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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).

Contact

jurist.afi@usn.no
USN also has a dedicated unit for commercialization and innovation that assists researchers with IPR management, patenting, and spin-offs.

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 organization of medical and health research – Lovdata:

“A multicenter study must have one project manager. The project manager shall coordinate activities and ensure that prior approval is obtained from the relevant Regional Committee for Medical and Health Research Ethics (REK), and ensure that the research-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 the participating Norwegian institutions accordingly.”

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 one will submit the form.

Resources

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

International Collaboration

The following rules for multicentre studies apply to health research projects subject to the Health Research Act and requiring approval from REK.

International research collaboration presents a number of issues and challenges. This is especially true regarding privacy, information security, and research ethics, as legal requirements and ethical standards can vary from country to country.

Researchers employed by a Norwegian research institution are obliged to follow Norwegian research ethical standards even when operating in countries with different ethical norms.

In international research projects, it is important to clarify rules and expectations with collaboration partners. Particular attention should be given to rules for data sharing and personal data protection.

Norway also has an export control regime designed to prevent goods, services, technology, and knowledge about technology from being exported in violation of Norwegian security and defence policy, or contributing to the proliferation of weapons of mass destruction.

Resources

General information on export control and the routines 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.