The Effect of Racial and Ethnic Discrimination/Bias on Health Care Delivery

Part I Overview Information


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.nci.nih.gov/)
National Institute for Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov/)

Office of Behavioral and Social Science Research (OBSSR),(http://obssr.od.nih.gov)
National Heart Lung and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib1.nih.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)

Announcement Type:

Update: The following update relating to this announcement has been issued:

PA Number: PA-05-006

Catalog of Federal Domestic Assistance Number(s):
93.393, 93.394, 93.395, 93.399 (NCI); 93.847, 93.848 (NIDDK); 93.233, 93.837,93.838, 93.839 (NHLBI); 93.286 (NIBIB); 93.279 (NIDA)

Key Dates
Release/Posted Date: October 20, 2004
Application Receipt Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Dates: June-July, October-November, February-March
Council Review Dates: September-October, January-February, May-June
Earliest Anticipated Start Dates: December, April, July
EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007


Due Dates for E.O. 12372
Not Applicable

Executive Summary


The purposes of this Program Announcement (PA) are: (1) to improve the measurement of racial /ethnic discrimination in health care delivery systems through improved instrumentation, data collection and statistical/analytical techniques; (2) to enhance understanding of the influence of racial/ethnic discrimination in health care delivery and its association with disparities in disease incidence, treatment and outcomes among disadvantaged racial/ethnic minority groups; and (3) to reduce the prevalence of racial/ethnic health disparities through the development of interventions to reduce the influence of racial/ethnic discrimination on health care delivery systems in the United States.

This funding opportunity will use the NIH Research Project Grant (R01), the Exploratory/Development (R21) and the Small Grant (R03) award mechanisms .

Applications using the R01 award mechanism must have extensive preliminary data and build on previous pilot work or existing research in the proposed research area. Applicants without extensive preliminary data or who wish to develop research methodology or instruments to address a specific research question are urged to submit applications using the R21 mechanism. Applications using the R21 mechanism should be novel, exploratory or developmental. The R03 mechanism is for pilot work and is appropriate for funding for short periods of time for research projects that have limited costs, that are narrow in scope and that involve the use of widely accepted approaches and methods.

You may submit (an) application(s) if your organization has any of the following characteristics:

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance, contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Each applicant may submit only one application in response to this PA.

Telecommunications for the hearing impaired: TTY 301-451-5936.

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(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
  A. Eligible Institutions
  B. Eligible Individuals
2. Cost Sharing
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates
  A. Receipt and Review and Anticipated Start Dates
   1. Letter of Intent
  B. Sending an Application to the NIH
  C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Merit Review Criteria
  A. Additional Review Criteria
  B. Additional Review Considerations
  C. Sharing Research Data
  D. Sharing Research Resources

Section VI. Award Administration Information
1. Award Notices
2. Administrative Requirements
  A. Cooperative Agreement Terms and Conditions of Award
   1. Principal Investigator Rights and Responsibilities
   2. NIH Responsibilities
   3. Collaborative Responsibilities
   4. Arbitration Process
3. Award Criteria
4. 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

The purposes of this Program Announcement (PA) are: (1) to improve the measurement of racial /ethnic discrimination in health care delivery systems through improved instrumentation, data collection and statistical/analytical techniques; (2) to enhance understanding of the influence of racial/ethnic discrimination in health care delivery and its association with disparities in disease incidence, treatment and outcomes among disadvantaged racial/ethnic minority groups; and (3) to reduce the prevalence of racial/ethnic health disparities through the development of interventions to reduce the influence of racial/ethnic discrimination in health care delivery systems in the United States.

For the purposes of this PA, 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.

1. Research Objectives

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 (Institute of Medicine, 2002) as well as several other recent reviews (Shavers et al., 2003; Shavers et al., 2002; Bach et al., 2002) 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, healthcare providers, patients, and utilization managers may contribute to racial and ethnic disparities in health care. (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-US Department of Health and Human Services 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 insight into how and why racial/ethnic disparities occur and to test interventions and strategies to eliminate them, including research that provides further elucidation on: (1) patient, provider, and institutional contributions to health care disparities; (2) the relative contributions of provider bias, stereotyping, prejudice, and uncertainty to racial/ethnic disparities in diagnosis, treatment, and outcomes of care; and (3) the role of non-physician health care professionals, pharmacists, allied health professional, and non-professional staff in contributing to healthcare disparities.

The relationship of race/ethnicity to health disparities is complex. This PA 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 PA 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 PA 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 PA focuses on examining overt as well as subtle racial/ethnic discriminatory behavior and processes perceived or experienced by historically disadvantaged racial/ethnic minority groups and their contribution to the persistent disparities in the receipt of quality health care and disease outcomes that have been observed among these populations.

Racial/ethnic bias is hypothesized to contribute to disparities in health through five key pathways (Krieger, 2003). These include increased exposure and susceptibility to (1) economic and social deprivation; (2) toxic substances and hazardous conditions; (3) socially inflicted mental and physical trauma, either directly experienced or witnessed; (4) targeted marketing of potentially harmful commodities such as tobacco, alcohol, illicit drugs; and (5) inadequate or degrading medical care.

The influence of non-clinical characteristics, either actual or perceived, on provider perception of racial/ethnic minority patients might also have an impact on the health care received by patients (van Ryn et al., 2003; Rathore et al., 2000; van Ryn et al., 2000; Einbinder et al., 2000). Physician recommendations and referrals been shown to contribute to racial disparities in referrals for kidney transplantation (Epstein et al., 2000) and receipt of some cardiovascular procedures. Several mechanisms through which providers potentially contribute to racial/ethnic disparities in health have been suggested (Balsa et al., 2003). 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 (Bird et al., 2001). Similarly, 29 percent of African Americans and more than 10 percent of Latino/Hispanic, Filipino, and Korean respondents in the King County [Seattle, Washington] Health and Ethnicity Survey of 1995-1996 reported that they had experienced discrimination when seeking or obtaining health care due to their race or ethnicity (Hobson, 2001). 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 (Hobson, 2001).

Negative experiences in the health care setting may profoundly impact attitudes towards 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 (Diala et al., 2000). 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) (Hobson, 2001). The behaviors of (25.6 percent) of African American respondents did not change (Hobson, 2001).

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 (Nyborg, 2003). Perceived discrimination has also been found to be associated with depression (Noh et al., 2003). Studies that have examined the influence of self-reported experiences with racial/ethnic bias and physiologic changes have, however, provided inconsistent results (Harrell et al., 2003). For example, some studies have shown an association between discrimination related stress and increases in blood pressure (Kreiger, 1990; Kreiger, 1996) while others have not (Broman, 1996; Dressler, 1996). Other research suggests that the association between perceived racial discrimination and increases in blood pressure is dependent upon coping styles (Krieger,1996). 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 (Lawlor et al., 2003; Stead et al., 2001; Landrine et al., 2000) and alcohol and substance abuse (Gibbons et al., 2004).

This PA 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, R03, and R21 applications under this PA 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 healthcare 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, 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 health care delivery to racial/ethnic minority patients:

Patient beliefs systems, personal biases and attitudes, and their impact on relationships with providers and on the utilization of health care services and receipt of appropriate care.

Patient experiences or perception of racially/ethnically biased health care and its influence on the future utilization of health care services and willingness to comply with physician recommendations.

Intervention studies:

Studies that test interventions designed to overcome provider bias and/or patient perception of racial/ethnic discrimination to ensure the receipt of quality medical care among racial/ethnic minority patients. Proposed interventions should be based on empirical data from adequately powered preliminary/pilot studies that support the need for and potential benefit from the specific intervention in the proposed target population.

Section II. Award Information


1. Mechanisms of Support

This Program Announcement will use the Project Grant (R01), the Exploratory/Development (R21) and the Small Grant (R03) award mechanisms . As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Investigators are encouraged to seek continued support after completing an R21 or R03 grants through an R01.

Applicants without extensive preliminary data or who wish to develop research methodology or instruments to address a specific research question are urged to submit applications using the R21 mechanism. Applications using the R21 mechanism should be novel, exploratory or developmental. The total project period for an application submitted in response to this PA under the R21 mechanism may not exceed 2 years and is not renewable. Grant awards under the R21 mechanism may vary in size with the scope of the proposed research; however, it is expected that these applications will stay within the budgetary guidelines for an exploratory/developmental project with direct costs limited to $275,000 for the 2-year project period. For example, you may request $100,000 in the first year and $175,000 in the second year to meet the needs of your project. Normally, no more than $200,000 may be requested in any single year. (http://grants.nih.gov/grants/funding/r21.htm.)

The R03 mechanism is for pilot work and is appropriate for funding for short periods of time for applications that have limited costs, are narrow in scope and that use widely accepted approaches and methods. Applications for the R03 funding mechanism may be for periods of up to, but may not exceed, 2 years with a direct cost budget of $50,000 per year or two $25,000 modules and are not renewable. (http://grants.nih.gov/grants/funding/r03.htm.)

Please note that facilities and administrative [F&A] costs requested by any consortium participants are excluded from the direct cost limit per NIH Guide Notice NOT-OD-04-040. (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.htm

This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

2. Funds Available

No specific funds are set aside for this PA. We estimate that about 10 awards will be made per year. The awards will vary in amount and length of project period depending on the funding mechanism used.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

2. Cost Sharing

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

3. Other-Special Eligibility Criteria
Not applicable.

Section IV. Application and Submission Information

1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance, contact GrantsInfo, Telephone: (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.


2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See also Subsection VI.2. Administrative Requirements for additional information.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

SUPPLEMENTARY INSTRUCTIONS

All instructions for the PHS 398 must be followed, with these exceptions for R21 and R03 applications.

Supplementary Instructions for R03 applications: Please see the link for the NIH Small Grants Program at http://grants1.nih.gov/grants/funding/r03.htm for specific instructions on submitting R03 applications.

Supplementary Instructions for R21 applications: Please see the link for the NIH Exploratory/Developmental Research Grant Award Program at http://grants.nih.gov/grants/funding/r21.htm for specific instructions on submitting R21 applications.

3. Submission Dates

Applications must be mailed on or before the receipt date described at http://grants1.nih.gov/grants/funding/submissionschedule.htm.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: Not applicable
Application Receipt Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Dates: June-July, October-November, February-March
Council Review Dates: September-October, January-February, May-June
Earliest Anticipated Start Date: December, April, July
Expiration Date: January 3, 2008, unless reissued.


3.A.1. Letter of Intent
Not applicable

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)


3.C. Application Processing

Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

The NIH will not accept any application in response to this PA that is essentially the same as one currently pending initial 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks.


4. Intergovernmental Review


This initiative is not subject to intergovernmental review.


5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Award Criteria).

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the 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 a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

SPECIAL REQUIREMENTS

Grantees should plan to attend annual meetings of investigators funded under this PA for the purpose of reporting on research progress and sharing information with other investigators on data resources, methodology, analytical tools and preliminary results. Applicants should include the cost of attending this meeting in their proposed research budgets.

Plan for Sharing Research Data

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 website, 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.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm ). See Section VI.3. Award Criteria.

Section V. Application Review Information


1. Criteria

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned 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:

3. Merit Review Criteria

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.

1. 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?

2. 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?

3. Innovation . Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators . Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5. 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?

3.A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 Research Plan, Section E on Human Subjects in the PHS Form 398).


3.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

3.C. Sharing Research Data

1. 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.

Program staff will be responsible for the administrative review of the plan for sharing research data.

3.D. Sharing Research Resources

NIH policy requires that grant award 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 and http://www.ott.nih.gov/policy/rt_guide_final.html. Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the data sharing plan and the resources sharing plan 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 Grants Progress Report (PHS 2590). See Section VI.3 Award Criteria.

Section VI. Award Administration Information


1. Award Notices


After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a summary statement.

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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

The NGA will be sent via email to the administrative official whose name is listed in Block 12 on the Face Page of the Form PHS 398.


2. Administrative Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.


2a. Cooperative Agreement Terms and Conditions of Award
Not applicable

3. Award Criteria

The following will be considered in making funding decisions:

4. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually
(http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts


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 Blvd, EPN-Room 4005, MSC 7344
Bethesda, MD 20892-7344
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 594-1725
Fax (301) 435-3710
E-mail: shaversv@mail.nih.gov

Lawrence Agodoa, M.D.
Office of Minority Health Research Coordination
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 653, MSC 5454
Bethesda, Maryland 20892-5454
Telephone: (301) 594 1932
Fax: (301) 594 9358
E-mail: agodoal@extra.niddk.nih.gov

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
Email: Virginia_Cain@nih.gov

Lawrence J Fine, MD, Dr. P.H.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Dr., Suite 8138, MSC 7936
Bethesda, Maryland 20892-7936
Telephone: (301) 435-0305
Fax: (301) 480-1669
Email: Finel@NHLBI.NIH.GOV

Ellen Werner, Ph.D.
Blood Disease Program,
National Heart Lung and Blood Institute
6701 Rockledge Drive, Room 10156 MSC 7950
Bethesda, MD, 20892-7950
Telephone: (301) 435-0061
Email: wernere@nhlbi.nih.gov

John W. Haller, PhD
Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Blvd., Room 960, MSC 2077
Bethesda, MD 20892-2077
Telephone: (301) 451-4780
Fax: (301) 480-4973
Email : hallerj@mail.nih.gov

Dionne J. Jones, Ph.D.
Services Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3163
Bethesda, MD 20892
Telephone: 301-402-1984
Fax: 301-443-2636
E-mail: dj99r@nih.gov

2. Peer Review Contacts:

Not applicable.

3. Financial or Grants Management Contacts:

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6130 Executive Blvd., EPS Room 243
Bethesda, MD 20892
Telephone (301) 496-8634
Fax: (301) 496-4801
E-mail: wolfreyc@mail.nih.gov

Gary Fleming, J.D., M.A.
National Institute on Drug Abuse
6101 Executive Blvd.
Suite 270, MSC 8403
Bethesda, MD 20892-8403
Phone: (301) 443-6710
Fax: (301) 594-6849
E-mail: gf6s@nih.gov

David L. Mineo
Chief Grants Management Officer
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Blvd., Room 731, MSC 5456
Bethesda, MD. 20892-5456
Phone: (301) 594-8854
Fax: (301) 480-3504
E-mail: mineod@extra.niddk.nih.gov

Angela Eldridge
6707 Democracy Blvd., MSC 5469
Suite 900, Democracy II
Bethesda, MD 20892-5469 (regular mail)
Bethesda, MD 20817 (Fedex and Courier Services)
(301) 451-4793 (Telephone)
(301 480-4974 (Fax)

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (see 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. (See the NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998, (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 (http://grants.nih.gov/grants/policy/data_sharing) or state why this is not possible.

Investigators should seek guidance from their institutions, on issues related to institutional policies, local 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.

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 http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).

All investigators submitting an NIH application or contract proposal that plan to produce new, genetically modified variants of model organisms and related resources are expected to include a sharing plan or to state why such sharing is restricted or not possible. The sharing of model organisms for research purposes is important, because reproducibility is a key tenet of science and it demonstrates proper stewardship of public funds. It is expected that establishment of such plans as a term of award will foster more rapid scientific progress by avoiding the use of limited resources and investigator time to reproduce previously developed model organisms. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; 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 that is available at 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 (see 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.

Public 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 public 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 PA 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.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR 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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA 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:
(Be sure to cite any additional appropriate authorizations, regulations or policies below)
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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