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What is the IDeA States Program?

• The Institutional Development Awards (IDeA) Program, first authorized by Congress in 1993 and managed by the �����鶹��Ƶ Institute of General Medical Sciences, has been developed for the purpose of broadening the geographic distribution of �����鶹��Ƶ (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 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 (, , , , ).
• 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 to this funding opportunity to serve as clinical sites for this Network?

• Yes. This funding opportunity soliciting institutions to serve as clinical sites for the IDeA States Pediatric Clinical Trials Network is only available to institutions located within one of the 23 IDeA-eligible States or the Commonwealth of Puerto Rico.  However, an institution in one of those states does not need to have a current IDeA grant to be eligible to apply for this program.

Can two or more institutions join together to submit one application as a consortium site?

• Yes, multiple sites may submit a single application to perform as a consortium site within the Network. In fact, such a structure is encouraged. PDs/PIs at different institutions may collaborate on the development of a multiple PD/PI application.  However, a single application should 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. No additional base funds will be provided beyond the base annual budget award of $315,000 in direct costs.

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 () for more information on applying with multiple PIs.  Information is also included in the SF424 application instructions. However, in order to facilitate the professional development at each of the participating institutions, it would appear best to have a single PD/PI at each site to optimize communication.
• 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 multiple PD/PI team will be left up to the PDs/PIs and the applicant institution(s).  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 the NIH formally acknowledges. For the purposes of the IDeA States Pediatric Clinical Trials Network administrative functioning, the contact PI will assume the role of Clinical Site Director, unless otherwise arranged by the site PIs, as each site is only allowed one vote in the Steering Committee.

If we submit with a multiple PI plan, does each of the PIs listed need to commit 2.4 person months (20%) effort?

• Although it is preferred that all PIs in a multi-PI proposal commit to the minimum requirement of 2.4 person months (20%) effort, it is mandatory that at least one PI from a multi-PI plan commit a minimum of 2.4 person months (20%) effort. All PDs/PIs must be qualified to serve as the PD/PI and will share responsibility for the project. The structure and interaction of the multiple 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 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 Clinical Site Director, unless otherwise arranged by the site PIs, and will be responsible for the one vote on the IDeA States Pediatric Clinical Trials Network Steering 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 annual award limit (direct costs $315,000) will not be provided.

What biosketches should be included in the application?

• Required biosketches include those of the clinical site PD(s)/PI(s), the Research Nurse Coordinator, and the Data Manager at a minimum. Applicants should include biosketches of all key persons as defined in the SF424 Instructions.

What are the requirements of the clinical site research team personnel?

• Given the intent of the IDeA States Pediatric Clinical Trials Network to extend pediatric research to states historically underrepresented in terms of NIH funding and to provide access to rural and underserved children to state-of-the-art clinical trials, a previous track record of successful research is a less stringent criterion than in most NIH-supported clinical trials network competitions. A commitment to pediatric research, evidence of established success in clinical, academic, administrative, and / or research endeavors, and ready access to a rural or underserved / underrepresented pediatric population are the primary requirements.
• Specifically, the Clinical Site PD(s)/PI(s) must be a fully qualified, Board certified pediatrician who is able to make a substantial, long-term commitment of effort to Network responsibilities (2.4 person months for each year of the four year award). The PD(s)/PI(s) must have previous training and scientific expertise in some field of pediatrics and some prior clinical research experience. However, it is anticipated that the clinical site PDs/PIs will receive significant development of their research skills and that will be provided by the DCOC. The Research Nurse Coordinator need not have any prior experience in clinical research, although such experience is preferred. The DCOC will be tasked to provide the necessary professional development in clinical pediatric research for these research coordinators. The Research Nurse Coordinator will be expected to have a track record of success in other areas of medicine, and a demonstrable commitment to the field of pediatrics. The Data Manager should be trained in data compilation and analysis. The Network DCOC will also work closely with these individuals to assure quality data collection at the local level, and secure, effective and timely data transmission to a central repository.

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. Given that the intent of the IDeA States Pediatric Clinical Trials Network is to extend pediatric research to states historically underrepresented in terms of NIH funding, it is anticipated that many of the competing sites will have limited previous experience in pediatric research.

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 UG1 funding mechanism?

• The is a funding mechanism used to support single project applications conducting clinical evaluation of various methods of therapy and/or prevention (in specific disease areas). 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 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 �����鶹��Ƶ 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 letters of intent?

• March 15, 2016

The FOA states that the NICHD “intends to commit up to $30,000,000 in FY 2016 to fund up to 15 new grants for four years in response to this funding announcement. These will be multiyear funded awards beginning in FY 2016.” Is the indicated dollar amount for each award, or is it for all of the awards combined?  Does the amount include indirect costs?  Does the amount span the entire 4 years of the award?

• The dollar amounts indicated in the FOA represent the funds committed in fiscal year 2016 to cover all awards for this FOA, including both direct and indirect (facilities and administrative) costs, for the entire course of the four year study period. Because these are multiyear funded projects, the entire award will be funded in fiscal year 2016. Awardees will be required to submit annual budgets delineating the use of these funds as part of their annual progress report.
• The Clinical Site may request up to $315,000 in direct costs for each of the four years of the award.
• Key components to be included in the application base budget and permissible costs are described in the 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.
• The fees will be provided to the sites from the DCOC using a budget allocated to them as part of their NIH grant award.

What are the page limits for this application?

• All page limitations described in the SF424 Application Guide and the must be followed.
• 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 .

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, 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 and .  

Can an institution recruit protocol participants who reside in areas outside of the IDeA states?

• Yes, as long as the primary site is in an IDeA state and recruitment in the other state does not impede recruitment of patients in the IDeA state. A goal of the initiative is to enhance research opportunities to underserved children, and not simply satisfy accrual targets. Thus, recruitment from non-IDeA states should focus on these same patient populations.

Does a responsive application have to incorporate research capability for all four ECHO areas?

• No. The IDeA States Pediatric Clinical Trials Network (ISPCTN) will address any issue relevant to the care of children that has the potential for a large health impact, although preference will be given to the four areas of the ECHO Program. Additionally, a goal of the initiative is to extend opportunities for research to children in areas where historically such opportunities may not have been available. Thus, it is much more important to demonstrate access to these underserved children and a willingness to conduct high quality research for them than it is to demonstrate existing evidence of expertise in the four ECHO priority areas.

Does the PI have to be a pediatrician?

• Yes. In the funding opportunity announcement, it clearly states that “The PD(s)/PI(s) must be a fully qualified, Board certified pediatrician …”. However, in a multi-PI application, not all PIs need to be a Board certified pediatrician.

Can an institution serve as both the Data Coordinating and Operations Center (DCOC) and a Clinical Site in the 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.

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 Network. An applicant from any eligible institution in an IDeA state may apply.

What are the definitions of rural and underserved for the purpose of this award?

• There are no pre-specified definitions for rural and underserved for the purpose of this award. The census bureau offers definitions for urban and rural areas (). In general, the term “underserved” refers to patients who have socioeconomic, cultural, linguistic and/or other barriers to primary medical care services (). For the purpose of this initiative, that definition is being expanded to include children who have such barriers (including geographic distance) to participation in clinical research opportunities.

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 Network?

• 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 (). 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.

If descriptions of on-going and completed pediatric clinical trials at a site are included in a Clinical Site application, should biographical sketches of these investigators be included if they are not serving as PD(s)/PI(s) on the application?

• No. The Biographical Sketch Section should be limited to the three essential roles of Principal Investigator, Research Nurse Coordinator, and Data Manager. However, this information could be included elsewhere in the application as evidence of the ability of your site to effectively conduct pediatric clinical trials research. It is more valuable to focus on the patients being enrolled and the studies being conducted than to provide detailed biosketches of the associated investigators.

Can the Research Nurse Coordinator FTE be divided up among a number of individuals?

• Yes. Given the potential that a single Clinical Site may be constituted by a number of separate institutions, the role of the Research Nurse Coordinator may be distributed among a handful of individuals.

Does every site within a multisite application need to participate in every Network study?

• No. Although the expectation is that every clinical site in the Network will participate in every study “with the occasional exception of a specialized procedure or assessment not available or feasible at their particular location,” it is anticipated that for applications emanating from multisite “consortia” that not every site within the consortia will be able to participate in every study. This is both understandable and acceptable as long as the overall site attempts to participate in every study unless not feasible as described above. No site will be required to participate in a trial counter to their beliefs or mission.