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Splitsen? Of lopen ze tegen dezelfde problemen aan?
Quint Olislagers 16-12-2024:
Long-term cohort studies often face changing laws and regulations over the course of the study. Informed consent requirements have also changed over the years. The most recent informed consent applies to the participant's data. So it may be that 10 years ago no participant was asked whether their data may be shared outside the EU, but that this was done in a new round this year. With a cohort, however, you always face participants dropping out between measurement rounds. Therefore, it is possible that certain participants participated for the last time 10 years ago and have not participated since then. Therefore the informed consent of 10 years ago remains valid. This can lead to complicated situations within cohorts, for which it is advisable to contact the data protection officer of your institute.
One other common situation is when children in birth cohorts reach adulthood. Before they become adults, their parent or caregivers will have given informed consent for data collections concerning their child. As a adult they might not want their previous collected data to be used.
It is also advisable to think carefully from the beginning of a study about the possible retrieval or linking of data with other institutes in the future. An important point here could be asking permission to request the cause of death from CBS when a participant dies. Updating address information through the BRP can also be very important in cohort studies to ensure that participants are not lost from sight. Informed consent should also be requested for this.
Furthermore, an informed consent or the accompanying information material describes the retention period of the data, often 15 years. It is important that it then says 15 years after the study has ended. Otherwise, there could be situations where a cohort that has had measurement rounds for 20 years has to destroy data from its first measurement rounds. This can also be avoided by saying that instead of doing a specific number of years as the retention period, it will be evaluated every x number of years as to whether the data should still be retained and the participant will be informed of this.
Research involving animals.
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