Roles and Responsibilities

The Research Instruction: Responsibilities and Authorities in Research

Oslo University Hospital HF (OUS) is responsible for ensuring that all research conducted under the auspices of the organisation is planned, carried out, and concluded in accordance with statutory requirements and recognised research ethical standards.

The Research Instruction describes the responsibilities and authorities related to the organisation and execution of research projects. The instruction applies to all managers, staff, and others contributing to research conducted at and by OUS.

Responsibilities and Roles

System Responsibility

The overarching system responsibility for research lies with the OUS management, headed by the Chief Executive Officer, and is exercised by the Director of Research, Innovation, and Education. This system responsibility includes overall responsibility for strategy, policy, framework management, and monitoring of research activities at OUS. The system manager shall also establish and maintain the hospital’s system for internal control in research and facilitate systematic measures for implementing internal control in research within the hospital’s divisions.

Responsibilities and Tasks for Line Managers

Research is part of the regular activities at OUS. The line manager shall ensure that the activities are planned, organised, and conducted in a responsible manner, in accordance with regulations, requirements, recognised research ethical norms, and within the frameworks of allocated resources. The manager also decides whether research projects should be initiated within their unit. The manager’s responsibilities include:

Assessing whether a research project is medically and ethically justifiable, including ensuring that privacy and information security are maintained in accordance with requirements and regulations.
Evaluating whether necessary advice has been obtained in relation to privacy matters where required according to the research procedure, including ensuring that a privacy impact assessment is conducted for projects where this is required in accordance with the Data Protection Impact Assessment Procedure (DPIA).
Ensuring that projects are satisfactorily academically, financially, and administratively organised and planned, including that the project manager has sufficient competence.
Ensuring the proper handling of research data and human biological material (information security and privacy).
Ensuring that there is a sufficient legal basis for the processing of personal and health data in accordance with governing documents.
Ensuring that projects do not commence until all necessary statutory approvals (e.g., REK and/or DMP) are in place, including feedback on the legal basis for processing according to governing documents.
Ensuring that technical solutions for data collection and storage are security-approved in accordance with procedure.
Appointing a responsible person for the research biobank (see Responsible Person).

For more information on conducting health research projects, see the Research Procedure.

The line manager's responsibility to ensure the proper organisation and execution of research within their unit also includes:

Keeping track of research activities within the unit and conducting systematic reviews to ensure that ongoing projects have the necessary approvals and legal bases in accordance with privacy legislation (GDPR).
Facilitating that staff become familiar with and receive training in relevant regulations for research, including relevant governing documents and routines for "Notification to the Data Protection Officer”.
Ensuring that satisfactory internal routines are established in their unit and subordinate units. This should ensure a sound professional and administrative anchoring, execution, and reporting of research projects, in accordance with the hospital's governing documents.
Assessing whether the department has sufficient resources, patient base, infrastructure, and support staff to carry out planned studies.

Division Research Manager

The research manager is an advisory staff function in the division that assists the division manager in the overall monitoring of all research in the clinic. The research manager assists managers in implementing the internal control system for research and is responsible for following up on deviations and conflicts reported to the division manager, including those related to the conduct of doctoral work.

Project Manager

The project manager is responsible for the daily operation of the research project and must ensure that the project is planned, executed, and concluded in accordance with the Research Procedure and/or other relevant governing documents, including:

Ensuring that ethical, medical, health-related, privacy, and information security considerations are addressed at all stages of the project.
Obtaining necessary advice on privacy matters in connection with the processing of personal and health data in their project, including ensuring that necessary privacy impact assessments are conducted where required according to governing documents
Ensuring that the project is internally anchored and approved according to the Research Procedure and internal routines in the department, including collaborating departments.
Ensuring that necessary approvals (e.g., REK, DMP) and feedback on the legal basis for processing personal and health data are in place before the project commences.
Ensuring that the project is conducted in accordance with formal approvals, feedback on the legal basis, and in compliance with other requirements in the research procedure and other relevant governing documents.
Ensuring that change notifications are submitted where required according to governing documents (Notification to the Data Protection Officer and Change Notification in medical and health-related research projects).
Ensuring that all project staff have sufficient competence to carry out assigned tasks in the project.
Ensuring necessary agreements are in place in relation to research collaboration with external partners, including that the agreement is formalised in accordance with the prevailing authority structure at OUS.
Preparing necessary reports etc. for relevant bodies.

Responsible Person for the Research Biobank

Every research biobank shall have a responsible person with a higher degree in medicine or biology. This individual must have an employment relationship with OUS in projects conducted by the hospital.

The responsible person has daily operational responsibility for the research biobank and must ensure that the collection, registration, storage, processing, and destruction of materials is carried out in an ethically sound manner in accordance with relevant regulations and internal guidelines. Normally, the responsible person will be the project manager.

Project Staff

Project staff shall be designated by the project manager and listed in the research protocol and application to REK where relevant. Project staff have an independent responsibility to familiarise themselves with relevant regulations governing research, including relevant internal governing documents (eHåndboken). External project staff who are to be granted access to information systems at OUS must be subject to the hospital's authority.

Specific Responsibility for Doctoral Work

Staff with supervisory responsibilities for PhD candidates employed at OUS are responsible for ensuring that agreements between the relevant doctoral programme and OUS are followed, including familiarising themselves with and adhering to their supervisory responsibilities according to the PhD regulations of the relevant institution.

Supervisors employed at OUS are also responsible for keeping the department head and research leader in the division informed of nonconformities and any conflicts arising in connection with the execution of doctoral work.

For PhD candidates employed at OUS, the Research Instruction and responsibilities as project staff apply. Additionally, the PhD candidate is responsible for understanding and adhering to their obligations under the PhD regulations of the relevant institution.