Papers

Responses of local research ethics committees to a study with approval from a multicentre research ethics committee

Andrew L Lux, clinical research fellow,  Stuart W Edwards, research coordinator,  John P Osborne, professor of paediatrics and child health. 

Children's Centre, Royal United Hospital, Combe Park, Bath BA1 3NG

Correspondence to: A L Lux andrew.lux{at}ruh-bath.swest.nhs.uk

Studies approved by multicentre research ethics committees in the United Kingdom are submitted to a local research ethics committee in each health district. Guidelines on handling such submissions were issued in September 1998.¹ The United Kingdom infantile spasm study was approved that same month: as members of the steering committee we attempted to assess the impact of the guidelines on the practice of local research ethics committees.

	Participants, methods, and results

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We made 113 submissions on behalf of local investigators to 99 local research ethics committees between September 1998 and September 1999. We analysed the committees' responses to the first submission. A committee was classified as "fast track" if the administrator stated that the submission would be reviewed by an executive subcommittee, as recommended by the guidelines. Our main outcome measure was response time, defined as the number of days between arrival of the submission and the date on which written confirmation of the committee's decision was typed. We considered a response time of 21 days or less to be satisfactory since this was the upper limit suggested by the guidelines.¹ In a survey of 26 committees, submissions arrived a median of three days (range 1-7) after they were sent. For the other committees, we took the date of receipt to be seven days after the documents were sent. We defined earlier submissions as those received before April 1999.

Submissions were classified as approved if complete or conditional approval was granted, even if requests for clarification were made to the multicentre research ethics committee, the trial steering committee, or the local investigator. Requests for opinions from third parties, failure to grant at least conditional approval, and requests for amendments to study documents were classified as non-approval. Requests for minor amendments to study documents (such as changes to letter headings) were classified as approval, except in two cases when the local committee asked to review such changes before granting full approval.

Fewer than half of the committees used a fast track system (table), with 21 (44%) of earlier submissions and 23 (45%) of later submissions being reviewed by an executive subcommittee. A third of the committees reached a decision within 21 days. There were no significant differences in median response times between standard and fast track committees, or between earlier and later submissions. Seventeen committees did not approve the study after the first review. One committee had not had a quorum for over six months and, when it did meet, requested an opinion from a third party. Another committee recommended several amendments which the multicentre research ethics committee did not consider important enough to merit global amendments to the study protocol. The resulting impasse was unresolved six months later. The required number of complete copies of protocols and documents from the multicentre research ethics committee was significantly lower for local committees that used a fast track system (Mann-Whitney rank-sum test: z=3.11, P<0.002). However, four fast track committees requested 12 or more copies.

	Comment

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The two tier system of ethical approval of multicentre research was intended to combine rigorous local review with expedient timing.² We found that only a third of committees responded to submission of a study that had been approved by a multicentre research ethics committee within the recommended period of 21 days. A sixth of committees did not approve the study after the first review. There was no evidence of more efficient review or wider adoption of the NHS Executive's guidelines six months after these guidelines had been issued. Fewer copies of documents were required by committees using an executive subcommittee for fast track decisions, but these committees did not make faster decisions. Our findings echo the comments of other researchers, that the two tier system of ethical review retains the inefficiencies of the former system.³

	Acknowledgments

We thank the members of the United Kingdom infantile spasm study (UKISS) steering committee and local investigators for their support.

Contributors: ALL, SWE, and JPO designed the study and wrote the paper. ALL and SWE collected the data, and ALL analysed the data. ALL is guarantor for the study.

	Footnotes

Funding: Bath Unit for Research in Paediatrics (BURP) and Cow and Gate.

Competing interests: The authors are involved in a charitably funded, national study that would benefit financially from faster ethical approval.

	References

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1.	NHS Executive. Interim guidance: how should an LREC handle an MREC approved application? London: Department of Health, 1998.
2.	Alberti KGMM. Local research ethics committees: time to grab several bulls by the horns. BMJ 1995; 311: 639-640[Free Full Text].
3.	Larcombe I, Mott M. Multicentre research ethics committees: have they helped? J R Soc Med 1999; 92: 500-501[Medline].

(Accepted 11 February 2000)