Approval Process - Medical and Health Research

 

Use the recipe below for all research projects that are planned at Oslo University Hospital, and which are subject to prior approval form REK.

The recipe is based on OUS procedures for planning, execution and completion of medical and health research set forth in the eHåndboken , OUS Level 1 Research , Innovation and Education.
 

1. Planning

1.1 Ensuring local approval of the project in your own research group and department (eHåndboken id 61).

 1.2 Ensure local approval from collaborating departments at OUS, if applicable ( eHåndboken id 61).

 1.3 Secure anchoring the project with external partners, if applicable ( eHåndboken id 61)
 

2. REK application

2.1 Finalize relevant documents, including:

• A: Research Protocol

• B: Information / consent type

• C: OUS form : Form for access and storage of health research data 


2.2 Fill REK - form electronically and attach the relevant annexes. Remember that it is the department head which must be listed as the institution responsible for liaison in the REK application ( eHåndboken id 61).


2.3 Copy of the REK application and attachments to : godkjenning@ous-hf.no. Remember OUS form must be completed and submitted along with a copy of the REK application and all attachments to this email address.

2.4 Registering clinical trials on ClinicalTrials.gov and helsenorge.no (eHåndboken id 13301 )


3. Commencement of project

3.1 Ensure that all necessary approval in place before the project can start up ( 1 and 2) .

3.2 Provide the necessary agreements relating to cooperation projects.
 

4. Implementation

4.1 Ensure that all requirements of the IEC approval, including approval protocol , followed up ( steps 1 and 3).

4.2 Ensure that research data is processed in accordance with what is stated in the form for the treatment of health research data ( eHåndboken id , 11789 , 37730 and 11790 ) .

4.3 That the disclosure and sharing of biological materials and data is based on an agreement ( eHåndboken id 15408 and 1027 )

4.4 Subscribing to the IEC if significant changes are planned in the project ( eHhåndboken id 13300 )

4.5 Inform the person about the incidents and deviations in research ( eHåndboken id 53016 )
 

5. Termination of the project

5.1 Sending a final report to REK ( eHåndboken id 61)

5.2 Clarify with the IEC on human biological material can be disposed of , where this is not clarified earlier ( eHåndboken id 424)

5.3 Deleting and / or anonymous health research data (id 11789 )