The majority of grant applications received and funded by NICHD are unsolicited, submitted by extramural investigators working within the mission of the Institute. However, when NICHD program staff identify areas of research that would benefit from stimulation or that demonstrate specific gaps in knowledge that should be highlighted, a Funding Opportunity Announcement (FOA) for a focused grant solicitation may be proposed. We use two types of FOA: the Program Announcement, with no set-aside of funds, and the Request for Applications, with a specific commitment of funds.
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:
Eight concepts were reviewed at the January 2011 Council session.
Autism Centers of Excellence Contraceptive Development Research Centers Program Improving Adherence to Medical Regimens or Behavioral Guidelines in HIV+ or High Risk Individuals Male Reproductive Health Research Career Development Program Mentored Specialized Clinical Investigator Development Awards (MSCIDA) for the Maternal Fetal Medicine Units Network (MFMU) and the Neonatal Research Network (NRN) Perinatally HIV-infected youth at IeDEA sites in Africa and Asia Prevention of HIV Transmission/Acquisition through a better understanding of Reproductive Health Recompetition of the Global Network for Women’s and Children’s Health Research (previously reviewed during Interim Concept Review)
A Request for Applications (RFA) is proposed entitled "Autism Centers of Excellence." The proposed RFA will use the NIH Research Project grant (R01) and Specialized Center grant (P50) mechanisms.
The NIH historically supports a vast array of projects in autism research. Some of these investigators were supported via networks of centers, such as STAART (Studies to Advance Autism Research and Treatment) and CPEA (Collaborative Programs of Excellence in Autism programs). In 2007, consolidation of funding from the STAART and CPEA programs resulted in autism centers and networks called the Autism Centers of Excellence, or ACE. In FY 2007 and 2008, five centers and six networks were funded. The purpose of this RFA is to solicit new and competing continuation proposals for ACE. Two types of ACEs will be solicited: centers and multi-site research networks.
Research projects should focus on finding causes and preventive intervention for autism as well as improved treatment. Highest priority will be given to projects related to gaps identified by the IACC 2011 Strategic Plan. Examples include but are not limited to: identification and evaluation of interventions and services for ASD; identification of risk factors (e.g., viruses, medication, lifestyle factors, environmental chemicals, genetics) that contribute to the development of autism and their associated developmental windows; identification of biological signatures for autism and their relevance to prediction of treatment response and outcomes; and assessment of characteristics and evaluation of interventions in understudied populations (e.g. adults).
The objective of this RFA is to incorporate current scientific knowledge and tools in research that deepens our understanding of ASD, including the complex genetic and environmental factors that play a role in its causation, development of improved ASD diagnostic approaches and treatments, and science to enhance the level of services and supports available to people with ASD, their families and caregivers.
Alice Kau, Ph.D.Intellectual and Developmental Disabilities BranchCenter for Developmental Biology and Perinatal Medicine
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A Request for Applications (RFA) is proposed entitled "Contraceptive Development Research Centers Program." The proposed RFA will use the NIH Cooperative Agreement grant (U54) mechanism.
The purpose of this RFA is to continue funding the "Contraceptive Development Research Centers Program", which was an establishment of the Centers was directed in 1993 by an act of Congress under the Public Health Service Act (Public Law 103-42). This program uses an interdisciplinary approach to identify novel methods for male and female contraception. There is a recognized need to continue funding the effort of contraceptive research and development because unintended pregnancy continues to be a challenge now and for the foreseeable future. Moreover, the goal of developing new products to meet a variety of cultural and reproductive needs for both men and women has not been met. Thus, it is critical to support research centers with the goal of identifying novel targets and developing products to alleviate this problematic challenge.
Research projects funded under this program will be directed to male or female targets for purposes of developing novel methods for safe and effective contraception. A Center should consist of projects and/or core facilities capable of interacting in a coordinated, cooperative fashion. Activities may require collaboration with other institutions and/or Centers. It is possible for the research to progress from lead discovery through preclinical development and into clinical trials. Future efforts will continue to support target discovery and the long arduous process of product development of the most promising agents. Centers should provide training opportunities for new investigators to explore research careers in contraceptive development.
The primary objective of the Contraceptive Development Research Centers Program is to identify novel leads and to develop safe and effective contraceptive methods for men and women. There are three phases to development of new contraceptive methods: basic discovery, proof of concept, and clinical development. The intent of the U54 Centers program is to establish or maintain an organizational infrastructure that has the scientific and administrative capabilities to participate in developing new safe and effective contraceptive methods for either men or women. This program is a critical component in the CRHB mission to develop new contraceptive products that will serve the cultural and reproductive needs of the population.
Min S. Lee, Ph.D.Contraception and Reproductive Health BranchCenter for Population Research
A Request for Applications with set-aside (from Office of AIDS Research funds) is proposed entitled, “ Improving Adherence to Medical Regimens or Behavioral Guidelines in HIV+ or High Risk Individuals” using the research project grant (R01) mechanism.
According to a December 2009 AIDS epidemic update published by USAID, there were 33.4 million people living with HIV in 2008, 2.7 million newly infected individuals, and 2.0 million AIDS-related deaths. In order to arrest the progression of HIV infection, millions of people are faced with the need for daily medication. Medication adherence, the extent to which a patient takes a medication in the manner prescribed, is a critically important element in the care of HIV positive patients because it is a potentially alterable factor that can influence patient outcomes and health care costs. Despite its importance, adherence rates may be only 50-75% (DiMatteo, 2002, Sackett, 1979) or less in patients with HIV. There is an expanding literature on adherence to antiretroviral medication in adults but research efforts are lagging in studies of adherence in children and adolescents. The purpose of this RFA is to build the research field of pediatric adherence to medication and medical advice.
R01 grants will be used to allow multidisciplinary teams to develop and evaluate effective interventions to improve adherence in children, adolescents, and young adults. This will require an understanding of developmental stages as well as cognitive, social, and behavioral capabilities of individuals across childhood through young adulthood. Studies may involve characteristics relevant to individuals with HIV or at high risk of acquiring HIV (psychosocial, demographic, etc.), the disease state, barriers to adherence, measurement issues, and an understanding of the science of behavior change.
The ultimate goal of this FOA is to prevent or slow the transmission of HIV in children, adolescents, and young adults by improving adherence to medication and behavioral recommendations (i.e. abstinence when appropriate, condom use, avoidance of risky sexual behaviors). The purpose of the request for applications is to encourage the development and evaluation of effective interventions to enhance adherence to treatment regimens and behavioral recommendation in children, adolescents, and young adults. Improving adherence to medical and behavioral recommendations will depend upon recognizing and understanding the many factors associated with adherence. Research on these factors, the interactions of these factors, and on barriers to adherence will move the field forward in terms of developing effective methods of enhancing adherence, and ultimately improve patient compliance, reduce hospitalization rates and lengths of stay, and improve quality of life.
Lynne Haverkos, MDChild Development & Behavior BranchCenter for Research on Mothers and Children
A Request for Applications with set-aside is proposed entitled, “ Male Reproductive Health Research Career Development Program” using the K12 Physician Scientist Award program mechanism.
The purpose of this RFA is to announce the re-competition of the Male Reproductive Health Research (MRHR) Career Development Program. The National Institute of Child Health and Human Development (NICHD) provides funding for a limited number of center programs in male reproductive health. These centers support the research career development of urologists, reproductive endocrinologists and other clinicians who have recently completed sub-specialty training and who are commencing basic, translational and/or clinical research relevant to men's reproductive health. The goal of this initiative is to increase the clinical research capacity among practitioners in the area of male reproductive biology and promote the translation of basic science advances to clinical practice. The MRHR program will accomplish this through a mentored program, bridging clinical training with research independence. The intent is to increase the cadre of physician-scientists in male reproductive health.
Establishing a base of clinical investigators in male reproductive health will increase the ability to translate the rapid advances in male gamete biology and genetics into effective treatments for male infertility and contraception. To accomplish this goal, the research projects designed by the Scholars can be either basic or clinical in nature, as long as there is a described career development plan that would delineate how the project would enhance the Scholar's ability to conduct individual, peer-reviewed research at the end of the project period.
The MRHR Career Development awards will provide institutions with an opportunity to support the early careers of junior clinical investigators in male reproductive health. Established investigators at a research institution would combine to establish a career development program, agreeing to serve as mentors to recruited Scholars who are newly trained in a medical specialty relevant to male reproductive health. The mentors would make available their expertise, guidance and laboratory facilities to be utilized by the junior investigators for research projects that will enhance their basic science knowledge and skills, and lead to their development as independent physician-scientists.
Stuart B. Moss, PhDReproductive Science BranchCenter for Population Research
A Request for Applications (RFA) is proposed entitled “Mentored Specialized Clinical Investigator Development Awards (MSCIDA) for the Maternal Fetal Medicine Units Network (MFMU) and the Neonatal Research Network (NRN).” The proposed RFA will use the NIH Cooperative Clinical Research Agreement (U10) grant award mechanism.
The MSCIDA is intended to support the development of outstanding clinical research scientists, utilizing the existing resources and infrastructure of the Maternal Fetal Medicine Units Network (MFMU) and the Neonatal Research Network (NRN) to enhance the development of independent clinical investigators. The purpose of the Maternal Fetal Medicine Units Network and the Neonatal Research Network are to establish and maintain a multi-center research networks with an independent data-coordinating center and NICHD to perform clinical trials, observational research, and basic science. The network sites perform multi-center clinical trials in a rigorous manner to assess safety and efficacy of treatment and management strategies for pregnant women and newborn infants.
The NIH Cooperative Clinical Research Agreement (U10) grant award mechanism provides specialized study for individuals with a health professional doctoral degree committed to a career in laboratory or clinical based research. The proposed research must have intrinsic research importance as well as serving as a suitable vehicle for learning methodology, theories, and concepts necessary for a well-trained, independent researcher. The MSCIDA is intended to provide flexibility in supporting the research career development of fellows or junior faculty in Maternal Fetal Medicine and Neonatology. Due to the decreasing pool of clinical investigators, it is paramount that NICHD encourage development of individuals with research potential in the settings of the NICHD MFMU and NRN. This program is designed to train the next generation of clinical investigators. One application per site per network (MFMU and NRN) will be accepted on behalf of fellows or junior faculty, who will be board eligible or certified in Neonatology or Maternal Fetal Medicine, affiliated with Departments that have an active cooperative agreement in the NICHD Neonatal Research Network (NRN) or Maternal Fetal Medicine Units (MFMU) Network.
The objective of the Limited Competition for the FOA entitled Mentored Specialized Clinical Investigator Development Award (MSCIDA) is to encourage fellows or junior faculty in Maternal Fetal Medicine and Neonatal-Perinatal Medicine to develop skills in designing, executing, and interpreting research with emphasis in maternal-fetal and neonatal clinical trials research. In addition, the program is designed to suit and complement the experience and capabilities of awardees in coordinating multiple-site clinical trials, utilization of existing databases within the MFMU and NRN, and longitudinal studies in follow-up and outcomes research. Candidates must demonstrate the potential to develop into independent investigators. The award supports a two to three year period of a supervised research experience that may integrate didactic studies with laboratory or clinically based patient related research. Applications will be solicited on behalf of fellows or junior faculty, who will be board eligible or certified in Neonatology or Maternal Fetal Medicine, from Departments that have an active cooperative agreement in the NICHD NRN or MFMU Network. This program is for up to two new awards per network, and funding will be awarded as a supplement to the parent grant.
Rosemary D. Higgins, M.D.Pregnancy and Perinatology BranchCenter for Developmental Biology and Perinatal Medicine
A request for applications is proposed entitled “ Perinatally HIV-infected youth at IeDEA sites in Africa and Asia” using the U01 mechanism.
There has been a massive scale-up of antiretroviral treatment programs for children, including in sub-Saharan Africa, where approximately 90% of HIV-infected children worldwide live. While treatment access among African and Asian children still lags behind that of adults, in some areas over 40% of perinatally HIV-infected children in need of antiretroviral therapy are now receiving it. Overall, the scale up has resulted in an approximate quadrupling of the number of children receiving therapy between 2005 and 2008, with an approximate doubling in sub-Saharan Africa just between 2007 and 2008. These children, now surviving into young adulthood, will face the potential consequences of prolonged HIV infection and long term antiretroviral therapy on multiple organs and systems in the body, which may be exacerbated by endemic diseases and malnutrition in resource-limited countries and result in manifestations unique to this setting. Thus, it is critical to evaluate the effects of HIV and its therapy on youth in resource-limited countries as pediatric treatment is being scaled up.
A Request for Applications (RFA) is proposed entitled “ Prevention of HIV Transmission/Acquisition through a better understanding of Reproductive Health.”The proposed RFA will use the NIH Research Project grant (R01) and (R03) mechanisms.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), intends to issue a funding opportunity announcement (FOA) to further our understanding of HIV acquisition/transmission by increasing our knowledge regarding the intersection between reproductive health and HIV prevention. The emphasis of the FOA is to encourage comprehensive behavioral-biomedical approaches that can lead to new insights in HIV prevention research. The FOA will not support drug discovery or large scale clinical trials.
To date most clinical trials of both Microbicide and Vaccine candidates have been unsuccessful or marginally successful. There are many reasons for their lack of success, but suffice it to say that a vaccine with 30% efficacy or a Microbicide with 39% efficacy or a pill with almost complete reliance on daily adherence for efficacy is unlikely to be licensed. While such preventive measures may have public health implications, they will be unacceptable to the individual and health care workers, just as any contraceptive with a less than 90% success rate would be. Behavioral studies have also had limited success. To date the only two proven prevention strategies are condoms and circumcision. Condom use, however, given the continued high rates of pregnancy and HIV acquisition in women, would seem to also be of limited success. While male circumcision is 60% effective for male acquisition, it does not directly protect women from exposure. The premise of this FOA is that HIV prevention strategies must be integrally entwined with reproductive health strategies to be successful. Furthermore, such combination approaches have a much higher probability of acceptance.
An external analysis of the state of the field in this area including meeting reports and literature searches suggest research combining reproductive health and HIV acquisition/transmission would have high impact and significance. The recent Microbicides 2010 meeting highlighted the need for increased understanding of the role of fertility regulation/family planning studies in prevention programs. Many private foundations are in concert with this approach. This includes contraceptive choices for HIV-infected and at-risk women with biomedical-behavioral studies for fertility regulation. This also includes a better understanding of hormonal and other factors that impact on reproductive health and HIV transmission/acquisition in both women and men.
This FOA calls for a rethinking of science in the HIV prevention area, by going back to the basics. “Basics” is not limited to basic science but to a more a basic understanding of HIV prevention activities where they intersect with reproductive health. The initiative seeks to change the prevention effort from focusing on the discrete development of a specific vaginal (or oral) formulation compound, the sole purpose of which is to prevent HIV transmission, towards looking at the complexities and interactions surrounding fertility regulation, hormone use, sexuality and people’s desire to prevent both infectious disease and unwanted pregnancy. In this new direction the FOA calls for an examination of the role of hormones and hormonal fluctuation as a co-morbidity in HIV acquisition/transmission. We see the consequence of the actions or lack thereof of the co-morbidities as being pregnancy and/or HIV acquisition/transmission.
The FOA is broken into three general areas: the role of behavior in HIV-infected and at-risk women and couples that may impact on HIV acquisition/transmission; biomedical-behavioral studies for fertility regulation and its impact on HIV acquisition/transmission; and basic science research on endogenous and exogenous hormones and their affect on HIV acquisition/transmission. These studies may also improve our understanding of people’s fertility choices in uncertain contexts and situations. The rationale behind the approach is that a better understanding of the issues in reproductive health will enlighten our understanding of HIV acquisition/transmission.
Patricia Reichelderfer, Ph.D.
A Request for Applications (RFA) is proposed entitled “ Global Network for Women’s and Children’s Health Research.” The proposed RFA will use the NIH Cooperative Clinical Research Agreement (U01) for individual Research Units and the NIH Cooperative Research Project (U10) grant award mechanism for the Data Coordinating Center.
The purpose of this RFA is to announce the re-competition of the existing Global Network (GN) to design and develop urgently needed evidence-based research, and to test the potential for scale up of such interventions which would serve to inform DHHS, US Health Programs, international governments, NGOs, and other agencies. The GN is intended to strengthen and expand the global infrastructure for women’s and children’s health research by increasing knowledge development and transfer, forming collaborative partnerships among US and foreign investigators and institutions, and increasing opportunities for scientific linkages and interaction.
The scope of the proposed RFA will be to conduct research, including randomized trials, critical observational and qualitative studies, and impact evaluations that address the major causes of maternal, neonatal and early childhood morbidity and mortality.
The Global Network was funded in 2002 by NICHD, other Institutes, and the Bill and Melinda Gates Foundation in response to the alarming rates of morbidity and mortality among women and children in the developing world. Its mission is to enhance research capacity and infrastructure, by funding partnerships between US and foreign teams to conduct research on feasible, cost-effective, sustainable interventions that address the major causes of morbidity and mortality in women and young children. It was originally funded as cooperative agreements between NICHD, a data coordinating center (RTI), and 10 research units in South/Central America and Asia, each conducting large individual protocols to address such problems as postpartum hemorrhage, preeclampsia, and infection-related perinatal mortality. Two African sites were added in 2004. When the Global Network was recompeted in 2007, only 7 sites were included because of limited available funds. The GN now conducts multi-center population-based common protocols in order to test generalizability of interventions from the outset and allow for more rapid assessment of interventions than individual centers acting alone. An External Advisory Board will advise the Steering committee on the identification and prioritization of topics for research.
The objective of this solicitation is to accelerate the development of research capacity and infrastructure and to test urgently-needed interventions in up to 7 research units. The goal is to provide more evidence-based, cost-effective solutions to the maternal and child health problems that have plagued our partners in the developing world, the US and foreign governments, and the many NGOs working in international health.
Linda Wright, M.D.Global Network for Women's and Children's Health ResearchCenter for Research for Mothers and Children