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 Heart Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)
National Institute
of Aging (NIA) (http://www.nia.nih.gov/)
Title: The Effect of Racial and Ethnic Discrimination/Bias on
Health Care Delivery (R21)
Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of PA-06-306, which was
previously released on March 31, 2006.
Update: The following updates relating to this announcement have been issued:
NOTICE: Applications submitted in response to this 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 4 weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PA-08-084
Catalog of Federal
Domestic Assistance Number(s)
93.393,
93.394, 93.395, 93.399; 93.233, 93.837, 93.838, 93.839; 93.279; 93.242; 93.866
Key Dates
Release/Posted Date: February 1, 2008
Opening Date: February 5, 2008 (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(s): 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: May 8, 2011.
Due Dates for E.O. 12372
Not Applicable.
Additional
Overview Content
Executive Summary
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. Submitting an Application Electronically
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. Resource Sharing Plan(s)
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 goals of this funding opportunity 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 (U.S.).
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 (IOM, 2002), 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 (DHHS) Health Disparities Progress Review Group (Health Disparities Progress Review Group, 2004) 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 insights 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 (National Research Council, 2004). 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. These pathways 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, and 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 have 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 19951996 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, non-responsiveness, 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 as a result 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 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 policies 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.
Measurement of organizational factors and relationships between organizational entities such as treatment agencies and other health, social services, and criminal justice system agencies as they relate to the disproportionate use and availability of substance abuse services among racial/ethnic minorities..
The role of public and institutional policies as they relate to the disproportionate use, availability or satisfaction with substance abuse services among racial/ethnic minorities.
The association between racial/ethnic stigma and gaps between substance abuse needs (e.g., treatment, prevention, and related services) and service availability.
The role of economic and personal costs as they relate to the disproportionate use, availability, and satisfaction with substance abuse services among racial/ethnic minorities.
Studies of policy shifts (e.g., related to privacy policies, treatment immediacy, cost variation) in service delivery and their effects on stigma and/or discrimination related to mental health or HIV/AIDS.
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.
The role of perceived racial/ethnic discrimination in substance abuse and the attainment of optimal substance abuse prevention and treatment outcomes among racial and ethnic minorities
The role of racial/ethnic stigma in willingness to seek care for substance abuse.
Studies to assess the role of culture, behaviors, and attitudes on perceived racial and ethnic discrimination in the delivery and access of quality care for mental health or HIV/AIDS;
Studies to examine the mechanisms through which mental illness stigma and discrimination influence acceptance or denial of illness, help-seeking decisions and preferences, the helping relationship, and disparities in access to care; and diagnosis of mental disorders and the diagnostic process among racial and ethnic groups
INTERVENTION STUDIES
Studies that test interventions designed to reduce provider bias and/or patient perception of racial/ethnic discrimination or consequences designed to ensure the receipt of quality medical care among racial/ethnic minority patients are of particular interest. 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.
Studies of the effectiveness of suicide prevention gatekeeper programs (church-based, school-based, college-based, platoon-based) on referrers attitudes, behaviors, and referral patterns.
Studies to assess the relationship between perceptions of care discrimination and use of services intervention, prevention and treatment related to mental health or HIV/AIDS.
The study should address at least one the following criteria:
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1.
Mechanism of Support
This FOA will use the NIH
Exploratory/Developmental Research Grant (R21) award
mechanism. As an applicant, you will be solely
responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses the modular as well as the non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. 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 3.4, Modular Budget Component, of the Application Guide).
Foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation) applications will not be accepted. Applicants may submit a resubmission, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).
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 Institutes
and Centers (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.
The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed 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. 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.
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
institution/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 as the Project Director/Principal Investigator (PD/PI) 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.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does not fit the single-PD/PI model.Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically.Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
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
Exploratory/developmental grant support is for new projects only;
competing renewal (formerly competing continuation) applications will not be
accepted.
Applicants may submit a resubmission, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).
Applicants may submit more than one application, provided each application is scientifically distinct.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and
SF424 (R&R) 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:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
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 organization/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; Email: 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/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, 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 Modular Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget (applications from Domestic institutions)
Research & Related Budget (applications from Foreign institutions, see
details below)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign Organizations (Non-domestic
(non-U.S.) Entity)
All foreign
applicants must complete and submit budget requests using the non-modular
Research & Related Budget component found in the application package for
this FOA. See NOT-OD-06-096,
August 23, 2006.
NIH policies concerning grants to Foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from Foreign organizations must:
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.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover component.All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI.Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission.The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component.Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts.The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component.All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form.See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only.Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 3.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component
3.
Submission Dates and Times
See Section IV.3.A for details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: February
5, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not
applicable.
Application Submission/Receipt Dates: Standard dates
apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Dates: Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Dates: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Dates: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Dates: 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. Submitting an Application Electronically 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 2 business days to view the application image.
Upon receipt, applications will
be evaluated for completeness by the Center for Scientific Review (CSR), 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.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status 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. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
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
PD/PI
Credential (e.g., Agency Login)
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 Registration FAQs Important Tips -- Electronic Submission of Grant Applications.
Organizational DUNS
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 Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified below for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
PHS398 Research Plan Component Sections
While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component 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.
All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, incorporating "Just-in-Time" information concepts, and with the following requirements for R21 applications:
Appendix Materials
NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.
Foreign Applications (Non-domestic (non-U.S.) Entity)
Indicate how the proposed project has specific relevance to the mission and objectives of the National Cancer Institute and has the potential for significantly advancing the health sciences in the United States.
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. GWAS is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
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 institutes and centers (ICs) on the basis of established Public Health Service (PHS) referral
guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://cms.csr.nih.gov/ResourcesforApplicants/)
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 R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research. Because the Research Strategy is limited to 6 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place 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, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included, if available.
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 critiques, 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. Each of these criteria will be addressed and considered in assigning the 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 impact/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.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 this study address
an important 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?
Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, 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? For applications designating multiple PDs/PIs, is the
leadership approach, including the designated roles and responsibilities,
governance, and organizational structure, consistent with and justified by the
aims of the project and the expertise of each of the PDs/PIs?
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
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.
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.
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.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), 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.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agents 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).
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.
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 (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm);
2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html);
and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
2.C. Resource Sharing Plan
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or impact/priority score, unless noted otherwise. Program staff within the Institute or Center will be responsible for monitoring the resource sharing.
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/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 email
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
Barbara
Wells, Ph.D.
Division
of Prevention and Population Sciences Clinical Applications and Prevention
Branch
National
Heart, Lung and Blood Institute
6701
Rockledge Drive, Room 10114, MSC 7936
Bethesda, MD 20892-7936
Telephone:
(301) 435-0417
Email: wellsb@nhlbi.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, MSC 9593
Bethesda, MD 20892-9593
Telephone: (301) 402-1984
Fax: (301) 443-2636
E-mail: dj99r@nih.gov
Denise Juliano-Bult, M.S.W.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room, 7137 MSC 9631
Bethesda, MD 20892-9631
Telephone: 301-443-3364
Email: djuliano@mail.nih.gov
(NIMH, non-HIV/AIDS-related applications in areas of interest to DSIR)
Emeline Otey, Ph.D.
Chief, Stigma and Health Disparities Program
Division of AIDS and Health and Behavior Research (DAHBR)
National Institute of Mental Health
6001 Executive Boulevard, Room 6227, MSC 9615
Bethesda, MD20892-9615
Telephone: (301) 443-9284
Fax: (301) 480-2910
Email: eotey@mail.nih.gov
(NIMH, non-HIV/AIDS-related applications in areas of interest to DAHBR)
David M. Stoff, Ph.D.
Chief, HIV/AIDS Neuropsychiatry Program, AIDS Research Training and HIV/AIDS
Disparities Program
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6210, MSC 9619
Bethesda, MD20892-9619
Telephone: (301) 443-4625
Fax: (301) 443-9719
Email: dstoff@mail.nih.gov
(HIV/AIDS-related applications only)
John G Haaga, PhD
Behavioral & Social
Research Program
National Institute on Aging
(NIA)
7201 Wisconsin Avenue, Gateway Building
Room 533, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-3131
E-mail: jh735i@nih.gov
2.
Peer Review Contacts:
Not applicable.
3. Financial or Grants
Management Contacts:
Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, 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) 496-8601
E-mail: wolfreyc@mail.nih.gov
Denise
H. Payne
National
Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive,
RKL2 Room 7155, MSC 7926
Bethesda, MD 20817-7926
Telephone: (301) 594-9529
Fax: (301) 451-5462
Email: dp43b@nih.gov
Edith Davis
Grants
Management Branch
National
Institute on Drug Abuse (NIDA)
6101 Executive Boulevard, Room 270, MSC 8403
Rockville, MD 20852
Telephone: (301)
443-6710
Fax:
301-594-6849
E-mail: edavis1@nida.nih.gov
Joy R.
Knipple
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-8811
Fax: (301) 443-6885
Email: jk173r@nih.gov
Linda C. Whipp
National Institute of Aging (NIA)
7201 Wisconsin Avenue, Gateway Building Room 2N212, MSC
9205
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
Fax: (301) 402-3672
Email: whippl@gw.nia.nih.gov
Section VIII. Other Information
Required Federal Citations
Vertebrate Animals:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) 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).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions,
on issues related to institutional policies and local institutional review
board (IRB) rules, as well as local, State, and Federal laws and regulations,
including the Privacy Rule. Reviewers will consider the data sharing plan but
will not factor the plan into the determination of the scientific merit or the impact/priority score.
Policy for Genome-Wide Association Studies (GWAS):
NIH is
interested in advancing genome-wide association studies (GWAS) to identify
common genetic factors that influence health and disease through a centralized
GWAS data repository. For the purposes of this policy, a genome-wide
association study is defined as any study of genetic variation across the
entire human genome that is designed to identify genetic associations with observable
traits (such as blood pressure or weight), or the presence or absence of a
disease or condition. All applications, regardless of the amount requested,
proposing a genome-wide association study are expected to provide a plan for
submission of GWAS data to the NIH-designated GWAS data repository, or provide
an appropriate explanation why submission to the repository is not possible.
Data repository management (submission and access) is governed by the Policy
for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide
Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
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). Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal 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.
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.
Inclusion of Women, Minorities, and Children:
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) application; 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-09-116.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:
In accordance with the NIH Public Access Policy, investigators funded by the NIH
must submit or have submitted for them to the National Library of Medicines
PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic
version of their final, peer-reviewed manuscripts upon acceptance for
publication, to be made publicly available no later than 12 months after the
official date of publication. The NIH Public Access Policy is
available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For
more information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (HHS)
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 HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (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. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for 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 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 Part 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 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.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged. The
periods of career award and LRP award may overlap providing the LRP recipient
with the required commitment of time and effort, as LRP awardees must commit at
least 50% of their time (at least 20 hours per week based on a 40 hour week)
for 2 years to the research. For further information, please see http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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