FAQ: Medical and health research in low- and middle-income countries
Do we have to apply for pre- approval from the Norwegian REC when master's students or PhD research fellows associated with a Norwegian institution are added to a project that has been approved in the country it is being conducted, and where data acquisition has already started?
If a master's student or PhD research fellow is associated with a Norwegian research institution, they must apply to REC for approval of the part of the project they will be carrying out. If the project originates from a Norwegian research institution, he or she can apply for an amendment of the main project. If the project originates from a foreign research institution, they will have to apply to REC for approval of their part of the research project as a separate project. If data has already been collected, and the master's student or PhD research fellow will contribute to the analysis of this data, REC will ask to see the original consent document, to assess whether the analyses the master's student or PhD research fellow will perform are covered by the original consent.
Do we have to apply to the Norwegian REC if master's students or PhD research fellows from other countries, but who are associated with a Norwegian institution, will be using already collected de-identified data from their home country?
If the master's student or PhD research fellow is associated with a Norwegian research institution, they must apply to the Norwegian REC for pre-approval of their project. Among the factors the REC will assess are whether re-use of the already collected data is covered by the original consent.
A foreign research fellow is enrolled in a PhD programme associated with both a Norwegian and a foreign research institution and will receive a degree from both universities. Does the research fellow have to apply for approval from the Norwegian REC?
If the foreign research fellow is associated with both the Norwegian and the foreign institution, and/or the Norwegian institution is contributing funding for the degree, they must apply for approval from the Norwegian REC.
A project is planned and funded by researchers abroad. The project manager is a Norwegian professor who is involved as an advisor to a research fellow who takes part in the project. Does the project need approval from the Norwegian REC?
If the project manager is associated with a Norwegian research institution, pre- approval must be sought from the Norwegian REC.
A study is being planned abroad. Biological material will be collected for microbiological testing. The material will also be sent to Norway for analyses. Does the project need approval from the Norwegian REC?
If researchers / research staff associated with a Norwegian institution will be participating in the project, an application must be sent to the Norwegian REC. If a Norwegian laboratory will only be used to analyse the samples, which are then destructed or sent back, no application to the Norwegian REC is needed.
A Norwegian company is planning to conduct genetic analyses to identify the risk of e.g. Alzheimer's disease. The biological material was collected in another project and has received ethics approval in the country in which the samples were collected. The participants have consented to participation, as well as to the collection of the biological material. No Norwegian research participants will be recruited. The biological material will be brought to Norway in de-identified form. Is the project subject to application in Norway, and is there a need to establish a new, specific research biobank in Norway for storage of the imported biological material?
As long as a Norwegian company is planning/funding the project, an application for pre-approval from the Norwegian REC will be needed in this case. The question as to whether a research biobank must be established, and whether this requires Norwegian pre-approval, must be determined following a concrete assessment. One factor here will be how long the human biological material will be stored in Norway.
A study is being planned abroad where the research participants will be children under the age of 16. Pursuant to Norwegian law, the consent of both parents will then be required. However, for practical and cultural reasons, it will be difficult to secure the father’s consent in this connection. The mother will usually be the primary care provider, and the father will be away from the home due to work. Can a deviation be made from the main rule of consent from both parents in such cases?
As a point of departure, deviations cannot be made from the provisions of the Health Research Act. The issue of consent from both parents was addressed in appeal case 2018/348.
The assessment of this project placed decisive emphasis on the fact that the research was closely related to treatment, where there are different rules for consent. NEM determined that, in this concrete project, the mother's consent was sufficient. In the ethical assessment, NEM also emphasised that the concrete project was considered directly beneficial for the individual child taking part in the project, as well as for other new-borns in low-income countries. The participation also entailed no disadvantage for the research participants, but rather an opportunity for treatment. The project was properly organised and had already secured local ethics approval. The local approval did not require consent from both parents. If the requirement for consent from both parents was upheld, the project most likely could not be conducted due to the difficulty in obtaining consent from the father. NEM also referred to the fact that, in connection with research in low- and middle-income countries, it is important to exercise cultural sensitivity by adapting to and respecting local cultural circumstances when this is possible.
A registry study is planned in a low- and middle-income country. Master's students at a Norwegian educational institution will participate as project staff. The project will not have access to identifiers, and the information will be anonymous for them. Do they need to send an application to REC?
In this instance, the information will not be anonymous as long as the registry owner has an identifier. The project therefore requires pre-approval from REC.
If the information is truly anonymous, it is not considered to be personal health data, and research projects on anonymous information do not require pre-approval from REC. This means that it will be important to ensure that the information is truly anonymous; it must not be possible, either directly or indirectly, to trace the information back to the person who gave the information. It will therefore not always be adequate to remove identifiers, names, national ID numbers or other personally identifying characteristics. More about when information is considered anonymous can be found in recital 26 of the preamble to the EU's General Data Protection Regulation (GDPR).