BMJ 2000;320:1179-1182 ( 29 April )

Papers

The new system of review by multicentre research ethics committees: prospective study

Editorial by Alberti, pp   1182 , 1217

Joanna Tully, clinical research fellow, ^a Nelly Ninis, clinical research fellow, ^c Robert Booy, professor, ^b Russell Viner, consultant in adolescent medicine. ^d

^a Department of Epidemiology, Institute of Child Health, London WC1N 1EH, ^b Department of Child Health, Royal London Hospital, London E1 1BB, ^c Royal College of Paediatrics and Child Health, London W1N 6DE, ^d Middlesex Adolescent Unit, Middlesex Hospital, London W1N 8AA

Correspondence to: J Tully j.tully{at}ich.ucl.ac.uk

Objective: To assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed.
Design: Prospectively collected data from a multicentre study was examined with respect to the ethics review process. Administrative, financial, and time elements of the review process were audited.
Setting: A single multicentre research ethics committee and 125 local ethics committees from six regions of England.
Main outcome measures: Time to reply, time to approval, and number of non-local changes to the application requested.
Results: Only 40% of local ethics committees considered our study in the manner specified in the 1998 directive. Less than a third of committees replied within the 21 day period stipulated, although committees acting by executive subcommittee replied more quickly than those not acting by executive subcommittee. There was a tendency for executive subcommittees to approve studies in a shorter time. Local ethics committees asked for a large number of non-local changes to the application. The financial cost of applying to multiple ethics committees remains high, mainly because multiple copies of research applications are being requested.
Conclusions: The new system of approval by multicentre research ethics committee for multicentre studies was introduced to reduce administrative costs, speed up the process of reviews by multiple research ethics committees, and standardise the conclusions of the local research ethics committees. Since its introduction an improvement has been seen, but the system is not yet universally functioning as intended. Ethics review still remains a hindrance to the financial resources and commencement of national studies. We strongly support the structure of review by multicentre research ethics committees but suggest that the system has yet to achieve its aims.

---

© BMJ 2000
CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

Relevant Articles

Risk and protective factors for meningococcal disease in adolescents: matched cohort study

Joanna Tully, Russell M Viner, Pietro G Coen, James M Stuart, Maria Zambon, Catherine Peckham, Clare Booth, Nigel Klein, Ed Kaczmarski, and Robert Booy
BMJ 2006 332: 445-450. [Abstract] [Full Text] [PDF]

Ebrahim's quartet
BMJ 2000 320: 0. [Full Text] [PDF]

Ebrahim's quartet
BMJ 2000 320: 0. [Full Text] [PDF]

Ethics approval for multicentre research is expensive, slow, and inconsistent
BMJ 2000 320: 0. [Full Text]

Multicentre research ethics committees: has the cure been worse than the disease?

K G M M Alberti
BMJ 2000 320: 1157-1158. [Extract] [Full Text] [PDF]

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

Andrew L Lux, Stuart W Edwards, and John P Osborne
BMJ 2000 320: 1182-1183. [Full Text] [PDF]

The ethics of research ethics committees

Jon Nicholl
BMJ 2000 320: 1217. [Full Text]

This article has been cited by other articles:

• Porcu, L, Poli, D, Torri, V, Rulli, E, Di Tullio, M C, Cinquini, M, Bajetta, E, Labianca, R, Di Costanzo, F, Nitti, D, Floriani, I (2008). Impact of recent legislative bills regarding clinical research on Italian ethics committee activity. J. Med. Ethics 34: 747-750 [Abstract] [Full text]  
• Elliott, L, Hunter, D (2008). The experiences of ethics committee members: contradictions between individuals and committees. J. Med. Ethics 34: 489-494 [Abstract] [Full text]  
• Emery-Barker, J., McClure, I., Wood, A., Robertson, R., Minnis, H. (2008). Bypassing bureaucracy to answer important questions quickly. JRSM 101: 217-218 [Full text]  
• Seiler, C M, Kellmeyer, P, Kienle, P, Buchler, M W, Knaebel, H-P, the INSECT Study Group, (2007). Assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomised surgical trial. J. Med. Ethics 33: 113-118 [Abstract] [Full text]  
• Peel, E., Parry, O., Douglas, M., Lawton, J. (2006). "It's No Skin off My Nose": Why People Take Part in Qualitative Research.. Qual Health Res 16: 1335-1349 [Abstract]  
• Tully, J., Viner, R. M, Coen, P. G, Stuart, J. M, Zambon, M., Peckham, C., Booth, C., Klein, N., Kaczmarski, E., Booy, R. (2006). Risk and protective factors for meningococcal disease in adolescents: matched cohort study. BMJ 332: 445-450 [Abstract] [Full text]  
• Al-Shahi, R. (2005). Research ethics committees in the UK--the pressure is now on research and development departments. JRSM 98: 444-447 [Full text]  
• Dal-Re, R, Ortega, R, Morejon, E (2005). Multicentre trials review process by research ethics committees in Spain: where do they stand before implementing the new European regulation?. J. Med. Ethics 31: 344-350 [Abstract] [Full text]  
• Ward, H. J T, Cousens, S. N, Smith-Bathgate, B., Leitch, M., Everington, D., Will, R. G, Smith, P. G (2004). Obstacles to conducting epidemiological research in the UK general population. BMJ 329: 277-279 [Full text]  
• Glasziou, P., Chalmers, I. (2004). Ethics review roulette: what can we learn?. BMJ 328: 121-122 [Full text]  
• Martyn, C. (2003). The ethical bureaucracy. QJM 96: 323-324 [Full text]  
• Boyce, M. (2002). Observational study of 353 applications to London multicentre research ethics committee 1997-2000. BMJ 325: 1081-1081 [Full text]  
• Cave, E, Holm, S (2002). New governance arrangements for research ethics committees: is facilitating research achieved at the cost of participants' interest. J. Med. Ethics 28: 318-321 [Abstract] [Full text]  
• Ferris, L. E. (2002). Industry-sponsored pharmaceutical trials and research ethics boards: Are they cloaked in too much secrecy?. CMAJ 166: 1279-1280 [Full text]  
• , J., , , , J. (2001). Ethical approval for research involving geographically dispersed subjects: unsuitability of the UK MREC/LREC system and relevance to uncommon genetic. J. Med. Ethics 27: 347-351 [Abstract] [Full text]  
• Burman, W. J., Reves, R. R., Cohn, D. L., Schooley, R. T. (2001). Breaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review Boards. ANN INTERN MED 134: 152-157 [Abstract] [Full text]  
• Alberti, K G M M (2000). Multicentre research ethics committees: has the cure been worse than the disease?. BMJ 320: 1157-1158 [Full text]  

Rapid Responses:

Read all Rapid Responses

The Ethics of Cost

R V Hazlehurst
bmj.com, 8 May 2000 [Full text]

Author's reply

Joanna Tully
bmj.com, 9 May 2000 [Full text]

A European issue

Alain Braillon
bmj.com, 19 May 2000 [Full text]

Should multi-centre research ethics committee approval alone be sufficient?

David Dunn
bmj.com, 23 May 2000 [Full text]

Multicentre Research Ethics Committees

Dan Shears
bmj.com, 23 May 2000 [Full text]

LRECs have a constructive role in multicentre research

Christine Brown
bmj.com, 26 May 2000 [Full text]

Role of LRECs in review of MREC decisions

Peter A Andrews
bmj.com, 4 Jun 2000 [Full text]

Ethical review of multicentre research

Donal Manning
bmj.com, 20 Jun 2000 [Full text]