Intervening with Cancer Caregivers to Improve Patient Health Outcomes and Optimize Health Care Utilization (R21)

PAR-16-318
Intervening with Cancer Caregivers to Improve Patient Health Outcomes and Optimize Health Care Utilization (R21)
Department of Health and Human Services
National Institutes of Health

breast-cancer-caregivers
Breast cancer care
Purpose

This purpose of this Funding Opportunity Announcement (FOA) is to promote research on interventions designed to support caregivers of adult cancer patients. Interventions that are appropriate for this FOA may be intended to provide caregivers with care training, promote coping skills, and ultimately help them manage care. Outcomes of such interventions are expected to (1) optimize patient health care utilization, (2) improve caregiver well-being, and (3) improve patient physical health and psychosocial outcomes.

Applications submitted to this FOA should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Whereas this FOA is for pilot/exploratory projects, a companion FOA of identical scientific scope (PAR-16-317) is meant for well-developed projects supported by preliminary data.

Background

Informal/family cancer caregivers are individuals who manage care for cancer patients, usually a friend or family member. The care that they manage is typically uncompensated, delivered at home, involves significant amounts of time and energy, and requires the performance of tasks that may be physically, emotionally, socially, or financially demanding. Caregiving tasks can include monitoring for treatment side effects, helping manage symptom burden, treatment decision-making, administering medication, and performing some technical medical tasks (e.g., managing infusion ports, changing dressings). Cancer treatment is now more frequently provided in outpatient and community-based centers, which increases the day-to-day demands on informal caregivers. As lay supporters, caregivers are often underprepared to perform the many tasks required of them and this can lead to negative health consequences. Given that the prevalence of people, in particular older adults, living with cancer is growing, the number of cancer caregivers can also be expected to grow. This anticipated growth will be accompanied by simultaneous increases in the demands placed on caregivers, compounded by the fact that cancer care continues to move further into the outpatient and home settings. The physical and psychosocial health (e.g., comorbidities, depression) of patients and their caregivers are often related, suggesting a need to intervene to improve outcomes for both caregivers and patients.

Specific Research Objectives

Applications submitted to this FOA should propose intervention studies that target a combination of the cancer caregiving outcomes in the following three areas:

1. Healthcare utilization outcomes (e.g., patient readmission to the hospital, number of emergency room visits, caregiver use of health care services, and caregiver use of cancer support services);

2. Caregiver well-being outcomes (lower burden, higher capacity, and better quality of life), and

3. Patient health outcomes (e.g., physical health, symptom burden, health-related quality of life and functioning).

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-16-318
Funding Opportunity Title: Intervening with Cancer Caregivers to Improve Patient Health Outcomes and Optimize Health Care Utilization (R21)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Education
Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.395 — Cancer Treatment Research
93.399 — Cancer Control
Cost Sharing or Matching Requirement: No
Posted Date: Jun 08, 2016
Last Updated Date: Jun 08, 2016
Original Closing Date for Applications: Apr 11, 2019  
Current Closing Date for Applications: Apr 11, 2019  
Archive Date: May 12, 2019
Estimated Total Program Funding:
Award Ceiling: $200,000

Eligibility

Eligible Applicants:
Independent school districts
Private institutions of higher education
Native American tribal governments (Federally recognized)
City or township governments
Small businesses
Others (see text field entitled “Additional Information on Eligibility” for clarification)
State governments
Public and State controlled institutions of higher education
County governments
Special district governments
Public housing authorities/Indian housing authorities
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
For profit organizations other than small businesses
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Additional Information on Eligibility: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Additional Information

Agency Name: National Institutes of Health
Description: This Funding Opportunity Announcement (FOA) invites applications for intervention research designed to support caregivers of adult cancer patients. Interventions supported by this FOA are intended to provide caregivers with care training, promote coping skills, and ultimately help them manage care. Outcomes of such interventions are expected to (1) optimize patient health care utilization, (2) improve caregiver well-being, and (3) improve patient physical health and psychosocial outcomes.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-16-318.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

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Innovative Questions in Symptom Science and Genomics (R21)

PA-16-023
Innovative Questions in Symptom Science and Genomics (R21)DNAstethoscopesmaller
Department of Health and Human Services
National Institutes of Health

Research Objectives

Symptom Science

  • What are the biological and behavioral dynamics of symptoms (e.g., dyspnea, fatigue, impaired sleep/insomnia, pain, depression) that can change the trajectory of chronic illnesses, and how can the dynamics be optimized and maintained to prevent symptom relapse?
  • What innovative care delivery models (e.g. interdisciplinary, family-based), research methods (e.g. community engaged research, pragmatic trials) and technologies (e.g. eHealth) can be leveraged to improve symptom management and change the chronic illness trajectory especially among individuals who experience disparate health outcomes?
  • How do lifestyle factors, environmental conditions, symptom clusters and symptom treatments impact quality of life and symptom management in different chronic conditions?
  • How do symptom precursors (e.g. biomarkers or conditions such as obesity) contribute to the physiology of symptom risk, severity, duration and response to treatment?
  • What are the ‘omic’, phenotypic and state dependent indicators related to the mechanism, assessment and management of high impact symptoms (e.g. pain, fatigue, dyspnea) and what is the added value of these indicators beyond clinical parameters in explaining physical and psychological symptoms in both patients and their informal caregivers?
  • What are the common mechanistic pathways (e.g. stimulus to perception, perception to report) that can distinguish underlying symptom cluster trajectories that are amenable to intervention at various points along those pathways?
  •  What are the personalized markers (e.g. biomarkers and clinical factors) that can be used to stratify subgroups of patients with different patterns among symptoms to determine the symptom management strategies most effective in improving quality of life?
  • What innovative methodologies (e.g. modeling) can be used to analyze symptom management algorithms to identify the interventions most likely to be successful in clinical or pragmatic trials?
  • How can we create a standardized, feasible, valid, and relevant data and technology infrastructure to routinely collect and aggregate symptom data from patient health records but also from other types of assessments (biological, physiological, performance) to inform clinical care and research?
  • What are the biological indicators that can help determine the presence and severity of subjective symptoms in individuals who cannot self-report (e.g. small children; individuals with cognitive decline) to help improve clinical assessment and management? Is there a role for fMRI?
  • What state-of-the-art research designs/methods (e.g. mixed methods, SMART, MOST) should investigators use to test personalized symptom management strategies to include scalable interventions?
  • What are the biologic, physiologic and/or omic mechanisms underlying symptoms and patient outcomes?
  • Based on individual omics, environmental factors, and behavior what are the most effective and targeted interventions that can be expedited for translation to reduce risk and promote health?
  • What are the relative contributions of omic markers and phenomic data in predicting individual responses to therapeutic interventions that improve patient outcomes such as quality of life?
  • For high risk patients who are at the end of life, how can genetic assessment and DNA banking be used to address familial risk?
  • How should omic discoveries be used to create and test technologies (such as clinical tools) that can be used to diagnose clinical problems, predict the clinical course and promote optimal outcomes?
  • In what ways can genomic information be used to promote adherence and improve self-management of chronic conditions?
  • How does the social environment interact with gene expression to influence resilience in coping with life challenges?
  • The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research.

General Information

Document Type: Grants Notice
Funding Opportunity Number: PA-16-023
Funding Opportunity Title: Innovative Questions in Symptom Science and Genomics (R21)
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Education
Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.361 — Nursing Research
Cost Sharing or Matching Requirement: No
Posted Date: Oct 30, 2015
Creation Date: Oct 30, 2015
Original Closing Date for Applications: Jan 7, 2019  
Current Closing Date for Applications: Jan 7, 2019  
Archive Date: Feb 7, 2019
Estimated Total Program Funding:
Award Ceiling: $200,000
Award Floor:

Eligibility

Eligible Applicants:
Small businesses
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Special district governments
Private institutions of higher education
City or township governments
Native American tribal governments (Federally recognized)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Public and State controlled institutions of higher education
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Others (see text field entitled “Additional Information on Eligibility” for clarification)
For profit organizations other than small businesses
Independent school districts
County governments
State governments
Additional Information on Eligibility: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

Additional Information

Agency Name: National Institutes of Health
Description: This initiative seeks to optimize innovation, insight and cutting edge conceptual and technological breakthroughs by catalyzing research that emanates from the identified innovative questions in symptom and genomic nursing science. These innovative questions are reflective of broad domains from which more specific novel hypotheses or problems to be solved can be derived.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PA-16-023.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

For More Grant Opportunities on this Topic please See:

R01: http://www.grants.gov/web/grants/view-opportunity.html?oppId=279905

R15: http://www.grants.gov/web/grants/view-opportunity.html?oppId=279906

Adaptation/Optimization of Technology (ADOPTech) to Support Social Functioning (R21)

RFA-MH-17-150

Adaptation/Optimization of Technology (ADOPTech) to Support Social Functioning (R21)
Department of Health and Human Services
National Institutes of Health

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A R21 Grant is an Exploratory/Developmental Research Grant

Research Strategy: Applications should discuss how the technology will produce a measureable impact on a key aspect of social functioning (e.g., social communication, perception and understanding of self or others, etc.) rather than increasing or improving a discrete behavior (e.g., eye contact). In addition, applications must discuss how the novel technology would eventually be translated into mainstream or everyday contexts (e.g., the feasibility of fully customized technologies vs. commercially available products which have been augmented for specialized use). Applications that do not address how the novel technology will be translated into mainstream contexts will be considered incomplete.

Finally, when such features are relevant, applications should address test-retest reliability, optimal duration or length of measurement, scalability of the technology, and use of indicators or metrics to determine accuracy, thresholds, and/or fidelity.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. The National Institute of Mental Health (NIMH) has established an informatics infrastructure to enable the sharing and use of data collected from human subjects in clinical research by the entire research community. Researchers funded by this FOA are expected to deposit data from human subjects into this infrastructure. Please refer to NOT-MH-15-012 for details regarding the available data repositories.

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

For more information on a SF424 please see the example under the Grant Writing tab above.

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-MH-17-150
Funding Opportunity Title: Adaptation/Optimization of Technology (ADOPTech) to Support Social Functioning (R21)
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.242 — Mental Health Research Grants
Cost Sharing or Matching Requirement: No
Posted Date: Oct 22, 2015
Creation Date: Oct 22, 2015
Original Closing Date for Applications: Feb 3, 2016  
Current Closing Date for Applications: Feb 3, 2016  
Archive Date: Mar 5, 2016
Estimated Total Program Funding: $2,500,000
Award Ceiling: $200,000
Award Floor:

Eligibility

Eligible Applicants:
Private institutions of higher education
For profit organizations other than small businesses
City or township governments
Independent school districts
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Native American tribal organizations (other than Federally recognized tribal governments)
Public and State controlled institutions of higher education
Small businesses
County governments
State governments
Special district governments
Additional Information on Eligibility: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

Additional Information

Agency Name: National Institutes of Health
Description: The purpose of this Funding Opportunity Announcement (FOA) is to facilitate the development and testing of new, cutting-edge technologies to enhance functioning in individuals with social impairments. Projects funded under this FOA would create social prosthetics: scalable technology or devices that would augment performance in this domain.
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-17-150.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

Examination of Survivorship Care Planning Efficacy and Impact (R01) and (R21)

PA-16-012
Examination of Survivorship Care Planning Efficacy and Impact (R01)
Department of Health and Human Services
National Institutes of Healthplan_beyond_cancer-slider

Specific Research Objectives

Applications are expected to assess whether care planning renders added benefits in terms of reducing morbidity, increasing adherence to follow-up guidelines, better self-management of late effects, appropriate utilization of follow-up care, and reduced cost.  The proposed research should also evaluate the pathways and processes through which such benefit is derived and clarify to whom such benefits accrue (survivors, clinicians, delivery systems, payers). Transdisciplinary approaches that link health services and health economics research with clinical, behavioral, and social science disciplines are encouraged. Studies documenting the organizational context and key processes through which successful care planning occurs are invited, including those that study how the generation and use of survivorship care plans intersects with processes of care delivery, inter-provider communication, patient-provider communication, and meaningful use of informatics. Studies linking care planning to use of electronic medical records, and exploring ways to harness electronic platforms, tools and applications are encouraged. Studies of how successful care planning initiatives are implemented in a variety of healthcare and community practice settings are encouraged. Studies may include family and caregiver outcomes in addition to survivor outcomes. Studies that will be considered for funding are limited to those that focus on individuals diagnosed with cancer at age 21 or older.

Research Applications are particularly encouraged to consider the following issues in the Research Strategy:

  • Inclusion of at least one survivor-level outcome (behavioral, physical and/or psychosocial morbidity) and at least one provider or system-level outcome (service use, time use, knowledge) related to care delivery or cost.
  • Studies assessing the impact of care planning or identifying effective models of care are expected to use comparative designs (randomized controlled trials, quasi-experimental, case-control, interrupted time series, or similar designs) that allow comparison of care planning strategies.
  • Adjunctive qualitative or quantitative observational approaches are encouraged in the context of the above designs.
  • Because the standard of care is not yet consistently established, investigators are expected to carefully document and describe the care planning protocol studied in all inquiries. Studies are encouraged to use care plans that include, but are not limited to, Institute of Medicine-recommended content for survivorship care plans.
  • Studies focused on the development and testing of instruments to evaluate survivorship care planning may use the R01 mechanism or the companion R21 mechanism, as appropriate.

Research areas of interest include, but are not limited, to:

  • What are the best constructs and outcomes for evaluating survivorship care planning and which metrics are best suited to measure these?
  • What is the impact of survivorship care planning on cancer survivors’ post-treatment psychosocial and physiologic morbidity?
  • What is the effect of survivorship care planning on adherence to screening recommendations, preventive behaviors, and self-management of late and long-term effects of cancer?
  • What is the optimal timing for delivery of survivorship care planning?
  • Does survivorship care planning decrease unnecessary health care resource utilization?
  • What are the differential costs associated with the generation and implementation of care plans versus usual care, and what value is added, if any?
  • How do care plans affect the number of patients seen/day, the length of patient visits, number of patient visits to oncology and/or primary care, information systems, and reimbursements?
  • Who should be involved, and how, in the development and delivery of care plans? What are the respective roles of oncology and primary care physicians, nurses, social workers, and other allied health professionals in the care planning process?
  • What systems, organizational and provider-level factors influence the generation, transmission, communication, usability, and ultimate consistent use of survivorship care plans?
  • What incentives and barriers affect adoption of survivorship care planning across diverse healthcare practice settings?
  • What economic strategies could encourage implementation of care planning?
  • Does provider participation in the development of care plans and the care planning process affect implementation of care planning?
  • How can electronic platforms, tools, and applications be harnessed to optimize patient knowledge, patient preparation, and/or care coordination in survivorship care planning?
  • What costs are associated with face-to-face vs. hybrid, automated, or wiki-supported approaches to survivorship care planning?

General Information

Document Type: Grants Notice
Funding Opportunity Number: PA-16-012
Funding Opportunity Title: Examination of Survivorship Care Planning Efficacy and Impact (R01)
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Education
Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.399 — Cancer Control
Cost Sharing or Matching Requirement: No
Posted Date: Oct 23, 2015
Creation Date: Oct 23, 2015
Original Closing Date for Applications: Jan 7, 2019  
Current Closing Date for Applications: Jan 7, 2019  
Archive Date: Feb 7, 2019
Estimated Total Program Funding:
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants:
Independent school districts
Small businesses
Others (see text field entitled “Additional Information on Eligibility” for clarification)
For profit organizations other than small businesses
Public housing authorities/Indian housing authorities
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
County governments
City or township governments
Special district governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
State governments
Additional Information on Eligibility: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

Additional Information

Agency Name: National Institutes of Health
Description: The purpose of this Funding Opportunity Announcement (FOA) is to stimulate research evaluating the effect of care planning on self-management of late effects of cancer therapy; adherence to medications, cancer screening, and health behavior guidelines; utilization of follow-up care; survivors’ health and psychosocial outcomes. How organizational-level factors influence the implementation of care planning and its associated costs is also of interest. Specifically, the FOA aims to stimulate research that will: 1) develop and test metrics for evaluating the impact of survivorship care planning; 2) evaluate the impact of survivorship care planning on cancer survivors’ morbidity, self-management and adherence to care recommendations, utilization of follow-up care; 3) evaluate effects of planning on systems outcomes, such as associated costs and impact on providers and organizations implementing the care planning; and 4) identify models and processes of care that promote effective survivorship care planning. The ultimate goal of this FOA is to generate a body of science that will inform the development and delivery of interventions that improve follow-up care for cancer survivors.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PA-16-012.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

Novel Nucleic Acid Sequencing Technology Development (R43/R44)

Novel Nucleic Acid Sequencing Technology Development (R43/R44)
Department of Health and Human Servicesimages
National Institutes of Health

Purpose

This Funding Opportunity Announcement (FOA)  seeks R43/R44 SBIR grant applications from small businesses to develop novel technologies that will enable at least one order of magnitude improvement in DNA sequencing, and practical methods for direct RNA sequencing.  Advances in genomics and more broadly in biomedical research have been greatly facilitated by significant and sustained DNA sequencing throughput increases and cost decreases.  The goal now is to improve the quality and efficiency of DNA sequencing and enable direct RNA sequencing (e.g., longer read lengths, faster turn-around time, greater accuracy, and higher-throughput etc.) at reasonable costs with the anticipation that significant advances in any of these and related areas would make significant contributions to the mission of NHGRI and the field of genomics, including to many of NHGRI’s other technology development goals.

Background

The ability to sequence large and ever growing numbers of complete genomes and transcriptomes coupled with the free dissemination of sequence data have dramatically changed the nature of biological and biomedical research.  DNA and direct RNA sequence in combination with other genomic data have the potential to lead to remarkable improvement in many facets of human life and society, including the understanding, diagnosis, treatment and prevention of disease; advances in agriculture, environmental science and remediation; and our understanding of evolution and ecological systems.

The ability to sequence many genomes and transcriptomes has been made possible by the enormous reduction of the cost of sequencing in the past three decades, from tens of dollars per base in the 1980s to a small fraction of a cent per base today.  Technology advances, and in particular the development of a new generation of sequencing systems, have enabled the launch of many projects that are producing stunning insights into biology and disease.  Nevertheless, the cost to completely sequence very large numbers of entire genomes of individual cells or people remains very high, and we remain far from achieving the low costs and high quality needed to enable the use of comprehensive genomic and transcriptomic sequence information in individual health care.

One of the major contributions by NHGRI has been in the genomic technology domain.  Those efforts have been so transformative that it is hard to remember genomics without, for example, a reference human genome, inexpensive short-read sequencing, efficient bacterial artificial chromosome methods, microarrays, defined common human haplotypes, single molecule sequencing, and many other significant technical advances.  Bright prospects for future success motivate investing in genomic technology development specifically for novel sequencing methodologies.

Objectives

NHGRI seeks to fund research efforts in novel chemistries, physical approaches and instrumentation for DNA and direct RNA sequencing.  New methodologies and substantial advances beyond existing approaches are sought that would, if successful, significantly propel forward the field of genomics.  Applicants may propose work on DNA or direct RNA sequencing, or both, in a single application.

The FOA deliberately does not specify cost, quality, throughput or read lengths since achievable endpoints are likely to improve over the life of the opportunity, and applicants are encouraged to optimize and balance these key attributes for the technology approach proposed.  It is expected that awardees will develop scientific and practical definitions of optimal cost, quality and read lengths relative to enabling significant genomics opportunities. Priority will be given to applications that propose improvements of at least an order of magnitude (based on state of the art at the time the application is submitted); such improvements may be achieved by focusing on one critical factor, or a combination of important ones.

For DNA sequencing, novel methods that generate large numbers of long reads of high quality with a low cost are sought.  New physical or chemical detection methods for sequencing are especially encouraged along with substantive (at least an order of magnitude) improvement to current high-throughput DNA sequencing technologies.  Those methods that yield novel sequence based insights or that solve existing limitations in the field (e.g., de novo assembly of human genomes, base modification determination, complete and quantitative sequencing of all the DNA in a sample, essentially complete genomes of single cells, very small quantities of starting material down to a single cell, very long reads of at least 150Kb, etc.) are of especially high interest.

For RNA sequencing, the need is for quantitative and high-throughput direct sequencing of entire transcripts from the transcriptome.  Awardees are expected to develop novel methods for quantitatively assessing the sequence of full length RNA without a cDNA intermediate.  Enabling new approaches to RNA analysis is a key goal of direct RNA sequencing (e.g., exhaustive sequencing of every RNA molecule in a sample or precise quantification across the entire very high dynamic range of RNA transcripts, determination of base modifications, determining RNA secondary structural elements while sequencing, cost-effective and statistically-robust single cell transcriptomics, etc.).

High-risk and high-reward proposed research may plan to develop complete systems or novel key components for nucleic acid sequencing.  Very novel physical or chemical approaches to sequencing are solicited along with novel enzymatic methodologies.  The technology developed can either develop an entirely new way of sequencing or significantly improve existing sequencing methodology.

Document Type: Grants Notice
Funding Opportunity Number: RFA-HG-15-033
Funding Opportunity Title: Novel Nucleic Acid Sequencing Technology Development (R43/R44)
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.172 — Human Genome Research
Cost Sharing or Matching Requirement: No
Posted Date: Aug 17, 2015
Creation Date: Aug 17, 2015
Original Closing Date for Applications: Aug 27, 2017  
Current Closing Date for Applications: Aug 27, 2017  
Archive Date: Sep 27, 2017
Estimated Total Program Funding: $2,000,000
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants:
Small businesses
Additional Information on Eligibility: Other Eligible Applicants include the following: Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.

Additional Information

Agency Name: National Institutes of Health
Description: This Funding Opportunity Announcement (FOA) solicits R43/R44 SBIR grant applications from small businesses to develop novel technologies that will enable new approaches to DNA and direct RNA sequencing. Applicants may propose to develop novel complete sequencing systems, investigate challenges underlying key novel system components, or propose improvements of at least an order of magnitude improvement to existing systems. Exploration of methods other than those currently in use is highly encouraged. High-risk/high-payoff applications are appropriate to achieve the goals of this FOA.
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-HG-15-033.html

Ethical, Legal and Policy Issues in HIV Research with Key Populations (R21)

PAR-15-327hiv-aids
Ethical, Legal and Policy Issues in HIV Research with Key Populations (R21)
Department of Health and Human Services – National Institutes of Health

Purpose

This funding opportunity announcement (FOA) seeks applications to addresses ethical, legal, and policy challenges in HIV-related research and program implementation among key populations. The term “key populations” describes populations that experience high risk of HIV acquisition due to certain behaviors and risk exposures.  2014 WHO Guidance states: “Key populations are defined groups who, due to specific higher-risk behaviors, are at increased risk of HIV irrespective of the epidemic type or local context. Also, they often have legal and social issues related to their behaviors that increase their vulnerability to HIV The 2014 WHO guidance addresses five key populations: (1) men who have sex with men; (2) people who inject drugs; (3) people in prisons and other closed settings; (4) sex workers and (5) transgender people.  This FOA calls for research related to those five groups and also includes research related to adolescent girls and young women at high risk of HIV acquisition or living with HIV.

Adolescent girls and young women are not at high risk in all settings, and therefore, this FOA is directed to research in settings known to have a high incidence of HIV in this age group.  Young women are included in this FOA because social, legal and ethical issues related to inclusion of minors in research, structural factors affecting risk, and other complex contextual issues can pose challenges for research with adolescents and young women.

Research applications may include scholarship in ethical, legal or policy areas and can include conceptual analysis, empirical analysis using qualitative or quantitative methodology, or combined conceptual and empirical work.  This FOA will not include clinical trials.

Support for the “Ethical, Legal and Policy Issues in HIV Research with Key Populations” is available under two separate companion FOAs that are being published concurrently. This FOA is soliciting for R21 applications that will support shorter term (up to two years) developmental/exploratory research activities, whereas the companion R01 FOA will support more developed (up to 5 years) applications.

Background

HIV prevention, care and treatment for key populations are critical.  Because key populations have a high risk of HIV acquisition, reaching them with effective prevention, care and treatment is critical to ending the epidemic.  But the same behaviors or characteristics that lead to high risk of acquisition also lead to significant challenges in engaging with them, due to stigma, criminalization of certain behaviors, violence, marginalization, social isolation, and other social and economic factors.  Thus, development of effective research studies and accessible prevention, care and treatment programs is both necessary and profoundly complex in key populations.

There are challenges in research and program implementation with key populations.  Research and program activities involving key populations can be risky for study participants, care providers, and researchers.  Cultural, legal and political environments can increase stigma, risk of violence, social harm, or criminal sanctions.   These conditions also complicate the scientific and ethical conduct of research studies, including epidemiology, social science and behavioral studies, structural and policy interventions, clinical trials, and implementation studies.

At the same time, failure to include key populations in important research activities, or exclusion from health programming, leads to further exacerbation of HIV risk, poor health outcomes and increased transmission dynamics within affected communities. Previous studies have documented severe disparities in access to prevention, care and treatment for key populations in many settings.  These conditions are serious public health and human rights concerns, and impede efforts to control and reduce the impact of HIV.

In addition to challenging background conditions, many of the prevention and treatment interventions that have been tested or are under development do not address specific health needs of key populations, or may not be suited to the social, political or economic context in which they live.  Research studies developing and testing new approaches will need to include key populations at all stages of research and in some cases, tailor or adapt interventions to ensure their effectiveness, feasibility, acceptability and safety in these groups.

Topics of interest

Research projects addressing ethical, legal and policy issues of particular interest are described below.   This list is not exhaustive and applications may address other topics within the scope of the FOA.

Minimizing and Managing Risk  

Social and political conditions lead to key populations experiencing diverse risks, including social harm, violence, stigma, criminalization, aggressive policing practices, social isolation, loss of employment or housing, or other adverse outcomes.  Research studies have the potential to exacerbate these risks, to provide some level of protection from harm, or to elicit a mixture of harms and benefits.  Researchers and care providers may also experience some risks in settings where working with specific populations is illegal or stigmatized.  While it is critical for relevant research studies to include key populations, any risks imposed by the research itself, or exacerbation of background risks, must be minimized and managed appropriately.  The assessment of overall risks and benefits of research will need to take into account the level of baseline risk, whether or how research may affect risk, ways to mitigate these risks, and what kinds of benefits of research participation, if any, may offset risks.

Possible topics related to risk minimization and management include, but are not limited to:

  • Risk assessment and risk mitigation strategies for social, legal or other kinds of harms in the context of research; including threats to physical or mental health; problems with family or other relationships; economic issues such as loss of housing or employment, and other types of adverse consequences; risks related to data security or data breaches in the context of research or clinical care.
  • Development and testing of methods for risk management as part of site-preparedness activities for clinical research; activities might include rapid policy assessment, stakeholder engagement; creation of partnerships with government agencies or NGOs; agreements for referral arrangements for needed ancillary care, social services, or other mechanisms
  • Development and assessment of strategies for capacity building for risk assessment and risk mitigation in the context of research and implementation studies; for example, strategies to improve sustainability of risk mitigation efforts.
  • Empirical and conceptual analysis of benefits and risks of research participation for key populations; for example, questions of whether benefits of research participation can reasonably offset risks; whether any limits on research participation ought to be imposed based on background risks, and whether or how these limits could be set.

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Mental Health (NIMH)

Funding Opportunity Title

Ethical, Legal and Policy Issues in HIV Research with Key Populations (R21)

Activity Code

R21 Exploratory/Developmental Research Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-15-327

Companion Funding Opportunity

PAR-15-328 R01 Research Project Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.855, 93.856; 93.242

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages applications to analyze and address ethical, legal, or policy challenges specific to work with key populations in HIV research or health care.

Proposed projects should be focused on ethical, legal or policy challenges in relation to research studies or program implementation for HIV or associated co-morbidities, affecting one or more of the following key populations: (1) men who have sex with men; (2) people who inject drugs; (3) people in prisons and other closed settings; (4) sex workers; (5) transgender people or (6) adolescent girls and young women at high risk of HIV acquisition or who are living with HIV.  This FOA encourages both empirical and conceptual research projects addressing these topics.

Key Dates

Posted Date

August 7, 2015

Open Date (Earliest Submission Date)

December 7, 2015

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

January 7, 2016; September 7, 2016; January 7, 2017; September 7, 2017; January 8, 2018; September 7, 2018, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

February 2016; October 2016; February 2017; October 2017; February 2018; October 2018

Advisory Council Review

May 2016; January 2017; May 2017; January 2018; May 2018; January 2019

Earliest Start Date

July 2016; April 2017; July 2017; April 2018; July 2018; April 2019

Expiration Date

September 8, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons.