Editor—I recently took a similar length of time as Wald to complete a 60 page COREC form, for a study comparing two different approaches to the management of cancer pain.1 Wald may have been unduly harsh about the process and available support.
Perhaps I have been lucky, but I have had invaluable help from our trust's research and effectiveness department, based at the Bristol Royal Infirmary. Involving them at the protocol development stage undoubtedly facilitated this. I have also received useful (and money saving) advice from the Medicines and Healthcare Products Regulatory Agency and, like Wald, was able to apply for a doctors' and dentists' exemption, which was rolled over to a clinical trials authorisation on 1 May, thereby saving some £2000. Because other researchers were doing likewise (the agency's workload was quadrupled for that period; personal communication, 2004), this unsurprisingly resulted in some delay in issuing the certificates.
The COREC information technology helpline staff have been both helpful and friendly, even on the two occasions when it became clear that the technological problems I had in completing the form were due to my errors.
Wald refers to his difficulties with part A of the form, particularly the reference numbers requested. The COREC form website has documents with frequently asked questions and question specific advice, both highlighted when logging on to the system for the first time. These state clearly the nature of the reference numbers requested and what to do if they are not required or available for a study. I wonder if “resorting” to phoning local research and development offices and referring to available guidelines are the academic equivalent of asking for directions when lost?
Competing interests: None declared.
References
- 1.Wald DS. Bureaucracy of ethics applications. BMJ 2004;329: 282-4. (31 July.) [DOI] [PMC free article] [PubMed] [Google Scholar]