Child Health and Human Development Extramural Research

 

To conduct and support laboratory research, clinical trials, and studies with people that explore health processes. NICHD researchers examine growth and development, biologic and reproductive functions, behavior patterns, and population dynamics to protect and maintain the health of all people. To examine the impact of disabilities, diseases, and defects on the lives of individuals. With this information, the NICHD hopes to restore, increase, and maximize the capabilities of people affected by disease and injury. To sponsor training programs for scientists, doctors, and researchers to ensure that NICHD research can continue. By training these professionals in the latest research methods and technologies, the NICHD will be able to conduct its research and make health research progress until all children, adults, families, and populations enjoy good health.

The mission of the NICHD is to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability, and to ensure the health, productivity, independence, and well-being of all people through optimal rehabilitation.

General information about this opportunity
Last Known Status
Active
Program Number
93.865
Federal Agency/Office
Agency: Department of Health and Human Services
Office: National Institutes of Health
Type(s) of Assistance Offered
PROJECT GRANTS
Program Accomplishments
Fiscal Year 2014: Fiscal year 2014 competing and noncompeting research project grants actuals were 1,534. Of this number, 78 were SBIR/STTR awards. Exactly 53 research centers were awarded. A total of 486 other research grants were awarded. Institutional training awards were 555 in fiscal year 2014. The individual training awards in fiscal year 2014 were 91. Fiscal Year 2015: Fiscal year 2015 competing and noncompeting research project grants estimates are 1,538. Of this number, 83 are expected to be SBIR/STTR awards. Approximately 48 research centers will be awarded. A planned 456 other research grants are anticipated to be awarded. Projected institutional training awards are 542 in fiscal year 2015. The individual training award are projected for fiscal year 2015 to be 93. Fiscal Year 2016: Fiscal year 2016 competing and noncompeting research project grants estimates are 1,576. Of this number, 88 are expected to be SBIR/STTR awards. Approximately 74 research centers will be awarded. A planned 426 other research grants are anticipated to be awarded. Projected institutional training awards are 550 in fiscal year 2016. The individual training award are projected for fiscal year 2016 to be 106.
Authorization
Public Health Service Act, Section 301, 448 and 487, as amended, Public Laws 78-410 and 99-158, as amended, 42 U.S.C. 241; 42 U.S.C. 285g; 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564, Public Law 113-235.
Who is eligible to apply/benefit from this assistance?
Applicant Eligibility
Universities, colleges, medical, dental and nursing schools, schools of public health, laboratories, hospitals, State and local health departments, other public or private institutions, both nonprofit and for-profit, and individuals. National Research Service Award: Support is provided for academic and research training only, in health and health-related areas that are periodically specified by the National Institutes of Health. Individuals with a professional or scientific degree are eligible (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree). Predoctoral research training grants to institutions are also supported. Proposed study must result in biomedical or behavioral research training in a specified shortage area and which may offer opportunity to research health scientists, research clinicians, etc., to broaden their scientific background or to extend their potential for research in health-related areas. Applicants must be citizens of the United States or be admitted to the United Ss for permanent residency; they also must be nominated and sponsored by a public or private institution having staff and facilities suitable to the proposed research training. Domestic nonprofit organizations may apply for the institutional NRS grant. SBIR: SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees). Primary employment (more than one- half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the U.S. or its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more that 500 employees) which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.
Beneficiary Eligibility
Any nonprofit or for-profit organization, company, or institution engaged in biomedical or biobehavioral research.
Credentials/Documentation
Applicants should submit electronically via Grants.gov as directed in the relevant NIH Funding Opportunity Announcement. All required forms specified in the application kit are to be completed by the applicant and submitted with the application package. National Research Service Award: Individual Award: The applicant's academic record, research experience, citizenship, and institution sponsorship should be documented in the application. Institutional Award: the applicant organization must show the objectives, methodology, and resources for the research training program, the qualifications and experience of directing staff, the criteria to be used in selecting individuals for awards, and a detailed budget and justification for the amount of grant funds requested. For-profit organizations' costs are determined in accordance with 48 CFR, Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined by HHS Regulations, 45 CFR, Part 74, Subpart Q. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. 2 CFR 200, Subpart E - Cost Principles applies to this program.
What is the process for applying and being award this assistance?
Pre-Application Procedure
Preapplication coordination is not applicable. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.
Application Procedure
This program is excluded from coverage under 2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. National Research Service Award: Prior to formal application, an individual must arrange for acceptance at a sponsoring institution by a sponsor who will supervise the training. Individuals must be sponsored by a domestic or foreign institution. SBIR/STTR: Same as for grants (above). Applications are submitted electronically via Grants.gov following the general guidance provided at: http://grants.nih.gov/grants/forms.htm and the specific instructions for the respective Funding Opportunities Announcement which may be found at: http://grants.nih.gov/grants/guide/index.html?CFID=50541572&CFTOKEN=87322295&jsessionid=f630f3b44e23db8088b9e5e5224596361271
Award Procedure
Each application receives a dual scientific review by non-NIH scientists. Awards are issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). National Research Service Awards: Applications are reviewed for scientific merit by an appropriate study section committee or by an institute review committee. If recommended for approval and a decision is made to make an award, a formal award notice will be sent to the applicant and sponsor. Institutional Awards are issued by the Eunice Kenney Shriver National Institute of Child Health and Human Development (NICHD). All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for the available SBIR/STTR set-aside funds on the basis of scientific and technical merit and the commercial potential of the proposed research, program relevance, and program balance among the areas of research.
Deadlines
Contact the headquarters or regional office, as appropriate, for application deadlines.
Approval/Disapproval Decision Time
> 180 Days. From 6 to 9 months: National Research Service Awards: From 6 to 9 months. SBIR/STTR: approximately 6 months.
Appeals
A principal investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH web site at: http://public.csr.nih.gov/ApplicantResources/InitialReviewResultsAppeals/Pages/default.aspx.
Renewals
> 180 Days. Renewal applications are accepted, as described in the relevant Funding Opportunity Announcement (FOA) found at: http://grants.nih.gov/grants/guide/index.html?CFID=50541572&CFTOKEN=87322295&jsessionid=f630f3b44e23db8088b9e5e5224596361271. National Research Service Awards: awards may be made for 1, 2, or 3 years. No individual may receive NIH fellowship support at the postdoctoral level for more than 3 years. Institutional Awards may be renewed.
How are proposals selected?
The major elements in evaluating proposals include assessments of the significance of the proposed research; approach; innovation; investigators; and environment. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.
How may assistance be used?
Grantee agrees to administer the grant in accordance with the regulations and policies governing the research grant programs of the Public Health Service as stated in the terms and conditions on the application for the grant. National Research Service Awards: Awarded to individuals for full-time research training in specified behavioral and biomedical shortage areas. Awardees may utilize some of their time in academic and clinical duties if such work is closely related to their research training. Awards may be made to institutions to enable them to make NRS awards to individuals selected by them. Each individual awardee is obligated upon termination of the award to comply with certain service and payback provisions. SBIR Phase I grants (of approximately 6-months' duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants are for the continuation of the research initiated in Phase I and which are likely to result in commercial products or processes. STTR Phase I grants (normally of 1- year duration) are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential on Phase II application.
What are the requirements after being awarded this opportunity?
Reporting
NIH requires that grantees periodically submit financial and progress reports. Other required reports may include annual invention utilization reports, lobbying disclosures, conflict of interest reports, audit reports, reports to the appropriate payment points (in accordance with instructions received from the payment office), and specialized programmatic reports. Grantees also are expected to publish the results of research in peer-reviewed journals and to provide information to the public on the objectives, methodology, and findings of their NIH-supported research activities, as specified in Administrative Requirements—Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Research Resources.

The GMO is the official receipt point for most required reports. However, NIH has centralized the submission of annual progress reports; details are provided below. In addition, electronic submission through the eRA Commons is required for some annual progress reports and available for all closeout documents (final grant progress reports, final invention statements and certifications, and final financial status reports). When a paper non-competing continuation progress report is submitted, only a signed original is required; no copies are required. Submission of these reports to an address other than the centralized one may result in delays in processing of the non-competing continuation award or the submission being considered delinquent. FFRs must be electronically submitted to OFM (see Financial Reports below) through the eRA Commons eFFR feature unless otherwise indicated in the award’s terms and conditions.

Grantees are allowed a specified period of time to submit required financial and final progress reports (see 45 CFR parts 74.51 and 74.52, 92.40 and 92.41, and the discussion in this subsection). Failure to submit complete, accurate, and timely reports may indicate the need for closer monitoring by NIH or may result in possible award delays or enforcement actions, including withholding, removal of certain NIH Standard Terms of Award, or conversion to a reimbursement payment method (also see Administrative Requirements—Enforcement Actions). The schedule for submission of the non-competing continuation progress report is discussed in the next subsection. The FFR has a dedicated section to report Federal cash receipts and disbursements. For domestic grantees this information is submitted quarterly directly to the PMS using the web-based tool. Quarterly reports are due 30 days following the end of each calendar quarter. The reporting period for this report continues to be based on the calendar quarter. Questions concerning the requirements for this quarterly financial report should be directed to the PMS.

For awards issued to foreign institutions after October 1, 2012, even though payment is now through PMS, the requirement for quarterly cash reporting does not apply. These awards are now administered in PMS using subaccounts and payments will be specific to each grant at the time the grantee draws funds. Progress reports usually are required annually as part of the non-competing continuation award process. NIH may require these reports more frequently. The “Non-Competing Continuation Progress Report” (PHS 2590) or equivalent documentation (e.g., Research Performance Progress Report [RPPR]) must be submitted to, and approved by, NIH to non-competitively fund each additional budget period within a previously approved project period (competitive segment). Except for awards subject to SNAP, the progress report includes an updated budget in addition to other required information.

NIH continues to transition to using the RPPR for progress reporting. The RPPR is a federal wide format for the submission of required annual or other interim performance reporting on grant and cooperative agreement awards. The transition to RPPR will be implemented in phases through a module in the eRA Commons. The RPPR is now required for all SNAP and fellowship awards. The PHS 2590 non-competing continuation progress report is currently required for all other NIH awards; however, the RPPR will eventually replace the PHS 2590 paper progress report. Reports of expenditures are required as documentation of the financial status of grants according to the official accounting records of the grantee organization. NIH requires all financial expenditure reports to be submitted using the Federal Financial Report (FFR) system located in the eRA Commons. This includes all initial FFRs being prepared for submission and any revised FSR/FFRs being submitted or re-submitted to NIH. The eRA Commons Federal Financial Report (FFR) system allows participants to view information on currently due and late expenditure reports and to submit these reports electronically to NIH. Paper expenditure reports are not accepted. Expenditure data submitted to NIH is initially reviewed and accepted by OFM. NIH IC grants management staff also review these expenditure reports.

Except for awards under SNAP and awards that require more frequent reporting, the FFR is required on an annual basis. An annual FFR is required for awards to foreign organizations made prior to October 1, 2012 and Federal institutions made prior to October 1, 2013, whether or not they are under SNAP. When required on an annual basis, the report must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended. The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter. Failure to submit timely reports may affect future funding. The report also must cover any authorized extension in time of the budget period. If more frequent reporting is required, the NoA will specify both the frequency and due date.

In lieu of the annual FFR expenditure data, NIH will monitor the financial aspects of grants under SNAP by using the information submitted directly to PMS. The GMO may review the report for patterns of cash expenditures, including accelerated or delayed drawdowns, and to assess whether performance or financial management problems exist. For these SNAP awards, FFR expenditure data is required only at the end of a competitive segment. It must be submitted within 90 days after the end of the competitive segment and must report on the cumulative support awarded for the entire segment. An FFR must be submitted at this time whether or not a competing continuation award is made. If no further award is made, this report will serve as the final FFR. The grantee institution is required to submit a progress report on an annual basis for each grant award, which includes monitoring of performance.
Auditing
In accordance with the provisions of 2 CFR 200, Subpart F - Audit Requirements, non-Federal entities that expend financial assistance of $750,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Non-Federal entities that expend less than $750,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in 2 CFR 200.503. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal officials.
Records
Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period.
Other Assistance Considerations
Formula and Matching Requirements
This program has no statutory formula.
This program has no matching requirements.
This program does not have MOE requirements.
Length and Time Phasing of Assistance
Awards are usually made annually with no project period to exceed 5 years in length. National Research Service Awards: From 1 to 3 years. SBIR: Phase I awards are generally for 6 months; Phase II awards normally may not exceed 2 years. STTR Phase I awards are generally for 1 year; Phase II awards normally may not exceed 2 years. See the following for information on how assistance is awarded/released: Each year, submitted progress reports for awarded grants are reviewed, and if satisfactory progress is demonstrated, a Notice of Grant Award is issued.
Who do I contact about this opportunity?
Regional or Local Office
None.
Headquarters Office
Eugene G. Hayunga, 6100 Executive Blvd., Room 2C01, Bethesda, Maryland 20892-7510 Email: ehayunga@mail.nih.gov Phone: (301) 496-6856.
Website Address
http://www.nichd.nih.gov/Pages/index.aspx
Financial Information
Account Identification
75-0844-0-1-552 - DHHS/NIH/ Eunice Kennedy Shriver National Institute.
Obligations
(Project Grants) FY 14 $901,630,353; FY 15 est $900,146,000; and FY 16 est $918,210,000 - PROJECT GRANTS (non-SBIR/STTR and SBIR/STTR combined): FY 2014 actual $901,630,353; FY 2015 estimate $900.146,000; FY 2016 estimate $918,210,000.
Range and Average of Financial Assistance
For research project grants, fiscal year 2015, range is $50,000 to $5,000,000; average is $450,663. Individual research fellowship awards: Basic stipend (first year beyond the doctoral degree) of $44,556. The sponsoring institution will be provided, on application, with an allowance of up to $7,900 per year to help defray the cost of training. No dependency allowances. SBIR: Average Phase I awards are for approximately $225,000 (grant activity R43 - for up to six months); Phase II awards may be made for amounts up to $1,500,000 (grant activity R44 - for up to two years).
Regulations, Guidelines and Literature
42 CFR 52; 42 CFR 66; 45 CFR 74; 45 CFR 92; NIH Grants Policy Statement, (Rev.) March 1, 2001, available on the NIH website at http://grants.nih.gov/grants/policy/nihgps_2001/; NIH Guide to Grants and Contracts, available on the NIH website at http://grants.nih.gov/grants/guide/. Grants will be available under the authority of and administered in accordance with the NIH Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 USC 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications.
Examples of Funded Projects
Fiscal Year 2014: Reproductive Health, Pregnancy, and Perinatology: The program in reproductive health, pregnancy, and perinatology supports basic, clinical, and translational research on an array of topics, including contraception, fertility and infertility, gynecologic disorders, and pregnancy and care of the newborn. Contraception research encompasses discovery of potential and new pharmaceutical targets, non-pharmaceutical devices, and other methods to increase safe, effective, and acceptable contraceptive options for both women and men. Program research on male and female fertility and infertility addresses not only interventions, but also the underlying mechanisms, including environmental causes, that enhance or impair the capacity to conceive. In this context, researchers recently assessed whether exposure to common chemicals, often used in plastics manufacturing, could affect the ability to conceive. They found that women whose male partners had high urine concentrations of three common chemicals took longer to become pregnant than women whose male partners did not. However, female urinary concentrations of the same three substances were not associated with a delay in pregnancy. The program’s pregnancy-related research spans preconception care, pregnancy, fetal growth, labor and delivery, and maternal and neonatal health. Studies to reduce rates of high-risk pregnancies and preterm birth, as well as complications, such as preeclampsia and other conditions, are also supported.

Pediatric Health: The pediatric health program supports a comprehensive array of basic and clinical research and research training on such topics as basic scientific investigations of biological processes that control healthy and atypical development; clinical studies in pediatric pharmacology, pediatric HIV, and associated infections; nutrition science; pediatric endocrinology; and pediatric trauma and critical illness. This program includes studies of congenital and developmental disorders to understand processes that influence normal and abnormal embryonic and fetal development. Research to expand relatively limited scientific knowledge about the safety, efficacy, and appropriate doses of pharmaceuticals for children is also part of this portfolio. As part of NICHD’s responsibilities under the Better Pharmaceuticals for Children Act, the program collaborates with the Food and Drug Administration to improve labeling of drugs for use in children. Domestic and international research on HIV infection and its effects in pregnant women and children is also an important aspect of this program, including recent work to determine why some infants developed resistance to nevirapine (NVP), an antiretroviral drug used to decrease rates of mother-to-child HIV transmission. Using data from a large study of NVP, scientists found that, among infants who became infected with HIV after 6 weeks of age, those who received extended NVP regimens were more likely to develop NVP resistance. Similarly, infants who were already infected with HIV were more likely to develop resistance when their HIV-positive breastfeeding mothers were treated with NVP. When considered with previous research findings, these latest results help inform guidelines for treating HIV-infected infants. Additional program research on nutrition and endocrinology aims to describe the interactions between nutrients and hormones in growth and development, and the role of nutrition throughout the life cycle, but especially in infancy, childhood, and adolescence. Other program interests include lactation and breastfeeding, childhood obesity, antecedents of bone health, as well as pediatric critical illness and trauma.

Intellectual and Developmental Disabilities: The program in intellectual and developmental disabilities (IDDs) supports basic, clinical, and translational research, and research training to advance knowledge on origins of common and rare IDDs, such as Down, Fragile X, and Rett syndromes, inborn errors of metabolism, and autism spectrum disorders (ASD). The program includes an additional emphasis on research to unravel the complex processes through which these disorders compromise cognitive, emotional, social, and physical development in infants and children and through the lifespan. Recent research supported by the program, using data from Sweden’s universal health registry, found that most of the genetic risk for ASD came from genes common in the population, rather than from rare variants or spontaneous mutations in the genetic code. Other program advances and activities are based on the concept that it is best to detect and treat childhood illnesses as early as possible, particularly when so many IDDs start in infancy. Accordingly, the IDD program includes newborn screening studies and related research focused on diagnosing and treating a wide array of IDDs and other illnesses. This includes a recent effort in which scientists tested the reliability of a screening test for severe combined immunodeficiency (SCID), an inherited immune deficiency in newborns that affects the development and function of infection-fighting immune cells. Unless treated early, SCID is fatal usually within the first two years of life. By evaluating data from more than three million newborns across 10 States and the Navajo Nation, scientists found that screening detected 52 newborns with SCID, equivalent to 1 in 58,000 infants; previous estimates suggested SCID was less prevalent, affecting only 1 in 100,000 infants. Having a more accurate screening test allows physicians to diagnose and treat SCID infants promptly, before infections become overwhelming.

Demography and Behavior: The program in demography and behavior aims to increase understanding of how population structure and change affect individual, family, and community health, including understanding infants’ and children’s health and development and how local communities and the larger society may influence these outcomes. The program’s research examines factors that contribute to health risk behaviors and the spread of sexually transmitted infections, as well as factors that affect family formation, functioning, and stability. Consider the research on demographic and use patterns of young women who use, or fail to use, dual contraception to protect against sexually transmitted diseases and unplanned pregnancy: NICHD-supported researchers found that only one-fifth of young women used dual methods, and that those at highest risk for unplanned pregnancy were least likely to use them. A related study determined that although only 10 percent of women used the most effective types of reversible contraception, use of these methods has increased steadily over the last decade. This broad program also encompasses important topics in behavioral development, from work to understand trajectories of typical cognitive, affective, and social development, to studies of language, attention, reasoning, problem-solving, and multiple mechanisms underlying typical learning and learning disabilities, such as dyslexia. By exploiting emerging technologies, researchers are examining the combined neurobiological and genetic bases of behavioral development and learning as well as identifying the biobehavioral mechanisms that underlie resiliency and risk-taking behaviors, especially during adolescence. Researchers recently found that teens with higher cortisol responses to stress tended to be safer drivers, had fewer crashes and near crashes, and seemed to improve at avoiding crashes over time.

Rehabilitation: Through the National Center for Medical Rehabilitation Research (NCMRR), the rehabilitation program fosters research and research training to enhance the health, productivity, independence, and quality of life of people with disabilities. The program supports a broad range of research, including examinations of the underlying biology of injury and disability and the body’s mechanisms of recovery and adaptation. NCMRR’s activities include a special emphasis on research related to spinal cord injury (SCI), traumatic brain injury (TBI), and stroke, frequently in collaboration with other NIH ICs and other partners. In this context, researchers found that a physical therapy intervention, which incorporated a type of electrical muscle stimulation, helped to preserve bone mineral density in people with SCI. Another important aspect of this program is NCMRR’s support of the development of medical devices and equipment, and of treatments to improve mobility and enhance the functional capabilities of individuals with disabling conditions. Recently, NICHD-supported scientists tested a new type of prosthetic implant (in an animal model) and showed that the implants may be less prone to infection than those currently in use. Fiscal Year 2015: FY 2015: Program Directions and Changes -- Over the past two years, NICHD has begun to transform its “Scientific Vision: The Next Decade” into a living document and guide. However, to continue funding the investigator-initiated research that is central to its mission, NICHD will be able to expand work in only a few of the many promising areas that the document highlights. With very limited funds for new initiatives, NICHD will focus on funding a few additional grants in three areas: 1) creating new ways to study the workings arguably the most understudied human organ -- the placenta -- and its impact on fetal, maternal, and lifelong health; 2) the science needed to improve contraceptive options for both men and women; and 3) the long-term implications of assisted reproductive technologies. These topics represent significant research gaps unique to NICHD’s mission and ones unlikely to be funded through other public or private research investments.

This past year, NICHD worked with two Blue Ribbon Panels. One reviewed the science and organization of NICHD’s Division of Intramural Research (DIR); the other reviewed the science and organization of medical rehabilitation research across the NIH, particularly the National Center for Medical Rehabilitation Research (NCMRR) at NICHD. The final report of the DIR Blue Ribbon Panel focused on how to maintain essential intramural research in the face of significant resource cuts. The NCMRR report offered ways to reshape and reinvigorate rehabilitation research. NICHD will begin implementing the most important recommendations of each report by reorganizing its intramural programs and by strengthening collaboration in rehabilitation research across NIH.

For the past few years, NICHD has continued to make decisions that represent difficult tradeoffs. By maintaining and extending support for research training and career development grants and for the Small Business Innovation Research program, NICHD has continued to protect the next generation of researchers and the program that helps small business commercialize research innovations. To accomplish this, however, NICHD had to cut other grant mechanisms and significantly restrict the number of other new grants funded. Similarly, NICHD acted to preserve and help rebuild some of the research infrastructure lost in Hurricane Sandy, honoring all relevant requests, but at reduced levels.

Despite such tradeoffs, the nation continues to enjoy strong returns from NICHD’s research investments, which ultimately improve clinical care and save lives. For example, NICHD research showed that the biology underlying early developmental growth holds promise for addressing cancer and other conditions. Researchers have long known that some of the genes that promote rapid growth in prenatal and early postnatal life are reactivated in cancer cells. NICHD researchers identified a molecular on-off switch that controls some of these genes. This finding may help scientists understand the complex genetic choreography responsible for normal growth and identify some of the earliest origins of disease to help prevent certain cancers.

Recently, NICHD-supported researchers discovered possible new biomarkers for stillbirth and preeclampsia. This precision testing represents a first step to help scientists identify earlier, and eventually prevent, these life-threatening conditions. NICHD-supported researchers also helped to develop a wireless, implanted sensor to broaden the range of precision-oriented brain research. The sensor permits more natural studies of brain activity in moving subjects, a major step toward cord-free control of advanced prosthetics, powered by human thought, which could change the lives of those with physical disabilities.

Today’s far-reaching technological and computational capabilities also offer unprecedented opportunities to connect researchers with each other, industry partners, and the public. NICHD established the first national Down syndrome registry, a Web-based registry that serves as a national resource for people with Down syndrome and their families, researchers, and health care providers. Although nationally based data resources can accelerate scientific progress, they must be used with great care. Recently, NICHD announced that it will co-fund new studies to understand how genomics, newborn screening technologies, and the collection and use of related data influence parental decision-making and physician behavior.

Advances that improve clinical practice and public health rely on basic research that provides new insights into long-standing health challenges. NICHD-supported researchers discovered that cells of the placenta secrete tiny, balloon-like structures called vesicles. Absorbed by other cells, the vesicles program the recipient cells to ward off viral infections. One day, researchers hope to transfer this innate virus-fighting ability to other organs and tissues. This exciting finding also illustrates the potential of conducting research on the placenta. Data increasingly suggest that the placenta, which changes over time, has a huge impact on the lifelong health of both baby and mother. Yet the mechanisms that underlie these protective or harmful outcomes remain a mystery. The great challenge lies in finding non-invasive and safe ways to study the human placenta in real time, to give researchers and clinicians their first window into the forces that shape health over time. Being able to move forward in this and other exciting areas of developmental science, without jeopardizing the success of programs that NICHD has spent more than a half century building, is at the core of the difficult tradeoffs that we have made and continue to face. NICHD will persist in making difficult choices, focusing on areas that few others can or will pursue and that hold the most promise to improve the health of children, women, those with disabilities, families, and communities. Fiscal Year 2016: In FY 2016, NICHD will also support broad NIH scientific efforts:

•Precision Medicine Initiative: NIH proposes to launch a national research cohort of one million or more Americans – to propel our understanding of health and disease and set the foundation for a new way of doing research through engaged participants and open, responsible data sharing. Participants who voluntarily choose to join this effort will be able to share their genomic data, biological specimens, and behavioral data, and, if they choose, link it to their electronic health records (EHRs), taking advantage of the latest in social media and mobile applications, and with appropriate privacy protections in place. Bona fide researchers from across the country will have access to data voluntarily provided, thereby crowdsourcing rich data to the brightest minds in biomedical research. The cohort will be built largely by linking existing cohorts together taking advantage of infrastructure, data security and expertise already in place. NIH will help to connect these existing cohorts, but the current sponsors of the cohorts will maintain their ownership and management. Research on this scale promises to lead to new prevention strategies, novel therapeutics and medical devices, and improvements in how we prescribe drugs – on an individual and personalized basis. NICHD is requesting $4.5 million in its budget to support this priority.

•BRAIN Initiative: In FY 2014 NIH launched the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative as a large-scale effort to equip researchers with fundamental insights necessary for treating a wide variety of devastating brain disorders like Alzheimer’s, schizophrenia, autism, epilepsy, and traumatic brain injury. NIH is requesting a total of $70 million in new funding for this Presidential initiative. NICHD is requesting $2.25 million in its budget to support this priority.

 



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