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:

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

  These requirements are in accordance with the existing Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans (TCPS2), Tri-Agency Responsible Conduct of Research Framework, and Tri-Agency Open Access Policy on Publications

• Who is responsible for ensuring that a publication is freely accessible online?

  As of January 1, 2022, the Nominated Principal Investigators (NPIs) of CIHR-funded clinical trial grants are responsible for ensuring that all peer-reviewed publications describing clinical trials are open access (freely accessible online) from the date of publication. These publications must include an acknowledgement of CIHR contributions and the Funding Reference Number (FRN) or Application ID, as per the Tri-Agency Open Access Policy on Publications. The FRN is a number that identifies a unique research grant, and it can be found in the Authorization of Funding (AFF) document from CIHR that is provided to successful grant applicants.

• Why is trial registration and public disclosure important?

  Improving the timely registration and disclosure of clinical trial results will increase value and efficiency in the use of research funds, reduce reporting biases and waste in research, and contribute to better decisionmaking in health.

  Registering clinical trials helps prevent publication bias, that is, the selective publication of only those trials that yield results in support of an intervention. These registries contribute to the goal of preventing non-disclosure and the suppression of data in clinical research.

  Clinical trial registration also improves researchers' awareness of similar studies to avoid unnecessary duplication and burden on participants. Registration also improves researchers' ability to identify potential collaborators and gaps in research. Additional information is outlined in the WHO Joint Statement.

• Who is responsible for registering a clinical trial?

  The Nominated Principal Investigator (NPI), or lead Principal Investigator (lead PI) for multisite studies, is responsible for registering their trial.

• Where can I register a trial?

  All CIHR clinical trials must be registered in a publicly accessible registry that is acceptable to the World Health Organization (WHO) or the International Committee of Medical Journal Editors (ICMJE).

  To register a trial, review the WHO's international agreed standards and submit details directly to one of the Primary Registries in the WHO Registry Network or an International Committee of Medical Journal Editors (ICMJE) approved registry, such as ClinicalTrials.gov.

• When do I need to submit the summary results of my trial?

  Summary results of a trial must be publicly available within 12 months from the last visit of the last participant (for collection of data on the primary outcome).

  As per the TCPS2 (Chapter 11, Article 11.10), all fields outlined in the WHO Trial Registration Data Set (TRDS) must be completed in order for a trial to be considered fully registered. Researchers are required to provide the Research Ethics Board (REB) with evidence of registration (e.g., registration number).

• Will providing summary results on the trial registry site be sufficient to ensure compliance with this policy requirement?

  Yes, completing all fields, outlined in the WHO Trial Registration Data Set, (see summary results #23 for details), would ensure the Nominated Principal Investigator (NPI) is considered compliant with this policy requirement.

• What types of publications need to be made immediately open access?

  CIHR requires all clinical trial publications, including pre-prints and peer-reviewed publications, to be made immediately open access (i.e., made freely available online from the date of publication).

• How do I ensure publications describing clinical trial results are open access?

  To be compliant with this policy requirement, grant recipients can:

  • 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.

• Will CIHR help me pay for article processing charges (APCs) to make papers immediately open access?

  Yes, costs associated with open access publishing that align with the appropriate use of grant funds principles, as outlined in the Tri-Agency Guide on Financial Administration (TAGFA), are eligible to be paid from grant funds. CIHR encourages researchers to connect with their institution's Research Grants Office(rs) regarding policy requirements, eligible expenses, and use of grant funds.

  It is important to note that many journals allow authors to deposit their peer-reviewed journal publication in an institutional or disciplinary repository without cost to the researcher. The existing Canadian network of institutional repositories has an important role to play in preserving and making accessible the knowledge generated by academic institutions. Please visit the Canadian Association of Research Libraries: Institutional Repositories Online Resource Portal for more information.

• How will CIHR monitor and report on compliance with these guidelines?

  CIHR has committed to monitoring clinical trial registration, developing a process to monitor the reporting of results (e.g., annually requesting relevant details from Nominated Principal Investigators), and making the outputs of this process publicly available. CIHR will monitor compliance on an annual basis, using a combined approach of self-report and audit. CIHR will start monitoring policy compliance in 2022, with a review of the process planned for fall 2023. Every year, CIHR will publish aggregated, anonymous data indicating the degree of compliance with the guidelines.

• What are the consequences of non-compliance?

  Nominated Principal Investigators (NPIs) found to be non-compliant as a result of purposely contravening the requirements of the WHO Joint Statement will not be eligible for new CIHR funding.

• Which types of clinical research studies are considered “Clinical Trials” under this policy?

  For the purposes of this policy, a clinical trial is defined as a research study involving human participants that evaluates the safety and/or effects of one or more interventions on health outcomes. An observational study in which there is no pre-planned intervention is not considered to be a clinical trial. Interventions include, but are not limited to, drugs, vaccines, radiopharmaceuticals, cells and other biological products, surgical procedures, radiologic procedures, devices, genetic therapies, natural health products (NHPs), process-of-care changes, preventive care, manual therapies, and psychotherapies.

Date modified:

2022-12-13