EPIDEMIOLOGY OF ALCOHOL CONSUMPTION AND ALCOHOL-RELATED PROBLEMS IN OLDER
PERSONS

RELEASE DATE:  January 22, 2003
 
PA NUMBER:  PA-03-061

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. 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 thereafter. Applications relating to R33 and R34 
activities must be in response to NIH Institute/Center (IC)-specific announcements.

EXPIRATION DATE:  This PA will expire on December 15, 2005, unless 
reissued. 
 
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov)
 
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 Special Requirements 
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 on Alcohol Abuse and Alcoholism (NIAAA) and the 
National Institute on Aging (NIA) invite applications for research on 
the epidemiology of alcohol consumption and alcohol-related problems in 
older persons with the goal of enhancing our understanding of patterns 
of alcohol consumption and the epidemiology of alcohol-related problems 
in older populations.
 
Research objectives of this program announcement include, but are not 
limited to: (1) studying patterns of alcohol consumption and the 
distribution of alcohol-related problems in the older and elderly 
population as a whole and in specific sub-populations of this group; 
(2) studying risk and protective factors for alcohol-related problems 
in the older and elderly population as a whole and in specific 
subpopulations of this group; (3) elucidating disparities among 
racial/ethnic groups of older and elderly persons with respect to 
alcohol consumption and alcohol-related problems; (4) understanding the 
natural history, course, and short- and long-term outcomes of alcohol 
consumption among older and elderly persons.
 
RESEARCH OBJECTIVES
 
BACKGROUND
 
There are two compelling reasons to study alcohol consumption and 
alcohol-related problems among older people in the United States.  The 
first is demographic.  Older people are the fastest growing segment of 
the population.  According to the 2000 US census, there are about 59 
million Americans over 55, 35 million over 65, 17 million over 75 and 
4.2 million over 85 (US Census Bureau).  The Census Bureau estimates 
that by 2010, these numbers will be about 75, 40, 19 and 5.8 million, 
respectively and by 2020, about 96, 54 22 and 6.8 million, respectively 
(US Census Bureau).  The older population is growing dramatically both 
in absolute numbers, as well as relative to other age groups in the 
populations.  By 2020, one in six Americans will be over the age of 
65.  The second is the fact that older persons differ biologically, 
psychologically and socially from younger people.  As a result, they 
have different health and other needs and utilize different community 
and national resources.  
 
More specifically, older persons differ from younger persons in levels 
and patterns of alcohol consumption, in their biological response to 
alcohol, and in terms of the problems they may experience or benefits 
they may accrue from this consumption.  These factors have important 
public health ramifications.  Currently, we have insufficient knowledge 
about alcohol consumption in this population, the incidence and 
prevalence of the alcohol-related problems older people experience and 
the risk and protective factors associated with their problems.  In 
order to prepare appropriately to meet the alcohol-related health needs 
of the US population as it ages, we must address these gaps in our 
knowledge through well designed studies, including clinical trials, 
longitudinal, and cross-sectional studies.
 
The later years of life are variously described and subdivided.  One 
such categorization is: later adulthood (age 60 plus); late adult 
transition (ages 60-65); the elderly (65 plus): the young old (60-75); 
the old, old (75 plus); and the frail elderly or the very old (80 plus) 
(Zucker, 1996).  No matter how it is described or segmented, this time 
of life represents a broad span of years and a heterogeneous group of 
people who vary widely in age, fitness, income and many other ways.   
In later life, as in adolescence, there is a confluence of multiple 
transitions and developmental challenges; there are changes in roles 
and responsibilities, as well as physical, social, psychological and 
cognitive changes. Many may be difficult.  Retirement may result in a 
loss of routine, income, sense of purpose and self-worth, as well as 
increased loneliness and too much unstructured time.  Losses of friends 
and spouses may occur adding to loneliness and loss of purpose.  Some 
may turn to alcohol as a result.  In addition, changes in living 
arrangements (e.g. moves into retirement communities, nursing homes or 
other age-segregated settings) and physical problems, including sleep 
problems and pain, may cause some older persons to turn to alcohol or 
to increase consumption.  
 
Not only is America's population graying, but cohorts of persons aging 
currently (e.g. the so called baby boomers) consumed more alcohol and 
other substances during their early and middle years than the current 
cohort of elderly persons.  As a result, they may be more likely to 
continue to use or to turn to alcohol as a coping mechanism in their 
later years than the current older generation.  In addition, we know 
that some people increase their alcohol consumption later in life, 
often leading to late-onset alcoholism (Atkinson, 1995).  In fact, late 
onset problem drinkers may constitute as many as one-third to one-half 
of older problem drinkers (Brennan and Moos, 1996).  However, the 
etiologic agents which produce late onset drinking have not been well 
described.
 
An older person's biological reaction to alcohol is quite different 
than a younger person's.  There is clear evidence that aging results in 
a higher blood alcohol concentration (BAC) for a given dose of alcohol 
for a person of a given body weight (Watson et al., 1980).  Since there 
is a decrease in body water with age and since alcohol is water-
soluble, small amounts of alcohol may result in higher BACs in older 
than in younger persons (Dufour and Fuller, 1995).  The research is 
mixed regarding the existence of an age-related decrease in alcohol 
dehydrogenase, an enzyme which starts to break down alcohol before it 
reaches the bloodstream (Kechigas et at., 2001; Beresford, 1995).  In 
addition, elimination of alcohol from the body is less efficient as 
people age.  There is also good evidence that the elderly show greater 
effects of alcohol consumption (e.g. incoordination) at the same BAC, 
indicating decreased tolerance and increased sensitivity (Dufour and 
Fuller, 1995; Kalant, 1998; Poikolainen, 1984).  
 
Because of these biological changes, light to moderate, not just heavy 
or dependent use, among older populations can be a health risk and an 
elderly person may experience alcohol-related problems even though his 
or her drinking patterns have not changed.  Although the specific 
effects of alcohol on the older, as compared to the younger, brain are 
largely unknown, they are presumed to be different.  It is also 
hypothesized that alcohol may exacerbate or accelerate brain 
degeneration of varying etiology in the elderly (Adams WL, 1999; Tyas, 
2001).  Alcohol may also affect the health of an older person by 
exacerbating sleep problems (Aldrich, 1996, Block, 1986), elevating 
blood pressure  (Camargo et al., 1997) and negatively affecting bone 
mineral metabolism (Ganry et al., 2000; Hannan et al., 2000).  Alcohol 
use in the elderly is also associated with hip fractures due to falls 
(Rose and Maffulli, 1999) and other unintentional injuries including 
automobile crashes (Higgins et al., 1996).  The increased risk of 
hemorrhagic stroke seen in the general population may be especially 
important in this age group (English, 1995; Hillbom and Juvela, 1996).  
Consumption of over one to two drinks a day poses significant risks for 
cancer (Bagnardi et al, 2001), liver cirrhosis, brain damage, and 
unintentional injuries (Friedman and Klatsky 1993; Rehm and Sempos 
1995).   On the other hand, there is evidence of benefits from modest 
alcohol use.  Low to moderate consumption may offer some protection 
against cardiovascular disease (CVD) , including ischemic stroke, 
especially for those at moderate risk for CVD (Mukamal and Rimm, 2001) 
and some studies have shown increased bone mineral density in 
postmenopausal women who drink at moderate levels (Mukherjee et al., 
2000; Rapuri et al., 2000; Turner and Sibonga, 2001).
 
The majority of older persons take medications, and alcohol interacts 
adversely with many prescription and over the counter drugs.  Studies 
indicate that between 60 to 90 percent of elderly persons use some form 
of medication, often more than one at a time (Chriscilles et al., 1992; 
Dufour et al., 1992; Pollow et al. 1994).  Medications commonly taken 
by older people which have a high potential for a negative reactions 
with alcohol include analgesics, antihypertensives, anticoagulants, 
diuretics, antiarthritics and psychoactive agents (Forster et al, 
1993).  
 
Also significant is the fact that the diagnosis of alcohol abuse can be 
difficult in older people because its symptoms can be erroneously 
attributed to other medical or psychiatric conditions which are common 
in this age group (e.g. depression, insomnia, poor nutrition, and 
frequent falls) or to medication side-effects.  Hospital staff are 
significantly less likely to recognize alcohol problems in an older 
than in a younger patient (Curtis et al., 1989; Reid and Anderson, 
1997).  In fact, physicians rarely ask their older patients about 
alcohol consumption.  In addition, DSM criteria may be difficult or 
even inappropriate to use with elderly persons (Gomberg, 1990).  Some 
studies indicate a significant proportion of "hidden" alcoholics may be 
over 60 years of age (Cox et al., 1997).
 
There is an urgent need for better epidemiologic information about 
drinking among older and elderly persons and about the variables that 
influence drinking in this population.  Clearly, the factors which 
promote or sustain alcohol use are different in older compared to 
younger persons, as are the consequences of drinking.  Well-designed, 
focused, clinical, cross-sectional and longitudinal (both long and 
short-term) studies are needed to better identify the parameters of 
alcohol consumption and alcohol-related problems among the elderly, and 
delineate causal structure.  Enhanced understanding of the interplay of 
multiple factors in the determination of drinking behavior, better 
specification of the risks for, benefits of, and short and long-term 
consequences of drinking among older persons, is needed to address the 
alcohol-related prevention and treatment needs of a growing elderly 
population.
 
Areas of Research Interest
 
Broadly stated the research objectives of this initiative are to: (1) 
study patterns of alcohol consumption and the distribution of alcohol-
related problems in the older and elderly population as a whole and in 
specific sub-populations of this group; (2) study risk and protective 
factors for alcohol-related problems in the among the older and elderly 
population as a whole and in specific subpopulations of this group;  
(3) elucidate disparities among racial/ethnic groups of older and 
elderly persons with respect to alcohol consumption and alcohol-related 
problems; (4) understand the natural history, course, and short- and 
long-term outcomes of alcohol consumption among older and elderly 
persons.
 
More specifically the objectives of this initiative include, but are 
not limited to:
 
- Increasing knowledge about the incidence, prevalence, etiology, 
course, and natural history of alcohol-related problems, including 
alcohol abuse and alcohol dependence, among older and elderly 
populations, and among subgroups of this population (e.g. racial/ethnic 
groups, men and women, the very old, those in group housing).
- Examining the relationship of alcohol consumption and alcohol abuse 
and dependence to other psychiatric disorders and conditions among 
older and elderly populations.
- Examining the relationship of alcohol consumption to the development, 
course and outcomes of physical illnesses including heart disease, 
cancer, liver disease and degenerative brain disorders in older and 
elderly populations.
- Exploring patterns of alcohol consumption (e.g., frequency, quantity, 
duration, beverage type) which may increase or decrease risk for 
particular alcohol-related problems among older and elderly 
populations.
- Exploring combined patterns of prescription and over the counter 
medication use (e.g. regular vs. intermittent use, type of medication) 
and alcohol consumption (e.g., frequency, quantity, duration, beverage 
type) which may increase or decrease risk for particular alcohol-
related problems and/or adverse alcohol-medication interactions among 
older and elderly populations.
- Increasing knowledge about risk and protective factors (personal, 
environmental and genetic) for alcohol-related problems among older and 
elderly populations.
- Elucidating factors associated with the initiation of and abstinence 
from drinking among older and elderly persons. 
- Elucidating the role of alcohol consumption in intentional and 
unintentional injury, including falls, vehicular crashes and suicide in 
older and elderly persons.
- Conducting longitudinal follow-up studies in older and elderly 
populations to determine the relationships between personal, 
sociocultural and genetic factors in the development, course and short 
and long-term outcomes of alcohol-related problems.
 
MECHANISM(S) OF SUPPORT 
 
This PA will use the NIH Research Project grant (RO1), Small Grant 
(R03), and Exploratory/Development grant (R21) award mechanisms.  As an 
applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  
 
Applications for R01s may request support for up to 5 years.  
Facilities and Administrative (F&A) costs will be awarded based on the 
negotiated rate at the time of the award.  

Under the Small Grant mechanism (R03) applicants may request either 
$25,000 or $50,000 in direct costs per year for up to two years. These 
awards are not renewable; however, a no-cost extension of up to one 
year may be granted to the grantee institution prior to expiration of 
the project period. Before completion of the R03, investigators are 
encouraged to seek continuing support for research through a research 
project grant (R01). (See Program Announcement PA-99-098, "NIAAA Small 
Grant Program," http://grants.nih.gov/grants/guide/pa-files/PAR-99-098.html,
for a complete description of the R03 mechanism.) 

Exploratory/developmental grants (R21) are limited to 3 years for up to 
$100,000/year for direct costs. (See Program Announcement PA-99-131, 
"NIAAA Exploratory/Developmental Grant Program," 
http://grants.nih.gov/grants/guide/pa-files/PA-99-131.html, for a 
complete description of the R21 mechanism.)

Exploratory/Developmental Grants and Small Grants cannot be renewed: 
however, a no-cost extension of up to one year may be granted prior to 
expiration of the project period.  Investigators are encouraged to seek 
continued support after completing an Exploratory/Developmental Grant 
project or a Small Grant project through a Research Project Grant (R01).

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 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.   
 
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:
 
Rosalind Breslow, PhD, MPH
Division: Biometry and Epidemiology
Institute or Center: NIAAA
Building Willco, Room 514
Bethesda, MD  20892
Telephone:  (301) 594-6231
FAX:  301-443-8614
Email:  rbreslow@mail.nih.gov

Angie Chon-Lee, MPH
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 533, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-3138
FAX:  (301) 402-0051
Email:  ac176r@NIH.GOV (e-mail correspondence is preferred)
 
o Direct your questions about financial or grants management matters 
to:
 
Judy Fox
Chief, Grants Management Branch
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Boulevard, MSC 7003
Bethesda, MD 20892-7003
(301) 443-4704 (telephone)
(301) 443-3891 (fax)
email:  jsimons@willco.niaaa.nih.gov

Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD  20892
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  lw17m@NIH.GOV (e-mail correspondence is preferred)
 
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.
 
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. 
 
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. 93.273 and 93.866, 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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