​​Norwegian​

Project description  

A project description should mention the project's purpose and background. It should contain a project outline that describes the background to the project, contain hypotheses, methods,  a progress plan, a data management and a plan for financing. A project description is used to apply for funding for a project and it may have varying formal requirements depending on where one applying for support, and so it is therefore important to examine the requirements for project description from various funding sources before submitting an application.  

Research protocol  

All medical and healthcare research must be described in a research protocol. A research protocol is a document that describes a project scientifically. The protocol should demonstrate that the project is adequately planned and organized and should include information about objectives and hypotheses, as well as the selection of materials and methods. The research protocol can be written in Norwegian or English. 

A research protocol must in accordance with the regulation of the organization of medical and healthcare research (forskrift om organisering av medisinsk og helsefaglig forskning), at least state: 

• A project manager 

The research protocol must state who the project manager is. 

• A scientifically formulated project plan  

The research protocol should include a scientific plan that specifies the purpose, justification, material to be used, and method. The protocol should also explain how the chosen study design can provide answers to the research question, and it should estimate the time frame for the project. 

• How health information and biological material should be processed 

When using health information and biological material, the protocol must explain how this is to be processed. It must be clear from which sources and in what manner health information and biological material is to be obtained and whether such information is to be disclosed to others and/or transferred to countries outside the EEA. 

• An assessment of research ethical challenges 
  

The research protocol should describe relevant research ethical challenges raised by the project and how these will be addressed, including the benefit-risk aspect for research participants, such as the protection of participants' welfare and integrity (privacy and information security). 

• Funding sources, interests and dependencies 

The research protocol should describe how the project is intended to be financed. It should also indicate whether there are any financial interests and dependencies between the funding source and any of the project staff. 

• Plan for publication of research results and utilization 

The research protocol must contain a plan for the publication of results and information about possible extended use, including commercial use, of research results, data or biological material. 

Resources: 

• For projects originating from one of the healthcare organizations in Helse Nord, you will be able to receive research support and guidance concerning the design of the project and protocol from the Clinical Research Department: Research - Universitetssykehuset Nord-Norge (unn.no). 
• NorCRIN: Front page - www.norcrin.no    
• Projects in the medical and healthcare research category are regulated by Regulations on the organization of medical and healthcare research which defines the minimum requirements for what a research protocol must contain.  
• Guidance document for the preparation of a research protocol from Ahus.