Concept Review by Council
Concepts for proposed Requests for Applications (RFA) are reviewed during the Open Session of Council. These are the features of the process:
- A brief concept description, written by the program staff proposing a grant solicitation, is posted on the Council website.
- Dr. Alexander will present the concepts during the Open Session. Program staff will be available to answer questions if called upon but, in general, will not participate in the presentation.
- Following brief presentation and discussion, Council members will be asked to indicate their opinion of each concept.
- Comments, suggestions, and Council advice will be recorded by NICHD staff.
This approach to concept review:
- Meets the NIH requirement for public presentation of concepts and the opportunity for public comment.
- Provides a wide spectrum of expertise for the consideration of concepts, including scientific, policy, and advocacy perspectives. The process should encourage the presentation and evaluation of broad concepts, without detailed or in-depth discussion of the specific science. Such discussion, typical when concepts are reviewed by a group with more narrowly focused expertise, goes well beyond the purpose of this review. Indeed, it places those involved in a potential conflict of interest situation that would prevent them from responding to a resultant RFA should they choose to do so.
- Enables the full Council to consider individual initiatives within the broader context of many planned initiatives, giving us the benefit of multiple perspectives in the overall planning of an NICHD research agenda.
For this meeting, six concepts were reviewed:
Specialized Cooperative Centers Program in Reproduction and Infertility Research
Intellectual and Developmental Disabilities Research Centers
Maternal Fetal Medicine Units Network
Cooperative Multicenter Neonatal Research Network
Learning Disabilities Research Centers
Child Health Research Career Development Award Program
Concept Clearance by Council
September 2009
Specialized Cooperative Centers Program in Reproduction and Infertility Research
A Request for Applications (RFA) is proposed entitled “Specialized Cooperative Centers Program in Reproduction and Infertility Research (FY 2011).” The proposed RFA will use the Specialized Cooperative Research Center (U54) award mechanism.
Purpose
The purpose of this RFA is to announce the re-competition of the Specialized Cooperative Centers Program in Reproduction and Infertility Research (SCCPIR). The SCCPIR provides an arena for multidisciplinary interactions between basic and clinical scientists interested in establishing high quality translational research programs in the area of reproduction and infertility. The centers also serve as national resources for the training and career development of new scientists electing to pursue careers conducting translational research in high priority areas of reproduction and infertility. Finally, center investigators will participate in important community outreach and education efforts to increase awareness and convey the importance and implications of their research activities to the general public.
Scope
The research activities included in these center grants must comprise a multidisciplinary approach to biomedical problems in reproduction and infertility that are deemed of high significance to NICHD. Centers may have more than one theme, focus or emphasis, but all projects involved must be responsive to one or more mission-relevant areas supported by the Reproductive Sciences Branch. To meet the translational objectives of this centers program, one of the projects must be a clinical research project and all basic science projects must be linked to the clinical components of a center.
Objective
The objectives of the SCCPIR are to support specialized reproductive research programs of high quality, and to facilitate and accelerate bidirectional transfer of knowledge between the laboratory and clinic with the ultimate goal of improving human reproductive health. This RFA is specifically designed to stimulate the reproductive sciences research community to organize and maintain research-based centers of outstanding quality that, serving as national research resources, form a cooperative network with NICHD that fosters communication, innovation and high quality reproduction and infertility research. Such networking as afforded by the cooperative nature of this Centers Program will ensure that the reproductive research community remains in the forefront of the development and utilization of new technologies that can be used to diagnose, treat and ameliorate reproductive diseases and disorders, as well as to identify novel leads for fertility regulation.
Program Contact
Louis DePaolo, Ph.D.
Reproductive Sciences Branch
Center for Population Research
Concept Clearance by Council
September 2009
Intellectual and Developmental Disabilities Research Centers
A Request for Applications is proposed entitled “Intellectual and Developmental Disabilities Research Centers (IDDRC) 2010.” The proposed RFA will use the Centers award (P30) mechanism.
Purpose
This RFA is a continuation of one of NICHD’s cornerstone programs, the Intellectual and Developmental Disabilities Research Centers (IDDRCs), which eligibility is open to qualifying institutions. The original IDDRCs were established by Congressional mandate in the early 1960s to provide facilities and support for research in intellectual and developmental disabilities (IDD, formerly mental retardation), and develop university-affiliated facilities to train personnel to provide care for individuals with IDD. There are currently 14 funded IDDRCs located at universities and children’s hospitals throughout the country, with a focus on providing core equipment, services, and personnel to support investigators whose goal is to understand the causes of and develop treatments for IDD. Over the past 40 years, the Centers’ activities have increased this understanding dramatically, and the core services have expanded to include state-of-the-art infrastructure support in such fields as developmental neurobiology, genomics, proteomics, neuroimaging, epidemiology, biostatistics, behavioral science and clinical translational research. Since its original inception, the IDDRC program has continued to evolve and mature, with the Centers promoting collaborative, interdisciplinary projects within and between Centers and serving as focal points for IDD research and training throughout the US.
Scope
The proposed RFA will solicit applications to establish or continue an Intellectual and Developmental Disabilities Research Center that provides shared cores, resources, and facilities to promote multidisciplinary research in the field of IDD. Although the goal of the IDDRCs is provide research support to multiple investigators rather than directly fund research projects, the breadth and depth of the supported research projects is immense; in fact, many of these projects have as their funding sources other NIH Institutes such as NINDS and NIMH, and a number are supported by foundations and private research institutions. The IDDRCs have demonstrated a remarkable ability to leverage resources from their host institutions, private donors, and other sources to facilitate growth. This diversity allows the Centers to support substantially more projects and affiliates than would be possible using NICHD support alone.
Objective
The objective of this RFA is to fund Centers that will provide support and facilities for a cohesive, interdisciplinary program of research and research training in intellectual disabilities and related aspects of human development. Applicants are encouraged to develop translational and collaborative research programs that will provide infrastructure for investigators who will make substantive advances in the field of IDD.
Program Contact:
Melissa A. Parisi, M.D., Ph.D.
Intellectual and Developmental Disabilities Branch
Center for Developmental Biology and Perinatal Medicine
Concept Clearance by Council
September 2009
Maternal Fetal Medicine Units Network
A Request for Applications is proposed entitled Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal Fetal Medicine Units Network. This proposed RFA will use the cooperative agreement grant (U10) mechanism.
Purpose
This RFA is an open recompetition of the maternal fetal medicine units network, inviting applications from investigators willing to participate with the NICHD under a cooperative agreement (U10) in an ongoing multicenter clinical program designed to investigate problems in clinical obstetrics, particularly those related to prevention of low birth weight, prematurity, and medical problems of pregnancy. The objective of this program is to facilitate resolution of these problems by establishing a network of academic centers that, by rigorous patient evaluation using common protocols, can study the required numbers of patients and can provide answers more rapidly than individual centers acting alone. The infrastructure is set up for the ideal randomized double-blinded placebo controlled trial with the ability to follow short term (clinical effect) and long term (neurodevelopmental outcome) measures. The infrastructure is also set up for observational studies in perinatal medicine. This initiative will foster the conduct of multicenter trials in the perinatal population.
Scope
There are a number of controversial issues in maternal-fetal medicine that might be clarified by multicenter collaborative research. Funded Principal Investigators will cooperate with the NICHD Program Scientist in identifying research topics of high priority and in designing protocols appropriate to the evaluation of superior or even optimal management in these areas. The collaborative research may encompass any area of maternal-fetal medicine. However, special interest is encouraged in developing strategies for the prevention of preterm birth, evaluation of the causes or treatments of medical complications during pregnancy, and in the evaluation of interventions used during pregnancy and childbirth. The participating maternal-fetal medicine units (MFMUs), designated as "clinical centers," will recruit, assess, and treat the subjects in the clinical research of the Network, with each MFMU being supervised by its respective Principal Investigator. The data center (funded through a separate RFA) will have primary responsibility for data management and analysis for Network research in collaboration with the Steering Committee. The NICHD expects that ongoing clinical trials dealing with optimal management of subclinical hypothyroidism and progesterone for prevention of preterm birth in women with a short cervix likely will continue into the continuation grant period for existing centers. New protocols may be developed before the start of the continuation. Centers that join the Network in the next award period may participate in the protocols ongoing at that time.
Objective
The primary objective of the Maternal Fetal Medicine Units Network (MFMU) is to advance the field of maternal Fetal and obstetrical medicine by establishing and maintaining a network of academic centers that perform multi-center clinical protocols in a rigorous manner to investigate the safety and efficacy of treatment and management strategies to improve maternal, fetal and neonatal health. These include, but are not limited to reducing maternal, fetal and infant morbidity related to preterm birth, fetal growth abnormalities and maternal complications and to provide the rationale for evidence-based, cost-effective, obstetric practice.
Program Contact:
Catherine Y Spong MD
Pregnancy and Perinatology Branch
Center for Developmental Biology and Perinatal Medicine
Concept Clearance by Council
September 2009
Cooperative Multicenter Neonatal Research Network
A request for applications (RFA) is proposed entitled: Cooperative Multicenter Neonatal Research Network. This proposed RFA will use the cooperative agreement grant (U10) mechanism. This network has received support from other Institutes for ongoing and upcoming studies. National Heart, Lung and Blood Institute have provided capitation costs for the SUPPORT trial and NEI is currently support the Inositol for Retinopathy studies.
Purpose
The purpose of the Neonatal Research Network is to establish and maintain a multi-center research network of neonatal intensive care units with an independent data-coordinating center and NICHD to perform clinical trials, observational research, and basic science. The goal of the Neonatal Research Network is to advance the field of Neonatal-Perinatal by establishing and maintaining a network of academic centers that perform multi-center clinical medicine trials in a rigorous manner to assess safety and efficacy of treatment and management strategies for newborn infants. Treatment strategies include drugs and devices requiring multicenter studies for study.
Scope
Proposals considered responsive to this solicitation include neonatal intensive care clinical centers with at least 500 admissions per year with no more than 30% outborn population. The center must have an established follow up program with a designated facility in place at the institution. The study site must have an established neonatal/perinatal data system, and a full time clinical research coordinator. Clinical sites will be required to propose a concept protocol for implementation at all of the network sites. Specifically, the network will continue to conduct prospective randomized trials of neonatal therapies and interventions, observational studies including those involving very low birth weight infants, and performing long term follow up on high risk cohorts. The proposed network would include 18-22 clinical sites, an independent data-coordinating center, and NICHD.
Objective
The objective of this concept is to foster multicenter clinical trials in the neonatal population. The infrastructure is set up for randomized double-blind placebo controlled trials with the ability to follow short term (clinical effect) and long term (neurodevelopmental outcome) measures for the high risk neonatal population
Program Contact:
Rosemary D. Higgins, M.D.
Pregnancy and Perinatology Branch
Center for Developmental Biology and Perinatal Medicine
Concept Clearance by Council
September 2009
Learning Disabilities Research Centers
A Request for Applications (RFA) is proposed entitled “Learning Disabilities Research Centers.” This proposed RFA will use the specialized research center grant (P50) mechanism.
Purpose
The purpose of this recurring RFA is to continue to stimulate transdisciplinary research examining issues related to etiology, classification and definition of, and prevention and remediation of learning disabilities impacting listening, speaking, reading, writing and mathematics with an emphasis on comorbid conditions. The P50 mechanism allows for richly integrative, multi-method approaches to examining research topics focusing on learning disabilities that are simply not feasible through standard research mechanisms.
Scope
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) maintains a longstanding interest in the study of normal language and reading development, learning disabilities, and disorders that adversely affect the development of listening, speaking, reading, writing, and mathematics abilities. Continuation of the Learning Disabilities Research Centers program provides a unique opportunity to continue the strong transdisciplinary research connecting behavioral, neurobiological and genetic studies of reading, writing and related learning disabilities which is difficult to facilitate through other mechanisms.
Objective
The continuation of the Learning Disabilities Research Centers would refine the classification and definition models for learning disabilities, further extend basic and translational research on learning disabilities in the area of reading and writing skill development across the lifecourse, continue dissemination of translational research to researcher and practitioners, and increase the research data directly relevant to highly diverse populations.
Program Contact:
Brett Miller, Ph.D.
Child Development and Behavior Branch
Center for Research for Mothers and Children
Concept Clearance by Council
September 2009
Child Health Research Career Development Award Program
A Request for Applications entitled “Child Health Research Career Development Award Program”. The proposed RFA is to solicit career award grants (K12) and to recompete six currently funded pediatric departments whose funding expires December 1, 2010.
Purpose
The purpose of the proposed RFA is to train junior physician scientists (scholars) and to stimulate their careers in pediatric research. This Program provides basic science and translational research training for pediatricians who are within four years of completing their subspecialty training by providing career development support.
Scope
At each funded Center, established mentor-investigators offer their expertise and laboratory facilities to junior investigators, so that the latter can hone their research skills. This experience also enables the CHRCDA scholars to generate preliminary data, which can be included in grant applications for independent funding. The Program currently funds 20 centers, which receive five-year K-12 awards for new research projects. Thirty pediatric departments have received funding through this program, providing research support more than 650 highly skilled physician-scientists, who have successfully competed for NIH funding in 15 pediatric subspecialties.
Objective
The goal of the Child Health Research Career Development Award program is to establish “Centers of Excellence” in pediatric research.
Program Contact:
Karen Winer, M.D.
Endocrinology, Nutrition, Growth Branch
Center for Research for Mothers and Children
