word)
- 2.8 Checklist for internal presentation of health research projects (in Norwegian, Word)
- 6.2 Link key and overview of research subjects form (in Norwegian, Word)