Concepts for proposed Requests for Applications (RFA) are reviewed during the Open Session of Council. These are the features of the process:
This approach to concept review:
For this meeting, eight concepts were reviewed.
Renewal of Population Research Infrastructure Program (R24) Role of Prenatal Alcohol Exposure in SIDS and Stillbirth (U01)
Learning Disabilities Innovation Hubs (R24)
Systems-Oriented Pediatric Obesity Research and Training Centers [SPORT] (U54) Epigenetic Disorders in Human Development (R01) Identifying and Evaluating Effective Interventions for Orphans and Vulnerable Children Affected by HIV/AIDS (R01) Research in pediatric Developmental Pharmacology (U54) Disclosure of HIV-Status to children in Low-Resource Settings (R01, R21)
A Request for Applications is proposed entitled “Renewal of Population Research Infrastructure Program (FY 2011).” The proposed RFA will use the NIH Resource-Related Research Project (R24) mechanism.
The purpose of the proposed RFA will use the Resource-Related Research Project (R24) mechanism to increase the innovation and impact of population research by increasing population scientists’ productivity, facilitating interdisciplinary research, developing new population researchers—both early stage investigators and scientists from other disciplines who have the knowledge, skills, interest, and commitment to advance population research—and to successfully disseminating population research findings, tools, and data.
The Population Research Infrastructure Program (PRIP) provides essential and resource-efficient research infrastructure to population research centers. PRIP allows support for three types of population centers: fully established population research centers; emerging population research centers; and public infrastructure population research centers. The three types of support are: Research Support; Developmental Infrastructure; and Public Infrastructure. Research Support Cores provide shared resources supporting ongoing research projects and research grant/contract applications. Developmental Infrastructure Cores support the development of new research capacity by encouraging the development of innovative projects and approaches, new interdisciplinary collaborations, and new researchers and established researchers new to population research. Public Infrastructure Cores are intended primarily to benefit external audiences, not researchers at the applicant institution. Public infrastructure activities can either provide research resources to a broad external community of population researchers or provide translational resources for both scientific and non-scientific audiences.
The objects PRIP are to increase the scientific impact of funded research centers by increasing their research capacity in population research, especially in the areas signature population related themes.
Rebecca L. Clark, Ph.D.Demographic and Behavioral Sciences BranchCenter for Population Research
A Request for Applications is proposed entitled “Role of Prenatal Alcohol Exposure in SIDS and Stillbirth (PASS).” This proposed limited competition will use the NIH Cooperative Agreement (U01) mechanism. It is in collaboration with the National Institute on Alcohol Abuse and Alcoholism (NIAAA).
This purpose of the proposed RFA is for the completion of the Safe Passage Study. In Fiscal Year 2006, the NICHD and NIAAA funded the Prenatal Alcohol in SIDS and Stillbirth (PASS) Network to complete development of the Safe Passage Study and initiate enrollment. The 2006 RFA stated that the study would extend beyond the five years of the grant award period and would require renewal in 2011. The study will enroll 12,000 pregnant women to investigate the role of prenatal alcohol exposure in the risk for sudden infant death syndrome (SIDS) and adverse pregnancy outcomes such as stillbirth and fetal alcohol syndrome (FAS).
This study is designed to:
The study is recruiting in the Northern Plains and Capetown, South Africa. The information gained has the potential to improve preventive strategies and reduce racial disparities in rates of SIDS and stillbirth.
This RFA will solicit competing applications from the sites in the PASS Network. These are: the Comprehensive Clinical Sites at the University of Stellenbosch and University of South Dakota, the Developmental Biology and Pathology Center at Childrens’ Hospital Boston, the Physiology Assessment Center at Columbia University and the Data Coordinating and Analysis Center at DM-STAT. The applicants will be required to describe progress in protocol conduct and associated research studies, and to describe the approach for study completion and analysis.
The objective is to complete enrollment, follow up and primary data analyses. Enrollment began in August 2007 and as of Dec.14, 2009, 3363 pregnant women have been enrolled with outstanding visit compliance, and 97% delivery outcome ascertainment
We anticipate completing enrollment in 2015, with follow-up and primary analysis through 2016. This study is co-funded by NIAAA and they are committed to supporting through 2016.
Marian Willinger, Ph.D.Pregnancy and Perinatology BranchCenter for Developmental Biology and Perinatal Medicine
A Request for Applications is proposed entitled “Learning Disabilities Innovation Hubs.” This proposed RFA will use the Resource-Related Project (R24) mechanism.
The purpose of the proposed RFA is to stimulate innovative, cross-programmatic work that takes advantage of advances in behavioral, neurobiological and genetic approaches to examine singular as well as comorbid learning disabilities impacting listening, speaking, reading, writing, and mathematics abilities as well as other conditions frequently coexisting with learning disabilities, such as ADHD.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) maintains a longstanding interest in the study of normal development, learning disabilities, and disorders that adversely impact the development of listening, speaking, reading, writing, mathematics and reasoning abilities. The addition of these specific research projects (R24) would build capacity for cross-programmatic efforts to develop new and/or innovative approaches and research topics using neurobiological, genetic and/or behavioral approaches to address the needs of learners at risk for or identified with learning disabilities across the lifespan. These projects will interface with and complement the broader P50 Learning Disabilities Research Centers. but in contrast to the Centers that house well-developed, mature investigations, the R24 projects will focus on exploratory projects in less mature areas of science and/or on understudied groups including individuals with multiple learning disabilities or complex sets of comorbidities. The goals include (1) providing a research framework to facilitate an integration of knowledge across programmatic domains that do not currently have rich cross-talk, (2) creating a science base for topical areas that have been understudied due to the need for multiple programmatic research perspectives, and (3) building the scientific capacity through the development of junior investigators in domains of high programmatic relevance.
These thematic projects would be tasked with designing scientifically developmental, innovative research to aid in our understanding of the etiology, the refinement of classification and the definition of models for learning disabilities. These early studies will provide the evidence to inform possible prevention and remediation efforts for those at risk for or already identified with learning disabilities. The R24 projects will encourage involvement of the next generation of researchers, thereby not only moving the field but also building capacity.
Brett Miller, Ph.D.Child Development and Behavior BranchCenter for Research for Mothers and Children
A Request for Applications is proposed entitled Systems-Oriented Pediatric Obesity Research and Training Centers (SPORT). This proposed RFA will use the NIH Cooperative Agreement Centers (U54) mechanism.
Given the continued lack of effective and sustainable solutions to the obesity epidemic with past approaches, the purpose of the proposed RFA is to stimulate collaborative, transdisciplinary, and multilevel research in an area in which unsolicited applications have been too narrowly focused to advance the science optimally
Specifically, the proposed RFA will focus on the investigation of interactions of macrosocial and biological processes (i.e., connecting systems biology with population systems) that determine obesity, the testing and evaluation of downstream effects of environmental and policy interventions, and the development and implementation of predoctoral and postdoctoral training on substantive and methodological aspects of systems thinking in public health. In addition, the RFA will also solicit applications for a research coordinating unit that will house a web-based, GIS-enhanced database platform.
The objectives of this RFA are to incentivize the investigation of common problems across disciplines, to create the opportunity, space, and structure for understanding, preventing, and curbing obesity using a systems rather than individualistic approach, and to enhance the capacity for systems-oriented health research in the long term.
Terry Huang, Ph.D., MPHEndocrinology, Nutrition and Growth BranchCenter for Research for Mothers & Children
A Request for Applications (RFA) is proposed entitled “Epigenetic Disorders in Human Development”.
This proposed RFA will use the NIH Research Project Grant (R01) mechanism.
The purpose of the proposed RFA is to accelerate the pace of researchinvestigatingthe role of epigenetic processes at key points during normal and/or pathological embryonic, fetal, childhood, adolescent, reproductive development, or physical rehabiliation that are relevant to the NICHD’s mission areas.
The proposed RFA will solicit applications in targeted high priority branch areas. Examples of these areas include the following:
The objective of this initiative is to better understand epigenetic processes involved in health and disease. This knowledge will help to formulate rational and effective interventions that can prevent or ameliorate epigenetic based disorders.
John V. Ilekis, Ph.D.Pregnancy & Perinatology BranchCenter for Developmental Biology and Perinatal Medicine
A Request for Applications is proposed entitled “Identifying and Evaluating Effective Interventions for Orphans and Vulnerable Children Affected by HIV/AIDS.” This proposed RFA will use the R01 mechanism to address an underdeveloped area of research.
The AIDS epidemic has created a huge population of orphans and vulnerable children (OVC). A variety of non-governmental organizations (NGO), religious organizations, and the President’s Emergency Plan for AIDS (PEPFAR) provide relief services to OVC but little early consideration was given to the evaluation of services. PEPFAR tried to improve the quality of relief programs for OVC by requiring partners to track and report provisions of food and nutrition, shelter and care, protection, health care, psychosocial support, education and vocational training, and economic strengthening. In response to the global crisis involving AIDS orphans and other vulnerable children, Congress mandated the Assistance for Orphans and Other Vulnerable Children in Developing Countries Act (PL109-95) which called for a comprehensive, coordinated, and effective US Government response led by the United States Agency for International Development (USAID). More is currently known about services rendered to OVC because of reports submitted to Congress by the PL 109-95 Work Group but evaluation efforts for these programs have centered on the number and types of intervention programs and on services provided to OVC leaving a gap in knowledge concerning the health, developmental, and educational outcomes of children who received the relief programs and interventions. The proposed RFA will solicit rigorous outcomes evaluation research studies.
Evaluation studies of interest will include those that examine short- and longer-term health, developmental, and educational outcomes in OVC who received relief efforts. Health outcomes may include parameters of growth, health, physical development, and immunization and nutrition status. Other developmental outcomes include cognitive, social, and emotional development. Educational outcomes include academic achievement, vocational training, motivation to learn, and a knowledge base that includes health promotion and disease prevention (including sexually transmitted infections).
The objectives of this RFA are 1) to create a body of information regarding the effectiveness of AIDS intervention programs for OVC in terms of health, educational, and developmental outcomes and 2) to identify effective intervention programs and responsible elements of those programs that will guide future evaluation efforts and inform policy makers as to which intervention programs work for which children, under which circumstances. Both foreign and domestic research projects are invited.
Lynne Haverkos, M.D., M.P.H.Child Development and Behavior BranchCenter for Research for Mothers and Children
A Request for Applications is proposed entitled “Research in Pediatric Developmental Pharmacology.” This proposed RFA will use the NIH Cooperative Agreement Specialized Centers (U54) mechanism.
The purpose of this proposed RFA is to stimulate mechanistic research in pediatric and developmental pharmacology with the ultimate goal of improving use and delivery of pediatric medicinal products through innovation and research excellence.
The scope of the proposed solicitation is to form a national network which will perform mechanistic-based research in the area of developmental changes in drug disposition and response.
The objectives of the solicitation are to are to identify new basic and translational approaches to pediatric pharmacology research, including use of pre-clinical models and development of diagnostic tools and procedures for the detection, treatment and effective management of pediatric disorders.
Anne Zajicek, MD, PharmDObstetric and Pediatric Pharmacology BranchCenter for Research for Mothers and Children
A Request for Applications is proposed entitled “Disclosure of HIV-Status to Children in Low-Resource Settings.” This proposed RFA will use the NIH Research Project Grant (R01) and the NIH Exploratory/Developmental (R21) mechanisms.
The purpose of the solicitation is to solicit research project grant (R01 and R21) applications in order to stimulate rigorous scientific research in an area that has previously focused more on process evaluation than on outcomes evaluation. Interventions to facilitate disclosure to millions of children now surviving their HIV infection in low-resource settings are sorely needed and must be based on a fundamental understanding of the child’s developmental stages and cultural context. The profound lack of data about effective and appropriate disclosure paradigms and near absence of published disclosure intervention studies highlight the need for investigation of disclosure practices and barriers in these settings and for trials of disclosure interventions.
The scope will encompass R21 research to understand the current practice, barriers and facilitators, cultural influences and effects of disclosing to HIV-infected children their HIV status and of HIV-infected mothers and fathers disclosing their status to their children. The results of this research will be used to develop HIV disclosure intervention paradigms for low-resource settings. Where critical elements for developing an HIV disclosure intervention paradigm for low-resource settings have already been identified, or where two or more disclosure models are already implemented or under consideration in HIV care programs in low-resource settings, the scope also will encompass R01 proposals to validate disclosure intervention paradigms, assess the effect of the disclosure intervention on psychological, behavioral and medical outcomes in the child and family, and, where possible, evaluate the comparative effectiveness of two or more disclosure interventions that have already been developed.
The objective of this FOA is to create a body of evidence that pediatric HIV care program leaders and policy makers will use to enhance appropriate and effective disclosure of HIV diagnosis to children.
George Siberry, M.D., M.P.H.PAMA BranchCenter for Research for Mothers and Children