Respected journals BMJ and Trials have co-published guidelines about how personal information from clinical trials should be shared to help minimize risks to patient privacy.
Many peer-reviewed journals now require authors to be prepared to share their raw, unprocessed data with other scientists, or to state the availability of raw data in published articles. However, it has been noted that there is little guidance on how such data should be prepared for sharing.
Authors Hrynaszkiewicz, Norton, Vickers and Altman offer practical advice for masking identifying data to ensure patient privacy when sharing clinical research. They advise researchers to seek informed consent about data sharing from patients involved in clinical trials before studies begin. Further, the authors list 28 items of personal and clinical information that can make patients identifiable in ‘anonymized’ datasets, and 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. It is also recommended 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.
BMJ is now adopting some of these recommendations. The journal strongly supports the view that researchers should seek informed consent to data sharing from research participants up front, at the recruitment stage. The journal will also expand its advice to authors about data sharing, and will extend its data sharing statements to include explicit information about consent.
Read the article: Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers
Iain Hrynaszkiewicz, Melissa L Norton, Andrew J Vickers, Douglas G Altman
Trials 2010, 11:9 (29 January 2010)