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Collaborative Projects – Quality System for Health Research

In research projects involving multiple institutions, it is important to establish clear collaboration agreements to define roles and responsibilities, and to document consensus on how research data and results will be used.

Helseikon

Collaborative Projects

If data processing in a research project is carried out by another institution, a collaboration agreement must be established with that institution. If the processing is performed by a supplier, a data processing agreement must be signed. If the processing is part of a research collaboration, either a joint data controller agreement must be made, or the collaboration must be clearly defined in another way.

Resources

USN has a range of standard agreements for research collaboration (login required, Norwegian only). USN also has a dedicated unit for commercialisation and innovation that assists researchers with IPR management, patenting, and spin-offs. For further information, please contact jurist.afi@usn.no.

Multicenter Studies

The following rules apply to multicenter studies that fall under the Health Research Act and require approval from REK.

Multicenter studies are defined as “research projects conducted at multiple institutions simultaneously and according to the same protocol,” as stated in the regulation on the organisation of medical and health research (Lovdata, Norwegian only):

“A multicenter study must have one project manager. The project manager will coordinate activities and ensure that prior approval is obtained from the relevant Regional Committee for Medical and Health Research Ethics (REK). The project manager will also ensure that the responsible party at the other participating institutions is informed about the research project before it begins.

In international multicenter studies, a designated Norwegian project manager must be appointed for the parts conducted in Norway, and this person is responsible for informing participating Norwegian institutions accordingly” (USN translation of original Norwegian).

If a multicenter study involves the processing of personal data, the project must submit a notification form to Sikt. If several institutions use Sikt’s notification form, a joint form may be submitted for those institutions. The institutions must agree on which of them will submit the form.
 

Resources

You can find standard templates for research collaboration in USN’s agreement portal for research projects (login required, Norwegian only).

International Collaboration

Rules related to multicentre studies apply to health research projects that are subject to the Norwegian Health Research Act (Helseforskningsloven) and therefore require approval from the Regional Committees for Medical and Health Research Ethics (REK).

International research collaboration presents a number of issues and challenges, particularly with regard to privacy, information security, and research ethics, as legal requirements and ethical standards may vary from one country to another.

Researchers employed by a Norwegian research institution are required to comply with Norwegian research ethics standards, even when conducting research in countries with different ethical norms.
In international research projects, it is important to clarify rules and expectations with collaborating partners. Particular attention should be paid to regulations governing data sharing and the processing of personal data.

Norway also has an export control framework designed to prevent goods, services, technology, and technological knowledge from being exported in ways that conflict with Norwegian security and defence policy or that contribute to the proliferation of weapons of mass destruction.
 

Resources

Information related to export control and its administrative processing at USN:

Questions about the Quality Assurance System for Health Research?

The Department of Research, Innovation, and Library Services manages the Quality Assurance System for Health Research at USN. The quality assurance system is reviewed and updated as needed. If you have suggestions for improvements or notice that content is missing, feel free to report it to forskningsetikk@usn.no. We will reply to your email.