gms | German Medical Science

Introduction: Clinical studies, registers and cohorts offer a wealth of quality-assured health data. Participants’ consent provided, using this data for secondary research efficiently utilizes existing resources and is increasingly encouraged. Ensuring that the applicable regulatory frameworks allow secondary use of data collected as part of clinical studies and managed by large national research data infrastructures under given conditions, comprises challenges.

Methods: Studies are conducted using national infrastructures [1], [2] that enable data collection, storage, and analysis for primary and secondary use. Various types, respective regulatory requirements, and data governance models of studies and the infrastructure set up require customisation of consent documents in consultation with the study team and infrastructure partners.

For the formulation of informed consent forms (ICF) tailored to a specific study context, structural elements and text blocks of national solutions provided by the German Association of Medical Ethics Committees, the Medical Informatics Initiative and the electronic Tool for Informed Consent Documents (eTIC) [3] are used as initial templates, sometimes in combination, and, if applicable, amended.

To enable automised and standardised querying of varying consent forms for secondary use on patient level in a daily updated manner, the Semantic Consent Code was developed. By structured comparison and standardisation of existing solutions various consent modules were described with respect to type of data processing and source as well as context of data usage in a machine-readable way (publication submitted).

Results and discussion: Challenges addressed by the Ethics Coordination include promoting the compliance of data infrastructures and governance frameworks with AMG/MPDG and GCP standards applicable to clinical trials. While laws and regulations govern aspects of trial safety, they may not adequately address secondary use, potentially leading to ambiguity. As of now in large multi-center studies, individual Ethics Committees may review a project independently, resulting in different and sometimes conflicting requests for modifications [1], [2]. The long-term implementation of data subjects' rights in data processing scenarios with multiple partners requires clear points of contact for communication with the participants, which a Trusted Third Party may take over from the primary study center once a study ends. This must be detailed in the ICFs before the start of data collection. As Ethics Coordination, we advise on and coordinate these aspects in consultation with all project partners. Their early consideration is crucial for clarifying data processing roles in contracts, ICFs and further documents to establish long-term legal accountability, especially when primary trial sponsor responsibilities shift to secondary processing entities. We further act as a network‘s point of contact for requests regarding infrastructure and data processing by Ethics Committees. A central TTP offering pseudonym and consent management benefits the long-term implementation of data subject rights for all partners.

Conclusion: Enabling secondary use of data obtained during clinical studies requires a high level of in-depth knowledge of the infrastructure and the regulatory frameworks paired with willingness to tread new paths. Smart combination of standardisation and customisation allows data to be used across multiple studies while ensuring the protection of data subject rights and complying with regulatory requirements.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.