Guidelines for administration and use of research data from the HUNT study

The guidelines for Nord-Trøndelag Health Study have been is use since the time of HUNT 2. The guidelines are revised several times, to adjust to changes in legislation, organisation and administrative practises at the HUNT Research Centre, NTNU. This version of the guidelines is current from June 1st 2010.

1. Why guidelines for administration and use of HUNT research data?
The purpose of these guidelines is to optimise utilisation of research data, in a way that protect the interests of the collaborating partners and avoid potential conflicts regarding exploitation of data, provided that the collaboration between the joint partners/parties continues and develops further through research and publication of results.

2. Ethics and protection of the participants privacy
When research data from HUNT is used in research work it is a presumption that the participant's privacy is protected, that the research ethics is ensures, and that rules and regulations is complied with. Norwegian legislations is the current.

3. Ownership and right of disposal
The HUNT participants, i.e. those who have endowed data, are the owners of the collected data and biological material. It's only the one who has endowed data/biological material that can demand the data/biological material deleted/destroyed. The Faculty of Medicine at NTNU has the right of disposal. Which imply that Faculty of Medicine can enter into contract of access and privileges to use HUNT research data, but it is never topical with sale or other transfer of data or biological material.

4. The contracts are entered into with a Research Institution
This makes an institution, not the single researcher, the contract partner. The research institution appoints a Principal Investigator of each project.

5. Exclusive contract on research topics
The contracts encompass exclusive rights to analyse the subjects which are described in the protocol and defined precisely in the publication plan.

6. The contracts are delimited in size and period
The contracts are delimited in size and for a period. A PhD project is used as a template, with 3-4 publications in 4 years as standard. When an application contains only one publication the contract period is normally set to two years.

7. Presentation of manuscript to the publication committee
All manuscripts (articles, reports, and abstracts) must be submitted to HUNT Research Centre before they are submitted to a periodical. The purpose of this rule is to make sure that all results from the HUNT Studies are published in accordance with the contract. The publication process is not to be delayed as a result of this regulation.

8. Co–authorship
The Principal Investigator is responsible for the composition of the author group. It is a presumption that the Vancouver rules for authorship are followed.

9. Daily administrative duties
The head of faculty of medicine are responsible for HUNT databank and the use of it on behalf of NTNU. The daily administrative duties are delegated to the general manager of HUNT Research Centre.

10. Whole HUNT databank united
All the data in HUNT databank, i.e. data collected in HUNT 1, HUNT 2, HUNT 3, inclusive Young HUNT, additional projects and phase 2 projects, is administered according to the same guidelines.

11. Research data shall be returned or deleted by the end of the project
Results from new analysis, e.g. genotyping or other laboratory analysis, other "new" variable constructions shall be returned to HUNT databank. When the project is ended shall the data file be returned or confirmed deleted.

12. Reduced costs for NTNU and Helse Midt-Norge RHF (HMN)
Employees at NTNU and HMN get reduced cost to access HUNT research data.

13. Priority to researchers in additional and second phase projects
Also the data which is collected additional or second phase project is disposed by the faculty of medicine NTNU. Those who have carried out the data collection for these projects confer exclusive rights of disposal of their own-collected data in a limited period until December 31st 2012. When their own-collected data is to be combined with other HUNT data is standard procedure for applying for use of HUNT data to be followed.

14. No commercial utilization
The access to use HUNT research data do not include any rights to commercial utilization of the data or the results which source is HUNT databank.

15. Costs to access HUNT research data
To be able to ensure the running if HUNT databank, i.e. including development and quality assurance, it is necessary with an economic compensation:

Publication type Costs (NOK)
Scientific publication 25.000
Scientific publication in which HUNT data serve as reference material 10.000
Scientific publication in which HUNT data are used in combination with data from two or more data sources in international collaboration / consortia Hourly rate of 800 for processing of datafile, minimum cost 3.000.
Student paper 2.000 per paper
Extraction of ready-made tables Hourly rate of 800 for processing of data, minimum cost 3.000.

Please note:  Institutes not affiliated to NTNU need to add VAT to the prices

16. Costs to access biological material
There are specific cost accountings for different types and amounts of biological material. The costs for biological material are added to costs for access to other research data.

See the guidelines for administration and use of data from The Nord-Trøndelag Health Study complementary commentaries. [Only in Norwegian]

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