Research bureaucracy in the United Kingdom

Editor—Increasingly, genetic testing for newly discovered or recognised genes is only available in certain laboratories in the world. From 2000-3 I have on average each year submitted four full submissions and four “annex D” forms (these allow me to participate in someone else's medical research ethics committee proposal locally). Each full submission took four hours, and each annex D two hours. Most proposals allowed DNA analysis in a research study for clinical benefit as testing was not available in the NHS.

This year I have only been able to fill in one annex D equivalent—(the new “form C”)—and one full proposal. Form C took eight to nine hours because, although it was partly completed by the lead researcher using “Form Filler v.2,” my committee refused to accept anything other than v.3 (they eventually relented as a “one off” exception with a verbal warning). The full application related to six families with autosomal dominant renal cancer to send six DNA samples to a US researcher so that if renal cancer genes were isolated in the index cases, other family members could be screened for mutations, allowing 50% of cases to be reassured and spared screening, and 50% to have targeted screening which would reassure if clear, or pick up cancers early and “save lives.”

My committee required a full proposal, which took 19 hours to submit (eight months' calendar time, start to finish). The approved documentation was sent to the US committee, with a wait of four months before I could become an “accredited investigator” (all this so that I could not be sued for DNA theft, or closure of my or the US institution through penalty, etc, even though the families were keen for testing to be done). At the end of this year long process, I lost touch with one family, two index cases died, and the other three families are being asked consent with the long ethically approved consent form, having waited some time even on an urgent outpatient waiting list to be seen.

The last straw is the new consultant contract being introduced in our hospital. I am not supposed to be doing “research” during my NHS time. Parker et al and Jamrozik illustrate how new ethics committees will easily cope with their workload, as submissions from clinicians hoping to improve patient care will completely cease.¹,² Surely this is unethical?