NIH Challenge Grants in Health and Science Research (RFA-OD-09-003)

Please see NOT-OD-09-091 for information on the extension of the error-correction window until May 8, 2009 for grants submitted under this funding opportunity.

Please note: This Funding Opportunity Announcement has expired. The application due date was April 27, 2009.

NIH has received new funds for Fiscal Years 2009 and 2010 as part of the American Recovery and Reinvestment Act of 2009 (Recovery Act), P.L. 111-5 (PDF-1MB). The NIH has designated at least $200 million in FYs 2009 - 2010 for a new initiative called the NIH Challenge Grants in Health and Science Research.

This new program will support research on topic areas that address specific scientific and health research challenges in biomedical and behavioral research that would benefit from significant 2-year jumpstart funds.

The NIH has identified a range of Challenge Areas that focus on specific knowledge gaps, scientific opportunities, new technologies, data generation, or research methods that would benefit from an influx of funds to quickly advance the area in significant ways. Each NIH Institute, Center, and Office has selected specific Challenge Topics within the broad Challenge Areas related to its mission. The research in these Challenge Areas should have a high impact in biomedical or behavioral science and/or public health.

NIH anticipates funding 200 or more grants, each of up to $1 million in total costs, pending the number and quality of applications and availability of funds. In addition, Recovery Act funds allocated to NIH specifically for comparative effectiveness research (CER) may be available to support additional grants. Projects receiving these funds will need to meet this definition of CER: "a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy." Such research may include the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data as they apply to CER.

The application due date is April 27, 2009.


Broad Challenge Areas and Specific Challenge Topics

Note: Those marked with an asterisk (*) are the highest priority areas; however, applicants may apply to any of the topics.

For NINR, the Challenge Topics are:

(01) Behavior, Behavioral Change, and Prevention

01-OD(OBSSR)-101* Tools for Studying Cultural Phenomena

Development of new tools for: the measurement of culturally-shared mental phenomena (e.g. representations, scripts, prejudices); studying mechanisms by which these phenomena are transferred and adapted across individuals; and advancing research on the distribution and transmission of cultural phenomena within populations.
NINR Contact: Dr. Paul Cotton, 301-402-6423, cottonp@mail.nih.gov
OBSSR Contact: Dr. Christine Bachrach, 301-496-9485, cbachrach@nih.gov

01-OD(OBSSR)-102* Methods for Studying the Interactions among Behaviors, Environments, and Genetic/Epigenetic Processes.

Research is needed to develop analytic methods, systems science approaches, or computational models designed to address the interactions among individual behaviors, social and physical environments and genetic/epigenetic processes during critical developmental periods and over time. This research is essential to incorporating the dynamic complexity of behavior and environments in the study of gene-environment interactions in health.
NINR Contact: Dr. Joan Wasserman, 301-594-5971, wassermanje@mail.nih.gov
OBSSR Contact: Dr. Kay Wanke, 301-435-3718, wankek@od.nih.gov


(02) Bioethics

02-OD(OSP)-101* Unique Ethical Issues Posed by Emerging Technologies

Advances in biotechnology and biomedical science raise novel ethical, legal, and social issues. Research in this area is needed to understand the unique ethical concerns related to emerging technologies (e.g. biotechnology, tissue engineering, nanomedicine, and synthetic biology). These include issues such as dual use research, privacy, safety, intellectual property, commercialization and conflict of interest, among others. Research is also needed to assess how these novel issues are addressed under current oversight and regulatory structures and identify where there may be gaps and/or need for revised or new oversight approaches.
NINR Contact: Dr. Josephine Boyington, 301-594-2542, boyingtonje@mail.nih.gov
OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov

02-OD(OSP)-102* Ethical Issues in Health Disparities and Access to Participation in Research

Research is needed to assess the under-representation in biomedical and clinical research of U.S. minority populations, underserved populations, and populations who may be vulnerable to coercion or undue influence, to identify barriers to participation in research and to develop approaches for overcoming them. Additionally, studies are needed to assess the impact and ethical considerations of conducting biomedical and clinical research internationally in resource-limited countries.
NINR Contact: Dr. Josephine Boyington, 301-594-2542, boyingtonje@mail.nih.gov
OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov

02-OD(OSP)-103* Ethical Issues Associated with Electronic Sharing of Health Information

The development of an electronic health information infrastructure and the sharing of health information for patient care and research offer enormous promise to improve health care and promote scientific advances. However, the broad sharing of such data raises numerous ethical issues that may benefit from additional studies (e.g. those related to privacy and confidentiality). Examples include studies to assess risks associated with health information technology and the broad sharing of health information for research, and novel approaches for mitigating them. Examination could also include analysis of current oversight paradigms and suggestions for enhancements, as well as assessments of how privacy risks may change in the future.
NINR Contact: Dr. Josephine Boyington, 301-594-2542, boyingtonje@mail.nih.gov
OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov

02-OD(OSP)-104* Ethical Issues in the Translation of Genetic Knowledge to Clinical Practice

Genetics and genomics have great promise for the development of personalized medicine, yet the ethical, legal and social implications of both the research and application of genetic and genomic knowledge and technology are far reaching. Studies are needed to better understand the factors that influence the translation of genetic information to improved human health and the associated ethical issues. Examples of studies include those to address ethical issues related to broad sharing and use of new genetic information and technologies for research to improve human health, human subjects protection in genetic and genomic research, the identifiability of genetic/genomic information and how our understanding of identifiability is evolving, return of research results and incidental findings to subjects, alternative models of informed consent for broad data sharing for research, and the impact of intellectual property (IP) issues on development of new technologies.
NINR Contact: Dr. Josephine Boyington, 301-594-2542, boyingtonje@mail.nih.gov
OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov  

O2-OD(OSP)-105* Ethical Issues Raised by the Blurring between Treatment and Research

The distinction between clinical practice and research is growing less clear, a trend that may be more pronounced with respect to genetic information and medical records research. Studies are needed to better understand the ethical issues associated with this trend. Examples of studies include those to identify how this blurring in roles affects traditional human subjects protections, including, for example, essential practices such as informed consent, conceptions of the doctor/patient and investigator/subject relationship, and privacy protections.
NINR Contact: Dr. Josephine Boyington, 301-594-2542, boyingtonje@mail.nih.gov
OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov


(03) Biomarker Discovery and Validation

03-OD(OBSSR)-101* Developing High-throughput Biomarker Assays from Finger-stick Dried Blood Spots

Develop, using finger-stick dried blood spots, novel high-throughput biomarker assays, to identify lipids, proteins, metabolites, and genetic information to expand the array of available biomarkers for use in large community-based biosocial surveys.
NINR Contact: Dr. Karen Huss, 301-594-5970, hussk@mail.nih.gov
OBSSR Contact: Dr. Kay Wanke, 301-435-3718, wankek@od.nih.gov
 

(04) Clinical Research

04-NR-101* Integrating Cost-Effectiveness Analysis into Clinical Research

This initiative calls for the inclusion of rigorous cost-effectiveness analysis in the design and testing of new and innovative interventions, as well as existing interventions with demonstrated effectiveness. Cost-effectiveness research will provide accurate and objective information to guide future policies that support the allocation of health resources for the treatment of acute and chronic diseases across the lifespan. Innovative ideas and concepts are highly encouraged. Listed below are examples of research topic areas of interest involving cost-effectiveness analysis. This list is illustrative and not exhaustive.

--Examining health interventions for children, adults, or elders admitted to various health care settings (e.g., emergency rooms, traditional health care settings, specialty units, clinics, and non-traditional health care settings) and/or provided by different health care providers.
--Assessing health promoting interventions delivered for special populations (e.g., women and children, minority and underserved or vulnerable populations, those diagnosed with rare diseases).
--Testing the effects of new or novel health and clinical interventions.
--Comparing health and clinical interventions to improve access or delivery of health care directed towards improving patient, family, or community quality of life.
--Using study designs to compare health or clinical outcomes from electronic data sources, data from published studies, secondary data, and ongoing studies.
--Employing interdisciplinary research teams with scientific expertise in cost-effectiveness methodology, economics, decision analysis, outcome measurement, ethics, and/or the health professions.
--Examining strategies that translate disease prevention knowledge into improved clinical preventive services in a variety of health care settings.
--Exploring strategies to improve population-level health problems, such as health care disparities in underserved and vulnerable populations, that focus on health promotion/disease prevention, enhancing quality of life (e.g., symptom and pain management, caregiving), and improving end-of-life experiences.
NINR Contact: Dr. Linda Weglicki, 301-594-6908, weglickils@mail.nih.gov  

04-NR-102* Methods to Enhance Palliative Care and End-of-Life Research

This initiative will develop and test interventions to enhance the quality of care for persons with a life-threatening illness. This research will provide the foundation for the development of evidence-based guidelines to standardize palliative and end-of-life care. Innovative ideas and concepts are highly encouraged. Listed below are examples of research topic areas of interest involving palliative care and end-of-life research. This list is illustrative and not exhaustive.

--Use of empirically and theoretically based biobehavioral approaches to delineate symptoms and symptom cluster trajectories in different diseases, and to elucidate mechanisms underlying disparities in outcomes.
--Design technological approaches that support symptom management and promote positive patient and informal caregiver outcomes in diverse groups, including vulnerable populations.
--Facilitate positive adjustment and reintegration of bereaved survivors into society.
--Ascertain key issues related to quality of life across disease trajectories in clinical and community-based research settings.
--Identify, test, and/or create research tools and instruments for conducting studies across health disparate conditions.
--Elucidate issues about the feasibility, utility, robustness, and portability of tools in diverse research settings and populations.
--Support development of informatics to facilitate the integration and analysis of patient outcomes data from end-of-life studies.
NINR Contact: Dr. Josephine Boyington, 301-594-2542, boyingtonje@mail.nih.gov

04-NR-103* Improving Quality of Life of Patients and Family Following a War-Related Traumatic Injury

This initiative will develop and test personalized interventions to prevent complications in persons with war-related traumatic injuries during the post-hospitalization transition period, with the ultimate goal of improving the health and quality of life of individuals and families following a war-related traumatic injury. Innovative ideas and concepts are highly encouraged. Listed below are examples of research topic areas of interest for war-related traumatic injury. This list is illustrative and not exhaustive.

Studies using interventions that:
--Utilize interdisciplinary and community-based approaches targeted toward the individual and family members from the time between traumatic injury, intensive care unit treatment, rehabilitation, and the individual's return into the community.
--Prevent complications for the individual, targeting areas such as early detection of symptoms, symptom management, and continuity of care.
--Focus on adapting and adopting technologies to support individual and family well-being, functioning, health promotion, and quality of life throughout the rehabilitation continuum.
--Promote self-management for both the individual and family, including dissemination plans to improve quality of life.
NINR Contact: Dr. Karen Huss, 301-594-5970, hussk@mail.nih.gov


(06) Enabling Technologies

06-OD(OBSSR)-101* Using New Technologies to Improve or Measure Adherence

New and innovative technologies to improve and/or measure patient adherence to prescribed medical regimens and utilization of adherence-enhancing strategies in clinical practice would greatly enhance the health impact of efficacious treatments and preventive regimens. This challenge invites the development of new technologies to measure or improve patient adherence.
NINR Contact: Dr. Jeanette Hosseini, 301-594-5972, jeanetteh@mail.nih.gov
OBSSR Contact: Dr. Lynn Bosco, 301-451-4286, boscol@od.nih.gov


(07) Enhancing Clinical Trials

07-OD(OBSSR)-101* Improving and/or Assessing External Validity in Randomized Clinical Trials (RCTs)

The practice of conducting RCTs with volunteer samples recruited from patients in clinical or community settings limits the generalizability of results, a critical problem for comparative effectiveness research. Research is needed to develop scientific tools for improving and/or assessing the external validity of RCT results to known populations, including methods for applying probability sampling in the identification and recruitment of RCT participants, measuring biases in RCT participant pools, and accounting for such biases in the analysis of RCT results.
NINR Contact: Dr. Susan Marden, 301-596-9623, mardens@mail.nih.gov
OBSSR Contact: Dr. Ronald Abeles, 301-496-7859, abelesr@od.nih.gov


(08) Genomics

08-NR-101* Genetic and Epigenetic Predictors of Symptom Severity

This initiative will support research on the genetic underpinnings of symptom severity. The findings from this research will identify individuals at greatest risk for symptoms from both acute and chronic conditions and design individualized interventions that will maximize symptom management. Innovative ideas and concepts are highly encouraged. Listed below are examples of research topic areas of interest. This list is illustrative and not exhaustive.

--Identify genotypes associated with disease-protective strategies in individuals with chronic and acute conditions using advanced genomic technology (e.g., DNA chip and microarray analyses). These conditions include, but are not limited to, asthma, diabetes, hypertension, and osteoarthritis, or infectious disorders such as influenza, HIV/AIDS, chlamydia (clamidia), and hepatitis.
--Examine the complex interplay of genetics, culture, biology, and environment with health problems and the effectiveness of existing health-promoting interventions in populations and sub-populations (e.g., prostate cancer in African Americans; diabetes in Native Americans) using advanced genomic technology.
--Identify epigenetic factors such as environment, place of residence, and nationality which may be associated with differences in symptom expression.
--Evaluate the genetic contributions to the differences in patient outcomes that occur using evidence-based practices.
--Test genetically tailored, brief interventions which improve health-promoting or disease-preventing practices or self-management of symptoms leading to improved quality of life.
NINR Contact: Dr. Joan Wasserman, 301-594-5971, wassermanje@mail.nih.gov


(15) Translational Science
 
15-NR-101* NIH Partners in Research Program: Pathways for Translational Research

This two year initiative will develop strategies for dissemination of interventions with demonstrated effectiveness for translation into clinical practice by teams of academic and community research partners. This initiative will provide the knowledge to more rapidly move scientific findings into the communities to improve health. This initiative requires the involvement of two principal investigators with an established working relationship. One principal investigator will represent the research institution and one principal investigator will represent the community organization. Innovative ideas and concepts are highly encouraged. Listed below are examples of research topic areas of interest involving dissemination of translational research. This list is illustrative and not exhaustive.

--Evaluate strategies that promote interdisciplinary research collaboration between investigators and members of vulnerable/underserved communities.
--Utilize strategies that enhance community-based networks and infrastructure to translate research in collaboration with vulnerable and underserved populations.
--Identify technologies and environments that enhance and support the effective dissemination of research findings.
--Develop strategies that encourage investigators to integrate community and cultural factors in the dissemination of biobehavioral and clinical research findings.
--Evaluate strategies that promote consumer access and interpretation of health information based on research findings.
--Identify methods for assisting populations and communities in the adoption of results of biobehavioral and clinical research.
NINR Contact: Dr. David Banks, 301-496-9558, banksdh@mail.nih.gov


For general information on NINR implementation of NIH Challenge Grants, contact:
Dr. Linda Weglicki
Program Director
National Institute of Nursing Research
National Institutes of Health
Phone: 301-594-6908
E-mail: weglickils@mail.nih.gov

For Financial or Grants Management questions, contact:
Mr. Lawrence Haller
Grants Management Specialist
National Institute of Nursing Research
National Institutes of Health
Phone: 301-402-1878
E-mail: hallerl@mail.nih.gov

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