iCARE STUDY / RESEARCHERS / DATA ACCESS PROCESS

iCARE STUDY DATA ACCESS PROCESS

The iCARE study team encourages open-source data movement and continuous collaboration in order to maximize the scientific value of extensive epidemiological data collected in our study. As such, the study team is committed to making the iCARE research materials available to all study collaborators.

  • Collaborators can request direct access to iCARE study data or statistical assistance/analysis of iCARE study data.
  • No fees will be charged for accessing the iCARE research materials nor for statistical analysis/assistance requests.

To facilitate access to data and ensure optimal and timely scientific outputs that are of crucial importance in the context of the current COVID-19 pandemic, the iCARE study team has developed a step-by-step guide for interested research investigators.

STEP 1: Browse

Browse the available data and familiarize yourself with the ongoing iCARE analyses

  • Review available iCARE data (https://osf.io/nswcm/) and the publicly available data from the external repositories that have been collected as part of the iCARE Study (COVID-19 epidemiological data from Johns Hopkins University; COVID-19 governmental policies tracker from Oxford University, and Google community mobility data from Google).
  • Consult the iCARE analysis plan (iSAP) log and iCARE study-related publications webpages to avoid overlaps in analyses.

The purpose of the iCARE Study Analysis Plan (iSAP) log is to serve as a repository of prospective analyses stemming from the work of the iCARE project’s collaborators. The goal is to encourage sharing and collaboration through a collegial and transparent process.

STEP 2: Submit

Register your study proposal (iSAP)

  • Submit your research proposal to the iCARE Study Analysis Plan (iSAP) log. Submissions to the iSAP are coordinated with the assistance of one of the MBMC’s institutional partners, the International Behavioural Trials Network (IBTN).
  • Before and after submitting an analysis plan, collaborators are invited to search the iSAP log (or by using a keyword search) to identify any other similar, complementary or overlapping analysis plans.
  • Per the iSAP terms of use, analysis plans submitted to the iSAP log will be reviewed strictly for validation purposes. Project contact persons will receive a confirmation once their analysis plan is assigned a unique number and published on the iSAP page.
  • Every 6 months, the iCARE team will prompt project contact persons to review their project information and submit updates as needed. Analysis plans that are not updated after a certain period of time will simply be marked as closed.
  • Analysis plans that indicate needing statistical assistance, or any analysis plan requesting iCARE data, will be processed on a case-by-case basis.
  • Acknowledgements for publications and a Research Materials Distribution Agreement (RMDA) will govern these requests. You may contact the iCARE project’s primary investigators Drs. Kim Lavoie and Simon Bacon directly through the iCARE team at covid19study@mbmc-cmcm.ca.

Data Access

The iCARE research materials are only available to formal study collaborators. The iCARE team encourages global collaboration and invites you to become a collaborator of the iCARE study by contacting us directly: covid19study@mbmc-cmcm.ca.

Choose the “Data Access” tab above to view the next steps.

Data Analysis

Comprehensive reports and data analyses are conducted by the MBMC statistical team, and can be offered both to iCARE collaborators and external investigators. However, priority will be given to the current collaborators of the study. Our team encourages global collaboration and invites you to become a collaborator of the iCARE study by contacting us directly: covid19study@mbmc-cmcm.ca.

Choose the “Data Analysis” tab above to view the next steps.

Knowledge Translation

Please contact us if you are planning to generate knowledge translation (KT) products as an initial step of your research process. In the context of the current pandemic, the iCARE study team will ensure to prioritize the process of generating simple outputs for informative KT products.

Data Access Requests

The iCARE research materials are only available to formal study collaborators. The iCARE team encourages global collaboration and invites you to become a collaborator of the iCARE study by contacting us directly: covid19study@mbmc-cmcm.ca.

Step 3A: Ethics Approval

Investigators are fully responsible for obtaining local Human Research Ethics Committee (HREC) approval for the project specified in their analysis plan. Investigators certify that their HREC is operating under an official national or regional recognised accreditation process.

Evidence of local HREC review and/or approval (where appropriate) from an expedited or convened review must be provided to the iCARE study team prior to the release of any research materials.

Step 3B: Research Materials Distribution Agreement (RMDA)

  • Before accessing the iCARE study data, an RMDA between the MBMC, Recipient organization and the Local Lead investigator must be signed.
  • To protect the confidentiality and privacy of iCARE participants, investigators granted access to iCARE Research Materials must adhere to the requirements of the RMDA. Failure to comply with the RMDA could result in its termination and to legal action.
  • The iCARE Study RMDA can be accessed here: https://osf.io/nswcm/

Next, please refer to the “Data Transfer” section below in Step 4.

Data Analysis Requests

Comprehensive reports and data analyses are conducted by the MBMC statistical team, and can be offered both to iCARE collaborators and external investigators. However, priority will be given to the current collaborators of the study. Our team encourages global collaboration and invites you to become a collaborator of the iCARE study by contacting us directly: covid19study@mbmc-cmcm.ca.

Step 3A: Ethical approval

Authors are not required to provide evidence of local HREC review and/or approval. Since the proposed analyses will be conducted by the MBMC team, HREC approval obtained for the iCARE study by the Research Ethics Committee of the CIUSSS-NIM (Centre intégré universitaire de santé et de services sociaux du Nord-de-l’Île-de-Montréal; approval # 2020-2099 / 03-25-2020) applies in this context.

Step 3B: Research Materials Distribution Agreement (RMDA)

An RMDA is not required for data analysis requests, since direct sharing of the iCARE study data to the Recipient organization and the Local Lead investigator does not take place.

Next, please refer to the “Data Analyses Transfer” section below in Step 4.

Data Transfers

The iCARE study team will transfer the data to the Recipient organization.

Choose from “Data Transfers” tab above for details.

Data Analyses Transfers

The iCARE study team will conduct the analysis and transfer the results of the proposed analysis to the Recipient organization.

Choose from “Data Analyses Transfers” tab above for details.

 

STEP 4: Access and store the data

Data transfer:

  • The iCARE study team will transfer the data to the Recipient organization through Research Electronic Data Capture (REDCap) application, which is a web-based application offering a secure environment for data sharing.
  • Note that the iCARE standard data sharing procedure includes sharing datasets in R, SAS or csv formats, which are compatible with other statistical software applications. However, please note that we cannot guarantee the quality of the datasets in other software applications.

Storing iCARE Research Materials:

  • Investigators are obliged to store the iCARE Research Materials on a server with security controls adequate to protect sensitive or identifiable information, to ensure that only approved persons have access to the data, and to maintain appropriate control over the Research Material at all times.
  • Note that the iCARE Study does not have any identifiable data but that this level of security is still expected.

STEP 4: Access the iCARE research outputs

The iCARE study team will conduct the analysis after active engagement and direct discussion with the Local Lead Investigators in order to fine-tune the analyses and discuss any emerging discrepancies.

iCARE results transfer:

The iCARE study team will transfer the results of the proposed analysis to the Recipient organization in a secure manner via the Open Science Framework (OSF). OSF is an open access web application that will be used to enable and facilitate results sharing within the institutions. Visit the OSF help page for instructions on how to create a free account.

Additional Information

Deadlines for the data analysis

The iCARE team will occasionally prompt project contact persons to review their project information and submit updates to iSAP as needed. For data analysis requests, the iCARE study team will communicate directly with the Local Lead Investigators in order to fine-tune the analyses and discuss any emerging discrepancies.

Research integrity

The iCARE study team encourages the open-science movement, and highly recommends that all products created as part of the iCARE study be described in enough detail and made available in open access. The methodological paper, describing the iCARE study has been published: https://bmjopen.bmj.com/content/11/3/e046127

The iCARE study team is dedicated to maintaining high quality and transparency as well as increasing the value of all iCARE research processes.

Reporting standards

  • Open science: The iCARE study team encourages the open-science movement, and highly recommends that all products created as part of the iCARE study be described in enough detail and made available in open access. 
  • Pre-registration of the analysis: The iCARE study team has developed an analysis pre-registration template that is accessible here: https://osf.io/nswcm/. We highly encourage registering your research and analysis plan in advance. 
  • Reporting standards: We strongly recommend following the rules of good scientific practice and implementing established research reporting guidelines to increase the transparency of your iCARE study. Please refer to https://www.equator-network.org/ for more information.
  • Pre-print upload: reprints offer a good opportunity to share your research paper and receive feedback from the wider  community, without peer review. We invite you to submit your paper to a pre-print server prior to submitting it for a publication in a traditional scholarly journal. Possible on-line repositories are: OSF-preprints (https://osf.io/preprints/), PsyArXiv (https://psyarxiv.com/), SocArXiv (https://osf.io/preprints/socarxiv),  MedRixv (https://www.medrxiv.org/) etc.)

Research dissemination

The iCARE study team highly encourages dissemination and presentation of study results in different formats and for different audiences.

  • Knowledge translation products (e.g. infographics, one-page summaries, and dissemination through social media). Support for those materials can also be provided by our coordinating centre via covid19study@mbmc-cmcm.ca). You can also browse iCARE study infographics. We will provide our study collaborators with templates for creating their own infographic materials (available soon on OSF).
  • Policy briefs with concise summaries of the iCARE research and possible recommendations that can target government policymakers and have influence on both current and future policies
  • Scientific papers: publications in academic journals

Roles and responsibilities of the authors in research dissemination:

  • Authors are obliged to acknowledge the contribution of the iCARE study team, the iCARE funding bodies, and any required bodies that provided publicly available data as part of iCARE Research Materials in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on iCARE Research Materials.
  • Specific details of how and what should be reported are included in the iCARE collaborator acknowledgment document
  • Authors should submit a final version of the published manuscript and a web link of the publication to the iCARE study coordinator (covid19study@mbmc-cmcm.ca).
  • All manuscripts will be made available, consistent with Canadian copyright laws.

Notify the iCARE team if you receive funding for your iCARE-related research

We advise authors to inform us in case any funding becomes available as part of their individual iCARE-related research. This funding body can ultimately be added to the formal list of the iCARE study funders and acknowledged among the papers and presentations of the project (contact: covid19study@mbmc-cmcm.ca)

Questions?

Don’t hesitate to contact the iCARE study team at covid19study@mbmc-cmcm.ca.