Amendments and Special Requirements
Amendments to the Clinical Trial Protocols and Documentation
TUKIJA and regional Ethics Committees review only substantial amendments that are likely to have a bearing on the ethical aspects of trial proposals. Substantial amendments include changes relating for example to physical or mental integrity of subjects, scientific value and significance of trial, implementation of trial protocols or quality or safety of investigational products.
Opinions issued by The National Committee on Medical Research Ethics and regional Ethics Committees are non-appealable. However, a request for a new opinion may be made if amendments and changes are made to the trial protocol after it has been rejected. Regional Ethics Committees are obliged to refer any proposals that they have previously rejected to TUKIJA if the application is resubmitted unchanged. Previously rejected proposals can also be resubmitted to the Ethics Committee that initially reviewed them after any amendments requested by the said Ethics Committee have been introduced, in which case the regional Ethics Committee in question can issue an opinion without referring the case to TUKIJA.
Special Requirements for Trials Involving DNA Samples
TUKIJA requires separate consent forms for DNA samples and the following information should be included in subject information: Explicit information about the use of DNA samples, what information the subject can be given about his/her samples, how data protection is managed and the samples will be stored.
The National Committee on Medical Research Ethics recommends that DNA samples will be stored in Finland and sent abroad only for analyzes for avoiding gathering of data in “DNA banks”. In addition to this, samples should be anonymized, pseudonymized, or coded before sending abroad.