and Human Services (HHS)
EXPIRED
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [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 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) 710-0267, Email: [email protected].
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
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