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.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This funding opportunity announcement (FOA) is being issued by the NIH Adherence Network through the Office of Behavioral and Social Sciences Research (OBSSR), with participation from multiple NIH Institutes. This FOA encourages Exploratory/Developmental Research Project Grant (R21) applications for research and development of interventions to significantly improve medication adherence in individuals. Applications may target medication adherence in the context of treatment for a single illness or chronic condition (e.g., hypertension), to stave off a disease recurrence (e.g., cancer) or for multiple comorbid conditions (e.g., hypertension, diabetes, alcohol use disorders and HIV/AIDS). A well-articulated theoretical or conceptual framework is key for applications solicited under this announcement. Applicants should demonstrate the feasibility of collecting multi-modal data on the targets of the intervention including: a patient self-report of medication adherence, at least one non-self-report measure of medication adherence (e.g., pharmacy refill records, electronic monitoring, etc.), and a relevant health outcome or biomarker (e.g., blood pressure, viral load in HIV-infected individuals, cholesterol levels, HbA1c) that is expected to be affected by changes in the targeted adherence behavior. For diseases without identified biomarkers, inclusion of a clinical assessment (e.g., a medicine blood level, diagnostic interview or an independent clinician rating of the symptoms and behaviors) may be considered.

The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of adherence investigation or a new experimental system that has the potential to enhance health-related adherence research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area of adherence. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.

Many of the leading causes of death in the United States are behavior-related and, therefore, preventable. Increased adherence to recommended medication regimens is an area of the behavioral and social sciences that promises substantial improvements in public health as well as savings in healthcare costs. For these reasons, improving adherence has been identified by National Institutes of Health (NIH) Adherence Research Network as a top priority.

For these reasons, improving adherence has been identified by National Institutes of Health (NIH) Adherence Research Network as a top priority. There is a clear recognition of the need for rigorous, multidisciplinary, transformative adherence research that addresses this important health topic. This FOA is focused on testing practical, feasible, translatable, and ultimately sustainable approaches to improved medication adherence.

The importance of adherence is premised on the assumption that compliance with prescribed treatment regimens is necessary for improving health. To the extent that treatment outcomes are related to accurate dosing, poor adherence is very likely to result in a reduction of treatment benefit). Numerous studies and across many illnesses suggest a lack of compliance with recommended treatment regimens has been identified as a causal factor in preventable morbidity (Congressional Budget Office, 2012). Thus, efforts to improve treatment adherence has been labeled the "next frontier in (healthcare) quality improvement".

However, despite several decades of research in this area, poor adherence remains a considerable problem. Poor adherence to prescribed treatments is common, regardless of the disease targeted, type of treatment, or population studied, and even among disease survivors (e.g., individuals who have had cancer) who return to their general practitioners. Many reasons exist for non-adherence to treatment regimens. Past research has identified a range of causal factors, including but not limited to, problems with the treatment (e.g., side effects), regimen complexity, problems with forgetting, ineffective provider-patient communication, confusion about treatment instructions, misperception of the treatment’s necessity, depressive symptoms and active substance abuse, lack of social support, and financial burden.

A recent Agency for Health Care Research and Quality review on interventions to improve adherence found that the best evidence existed for policy interventions (e.g., out-of pocket expenses, education and case management; Agency for Healthcare Research and Quality, 2012). Little evidence was available on the effect of adherence interventions on health outcomes because past research has employed follow-up periods of relatively short duration, did not include clinical outcomes and/or did not measure durability of effect once the intervention was stopped.

Adherence to a medication treatment regimen is a complex, multi-factorial behavior. It reflects individual behavioral factors such as cognitive functioning, health literacy, self-efficacy and motivation for self-care in addition to the nature of the condition and complexity of the treatment regimen and social factors such as the individual s relationships and access to social support. Whether a person adheres to medication recommendations also depends on successively larger spheres of influence, such as economic issues (medication cost/co-pay), the patient-provider relationship and/or systemic and organizational factors (e.g., a lack of incentives associated with the follow-up necessary to improve adherence in at-risk individuals) associated with the health care system. Thus, sustainable interventions will consider the complexity of the factors affecting adherence behavior and may offer options for tailored approaches rather than providing one-size-fits-all solutions. In addition, data have consistently shown that some people are adherent with little or no support from the health care system, while others are poor adherers regardless of the interventions applied. Approaches which target adherence interventions to those individuals at-risk for poor adherence or who demonstrate poor adherence may help maximize potentially limited healthcare resources for these endeavors.

In addition to the complexity of intervention, past research has also has highlighted the difficulty of measuring adherence. There are well established challenges with self-report of adherence but for practical reasons, when adherence is even assessed in the healthcare setting, self-report is the primary method of assessment. As such, research that simultaneously uses both self-report and other methods of adherence assessment (e.g., MEMs caps, pharmacy records and pill counts), will have greater value than studies that use a single method.

Further, previous research has often assessed changes in adherence without including data on the relationship between changes in adherence and clinical outcomes. Research has also been limited by short or non-existent follow-ups, which limits the relevance for treatment of chronic conditions. Additionally, past research has largely omitted a cost assessment which limits potential for implementation and dissemination.

In summary, the current FOA seeks applications that aim to produce adherence interventions that will improve behavioral adherence and healthcare outcomes that could be rapidly translatable and feasible in real world practice. Applications may target medication adherence in the context of treatment for a single illness or chronic condition (e.g., hypertension) or multiple comorbid conditions (e.g., hypertension and COPD). Several Institutes, Centers and Offices within NIH have joined together to support this initiative. Applications should be relevant to both the general objectives of the FOA and to the specific research interests of at least one of the participating Institutes or Centers. Brief descriptions of the specific interests of the Institutes and Centers are listed below. Interested applicants should read the full specific interests of the Institutes and Centers can be found at: http://obssr.od.nih.gov/scientific_areas/health_behaviour/adherence/adherence_PA.aspx

The National Cancer Institute (NCI) is interested in basic and applied research in the behavioral, social, and population sciences to create or enhance interventions that reduce cancer risk, incidence, morbidity and mortality, and improve quality of life.

For the purpose of this program announcement, the National Center for Complementary and Alternative Medicine (NCCAM) is interested in applications proposing research studying mindfulness-based therapies to improve medication adherence.

The National Eye Institute supports innovative research that tests the feasibility, efficacy or effectiveness of interventions to prevent and treat blinding eye diseases. NEI encourages research that will improve the initiation and maintenance of interventions to manage chronic diseases which threaten vision health.

The National Heart, Lung, and Blood Institute supports research concerning the behavioral, psychosocial, and sociocultural factors related to the prevention and treatment of heart, lung, blood and sleep diseases and disorders. NHLBI is interested in supporting studies that develop, optimize, test and refine strategies to improve adherence to medications used to prevent or treat cardiovascular, lung, blood, and sleep diseases and disorders.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks to reduce the morbidity and mortality associated with problematic alcohol use. NIAAA s mission is to support and conduct research in a wide range of scientific areas including genetics, neuroscience, epidemiology, prevention, and treatment. In response to this FOA, NIAAA is particularly interested in supporting studies that utilize behavioral and social science research to develop and test interventions that will significantly improve alcohol use medication adherence in individuals with an alcohol use disorder.

The National Institute on Deafness and Other Communication Disorders (NIDCD) sponsors and conducts research and research training in biomedical and behavioral normal and disordered conditions of hearing, balance, taste, smell, voice, speech and language.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is interested in supporting research to improve medication adherence relevant to the diseases of interest to the NIDDK such as type 1 diabetes, type 2 diabetes, gestational diabetes, and chronic kidney disease. Approaches tested to improve adherence should have the potential to have a significant effect on a clinical outcome such as glycemic control.

The National Institute of Mental Health (NIMH) has interest in adherence in the context of HIV/AIDS and in mental health services and interventions.

The National Institute on Nursing Research (NINR) is seeking applications that will define behaviors which support medication adherence in persons with complex acute and chronic illnesses. Applications that develop and test self-management decision-making strategies and technologies to promote medication adherence are also encouraged.

Appropriate applications should propose to test interventions for settings where healthcare is delivered, including, but not limited to, primary care settings (e.g. family medicine, internal medicine, community health centers, pediatric medicine), healthcare settings specific to a condition of interest (e.g., dental, eye care, endocrinology, oncology, infectious diseases), and other healthcare related settings (e.g., pharmacies, community outreach programs). Where possible, the use of existing networks is encouraged such as the Practice-Based Research Networks (PBRNs) supported by the Agency for Healthcare Research and Quality (www.pbrn.ahrq.gov).

Potential study topics and intervention approaches may include, but are not limited to:

• The intervention can include attention to appropriate contextual factors in the patient’s life e.g., family, community, neighborhood, school, worksite, pharmacy, or other setting(s);
• The intervention may be population-based or a more tailored approach (i.e., individualization based on patient characteristics, and/or directing intensive intervention to specific risk groups. For example, interventions to address racial and ethnic disparities in treatment adherence and outcomes or to target high risk age groups such as adolescents/young adults and the elderly;
• Studies of approaches to address adherence in individuals who have completed surgery or survived a disease (e.g., cancer) and return to primary care from their specialty care practitioner;
• Research testing innovative approaches for maintaining patient adherence to medication regimens through social or peer support, lay health worker delivered approaches (e.g., peer-led, patient navigator, or community health worker), and/or the integration of adherence monitoring/support within routine health care;
• Testing the efficacy of institutional-level interventions that target clinic or provider practice (i.e., health care policy, electronic medical record practices, or physician, nursing and other health care and support staff) in order to promote patient adherence;
• Developing screening tools that will help identify individuals who are non-adherent and test targeted interventions to improve adherence, particularly in groups at high risk for non-adherence such as individuals with cognitive impairment, complex medical conditions or regimens, psychiatric comorbidity, and/or substance abuse;
• Studies of adherence-promoting interventions that incorporate technological tools, such as electronic health records and mobile health technologies, to target clinician behavior, patient behavior, both, and/or provider-patient interaction and feedback;
• Interventions that test targeted and multi-level interventions (e.g., at the patient, clinician and community level) to improve adherence behavior;
• Research to test interventions that enhance health literacy and/or health numeracy to improve medication adherence in settings that deliver primary care;
• Research testing complementary or integrative health approaches to improving medication adherence.

Literature cited

Congressional Budget Office. Offsetting Effects of Prescription Drug Use on Medicare’s Spending forMedical Services. November 2012. Available at: http://www.cbo.gov/sites/default/files/cbofiles/attachments/43741-MedicalOffsets-11-29-12.pdf

Agency for Healthcare Research and Quality. Medication Adherence Interventions: Comparative Effectiveness. Closing the Quality Gap: Revisiting the State of the Science. Evidence Report No. 208. (Prepared by RTI International University of North Carolina Evidence-based Practice Center under Contract No. 290-2007-10056-I.) AHRQ Publication No. 12-E010-EF. Rockville, MD: Agency for Healthcare Research and Quality. September 2012. Available at: http://www.effectivehealthcare.ahrq.gov/reports/final.cfm.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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.

Applicant Organizations

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

This initiative is not subject to intergovernmental review.

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.

Important reminders:
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.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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.

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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?

Investigator(s)

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?

Innovation

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

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?

Environment

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?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Children

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.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described 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.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-945-7573
Email: [email protected]

The Office of Behavioral and Social Sciences (OBSSR) does not accept assignment of applications or manage awards that are funded. Please contact one of the ICs listed below for inquiries regarding the suitability of the proposed project for the FOA and the IC’s research portfolio.

Dana Wolff-Hughes, PhD
Office of Behavioral and Social Sciences Research (OBSSR)
Phone: 301-496-0979
Email: [email protected]

Wendy Nelson, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-6971
Email: [email protected]

Eleanor Schron, PhD
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]

Nicole Redmond, MD, PhD, MPH
National Heart, Lung, Blood Institute (NHLBI)
Phone: 301-435-0379
Email: [email protected]

Brett T. Hagman, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0638
Email: [email protected]

Gordon Hughes, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: (301-435-4085
Email: [email protected]

Susan Azrin, PhD
National Institute of Mental Health (NIMH)
Telephone: (301) 443-3267
Email: [email protected]

Karen Huss, PhD, RN, ANP-BC, FAAN, FAAAAI, FAHA
National Institute of Nursing Research (NINR)
Telephone: 301-594-5970
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
Email: [email protected]

William Darby
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]

Tawana McKeither
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-402-3842
Email: [email protected]

Judy S. Fox
National Institute on Alcohol Abuse and Alcoholism
Telephone: 301-443-4704
Email: [email protected]

Chris Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-401-0909
Email: [email protected]

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.