James Randerson's article on the effect that NHS research ethics committees are having on medical research was misleading (Ethical red tape is stifling us, say medical researchers, August 4). It expressed the view of some researchers that ethical safeguards brought in after the Alder Hey body-parts scandal are making it difficult to carry out research. In fact, the changes in legislation were brought about by the 2001 EU clinical trials directive - not a response to any scandal - which ensured that Europe-wide standards of good clinical practice and patient safety are paramount in clinical drug research. The UK adopted this with the Medicines for Human Use (Clinical Trials) Regulations 2004 and, to cover non-drug research, the Research Governance Framework 2003.
In the article, the researchers Jenny Hewison and Andy Haines said "opt-in consent", whereby patients must give consent before they can be approached to participate in a study, resulted in potential recruits not being identified, hindering research. This is misleading. Without "opt in", medical researchers would have access to a patient's clinical records to assess whether they may be eligible to participate in a research project. For example, if researchers were identifying participants for an HIV study, although they would have no role in the care of the patients they would be able to read their notes, finding out about their sexuality, sexual practices and potential drug use. This would be done without the patient's knowledge. What we on research ethics committees (RECs) insist on in "opt in" is that the patient's doctor first approaches them and asks if they mind a researcher reviewing their records for a specific study.
Randerson went on to restate the myth that the new online REC application system led to a researcher spending 40 hours completing a 64-page form. This statement was investigated as part of Lord Warner's review into REC practice. The Warner report (2005) refuted this claim. It is possible that a researcher would be required to complete 64 pages, but they would need to be carrying out research into an investigational drug, involving a new medical device, requiring the collection of human tissue, while administering questionnaires and ionising radiation to prisoners, who were children with learning disabilities, with a terminal illness, in a young offenders' institution, suffering from dementia and unable to consent themselves. Even the most committed researcher would find it difficult to devise such a study. In fact the form automatically removes unnecessary pages and, as an ethics-committee member who reviews eight applications each month, I can assure you that the average application is about 20 pages.
Finally, in the article Stephen Dealler, a consultant microbiologist, claimed researchers are bypassing RECs because it can take six months to get approval for a study. Under the MHU regulations an REC must provide an opinion within 60 days. Failure to do so is a breach, as is failure to submit research for review; either can lead to a fine of up to £3,000 or a jail sentence of up to three years.
· Paddy Stevenson is vice-chairman of the NHS research ethics committee for Newcastle and North Tyneside
· The Response column offers those who have been written about in the Guardian an opportunity to reply. If you wish to respond, at greater length than in a letter, to an article in which you have featured either directly or indirectly, please email response@theguardian.com or write to Response, The Guardian, 119 Farringdon Road, London EC1R 3ER. We cannot guarantee to publish all responses, and we reserve the right to edit pieces for both length and content
