Analysis And Comment Research protocols

Waiving confidentiality for the greater good

BMJ 2006; 332 doi: https://doi.org/10.1136/bmj.332.7549.1086 (Published 04 May 2006) Cite this as: BMJ 2006;332:1086
  1. An-Wen Chan, special advisor ([email protected])1,
  2. Ross Upshur, director2,
  3. Jerome A Singh, head3,
  4. Davina Ghersi, director4,
  5. François Chapuis, senior researcher5,
  6. Douglas G Altman, director6
  1. 1 Randomized Controlled Trials Unit, Canadian Institutes of Health Research, Toronto, Canada
  2. 2 Primary Care Research Unit, University of Toronto, Canada
  3. 3 Bioethics and Health Law Programme, Centre for the AIDS Program of Research, Durban, South Africa
  4. 4 Systematic Reviews and Health Care Assessment, National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Australia
  5. 5 Clinical Epidemiology Unit, Hospices Civils de Lyon, Claude Bernard University, Lyon, France
  6. 6 Cancer Research UK and NHS Centre for Statistics in Medicine, Oxford
  1. Correspondence to: A-W Chan
  • Accepted 11 March 2006

Research protocols are usually kept confidential to protect intellectual and commercial interests. But secrecy can also hide deviations that affect the validity of results and threaten the integrity of medical research

Recent high profile events have highlighted the harms of undisclosed research data,1 2 and methodological studies have found important discrepancies between the protocols and publications of randomised trials.3 4 5 These findings have undermined the credibility of clinical research. Comparisons between the protocol and the published study constitute the most reliable means of evaluating the conduct and reporting of research. However, accessing the confidential protocols and amendments approved by research ethics committees is difficult. Formal policies do not exist for granting access to these documents without requiring permission from researchers or sponsors, and standards vary widely across individual committees within and between countries. We outline the controversies and propose a procedural framework for allowing external reviewers access to trial protocols for methodological research and oversight.

Role of ethics committees

Ethics review is under assault in many countries as being needlessly bureaucratic, subject to inexplicable variation, and of uncertain value.6 7 Although research ethics committees are responsible for ensuring that trials are reported and carried out as they have been approved,8 9 10 w1 most committees are not required to do more than request interval reports from researchers.11 12

Comparing publications with the original protocols and amendments is an objective means of evaluating reporting of trials and adherence to the protocol. Discrepancies may indicate that the study was not performed as originally intended; subject to amendments that were not officially submitted to ethics committee for approval; or misrepresented in the publication. This oversight mechanism has become increasingly recognised by some journals, which now require authors to submit the trial protocol with the manuscripts as well as trial registration.w2-w4 …

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