Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Office of Behavioral and Social Sciences Research (OBSSR) National Cancer Institute (NCI) National Eye Institute (NEI) National Heart, Lung, and Blood Institute (NHLBI) National Institute on Aging (NIA) National Institute on Deafness and Other Communication Disorders (NIDCD) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)) National Institute of Mental Health (NIMH) National Institute of Nursing Research (NINR) National Center for Complementary and Alternative Medicine (NCCAM)
Funding Opportunity Title	Practical Interventions to Improve Medication Adherence in Primary Care (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	September 05, 2014 - This PA has been reissued as PA-14-334. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number	PA-12-022
Companion FOA	PA-12-023, R21 Exploratory/Developmental Research Grant Award
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.399, 93.867, 93.837, 93.866, 93.173, 93.847, 93.242, 93.361, 93.213
FOA Purpose	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 the National Cancer Institute (NCI), the National Eye Institute (NEI), the National Heart, Lung, and Blood Institute (NHLBI), the National Institute on Aging (NIA), the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Mental Health (NIMH), the National Institute of Nursing Research (NINR), and the National Center for Complementary and Alternative Medicine (NCCAM). This FOA seeks Research Project Grant (R01) applications that propose practical interventions to improve adherence to medication. This FOA will support research to test interventions with the potential to significantly improve medication adherence in patients with chronic health conditions in settings where primary health care is delivered (including, dental and eye care settings). 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 HIV/AIDS). Studies should use the most rigorous design and methodology possible given the populations and settings in which the study is taking place. Primary outcomes of the research should include: a patient self-report of medication adherence, and at least one other non-self-report measure of medication adherence (e.g., pharmacy refill records, electronic monitoring, etc.). In addition, applications should include a health outcome or biomarker (e.g., blood pressure, viral load in HIV patients, cholesterol levels, HbA1c) that is expected to be affected by changes in the targeted adherence behavior. Researchers should address the capacity of the tested approach for wide dissemination, the sustainability of the approach once the research is concluded, and are encouraged to include measurement and costs of the intervention characteristics and contextual factors that affect implementation and adoption.

Posted Date	November 18, 2011
Open Date (Earliest Submission Date)	January 5, 2012
Letter of Intent Due Date	Not applicable
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	January 8, 2014
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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), issued by the issued by the NIH Adherence Network through the Office of Behavioral and Social Sciences Research (OBSSR), with participation from the National Cancer Institute (NCI), the National Eye Institute (NEI), the National Heart, Lung, and Blood Institute (NHLBI), the National Institute on Aging (NIA), the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Mental Health (NIMH), the National Institute of Nursing Research (NINR), and the National Center for Complementary and Alternative Medicine (NCCAM) ], is to encourage innovative new medication adherence research. Adherence is inextricably connected to the efficacy of medical treatment regimens and therefore to health outcomes. Although adherence has been the topic of considerable research for the last two decades, continuing evidence of sub-optimal medication adherence in many chronic conditions highlights the need for transformative research in this area. This FOA will support research to test interventions with the potential to significantly improve medication adherence behaviors in patients with chronic health conditions. Research testing complementary and alternative medicine approaches to improving medication adherence will also be supported by this FOA.

As such, researchers should consider and explain the capacity of the tested approach for dissemination and sustainability once the research is concluded. Researchers use the term sustainability to describe the degree to which an intervention can be delivered in a lasting way for the target population(s) by the intended providers and in one or more delivery systems. NIH recognizes that there are different perspectives regarding how intervention research should approach sustainability. Appropriate planning activities may include preparations to test the sustainability of an intervention or potential plans for the sustainability of interventions found to be efficacious .

Proposed studies are not required to include full cost effectiveness evaluations but applicants should address issues of cost in relation to sustainability and clinical outcomes. Studies should use randomized controlled trial designs with appropriate statistical power, or alternatively should employ the most rigorous non-randomized designs and methodology possible given the populations and settings in which the study is taking place. Primary outcomes of the research should include: a patient self-report of medication adherence, and at least one other non-self-report measure of medication adherence (e.g., pharmacy refill records, electronic monitoring, etc.). In addition, applications should include a biological health-related indicator (e.g., blood pressure, viral load in HIV patients, cholesterol levels, HbA1c) that is expected to be affected by changes in the targeted adherence behavior.

Background

Many of the leading causes of death in the United States are behavior-related and, therefore, preventable (Schroeder, 2007). 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.

A recent NIH Adherence Network meeting ( A Framework for Adherence Research and Translation, 2008, Jersey City, NJ) and 2010 Request for Information (NOT-OD-10-078: Priorities for the NIH Adherence Network ) represented the coalescing of efforts to help shape an exciting new research agenda for a trans-NIH, inter-disciplinary initiative focused on improving adherence. The issues and ideas put forth by meeting participants and the responses to the RFI stimulated innovative thinking for accelerating the transformation of healthcare through increased adherence. Recommendations from the scientific community from both the meeting and RFI highlighted the need for rigorous, multidisciplinary, transformative adherence research that is practical, feasible, translatable, and ultimately sustainable.

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 (DiMatteo, 2004). A lack of compliance with recommended treatment regimens has been identified as a causal factor in preventable morbidity and mortality in numerous studies and across many illnesses (see review, Osterberg & Blasche, 2005). Thus, efforts to improve treatment adherence has been labeled the "next frontier in (healthcare) quality improvement" (Heidenreich, 2004).

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 (DiMatteo, 2004). 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 (see review, Osterberg & Blasche, 2005).

A recent Cochrane review on interventions to improve adherence (Haynes et al., 2008) found that most studies did not improve patient outcomes or achieve sustained adherence. Closer review of available work suggests that many studies have small samples of willing volunteers, which may have sampling biases or be underpowered to detect any benefit (Haynes et al., 2008). In addition, much of the past work on adherence interventions has employed follow-up periods of relatively short duration, did not include clinical outcomes, and did not measure durability of effect once the intervention was stopped (Haynes et al., 2008).

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 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 patients) 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 patients 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. Responses to the Adherence Network RFI consistently noted the challenges with self-report of adherence, as well as the need to collect additional adherence measurement data. Given that self-report is a primary method for assessing adherence in the health care system, 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.

The current FOA seeks applications that aim to produce adherence interventions that are directly translatable and feasible within the settings in which individuals with chronic health conditions receive their health care. Studies that propose innovative medication adherence interventions for chronic health conditions are encouraged. 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 HIV/AIDS). 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. The specific interests of the Institutes and Centers can be found at: http://obssr.od.nih.gov/scientific_areas/health_behaviour/adherence/PA-11-489R01.aspx. Appropriate applications should propose to test interventions for settings where primary healthcare is delivered, including, but not limited to, the primary care Practice-Based Research Networks (PBRNs) supported by the Agency for Healthcare Research and Quality (www.pbrn.ahrq.gov) or primary care settings specific to a condition of interest (e.g., dental and eye care settings).

Successful applications should include the following:

• Justification that the approach to improve adherence behavior is feasible (e.g. practical and acceptable) and a potentially sustainable; that is, interventions, which if successful, have the potential to be widely implemented within the current health care system;
• All applications must demonstrate an ability to identify and enroll representative participants with sub-optimal adherence;
• The most rigorous design and methodology possible, given the populations and settings in which the study is taking place. In some cases, randomization (by patient, clinic, or community) is possible and feasible; in others, randomization may not be possible, and other rigorous but non-randomized designs (e.g., quasi-experimental) that are both internally and externally valid may be necessary;
• The assessment and measurement of self-reported participant adherence outcomes as a function of the proposed intervention (i.e., did the program alter adherence behaviors?);
• A non-self-report measure of adherence, such as MEMS caps, pharmacy refill records, or pill counts;
• Inclusion of health outcomes or biomarkers (e.g., blood pressure, cholesterol levels, viral load in HIV or HbA1c) that are expected to be affected by adherence changes. For diseases without identified biomarkers, such as, mental health disorders, inclusion of a clinical assessment (e.g., a medicine blood level, diagnostic interview or an independent clinician rating of the symptoms and behaviors) , should be included;
• To increase the potential for sustainability, applicants are encouraged to measure costs of the intervention as well a characteristics and contextual factors that affect implementation and adoption (e.g., necessary personnel, training, feasibility, staff and/or leadership acceptance).

Applications may wish to include the following features (optional features, not required):

• The intervention can include 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 those either demonstrating or at-risk for worse adherence based on psychosocial, sociocultural or biological vulnerabilities such as depression, ethnic minorities or those living in poverty, genotype, or physical disability);
• Use technologies (e.g., cellular phone applications, wireless medication monitors) that might enhance adherence.
• Potential study topics include, but are not limited to:
• 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 individuals with cognitive impairment, complex medical conditions or regimens, psychiatric comorbidity, and/or substance abuse.
• Studies which test the effectiveness and potency of adherence-promoting interventions that incorporate technological tools to target clinician behavior, patient behavior, both, and/or provider-patient interaction and feedback. For example, how can providers use specific technologies to monitor patient adherence when adding new medication or changing treatment regimens? What real time data (e.g., graphical feedback on medication use and any periodic tests that are needed) would providers want to collect in order to monitor adherence and intervene concomitant to the nonadherent behaviors of populations?
• Research to test developmentally and/or culturally appropriate medication adherence interventions among 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 brief counseling or peer-led approaches to improving adherence in settings that deliver primary care.
• 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 and alternative medicine approaches to improving medication adherence.

Literature cited

DiMatteo MR. (2004). Variations in patients adherence to medical recommendations: A quantitative review of 50 years of research. Medical Care, 43(2): 200-9.

Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. (2008). Interventions for enhancing medication adherence. Cochrane Database of Systematic Reviews 2008, Issue 2.

Haynes RB. (2001). Interventions for helping patients to follow prescriptions for

medications. Cochrane Database of Systematic Reviews, Issue 1.

Heidenreich P. (2004). Patient adherence: the next frontier in quality improvement. American Journal of Medicine, 117(2): 130-132.

Osterberg L & Blaschke T. (2005). Adherence to medication. JAMA, 353(5): 487-497.

Schroeder (2007). We Can Do Better Improving the Health of the American People. New England Journal of Medicine, 357(12):1221-8.

Funding Instrument	Grant
Application Types Allowed	New Renewal Resubmission Revision The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project.
Award Project Period	Scope of the proposed project should determine the project period.

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

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 must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (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.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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, 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.

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 Application Guide and the Table of Page Limits 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, with the following modification:

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

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.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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 SF 424 (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 SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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 Central Contractor Registration (CCR). 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 requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

Reviewers will provide an overall impact/priority 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 New Investigators, or 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(s)/PI(s), 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 clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion 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/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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

For Renewals, the committee will consider the progress made in the last funding period.

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/priority 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) , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments 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/priority 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. 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(s)/PI(s) 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually 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.

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Wendy Nilsen, PhD
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: (301) 496-0979
Email: [email protected]

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

Kristen Huntley
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: (301) 594-9346
Email: [email protected]

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

Susan Czajkowski, PhD
National Heart, Lung, Blood Institute (NHLBI)
Telephone: (301) 435-0406
Email: [email protected]

Sidney Stahl, PhD
National Institute on Aging (NIA)
Telephone: (301) 496-3131
Email: [email protected]

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

Christine Hunter, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-4728
Email: [email protected]

Michael Sirratt, PhD
National Institute of Mental Health (NIMH)
Telephone: (301) 443-6802
Email: [email protected]

Joan Wasserman, Dr. PH
National Institute of Nursing Research (NINR)
Telephone: (301) 594-5971
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: (301) 496-7205
Email: [email protected]

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

Robert Tarwater
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: (301) 402-6090
Email: [email protected]

Jeff Ball
National Institute on Aging (NIA)
Telephone: (301) 496-1472
Email: [email protected]

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

Natasha Loveless
National institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-8853
Email: [email protected]

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: (301) 443-2805
Email: [email protected]

Judy Sint
National Institute of Nursing Research (NINR)
Telephone: (301) 402-6959
Email: [email protected]

George Tucker, MBA
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: (301) 594-9102
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.