Roles and responsibilities

Here is a table overview of designated roles and responsibilities connected with medical and health research at the University of Oslo.

When initiating a medical and health research project, it is important to be aware of the designated roles of the parties involved in the project. This overview indicates different positions/job titles and the roles connected to them. It also specifies the designated responsibilities and tasks of each participant. 


Position

Role

Responsibility and tasks according to UiO  Procedures 

Delegation of tasks

The University Director

Entity or person responsible for research ("Forskningsansvarlig") oursuant to the Health Research Act

Sponsor at clinical trials of medicinal products  and medical devices

The overall responsibility for all health-research at UiO.

UiOs responsible in  multicenter-studies

Responsible for UiOs  research- biobanks

Responsible for the internal control and QA of research projects

Responsible for the compensation if harm is inflicted  in humans during a medical research or if biological material or health data is not treated according to the law and regulations. 

Shall faciliate that the medical and health research, including clinical trials of medicinal products and medical devices, observes and is compliant with  professional ethical, medical, health, scientific, privacy- and information security aspects

 

Permanent delegation to each Dean of the faculties, Directors for the museums and centers subjected to the University Board, together with the Leader of the interdisciplinary units with underlying centers

Director
of Research

 

The quality system for medical and health research, including document control.

Can delegate tasks within own department

IS Director

 

Internal control of data security

 

IT Director (USIT)

 

The operation of the UiO data system

Can delegate tasks within own department

Head of internal
Audit

 

Responsible for conducting the internal audits and
supervising external inspections.

Can delegate tasks within own department

Faculty Deans, Directors of museums and centers subjected to the University Board, together with the leader of the interdisciplinary unit with underlying centers.

Entity or person responsible for research's permanent representative at their unit
 

Shall arrange for organization, planning, initiation , implementation, dissemination,, completion and managing of the research projects
Responsible for keeping an continuous ongoing overview record of all medical and health research projects that involves humans,
human biological material, or personal health information.

Responsible for secure processing of research data and
human biological material.

Responsible that necessary insurance is available
for the research participants
Responsible for biobanks and for appointing  the
Responsible Manager for the biobank.

Responsible for handling deviation reports.

 

May delegate further to the leaders of the institutes

The head of department/ institute or corresponding organizational level

Entity or person responsible for research's   Representative
according to
documented delegation from permanent Representative at  their unit.

 

Responsible for that the research projects are planned, organized, initiated, implemented, communicated, completed and managed in compliencecompliance with applicable law.
Responsible for keeping  the employees informed about the qualitysystemquality system
Responsible for notifying his/her  Superior and the Head of the Audit about  notification of  external inspection
Establishment and maintenance of institute-specific procedures

duties delegated by the person or entity responsible for research’s representative at their faculty, such as updating a project record, safeguarding internal presentation before applying to REK, designation of persons responsible for each biobank and keeping an updated register of biobanks associated one’s own institute.

 

May delegate further to a lower level

The underlying level of the head of department/ institute or equivalent

Entity or person responsible for research's   Representative
according to
documented delegation from the head of department/ institute or equivalent 

Tasks delegated from department/ institute level

The underlying level cannot delegate these tasks further.
The delegation is determined by the head of department/ institute or equivalent

Scientist at UiO

Principal  Investigator
(Project Manager)

Proper assessment of the project's soundness / justifiability.

Daily operation of the research project.

Communication with entity or person responsible for research`s representative (head of faculty / institute / group)

Obtaining the necessary internal and external approvals and completion according to approved conditions

Processing and storage of research data

Project documentation and follow up of the project’s financial status

 

In this position the Principal Investigator can delegate practical project tasks to employees, including students, who are qualified for the relevant task

Independent assessment of the project’s soundness can not be delegated

 

Doctor or dentist employed by the UiO 

Principal Investigator

Responsibility for implementation of clinical trials of medicinal products and / or medical devices

Can, by written documentation, delegate project  tasks to qualified employees 

Project employee appointed by the
Principal Investigator
 

Co-investigator

In accordance with delegation from the Principal  Investigator

Cannot delegate task further. Delegation must be decided by the
Principal  Investigator
 

Employee appointed by the Leader of faculty or Director of the museum or centers under the University Board or the Leader of interdisciplinary unit with underlying Centre

Responsible Biobank Manager

Responsible for proper storage and handling of the material in research biobanks
 

Can delegate tasks to employees who are qualified for the relevant task.

Delegation must be documented

 

Student

Project team member,
cannot be
Principal  Investigator
 

In agreement with the supervisor, who is  the project manager
for  the student educational project
 

Cannot delegate the task further.
The delegation is determined by the
Principal  Investigator  

 

Published Apr. 19, 2013 3:19 PM - Last modified Apr. 25, 2013 9:47 AM