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Notice of Intent to Publish a Notice of Funding Opportunity for Advancing Genomic Medicine Research (R01 Clinical Trial Optional)

List of required information for application:

1. Project Title: The title of the proposed project that clearly represents the research objective.

2. Project Summary/Abstract: A concise summary of the proposed research, including the objectives, methods, and expected outcomes.

3. Project Description: A detailed description of the research plan, including the background, significance, specific aims, methods, expected results, and potential impact on advancing genomic medicine research and addressing health disparities.

4. Justification for Clinical Trial Option (if applicable): If the proposed research involves clinical trials, a justification should be provided explaining why a clinical trial is necessary and how it will contribute to the advancement of genomic medicine research.

5. Research Team: Information about the principal investigator(s), co-investigator(s), and other key personnel involved in the project, including their qualifications and expertise in genomics and clinical care.

6. Collaboration Plan: A description of any meaningful collaborations that have been established or planned to enhance the proposed research, including partnerships with underrepresented populations and communities experiencing health disparities.

7. Budget and Budget Justification: A detailed budget outlining the estimated costs for personnel, equipment, supplies, travel, and other expenses required to conduct the research. A budget justification should provide a rationale for each budget item.

8. Timeline: A proposed timeline for the research activities, including milestones and deliverables.

9. Data Sharing Plan: A plan for sharing genomic data and research findings, including considerations for privacy, ethics, and potential barriers to data sharing in different populations or communities.

10. Evaluation Plan: A plan for evaluating the progress and impact of the research project, including methods for assessing the effectiveness of genomic information and technologies in clinical care and addressing health disparities.

11. Institutional Support: Documentation of institutional support and commitment to the proposed research, such as letters of support from relevant departments or organizations.

12. Human Subjects Research: If the proposed research involves human subjects, documentation of compliance with ethical guidelines and appropriate institutional review board approval.

13. References: A list of relevant references cited in the project description.

14. Biosketches: Biosketches or curriculum vitae of the principal investigator(s), co-investigator(s), and key personnel involved in the project.

15. Other Support: Information about any current or pending funding or support for the principal investigator(s) and key personnel that may overlap with the proposed research.

16. Letters of Collaboration: Letters of collaboration or support from external partners or organizations involved in the proposed research.

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