Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)
National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Research to Characterize and Reduce Stigma to Improve Health (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

New

Related Notices

  • July 8, 2014 - NIMH Focus for Intervention Studies Submitted Under the Stigma and Health Literacy Announcements. See Notice NOT-MH-14-016.
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
  • 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-13-246

Companion Funding Opportunity

PA-13-248, R01 Research Project Grant
PA-13-247, R03 Small Grant Program

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.866, 93.393, 93.394, 93.395, 93.396, 93.397, 93.398, 93.399, 93.242, 93.172, 93.173, 93.853  

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages research grant applications to characterize the role of stigma in health, life course development, and aging, both in the U.S. and globally, and to test interventions to prevent or reduce the impact of stigma at the individual, community, health care system, and policy levels.  The goal of this FOA is to promote research addressing the health-related aspects of stigma, including the etiology and perpetuation of stigma; its impact on physical and mental health, well-being, life course development, and aging; its influence on health behaviors and on use, access to, and quality of received healthcare services; its contribution to health disparities affecting vulnerable demographic groups;  and  intervention strategies to reduce health-related stigma and/or the negative health and life course developmental impacts of stigma.

Key Dates
Posted Date

June 14, 2013

Open Date (Earliest Submission Date)

September 16, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

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

AIDS Application Due Date(s)

Standard AIDS 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

Standard dates apply

Expiration Date

September 8, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Research Objectives

Stigma refers to the process by which certain human characteristics are labeled as socially undesirable and linked with negative stereotypes about a class of individuals, resulting in social distance from or discrimination towards labeled individuals. Stigma can be differentiated into enacted stigma, in which labeled individuals are treated differently from or denied opportunities available to non-labeled individuals, and felt or internalized stigma, in which labeled individuals avoid particular situations, interactions, or roles to prevent anticipated stigmatization,  and/or endorse negative stereotypes about the group to which they belong.

Stigmatized statuses include those related to certain broadly based or rare health conditions with the potential for depersonalization, physical or mental disabilities, or to demographic characteristics such as race/ethnicity, gender, age, socioeconomic status, sexual orientation, religion or nativity. Individuals from stigmatized demographic groups who have a stigmatized health condition may face the particular challenges of compound stigma. For racial/ethnic minorities, the nature and intensity of stigma surrounding particular health conditions may be greater due to cultural differences in health beliefs and behaviors.

Demographic and policy changes, as well as emerging trends in disease incidence, prevalence, and/or mortality, may increase or decrease the impact of stigma on health outcomes, requiring researchers to continually examine the problem in a new light. For example, global trends in population aging and increases in life expectancy are raising concerns about how societies will manage the health and economic impact of an increasingly large older adult population. At the same time, research on ageism has identified biases and discrimination in health care institutions, workplaces, and the media that perpetuate misconceptions about aging and can put older individuals at risk of under-treatment, under-prioritization, and even abuse or neglect (North & Fiske, Psychological Bulletin, 2012).  Older age, the leading risk factor for many chronic diseases, represents just one of many potentially stigmatizing conditions faced by members of our society.

In 2002, the NIH Fogarty international Center and participating NIH institutes released a FOA to encourage global and domestic research on stigma and health (http://www.fic.nih.gov/programs/Pages/stigma.aspx). A significant proportion of the grants were awarded to projects conducted in low and middle income countries, where stigma may exacerbate the effects of limited health care resources. An independent evaluation of the stigma program recommended a second phase of research focusing on community based research to identify and develop interventions to reduce the prevalence and effects of stigma on health and disease in low resource settings (see above web site).  Recent NIH portfolio assessments and emerging health trends further indicate that in the case of understudied health conditions or demographic subgroups, research is also needed to characterize the nature and impact of stigma, with the goal of moving the science closer to invention development.

This FOA encourages research on stigma, particularly in health conditions, settings, and populations where it is not well characterized although the burden is high, and/or where the development and implementation of interventions to reduce its detrimental effects are now possible.  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 investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. 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 submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.

Scientific Scope

The goal of this FOA is to promote research addressing the health-related aspects of stigma, including the etiology and perpetuation of stigma; its impact on physical and mental health and well-being, life course development, and aging; its influence on health behaviors and use, access to, and quality of healthcare services; its contribution to health disparities affecting vulnerable demographic groups; and intervention strategies to reduce health-related stigma and/or the negative health and life course developmental impacts of stigma.

Research approaches of interest include but are not limited to:

With respect to specific conditions or populations, individual institutes and centers at the NIH may have distinct research priorities, such as those listed below. Applicants are encouraged to contact the Scientific/Research Contacts listed in Section VII of this FOA to discuss areas of scientific interest for particular institutes and centers.

National Institute on Aging (NIA)

Stereotypes about aging as a time of infirmity, disengagement, and reduced potential are pervasive in our society and often propagated through the media. These negative expectations may lead people in general, as well as older adults themselves, to underestimate their potential, and may give rise to a cascade of behavioral and psychological processes that undermine health and adaptive aging (When I’m 64, National Research Council, 2006, see http://www.nap.edu/catalog.php?record_id=11474 ). Research suggests that individuals’ own attitudes toward aging can impact a range of clinical and functional health outcomes.

The National Institute on Aging encourages research focused on the health and life course developmental impact of ageism, including self- and other stereotypes of aging, and on how health disparities are exacerbated or perpetuated by stigma.  It also encourages research on the health and economic impact of other forms of discrimination, including racial or ethnic discrimination or discrimination arising from lower socioeconomic status, as well as stigma associated with age-related diseases, including dementia. Some of this work may well be served by cross-national research on stigma related to aging and its intersection with other forms of stigma, stereotyping and discrimination.

National Cancer Institute (NCI)

The National Cancer Institute encourages research focused on associations between experienced stigma and biological cancer outcomes; associations between stigma and stress, negative affectivity, and/ or social isolation; ways in which health disparities are exacerbated or perpetuated by stigma.  It also encourages research on the health and economic impact of other forms of discrimination, including racial or ethnic discrimination or discrimination arising from lower socioeconomic status, as well as stigma associated with cancer. Another area of interest concerns the influence of stigma on process of care behaviors and medical decisions (e.g., willingness to seek preventive services), particularly among cultures with cancer-related stigma convictions (e.g., Vietnamese and other Asian American populations). Other areas of research include but are not limited to factors that contribute to the internalization of a stigmatized identity; studies that address the role of compounding or interactive stigmatized identities; and, factors that may attenuate or buffer against stigma or stigma-related consequences (e.g., positive affectivity, social support). Of particular interest are intervention or health communication studies aimed at targeting cancer-related stigma and methodological studies aimed at improving detection of cancer-related stigmas.

In the area of cancer and global health, the program will focus on the development of measurement and screening tools that could be used to understand the etiology and impact of stigma related to cancer in Low and Middle Income countries (LMICs),  including the identification and characterization of cancer stigma as a barrier to preventive and oncology care in LMICs. The program will also support studies to develop interventions in LMICs to reduce cancer-associated stigma. Other areas of interest for both the domestic and global health programs at NCI include: stigma associated with palliative care/pain management, addressing stigmas associated with psychological/ psychiatric outcomes in the context of clinical cancer care (e.g., enhancing provider communication skills), motivating behavior change to improve screening and treatment adherence, and determining predictors of cancer-related stigma.

National Human Genome Research Institute (NHGRI)

The National Human Genome Research Institute (NHGRI) encourages research related to the impact of concerns about stigma on participation in genetic or genomic research and testing, including differences in the degree of perceived or feared stigma across communities or groups.  Such research may include, but not be limited to, assessing the impact of perceived or feared stigma on decisions about participation in carrier testing, prenatal testing, newborn screening, and predictive testing for adult onset genetic disorders. NHGRI is also interested in research related to how the genetic attribution of disease affects the degree of stigma perceived by patients, health care professionals, and the public, including any resultant differences in patient care, patient behavior or outcomes, or public perceptions about health and disease. NHGRI encourages the development and evaluation of interventions to reduce stigma based on genetic information or misperceptions about genetics at multiple levels, including individual, community, and/or institutional.

National Institute on Deafness and Other Communication Disorders (NIDCD)

The National Institute on Deafness and Other Communication Disorders encourages research focused on how social stigma affects access to and utilization of prevention measures and treatments for disorders of hearing, balance, smell, taste, voice, speech and language.  Specific NIDCD research interests include: 1) the role that stigma plays in the reticence of many working age and older individuals with mild to moderate/severe hearing loss to use amplification devices unless their hearing loss progresses to present marked communication handicaps; 2) how stigma and misconceptions that lead to negative attitudes and erroneous assumptions affect the well-being of individuals with communication disorders, such as those with aphasia, stuttering, or high-functioning autism; and 3) understanding and minimizing stigma as  a contributor to health disparities affecting vulnerable demographic groups, including those individuals with deafness who use American Sign Language.  NIDCD is interested in the development and evaluation of prospective interventions to reduce stigma at the individual and societal level, and improving quality of life for individuals with deafness and other communication disorders.

National Institute of Mental Health (NIMH)

The National Institute of Mental Health encourages two specific areas of research focused on reducing stigma: AIDS-related and suicide prevention-related research.   AIDS-related research should focus on how HIV-associated stigma, and stigma associated with being a member of a high-risk group (men who have sex with men, minority women) impact access to and uptake of HIV prevention, care and treatment.  Research on the health and economic impact of other forms of HIV-associated discrimination, including the combination of HIV–associated stigma/discrimination and racial or ethnic discrimination or other forms of discrimination is also of interest.

Stigma research related to mental disorders and their treatment should test stigma reduction strategies where improvement in symptoms of the disorder (via improved help-seeking, identification and treatment, or adherence) and/or in functioning (e.g. employment) are the primary outcomes.  There is particular interest in determining whether decreasing stigma related to suicidality leads to increased help-seeking and referrals for at-risk individuals. (See http://actionallianceforsuicideprevention.org/task-force/research-prioritization). 

National Institute of Neurological Disorders and Stroke (NINDS)

Attitudes regarding neurological disorders have become less negative over time, but problems of stigma remain widespread.  Often, misinformation and misconceptions lead individuals to have negative attitudes and behaviors toward people with neurological disorders.  Stigma, whether felt or overtly experienced, has many negative consequences for both health and quality of life for individuals with a neurological disorder and their families. 

The National Institute of Neurological Disorders and Stroke encourages research focused on the development and evaluation of programs that reduce stigma and lead to increased access to care, minimize health disparities, and improve health and quality of life for individuals with neurological disorders across the lifespan. 

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission

The OER Glossary and the SF424 (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

The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period.

Award Project Period

The total project period may not exceed 2 years.

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.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

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

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

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.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

PHS 398 Cover Letter

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.  

6. Other Submission Requirements and Information

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.

Post-Submission Materials

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

Section V. Application Review Information


1. Criteria

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.

For this particular announcement, note the following:

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.

Overall Impact

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).

Scored Review Criteria

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/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 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?   

Additional Review Criteria

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 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

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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.

2. Review and Selection Process

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. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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:

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information


1. Award Notices

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, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

3. Reporting

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. 

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding 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)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Melissa Gerald, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-4156
Email: Melissa.Gerald@nih.gov

Luis A. Salicrup. Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5810
Email: salicrul@mail.nih.gov

Carmen P. Moten, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-6181
Email:cmoten@mail.nih.gov

Veronica Chollette, RN, MS
National Cancer Institute (NCI)
Telephone: 240-276-6969
Email: vc24a@nih.gov

Nicole C. Lockhart, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-5697
Email: lockhani@mail.nih.gov

Amy Donahue, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3458
Email: donahuea@nidcd.nih.gov

Cynthia Grossman, Ph.D.
National Institutes of Mental Health (NIMH)
Telephone: 301-443-8962
Email: grossmanc@mail.nih.gov

Denise Juliano-Bult, M.S.W.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1638
Email: djuliano@mail.nih.gov

Vicky Holets Whittemore, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone:  301-496-1917
Email:  whittemorevr@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

John Bladen
National Institute on Aging (NIA)
Telephone: (301) 402-7730
Email: bladenj@nia.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

Cheryl Chick
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: chickc@mail.nih.gov

Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: myersc@mail.nih.gov

Jackie Chia
National Institutes of Mental Health (NIMH)
Telephone: 301-443-1341
Email: chiah2@mail.nih.gov

Maxine Davis
National Institutes of Neurological Disorders & Stroke (NINDS)
Telephone: 301-496-7359
Email: davisma@ninds.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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.


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