Plan and implement a health research project - Kunnskapsbasen
Plan and implement a health research project
- Evaluation of the project by the person or body responsible for research
- Risk assessment
- Registration for publication
- Collaboration with St Olavs Hospital
- Obtaining a declaration of confidentiality
- Obtain consent from research participants
- Handling research data
- Changing, extending and ending projects
- Requirements for publications
Norsk versjon: Planlegge og gjennomføre helseforskningsprosjekt
The aim of the procedures and guidelines for research administration is to help ensure that medical and health research at NTNU is conducted responsibly and in compliance with the law. Before you start your project, you should familiarize yourself with the requirements for conducting health research.
Evaluation of the project by the person or body responsible for research
Before the project manager can start the project, the person or body responsible for research at the unit must consider whether:
- the project fits in with the unit’s strategy
- adequate resources in terms of funding, staff, equipment and infrastructure are available
- the project manager has the necessary expertise in the discipline
- the distribution of responsibilities between any external parties has been clarified
After the project manager has checked that the person or body responsible for research has been informed, the project can begin.
The Head of Department is the person responsible for research at the Faculty of Medicine and Health Sciences (MH), the Faculty of Social and Educational Sciences (SU), and the Faculty of Information Technology and Electrical Engineering (IE) at NTNU.
Read more about the person responsible for research and the project manager’s responsibility on the page Roles and responsibilities in health research projects.
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 benefits 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 the level of risk that 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 incidental findings should be handled.
Regional committee for medical and health research ethics (REC)
The Regional Committee for Medical and Health Research Ethics (REC) must grant approval in advance for medical and health research on humans, human biological material or health information. For more information, see the REC website.
Data Protection Impact Assessment (DPIA)
If you process personal data in your research project, you must consider the need for a data protection impact assessment and do the assessment where necessary.
At the Faculty of Medicine and Health Sciences, the Head of Department must approve the DPIA before the project starts.
Norwegian Centre for Research Data (NSD)
Research that falls outside the category of “medical and health research” but that involves personal data must be reported to the Norwegian Centre For Research Data (NSD).
Other approval bodies
For some types of research, other bodies must also grant permission before the project starts. See the list of approval bodies
Registration for publication
A plan for publication and co-authorship should be drawn up. As a condition of consideration for publication, many medical journals require registration of clinical trials in a public trials registry before the first patient is enrolled.
The database Clinicaltrials.gov meets the criteria. NTNU has an account in ClinicalTrials.gov so that individual researchers can register their research project.
Collaboration with St Olavs Hospital
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. See
Do you have a combined position at the Faculty of Medicine and Health Sciences and St. Olav’s Hospital? Remember that in most cases you must specify both institutions as bodies responsible for the research when you apply to the regional committee.
Obtaining a declaration of confidentiality
Do you need to obtain a declaration of confidentiality from colleagues or employees in health research projects? Here is a template you can use:
Obtain consent from research participants
Read more about:
- Consent from research participants in health research
- Rights of research participants in health research
Handling research data
Research data and personal data must be handled and stored in a legal and responsible manner. Read more about:
Changing, extending and ending projects
Substantial changes in the objectives, methods, schedule, or organization of the research project must be approved by the regional committee for medical and health research ethics (REC), and if applicable by the other agencies that originally approved the project. The project manager must write an application stating reasons.
The person or body responsible for research (“forskningsansvarlig”) must be informed and must conduct an internal assessment of whether the prerequisites for an amendment or extension apply.
The project manager must submit the form for the final report to the REC when the project is completed.
Requirements for publications
Research and studies to be published as articles in journals in the “Vancouver Group” must fulfil certain criteria:
- criteria of the International Committee of Medical Journal Editors
- criteria for Tidsskrift for den norske legeforening (the Journal of the Norwegian Medical Association).
Rules for authorship and co-authorship
When the research results are to be published, the project manager must ensure that the rules for authorship and co-authorship are followed. The project manager is responsible for ensuring that the individual researcher is familiar with the rules for authorship and co-authorship and for checking that the rules are followed. The Vancouver rules for co-authorship present the criteria for being a co-author of an academic publication.
The person who creates a literary, scientific or artistic work has the copyright to the work. The author of a text then has the right to decide whether, when and where to publish it. The copyright also provides protection against other people copying the text without paying for it, unless the copying takes place for personal use or according to the rules of citation.
When NTNU has supported the author’s contribution to the publication, the author must specify NTNU as their address so that NTNU is credited.
Child Pages (9)
Norsk versjon: Godkjenningsinstanser for helseforskning The Regional Committee for Medical and Health Research Ethics (REC) must grant approval in advance for medical and health research on humans,...
Norsk versjon: Samtykke fra forskningsdeltakere i helseforskning Also see: Rights of research participants rights in health research | Health research topic page | Consent for processing of...
Health Research topic page | Norwegian version: Kontrollrutiner og tilsyn - helseforskning Innholdsfortegnelse [-] Internal control Review of implementation Review at project completion The...
Norsk versjon: Håndtering av forskningsdata fra helseforskning Health Research topic page | Data management plan Innholdsfortegnelse [-] Important requirements Storage of research data Long-term...
Norsk versjon: Helseforskning - Definisjon av medisinsk og helsefaglig forskning Health Research topic page The Health Research Act defines medical and health research. The following are defined as...
Health Research topic page | Norsk versjon: Avvik og uønskede hendelser i helseforskning Innholdsfortegnelse [-] Dealing with non-conformances Procedure for resolving non-conformances Dealing with...
Norsk versjon: Forskningsdeltakeres rettigheter i helseforskning Also see: Consent from participants in health research Innholdsfortegnelse [-] Right of access Right to confidentiality Consent and...
Norsk versjon: Roller og ansvar i helseforskningsprosjekt - helseforskning Also see: Guidelines for health research Innholdsfortegnelse [-] Project manager Person or body responsible for research -...
Norsk versjon: Oppbevaring og utlevering av humant biologisk materiale Material in research biobanks must be stored and handled appropriately, with respect for the donor of the material.The project...