Florida Health Equity Research Institute (HERI)

Florida Health Equity Research Institute (HERI) Multi-Disciplinary, Multi-Institutional and Community-Based (MMC) Grants Program for Health Equity Research & Research Infrastructure Fiscal Year 2015-2016 Due Date for Proposals: 11:59 p.m. EST, February 20, 2015 Florida Health Equity Research (HERI) Program Page 1

TABLE OF CONTENTS Florida Health Equity Research Institute (HERI) Multi-Disciplinary, Multi-Institutional and Community-based (MMC) Grants Program for Health Equity & Research Infrastructure (HERI) Call for Grant Applications: FY 2015-2016 1. GRANT SUBMISSION & RECEIPT PROCESS Page 3 2. INTRODUCTION Page 3 3. IMPORTANT DEADLINES Page 5 4. APPLICATION REQUIREMENTS Page 5 5. ELIGIBLE APPLICANTS Page 6 6. ALLOWED AND DISALLOWED COSTS Page 7 7. GENERAL REGISTRATION INSTRUCTIONS AND LETTERS OF INTENT Page 8 8. GENERAL INSTRUCTIONS FOR APPLICATION SUBMISSION Page 8 9. APPLICATION REVIEW INFORMATION Page 10 10. NOTIFICATION OF FUNDING DECISION Page 10 11. GRANTEE REQUIREMENTS Page 10 12. FREQUENTLY ASKED QUESTIONS Page 10 Florida Health Equity Research (HERI) Program Page 2

1. GRANT SUBMISSION & RECEIPT PROCESS Solix, Inc. has been contracted by the Florida Health Equity Research Institute (HERI) to manage the grant activities for the Multi-Disciplinary, Multi-Institutional and Community-based (MMC) Grants Program for Health Equity Research & Research Infrastructure. Solix, Inc. will provide both pre- and post-award support. See Section 3 below for important due dates. Reviewers are investigators outside Florida. Florida investigators, including HERI leaders or members, will NOT be included as reviewers. Further, application information remains blinded until a funding decision is made. All questions about the HERI MMCG Grants Program should be directed to: K. Cameron Schiller, MS Research Programs Coordinator HERI Research Core University of Florida Gainesville, FL 32610 Phone: 352-273-7310 Email: HERIResearchCore@gmail.com All questions about the online application process, technical support and related issues (e.g. username and password problems) should be directed to: Hope Davis, Grant Manager Solix Grant Management Solutions Phone: 913-322-9449 Email: HERIMMC@solixinc.com 2. INTRODUCTION: ABOUT HERI 2.1. The Florida Health Equity Research Institute (HERI) Florida is one of the most diverse states in the U.S. With this diversity, there are populations that have a high incidence of disease burden, including those from ethnic/racial, rural, socioeconomically disadvantaged and other medically underserved backgrounds. To better understand health disparities and develop approaches to promote health equity in the state, the Florida Department of Health, including the Biomedical Research Advisory Council (BRAC) and the Office of Minority Health, convened a group of over 30 scholars and community stakeholders to develop the Health Disparities Research (HDR) Agenda for Florida (see the final agenda on http://cancer.ufl.edu/files/2012/08/fl_cured.pdf). The Florida Health Equity Research Institute (HERI) was created to implement the recommendations from the HDR Agenda. The need for HERI arises from the lack of large multi-institutional, multi-disciplinary efforts to improve health in these populations. The overall purpose of the Florida Health Equity Research Institute is to implement the HDR Agenda for Florida through proactive collaborations among academic institutions, health care providers, government organizations, community-based organizations, and funding organizations. Through this effort, HERI will facilitate the design of broad-based studies to address health disparities in medically underserved populations and to evaluate the outcomes consistent with the following goals: Increase the development of health innovations that will improve the health of medically underserved populations. Increase the translation, adaptation and implementation of evidenced-based health innovations in underserved populations. Increase the pool of individuals from underrepresented groups for the health professions and biomedical research. Florida Health Equity Research (HERI) Program Page 3

Increase external funding that will improve economic development in the state. Increased recognition of Florida as a leader in improved health outcomes for medically underserved populations. 2.2. HERI Research Goals 1. Advance the understanding of the relationships between multi-level health determinants (such as genomics, environment, behavior, cultural norms/beliefs/values) and health disparities using multiple levels of analysis across the life span. 2. Develop cost-effective and sustainable health intervention programs that are culturally competent and linguistically sensitive to the ethnic/racial emerging majority, medically underserved, rural, and socioeconomically disadvantaged populations. 3. Develop new or improved approaches for disseminating evidence-based health promotion and disease prevention information to ethnic/racial emerging majority, medically-underserved, rural, and socioeconomically disadvantaged populations. 4. Improve quality of life of ethnic/racial emerging majority, medically underserved, rural and socioeconomically disadvantaged populations by implementing best practices to prevent, manage or reduce the recurrence of disease. 2.3. HERI Research Capacity Goals 1. Develop infrastructure for research on health disparities, including, among others, collaborative biobanks, registries, and health informatic systems (i.e., electronic medical records systems and patient health portals). 2. Improve quality, accuracy and specificity of data in registries and health informatic systems (e.g., accuracy of ethnic/racial identifiers, inclusion of ancestry/country of origin and years in the United States as mandatory data). 3. Promote the involvement of ethnic/racial, rural and medically underserved populations in research, seeking necessary resources to recruit and retain their participation in multiple types of health research. 4. Engage, develop and sustain equitable academic-community partnerships that facilitate health disparities research. 5. Engage, develop and sustain partnerships between minority serving institutions and health care centers (e.g., cancer centers) to facilitate health disparities research, education, training and community outreach. 6. Facilitate statewide translational research for community stakeholders, clinicians, population scientists and basic scientists in order to provide an avenue for scientific exchange that will facilitate transfer of knowledge from trench (community) to bench to bedside and back. 7. Increase access to new genomic and other emergent technologies available in the state to improve diagnostics and treatments for all cancers as well as other diseases. 8. Provide a collaborative mechanism to educate current and future researchers to effectively engage in culturally and linguistically competent/sensitive research. 9. Build capacity to disseminate evidenced-based best practices from health disparities research. 10. Identify, train and mentor the next generation of health disparities researchers. To achieve the goals outlined above, the HERI Multi-Disciplinary, Multi-Institutional and Communitybased (MMC) grants program for Health Equity Research & Research Infrastructure is soliciting grant applications from eligible investigators in Florida. Florida Health Equity Research (HERI) Program Page 4

3. IMPORTANT DEADLINES Activity Dates Important Information Opening Date for Application and Registration February 2, 2015 Website: https://lytmos.com/heri/ Question & Answer Session for Grant Mechanisms Application Registration Due Date Letter of Intent Due Date Online Applications Due February 10, 2015, 11:30am- 1:00pm EST February 12, 2015, 11:59pm EST February 13, 2015, 5:00pm EST February 20, 2015, 11:59pm EST Dial-in Instructions: 712-432-0360 Access Code: 909059# Submit online at Website: https://lytmos.com/heri/ NOTE: Technical support for online registration process and related issues (e.g. username and password problems) is available up till 5:00pm EST. Technical support will NOT be available after 5:00pm EST. Hardcopy mailed to: Solix Grant Management Solutions Corporate Woods 9 9200 Indian Creek Parkway, Suite 410 Overland Park, KS 66210 913-322-9449 Submit online at Website: https://lytmos.com/heri/. No paper copies will be accepted. NOTE: Technical support for online application process and related issues (e.g. username and password problems) is available up till 5:00pm EST. Technical support will NOT be available after 5:00pm EST. Awards Announced April 10, 2015 Award letters will be emailed to the applicant Principal Investigator. Starting Date for Award May 1, 2015 Progress Status Updates June 15, 2015, November 1, 2015, February 1, 2016 Ending Date for Award April, 30 2016 4. APPLICATION REQUIREMENTS 4.1. Goal and Deliverables The primary goal of the MMC for Health Equity Research & Research Infrastructure is to facilitate Florida investigators in securing federal or other funding for competitive, multi-disciplinary, multi-institutional and community-based projects reflecting HERI research goals as outlined in the Health Disparities Research Agenda for Florida (http://cancer.ufl.edu/files/2012/08/fl_cured.pdf). The completion of the projects funded by HERI is expected to lead to a statewide collaborative health disparities research program that includes the following deliverables: submission and award of external grants; establishment of research infrastructure; publication of articles in high impact refereed journals; and creation of other support needed to facilitate health disparities research in Florida. Florida Health Equity Research (HERI) Program Page 5

4.2. HERI Research Grant Mechanism Information The purpose of this HERI Funding Opportunity Announcement (FOA) is to invite applications for investigatorinitiated research or research infrastructure grant proposals addressing health disparities in Florida. The HERI FOA encourages applications that are novel, collaborative, and have high potential to lead to federal funding within one year. HERI FOA will employ multiple grant mechanisms to fund diverse projects, including: a. Exploratory Research Grant to provide support for the early and conceptual stages of project development, including: (a) exploratory, novel studies that break new ground or extend previous discoveries toward new directions or applications; and (b) high risk high reward studies that may lead to a breakthrough in a particular area, or result in novel techniques, agents, methodologies, models or applications that will impact health disparity research. b. Research Grant to provide support for advanced stage projects that reflect substantial conceptual development and a well-developed research strategy. Grants submitted should result in novel techniques, agents, methodologies, models or applications that will impact health disparity research. c. Research Infrastructure Grant - to support infrastructure development for research that will: (1) enhance the quality and quantity of health disparity research conducted in Florida; and (2) develop new research capabilities to advance health disparity research through innovative approaches. A central goal of this program is to facilitate interdisciplinary collaboration and innovation in health disparity research while providing essential and cost-effective core services in support of the development, conduct, and translation of health disparity research in multiple institutions. The emphasis of the HERI FOA is on collaboration, uniqueness, and potential to impact health disparity research. The HERI FOA will provide funding support for high impact multi-disciplinary, multi-institutional and, community-based research projects competitively selected through a scientific peer-review process. All applications must clearly demonstrate how the proposed project addresses health disparity. Proposals that do not or cannot demonstrate impact on eliminating health disparities will not be funded. 4.3. Award Amount and Duration Given that the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award may vary. In addition, the total amount awarded and the number of awards will depend upon the numbers, quality, duration, and costs of the applications received. The maximum award will be $50,000 direct costs. Indirect costs are not an allowable for HERI award. The awards are for a maximum period of 12 months. Progress reports are due on June 15, 2015, November 1, 2015 and February 1, 2016. The final project report is due on April 30, 2016. 5. ELIGIBLE APPLICANTS 5.1. Eligible Institutions You may submit (an) application(s) if your organization is in Florida and has any of the following characteristics: Florida organizations or institutions. Non-profit organizations Public or private institutions, such as universities, colleges, hospitals, and laboratories Units of State government Units of local government Eligible agencies of the Federal government Domestic Institutions Florida Health Equity Research (HERI) Program Page 6

Faith-based or community-based organizations Indian/Native American Tribal Government (Federally Recognized) Indian/Native American Tribal Government (Other than Federally Recognized) Indian/Native American Tribally Designated Organizations Foreign institutions/organizations are not eligible to apply. 5.2. Eligible Individuals Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are encouraged to apply. Investigators from at least two (2) different institutions must serve as Principal Investigators (PIs). A community representative (for example, a community leader, a health advocate, a religious leader, among others) should serve as Co-Investigator (Co-I). The PIs should be scientists or science administrators who can provide effective administrative and scientific leadership, working collaboratively team as a team with the Co-I. For purposes of registering, submitting an application, and notification of results, we recommend identifying the Primary Principal Investigator. 6. ALLOWED AND DISALLOWED COSTS Only direct cost expenses directly related to the project are allowed and include: Salaries Student stipends Fringe benefits Supplies Equipment Lab Services Domestic travel Consultant costs Patient-care costs Animal-care costs Local or other IRB or IACUC fees (if required) Department of Health IRB fees (if required) Consortium or contractual costs Indirect costs (also referred to as IDC, F&A, or administrative costs) are not allowed. Other disallowed costs are: Construction, renovation, or remodeling International travel (including Canada) Vehicles Entertainment Employment subsidies Dues/Membership fees Meals/Food (other than as part of travel costs) Malpractice insurance premiums Tuition Florida Health Equity Research (HERI) Program Page 7

7. GENERAL REGISTRATION INSTRUCTIONS AND LETTERS OF INTENT Applicants must register to access the online application. Register for an online application at https://lytmos.com/heri/ and complete a brief project profile. Information entered into the registration fields will carry forward to the online application fields. Registration will be acknowledged with an email message containing login instructions a username and password. Everyone must register by the due date indicated in Section 3. Important Deadlines above to obtain access to the online application process. A login is intended to be used by one person at a time. We recommend the Primary Principal Investigator to be the contact for used with the application system. The Letter of Intent must be received by the due date indicated in Section 3. Important Deadlines above. The Letter of Intent must include a summary of how the proposed health disparities research/project satisfies the multi-disciplinary, multi-institutional, and community based collaboration addressing Florida s Health Disparities. Letter of intent should specifically identify principal investigators and community partnerships. Letters of institutional/organization support should be included in the application for all parties involved 8. GENERAL INSTRUCTIONS FOR APPLICATION SUBMISSION A complete Grant application package must contain all the required items listed in the Table below. Use NIH format: 0.5 inch margins; Arial 11 font. The application must be a single file in PDF format. MAXIMUM PAGE LIMITS WHERE APPLICABLE ARE INDICATED BELOW Grant Application Components and Page Limits Section Category Page Limit Comment General Research Information: A General Project Information 1 Required. Identifies project title, grant mechanism, general project information, the applicant organization, the applicant, the PIs from at least two institutions and the community Co-I and their contact information. B Table of Contents 1 Required. C Scientific Abstract 2000 characters D E Specific Aims 1 Research Strategy Plan / Research Infrastructure Implementation Plan 6 Required. This is the scientific description of the project. Required. Aims should reflect research or research infrastructure goals in the Health Disparities Research (HDR) Agenda (http://cancer.ufl.edu/files/2012/08/fl_cured.pdf) Required. Sections must include Resources, Significance, Relevance to Health Disparities, Innovation, Approach, and Environment. In the Resources section, describe any special facilities used for working with biohazards or other potentially dangerous substances. Florida Health Equity Research (HERI) Program Page 8

F Human Subjects No Limit G Vertebrate Animals No Limit Required. You must provide sufficient information for reviewers to determine that the proposed research meets (1) the requirements of the DHHS regulations to protect human subjects from research risks (45 CFR part 46), and (2) the requirements of NIH policies on inclusion of women, minorities, and children. If no human subjects research is proposed in the application, indicate No Human subject research. If all of the proposed human subjects research meets the criteria for one or more of the exemptions from the requirements in the DHHS regulations (46.101(b)), then provide a justification for the exemption(s) containing sufficient information about the involvement of the human subjects to allow a determination by peer reviewers that claimed exemption(s) is/are appropriate. Required. If Vertebrate Animals are involved in the project, address each of the five points identified in the NIH SF424 Guidelines (http://grants.nih.gov/grants/funding/424/sf424_rr_gui de_general_adobe_verc.docx) on page 121 (I-115). H Literature Cited No Limit Required. I Research Milestones No Limit J Budget & Budget Justification No Limit (If applicable.) Provide an overview of the research schedule and a plan for the progress status update at 3-month intervals, final report and federal proposal submission. Required. The budget must explain the planned spending. K Key Personnel 1 Required. Identifies all key personnel. L Biographical Sketches 4 page limit per person Required for all key personnel. Use NIH Format. M Other Support* No Limit Required. All other active and pending awards for the PIs and community Co-I.* N Letters of Agreement and Support No Limit TOTAL MAXIMUM PAGE LIMIT: 50 printed pages MAXIMUM UPLOADED SINGLE FILE SIZE: 3 MB Required. Relevant support letters from institution, collaborators and community-based organizations. Must include letters of agreement from the two PIs and the community organization Co-I. * Applicants must ensure that their proposed project does not duplicate or significantly overlap, scientifically or financially, with other projects in which they or any key personnel are involved. Overlap, whether scientific or financial, or commitment of a project member s effort greater than 100% is prohibited. Florida Health Equity Research (HERI) Program Page 9

9. APPLICATION REVIEW INFORMATION The NIH review criteria will be employed. Reviewers will also provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria: Significance, Relevance to Health Disparity, Investigator(s), Innovation, Approach and Environment. Unscored additional review criteria will include: Protections for Human Subjects; Inclusion of Women, Minorities, and Children; Vertebrate Animals; and Biohazards 10. NOTIFICATION OF FUNDING DECISION The applicant organizations sponsored research office and the primary applicant (Principal Investigator) will receive written notification of the funding decisions via email by April 10, 2015. 11. GRANTEE REQUIREMENTS 11.1. Terms and Conditions After awards are made, each grantee must sign a contract, called the Terms and Conditions, agreeing to certain requirements of the award. The Terms and Conditions are non-negotiable and acceptance is required as part of the grant award process. The Program reserves the right to change or modify the Terms and Conditions as needed. The Terms and Conditions include the post-award schedule of deliverables. 11.2. Grantee Reporting Requirements If the applicant s proposal is funded, the Grantee must commit to and show proof of submitting a federal proposal directly related to the funded research or utilizing the research infrastructure by the end of the project. This proof of a federal grant submission along with the project final report will serve as the final deliverable for receipt of the final grant payment. If the applicant s proposal is funded, the Grantee must respond to Program requests for information for a period of five (5) years after the end of the grant period, including any no cost extensions. The requested information may include long-term outcomes based on the funded project, including the value of additional grant awards for health disparity-related research, a list of health disparity-related presentations, a list of health disparity-related publications in peer-reviewed journals, commercialization results and any invention disclosures, patent filings, patents received, et cetera. 11.3. Open Innovation and Sharing of Publication-Related Materials, Data, and Software Grantees funded through this Program are encouraged to use materials transfer agreements to make materials, data and databases, and software that result from this funding and which is integral to their research findings, freely and promptly available upon request for research use by other scientists. 12. FREQUENTLY ASKED QUESTIONS Below are the responses to the frequently asked questions about the HERI grant mechanism. Questions Is community Co-I a requirement for any project or only for outreach projects? Can a community representative serve as Principal Investigator? Answers Section 5.2 provides the details about eligible individuals. Yes, a community representative should serve as Co-Investigator (Co-I) regardless of the type of project. The primary intent of the HERI grant mechanism is to facilitate broad-based studies that will address health disparities in medically underserved populations. It is thus important that a member of the targeted population is represented on the research team. Section 5.2 provides the details about eligible individuals. The PIs should be scientists or science administrators who can provide effective Florida Health Equity Research (HERI) Program Page 10

Can two investigators from the same institution but different campuses serve as Co-PIs? For example, an investigator from University of Florida in Gainesville and University of Florida in Jacksonville. Will the fund be awarded to the applicant institution or the grant expenses will be paid by HERI? Is a Letter of Intent required? When will successful applicants be notified? What is the source of funding for these grants? Can the application be a "multiinstitutional" application with a University in another state? Will an infrastructure proposal focused on methodology be considered appropriate to this announcement? Is online registration open till the grant deadline? What are the exact expectations for this award mechanism? I have an R21 grant that received very good scores from NCI. Can I submit this grant as a bridge grant program? Is the Exploratory Research Grant similar to NIH exploratory grants and thus, does not require preliminary studies? If indirect cost is not allowed for HERI grant mechanism, do we show our institutions the FOA to approve the budget. Does the grant submission have to be completed by the PI or a grants specialist on behalf of the institution? How should we submit the approval from the institution? What are the review criteria for HERI? administrative and scientific leadership, working collaborative team with the Co-I. Section 5.2 provides the details about eligible individuals. Investigators from at least two (2) different institutions must serve as Principal Investigators (PIs). If the proposed campuses have the same Division of Sponsored Research and share the same VP for Research/President, this will be regarded as one institution. The fund will be awarded to applicant institutions via contract mechanism. Section 7 provides the details about LOI. The Letter of Intent must be mailed to Solix Grant Management Solutions and received by 5:00pm EST, February 13, 2015. This requires postage before due date. Section 3 provides the details about important deadlines. Successful applicants will be notified by email on April 10, 2015. Successful applicants will receive funding directly from HERI. The Florida Legislature has provided $400,000 to fund the start-up phase for HERI, with $200,000 allocated to the HERI grant mechanism. The primary goal of HERI is to increase federal funding for health disparity research in the State of Florida. Thus, all Co-PIs must be affiliated with a Florida institution. Section 2.3 of the FOA provides the details about HERI Research Capacity goals. Any infrastructure that will improve the research capacity for health disparities in Florida will be appropriate. Section 3 provides the details about important deadlines. Application registration is due by 11:59pm EST on February 12, 2015. Please note that you will not be able to register to apply after this date. Section 4.1 provides the details about HERI goal and deliverables. The completion of the projects funded by HERI is expected to lead to a statewide collaborative health disparities research program that includes the following deliverables: submission and award of external grants; establishment of research infrastructure; publication of articles in high impact refereed journals; and creation of other support needed to facilitate health disparities research in Florida. Section 4.2 provides the details about HERI grant mechanism. It does not include Bridge Grant. The mechanisms are Exploratory Research Grant, Research Grant, and Research Infrastructure grant. Yes, the Exploratory Research Grant does not require preliminary studies. Section 6 provides the details about allowed and disallowed costs. Indirect costs (also referred to as IDC, F&A, or administrative costs) are not allowed. Please refer your grants specialist to this section. The PI may choose to designate anyone in their institution to submit the grant e.g. a grants specialist. However, the applicants listed on the application must be the PIs. Institution s signature pages and support letters should be included in the grant application package and submitted as a single file in PDF format. Section 9 provides the details about the review criteria. The NIH review criteria will be employed. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria: Florida Health Equity Research (HERI) Program Page 11

Significance Relevance to Health Disparity Investigator(s) Innovation Approach Environment. Who are HERI reviewers? Since only investigators from state institutions are allowed to serve as PIs, does this mean that investigators will not be penalized if they don t have a history working together? If an institution has a community outreach component, can a faculty or staff within the institution serve as the community Co-I? Can someone from a communitybased organization serve as the community Co-I? Since the application will be led by one PI who will be submitting the application online, what do we do if the PI has an emergency and unable to finish the submission? Can an investigator submit more than one application as PI? Can more than one application be submitted from an institution? Is student tuition an allowable cost? I am one of the members of the Steering Committee. Can I submit an application for the HERI research grant? Unscored additional review criteria will include: Protections for Human Subjects Inclusion of Women, Minorities, and Children Vertebrate Animals Biohazards Solix, Inc. has been contracted by the HERI to manage the grant activities for the Multi-Disciplinary, Multi-Institutional and Community-based (MMC) Grants Program. Reviewers are investigators outside Florida. Florida investigators will NOT be included as reviewers. One of the goals of HERI is to foster statewide multi-disciplinary, multiinstitutional and community-based collaborations. Thus, new collaborations are appropriate and investigators will not be penalized if they do not have any history working together. Investigators are however strongly encouraged to include evidence of successful multi-institutional collaborations with others in the application. The deciding factor is the pace of employment of the individual. An individual whose primary place of employment is an academic institution cannot serve as the community Co-I. A community representative (for example, a community leader, a health advocate, a religious leader, among others) should serve as the community Co-I. Yes. An individual from community-based organization can serve as the community Co-I. It is advisable that the two collaborating PIs should know the username and password for the online application. This way, the Co-PI can still submit the application if there is an emergency with the lead PI. Note that both PIs cannot work on the online application at the same time. In a situation that the second PI becomes the lead PI and the deadline for online registration has passed, please contact Solix by phone (913-322-- 9449) or via email to HERIMMC@solixinc.com to change the lead PI and institution. Yes. An investigator is allowed to submit multiple applications as PI. Yes. The HERI grant mechanism is not an institutional grant so multiple applications can be submitted from an institution. No. Tuition is not an allowable cost. However, stipends or salaries can be paid to students. Yes. Steering Committee members and Community Advisory Board members are eligible to submit applications for the HERI research grant mechanism? However, HERI key personnel, such as core directors and staff, are not eligible to submit applications for the HERI research grant mechanism. Florida Health Equity Research (HERI) Program Page 12