and Human Services (HHS)
EXPIRED
Department
of Health and Human Services
Participating
Organizations
National
Institutes of Health (NIH), (http://www.nih.gov)
Components
of Participating Organizations
National Cancer Institute (NCI), (http://www.cancer.gov)
National
Institute for Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov/)
Office of Behavioral and Social Science Research (OBSSR), (http://obssr.od.nih.gov)
National Heart Lung and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib1.nih.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
Title: The Effect Of Racial
And Ethnic Discrimination/Bias On Health Care Delivery (R03)
Announcement Type
This is a reissue of PA-05-006,
which was previously released on October 20, 2004, , and now is divided into separate Funding
Opportunity Announcements (FOAs) for R03, R21, and R01 grant funding mechanisms
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with
the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter
called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program
Announcement (PA) Number: PA-06-348
Catalog of Federal
Domestic Assistance Number(s)
93.393, 93.394,
93.395, 93.399, 93.847, 93.848, 93.233, 93.837,93.838, 93.839, 93.286, 93.279
Key
Dates
Release/Posted Date: April 12, 1006
Opening Date: May 2, 2006 (earliest date an application may be
submitted to Grants.gov).
Letters of Intent Receipt Date(s): Not
applicable.
NOTE: On time submission requires
that applications be successfully submitted to Grants.gov no later than 5:00
p.m. local time (of the applicant institution/organization).
Application Submission/Receipt
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt
Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information To Be Available Date
(URL Activation Date): Not applicable.
Expiration Date: January 3, 2008 (now January 8, 2008 per NOT-OD-07-093)
Due Dates for E.O. 12372
N ot Applicable.
Additional Overview
Content
Executive Summary
The purposes of this FOA are: (1) to improve the measurement of racial /ethnic discrimination in health care delivery systems through improved instrumentation, data collection and statistical/analytical techniques; (2) to enhance understanding of the influence of racial/ethnic discrimination in health care delivery and its association with disparities in disease incidence, treatment and outcomes among disadvantaged racial/ethnic minority groups; and (3) to reduce the prevalence of racial/ethnic health disparities through the development of interventions to reduce the influence of racial/ethnic discrimination on health care delivery systems in the United States.
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible
Institutions
B. Eligible
Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and
Anticipated Start Dates
1. Letter of Intent
B. Electronic
Transmission of an Application to the
NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Purpose and background
The purposes of
this FOA are to: (1) Improve the measurement of racial /ethnic discrimination
in health care delivery systems through improved instrumentation, data
collection, and statistical/analytical techniques; (2) enhance understanding of
the influence of racial/ethnic discrimination in health care delivery and its
association with disparities in disease incidence, treatment, and outcomes
among disadvantaged racial/ethnic minority groups; and (3) reduce the
prevalence of racial/ethnic health disparities through the development of
interventions to reduce the influence of racial/ethnic discrimination in health
care delivery systems in the United States.
For the purposes of this FOA, health care delivery is defined as the provision
or receipt of a broad range of health-related services including preventive,
primary, ambulatory and in-patient, emergency, specialty and long-term care. Health
care delivery systems are defined as insurance plans, hospitals, clinics,
private physician offices, or public and community health facilities that
provide or finance health care delivery.
Nature of the Research Problem
Racial/ethnic minorities suffer disproportionate morbidity and mortality from
chronic diseases such as cancer, heart and lung diseases, blood and sleep
disorders, diabetes, and stroke. Although racial/ethnic differences in
morbidity and mortality can be partially explained by differences in lifestyle,
health-seeking behavior, and financial access to care, these factors do not
entirely explain differences in incidence, treatment, or outcomes. The recent
report from the Institute of Medicine (IOM) on unequal treatment as well as
several other recent reviews show that racial/ethnic minorities also less
frequently receive appropriate care which has an adverse impact on their health
outcomes including higher recurrence rates, morbidity, and mortality. The IOM
report concluded in part that (1) racial/ethnic disparities in health care
occur in the context of broader historic and contemporary social and economic
inequality and evidence of persistent racial and ethnic discrimination in many
sectors of American life, (2) health systems, health care providers, patients,
and utilization managers may contribute to racial and ethnic disparities in health
care, and (3) health provider bias, stereotyping, prejudice, and clinical
uncertainty may contribute to racial and ethnic disparities in health care. A
more recent report from a Trans-U.S. Department of Health and Human Services
Health Disparities Progress Review Group recognized the need to discuss the
impact of racism as a fundamental cause of health disparities.
The IOM committee recommended that additional research be conducted to provide
insight into how and why racial/ethnic disparities occur and to test
interventions and strategies to eliminate them, including research that
provides further elucidation on: (1) patient, provider, and institutional
contributions to health care disparities; (2) the relative contributions of
provider bias, stereotyping, prejudice, and uncertainty to racial/ethnic
disparities in diagnosis, treatment, and outcomes of care; and (3) the role of
non-physician health care professionals, pharmacists, allied health
professional, and non-professional staff in contributing to health care disparities.
The relationship of race/ethnicity to health disparities is complex. This FOA supports
research directed at developing methodology and defining the specific ways in
which institutional or personal bias influence the health status, health
outcomes and utilization of health services among racial/ethnic minority
patients. The FOA also supports the development of interventions designed to
reduce racial/ethnic bias or perceptions of racial/ethnic bias in the health
care setting.
Pertinent Background Information
The National Research Council recently defined racial discrimination as the
(1) differential treatment on the basis of race that disadvantages a racial
group and (2) treatment on the basis of inadequately justified factors that
disadvantage a racial group. For the purposes of this FOA, race is defined as
a continuously evolving social construct used to categorize individuals into
groups that have typically been based on the physical characteristics (e.g.,
skin color, hair texture, or other distinctive characteristics, etc.) of an
individual or his/her ancestors. Ethnicity refers to cultural groups that have
been typically defined by a common language, religion, nationality, or
heritage. This FOA focuses on examining overt as well as subtle racial/ethnic
discriminatory behavior and processes perceived or experienced by historically
disadvantaged racial/ethnic minority groups and their contribution to the
persistent disparities in the receipt of quality health care and disease
outcomes that have been observed among these populations.
Racial/ethnic bias is hypothesized to contribute to disparities in health
through five key pathways (Krieger, 2003). These include increased exposure and
susceptibility to (1) economic and social deprivation; (2) toxic substances and
hazardous conditions; (3) socially inflicted mental and physical trauma, either
directly experienced or witnessed; (4) targeted marketing of potentially
harmful commodities such as tobacco, alcohol, illicit drugs; and (5) inadequate
or degrading medical care.
The influence of non-clinical characteristics, either actual or perceived, on
provider perception of racial/ethnic minority patients might also have an
impact on the health care received by patients. Physician recommendations and
referrals been shown to contribute to racial disparities in referrals for
kidney transplantation and receipt of some cardiovascular procedures. Several
mechanisms through which providers potentially contribute to racial/ethnic
disparities in health have been suggested. These include provider bias against
racial/ethnic minorities, uncertainty in their interactions with minority patients,
beliefs or stereotypes regarding the health behavior of minority patients and
patient response to perceived provider mistreatment or other negative racial
experiences. In one report, 63 percent of the 76 participants in a
cross-sectional survey indicated that they had experienced discrimination in
their interactions with their health care provider because of their race or
color. Similarly, 29 percent of African Americans and more than 10 percent of
Latino/Hispanic, Filipino, and Korean respondents in the King County [Seattle, Washington] Health and Ethnicity Survey of 1995 1996 reported that they had
experienced discrimination when seeking or obtaining health care due to their
race or ethnicity. In interviews conducted among African Americans after the
survey, perceived discriminatory experiences reported by participants included
differential treatment, negative attitudes, being treated as if they were
unintelligent, being ignored, inappropriate allegations, and racist remarks.
Negative experiences in the health care setting may profoundly affect attitudes
toward receiving care and influence further utilization of health care
services. Data from the National Co-morbidity Study show that although African
Americans had more favorable attitudes towards seeking mental health services
than whites prior to using them, the reverse was true after using the services.
In the Hobson study, nearly 27 percent of African American respondents reported
that because of a discriminatory event, they were more hesitant to seek health
services. Others avoided the health care facility (25.6 percent), avoided the
provider (23.1 percent), avoided the personnel involved (10.3 percent), stopped
using specific services (15.4 percent), or used service less frequently (7.7
percent). The behaviors of (25.6 percent) of African American respondents did
not change.
Racial/ethnic discrimination also has the potential to influence the health of
racial/ethnic minorities through its association with changes in mental and
physiologic states and through its influence on participation in high-risk
behaviors such as excessive alcohol consumption and substance abuse. Several
studies have examined the effect of racial discrimination on mental health and,
in general, show that racial discrimination can be a significant source of
stress for racial/ethnic minority populations and that it is associated with
decreases in the sense of well-being (e.g., self-esteem, happiness, life
satisfaction) and increased psychosis, hopelessness, anxiety, anger, and
substance abuse. Perceived discrimination has also been found to be associated
with depression. Studies that have examined the influence of self-reported
experiences with racial/ethnic bias and physiologic changes have, however,
provided inconsistent results. For example, some studies have shown an
association between discrimination related stress and increases in blood
pressure while others have not. Other research suggests that the association
between perceived racial discrimination and increases in blood pressure is
dependent upon coping styles. A few studies have also shown that individuals
who experience discrimination and other sources of stress have a higher
prevalence of chronic disease behavioral risks such as cigarette smoking and
alcohol and substance abuse.
This FOA Specifically Encourages:
All proposed studies should be sufficiently powered to provide
adequate control for potential confounders including, but not limited to,
gender, age, income, disability, and other factors that might explain
racial/ethnic differences in study outcomes. Applicants are encouraged to
submit applications that go beyond simply identifying an association between
race and an outcome as the sole measure of racial/ethnic discrimination.
Studies that measure the prevalence, causes, and effects of racial
discrimination; explanatory mechanisms that lead to discriminatory behavior and
mediating factors; and processes in health delivery systems are of particular
interest.
Examples of research topics and approaches that would be relevant areas of
investigation for development of R03 applications under this FOA include, but
are not limited to:
Methodology for Measuring Racial/Ethnic Discrimination
Studies that develop and evaluate innovative methods for measuring
physician and other health care provider bias and/or use of stereotypes with
racial/ethnic minority patients, patient exposure to racial/ethnic
discrimination, and patient strategies used to cope with exposure to
racial/ethnic discrimination in the health delivery systems. With the exception
of studies that examine patient perception of exposure to discriminatory
behavior, studies should go beyond identifying an association between race and
an outcome as a measurement of discrimination.
Discriminatory Behavior by Providers or Other Staff in the Health Care Setting
Studies that employ innovative methods for measuring provider attitudes, beliefs,
and behaviors towards racial/ethnic minority patients including perceptions
that are likely to influence recommendations, referral patterns, and receipt of
appropriate care.
Patient Perception of the Receipt of Discriminatory Care
Studies that examine factors that influence patient experiences and
perception of racial/ethnically biased health care and its relationship to
trust of health care providers and its influence on the future utilization of health
care services including compliance with provider recommendations, delays in
seeking care, and continuity in care.
Studies that examine racial/ethnic concordance, provider communication styles
and their relationship to patient perception of the receipt of racially/ethnically
biased care.
Institutional Racism
Studies that examine the impact of health delivery system practices and
policies such as patient dumping , Medicare nursing care bed certification
limits, privatization, closure or relocation of public hospitals, or other
policies that may adversely impact the supply of racial/ethnic minority health
care providers and how this might relate to racial/ethnic disparities in access
to care, health status and outcomes.
Health delivery systems, health care policies, and changes to systems and polices
that have a disparate impact on racial/ethnic minorities and the roles that
they might play in racial/ethnic health disparities including the utilization
of health services and receipt of appropriate care by members of racial and
ethnic minority populations.
The Effects of Racial/Ethnic Discrimination on Health Care Delivery to Racial/Ethnic
Minority Patients
Patient beliefs systems, personal biases and attitudes, and their impact on
relationships with providers and on the utilization of health care services and
receipt of appropriate care.
Patient experiences or perception of racially/ethnically biased health care and
its influence on the future utilization of health care services and willingness
to comply with physician recommendations.
Intervention Studies
Studies that test interventions designed to overcome provider bias and/or
patient perception of racial/ethnic discrimination to ensure the receipt of
quality medical care among racial/ethnic minority patients. Proposed
interventions should be based on empirical data from adequately powered
preliminary/pilot studies that support the need for and potential benefit from
the specific intervention in the proposed target population.
See Section
VIII, Other Information - Required Federal Citations for policies related
to this announcement.
1. Mechanism of Support
This Funding Opportunity Announcement (FOA) will use the NIH Small Research Grant (R03) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. All applications submitted in response to this FOA must use the modular budget format. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).
Competing renewal (formerly competing continuation ) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed small grant application may be submitted as defined in NIH Policy. See NOT-OD-05-046, which was published in the NIH Guide on April 29, 2005.
For specific information about the R03 programs, see: http://grants.nih.gov/grants/funding/r03.htm.
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIH ICs provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
A project period of up to two years and a budget for direct costs of up to two $25,000 modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each). Commensurate Facilities and Administrative (F&A) costs are allowed.
F&A costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004, November 2, 2004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
You may submit an application(s) if your
organization has any of the following characteristics:
1.B.
Eligible Individuals
Any individual with the skills,
knowledge, and resources necessary to carry out the proposed research is
invited to work with his/her institution 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.
2. Cost Sharing or
Matching
This program does not require cost sharing as
defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Applicants may submit more than one
application, provided each application is scientifically distinct. Small grant
support may not be used for thesis or dissertation research.
Section
IV. Application and Submission Information
To download an Application Package and Application Guide for completing
the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
Project Directors/Principal Investigators (PDs/PIs) should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organization/Institutional Registration in Grants.gov/Get Started.
Grants.gov
Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. 9:00 p.m. Eastern Time
E-mail support@grants.gov
2) Organization/Institutional Registration in the eRA Commons
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
E-mail commons@od.nih.gov
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take 4 weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1.
Request Application Information
Applicants must download the SF424 (R&R)
application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a specific FOA can be
used. You will not be able to use any other SF424 (R&R) forms (e.g., sample
forms, forms from another FOA), although some of the Attachment files may be
useable for more than one FOA.
For further assistance, contact GrantsInfo; Telephone: 301-710-0267, E-mail: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of
Application Submission
Prepare all applications using the SF424 (R&R) application forms and in
accordance with the SF424 (R&R) Application Guide
(MS
Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site
Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget
Optional Components:
PHS398 Cover Letter File
Research &
Related Subaward Budget Attachment (s) Form
Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R03 uses ONLY the PHS 398 Modular Budget. (Do not use the detailed Research and Related Budget.)
Foreign
Organizations
Several special provisions apply to applications
submitted by foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
3. Submission Dates and
Times
See Section
IV.3.A for details.
3.A. Submission,
Review, and Anticipated Start Dates
Opening Date: May 2, 2006 (earliest date an application may be
submitted to Grants.gov).
Letters of Intent Receipt Date(s): Not
applicable.
Application Submission
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
3.A.1. Letter of Intent
A letter of
intent is not required for the funding opportunity.
3.B. Electronic
Transmission of an Application to the NIH
To submit an application in response to this
FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C.
Application Processing
Applications may be submitted on or after the opening date and must be successfully
received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application
submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.
Once an application package has been successfully
submitted through Grants.gov, any errors have been addressed, and the assembled
application has been created in the eRA Commons, the PD/PI and the Authorized
Organization Representative/Signing Official (AOR/SO) have two business days to
view the application image.
Upon receipt, applications will be
evaluated for completeness by the Center for Scientific Review, NIH. Incomplete
applications will not be reviewed.
There will be an acknowledgement of receipt
of applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note that such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental Review
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. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.
6. Other Submission Requirements
The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
Renewal (formerly competing continuation or Type 2 ) applications are not permitted.
All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R03 applications:
Note: While each section of the
Research Plan needs to be uploaded separately as a PDF attachment, applicants
are encouraged to construct the Research Plan as a single document, separating
sections into distinct PDF attachments just before uploading the files. This
approach will enable applicants to better monitor formatting requirements such
as page limits. All attachments must be provided to NIH in PDF format,
filenames must be included with no spaces or special characters, and a .pdf
extension must be used.
Plan for Sharing
Research Data
Not applicable.
Sharing
Research Resources
NIH policy requires that
grant awardee recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.
Section
V. Application Review Information
1. Criteria
Only the review criteria described below
will be considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity
will be assigned to the NIH ICs on the basis of established PHS referral
guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications
will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research plan is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written comments, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.
Note that an application does not need to be
strong in all categories to be judged likely to have major scientific impact
and thus deserve a high priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative but is
essential to move a field forward.
Significance: Does this study address an important scientific health
problem? If the aims of the application are achieved, how will scientific
knowledge or clinical practice be advanced? What will be the effect of these
studies on the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods,
and analyses adequately developed, well integrated, well reasoned, and
appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does
the project challenge existing paradigms or clinical practice; address an
innovative hypothesis or critical barrier to progress in the field? Does the
project develop or employ novel concepts, approaches, methodologies, tools, or
technologies for this area?
Investigators: Are the investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the PD/PI and other researchers? Does the investigative team bring
complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed studies benefit
from unique features of the scientific environment, or subject populations, or
employ useful collaborative arrangements? Is there evidence of institutional
support?
2.A. Additional Review
Criteria
In addition to the above criteria, the following
items will continue to be considered in the determination of scientific merit
and the priority score:
Protection of Human Subjects from
Research Risk: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. See item 6 of the
Research Plan component of the SF424 (R&R)).
Inclusion of Women, Minorities and
Children in Research: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See item 7 of the Research Plan component of the SF424
(R&R)).
2.B. Additional Review
Considerations
Budget and Period of Support: The reasonableness of the proposed budget and
the appropriateness of the requested period of support in relation to the
proposed research may be assessed by the reviewers. Is the effort listed for
the PD/PI appropriate for the work proposed? Is each budget category realistic
and justified in terms of the aims and methods?
2.C. Sharing
Research Data
Not applicable.
2.D. Sharing
Research Resources
NIH policy requires that grant awardee recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the
administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan will be
considered by Program staff of the funding organization when making
recommendations about funding applications. Program staff may negotiate
modifications of the data and resource sharing plans with the awardee before
recommending funding of an application. The final version of the data and
resource sharing plans negotiated by both will become a condition of the award
of the grant. The effectiveness of the resource sharing will be evaluated as
part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.
Reporting.
Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan
in an administrative note. The sharing plan itself should be discussed after
the application is scored. Whether a sharing plan is reasonable can be
determined by the reviewers on a case-by-case basis, taking into consideration
the organism, the timeline, the applicant's decision to distribute the resource
or deposit it in a repository, and other relevant considerations. For the R03
mechanism, the presence or adequacy of a plan should not enter into the scoring
of the application.
3. Anticipated
Announcement and Award Dates
Not
applicable.
Section VI. Award Administration Information
1. Award Notices
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 NIH eRA Commons.
If the application is under
consideration for funding, NIH will request "just-in-time"
information from the applicant. For details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and
Conditions of NIH Grant Awards, Subpart A: General.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via
e-mail notification from the awarding component to the grantee business
official.
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. See Section IV.5.,
Funding Restrictions.
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.
3. Reporting
When multiple years are involved, awardees will be
required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
We encourage your inquiries
concerning this funding opportunity and welcome the opportunity to answer
questions from potential applicants. Inquiries may fall into three areas:
scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research
Contacts:
Vickie L.
Shavers, Ph.D.
Applied Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN Room 4005, MSC 7344
Bethesda, MD 20892-7344 (for U.S. Postal
Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 594-1725
FAX: (301) 435-3710
E-mail: shaversv@mail.nih.gov
Lawrence
Agodoa, M.D.
Office of Minority Health Research Coordination
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 653, MSC 5454
Bethesda, Maryland 20892-5454
Telephone: (301) 594-1932
FAX: (301) 594 9358
E-mail: agodoal@extra.niddk.nih.gov
Lawrence
J Fine, M.D., Dr. P.H.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 8138, MSC 7936
Bethesda, Maryland 20892-7936
Telephone: (301) 435-0305
FAX: (301) 480-1669
E-mail: Finel@nhlbi.nih.gov
Ellen
Werner, Ph.D.
Blood Disease Program
National Heart Lung and Blood Institute
6701 Rockledge Drive, Room 10156, MSC 7950
Bethesda, MD, 20892-7950
Phone: (301) 435-0061
E-mail: wernere@nhlbi.nih.gov
John
W. Haller, Ph.D.
Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Room 960, MSC 2077
Bethesda, MD 20892-2077
Telephone: (301) 451-4780
FAX: (301) 480-4973
E-mail : hallerj@mail.nih.gov
Dionne
J. Jones, Ph.D.
Services Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3163
Bethesda, MD 20892 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: 301-402-1984
FAX: 301-443-2636
E-mail: dj99r@nih.gov
2. Peer Review Contacts:
Not applicable.
3. Financial or Grants Management Contacts:
Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
6130 Executive Blvd., EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone (301) 496-8634
FAX: (301) 496-4801
E-mail: wolfreyc@mail.nih.gov
Gary
Fleming, J.D., M.A.
National Institute on Drug Abuse
6101 Executive Blvd.
Suite 270, MSC 8403
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6849
E-mail: gf6s@nih.gov
David
L. Mineo
Chief Grants Management Officer
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Blvd., Room 731, MSC 5456
Bethesda, MD. 20892-5456
Telephone: (301) 594-8854
FAX: (301) 480-3504
E-mail: mineod@extra.niddk.nih.gov
Angela
Eldridge
6707 Democracy Boulevard, Democracy II Suite 900, MSC 5469
Bethesda, MD 20892-5469 (for U.S. Postal Service express or regular mail)
Bethesda, MD 20817 (for express/courier delivery)
Telephone:
(301) 451-4793
FAX: (301) 480-4974
Section VIII. Other Information
Required Federal
Citations
Human Subjects Protection:
Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); and efficacy, effectiveness, and
comparative trials (Phase III). Monitoring should be commensurate with risk.
The establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Access to Research Data through the Freedom of
Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time, the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004, receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical
Research:
It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R); and updated roles and
responsibilities of NIH staff and the extramural community. The policy continues
to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human
Subject Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access
Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from: (1) currently funded NIH research projects; or (2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters, editorials,
reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the
submission process, please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information," the "Privacy Rule," on August 14, 2002. The Privacy Rule is a Federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and enforced
by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
Web site (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and a set
of decision tools on "Am I a covered entity?" Information on the
impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be
self-contained within specified page limitations. Unless otherwise specified in
an NIH solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described
in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. 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 52 and 45 CFR
Parts 74 and 92. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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