Consideration of publishing raw data

Case number:
06-25

Case text (Anonymised)

Our journal has received a submission regarding clinical trial results. The authors wish to include the “raw data” as an appendix to the manuscript. The study was completed several years ago and was controversial at the time. The authors wish to publish the raw data to allow the public to view the findings and make their own decisions about the trial. We do not know the best way to handle this situation.

Does anyone already publish anonymised raw data in their journal and, if so, how does one handle the ethics of such a publication:

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Do you assume that the original ethics approval covers this new publication?

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Do you require the authors to go back and obtain ethics approval to publish raw data? If so, does the author have to go back to the original ethics committee?

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Also, does one allow the authors to publish only “relevant” data or does one require all of the data generated from the trial to be published?

Advice: 

The discussion centred on the definition of anonymised data. If there are three or more patient identifiers, strictly speaking the data are considered pseudo-anonymised, as theoretically patients could be traced. The committee acknowledged that ethics committee approval should be sought. If this is not possible from the original ethics committee, the author’s current ethics committee should be contacted. Regarding the question of publishing only “relevant” data, the committee agreed that this decision could be made by the editor.

Follow up: 

The data were never submitted by the authors, and the manuscript was not published.

Year: