CIHR-IMHA Open Science Hub: Practical guidance for health research teams

To develop a detailed protocol that addresses the rationale, objectives, methods, statistical analyses, ethical considerations, dissemination plans, and administration of the study

2. Benefits of a comprehensive protocol

• Promotes consistent study conduct by the research team
• Enables appraisal of study validity, feasibility, and ethical rigour by external reviewers
• Provides methodological context to fully interpret and apply the results
• Facilitates reproduction and replication of study results

3. Key steps

a) Search the EQUATOR website to identify a core reporting guideline based on the type of study you are conducting. Reporting guidelines provide a list of minimum items to address in a protocol.

Core protocol guidelines

b) Search the EQUATOR website to identify any extensions to the core reporting guideline that may be relevant to your study. Extensions provide additional recommendations for a specific protocol component or design.

Key extension guidelines

c) Ensure that the study protocol addresses all items defined in the relevant reporting guidelines.

d) If no guideline is available, then provide full details in the protocol to enable understanding and replication of the study. Key sections include the study background, rationale, objectives, design, methods, statistical analyses, ethical considerations, dissemination plans, and administration.

4. Examples

Model examples of protocol content are available in the SPIRIT and PRISMA-P explanatory papers for randomized trials and systematic reviews, respectively.

5. Key resources

To support responsible research data management practices. A data management plan (DMP) is a living document that describes how data will be managed across the research lifecycle (e.g., collected, managed, stored, shared, and preserved). Early development of DMPs can help to support open data sharing practices by ensuring that the necessary permissions are obtained up front.  Note that DMPs are useful in formalizing data management processes whether data are intended to be shared openly or not.

2. Benefits of a DMP

• Facilitates a common understanding among team members about how to manage data
• Helps to mitigate potential data problems (e.g., data loss, security breaches, duplication of effort)
• Promotes transparency and trustworthiness in data management processes
• Ensures that data processes align with best practice principles including:
  • FAIR (Findable, Accessible, Interoperable, Reusable)
  • CARE (Collective Benefit, Authority to Control, Responsibility, Ethics)
  • OCAP (Ownership, Control, Access, and Possession)
• Supports compliance with mandates or norms; many funders require or strongly encourage a DMP (e.g., Tri-Agency Research Data Management Policy)
• Helps to prospectively ensure that resources and budgets are in place to support research data management

3. Key steps

a) Consider context: Depending on the research environment and local requirements, there may be formal processes to consider (e.g., institutional process via research ethics boards; funder template requirements).

b) Identify relevant tools: Below is a listing of common tools used in Canadian health research setting to create DMPs:

4. Examples

5. Key resources

To publicly inform researchers, patients, health care providers, and policymakers about the existence and basic characteristics of a study before it begins. Study registration refers to the public posting a brief outline of the research objectives and planned methods in an online registry prior to starting the work.

2. Benefits of study registration

• • Reduces unnecessary duplication of research
  • Facilitates recruitment by informing potential participants about ongoing clinical studies
  • Deters and enables identification of selective reporting of data or entire studies
  • Enables mapping of global trends in research
  • Ensures compliance with federal and international policy or norms implemented by journals, regulators, funders, ethics boards, sponsors, and institutions
  • Promotes transparency and trust in research

3. Key steps

a) Identify an appropriate registry based on the study design. Different types of studies have different requirements and processes for registration.

Examples of registries for different study designs

b) Register the study before starting to enroll participants, perform experiments, or collect data. It is not recommended to register a study protocol retrospectively (i.e., after the research begins) because this greatly reduces the benefits of registration. Most often the full registry record is made public right away (e.g., required for clinical trials), but in some instances for other study designs, it can be temporarily embargoed (i.e., not published until certain conditions are met).

4. Examples

Examples of registry records can be found in the registries listed above. The following are examples of monitoring of protocol registration in the Canadian context; efforts are being made to address historical non-compliance to clinical trial registration and subsequent results reporting.

• CIHR’s Monitoring of Clinical Trials Registration and Disclosure 2022 – CIHR
• Evaluating prospective study registration and result reporting of trials conducted in Canada from 2009 to 2019

5. Key resources

To make a full study protocol available to the public, including the scientific community, patients, and health care providers.

 2. Benefits of sharing a protocol

• Prior to study completion: provides details of studies that are planned and ongoing to the public and the research community, including other researchers, health care providers, and potential research participants.
• After study completion: enables transparency, allowing readers to interpret the study findings, appraise the methods, and confirm that the study results presented by the investigators align with the protocol

3. Key steps

a) Share the full protocol online in the following venues:

4. Examples

To write a manuscript that fully reports the methods and results of the completed study in sufficient detail to facilitate interpretation, appraisal, and replication. A final report should address the study rationale, objectives, methods, ethical considerations, and study findings in a clear and structured manner —­ often through tables, figures, and narrative descriptions.

 2. Benefits

• Contribution to Knowledge: Results and methods that are fully reported contribute to the collective understanding of a field, allowing researchers to build on one another’s work.
• Better understanding and impact of the study: Accurate and complete reporting allows others to fully understand, critically appraise, and replicate the study, as well as use the data in systematic reviews.
• Informed Decision-Making: Study results provide the evidence base for policy decisions, clinical guidelines, and best practices.
• Transparency: Full reporting of key study elements builds trust in research.

3. Key steps

a) Search the EQUATOR website to identify a core reporting guideline based on the type of study being conducted (see Key Resources below). Reporting guidelines provide a list of minimum items to address in a manuscript.

b) Search the EQUATOR website to identify any extensions to the core reporting guideline that may be relevant to your study. Extensions provide additional recommendations for a specific study design or topic.

c) Ensure that the final report addresses all items defined in the relevant reporting guidelines.

 4. Examples of exemplary (published) reports

5. Key resources:

To ensure the quality and transparency of final research reports, many fields have established reporting guidelines that define the key minimum elements to address. The EQUATOR network hosts these guidelines.  Below are some key guidelines (note that there are also extensions to the guidelines for specific fields):

To make research findings and descriptions of study methods and processes publicly available, and distribute those findings to the people who might need or use them.

The fields of knowledge translation and mobilization are well developed and broader than the relatively narrow concept of open findings.  The former refer to comprehensive strategies and approaches to ensure that study findings are taken up and incorporated into practice. Herein “open findings” refers to efforts to ensure that findings are made available according to principles of open science.

2. Benefits of open findings

• Increases research impact and citations by making study results promptly available and readily accessible.
• Enables peer review and reproducibility by reporting study processes and their timing, including protocol implementation, study adaptations, protocol deviations, and analyses.
• Adds transparency and accessibility to revisions arising from the peer review and editorial process.
• Offers and maintains equitable, cost-free, public access to study findings.
• Retains research intellectual property where appropriate.
• Indexes and archives the study for immediate and future retrieval and use.
• Enables and advances future research and collaborations.

3. Key steps

a) Incorporate open findings into the study’s knowledge mobilization ^[1],[2]

b) Consider preprint publication, with awareness of its advantages and disadvantages.^[3]

c) Review the institutional and funder policies applicable to the dissemination of study. Some funders require Open Access publication or free access in journals or repositories.

d) Consider the advantages and uncertainties regarding open access publication.^[4],[5] Consult the Directory of Open Access Journals to identify appropriate journals.

e) Report the summary results and link to the study publication in the online registry or repository where the study was registered (see ”Register the study”).

[1] Canadian Institutes of Health Research.  Section 5.1: Knowledge dissemination and exchange of knowledge.  In: Knowledge Mobilization.  Available: https://www.cihr-irsc.gc.ca/e/41953.html.  Accessed 13 Dec 2024.

[2] Graham ID, Logan J, Harrison MB, Straus SE, Tetroe J, Caswell W, Robinson N. Lost in knowledge translation: time for a map? J Contin Educ Health Prof. 2006 Winter;26(1):13-24. doi: 10.1002/chp.47. PMID: 16557505.

[3] Smart P. The evolution, benefits, and challenges of preprints and their interaction with journals. Science Editing. 2022 Feb 20;9(1):79-84.

[4] Langham-Putrow A, Bakker C, Riegelman A. Is the open access citation advantage real? A systematic review of the citation of open access and subscription-based articles. PloS one. 2021 Jun 23;16(6):e0253129.

[5] Laakso M, Welling P, Bukvova H, Nyman L, Björk BC, Hedlund T. The development of open access journal publishing from 1993 to 2009. PloS one. 2011 Jun 13;6(6):e20961.

4. Key resources

*Predatory journals are fake or fraudulent publications that claim to be legitimate journals. They often misrepresent their    review and publishing process to mislead authors for the purpose of profiting.

To have research datasets and materials findable, accessible, interoperable, and reusable (FAIR principles).

Sharing of research data typically refers to de-identified participant-level data (e.g., measurements, images). Shared materials include additional information needed for reproducibility on datasets, such as statistical code, data dictionary, and protocols. In alignment with recent Sensitive Technology Research and Affiliations of Concern (STRAC)  policies, it is important to remember that data and materials should be as open as possible and as closed as necessary. Scientists and patient partner researchers should be aware of these policies and weigh them when considering how to make their data open.

2. Benefits of sharing data and materials

• Promotes greater efficiency and faster advancement of the field by leveraging existing data and analysis procedures.
• Ensures research is reproducible and transparent.
• Amplifies the impact of existing data by enabling additional research questions to be investigated in secondary analyses.

3. Key steps

a) Determine the data and materials that will be shared.

b) Consider what permissions are needed for sharing data (e.g., consent from individual participants, approval by research ethics board) as well as steps needed for deidentification or anonymization. These permissions should be considered in the research planning phase (see “Create a Data Management Plan”).

c) Identify an appropriate venue to share data and materials. This could be an established repository or a resource developed by the research team (e.g., Normative.ca).

Examples of repositories

d) Add a description of the process and conditions that govern how the data and materials can be accessed and used (i.e., data access statement), including an appropriate license if relevant. Consider the level of data access to provide (e.g., open, restricted, or controlled access; see ORMIR guidance).

Examples of conditions for accessing data and materials

e) Ensure the resources are usable by others and presented in a standardized format. ORMIR provides guidelines for sharing code and data.

• • Data: organize in a standardized way (e.g., BIDS format for neuroimaging data; ORMIR-MIDS is in development for MSK imaging data)
  • Code/scripts/software: Use a standard coding style (e.g., Style Guide for Python Code) and provide comments/documentation so that users can follow.

f) Upload the data and material files to the repository. Ensure data are appropriately deidentified or anonymized if necessary.

g) Provide a summary of the project in the repository or cite the journal publication and registration record.

h) Assign a DOI or other citation form to ensure that shared data can be cited.

i) Inform others (e.g., in your publication) how the shared data and materials can be accessed.

 4. Examples

5. Other important resources