Heart, Lung, and Blood Co-morbiditieS Implementation Models in People Living with HIV (HLB-SIMPLe) Research Coordinating Center (U24 - Clinical Trial Not Allowed)

Q1: Am I required to submit a letter of intent?

A1: Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

Q2: When are applications due?

A2: The receipt date for this FOA is Tuesday, December 10, 2019. Applications must be submitted by 5:00 PM local time of applicant organization.

Q3: Does the application have a page limit?

A3: Yes. All page limitations are described in the SF424 Application Guide and the Table of Page Limits must be followed.

Q4: How should I submit my application?

A4: All applications must be submitted electronically. Applicants should follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise [in this FOA (Section IV. Application and Submission Information) or in a Notice from NIH Guide for Grants and Contracts.

Q5: How many HLB SIMPLe Research Coordinating Center (RCC) (U24) awards does NHLBI intend to fund?

A5: The NHLBI intends to fund one HLB SIMPLe RCC (U24), contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Q6: Are foreign institutions eligible to apply?

A6: No. Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply, although non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply, and foreign components, as defined in the NIH Grants Policy Statement, are allowed. As such, partnerships between domestic and foreign institutions are allowed and encouraged, but the domestic institution should be the applicant organization.

Q7: Per the SF424, "if you are requesting a budget with $500,000 or more in direct costs for any budget period, contact the awarding component to determine whether you must obtain prior approval before submitting the application." Do I need prior approval?

A7: No. Applicants to this RFA do not need prior approval as budget thresholds are spelled out in the RFA.

Q8: The HLB SIMPLe initiative has both a UG3/UH3 FOA (RFA-HL-20-025) and a U24 Research Coordinating Center FOA (RFA-HL-20-026)—can my institution apply to both?

A8: Please note that the HLB SIMPLe RCC (U24) FOA requests applications from domestic institutions (although non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply and foreign components, as defined in the NIH Grants Policy Statement, are allowed) while the HLB SIMPLe (UG3/UH3) FOA requests applications from foreign institutions as the applicant organization.

Q9: Can I be a named researcher on more than one application?

A9: Investigators may be named as personnel on more than one application

Q10: Are applications with multiple PIs permitted?

A10: Yes. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Q11: Collaboration between domestic and foreign institutions is allowed. Who must be the lead?

A11: For this FOA, collaborative applications must be led by a U.S. organization. Multi-PI (MPI) leadership among researchers in LMICs and U.S. institutions (as well as other high income country (HIC) partners) is allowed and encouraged.

Q12: Can I apply to both NHLBI and FIC for this FOA?

A12: Applicants may not apply to more than one NIH Institute or Center with the same project. We strongly recommend that prospective applicants contact the Scientific Contacts for guidance before submitting an application.

Q13: Can an organization submit more than one application?

A13: Yes. Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

Q14: Are letters of support required?

A14: Applicants are encouraged to include letters of resource support specific to the RCC, including support provided by the applicant institution and partner organizations that will enhance the potential for success. Examples of such support would include, but are not limited to, institution-funded staff time and effort, donated equipment and space, providing free and open access to tools, web space, databases, workflow processes, logistical resources or other resource investments. Specific and detailed descriptions of these contributions, as well as the assurances that partner organizations are committed to providing these resources to the RCC should be included. Also include individual letters of commitment to the partnership specific to the RCC by all other partners and/or consultants.

Q15: Where will my application be reviewed?

A15: Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NHLBI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

Q16: While the HLB SIMPLe RCC (U24) is designated as “Clinical Trial Not Allowed,” HLB SIMPLe (UG3/UH3) is designated as “Clinical Trial Optional;” considering that the HLB SIMPLe RCC will oversee many of the collaborative elements of the HLB SIMPLe global research network, what are the expectations of the RCC for clinical trial oversight?

A16: The HLB SIMPLe RCC (U24) will provide oversight, coordination, and support (including robust biostatistical support) to HLB SIMPLe awardees and other NHLBI global efforts, as appropriate, through administration of a global Data and Safety Monitoring Board (DSMB). The RCC will coordinate with NHLBI for the selection of DSMB board members; protocol and consent review; oversight of regulatory reviews and approval processes; monitoring adherence to good clinical practice standards, study protocols, and adverse events reporting; and monitoring enrollment and data integrity. The RCC will conduct clinical site and study monitoring for HLB SIMPLe awardees to ensure compliance with U.S. and country-specific regulatory requirements and guidelines.

Q17: Where do the research sites’ responsibilities end and the RCC’s begin in terms of data collection?

A17: The RCC will play a central role in organization, management, and data analysis, which will require collaboration with the UG3/UH3 awardees. Each UG3/UH3 awardee site will be responsible for collecting and storing local data. Key actions from the RCC include, but are not limited to, promoting standardized data collection, monitoring study data for quality and accuracy, and developing common data elements.

Q18: What is NIH’s role in the activities of the RCC efforts I’m proposing?

A18: The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined in this FOA under Section VI. Award Administration Information.

Q19: How often will the HLB SIMPLe global research network (HLB SIMPLe (UG3/UH3) awardees and the HLB SIMPLe RCC (U24) awardee) meet over the course of the proposed 5 year period of performance?

A19: It is anticipated that representatives from the HLB SIMPLe UG3/UH3 and U24 awardees will meet at least one time per year. In Year 1, a start-up meeting will take place in the Washington, DC area, and representatives from each funded UG3/UH3 and U24 program are expected to attend. In the Year 2 and beyond (until the end of the award), HLB SIMPLE global research network meetings will continue to take place annually but in an HLB SIMPLe activity site; the activity site will be expected to co-host an annual meeting with the HLB SIMPLe RCC, which will provide primary administration.

Q20: For budgeting purposes, should applicants anticipate multiple visits to each of the proposed 7 sites?

A20: It is anticipated that the HLB SIMPLe RCC will coordinate activities across all of the HLB SIMPLe global projects, including, but not limited to, coordinating and managing in-person and virtual network steering committee meetings and working groups. Applicants should present a detailed budget for the HLB SIMPLe RCC for activities related to coordinating the HLB SIMPLe network administration, hosting annual meetings in HLB SIMPLe research sites around the world during the 5 year period of the award, and regular research site supervision/monitoring for all UG3/UH3 research site clinical trials. As noted in Section IV. Application and Submission Information of this FOA, all instructions in the SF424 (R&R) Application Guide must be followed.

Q21: If we submit an MPI application, do we budget for these additional people to attend the annual meetings?

A21: Yes. Travel costs for at least three individuals from the RCC (including PD(s)/PI(s) and two additional representatives) to attend the annual alliance meeting in an HLB SIMPLe awardee country must be reflected in the budget.

For any questions related to the HLB SIMPLe RCC(U24) FOA, please send your inquiries to:
Brad Newsome, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8170
Email: brad.newsome@nih.gov