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Short description
‘A great quote’ (source)
[Miriem]
IC (Informed Consent):
Informed consent Informed consent (IC) is a process by which a patient or research participant is fully informed about the nature, purpose, risks, and potential benefits of a study or treatment. It ensures that individuals agree to participate voluntarily, with a full understanding of what their involvement entails. In the context of health data, informed consent is also vital for GDPR compliance, as processing personal data (especially sensitive health data) often requires explicit consent from the data subject.
Obtaining patients’ informed consent for collecting their data for scientific purposes is usually required [De novo]. Furthermore, patient consent may be necessary for archiving and sharing [uu_consent] and linkage with e.g. external registries.
When sharing or linking health data with external registries (e.g., disease-specific databases, national health registries, or international research databases), the informed consent process must clearly define:
What data will be shared or linked: The type and nature of the health data (e.g., genetic data, medical history, treatment outcomes) that will be shared or linked with external registries.
Who the data will be shared with: This includes identifying the external registries, research institutions, or third parties that will have access to the data.
Purpose of data sharing/linking: The consent form should explicitly state the research purposes for which the data will be shared, such as epidemiological research, clinical studies, or public health monitoring.
Data security and anonymizationanonymisation/pseudonymizationpseudonymisation: Participants should be informed about how their data will be protected, whether the data will be anonymized anonymised or pseudonymizedpseudonymised, and what security measures are in place during data sharing.
Furthermore, consent information is necessary for the data to be machine-actionable, as without such data a computer cannot know whether it is allowed to use the data [FAIR].
A general informed consent form may be is availableon the website of the CCMO, but a local Institutional Ethical Review Board may demand changes after reviewing . and assesses whether the IC aligns with ethical standards, legal requirements and takes considerations into account such as age. This is important because:
It ensures that the consent form is written in a way that participants in that particular region can understand.
The local committee will assess whether the consent form adequately explains the data processing activities, the purpose of data collection, and participants' rights (e.g., the right to withdraw consent).
The committee ensures that the study adheres to local regulations regarding the use of personal and sensitive health data.
It is crucial that essential data sharing aspects are explicitly handled in the informed consent form [De Novo]. The consent information should be made available as metadata.
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Why is this step important
A properly designed informed consent is crucial for data reuse. Without it, archiving, sharing, etc may not be possible.
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A properly designed informed consent is crucial for data reuse. Without it, archiving, sharing, etc may not be possible.
To accommodate FAIR data principles (Findable, Accessible, Interoperable, and Reusable) in the Informed Consent (IC) for health research data, the IC must include specific information that addresses not only the immediate use of the data but also its potential future uses in a way that aligns with GDPR requirements. The FAIR principles encourage making data more useful for both immediate research purposes and future secondary purposes (like replication, validation, or meta-analysis), while still protecting participants' privacy and rights.
Current Research Purpose: The IC should clearly explain the primary purpose for which the health data is being collected (e.g., a specific clinical study, disease research, or a longitudinal health survey).
Potential Future Use: To align with the FAIR principles, the IC should also mention the possibility that the data may be used for future research purposes, which may not yet be fully known at the time of data collection. However, the scope of future research should be described as broadly but as clearly as possible, respecting GDPR’s transparency principle.
FAIR Data Goals: The IC should include a statement that aligns with the goals of FAIR data, explaining that the data will be made findable, accessible, interoperable, and reusable by other researchers and stakeholders in the scientific community.
Data Registries or Repositories: If applicable, the IC should state that the data will be deposited into data repositories or registries that adhere to FAIR principles, allowing it to be discoverable and reusable by others.
Who Will Access the Data: Provide clarity on who will be allowed to access the data. This includes mentioning both internal and external researchers and potential data-sharing partnerships.
Controlled vs. Open Access: Explain whether the data will be made available via open access (where anyone can access the data) or via controlled access (where only approved researchers or organizations can access it).
Cross-border Data Transfers: If the data may be shared internationally, the IC must comply with GDPR’s rules on cross-border data transfers. Explain if the data will be shared with researchers outside the EU and what safeguards are in place to protect the data in international transfers.
How to
Opt-in, opt-out? What about the PIF?
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