Topic: Research Funding Applications
Please create a high-level masters level PowerPoint (15 slides) with speaker notes on each slide for the following 2 questions
1. Explain the processes involved in obtaining funding for clinical research.
2. How would you determine what elements to include in your budget and project plan? What strategies or tools might you use to create a budget?
**Please utilize the following YouTube videos as well as the Attached PDFs, which is requirement of the paper – feel free to utilize other resources if needed but these videos and pdf are part of the requirement**
https://www.youtube.com/watch?v=mFVzBRYhA2w&t=2s
https://www.youtube.com/watch?v=ov7h-WhIv9w
https://www.youtube.com/watch?v=JqwZDG2RJuc
https://www.youtube.com/watch?v=kL2uumPGDs8
https://www.youtube.com/watch?v=YiG_CWxGCVQ
https://www.youtube.com/watch?v=Qok-LNyfXFg
https://www.youtube.com/watch?v=EyPFi0YO32M
PowerPoint Presentation Grants, Contracts, and Budget Development Beth Loots, MPH MSW Contents Funding pathways Sponsored projects (contracts) Confidentiality agreement Protocol review and feasibility assessment (esp. financial feasibility) Contract and budget negotiation and CTA Investigator-initiated studies (grants) FOA and funding mechanisms Writing a grant application Developing a budget and budget justification Other agreements Funding pathways Grants and Contracts General funding pathways Sponsored Projects (contracts)Investigator-Initiated (grants) 1. Confidentiality Agreement (CDA) 1. Respond to FOA RFA or other funding mechanism 2. Review of protocol created by sponsor2. Feasibility assessment at the site before applying 3. Feasibility assessment3. Study application including budget & justification 4. Site Selection Visit (SSV)4. Scientific peer review of application 5. Contract and budget negotiation5. Notice of Award (NOGA) 6. Clinical Trials Agreement (CTA) with Sponsor6. Development of protocol by the site Sponsored projects (contracts) Funding pathway Funding pathway for Sponsored Projects Confidentiality Disclosure Agreement (CDA) Review of protocol created by sponsor Feasibility assessment Site Selection Visit (SSV) Contract and budget negotiation Clinical Trials Agreement (CTA) 1. Confidentiality Disclosure Agreement (CDA) A.k.a. Non-Disclosure Agreement (NDA) or Proprietary Information Agreement (PIA) Keep secret the materials or knowledge shared between Sponsor and site Mutual or one-way Must be signed by the institutional authority Now the PI can learn the details of the proposed study The Clinical Trials Guru (2016). The clinical trial process explained from study start to closeout. https://www.youtube.com/watch?v=JKIWRv1AmuQ 2. Review of protocol created by sponsor Is the research question important to you? Do you have a personal passion for the project? What are the strengths or weakness of the study design? Who will be eligible – do targets seem reasonable, and can you recruit? Will it be easy for patients to participate? https://www.iths.org/wp-content/uploads/ResearchStudyFeasibilityTool_V12017Feb6.pdf 3. Feasibility assessment Site does a feasibility survey for the Sponsor Therapeutic expertise Standard of care Previous research study experience Projected site enrollment numbers Should also do an internal feasibility assessment Don't overcommit Know what you would need in order to do the study (staffing, space, other resources) 4. Site Selection Visit (SSV) Sponsor reviews all potential sites and chooses those that are a good fit based on Feasibility Survey and other factors Sponsor uses this to confirm that the feasibility survey is accurate CRA asks for documentation from site GCP IATA CLIA Waiver Site tour Calibration and temperature logs for equipment, freezers 5. Contract and budget negotiation Sponsor sends draft budget Budget reviewed internally Negotiations on budget begin, may have several back and forth If/when budget agreed, then contract process is initiated Contract process includes items such as scope of work, PI role, required reports, monitoring, liability, indemnification, data access, and publication/product rights PM may play an advisory role in this as it moves through institution Budget review questions IRB fees Startup and closeout costs Schedule of events Milestones payments – what activities trigger payments Costs for screen fails Can budget be amended in future for protocol changes Budget review questions How many patients enrolling? Pharmacy and lab costs Shipping Participant reimbursement Advertisements and recruitment costs Includes time for staff, PI, and collaborators Institutional overhead Infrastructure – Staffing Usually the staffing needed for clinical trials has been underestimated Consider whether you need a research nurse or other licensed staff on the team for medication management, AEs, coordinating care ...depends on nature of study ...org may have budget standards to guide this About 80% of your grant/funding should be to support people working on the study https://www.youtube.com/watch?v=Qok-LNyfXFg 16 Infrastructure – Organization Depending on the setting you may have more or less support from a central entity...results in study team having to do more or less of this other work Important to know what support you will and won't expect to receive Often the organization has standard procedures in place that you will need to do in order to access supports and services, so you need to learn what those are 17 Common mistakes Overestimate number of participants can enroll Budget too much or too little for study staff needed to run the trial Not enough coverage for startup time and effort or for ongoing regulatory work Payment for invoices from outside entities such as professional fees for reading, hospital services Inadequate funding for training, storage, travel, shipping Unclear payment terms and processes "5 common clinical trial budgeting mistakes to avoid" (6:00). GuideStar Research. January 21, 2014. https://www.youtube.com/watch?v=YiG_CWxGCVQ Internal budget preparation Per patient charges based on schedule of assessments Standard of Care versus research charges Costs for research-only charges (billing department) Personnel costs Based on number of patients Include daily or weekly monitoring of patients, medical record review, ECRF completion IRB and regulatory Training and study procedures Indirects Usually higher for industry than for NIH funded studies Participant incentives and reimbursements Supplies and equipment Institutional processes Timely In clinical research, we are often operating in a competitive environment. Study sponsors can choose to go elsewhere. Must be attentive to their requests. Rapid work turnover is often expected. Overview – institutional processes Most institutions have these, and it’s your job to learn what they are and how to navigate them. Which offices require what? What committees do you need to involve? At this stage we are primarily concerned with the budgets and contracts office, but it’s not too early to start thinking about the other stakeholders that will need to be involved. 18 6. Clinical Trials Agreement (CTA) The legal document binding the Sponsor and the site for the planned work Contract Agreement should define and allocate responsibilities to investigator Sponsor should indemnify the investigator or provide insurance against any claims related to the trial (except for malpractice or negligence) Costs of treatment for participants in the event of injury https://www.youtube.com/watch?v=CTdH2OWJ-o8 Investigator-Initiated Studies (Grants) FOA (Funding opportunity announcement) Funding pathway for Investigator-Initiated New application for funding: respond to FOA, RFA, or other funding opportunity NIH and clinical trials FOAs, funding mechanisms Feasibility assessment at the site before applying Study application including budget & justification Writing a grant application Developing a budget and budget justification Scientific peer review of application Writing a grant for peer review Notice of Award (NOGA) Development of protocol by the site Grants process for a new application All federal agencies use FOA to announce publicly available funding Identify FOA and determine eligibility and application requirements Register on NIH prior to submission (organization and PI) Prepare to use ASSIST (NIH web-based application portal) Write application Develop budget and justification Submit NIH and Clinical Trials A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. https://grants.nih.gov/policy/clinical-trials/definition.htm FOA Key Elements Program purpose, goals, measurement CFDA number for the grant program Type of award Due date for application FOA number Reporting requirements Full text of the announcement Application instructions https://grantsgovprod.wordpress.com/2020/08/18/what-is-a-funding-opportunity-announcement/ FOA announcements @ Grants.gov https://www.grants.gov/web/grants/search-grants.html and Federal agency websites https://www.grants.gov/web/grants/search-grants.html NIH Funding Mechanisms Research Grants (R series) Career Development Awards (K series)- individual awards to grow new investigators Research Training and Fellowships (T & F series) Program Project/Center Grants (P series) Resource Grants Trans-NIH Programs Inactive Programs https://grants.nih.gov/grants/funding/funding_program.htm Research Grants (R Series) Largest category is R01 The traditional grant mechanism Awarded to orgs on behalf of a PI in a variety of settings (universities, medical centers, research orgs, government orgs, for profits Investigator can use to pursue research of interest/competence area Provide funding for salaries, equipment, supplies, travel, and other costs; plus indirects https://grants.nih.gov/grants/funding/funding_program.htm U01 Research Project Cooperative Agreement Used when there is significant programmatic involvement (support) between funder and sites One of several types of cooperative agreements https://grants.nih.gov/grants/funding/funding_program.htm Determine your eligibility for FOA What type of organization are you in? Nonprofit, research lab, etc. Search by keyword then narrow based on categories on left side Read FOA announcement in detail "related documents" tab Reach out to agency contact for questions Note that often investigators are made aware of upcoming FOA through their current studies, colleagues, or institutional funding watch notices https://grantsgovprod.wordpress.com/2021/03/17/how-to-determine-eligibility-for-federal-funding-opportunities/ Key elements in NIH grant application Cover letter Research plan (scientific rationale and planned activities) Budget and budget justification; consortium and contractual agreements Letters of support Collaborators and consultants Facilities, resources, and institutional support Biosketches Inclusion of Women, Minorities and Children in Research Protection of Human Subjects Resource Sharing Plan https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/write-your-application.htm NIH submission advice 1. Have realistic project goals. Make sure you can accomplish the work you say you will do with the planned budget and within the project period. Justify the involvement of people in project. 2. You application should be well organized. The thought process of the application should be easy for the reader to follow. 3. Write clearly and concisely. Simple and clear sentences, straightforward topic sentence for each paragraph, avoid jargon, spell out acronyms. 4. Sell your idea. Justify why the work is important and why you should be the one to do it. 5. Get help with proofreading and editing. Formatting, length, spacing requirements all need to be met. Don't let these kinds of errors trash your proposal. 6. Collaborate with others for content. Ask colleagues to comment on your aims and review your proposal with enough time to do so. https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/write-your-application.htm Writing a grant application for peer review Express the overall impact the study will have on a patient population or research field Significance – Does it address an important problem? Is it scientifically sound? How will it drive the field forward? Investigator – Do they have relevant expertise and/or experience in this research field? What leadership will they provide? Innovation – Does the application shift the paradigm? Is it novel? How will it move the field? Approach – Are the planned activities sound and appropriate to meet the scientific aims? Does the study adequately protect the rights of human subjects and the inclusion of diverse subjects? Environment – Does the setting make it likely that the project will be successful? Are their scientific collaborators, eligible study population, and adequate resources for research? https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/write-your-application.htm Developing a budget – general tips Based on the research plan, planned activities, number of enrolled participants Often you have a cost cap as a starting point, need to fit all in within it Start with investigators and staff, FTE projections for planned roles/activities Think about costs per patient enrolled – incentives, medical supplies, PCRC or other patient charges Travel costs – for participants, staff; local and/or national Reimbursement costs if any Equipment – anything needed for study that you don't already have (remember costs to upkeep, calibrate, store, etc.) Supplies – office supplies, storage space Developing a budget – general tips Useful to use an Excel spreadsheet (often org. will have standard template) Be sure to include yearly increases for staff as well as % for benefits Think about any places internal or external that will charge study for services or activities Know the indirects percentage (may be 50% or higher for clinical research) Ask for no more and no less than you need PI, PM, and budget person should collaborate on budget documents because each has different info and perspective to lend Direct