Message from the President - Policy on ethical conduct of research involving humansIn March 2011, CIHR removed its document on Registration and Results Disclosure of Controlled and Uncontrolled Trials (CIHR registration document) from its website in an effort to harmonize all of its ethics policies on research involving humans and to integrate operational requirements in relevant programs where appropriate and feasible. In so doing, CIHR recognized that the second edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS-2) was now the single reference document dealing with these issues.
Released in December 2010, TCPS-2 is the premier Canadian ethics policy document. This major revision of the original 1998 TCPS is the result of extensive consultations with all stakeholders over a two-year period. A major achievement of TCPS-2 is its requirements for trial registration and public disclosure that are in line with those set by the International Committee of Medical Journal Editors, the World Medical Association and the World Health Organization.
Both TCPS-2 and the CIHR registration document endorse the same principles and policy promoting transparency and the protection of research participants, the safety of trials, the duty of care owed to research participants, and the mitigation of conflict of interest by all involved in the design, conduct, sponsorship and review of trials.
Some operational elements of the CIHR registration document however, did provide specific directions not detailed in TCPS-2. The removal of this document from our Web site therefore raised concerns about decreased stringency in the research community, which were also reflected in media reports. In order to address these concerns, CIHR will be integrating the following operational requirements as part of the terms and conditions of its relevant programs:
- Grant recipients will be encouraged to publish the systematic review submitted to CIHR;
- CIHR will continue to require registration and compliance with WHO requirements related to the minimum data set as part of the requirements for relevant program competitions; and
- Researchers conducting CIHR-funded randomized control trials (RCTs) will continue to be required to submit a report in the Consolidated Standards of Reporting Trials (CONSORT) format within 12 months of the end of the trial. Since March 2011, CIHR also requires that all grant recipients submit a final report within 18 months of the grant's expiry.
Furthermore, there were some policy elements in the CIHR registration document that CIHR would like to see included in TCPS-2. CIHR will propose four revisions to TCPS-2 for prompt consideration by the Panel on Research Ethics. These are:
- Expanding coverage to all trials and not only clinical trials;
- Requiring researchers to update trial registries with any changes in the trial protocol,
adverse events that occur during a trial, and decisions taken to end a trial early;
- Requiring researchers to disclose serious adverse events at the end of the trial in
subsequent publications; and
- Requiring researchers to deposit aggregate data in an unbiased, publicly accessible
database (e.g. the trial registry).
In the interim, CIHR will specify in its competition requirements in relevant programs that CIHR-funded researchers must comply with all the requirements mentioned above.
Alain Beaudet, MD, PhD
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