ArticleScience and engineering ethics2020
Context-Relative Norms Determine the Appropriate Type of Consent in Clinical Biobanks: Towards a Potential Solution for the Discrepancy between the General Data Protection Regulation and the European Data Protection Board on Requirements for Consent.
Article in Science and engineering ethics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- The Regulatory Landscape of Biobanks In Europe: From Accreditation to Intellectual Property.Current genomics · 2025Review
- A contextual integrity approach to genomic information: what bioethics can learn from big data ethics.Medicine, health care, and philosophy · 2024Article
- Be an ethicist not a stranger! : The critical patient stuck between the right to evidence-based medicine, informed consent, and social duty. Are we still "Strangers at the bedside"?Journal of anesthesia, analgesia and critical care · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Clinical biobanks processing data of participants in the European Union (EU) fall under the scope of the General Data Protection Regulation (GDPR), which among others includes requirements for consent. These requirements are further specified by the Article 29 Working Party (WP29)-an EU advisory body currently known as the European Data Protection Board (EDPB). Unfortunately, their guidance is cause for some confusion. While the GDPR allows participants to give broad consent for research when specific research purposes are still unknown, the WP29 guidelines suggest that additional consent for specific uses should be obtained in addition to broad consent when this becomes applicable. This discrepancy elicits the question whether clinical biobanks can fail the requirement of consent if they obtain broad consent, but not a specific consent for each biomedical study. We analysed this discrepancy within the framework of contextual integrity, in order to describe the context-relative informational norms that govern information flows in clinical biobanks. However, our analysis demonstrates that there is no uniform set of norms that can be applied to all clinical biobanks. As such, neither the GDPR nor the WP29 guidance can act as a "one size fits all" approach to all clinical biobanks. Rather, differences between clinical biobanks-especially regarding the scientific aims and patient populations-make the case for context-relative norms that determine the appropriate type of consent.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.