Complaints Regarding Decisions in the Committee System

Read here about your options for filing a complaint, as well as the formalities and deadlines associated with complaints.

The trial sponsor may file a complaint against a decision of a regional scientific ethics committee regarding a specific project or an additional protocol.

Similarly, others who are considered a party to the case under administrative law have the right to file a complaint about both rejections and approvals.

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: 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.

NB: No changes must be made to the documents that have been reviewed by the regional committee, as the case will otherwise be returned to the committee.


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 person responsible for the trial can also appeal a decision by the regional scientific ethics committee regarding whether a project is subject to notification or not. NVK also has the competence to ensure legality in the decisions of the regional scientific ethics committees, i.e., handle legal questions concerning case processing.

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.

Last updated 01-02-2024

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