1. Planning

Before you start your project, you should click through the whole process for conducting health research. Before the project starts, the project manager should involve the person/entity responsible for research. It is wise to do this early in the planning phase.

Risk assessment
In the planning stage, the project manager must conduct an in-depth assessment to ensure that the research project is justifiable and responsible. The risk and burden for participants as well as the need for the project must be determined. The risks and burdens must be proportional to the expected advantages for the participant personally or for other people. If vulnerable groups are to be included, such as children, elderly people or people with illnesses, particular attention must be given to their needs and to the additional provisions of the law.

In the planning phase, a risk assessment of information security must also be performed to chart the likelihood and consequences of security violations as well as what level of risk is acceptable. This assessment provides the basis for deciding on the measures to be used to achieve a satisfactory security level.

The project team members must also consider whether they have adequate expertise and response capacity to manage risks and adverse events. This includes assessing how any unintended findings should be handled.

Template for risk assessment. (PDF)

Pre-approval
The Regional Committee for Medical and Health Research Ethics (REK)  must grant approval in advance for medical and health research on humans, human biological material or health information. The person/entity responsible for research ("forskningsansvarlig") at the unit must carry out an internal assessment of the project. For certain types of research, other agencies must also grant permission before the project commences.

Research that falls outside the category of "medical and health research" but that involves personal data must be reported to the Norwegian Social Science Data Services (NSD).

REK can provide advice and guidance in the planning phase, and can determine what should be regarded as medical and health research. REK can also provide information about other agencies that must approve the research.

Registration for publication
As a prerequisite for publishing articles, many medical journals require clinical trials to be recorded in a publicly accessible registry before the first patient is included. The database Clinicaltrials.gov meets the criteria. NTNU has an account (linked page in Norwegian) in ClinicalTrials.gov so that individual researchers can register their studies.

A plan for publication and co-authorship should be prepared.

Collaborative and multi-centre projects
NTNU and St. Olav's Hospital have agreed on how collaborative projects are to be managed and controlled. Special rules also apply to multi-centre projects.


Only digital versions retrieved from this website are valid.

Version 1.0. Date: 1 January 2012