Data sharing advice helps protect patient privacy

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New guidance published in the journal Trials and sets out how personal information from clinical trials should be shared in the publication process to help minimise risks to patient privacy.

Many peer-reviewed journals require authors to be prepared to share their raw, unprocessed data with other scientists or state the availability of raw data in published articles, but there has been little guidance on how such data should be prepared for sharing.

In their article, Iain Hrynaszkiewicz and colleagues offer advice for anonymising data to ensure patient privacy when sharing clinical research.

They list 28 items of personal and clinical information that can make patients identifiable in anonymised datasets. They recommend that, unless patients have explicitly consented, all direct identifiers such as names should be removed from datasets. If three or more indirect identifiers such as age and sex are given about any patient, the researchers should ask an independent expert or an ethics committee to assess the risk of breaking confidentiality before sharing the data.

They also advise researchers to seek informed consent about data sharing from patients involved in clinical trials before studies begin and recommend that researchers should make explicit statements in research articles that have linked raw data, about patients' consent to the sharing of those data.

This, say the authors, should be the minimum standard for ensuring that participants’ privacy is not put at unnecessary risk.

The BMJ is already adopting some of these recommendations, according to Trish Groves, BMJ deputy editor in an accompanying editorial.