The European Society for Medical Oncology has raised concerns over the wording of the proposed European Union General Data Protection Regulation, which could be interpreted as requiring explicit patient consent for every new study on already available data and tissues, thereby significantly hampering the pace of cancer research.
The European Society for Medical Oncology (ESMO) is worried that a proposed European Union (EU) General Data Protection Regulation about the handling of personal data could have unintended consequences for cancer research. Specifically, ESMO is concerned that the wording of the regulation might be interpreted as requiring a patient's explicit—and repeated—consent prior to using their data or tissue samples in any new studies.
Such a stipulation “may put at stake the survival of retrospective clinical research, biobanking, and population-based cancer registries in the EU,” writes Paolo Casali, MD, author of the official ESMO position paper, published in August and endorsed by nine other European cancer-related organizations (Ann Oncol 2014;25:1458–61). Repeatedly needing to seek consent would be “time-consuming, administratively burdensome, expensive, and intrusive into patients' lives,” he says.
Instead, ESMO calls for a “broad, one-time consent.” This way, fully informed patients could agree from the outset that their data and/or tissues can be used for future research unless they specifically withdraw their consent. This arrangement would mitigate the risk of cancer research grinding to a halt due to the need to obtain explicit consent for each new study.
The paper notes that existing safeguards at biobanks already adequately protect a person's privacy, and that adapting those safeguards as new situations arise should provide continued protection. Furthermore, Casali says that the publication of research studies involves aggregate data, not individual results or identities.
When it comes to population-based studies, Casali argues that if individual patients are allowed to opt out, “the relevant registry will be incomplete or unrepresentative, and can lead to incorrect conclusions.” Even if the number of patients opting out is small, obtaining consent from everyone in a country or region “would be almost impossible.”
The European Commission, European Council, and European Parliament are still determining their respective positions on the regulation, after which joint negotiations over the final text will begin, likely in 2015.
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