COMMUNITY-PARTNERED INTERVENTIONS TO REDUCE HEALTH DISPARITIES

RELEASE DATE:  July 24, 2002

PA NUMBER:  PA-02-134

EXPIRATION DATE:  June 14, 2005, unless reissued. 

National Institute of Nursing Research (NINR)
 (www.nih.gov/ninr)

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 Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

The National Institute of Nursing Research (NINR) invites applications for 
community-partnered interventions to reduce health disparities in racial and 
ethnically diverse minority populations. Specifically, this announcement 
seeks applications with a focus of reducing health disparities through 
demonstrated partnerships with the target community(ies) throughout all 
phases of the research process. 

For purposes of this announcement, community-partnered interventions are 
defined as interventions in which the investigator(s) establishes a research 
partnership with members of the target community throughout all phases of the 
research process. Consistent with the tenets of participatory research, 
inclusion is a critical component for building and sustaining community 
partnerships in research. Full participation and engagement of the targeted 
community must be accomplished throughout the research process. Thus the 
research partnership begins with the identification of the research focus and 
continues throughout the dissemination and follow-up phases related to the 
research.  

RESEARCH OBJECTIVES

Since the release of the landmark document, the Secretary's Task Force report 
on Black and Minority Health in 1986, numerous initiatives have been 
implemented to address the ongoing health disparities noted among racial and 
ethnically diverse minority populations. Specific conditions, namely 
cardiovascular disease, cancer, infant mortality, diabetes, lack of 
immunization, and HIV/AIDS, affect racial and ethnically diverse minority 
communities at rates several times higher than the national averages. For 
example, in 1988, the age-adjusted death rate for coronary heart disease 
among non-Hispanic black people was 40% higher than the rate for non-Hispanic 
whites, 136.3 per 100,000 population vs. 95.1 per 100,000 population 
respectively. The fact that Native Americans have the poorest five-year 
survival for all cancers combined when compared to other populations provides 
yet another example of the disparities in health among racial and ethnically 
diverse minority populations. Despite the numerous initiatives and 
interventions targeting these populations, the disparities in health remain.

The goal of eliminating health disparities has received considerable national 
attention in recent years. In concert with the national emphasis on 
eliminating health disparities, NINR along with other Institutes and Centers 
at the National Institutes of Health (NIH) have outlined their respective 
objectives and strategic plans related to reducing/eliminating health 
disparities. The NIH strategic plan on reducing health disparities is located 
at http://healthdisparities.nih.gov/working.html.  NINR's strategic plan on 
reducing health disparities is located at http://www.ninr.nih.gov.  This 
initiative places an emphasis on reducing health disparities through 
establishing and sustaining community partnerships during the research 
process. 

Definitions related to health disparities and health disparity populations 
are outlined in the National Institutes of Health's Comprehensive Plan to 
Reduce or Eliminate Health Disparities, and are used for purposes of this 
solicitation. Health disparity research is basic, clinical, and behavioral 
studies on health conditions that are unique to, more serious, or more 
prevalent in subpopulations that are economically disadvantaged and medically 
underserved [and confirmed by the Agency for Healthcare Research and Quality 
as "health disparity groups"]. A health disparity population is defined as 
one where a documented, and significant disparity has been identified in the 
overall rate of disease incidence, morbidity, mortality, and survival rates 
in the population as compared to the health status of the general population. 
Minority population refers to racial and ethnic minority groups which usually 
include African Americans, Hispanics, Native Americans, Alaska Natives, 
Hawaiian Islanders, Asian and Pacific Islanders. Accordingly, these groups 
will be the target populations for this announcement. 

In 1986, the disparities in health status and health outcomes among minority 
populations were identified in the Secretary's Task Force on Black and 
Minority Health (1). Since the release of this landmark document in 1986, 
numerous initiatives have been implemented to address the ongoing disparities 
noted among racial and ethnic minority populations. Special objectives and 
activities targeting racial and ethnic minority populations have been 
outlined in Healthy People 2000 (2), the Health and Human Services Initiative 
to Eliminate Racial and Ethnic Disparities in Health (3), and, most recently 
Healthy People 2010 (4).

Similar to Healthy People 2010, Healthy People 2000 included over 200 special 
population subobjectives related to addressing health disparities in special 
populations at higher risk than the total population for death, disease, or 
disability. Although much remains to be done, data from the Healthy People 
2000 Final Review show progress in reducing health disparities in some areas.  
For example the American Indian Alaska Native population demonstrated 
improvements in hepatitis and bacterial meningitis, and Asian Pacific 
Islanders showed a reduction in such important areas as cigarette smoking. 
Disparities also narrowed for African-Americans in such categories as cancer 
deaths, firearm related deaths, unintentional injuries, clinical breast 
examination, mammography and syphilis.  Data for Hispanic persons indicated a 
reduction in disparities related to infant mortality, and use of clinical 
breast exam and mammography (5). 

However, despite numerous initiatives, racial and ethnic minorities continue 
to experience poorer health and poorer health outcomes when compared to their 
white counterparts.  For example, African-American men are 26% more likely 
than white men and almost twice as likely than Hispanic men to die from heart 
disease. They also are more likely to die of heart disease before age 65. 
Diabetes constitutes the leading cause of death among American Indians. Black 
and Hispanic women accounted for 81% of AIDS cases from July 1999 to June 
2000 (6). The fact that Native Americans have the poorest five-year survival 
for all cancers combined when compared with other populations provides yet 
another example of the disparities (7).

The disparity in disease incidence, mortality, and morbidity is even more 
striking among socioeconomically disadvantaged individuals. This is 
particularly important given the disproportionate number of racial and ethnic 
minorities that are socioeconomically disadvantaged. Progress in successfully 
addressing health disparities will be greatly facilitated by ongoing efforts 
within the NIH and other initiatives and priorities outlined by the 
Department of Health and Human Services.  

While much has been gleaned from previous research with racial ethnic 
populations, ongoing research is needed to provide direction for improving 
standards of care, informing public policy, and identifying strategies aimed 
at improving the health status and health outcomes of racial and ethnic 
minorities. The need to further enhance our knowledge and understanding of 
the numerous and complex factors (i.e., socioeconomic, cultural, societal, 
behavioral and biologic aspects of health) that influence the health status 
of racial and ethnic minority populations across the lifespan is important.  
The projected growth in minority populations further underscores the need to 
examine health disparities. 

Community partnered interventions devoted to reducing health disparities are 
particularly needed because of their potential to: 1) build on existing 
community resources, knowledge, skill, and attributes; 2) engage community 
members in actively identifying and addressing key health issues or concerns; 
3) facilitate the building of trusting relationships between the research 
community and target population; and 4) enhance the likelihood of long-term 
sustainability and follow-up. Additional benefits associated with a partnered 
approach in research include: 1) enhancing the validity and quality of the 
research by incorporating the knowledge of the people involved; 2) bridging 
"cultural gaps" that may exist between the partners involved; 3) 
incorporating cultural, social, and economic factors that may influence 
health; and 4) facilitating the design of culturally appropriate, sensitive, 
and linguistically appropriate measures and methods as well as 5) providing 
resources and opportunities for the involved community. Challenges associated 
with conducting community-partnered interventions can include: difficulties 
maintaining trust and sustainability while preserving scientific integrity, 
time consuming goals and activities, and lack of skill and resources related 
to successfully conducting an intervention.

While the purpose of this initiative is to stimulate research utilizing 
community-partnered research interventions to reduce health disparities, 
preliminary studies that will lead to such studies are encouraged if such 
work is essential to achieve the overall purpose(s). This may be particularly 
needed in research on less studied populations. For example, while some 
studies have focused on racial and ethnic minority populations, there is a 
need for additional studies that focus on minority populations and their 
subpopulations. To illustrate, while there is a growing body of research on 
the breast cancer screening among Hispanic women in general, there are fewer 
studies focusing on Hispanic subpopulations (e.g., Puerto Rican, Mexican 
American). 

Federally Qualified Health Centers (FQHCs) may provide a valuable resource to 
applicants interested in responding to this PA, particularly those that have 
an active collaboration with colleges and universities.  These FQHCs include 
Community Health Centers and Migrant Health Centers across the country.  
Information may be found at the DHHS Health Resources and Services 
Administration website for the Bureau of Primary Health Care: 
http://pubs.niaaa.nih.gov/publications/datasys.htm

An executive summary of a recent NINR sponsored workshop, titled "Community-
Partnered Interventions in Nursing Research to Reduce Health Disparities" may 
be found at www.nih.gov/ninr/news-info/publications.html.

References

1.  U.S. Department of Health and Human Services. Report of the Secretary's 
task force on black and minority health. Vol. 1. Executive Summary. 
Washington, DC: U. S. Government Printing Office, 1986.

2.  U.S. Department of Health and Human Services. Healthy People 2000: 
National Health Promotion and Disease Prevention Objectives. Department of 
Health and Human Services Publication No. (PHS) 91-5050212. Washington, DC: 
U.S. Government Printing Office, 1993. 

3.  U.S. Department of Health and Human Services. HHS reshaping of minority 
communities and underserved populations [Online]  
http://www.hhs.gov/news/press/2001pres/01fsminhlth.html   2001.

4.  U.S. Department of Health and Human Services. Healthy People 2010: 
Understanding and improving health (second edition) Superintendent of 
Documents Stock No. 017-001-00550-9, 2000.

5.  U.S. Department of Health and Human Services.  Health People 2000 Final 
Review.  Washington, DC:  U.S. Government Printing Office, 2001.

6.  U.S. Department of Health and Human Services.  Achieving new milestones 
in minority health. [Online]  
http://www.hhs.gov/news/press/2001pres/01fsminorityhealth.html   2001.

7.  American Cancer Society. Cancer facts and figures. Atlanta, GA: Author, 
2000.

Potential Research Areas
 
The following are potential areas of research related to this program 
announcement. These examples are not listed in any priority order and are not 
to be viewed as an exhaustive or exclusive listing of potential areas.  Given 
the need for community involvement in identifying the research focus, the 
following represent broad topical areas that have been identified as 
potential areas of inquiry:

o Development and testing of culturally relevant measures of clinical and 
cost outcomes of community-partnered interventions aimed at reducing health 
disparities.

o Intervention studies designed to reduce risk factors and risk exposures 
that contribute to the six disparity areas of cardiovascular disease, 
diabetes, HIV/AIDS, cancer screening and management, infant mortality, and 
immunization.  

o Intervention studies to enhance health seeking and health maintenance  
behaviors that incorporate the sociocultural attributes and cultural 
strengths of racial and ethnic minority populations and their subpopulations.

o Intervention studies devoted to preventing, reducing, or ameliorating 
health behaviors associated with the nine major contributors of mortality in 
the United States (e.g., tobacco use, diet and activity patterns, alcohol 
use, microbial agents, toxic agents, firearm use, sexual behavior, motor 
vehicle accidents, and illicit drug use) among racial ethnic minority 
populations.
 
o Evaluation of existing community-partnered interventions for their impact, 
effectiveness, and efficiency in reducing health disparities.

o Innovative intervention studies using technology to monitor and/ or 
facilitate the management of chronic illness among racial ethnic minority 
populations.

o Intervention studies that address the excess cancer burden noted among 
racial and ethnic minority populations.

o Intervention studies using culturally appropriate strategies to address the 
high incidence of diabetes in Native American populations.

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 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 community partnered interventions.  
Investigators are encouraged to explore the feasibility of an innovative 
research question or approach that will provide a basis for future research 
project applications.  Exploratory/developmental grants (R21) are limited to 
2 years of support and up to $150,000 per year in direct costs.

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format. (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 format.

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
o Faith-based institutions and tribal nations 
o 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

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/review issues to:

Dr. Janice Phillips
Office of Extramural Programs
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

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

Ms. Sally York
Office of Grants and Contracts Management
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD  20892-4870
Telephone:  (301) 594-2154
FAX:  (301) 480-8260
Email:  Sally_York@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  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.

Please note, when completing an application for the R21 mechanism, Items a-d 
in the Research Plan must not exceed a total of 15 pages. Tables and figures 
are included in the page limitations. Applications that exceed the page 
limitation or NIH requirements for type size and margins (refer to PHS 398 
application for details) will be returned to the applicant without further 
consideration. The 15-page limitation does not include Items e-i (Human 
Subjects, Vertebrate Animals, Literature Cited, Consortia and 
Consultants/Collaborators).

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 GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular 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:

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. 

In addition to the research plan and related timelines, applicants responding 
to this announcement MUST include the following:

o Identification of the target community, selected health disparity topic and 
rationale(s)for these choices. Health disparity topics should focus on a 
specific health problem vs. a health care delivery issue. Topics such as the 
excess cancer burden in racial/ethnic minority populations, the high 
incidence of diabetes in Native Americans, or the excess death rate from 
cardiovascular disease among African Americans, to name a few.

o Evidence of an existing community partnership or plans for establishing and 
sustaining a partnership with the target community in the form of letters of 
agreement to participate. 

o A plan for sustaining the partnership in the community after completion of 
the grant.  

o Information related to the research partnership between the target 
community and the research team. For example, 
--How will key members of the target community be involved throughout all 
phases of the research process? 

--How will the research team facilitate a collaborative relationship and 
sustain equitable involvement throughout the research project? 

--What are some potential mutual benefits to the community and the research 
team? 

--How will the strengths and resources of the community be utilized to 
enhance the community partnership? 

--What are some suggested plans for disseminating the research findings to 
the target community?

--What are some opportunities and strategies for use by the target community 
to enhance their health and well being as well as reduce the health disparity 
topic? 

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 received by or 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 application already reviewed, but 
such application must include an Introduction addressing the previous 
critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
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 Receive a written critique
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 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 discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your 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, you 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 your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?

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

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your 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, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  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.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

DATA SHARING:  The adequacy of the proposed plan to share data. 

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 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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 AMENDMENT "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.

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.

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: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.361, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

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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