OCS Research Project Proposal Checklist The OCS Research Project Proposal must be a maximum of 6 pages (excluding attachments, references, tables and figures) and include the following components: Contact Information Name, title, contact information and affiliation of Principal Investigator and Co-Investigators Project Title Plain Language Statement (maximum 500 words) Summarize the proposed project in language that will be intelligible to a lay reader. Research Objectives and Rationale List the proposed research objectives/questions and hypothesis(es), if applicable. Justify the proposed research in terms of the scientific literature and relevance. Demonstrate how the proposed research is commensurate with the Mission and Values of the OHTN and the Principle Aims of the OCS . Research Design Specify inclusion and exclusion criteria and provide justification where applicable. Provide an estimate of the sample size (based on results of an OCS Data Scan, consultation with OCS Biostatistical Staff or other means as appropriate). Outline the analysis plan. Data Requested List the specific OCS data elements requested. Justify requests for any High Risk Data Elements (listed in OCS Data Release Policy). Describe methods for the collection of additional primary data, if applicable. Describe planned data linkages, if applicable. Potential Benefits and Harms Indicate any potential benefits and harms of the proposed research to the research participants and/or communities and the approach to mitigate potential harms. Ethical Review Requirements Describe the requirements and/or plan for ethical review of the proposed research. Indicate if the research proposal qualifies for Implicit University of Toronto REB approval. Data Management and Security List the names of all Researchers who will have access to the OCS research data set (must also be listed as coinvestigators). All Researchers must adhere to the OCS Data Security Requirements for Researchers. If this is not possible, describe and justify an alternative Data Management and Security Plan. Plan for Community Engagement and Knowledge Translation and Exchange Community involvement in OCS research projects is mandatory, and is recommended in all stages of research. Provide a plan for community engagement and results dissemination to scientific, community based, and stakeholder audiences. Student Research Project Information (if applicable) Student PIs are asked to confirm that their thesis advisor(s) / committee has reviewed and approved the submitted proposal. Student PIs are also asked to indicate whether their proposal has or will be presented for defence at an academic institution as part of their thesis requirements Attachments Cover Letter and Suggested Reviewers Cover letters should provide a list of all documents included in the submission. For Researchers requesting a scientific review of their Proposal, include the names and email addresses of a minimum of four suggested reviewers. External Scientific Reviews (if applicable) For Researchers who have undergone external scientific review as part of an application for funding, attach copies of the scientific reviews. Curriculum Vitae Include copies of CVs for the Principal and any Co-Principal Investigators (unless currently on file at the OHTN). Researcher’s Agreement Include copies of signed OCS Researcher’s Agreements for each Investigator or indicate when these will follow in the Cover Letter. They are required prior to OCS data release. Research Ethics Board Approval Letter If applicable, include a copy of the REB letter of approval for the Research Proposal or indicate when these will follow in the Cover Letter. They are required prior to OCS data release. Letter from Academic Supervisor (if applicable) Student PIs are asked to include a letter of support from their academic supervisor.