IDeA States Pediatric Clinical Trials Network Data Coordinating and Operations Center FOA

What is the IDeA States Program?

• The Institutional Development Awards (IDeA) Program, first authorized by Congress in 1993 and managed by the National Institute of General Medical Sciences, has been developed for the purpose of broadening the geographic distribution of National Institutes of Health (NIH) funding for biomedical and behavioral research by enhancing the competitiveness for research funding of institutions located in states in which the aggregate success rate for grant applications to the NIH has historically been low. The IDeA States are composed of the Commonwealth of Puerto Rico and the following 23 states:Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, Wyoming.
• The goal of this initiative is to further expand research capacity within IDeA-eligible states by establishing the IDeA States Pediatric Clinical Trials Network.

What is the purpose of the IDeA States Pediatric Clinical Trials Network?

• The IDeA States Pediatric Clinical Trials Network is being established to provide an opportunity for children in rural and medically underserved locations to participate in state-of-the-art clinical trials, to enhance pediatric clinical trial capacity at state and national levels, and to facilitate implementation of well-designed clinical trials in pediatric populations. The goal is to enhance current research infrastructure and capacity at institutions located within IDeA States such that NIH-supported and other peer-reviewed, state-of-the-art clinical trials can be readily extended to these locations and pediatric populations. In doing so, these children will have access to state-of-the-art clinical trials, and thus, provide an opportunity to recruit patients who are often underrepresented in such studies.

What is the relationship between the IDeA States Pediatric Clinical Trials Network and the Environmental influences on Child Health Outcomes (ECHO) Program?

• The ECHO Program is a series of funding opportunity announcements designed to investigate the longitudinal impact of pre-, peri-, and postnatal environmental exposures on pediatric health outcomes with high public health impact (RFA-OD-16-003, RFA-OD-16-004, RFA-OD-16-005, RFA-OD-16-006, PA-16-046).
• The IDeA States Pediatric Clinical Trials Network is being developed as a separate, but related program to the ECHO Program. The IDeA States Pediatric Clinical Trials Network is being created to study any disease or condition relevant to the pediatric population, but priority will be given to the four focus areas of the ECHO Program which include: 1) upper and lower airway disease; 2) obesity; 3) pre-, peri-, and postnatal outcomes; and 4) neurodevelopment. All prospective data collection will be encouraged to utilize the ECHO standardized research measures – the Core Elements. Structurally, there will be an IDeA States Pediatric Clinical Trials Network Subcommittee as part of the overall ECHO Program Steering Committee. Additionally, the PI of the Data Coordinating and Operations Center (DCOC) of the IDeA States Pediatric Clinical Trials Network will be a member of the overall ECHO Program Steering Committee.

Are only institutions located within the IDeA-eligible States or Puerto Rico permitted to apply for the Data Coordinating and Operations Center FOA for this Network?

• No. Applications for the DCOC can either be from an eligible institution or organization that is located in an IDeA state or territory, or one who will partner with an IDeA State institution or organization. Given the intent of the funding opportunity, partnership with an IDeA State institution or organization will be required. Applicants from non-IDeA States who do not partner with an IDeA State institution will be considered nonresponsive to this FOA.

Can two or more institutions join together to submit one application to serve as the DCOC?

• Yes, multiple sites may join together to submit a single application to perform as the DCOC. In fact, institutions outside the IDeA-eligible states may partner with an institution within the IDeA-eligible states to jointly serve as the Network DCOC.  PDs/PIs at different institutions may collaborate on the development of a multiple PD/PI application.  However, a single application must be submitted from one institution that identifies all PDs/PIs, including those from institutions other than the applicant institution. 
• If funded, the NIH will issue a single award to the applicant institution which will administer the award using the traditional subcontract approach to the other collaborating sites.

Can a multiple PI option be used for this application/award?

• Yes, multi-PI applications may be used for this award.  Refer to the NIH website (http://grants.nih.gov/grants/multi_pi/faq.htm) for more information on applying with multiple PIs.  Information is also included in the SF424 application instructions. When a multi-PD/PI option is used, all PDs/PIs have equal responsibility and accountability for leading and directing the project.  The structure and interaction of the PD/PI team will be left up to the PDs/PIs and the applicant institution(s), but needs to be described in the Multiple PD/PI Leadership Plan which is required for applications using multiple PDs/PIs.  All PDs/PIs must be qualified to serve as PD/PI and will share responsibility for the project.  Although the PDs/PIs may identify a leader of the project or a coordinator of the overall team, that is not a role that NIH formally acknowledges. For the purposes of the IDeA States Pediatric Clinical Trials Network administrative functioning, the contact PI will assume the role of DCOC Director, unless otherwise arranged by the DCOC PIs, as the DCOC is only allowed one vote on the Steering Committee. The contact PI of the DCOC will also serve on the overall ECHO Program Steering Committee.

If we submit with a multiple PI plan, does each of the PIs listed need to commit 6 person months (50%) effort?

• No. In a multi-PI proposal, there needs to be clear commitment to a minimum cumulative commitment of 6 person months (50%) effort from the PIs. All PDs/PIs must be qualified to serve as PD/PI and will share responsibility for the project. The structure and interaction of the PD/PI team will be at the discretion of the PDs/PIs and the applicant institution(s), but should be well delineated in the application. The time/effort commitment of each PD/PI should be clearly described. Although the PDs/PIs may identify a leader of the project or a coordinator of the overall team, that is not a role that the NIH formally acknowledges. For Network administrative functioning, the contact PI will assume the role of DCOC Director, unless otherwise arranged by the DCOC PIs, and will be responsible for the one vote on the IDeA States Pediatric Clinical Trials Network Steering Committee. That individual will also serve on the overall ECHO Program Steering Committee and Executive Committee. Funds to offset the costs of additional PIs may be included in the annual awardee budget, but additional funds beyond those allocated by the award limit (direct costs $2,500,000 per year) will not be provided.

What biosketches should be included in the application?

• Applicants should include biosketches of all key persons as defined in the SF424 Instructions.

What are the requirements of the DCOC?

• The DCOC will serve a host of essential roles for this Network. These various roles are delineated in detail in the FOA.

Is there a requirement for a concept proposal as part of this application?

• No. There is no requirement for a concept proposal in this application, and concept proposals should not be included in the application.

Who should provide letters of support?

• The application must include a statement from the applicant institution (senior institutional official) documenting a strong commitment to the planned program. However, other letters of support that can attest to the commitment of an applicant institution to the Network are encouraged. For multiple site applications, only the senior institutional official of the institution listed in the Notice of Award is required to provide a letter of support; however, letters of support from the senior institutional official at each of the other sites is strongly encouraged.

What is the U24 funding mechanism?

• The U24 is a resource-related funding mechanism that is used to support research projects contributing to improvement of the capability of resources to serve biomedical research. It is a cooperative agreement mechanism meaning that there will be substantial federal (NIH) scientific and/or programmatic involvement. Substantial federal programmatic staff involvement is intended to assist investigators during performance of the research activities, as defined in the terms and conditions of the award.

What is a Cooperative Agreement?

• A Cooperative Agreement is a financial assistance instrument under which substantial involvement is anticipated between the federal agency and the recipient during performance of the contemplated project or activity.  These agreements are similar to grants, but federal (NIH) staff have substantial scientific or programmatic involvement.

Are resubmission (A1) applications allowed?

• No, resubmission applications are not allowed for this FOA.  This is a one-time-only submission.

Is a letter of intent (LOI) required? What is the value of a letter of intent?

• No, a letter of intent is not required. 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 staff at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to estimate the potential review workload and to plan the review.

What information should be included in the letter of intent?

• Descriptive title of proposed activity
• Name(s), address(es), and telephone numbers of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity announcement (FOA)

To whom should the letter of intent be sent?

• Robert Tamburro, MD, MSc
  Email: robert.tamburro@nih.gov
  Telephone: 301-480-2619

What is the due date for the letter of intent?

• March 15, 2016

The FOA for the DCOC states that the NIH “intends to commit up to $ 45,000,000 in FY 2016 to fund one four year award. This will be a multiyear funded award beginning in FY2016.” What is the distribution of these funds?  Does the amount include indirect costs?  Does the amount span the entire 4 years of the award?

• The dollar amounts indicated in the FOA for the DCOC represent the funds committed in fiscal year 2016 to cover the entire four year budget for this FOA, including both direct and indirect (facilities and administrative) costs. Because this is a multiyear funded project, the entire award will be funded in FY 2016. The awardee will be required to submit annual budgets delineating the use of these funds in their annual progress report.
• The DCOC may request a budget for up to $2,500,000 per year in direct costs as a base award for the running of the DCOC. An additional $4,530,000 per year in direct costs may be requested for capitation fees for distribution to the Clinical Sites for patient recruitment, enrollment and study performance, and for necessary monitoring, Data Safety Monitoring Board (DSMB) visits, and Scientific Oversight Board activities.
• Key components to be included in the application base budget and permissible costs are described in the FOA under Section IV.2 Content and Form of Application Submission/R&R or Modular Budget.
• Capitation fees and study implementation costs will be provided by the DCOC for the Network.

What are capitation fees?

• Capitation fees in clinical trials are a method of payment for services in which an individual or institutional provider is paid a fixed, per capita amount for each patient enrolled in a study. Capitation fees may be provided to offset the costs of recruitment, enrollment and data collection for potential study patients.

What are the page limits for this application?

• All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the EXCEPTION that the Research Strategy section limit has been expanded to 30 pages. Given the vast and diverse responsibilities of the DCOC, the page limit has been expanded to afford applicants the best opportunity to describe their ability to serve in this essential role.
• The NIH has the authority to withdraw an application from review and funding consideration for egregious cases in which the Appendix or certain other sections of the application are used to circumvent page limits or to include inappropriate material in the application.

Can supplemental material be submitted after the application receipt date, but prior to the initial peer review?

• The NIH policy on post-submission application materials (those submitted after the initial grant application submission but prior to peer review) specifies that, for the majority of applications, the only post-submission materials that the NIH will accept are those resulting from unforeseen administrative issues, an option to be used when an unexpected event such as the departure of a participant, natural disaster, etc. has occurred, and not to correct oversights/errors discovered after submission of the application. 
• Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Will the applications be reviewed in a standing NIH study section?

• No. Applications submitted in response to this FOA will be reviewed in a Special Emphasis Panel convened by the Scientific Review Branch at the NICHD. Reviewers with specific expertise in pediatrics, clinical trials, statistics, management of a multicenter data coordinating center, and other areas particularly relevant to this FOA will be recruited.

When will the pre-application workshop be held?

• Informational pre-application workshops via webinar, addressing the scientific and administrative issues associated with this initiative, are planned to occur on January 14 and February 1.  The purpose of these webinar workshops is to (1) familiarize the potential applicant with established NIH guidelines and criteria for review, (2) discuss the areas of NIH programmatic emphasis, and (3) facilitate the submission of a well-organized application. Information about the webinar will be provided at www.nih.gov/ECHO and www.nichd.nih.gov.   

Can an institution serve as both the Data Coordinating and Operations Center (DCOC) and a Clinical Site in the IDeA States Pediatric Clinical Trials Network (ISPCTN)?

• Yes. The same institution can serve as both the DCOC and a Clinical Site in the ISPCTN. However, an individual cannot serve as the PD/PI for both the DCOC and a Clinical Site. In fact, any individual listed (in any role) on an ISPCTN Clinical Site application may not serve in any role for a DCOC application. Individuals affiliated with an institution applying to be an ISPCTN Clinical Site, but who are not listed in anyway on that application, may serve in any role for a DCOC application including serving as the PD/PI. In those instances, a plan addressing potential or perceived conflicts of interest should be described in the proposal.

For a non-IDeA state institution applying to serve as the DCOC, does their partnership with an IDeA state institution require a multi-PI application?

• Yes. Eligible individuals from non-IDeA states must partner in a multi-PD/PI application with a PD/PI from an IDeA eligible state to apply to serve as the DCOC.

Who can serve as the “IDeA state partner” PI for a non-IDeA state institution applying to serve as the DCOC?

• Any appropriately qualified individual in an IDeA eligible state who is not named as an investigator on an ISPCTN Clinical Site application (e.g. principal investigator, co-investigator, etc.) may serve as the PI in a multi-PI application with a non-IDeA state institution. Individuals listed (in any role) on an ISPCTN Clinical Site application may not serve in any role for a DCOC application. Individuals affiliated with an institution applying to be an ISPCTN Clinical Site, but who are not listed in anyway on that application, may serve in any role for a DCOC application including serving as a PI in the multi-PI application. In those instances, a plan addressing potential or perceived conflicts of interest should be described in the proposal. The multi-PI partnership between a non-IDeA state investigator and an IDeA state investigator is intended to be a robust one with all individuals contributing substantially.  

Does an applicant need to be located at an institution currently funded through the IDeA States Program in order to apply?

• No. An applicant does not need to be located at a currently supported IDeA state institution to apply for the ISPCTN. An applicant from any eligible institution in an IDeA state may apply.

What is the upper and lower age limit for the pediatric population for this award?

• Starting with applications/proposals submitted for due dates on or after January 25, 2016, the NIH has defined the age of a child for the purposes of inclusion policy as individuals under 18 years old (NOT-OD-16-010). Thus, as a general parameter, 18 years of age will serve as the Network upper age limit.  The lower age limit will be newborns given that pre-, peri-, and post-natal outcomes are a priority area of the ECHO Program.

What is the best way to address the planned enrollment report in the application since it is not known how many studies or what types of studies will be coming to the ISPCTN? 

• Given that there is no way to predict which studies the ISPCTN will conduct, it is impossible to complete a Planned Enrollment Table / Report. The NIH has recognized the potential for this situation in these types of applications and has offered guidance (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-129.html). Independent of the Planned Enrollment Table / Report, the applicant is encouraged to demonstrate evidence of their access to relevant pediatric patient populations and their ability to enroll these children into clinical trials.

Is there a specific data platform that the DCOC should plan to use?

• No. The funding opportunity announcement does not advocate for a specific data platform. Instead, given the role of the DCOC to interact with a number of different investigators, trials, networks as well as with the ECHO data platforms, it would seem important to demonstrate flexibility and a capacity to work with a variety of different platforms. However, the data platform is expected to be compliant with international data acquisition and transmission standards such as those endorsed by the FDA and developed by the Clinical Data Interchange Standards Consortium (www.cdisc.org). Multiple data platforms can be, or may already be, compliant with the appropriate standards.

In a multi-PI DCOC application, can the minimum PD(s)/PI(s) time commitment of 0.5 FTE (six person months) be divided up among the PI(s)?

• Yes, for the DCOC, the time commitment can be split between two or more PIs. In the funding opportunity announcement, it states “A minimum PD(s)/PI(s) time commitment of 50% (6 person months) should be made. Applications with differing leadership effort commitment plans should document in detail how Network needs will be met.” Thus, in a multi-PI DCOC application, it is not mandatory that one PI commit a full 0.5 FTE; however, that approach to time commitment is encouraged. A substantial and well delineated contribution will be expected from each of the PIs. In contrast, a full 0.2 FTE from at least one of the Clinical Site PIs in a multi-PI Clinical Site application is required.