HEALTH PROMOTION AMONG RACIAL AND ETHNIC MINORITY MALES 

RELEASE DATE:  September 8, 2003

PA NUMBER:  PA-03-170 

Reissued as PA-07-421 (R21) and PA-07-422  (R01)

(see addendum NOT-CA-03-041)

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 All R01 Applications: August 31, 2006, unless reissued.

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:  

National Institutes of Health (NIH) 
 (http://www.nih.gov)
Agency for Health Research and Quality (AHRQ) 
 (http://www.ahrq.gov)

COMPONENTS OF PARTICIPATING ORGANIATIONS: 

National Institute of Nursing Research (NINR) 
 (http://www.ninr.nih.gov)
National Institute on Aging (NIA) 
 (http://www.nia.nih.gov)
National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
 (http://www.niddk.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI) 
 (http://www.nhlbi.nih.gov/)
Office of Behavioral and Social Sciences Research (OBSSR) 
 (http://obssr.od.nih.gov)
Office of Disease Prevention (ODP) 
 (http://odp.od.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.361 (NINR), 93.866 
(NIA), 93.864 (NICHD), 93.849 (NIDDK), 93.837 (NHLBI), 93.226 (AHRQ)

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 and expand research in the 
health of minority men. Specifically, this initiative is intended to: 1) 
enhance our understanding of the numerous factors (e.g., sociodemographic, 
community, societal, personal) influencing the health promoting behaviors of 
racial and ethnic minority males and their subpopulations across the life 
cycle, and 2) solicit applications focusing on the development and testing of 
culturally and linguistically appropriate health-promoting interventions 
designed to reduce health disparities among racially and ethnically diverse  
males and their subpopulations age 21 and older. 

Each of the sponsors of this PA has a strategic plan, which addresses 
research related to minority health and health disparities. This is located 
on their websites. 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 
http://www.ninr.nih.gov.  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 
US. Specific population groups are identified as African American, Asian and 
Asian Pacific Islander, Hispanic and Latino, American Indian and Alaska 
Native. These groups are the target populations for this announcement.

RESEARCH OBJECTIVES

It is well documented that males experience approximately a seven-year 
shorter life expectancy when compared with females. During the 20th Century, 
life expectancy at birth increased from 48 to 74 years for males and from 51 
to 79 years for females. Increases in life expectancy are, in part, 
attributed to improvements in lifestyle, nutrition, housing, hygiene and 
medical care. The disparities in life expectancy are more pronounced among 
men of color and economically disadvantaged males. For example, the life 
expectancy of European American males and African American males is 74.6 and 
67.7 years respectively.

In 2001, the National Center for Health Statistics reported the leading 
causes of death in males as heart disease, cancer (lung and prostate), 
stroke, accidents and unintentional injuries, lung disease, diabetes, 
pneumonia, and influenza, suicide, chronic liver disease, and kidney disease. 
Mortality rates from these causes of death are higher for minority males 
because their diseases are at a more advanced stage at diagnosis and are 
often complicated by co-existing conditions.

To illustrate, while cardiovascular disease is the leading cause of death for 
all Americans, African American males in particular experience an earlier 
onset of the disease and experience a higher rate of complications. White 
males have the greatest mortality from cardiovascular disease, 39.2% of all 
deaths, followed by 36.1% of all deaths for Asian American and Pacific 
Islander males, and 34.2% of all deaths for African American males.  While 
Hispanic males experience the lowest death rate from cardiovascular disease, 
27.9%, they suffer disproportionately from other conditions related to heart 
disease namely hypertension, high cholesterol and diabetes. Similarly, 
minority males have a higher risk of fatality from stroke when compared to 
their White counterparts. 

Other examples of health disparities noted among minority males include the 
following:
o  HIV infection is the third leading cause of death for Hispanic males ages 
25-44, and the second leading cause of death in African American males within 
the same age group. 
o  Diabetes affects all racial and ethnic populations, but American Indians 
have the highest rate of diabetes in the world. 

Many of the disparities in health status noted among racial and ethnically 
diverse male populations are related to lifestyle and are either preventable 
or amenable to early detection or intervention. For example, tobacco use 
constitutes the single most preventable cause of premature death in the US.  
In 1999, an estimated 46.5 million adults in the United States were smokers - 
25.7% of men and 21.5% of women.  Male smoking use was highest among Alaska 
Natives (40.9%), followed by African Americans (28.7%), Hispanics (24.1%), 
and Asian/Pacific Islanders (23.3%). 

Similarly, many unintentional injuries are preventable and may be amenable to 
early intervention.  According to epidemiologists, over 400 Americans die 
each day from unintentional injuries such as motor vehicle crashes, 
poisonings, drowning, falls, fires, suffocation, and firearms. A major 
objective outlined by Healthy People 2010 is to reduce deaths from 
unintentional injuries from baseline 35.0 deaths per 100,000 population to 
17.5 deaths per 100,000 population. Males are more likely than females to 
experience death from unintentional injury. Minority males are more at risk 
to die from such injuries when compared with their White counterparts. For 
example, the death rate for unintentional injuries is 48.7 per 100,000 deaths 
for White males. This compares with 83.6 deaths per 100,000 for American 
Indian/Alaska Native males followed by 60.8 per 100,000 deaths for African 
American males and 46.2 per 100,000 deaths for Hispanic males.       

The disparities in health are often more pronounced among underserved and 
uninsured racial and ethnic minority males. There are ample data highlighting 
that uninsured individuals experience greater declines in health status and 
die prematurely from a variety of illnesses when compared to those with 
continuous health care coverage. This is particularly important given that 
racial and ethnic minority populations are disproportionately represented 
among the uninsured. For example, in 1998, 23% of African American males were 
uninsured followed by 37% of Hispanic males. This compares with 15% White 
males. These and other health disparities noted among minority males require 
greater elucidation and intervention.

However, the focus of this PA is on health promotion and not on all aspects 
of disease. A scientific exploration of these disparities is central to all 
sponsors' commitment to reducing health disparities. Research in this area is 
essential to addressing Goal 2 outlined in Healthy People 2010:  "To 
eliminate health disparities among segments of the population, including 
differences that occur by gender, race or ethnicity, education or income, 
disability, geographic location or sexual orientation."    

The following are potential areas of research related to this announcement. 
These suggested areas of research are not listed in any priority and are not 
to be viewed as an exhaustive or exclusive list. Investigators responding to 
this announcement may target other groups of minority males (e.g., men of 
diverse sexual orientation, migrant workers, disabled men, rural and 
immigrant men).

Potential research topics include but are not limited to:

o Studies that test innovative interventions to reduce risk factors 
associated with the leading causes of morbidity and mortality (e.g., smoking, 
poor nutrition, alcohol use, sedentary lifestyle, risky sexual behavior) 
among racial and ethnic minority men and their subpopulations in rural, 
urban, and nontraditional settings, including interventions addressing 
multiple risk factors in the same individual.

o Multifaceted interventions designed to increase both initial and repeat 
health screenings and risk assessment among racial and ethnic minority and 
underserved men age 40 and older.

o Studies that include innovative approaches involving families, social 
networks, or communities in interventions designed to enhance health-
promoting behaviors.

o Unique interventions developed to promote positive health seeking and 
health maintenance behaviors among diverse groups of men across the life 
cycle.

o Interventions that incorporate cultural and family values and are designed 
to test the effects of unique and creative intergenerational health promotion 
activities. 

o Interventions that target two or more high-risk behaviors in a single 
application, e.g., tobacco use, risky sexual behaviors, unintentional 
(accidents) and intentional behaviors (firearm related injuries.)

o Culturally and linguistically appropriate studies designed to enhance self-
efficacy, competence, and skill development to support the initiation and 
maintenance of health promoting behaviors. 

o  Studies that develop and test innovative interventions that improve 
patient-provider communication around preventive services. These 
interventions can be aimed at the provider and or the patient.
 
o  Studies that develop and test strategies to increase the use of 
best practices in men's health, such as evidence based guidelines or research 
syntheses, in health care settings.

MECHANISM(S) 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. The objective of the 
exploratory/developmental mechanism (R21) is to encourage applications from 
individuals who are interested in testing innovative or conceptually creative 
ideas that are scientifically sound and may advance our understanding of 
health promotion among racial and ethnic minority males. 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.
    
Starting with the October 1, 2003 receipt date, 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. 

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:

Dr. Janice Phillips
Office of Extramural Programs
NIH, National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD  20892-4870
Telephone:  (301) 594-6152
FAX:  (301) 480-8260
Email:  Janice.phillips@nih.gov

Dr. Sidney M. Stahl
Behavioral and Social Research Program
NIH, National Institute on Aging
7201 Wisconsin Ave., Room 533
Bethesda, MD  20892-9205
Telephone:  (301) 402-4156
FAX:  (301) 402-0051
Email:  Sidney_Stahl@nih.gov

Dr. V. Jeffery Evans
Director of Intergenerational Research
Demographic and Behavioral Sciences Branch
NIH, National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1176
FAX:  (301) 496-0962  
Email:  evansvj@mail.nih.gov

Dr. Lawrence Agodoa
Office of Minority Health Research Coordination
NIH, National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 653, MSC 5454
Bethesda, MD 20892-5454
Telephone:  (301) 594-1932
FAX:  (301) 594-9358
Email:  la21j@nih.gov

Dr. Jared B. Jobe 
Behavioral Medicine Scientific Research Group  
Division of Epidemiology and Clinical Applications  
NIH, National Heart, Lung, and Blood Institute  
6701 Rockledge Drive, Room 8122, MSC 7936  
Bethesda, Maryland  20892-7936  
Telephone: (301) 435-0407   
FAX: (301) 480-1773 
Email: jobej@nhlbi.nih.gov 

Dr. Lawrence J. Fine 
Medical Advisor 
NIH, Office of Behavioral and Social Sciences Research  
Building One, Room 256  
One Center Drive  
Bethesda, MD 20892  
Telephone: (301) 435-6780  
FAX: (301) 402-1150
Email: finel@mail.nih.gov

Ms. Martina Vogel-Taylor, M.T.
Senior Advisor for Disease Prevention & Health Promotion
NIH, OD, Office of Disease Prevention
6100 Executive Blvd., Suite 2B-03, MSC 7523
Bethesda, MD  20892-7523
Phone: (301) 496-6614
FAX: (301) 480-7660
Email: MartinaV@nih.gov

Dr. Kaytura Felix Aaron
Senior Advisor, Minority Health
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Phone:  (301) 427-1395
Fax: (301) 427-1562
Email: kfaaron@ahrq.gov

o Direct your questions about financial or grants management matters to:

Ms. Tara Mowery
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) 594-5979
FAX:  (301) 451-5650
Email:  tara.mowery@nih.gov

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 DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com. The DUNS 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 GrantsInfo, Telephone 
(301) 435-0714, Email: GrantsInfo@nih.gov.

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 more than $500,000 must carry out the following steps:
   
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 more than $500,000 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 

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:  Starting with the October 1, 2003 receipt date, 
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. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998. 

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). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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