Feature Open Data

Freedom of information: can researchers still promise control of participants’ data?

BMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i5053 (Published 21 September 2016) Cite this as: BMJ 2016;354:i5053
  1. Nigel Hawkes, freelance journalist, London, UK
  1. nigel.hawkes1{at}btinternet.com

After a five year battle, patients with chronic fatigue syndrome have forced researchers to release data from controversial research into treatment of the condition. But participants in the trial never consented to this. Nigel Hawkes reports

The consent agreements researchers make with patients participating in trials will have to be rethought, experts have warned, after researchers were forced by a court ruling to release data from a controversial trial despite not having obtained the participants’ authorisation to do so.

Queen Mary University of London said this month that it has released the data from the PACE trial (a randomised evaluation of pacing, graded activity, cognitive behaviour therapy, and specialised medical care for chronic fatigue syndrome1) to a patient who had requested it under the Freedom of Information Act. The university had long battled against the request, citing concern that the participants could be identified if the data were released.

Frances Rawle, head of corporate governance and policy at the Medical Research Council, says that it will now be necessary to rethink how consent forms for future trials are drafted if it is no longer possible to assure participants that data will not be shared.

“People who run trials have to say what will happen to the data they collect, so we’ll have to look very carefully at the wording of consent forms,” she says. “As things stand they are no longer consistent with the Freedom of Information Act.”

If people have to be told that data may be shared, even if only after anonymisation, it could …

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