The purpose of this Funding Opportunity Announcement (FOA) is to seek research applications that pilot test approaches to improve diabetes and obesity prevention and/or treatment in healthcare settings where individuals receive their medical care. Research applications should be developed to pilot test practical and sustainable strategies to improve processes of care and health outcomes for individuals with or at risk of diabetes and/or obesity. The research should also focus on approaches with the potential to be broadly disseminated outside the specific setting where it is being tested. The goal is that, if the pilot study shows promising results, the data from the R34 will be used to support a full-scale trial focused on improving routine healthcare practice and informing healthcare policy for the prevention or management of diabetes and obesity. Therefore, interventions must be integrated into the existing healthcare structure and/or processes. The healthcare setting may not be used solely as a venue for recruitment.
November 1, 2018, February 14, 2019, May 14, 2019, November 1, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS 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.
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 available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
The purpose of this Funding Opportunity Announcement (FOA) is to seek research applications that develop and pilot test approaches to improve diabetes and obesity prevention and/or treatment in healthcare settings where individuals receive their medical care. Research applications should be developed to pilot test practical and sustainable strategies to improve processes of care and health outcomes for individuals with or at risk of diabetes and/or obesity. The research should also focus on approaches with the potential to be broadly disseminated outside the specific setting where it is being tested. The goal of the research is to use data from the R34, if the pilot study shows promising results, to support a full-scale trial focused on improving medical care and informing healthcare policy for the prevention or management of diabetes and/or obesity.
This FOA seeks applications for pragmatic pilot and feasibility studies that leverage existing staff and resources in healthcare settings. Applications that rely on grant support for interventionists do not meet the intent of this FOA and may be appropriate for one of the NIDDK FOAs for R21s (https://www.niddk.nih.gov/research-funding/current-opportunities), or other appropriate FOAs.
Diabetes is a common chronic disease that imposes considerable demands on the individual as well as the U.S. healthcare system. People with diabetes have a higher rate of cardiovascular disease than those without diabetes and are at increased risk for microvascular complications that may lead to kidney failure, lower limb amputation, and blindness. Obesity is a significant risk factor for type 2 diabetes and the prevalence of obesity in children and adults in the United States has dramatically increased in the past four decades. Overweight, obesity, and/or excessive weight gain during pregnancy are also contributing to rising rates of gestational diabetes mellitus (GDM) which in turn increases risk of future type 2 diabetes in the mother and child. Both type 1 and type 2 diabetes in youth are on the rise. Aging is also a risk factor for type 2 diabetes, and one in four nursing home patients have diabetes. Although diabetes occurs in all populations in the U.S., many minority racial and ethnic groups and individuals with low education and income are at higher risk for diabetes and its complications.
Diabetes prevalence and healthcare economics
Diabetes currently affects an estimated 30.3 million people in the United States. Another 86 million Americans aged 20 years or older are estimated to have prediabetes. The CDC estimates that one in three American children born in 2000 will develop diabetes at some point in their lives. The total estimated cost of diagnosed diabetes in 2017 was $327 billion, including $237 billion in direct medical costs and $90 billion in reduced productivity.
Diabetes treatment improves outcomes but many patients are not at goal
Large clinical trials clearly demonstrate that glycemic control and cardiovascular risk factor modification can reduce the risk of complications in both type 1 and type 2 diabetes. Although there have been considerable improvements in diabetes treatment options and in risk-factor control over the past three decades, research demonstrates that many individuals with diabetes (youth and adults) do not meet the recommended goals for diabetes care. Of particular concern, youth with type 2 diabetes frequently have poor glycemic control and high rates of co-morbidities (e.g., hypertension, microalbuminuria, and dyslipidemia) early in the course of their disease, putting them at high risk for developing cardiovascular complications in the prime of their lives. In addition, emerging adults with type 1 or type 2 diabetes may be particularly vulnerable to poor control of diabetes and CVD risk factors as they transition from pediatric to adult care systems. Women diagnosed with GDM represent another important vulnerable group, as responsibilities for the newborn may interfere with their obtaining appropriate postpartum screening and care to prevent the development of type 2 diabetes.
Lifestyle modifications prevents or delays diabetes but it is underutilized
It is also well established that behavioral lifestyle interventions, with modest (5-7%) weight loss, can prevent or delay development of type 2 diabetes in individuals at high risk for the disorder and, in individuals who already have type 2 diabetes, can decrease sleep apnea, reduce the need for diabetes medications, help maintain physical mobility, and improve quality of life. Although intensive lifestyle interventions, delivered by trained interventionists with highly motivated participants, lead to clinically meaningful weight loss, there is a need to develop and test approaches to weight loss and/or weight management that are implementable and sustainable in diverse healthcare settings and applicable to diverse populations. Governmental and non-governmental organizations have proposed prevention and intervention strategies to be carried out in such settings for adults (e.g., the Centers for Medicare & Medicaid Services) and children (e.g., the American Academy of Pediatrics); however, these strategies have not been widely tested for feasibility and effectiveness in clinical care.
Goals for this FOA
There is a need to test innovative and practical approaches to close gaps in care, including system, policy, clinic, provider(s), and patient-level interventions to improve care and outcomes for patients with diabetes. This FOA seeks research to develop and pilot test implementable and potentially scalable and sustainable strategies for healthcare delivery to prevent type 2 diabetes in at-risk individuals, improve care for individuals with type 1 and type 2 diabetes, and reduce associated long-term complications, or to pilot test obesity prevention and treatment strategies that can be implemented in healthcare settings where individuals receive their medical care. It is expected that data from pilot and feasibility studies that show promising results will be used to support a full-scale trial focused on improving routine healthcare practice and informing healthcare policy for the prevention or management of diabetes and obesity.
This funding announcement seeks applications to pilot test pragmatic research designs. Pragmatic research evaluates the effectiveness of interventions or therapeutic approaches in research designed to maximize applicability of the trial’s results to healthcare settings where individuals receive their medical care. Therefore, proposed interventions must be well-integrated into the existing healthcare delivery structure and/or processes and utilize the staff, resources, and facilities in healthcare setting/s where medical care is provided. Proposed interventions should not rely on research staff for implementation. In addition, the healthcare setting should not simply be used as a venue for recruitment. This supports the practicality of the intervention, and if effective, approaches tested under usual conditions will have greater potential to be adopted by similar healthcare providers and systems.
Obesity prevention and treatment strategies likely to be effective in healthcare settings may require some differing approaches and resources from those useful in diabetes care (e.g., more linkages with trained interventionists or programs outside of the clinical practice). However, the goal of testing pragmatic approaches that are well-integrated into medical care is similar for studies focused on diabetes and/or obesity prevention and treatment.
Applications may include approaches focused on the patient, provider, healthcare team, and/or healthcare system. Pilot studies that focus on providers may target physician as well as non-physician healthcare professionals or staff within the healthcare setting being studied or, for obesity prevention and treatment, may include linkages with providers or programs outside of the clinical settings. Areas of research focus should have the potential to generalize to other settings and types of payment and clinical practice situations. Applications should also study factors that will assist with determination of sustainability, acceptability, and feasibility for wide-spread implementation.
Trials that include community resources to augment healthcare should be designed so that the community resources are sustainable and well-integrated into healthcare delivery. Applications involving community resources should not create that resource but rather utilize existing community resources that are broadly available in communities. Referral to community programs or to providers outside of the clinical setting by the healthcare system or staff is not, by itself, an adequate linkage. For applications that include referral to or partnership with community programs, there should be some evidence that the community program or policy is directly linked to healthcare delivery through regular communication about patient progress and outcomes.
The focus of this FOA is on research in humans. Animal studies are not consistent with the intent of this FOA.
Interventions testing new or unapproved drugs or interventions designed with a placebo comparison are not appropriate for this FOA.
Multicenter trials (defined below) are not appropriate for this FOA.
Acceptable study endpoints
Research for this FOA should evaluate the feasibility of the proposed intervention and the preliminary impact of the intervention on a clinically meaningful and objective diabetes and/or obesity-related primary endpoint (e.g., HbA1c, weight/BMI change, hospitalizations, or ER visits). While blood pressure and lipid control are of major importance to prevention of diabetes complications, studies directed primarily at blood pressure and/or lipid control are outside the mission of NIDDK.
Studies addressing comprehensive management of diabetes including glucose, blood pressure and lipid control are encouraged. A co-primary endpoint that addresses glycemic control and another clinically meaningful endpoint (e.g.,
blood pressure and/or lipids) is responsive. Self-reported outcomes are not acceptable primary endpoints for the R34 or future R18 applications. However, Patient Reported Outcomes (PROs) such as quality of life or diabetes distress are
acceptable as a co-primary endpoint together with an objective clinical diabetes or obesity outcome (e.g., HbA1c, weight/BMI). A PRO is defined as the status of a patient’s health condition/s that is reported directly from the patient without amendment or interpretation of the patient’s response by anyone else ( https://www.fda.gov/downloads/drugs/guidances/ucm193282.pdf ). Under this FOA, PROs do not encompass any measure self-reported by a participant but must reflect this narrow definition. A PRO must also be assessed using a valid and reliable patient reported outcome measure.Other self-reported outcomes (e.g., knowledge, diet, physical activity, adherence) are not acceptable as primary or co-primary endpoints but may be secondary endpoints.
Improved processes of care, changes in patient or provider behavior, or acceptability from the perspective of intervention providers, or adoption of new models of care are also examples of important measures that, if used, should be included as secondary endpoints. Appropriate measures of feasibility may include, but are not limited to, measures to assess acceptability from the perspective of intervention providers and/or patients, an assessment of outreach strategies, recruitment and retention rates, visit attendance rates, and adherence to intervention protocol.
Examples of prevention or treatment approaches
Treatment approaches to be tested and populations of special interest include, but are not limited to:
Proposed interventions that are designed to address clinical outcomes for lower literacy patients, those with low-access to healthcare services, and diverse populations disproportionately affected by diabetes, prediabetes, and obesity are highly encouraged. Interventions that target populations vulnerable to poor glycemic control, such as adolescents, those transitioning to adult care, and young adults are encouraged. Interventions that test care strategies for older adults with diabetes who struggle with multiple chronic conditions and polypharmacy are also encouraged. Pragmatic trials focused on vulnerable populations should address their engagement, recruitment and retention.
Definition of a multicenter trial (not appropriate for this FOA)
Only pilot and feasibility studies designed with one or two distinct clinical research centers are appropriate under this announcement. For the purpose of this FOA, a clinical center may encompass one or more physical locations where the pilot trial is being conducted -- i.e., where study participants are recruited and/or intervened upon and/or have outcomes assessed under a single protocol – as long as all locations are under the overall direction of the principal investigator(s).
Multi-center pilot and feasibility trials (not appropriate for this announcement) are defined as those that include three or more clinical research centers where the study is conducted under the direction of investigators from three or more separate research centers, each responsible for the overall conduct of their center's performance. A data coordinating center is not considered a clinical research center.
Applicants are reminded of the NIH policy on the use of a single Institutional Review Board for multi-site research (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-076.html), as well as the NIH policy on the registration and reporting of the results of clinical trials (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-149.html).
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account.PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
Applications must describe the scientific rationale for pilot testing the proposed pragmatic intervention and strategies used to improve healthcare practice and inform policy for the prevention and/or management of diabetes and/or obesity. A discussion of how meaningful integration into the existing clinical care setting will be accomplished (i.e., making use of existing staff, resources, and facilities) is required. This discussion should include, where applicable, issues related to cost; potential for reimbursement; personnel; relevant partnerships with key decision-makers and staff; and other necessary resources for implementation and maintenance.
Applications must provide a scientific rationale for the selected primary study endpoint/s, which must be a clinically meaningful and objective diabetes and/or obesity related outcome (e.g., HbA1c, weight/BMI change, hospitalizations, or ER visits), either alone or as a co-primary endpoint in conjunction with another clinically meaningful endpoint (e.g., blood pressure and/or lipids) or an acceptable PRO (e.g., quality of life, diabetes distress). If applicable, a scientific rationale of additional secondary endpoints (e.g., processes of care, knowledge, diet, physical activity, or other self-reported measures) must be provided. Applicants must also provide a rationale for the selected measures and/or approach used to evaluate feasibility. Healthcare cost can be one of multiple measured endpoints or outcomes but cannot be the sole or primary endpoint that is measured.
For projects that include existing community resources to augment healthcare (e.g., 3rd party reimbursement for dietitians or lifestyle coaches or linkage to low-cost community-based or commercial weight management programs), although referral to such programs alone is not appropriate for this announcement, applications must describe how the resources are broadly available to community members and are well-integrated into the healthcare setting beyond serving as a referral linkage. For example, describe the feasibility of the proposed linkage between the healthcare setting and community resource, and the methods, systems, and /or processes in place for regular communication about patient progress and outcomes.
A full cost effectiveness analysis is not required but research funded implementation costs should be measured and considered in the study analyses.
Applicants are encouraged, where possible, to use electronic medical records or registries to ascertain study outcomes.
As applicable, applicants must describe the role of trainers and a plan for developing a training protocol should the R34 data be used for a full-scale trial.
Applicants must detail a plan for determining feasibility and evaluating whether the approach is successful enough to warrant moving to a full-scale trial. In addition, applicants should describe how the intervention may generalize to other healthcare settings; and how the research question and design will meaningfully inform healthcare practice and/or policy. A discussion on the potential scalability and sustainability of the proposed intervention, if successful as a full-scale trial, is also encouraged.
Letters of Support: Letters of support from leaders in the healthcare setting or system in which the research will be conducted are required. Letters must address the level of integration of the proposed project into clinical care practices and community resources as applicable; how existing resources will be leveraged; and the commitment to supporting a full-scale trial should the R34 study achieve the desired outcomes. In rare instances when grant funds are used to pay for interventionists, letters of support must state how the healthcare system will support the interventionists in a full-scale trial and address the potential for sustainability of these investments beyond a research funding period.
The following modifications also apply:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
2.5 Recruitment and Retention Plan
Please include a discussion of the availability of potential participants for the proposed study and anticipated yield from recruitment and screening efforts. If there is more than one site, provide a table showing the expected number of participants to be recruited at each site and overall. You may refer to the Inclusion Enrollment Report but do not duplicate information. The plan should also include a discussion of past experience in recruiting and retaining similar populations, expected challenges to recruitment and retention, and possible contingency plans.”
Section 3 - Protection and Monitoring Plans
3.3 Data and Safety Monitoring Plan
In addition to the description of safety monitoring, address plans to monitor trial performance, including plans to assure fidelity to the protocol and integrity of the data. Information about Data and Safety Monitoring Plans is available on the NIDDK website: https://www.niddk.nih.gov/research-funding/human-subjects-research/policies-clinical-researchers/data-safety-monitoring-plans .
Section 4 - Protocol Synopsis
4.3 Outcome Measures
Please indicate all timepoints when an outcome measure will be collected.
4.4 Statistical Design and Power
Since this FOA is designed to support pilot and feasibility, an efficacy based power analysis is not necessary. However, the sample size needed to pilot the proposed approach, including the assumptions used when estimating the sample size, should be detailed in relation to the analysis plan. If using more than one primary endpoint, applicants should also describe the appropriate analytical adjustments required for multiple primary endpoints, including secondary outcomes.
Section 5 - Other Clinical Trial-related Attachments
5.1 Other Clinical Trial-related Attachments
The filename "Milestone Plan.pdf" must be used for this attachment. If multiple Milestone Plans are needed, amend the file name accordingly (e.g., Milestone Plan 1, Milestone Plan 2, etc.)
The Milestone Plan attachment is separate and distinct from the Study Timeline attachment. Applicants are required to provide detailed interim performance measures and timelines for completing key objectives and administrative functions for the proposed clinical trial(s), as applicable. Milestones should be easily measurable and realistic. Milestones for a two-year R34 pilot and feasibility study may not be as extensive as a full-scale trial, but may include as appropriate:
These milestones will be negotiated at the time of the award, as appropriate. Future year support is contingent on satisfactory achievement of performance milestones. If milestones are not achieved fully, NIDDK may request development of a remedial plan and more frequent monitoring of progress, or take other remedial actions.
Applications that lack the Milestone Plan are considered incomplete and will not be peer-reviewed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
A proposed Clinical Trial application may include study design,? methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is the trial needed to advance scientific understanding?
Specific to this FOA
Will the research question and design meaningfully inform healthcare practice or policy? Does the intervention generalize to other healthcare settings?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance the field, scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Does the application adequately address the following, if applicable
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered or justified to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Specific to this FOA
Is the proposed intervention well-integrated into the routine practices of the healthcare setting or system (i.e., making use of existing staff, resources, and facilities)? Has the investigator demonstrated appropriate partnerships with the key decision makers and staff in the healthcare setting to justify that the proposed research is feasible? Have the researchers justified the potential for sustainability and dissemination of the approach if the pilot and feasibility study is promising? Is there a sufficient evaluation of the implementation costs and implementation process to meaningfully inform a future fully powered pragmatic trial? This evaluation should include, where applicable, issues related to cost, reimbursement, personnel, and other resources.
Do the required letters of support from leaders at the healthcare system and community resources, as applicable, provide compelling commitment to supporting a full-scale trial and the potential of sustainability of the intervention beyond the funded project period should the study achieve the desired outcomes?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
?Are the proposed milestones appropriate for the study? Will they allow meaningful tracking of study performance and are they feasible for the work proposed?
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials by law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nig.gov/ClinicalTrials_fdaaa/.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Robert Kuczmarski, Dr.P.H. (for adult obesity research)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Christine Lee, M.D. (for geriatric medical diabetes research)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Barbara Linder, M.D., Ph.D. (for pediatric diabetes research and gestational diabetes research)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Stavroula Osganian, M.D., Sc.D., M.P.H. (for pediatric obesity medical research)
National Institute of Diabetes and Digestive and Kidney Diseases
Pamela L. Thornton, Ph.D. (for behavioral and health disparities diabetes research)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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