Landspitali - University Hospital
Clinical research center
Scientific study in humans
A scientific study in humans is a study where a person is actively involved in a scientific study, such as undergoing a study, submitting a sample or providing information for the study.
It is important that the principal investigator has the facilities, time, staff, and a sufficient number of participants to carry out the study.
Attention must be given to the research protocol, including the SPIRIT guidelines for writing a study protocol.
Essential documents, such as participant information sheets and informed consent forms, must be prepared.
Measurement tools, such as questionnaires, must be translated and adapted.
Equipment used must be inspected and calibrated.
Requirements for monitoring and recording temperature during the storage of samples and investigational medicinal products must be met.
Regulation and guidance in Icelandic
Landspítali offers financial administration for research projects conducted by its employees. The project must be registered in the hospital’s accounting system.
The project’s principal investigator must send a completed form (pdf) to the financial manager at the Office of nursing and medicine at the following email address: eyrunst@landspitali.is.
The same rules apply to employee research funds as to public financial administration. If the researcher is also employed by the University of Iceland, another research institution, or a company, that institution may be entrusted with managing the funds.
Request for financial administration
Request for data storage space
Hiring staff
If staff are to be hired for a research project, it must be ensured that funds are available for the payment of wages and related salary costs, and that approval from the relevant department head/chief physician/unit manager or managing director at Landspítali has been obtained.
The employment must comply with Landspítali’s rules and salary classifications. The person with the authority to hire in the field where the employee will work must sign the employment contract.
The employment contract should be timed so that the employment is subject to the funding of the scientific research. These fixed-term positions can last for a maximum of two years, as set out in the rules on temporary employment for government employees in the Act on the Rights and Obligations of Public Servants.
In the case of contractor payments, the signatory/principal investigator of the research project must ensure that funds are available and approve the payments.
Hospital employees
A principal investigator or their colleagues/assistants working at Landspítali may receive payment for their contribution to research carried out at the hospital, provided it is outside their regular working hours there. The percentage of working time to be devoted to the research, both within and outside regular working hours, must be specified if payment is expected for the work. This must be done in consultation with the relevant supervisor.
All handling of funds must be in accordance with Landspítali’s rules on financial administration.
Information on Applying for a Research Permit at Landspítali
Other Permits
Before applying for a research permit, approval from the head of department (pdf) for the execution of the research must be secured.
If you intend to request biological samples from a biobank, you must apply for them.
As applicable:
Application for a data storage area for electronic data
If ionizing radiation is used in the research, an application must be submitted to the Icelandic Radiation Safety Authority.
The Landspítali National Bioethics Committee for Health Research does not review drug trials.
If the services of other units of Landspítali are to be used, the investigator must contract with the relevant unit regarding service and payment.
Blood test. If the services of the National University Hospital's Research Department are to be used for a scientific study, the responsible party shall conclude an agreement with the department regarding services and payments. The Chief Medical Officer of the Research Core is Ísleifur Ólafsson.
Imaging. If the services of the imaging department are to be used in a scientific study, the responsible person shall conclude an agreement with the department regarding services and payments. The Chief Physician of the X-ray department is Pétur Hörður Hannesson.
A pharmacy. If the services of a hospital pharmacy are to be used for a scientific study, the investigator must make an agreement with the pharmacy regarding services and payments. The chief pharmacist of the hospital pharmacy is Tinna Rán Ægisdóttir.
In the case of partners outside Landspítali, a contract shall be concluded between Landspítali and the partners. Examples of partners are pharmaceutical companies, Primary Care Center (Heilsugæslan), various research institutions and foreign universities and hospitals.
The investigator is responsible for training the investigating staff.
All pharmaceutical research staff should be trained in GCP
The training is useful in all scientific research on humans.
Generally, GCP training is required to be updated every 2-3 years.