Intended for healthcare professionals

Rapid response to:


Revising the Declaration of Helsinki

BMJ 2013; 346 doi: (Published 08 May 2013) Cite this as: BMJ 2013;346:f2837

Rapid Response:

Re: Revising the Declaration of Helsinki

I would have some concerns about the introduction of 'exceptional' in 'There may be exceptional situations where consent would be impossible or impracticable to obtain for such research ...'.

For large data collections or re-use of older data this will frequently be the case, so 'exceptional' is the wrong term to use.

There is the check that such studies should be subject to REC review, though I note that current UK NRES guidance would suggest not (at least where de-identified data is used). From personal experience, REC review on data re-use can be highly variable depending on the experience of the REC members with data protection issues.

Frankly, this paragraph seems to be an area where the Helsinki Agreement is moving into data protection rather than ethical research behaviour; fundamental human rights rather than prevention of inappropriate 'research'.

Clearly, research participants should know that their data is being collected (so odd that this is now dropped), retained, and will be re-used for research purposes when they agree to participate. There is already the protection of privacy and confidentiality in para. 24 (previously para 23) to limit or eliminate potential harm.

There seems little reason to shackle 'research' more than other areas of data re-use (of which there is far too little in healthcare in comparison with other industries), which is why aspects of general data protection should be left to data protection law - 'render unto Caesar the things that are Caesar's'

Competing interests: No competing interests

20 May 2013
Peter D Singleton
Health Informatician
Cambridge Health Informatics
Cambridge, CB3 9HH