Who stole the Canadian Institutes of Health Research’s trial transparency policy?
Canadian health researchers report that the policy, only four months old, went missing sometime in mid-March. The policy’s full name is Policy on the registration and results disclosure of controlled and uncontrolled trials funded by CIHR.
It was last seen in the vicinity of the CIHR/IRSC website, at http://www.cihr-irsc.gc.ca/e/42831.html. The policy is described as an expansion of a previous CIHR policy, aimed at increasing clinical trial transparency and reducing biased disclosure of trial results.
We have evidence that the policy was alive not long ago.
CIHR announces new policy
Policy on the registration and results disclosure of controlled and uncontrolled trials funded by CIHR (http://www.cihr-irsc.gc.ca/e/42831.html)
In 2006 the CIHR endorsed, in principle, the World Health Organization (WHO) international standards for clinical trial registration. Consequently, CIHR has updated its policy effective 20th December 2010. The new Policy will apply to all competitions with application deadlines after 1st January 2011.
The new Policy requires researchers awarded CIHR funding to:
* Register a trial in one of the WHO primary registries or ClinicalTrials.gov prior to participant recruitment;
* Regularly update the information during the trial;
* Report and publicly disclose trial results; and
* Retain all trial information for 25 years.
The updated Policy expands on the 2004 policy on RCT registration. This Policy complies with the WHO International standards, ICMJE requirements and the Declaration of Helsinki.The Policy will help ensure that clinicians, researchers, patients and the public have access to information about CIHR-funded trials. The aim is to increase transparency and accessibility of trials by their prospective registration and disclosure of results, thereby reducing publication bias and fulfilling ethical responsibilities.
The new Policy can be accessed via the CIHR Funding Policies web page (http://www.cihr-irsc.gc.ca/e/204.html)
2) The CIHR glossary refers to this policy (under “Results”).
3) There’s a nice archived abstract and PDF of the slides from a presentation explaining the origins, development and details of the new policy, “Towards Greater International Transparency of Clinical Trials – Short Term Efforts for Long term Benefits: CIHR Trial Policy 2010” given in February by Karmela Krleza-Jeric,MD, M.Sc., D.Sc.
But the policy hasn’t been seen in at least a week, possibly longer.
The URL to which the above sources refer as the policy document on the CIHR website is currently a 404 Error page.
At first, it might seem to be merely a website glitch. However, the policy is also missing entirely from the above mentioned CIHR Funding Policies web page, despite the fact that the other recently added policy on Gender and Sex Based Analysis is listed, and the page currently says it was last updated a week ago on March 28, 2011.
Policy wonks continue to search for the missing policy, last seen at least one week ago.
At this point, authorities can only speculate on motives for this disappearance. However, the spectre of institutional conflict of interest has been raised. At this point, we are making an appeal to the public to please contact us with any information you may have about the policy’s disappearance.
Anyone with information on the current whereabouts of the CIHR Policy on the registration and results disclosure of controlled and uncontrolled trials is asked to please leave a comment below. We hope to see this young policy safely back at home again as soon as possible.
ETA – Cached copy of the policy text is now available here.