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Informed consent (IC) is the process by which a patient voluntarily agrees to a medical procedure, treatment, or participation in research after being fully informed of the relevant details. Collecting data for scientific purposes typically requires participants' IC [De Novo]. To align with the FAIR principles, it is essential that data-sharing practices are explicitly addressed in the informed consent form. Additionally, consent may also be required for activities such as data archiving and linkage to external registries.
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Evolving laws and consent requirements. Long-term cohort studies often encounter changes in laws and regulations over time, including evolving IC requirements. Consider how earlier IC agreements may differ from current standards, such as permissions for sharing data outside the EU.
Participant dropouts. Account for participants who drop out between measurement rounds. For example, if a participant last contributed 10 years ago, their original IC remains valid, which can create complexities.
Transition to adulthood in birth cohorts. For birth cohorts, consider how IC changes when children reach adulthood. While parents initially provide consent, adults may decide to withdraw or modify the use of their previously collected data.
Future data retrieval and linkage. Plan for potential future data uses, such as retrieving cause-of-death information from CBS (see 3.3) or updating addresses through the BRP. Ensure IC explicitly addresses these possibilities.
Dit hebben we ook bij step 3.3. Zou de informatie die daar staat jou geholpen hebben?
Heb je eventueel zelf een voorbeeld van wat je hebt toegevoegd? Dit kunnen we ook gebruiken bij “Examples from the community”
Retention period for data and biomaterial. Clearly define the data retention period in the SIS/ICF. Specify whether the 15-year period (or similar) begins after the study concludes to avoid premature data deletion. Alternatively, consider specifying periodic evaluations of data retention (e.g., every 5 years) with participant notification.
Dit hebben we ook bij step 3.x.
Zou dat jou geholpen hebben? Ik heb het idee dat dat niet specifiek genoeg is voor jou case, omdat er niet iets staat in de trend van “after the study concludes”?
Heb je eventueel zelf een voorbeeld van wat je hebt toegevoegd? Dit kunnen we ook gebruiken bij “Examples from the community”
Geldt dit niet ook voor biomateriaal?
Always consult your data protection officer for guidance.
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.
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Research involving animals.
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