The trial sponsor may file a complaint against a decision of a regional scientific ethics committee regarding a specific project or an additional protocol.
The complaint must be submitted electronically using a digital signature and encryption if the protocol contains confidential information. This can be done at the address: dketik@dketik.dk. See here how to send secure mail to the NVK.
The complaint must be justified and accompanied by a copy of the decision of the regional scientific ethics committee and the case documents that the regional scientific ethics committee based its decision on.
Decisions regarding the assessment of a specific project
Decisions in which the regional scientific ethics committee has completely or partially (approval with conditions) rejected an application to initiate a health scientific research project can be appealed to the NVK [The National Committee on Health Research Ethics]. The same applies to complete or partial rejections of an application for a supplementary protocol.
Other decisions
The committee's decision can be appealed to the NVK no later than 30 days after the decision has been received. The NVK may, for the sake of ensuring the rights of the trial subjects, consider elements of the project that are not covered by the complaint itself.
If the complaint deadline expires on a Saturday, Sunday, or public holiday, it is extended to the next weekday.
The complaint deadline cannot be extended. A complaint that is not received within the committee law deadline cannot be processed by the NVK, so it will be rejected.
NVK conducts a new scientific ethical review and assessment of the case. NVK can thus consider elements of the project that are not covered by the specific complaint. This can be relevant if, for example, a complaint is made about a partial rejection of a research project or a special condition for approval.
The normal deadline for case handling is 60 days for a new research project and 35 days for an additional protocol.
NVK's decision cannot be appealed to another administrative authority. A research project that has been submitted to NVK must not be started before the committee's decision is available.