IMPORTANT NOTE: 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.EXPIRED
Department
of Health and Human Services
Issuing Organization
National Cancer Institute (NCI) (http://www.cancer.gov)
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 of Biomedical Imaging and
Bioengineering (NIBIB) ( http://www.nibib1.nih.gov/)
National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA) ( http://www.nida.nih.gov)
Office of Behavioral
and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov)
Title: The Effect of Racial and Ethnic Discrimination/Bias on
Healthcare Delivery (R01)
Announcement Type
This is a reissue of PA-05-006, which was previously released September 17, 2004.
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 4 weeks prior to the grant submission date. See Section IV.
Program
Announcement (PA) Number: PA-07-206
Catalog of Federal
Domestic Assistance Number(s)
93.393, 93.394, 93.395, 93.399; 93.233, 93.837, 93.838, 93.839;
93.286; 93.847, 93.848;
93.279
Key Dates
Release/Posted Date: December 19, 2006
Opening Date: January 5, 2007 (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: January 3, 2008 (now January 8, 2008 per NOT-OD-07-093)
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. 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 Contacts
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
The purposes of this Funding Opportunity Announcement (FOA) are: (1) to improve the measurement of racial /ethnic discrimination in healthcare delivery systems through improved instrumentation, data collection, and statistical/analytical techniques; (2) to enhance understanding of the influence of racial/ethnic discrimination in healthcare 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 in healthcare delivery systems in the United States.
For the purposes of this FOA, healthcare 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. Healthcare delivery systems are defined as insurance plans, hospitals, clinics, private physician offices, or public and community health facilities that provide or finance healthcare 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 healthcare 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, healthcare providers, patients, and utilization managers may contribute to racial and ethnic disparities in healthcare; and (3) health provider bias, stereotyping, prejudice, and clinical uncertainty may contribute to racial and ethnic disparities in healthcare. A more recent report from a Trans-U.S. Department of Health and Human Services (DHHS) 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 healthcare 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 nonphysician healthcare professionals, pharmacists, allied health professional, and nonprofessional staff in contributing to healthcare 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 healthcare 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 healthcare 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 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 nonclinical characteristics, either actual or perceived, on provider perception of racial/ethnic minority patients might also have an impact on the healthcare 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 healthcare 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 healthcare 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 healthcare setting may profoundly impact attitudes toward receiving care and influence further utilization of healthcare services. Data from the National Comorbidity Study show that although African Americans had more favorable attitudes toward seeking mental health services than whites prior to using them, the reverse was true after using the services. In one 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 healthcare 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 services less frequently (7.7 percent). The behaviors of (25.6 percent) 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 R01 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 healthcare 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 healthcare setting:
Studies that employ innovative methods for measuring provider attitudes, beliefs, and behaviors toward 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 racially/ethnically biased healthcare and its relationship to trust of healthcare providers and its influence on the future utilization of healthcare 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 healthcare providers and how this might relate to racial/ethnic disparities in access to care, health status, and outcomes.
Health delivery systems, healthcare 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 healthcare 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 healthcare services and receipt of appropriate care.
Patient experiences or perception of racially/ethnically biased healthcare and its influence on the future utilization of healthcare 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.
Section
II. Award Information
1. Mechanism of Support
This FOA will use the NIH Research Project Grant (R01) award mechanism.
The applicant 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 nonmodular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are a U.S. organization and 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).
U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA.
2.
Funds Available
Applications received in response to
this funding opportunity will compete for funds in the general funding pool of
the NIH Institutes and Centers (ICs). No specific
funds have been set aside. The number of awards will depend on the number of
applications received, their relative scientific merit, and the general
availability of funds for investigator-initiated research. Applicants may
request up to 5 years of support for R01 awards with
costs appropriately tailored to the proposed work. No limit is set on the costs
requested by R01 applicants.
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 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.
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(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. 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
Applications can be renewed by competing for additional project periods.
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/applicants/apply_for_grants.jsp 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 Registered
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.
Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
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 from 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 the 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: [email protected].
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 for this FOA through Grants.gov/Apply.
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 Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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 or Research &
Related Budget: Select one, as appropriate. (See Section IV.6., Special Instructions,
regarding appropriate required budget component.) Research &
Related Budget is required for foreign applications.)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign
Organizations (Non-Domestic [non-U.S.] Entities)
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 U.S. 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 15 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 (Section 14 of the Research Plan Component in the SF424 (R&R)), 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 5.4 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; January 5, 2007 (Earliest date an application may be submitted to
Grants.gov)
Application Submission/Receipt
Date(s): Standard dates apply, please see http://grants.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
3.A.1. Letter of Intent
A letter of intent is not required for this 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/applicants/apply_for_grants.jsp 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 Commonshttps://commons.era.nih.gov/commons/.
The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI
receive Commons acknowledgments. Information related to the assignment of an
application to a Scientific Review Group is also in the Commons.
NOTE: Since e-mail can be unreliable, it is the responsibility of applicants to check periodially 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. 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 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 or competing renewal (formerly
competing continuation ) 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 or competing renewal award.
The incurrence of pre-award costs in
anticipation of a competing or noncompeting 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(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential login field of the Research & Related Senior/Key Person Profile component.
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.
PHS398 Research Plan Component Sections
Items 2 5 of the PHS398 Research Plan component are limited to 25 pages. While each section of the Research Plan component 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 are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Special Instructions for Modular Grant applications
R01 applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component. See Section 5.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.
Foreign organizations may not submit modular budgets.
Special Instructions for Applications Requesting $500,000 (direct costs) or More Per Year
Applicants
requesting $500,000 or more in direct costs for any year (excluding consortium
F&A costs) must carry out the following steps:
1) Contact the
NIH IC program staff at least 6 weeks before submitting the application, i.e.,
as you are developing plans for the study;
2)
Obtain agreement from the IC staff that the IC will accept your application for
consideration for award; and
3)
Include the PHS398 Cover Letter component with the application to identify the
staff member and IC who agreed to accept assignment of the application.
This policy applies to all new applications, competing renewal (formerly competing continuation ) applications, resubmission (formerly revised/amended ) applications, and revision (formerly competing supplemental ) applications. See NOT-OD-02-004, October 16, 2001.
Appendix Materials
IMPORTANT NOTE: 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.
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 of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Note: While each section of the PHS398 Research Plan component 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 monitor better 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.
Foreign Applications (Non-Domestic [non-U.S.] Entity)
The
precise content of the data-sharing plan will vary, depending on the data being
collected and how the investigator is planning to share the data. Applicants
who are planning to share data may wish to describe briefly the expected
schedule for data sharing, the format of the final dataset, the documentation
to be provided, whether or not any analytic tools also will be provided,
whether or not a data-sharing agreement will be required and, if so, a brief
description of such an agreement (including the criteria for deciding who can
receive the data and whether or not any conditions will be placed on their
use), and the mode of data sharing (e.g., under their own auspices by mailing a
disk or posting data on their institutional or personal Web site, through a
data archive or enclave). Investigators choosing to share under their own
auspices may wish to enter into a data-sharing agreement. References to data
sharing may also be appropriate in other sections of the application.
Applicants requesting more than $500,000 in direct
costs in any year of the proposed research must include a plan for sharing
research data in their application. The funding organization will be
responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
NIH
policy expects that grant 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.
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 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 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 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 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? 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?
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, or methodologies, tools, or technologies for this area?
Investigators: Are the PDs/PIs and other key personnel appropriately
trained and well suited to carry out this work? Is the work proposed
appropriate to the experience level(s) of the Principal Investigator(s) and
other researchers? Do the PDs/PIs and investigative team bring complementary
and integrated expertise to the project (if applicable)?
Environment: Do(es) the scientific environment(s) 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(s), 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:
Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
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 the Human Subjects Sections of
the PHS398 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 the
Human Subjects Sections of the PHS398 Research Plan component of the SF424
(R&R).
Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.
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 number of person months listed for the effort of the PD/PI(s)
appropriate for the work proposed? Is each budget category realistic and justified
in terms of the aims and methods?
Applications from Foreign Organizations: Whether the project presents 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 will be assessed.
2.C.
Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The funding organization will be responsible for monitoring the data sharing
policy (http://grants.nih.gov/grants/policy/data_sharing).
2.D. Sharing Research
Resources
NIH policy expects that
grant 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 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.
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 Contact(s):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: [email protected]
Virginia Cain, Ph.D.
Office of Behavior and Social Science Research (OBSSR)
National Institutes of Health
One Center Drive, Building 1, Room 256
Bethesda, MD 20892-0183
Telephone: (301) 402-1146
Fax: 301-402-1150
E-mail: [email protected]
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: [email protected]
Ellen Werner, Ph.D
Blood Disease Program
National Heart Lung and Blood Institute
6701 Rockledge Drive, Room 10156, MSC 7950
Bethesda, MD, 20892-7950
Telephone: (301) 435-0061
E-mail: [email protected]
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 : [email protected]
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
Telephone: 301-402-1984
Fax: 301-443-2636
E-mail: [email protected]
2. Peer Review
Contact(s):
Not applicable
3.
Financial/Grants Management Contact(s):
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 service)
Telephone
(301) 496-8634
Fax: (301) 496-4801
E-mail: [email protected]
Gary Fleming, J.D.,
M.A.
National Institute on Drug Abuse
6101 Executive Boulevard, Suite 270, MSC
8403
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
Fax: (301) 594-6849
E-mail: [email protected]
Chief Grants Management Officer
National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 731, MSC 5456
Bethesda, MD. 20892-5456
Telephone: (301) 594-8854
Fax: (301) 480-3504
E-mail: [email protected]
Angela Eldridge
6707 Democracy Blvd., 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 service)
Telephone: (301) 451-4793
Fax: (301 ) 480-4974
Section VIII. Other Information
Required Federal Citations
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
multisite 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 priority score.
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 the 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 supporting 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.
Inclusion of
Women And Minorities in Clinical Research:
It is the policy
of the NIH that women and members of minority groups and their subpopulations
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-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.
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 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. For publications listed in the appendix and/or
Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission
identification numbers must be used for publicly accessible on-line journal
articles. Publicly accessible on-line journal articles or PMC
articles/manuscripts accepted for publication that are directly relevant to the
project may be included only as URLs or PMC submission
identification numbers accompanying the full reference in either the
Bibliography & References Cited section, the Progress Report Publication
List section, or the Biographical Sketch section of the NIH grant application.
A URL or PMC submission identification number citation may be repeated in each
of these sections as appropriate. There is no limit to the number of URLs or
PMC submission identification numbers that can be cited.
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 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, healthcare, 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 percent 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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