HEALTH DISPARITIES AMONG MINORITY AND UNDERSERVED WOMEN

RELEASE DATE:  August 27, 2004

PA NUMBER:  PA-04-153

December 13, 2006 - The R01 portion of this funding opportunity has been 
replaced by PA-07-154, which now uses the electronic SF424 (R&R) 
application for February 5, 2007 submission dates and beyond.

March 2, 2006 (NOT-OD-06-046)   Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. Parent 
R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been 
issued for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter. Applications relating to R33 and R34 activities 
must be in response to NIH Institute/Center (IC)-specific announcements.

EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for 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

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:  
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Nursing Research (NINR) 
 (http://www.ninr.nih.gov)
National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov/)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov)
Office of Research on Women’s Health (ORWH)
 (http://www4.od.nih.gov/orwh/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):

No. 93.361, 93.865, 93.279, 93.847

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA  

The purpose of this initiative is to stimulate research aimed at reducing 
health disparities among racial/ethnic minority and underserved women. More 
specifically, this initiative seeks applications for: (1) research related to 
health promotion or risk reduction among minority and underserved women age 21 
and older; and, (2) intervention studies that show promise for improving the 
health profile of minority and underserved women. Investigators responding to 
this announcement should focus on enhancing the body of knowledge of a variety 
of factors (e.g., social, economic, demographic, community, societal, 
personal, cultural) influencing the health promoting and health compromising 
behaviors of racial and ethnic minority women and underserved women and their 
subpopulations.  The focus of this program announcement is on women age 21 and 
older, but investigators may also focus on the childhood antecedents of adult 
health disparities.

Each of the sponsors of this initiative has a strategic plan, which addresses 
health disparities and minority health. This can be found on each of the 
respective web sites.  For purposes of this initiative, the definitions of 
health disparities and minority populations are those outlined in the NINR’s 
Strategic Plan on Reducing Health Disparities located at www.nih.gov/ninr.  
Health Disparities are defined as differences in the incidence, prevalence, 
mortality, and burden of diseases and other adverse health conditions that 
exist among specific population groups in the United States when compared to 
non-Hispanic Whites. Specific population groups are identified as African-
Americans, Asian and Asian Pacific Islanders, Hispanic and Latino, Native 
American and Native Alaskan. Medically Underserved Populations are defined as 
populations that have inadequate access to, or reduced utilization of high 
quality health care. Included are low literacy, rural and low-income 
populations, including older minority women, geographically isolated women, 
lesbians, hearing and visually impaired women, physically or mentally 
disabled women, migrant workers, immigrant and refugee women, and language 
minority women.  (Language minority individuals are those who do not speak 
the most common language or languages in a country or region, which in the 
United States means individuals who do not speak English. For information on 
language minority populations, see 
http://www.nichd.nih.gov/publications/pubs/diverse_voices.cfm.)  (For NICHD’s 
plan to reduce health disparities, see 
http://www.nichd.nih.gov/strategicplan/disparities/disparities.pdf.)

RESEARCH OBJECTIVES

Racial and ethnic minorities represent one of the fastest growing segments of 
our society. Women in particular are becoming increasingly diverse as well. 
Of the 281 million people counted by the 2000 Census, more than half were 
women. Approximately 41 million of these were women of color, representing 
29% of all the U.S. population. Of these, 43% were classified as black non-
Hispanic, 41% Hispanic, 13% Asian non-Hispanic, 0.4% Native Hawaiian or other 
Pacific Islander (non-Hispanic) and 2.5% American Indian/Alaska Native (non-
Hispanic). While the population of racial/ethnic minority groups is growing 
in this country, the disparities in health between minorities and the 
majority group remain large in some cases.  Furthermore, according to the 
latest figures from the U.S. Bureau of the Census, in March 2002, there were 
32.5 million foreign-born individuals living in the United States, 
representing 11.5 percent of the U.S. population.  Foreign-born individuals 
represent increasing shares of the minority population of the United States, 
and immigrant status is related to many health outcomes, although the 
mechanisms are not fully understood.

It is well noted that many of the disparities in health are related to a 
variety of lifestyle factors and may be amenable to primary and or secondary 
preventive measures.  For example, physical activity aids in preventing 
coronary heart disease (CHD); physical inactive people are almost twice as 
likely to develop CHD. Regular physical activity is also noted to enhance 
muscle function and physical performance. Studies show that women are less 
likely to engage in physical activity when compared to men across the life 
span. In 1997, at least 50% of women of color led sedentary lifestyles never 
engaging in any vigorous, moderate, or light physical activity.  A higher 
percentage of African American and Hispanic women report no leisure-time 
physical activity when compared with non-Hispanic White women. Low levels of 
physical activity are also noted among women residing in rural areas. For 
example, 60% of African American and American Indian/Alaska Native women 
residing in rural areas report sedentary lifestyles during a two week span of 
time, followed by 48% White women and 42% Hispanic/Latino women. 

A similar profile is reported when discussing overweight and obesity as a 
major contributor to a number of preventable causes. Obesity is more 
prevalent among African American and Hispanic women when compared to whites. 
Between 1988 and 1994, 69.6% Mexican American women were considered 
overweight, as were 68.5% African American women. This compares with 47.2% 
White (non Hispanic) women who were overweight.  Women of lower income and 
lower education are also more likely to be overweight or obese. 

While tobacco use has declined since the late 1980’s among African American 
and white females, younger Hispanic and Asian American women have increased 
their use of tobacco. In a survey between 1997-1999, the age adjusted percent 
of women age 18 and older who reported smoking included 31.7% American 
Indian/Alaska Native, followed by 24.0% non-Hispanic Whites, 21.5% African 
American, 13.1% Hispanic/Latino and 10.3% Asian/Pacific Islander. Higher 
rates of tobacco consumption are also noted among women with less income and 
education. 

With respect to HIV/AIDS, between 1985 and 2000, HIV/AIDS has affected a 
growing number of women in the United States, increasing from 7 to 17% with 
the disease disproportionately affecting women of color.  African American 
and Hispanic women accounted for approximately 77% of all cases reported by 
1998, 61,874 and 21,937 cases respectively. In 2002, the majority of HIV/ADIS 
cases occurred among African American and Hispanic women.

These disparities in health are further influenced by low-income status and 
lack of access to health care. Racial and ethnic minority and underserved 
women, including foreign-born women, are disproportionately represented among 
the 43 million people who lack health insurance. Women in this category are 
at an increased risk for a variety of chronic illnesses including 
hypertension, heart disease, cancer, and diabetes. It is important to note 
that not all racial and ethnic minority women are categorized as underserved, 
and not all underserved women are characterized as being racial and ethnic 
minority women.  

In an effort to improve the nation’s health, Healthy People 2010 encourages 
the design of strategies and action plans to address one or more of the 
leading health indicators. Successful interventions that target these 
indicators are integral to improving the quality of life and reducing the 
incidence of the leading causes of death for all people. Specifically, this 
initiative will target minority and underserved women with a special emphasis 
on six of the leading health indicators: physical activity, overweight and 
obesity, tobacco use, substance abuse, responsible sexual behavior, and 
injury and violence.  

Many of the leading health indicators are interrelated and thus may be 
amenable to interventions that target one or more indicators simultaneously. 
Studies targeting a group of health indicators may be more successful in 
improving the overall health profile of minority and underserved women.  
Thus, applicants responding to this initiative may address one leading health 
indicator in a single application or two or more of the aforementioned health 
indicators as a complex or group in a single application.  

OBJECTIVES: 

Potential research topics include but are not limited to:
o Interventions that incorporate an array of factors such as, physiological, 
social, economic and demographic, emotional, environmental, cultural and 
genetic factors thought to influence the development of two or more of the 
leading health indicators.
o Interventions designed to reduce risk factors and exposures that lead to 
development of one or more of the leading health indicators.
o Unique and culturally sensitive interventions that promote increased 
physical activity and healthier dietary intake or other health enhancing 
behaviors.
o Innovative interventions that target prevention or cessation of tobacco 
use, substance abuse, and injury and violence simultaneously.
o Unique interventions that incorporate technology in decision making related 
to health promotion.
o Interventions that target the specific health promotion needs of minority 
women with a known illness and/or disability.
o Studies that test and evaluate the cost effectiveness of health promotion 
interventions conducted in nontraditional settings. 
o Studies that evaluate how gender and immigrant status (including legal and 
visa status) affect health and access to health care.
o The development, implementation, and/or evaluation of interventions based 
on the science of social/sexual networks to help prevent the sexual 
transmission of HIV and other STDs among ethnic/racial minority and 
underserved women.

Descriptive components of the research may be proposed specific for 
understudied populations.  Investigators must provide a strong justification 
and rationale along with a discussion of how such descriptive work will lead 
to the design of interventions aimed at reducing health disparities among 
racial/ethnic minority and/or underserved women in future studies.  Potential 
research topics that are descriptive or analytical and will lead to the 
development of interventions include but are not limited to:

o Studies on how social and cultural understandings of gender, gender-related 
beliefs and expectations, and gender dynamics affect HIV and other STD risk 
among women from different racial, ethnic, and socioeconomic groups.
o Studies on how interpersonal and peer-related factors impact on HIV and 
other STD risk among women from different racial, ethnic, and socioeconomic 
groups.
o Studies on barriers to prevention, diagnosis, and treatment of STDs among 
racial/ethnic minority and underserved women.
o Studies that identify specific social, cultural, and community factors that 
lead to racial/ethnic and socioeconomic differences in: 1) responses to 
disabilities and to rehabilitation interventions, 2) access and use of 
outpatient rehabilitation services with varying impacts on health outcomes, 
3) risks in developing secondary conditions associated with disabilities 
among women, and, 4) return to work, school, and other educational 
opportunities.

MECHANISMS OF SUPPORT 

This PA will use the NIH R01 and R21 award mechanisms.  As an applicant, you 
will be solely responsible for planning, directing, and executing the 
proposed project.  The objective of the R01 mechanism is to support a 
discrete, specified circumscribed project.  Investigators are encouraged to 
explore the feasibility of an innovative research question or approach that 
will provide a basis for future research projects. Exploratory/developmental 
grants (R21) are limited to 2 years of support with a combined budget for 
direct costs of up $275,000 for the two-year period.  For example, the 
applicant may request $100,000 in the first year and $175,000 in the second 
year.  The request should be tailored to the needs of the project. Normally, 
no more than $200,000 may be requested in any single year.  Please see the 
NIH-wide R21 program announcement (PA-03-107) (see 
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). Please see the 
"Submitting an Application" section for more details. 

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/grants/policy/nihgps_2001/part_i_1.htm.    

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics: 
   
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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.   

SPECIAL REQUIREMENTS 

Data and safety monitoring is required for all types of clinical trials. The 
establishment of data and safety monitoring boards (DSMBs) is required for 
clinical trials involving interventions that entail potential risk to the 
participants.
  
WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Yvonne Bryan, PhD, RN
Program Director
National Institutes of Health   
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD  20892-4870
Telephone:  (301) 594-6908
Fax:  (301) 480-8260
Email:  [email protected]

Rebecca L. Clark, Ph.D. 
Health Scientist Administrator 
National Institute of Child Health and Human Development 
6100 Executive Boulevard, Room 8B07, MSC 7510 
Bethesda, MD 20892-7510 
Telephone: (301) 496-1175 
Fax: (301) 496-0962 
Email:  [email protected] 

Lisa Begg, Dr.P.H., R.N.
Director of Research Programs
Office of Research on Women's Health
DHHS/NIH/OD
Bethesda, MD. 20892
Telephone:  301/496-7853
Fax: 301/402-1798
Email: [email protected]

Lawrence Agodoa, MD
Director of Office of Minority Health Research
Coordination
2 Democracy Plaza
Room 653
Bethesda, MD  20892
Telephone:  301-594-1932
Fax:  301-594-9358
Email:  [email protected]

Cora Lee Wetherington, Ph.D.  
Women & Gender Research Coordinator  
National Institute on Drug Abuse  
6001 Executive Boulevard, Room 4282, MSC 9555  
Bethesda, MD 20892-9555   
Phone:  301-435-1319  
FAX:  301-594-6043  
Email:  [email protected] 

Direct your questions about financial or grants management matters to:

Ms. Cindy McDermott
Office of Grants and Contracts Management
NIH, National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD  20892-4870
Telephone:  (301) 594-6869
FAX:  (301) 451-5650
Email:  [email protected]  

Ms. Annette Hanopole  
Chief Grants Management Officer 
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A01 , MSC 7510 8A01
Bethesda, MD 20892-7510
Telephone: (301) 496-5001
FAX: (301) 402-0915 
Email: [email protected]

Lisa Begg, Dr.P.H., R.N.
Director of Research Programs
Office of Research on Women's Health
DHHS/NIH/OD
Bethesda, MD. 20892
Telephone:  301/496-7853
Fax: 301/402-1798
Email: [email protected]

Gary Fleming, J.D., M.A.  
Chief Grants Management Officer  
National Institute on Drug Abuse  
National Institutes of Health  
6101 Executive Blvd.  
Suite 270, MSC 8403  
Bethesda, MD 20892-8403  
Telephone: (301) 443-6710  
FAX: (301) 594-6849  
E-mail: [email protected] 

David Mineo
Chief Grants Management Officer
National Institute of Diabetes, and Digestive,
And Kidney Diseases
National Institutes of Health
2 Democracy Plaza
Bethesda, MD  20892
Telephone:  301-594-8854
Fax:  301-480-3504
Email:  [email protected]

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (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.dunandbradstreet.com/  The D&B number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html 
in an interactive format.  For further assistance contact Grants Info, 
Telephone (301) 710-0267, Email: [email protected].

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

SUPPLEMENTARY INSTRUCTIONS 

When submitting an R21 application, all instructions for the PHS 398 (rev. 
5/2001) must be followed, with these exceptions:

o Research Plan

Items a - d of the Research Plan (Specific Aims, Background and Significance, 
Preliminary Studies, and Research Design and Methods) may not exceed a total 
of 15 pages.  No preliminary data is required but may be included if it is 
available.  Please note that a Progress Report is not needed; competing 
continuation applications for an exploratory/developmental grant will not be 
accepted.  

Appendix. Use the instructions for the appendix detailed in the PHS 398 
except that no more than 5 manuscripts, previously accepted for publication, 
may be included.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format.  The modular budget grant 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 grants.  Additional 
information on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting $500,000 or more 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) Identify, in a cover letter sent with the application, 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. 

SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be mailed on or before the receipt 
dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR 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 CSR 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 unfunded version 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.

PEER REVIEW PROCESS

Applications submitted for this PA 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:

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the appropriate national advisory council 
or board  

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to evaluate application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of the following criteria in assigning 
the application’s overall score, weighting them as appropriate for each 
application.

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The 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 be advanced? What 
will be the effect of these studies on the concepts or methods that drive 
this field?

APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project? Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

INNOVATION: Does the project employ novel concepts, approaches or methods? 
Are the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies?

INVESTIGATOR: Is the investigator 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 (if any)?

ENVIRONMENT: Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements? Is there evidence of institutional support?  

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:

The NIH R21 exploratory/developmental grant is a mechanism for supporting 
novel scientific ideas or new model systems, tools or technologies that have 
the potential to significantly advance our knowledge or the status of health- 
related research.  Because the research plan is limited to 15 pages, an 
exploratory/developmental grant application need not have extensive 
background material or preliminary information as one might normally expect 
in an R01 application.  Accordingly, reviewers will focus their evaluation on 
the conceptual framework, the level of innovation, and the potential to 
significantly advance our knowledge or understanding.  Reviewers will place 
less emphasis on methodological details and certain indicators traditionally 
used in evaluating the scientific merit of R01 applications including 
supportive preliminary data. Appropriate justification for the proposed work 
can be provided through literature citations, data from other sources, or, 
when available, from investigator-generated data.  Preliminary data are not 
required for R21 applications.    

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 criteria included in the 
section on Federal Citations, below).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

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 Inclusion Criteria in the sections on 
Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS 

Sharing Research Data 

Applicants requesting $500,000 or more in direct costs in any year of the 
proposed research are expected to include a data-sharing plan in their 
application. The reasonableness of the data-sharing plan or the rationale for 
not sharing research data will be assessed by the reviewers. However, 
reviewers will not factor the proposed data-sharing plan into the 
determination of scientific merit or priority score. The Final NIH Statement 
on Sharing Research data is found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html
 
BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on Humane Care 
and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as 
mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA 
Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants.  (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 
more than $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, 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.

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 - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects 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 proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, 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.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm 

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

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