New CIHR requirements for registration and public disclosure of results from clinical trials

On October 28, 2020, CIHR formally signed onto the WHO Joint Statement on Public Disclosure of Results from Clinical Trials (“WHO Joint Statement”), affirming CIHR’s commitment to advancing open science, research excellence, and greater transparency in clinical trials. To that end, CIHR has launched a Policy Guide outlining existing and new policy requirements for CIHR-funded clinical trials to meet and exceed our role as a signatory of the WHO Joint Statement.

In alignment with international best practices and in accordance with existing tri-agency policies, Nominated Principal Investigators receiving CIHR grant funds for clinical trial research on or after January 1, 2022 must comply with the following practices to remain eligible for any new CIHR funding:

Clinical trials must be registered in a publicly available, free-to-access, searchable clinical trial registry complying with the WHO's international agreed standards before the researcher meets with the first study participant.

CIHR-funded researchers are already doing this!

Public disclosure of results must be done within a mandated time frame:

• Publications describing clinical trial results must be open access from the date of publication.
• Summary results must be publicly available within 12 months from the last visit of the last participant (for collection of data on the primary outcome).

This new requirement applies to all trials funded on or after 1 Jan. 2022.

All study publications must include the registration number/Trial ID (to be specified in the article summary/abstract).

This new requirement applies to all trials funded on or after 1 Jan. 2022.

By introducing these new requirements for clinical trial reporting, CIHR is proud to demonstrate its ongoing commitment to advancing open science and research excellence. Timely disclosure of results reduces waste in research, increases value and efficiency in the use of funds and reduces reporting bias, which should lead to better decision making in health policy and practice.

Questions?

For more information, please refer to the Policy Guide.

If you have questions, please contact the CIHR Contact Centre.

Frequently Asked Questions

• What is the World Health Organization (WHO) joint statement on public disclosure of results from clinical trials and why did CIHR sign it? In October 2020, CIHR joined some of the world's largest funders of health research and international non-governmental organizations by signing the World Health Organization (WHO)'s Joint Statement on Public Disclosure of Results from Clinical Trials (“WHO Joint Statement”). The signatories affirm that the upfront registration and timely public disclosure of results from all clinical trials is of critical scientific and ethical importance. CIHR's signing of the WHO Joint Statement affirms our commitment to improving transparency and reducing publication biases in the Canadian health research enterprise by ensuring clinical research findings are made available to those who can benefit from and build upon them. CIHR's implementation of the WHO Joint Statement, through CIHR's Policy Requirements for the Registration and Disclosure of Clinical Trials, is a commitment within CIHR's Strategic Plan (Priority A: Advancing Research Excellence in all its Diversity Action Plan for Year 1) and will ensure Canadian health research will be internationally recognized, inclusive, collaborative, transparent, culturally safe, and focused on real-world impact. Requiring the results of all clinical trials to be available will enable more informed decisions about health care in Canada and around the world.
• What are CIHR's clinical trial requirements? As per previously established tri-agency policies:
  • Clinical trials must be registered in a publicly available, free-to-access, searchable clinical trial registry complying with the WHO's international agreed standards before the first visit of the first participant.

  The following new requirements apply to all clinical trial grants funded on or after January 1, 2022

  • Public disclosure of results must be done within a mandated time frame:
    • Publications describing clinical trial results must be open access from the date of publication.
    • Summary results must be publicly available within 12 months from the last visit of the last participant (for collection of data on the primary outcome).
    • Option 1: publish their clinical trial results in an open access journal or in a journal that offers free and immediate open access on its website; and/or
    • Option 2: deposit the final, peer-reviewed, full-text manuscript in online repositories (e.g., institutional, discipline or adoptive), in Canada or elsewhere, that are open access.
      Please note that these two routes are not mutually exclusive.

    Option 1: There are more than 9,000 open access scientific and scholarly journals that publish articles that are freely available. For more information, consult the Directory of Open Access Journals (DOAJ). It is the responsibility of the grant recipient to determine which publishers allow authors to retain copyright and/or allow authors to archive journal publications in accordance with funding agency policies.

    Option 2: For a list of repositories in Canada, please consult the Canadian Association of Research Libraries (CARL) Institutional Repository Project: Online Resource Portal. There are several university libraries that welcome articles from researchers whose home institutions do not have an institutional repository. Some of these libraries provide this service only to researchers within their province or region, while others provide this service to any researcher in Canada. For more information, visit the CARL Adoptive Repositories page.

    Note that although making articles available on a personal website is permissible, CIHR requires that a copy also be made available, cost- and barrier-free, through an online repository or journal upon publication in order to reach a broad audience more effectively and to ensure long-term accessibility.

    For additional information on how to publish open access, refer to the Tri-Agency Open Access Policy on Publications, Toolbox and Frequently Asked Questions.