#22 Practical RWE – Informed Consent


Informed consent in the context of RWE studies in Europe is subject to various regulations and ethical standards, which can differ based on the type of study and the data being used.

  1. Explicit Informed Consent: This is the ‘traditional’ model of informed consent (as per Section 25 to 32 of the Declaration of Helsinki) where participants are given detailed information about the study, including its purpose, duration, required procedures, risks and benefits, and their rights as participants. After receiving this information, participants must explicitly agree to take part in the study.
  2. Broad Consent: For studies that intend to use data (and/or biosamples) for a range of research purposes over an extended period, broad consent may be possible. This type of consent involves participants agreeing to the use of their data (and/or biosamples) for various future research projects, which may not be fully defined at the time of consent. Broad consent is subject to strict regulations and oversight to ensure ongoing participant rights and data protection and may not be possible in certain regions e.g., Ireland.
  3. Opt-out Consent: In some European countries (e.g., MR-004 compliance procedures for RIPH-3 studies in France) and contexts, an opt-out approach may be used. Here, patients’ data is included unless they explicitly state their desire not to participate.
  4. Waiver of Consent: Under certain circumstances, regulatory bodies may grant a waiver of consent for a study. This usually happens when the research involves minimal (no additional risks above routine clinical practice) risk to participants, involves the use of existing data or biological specimens, and it would be impractical to obtain consent from all participants. However, this waiver is strictly regulated and must adhere to specific ethical and legal standards (e.g., Section 251 waivers in the UK).
  5. Secondary Use of Data: When using existing data collected for a different primary purpose (e.g., clinical records), informed consent may vary. If the data is fully anonymous, informed consent is not required. However, if data can be linked back to individuals (pseudonymised), researchers typically need to obtain either a new consent or have an ethical/legal basis for the secondary use of data without re-consent.

Consent to participate in research and consent to access and process sensitive healthcare data (e.g., in the context of GDPR compliance) are two different but overlapping types of consent,

Each country within Europe currently has additional specific regulations and practices, making it crucial for researchers to be aware of both EU-wide and national requirements.  This may change in the context of the European Health Data Space, but for now you do need to be aware of (and comply with) the national requirements.

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