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‘Start with a great quote from, for example, a paper, between single quotes, in italic.' (source as a hyperlink between parenthesis) In layman’s terms (Jip en Janneke), add an easy to follow summary, using around three sentences. |
Short description
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. Depending on the circumstances, it may be possible to switch to an op-out if their is a proper legal basis. Check with your local specialists.
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 period 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.
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