LONG-TERM CARE RECIPIENTS: QUALITY OF LIFE AND QUALITY OF CARE RESEARCH

RELEASE DATE:  September 4, 2002 (see addendum NOT-MH-02-010)

PA NUMBER: PA-02-162

EXPIRATION DATE:  August 31, 2005, unless reissued. 

National Institute of Nursing Research (NINR)
 (http://www.ninr.nih.gov)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 
 (http://www.niams.nih.gov)
National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR
 (http://www.nidcr.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
 (http://www.niddk.nih.gov)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanisms 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 purpose of this program announcement is to encourage research on 
improving the quality of life, health, functional abilities, and health 
outcomes for residents of long-term care (LTC) institutions such as nursing 
homes, extended care, and assisted living facilities. Impaired quality of 
life, poor functional status, and health concerns are well documented in LTC 
settings to have a deleterious impact on outcomes. Examples of areas of 
concern include, but are not limited to, poor nutrition, impaired oral 
health, diabetes related hyperglycemia and hypoglycemia, renal dialysis, 
impaired mobility, management of acute and chronic health conditions, and 
decreased social interactions. Research is also needed for understudied age 
groups, ethnic groups, and for certain health conditions. The goals of this 
PA are to stimulate clinical research to advance knowledge about long-term 
care populations and to encourage testing of interventions to improve quality 
of life, health, and functional status of long-term care residents. Another 
important goal of this PA is to encourage studies of interventions that can 
be translated into practice in current LTC environments.    

RESEARCH OBJECTIVES

There are approximately 2 million nursing home residents and over 1.5 million 
people in assisted living facilities and homes for adults. These numbers are 
expected to double by the year 2020. Currently, at least 40% of the 
population over age 75 is predicted to need extensive health care services 
late in their lives. Long-term care is also needed for many younger adults 
and children who have chronic disabling physical or mental disabilities or 
who have non-permanent conditions requiring LTC. Care needs are often related 
to the development of disabling conditions such as multiple sclerosis, 
stroke, complications of diabetes, or trauma. Moreover, with increasing life 
expectancies, individuals with disabling health conditions are likely to 
spend a longer period of time in long-term care facilities. The complexity of 
health care is also likely to increase with science advances, longevity, and 
increases in chronic disease prevalence and incidence.

Health care and quality of life issues in long-term care can be expected to 
grow as "baby boomers" reach 65 years and older, as the proportion of 
individuals over 85 continues to increase, and as other health-related 
disabilities and chronic diseases continue to affect all age groups.  

The Federal Interagency Forum on Aging-Related Statistics, in a published 
report titled Older Americans 2000: Key Indicators of Well-Being, noted that 
the racial and ethnic makeup of the U.S. is changing, including that within 
the older population. At the time of the report, about 84 percent of the 
population age 65 and older was non-Hispanic white with minority ethnic 
groups making up the remaining 16 percent. These proportions are projected to 
change significantly by 2050. The projections for older adults are that non-
Hispanic whites will make up 64 percent of the population while minority 
ethnic groups will increase to 36 percent of the population. This continuing 
change in the ethnic/racial makeup of the U.S. may have an impact on many 
health areas, including approaches to long-term care. For example, population 
groups may differ by access, utilization, health behaviors, family 
involvement, and personal views about LTC. Studies are needed on the use of 
existing data in LTC settings to bring about continuing improvements in 
health outcomes and quality of life.

The continuing increase in lifespan for the U.S. population, including those 
with chronic diseases or disabilities that require long-term care will create 
a demand for more and improved quality of long-term care. While older adults 
are healthier than ever, there continues to be large numbers of older people 
with chronic conditions and disabilities, especially at very advanced ages, 
along with cognitive impairments and depression, all of which can 
substantially diminish quality of life and functional status. 

Traditionally, LTC institutions have been identified as nursing homes. During 
the past 20 – 30 years, additional kinds of LTC facilities have evolved. 
Assisted living facilities, for example, are a fast growing segment for long-
term care.  Alternative living arrangements for dependent older adults, the 
mentally ill, and mentally handicapped individuals are becoming more 
prevalent. Little research has been done on assisted living and other 
alternative LTC populations and how they may differ from nursing home 
populations in quality of life and health outcomes and whether adaptations to 
setting are required for health care interventions.  

Serious problems with health care, including nursing home care, have been 
well documented during the past ten years. The Institute of Medicine (IOM) 
concluded, in a 2000 executive summary report, that although positive changes 
had occurred in long-term care since the 1986 IOM study, the quality of life 
for nursing home residents improved only slightly, and serious problems 
remain. Noted health care problems in nursing homes include pain, pressure 
sores, malnutrition, and urinary incontinence.  

Common problems experienced by LTC recipients continue to have a strong 
impact on their health status across the U.S. Problem areas in LTC that are 
well documented include impairment in the following areas: nutrition and 
hydration, functional status, falls and injuries, cognitive function, 
medication management, physical activity and mobility, bowel and urine 
continence, susceptibility to infection, vulnerability to depression, health 
maintenance, social engagement, and family involvement. In addition to 
current knowledge, questions remain about whether intervention effectiveness 
for these problem areas varies by diverse cultural and ethnic LTC groups.

The prevalence of depression in older adults in long-term care settings 
clearly impacts quality of life. Depression that occurs after placement in 
long-term care implies that there are influencing factors that may be 
amenable to change. The cause of depression in LTC residents is not fully 
understood and whether it is related to adaptation to change, the loss of 
independence, health care management, LTC experiences, loss of association 
with family members, or to multiple factors needs to be determined. Further 
research is needed to address these issues.

Quality of life in long-term care institutions is affected by, among other 
things, the physical, social, and health care environments. The physical 
environment impacts on quality of life throughout daily experiences such as 
the need to feel safe and secure during physical activity or activities of 
daily life, including, for example, mealtime, personal and oral hygiene, and 
recreational activities. The social environment affects quality of life from 
many aspects. The ability to maintain as much independence as possible and to 
continue to make immediate daily life and health care choices is important to 
supporting quality of life. Passive health care maintenance rather than 
dynamic, proactive health care for older adults and for debilitated 
individuals of any age has been identified as occurring when staff or 
decision makers view the individual as "too old" or "too sick" for new 
medical or dental advances resulting in poor quality of life during the 
person's final years of life.

Positive social engagement with LTC staff, other residents, and family 
members and friends has been shown to improve the quality of life for LTC 
recipients. Research is needed to develop and test strategies to facilitate 
ongoing social engagement over time.  

A recent GAO report notes an unacceptable level of physical and sexual abuse 
in nursing homes. Studies are needed to identify precipitating factors and 
how to prevent such occurrences.

The physical health and safety of LTC residents is an ongoing concern. Common 
goals are to maintain and improve health, to prevent injury or illness, and 
to facilitate a high quality of life for residents. These goals are difficult 
to achieve when the care environment leads to poor nutrition and hydration, 
and a compromised health state. Infections such as pneumonia or tuberculosis 
are more prevalent when the normal physiological and immunological 
protections are compromised. Although there is a progression of some 
illnesses and health conditions that cannot be reversed, a slowing or 
reversal of such conditions may be a feasible goal.

Long-term care residents may have multiple chronic conditions that require 
vigilance and daily monitoring. Frailty or impaired functional abilities of 
residents may prevent active self-management of their own health conditions 
as perhaps they once did. Strategies that promote participation in self-care 
and decision making to the resident's potential are important research 
topics, as are interventions that promote and maintain functional abilities. 
Interventions that promote more effective and efficient monitoring of health 
status and therapeutic, timely interventions for chronic and acute health 
problems are needed in tight economic and current staffing environments. 

Understudied LTC populations include those in rural nursing homes, ethnic 
minority populations in significant numbers for meaningful analysis, and 
residents without involved family or friends. All populations, but these 
groups in particular, need additional study for interventions that are cross-
cutting and identifications of interventions that lend themselves to 
adaptation to different groups or settings.   

Scope 

Responses to this announcement will focus on research opportunities for the 
growing population of institutionalized long-term care recipients. Another 
program announcement, PA02-155, titled Informal Caregiving Research For 
Chronic Conditions, focuses on caregiving for non-institutionalized care 
recipients. LTC institutions of interest are nursing homes, assisted living 
facilities, and alternative LTC sites. Studies of all ethnic/racial 
populations and age groups are of interest. Exploratory studies in new or 
understudied areas such as those just noted are encouraged. Studies are 
particularly encouraged that 1) test promising new or improved interventions 
for long-standing LTC resident health or quality of life concerns and 2) test 
effective interventions in understudied populations.  Of particular interest 
are innovative approaches that are evaluated for effectiveness within the 
current long-term care infrastructure and with current fiscal constraints.

Potential Research Areas:

The following research topics are provided as examples that would extend 
current research. The topics are not listed in any priority order and are not 
intended to be inclusive or restrictive. All responsive applications, 
regardless of design or target group, must display awareness of and 
sensitivity to cultural or race/ethnic/gender issues in appropriate 
components of the study.

o  Determine social, cognitive, psychosocial, cultural, race/ethnic, and 
other personal factors that influence or mediate residents' health or quality 
of life.
o  Identify staffing, environmental, and biotechnological factors that 
enhance quality of life and improve health outcomes.
o  Test interventions aimed at decreasing falls and injuries, preventing or 
reducing oral and other infections, improving medication management and pain 
and other areas of symptom management. 
o  Examine interventions to increase functional mobility, physical activity, 
and restful sleep.
o  Test interventions to maintain or improve health factors related to skin 
integrity, nutrition, hydration, dentition and oral function, and continence.
o  Assess methods to improve and maintain social engagement and cognitive 
stimulation in the LTC setting with a focus on long-term, integrated change. 
o  Examine methods to facilitate family and friends' involvement in the LTC 
resident's life experiences to enhance quality of life and health outcomes.
o  Test interventions to effectively manage acute (bone fractures, infection) 
and single or multiple chronic illnesses (diabetes, stroke, arthritis, 
cancer, AIDS) and to prevent complications such as pressure ulcers, 
contractions, pneumonia, and other infections.
o  Identify strategies to more effectively manage depression, agitation, and 
confusion and to facilitate emotional and social support in diverse health 
conditions.  
o  Examine physical, therapeutic, and social environments that enhance 
quality of care and resident satisfaction and social participation. A few 
examples may include selection of roommates, the proximity of residents, and 
the volume of radios and televisions.
o  Identify factors that facilitate psychosocial adjustment and adaptation to 
long-term care facilities for both residents and their family and friends.
o  Test the effectiveness of LTC interventions by various ethnic or cultural 
populations, age, gender, and cognitive status.
o  Assess methods that enhance resident participation in decision making 
about their care management and daily lifestyle to the level desired by the 
resident.
o  Develop studies focusing on younger LTC populations, i.e., youth and 
adults under 65 years, quality of life, and health status problems.  
o  Explore strategies to maximize LTC facilities' utilization of findings or 
expertise from existing research centers in academic and clinical settings to 
enhance quality of life, quality of care, and health outcomes. Examples may 
include research knowledge, evidence-based protocols, or processes and 
strategies to implement best practices.

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 quality of life issues in long 
term care.  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.  
Application page limits differ according to mechanism.  Please see the 
"Submitting an Application" section for more details. 

This PA uses just-in-time concepts.  It also uses the modular and 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 format.  Otherwise, use the standard PHS 398 
instructions for detailed budgets.

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:

Dr. Nell Armstrong
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD  20892-4870
Telephone:  (301) 594-5973
FAX:  (301) 480-8260
Email:  nell.armstrong@nih.gov

Dr. Sidney M. Stahl
Chief, Behavioral Medicine
National Institute on Aging
7201 Wisconsin Ave., #533
Bethesda, MD  20892-9205
Telephone:  (301) 402-4156
FAX:  (301) 402-0051
Email:  Sidney_Stahl@nih.gov

Dr. Deborah N. Ader 
Director, Behavioral and Prevention Research Program  
National Institute of Arthritis and Musculoskeletal and Skin Diseases 
One Democracy Plaza  
6701 Democracy Boulevard, Suite 800, MSC 4872  
Bethesda, MD  20872-4872  
Tel: (301) 594-5032  
Fax: (301) 480-4543
Email: deborah_ader@nih.gov

Dr. Louis Quatrano
Behavioral Sciences and Rehabilitation Engineering 
National Institute of Child Health and Human Development 
6100 Executive Boulevard, 2A03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 402-4221
FAX: (301) 496-0832
Email: quatranl@exchange.nih.gov

Dr. Patricia Bryant
Program Director
Behavioral and Social Science Research Program
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research
Natcher Bldg Room 4AN24E
45 Center Drive MSC6402
Bethesda, MD 20892-6402
Telephone: (301) 594-2095
FAX: (301) 480-8318
Email: Patricia.Bryant@nih.gov

Dr. Sanford Garfield
Senior Advisor for Biometry &
Behavioral Research
National Institute of Diabetes & Digestive & Kidney Diseases 
Two Democracy Plaza, Room 685
6707 Democracy Blvd
Bethesda, MD  20892-5460
Phone: (301) 594-8803
FAX: (301) 402-6271
E-mail: garfields@extra.niddk.nih.gov

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

Ms. Diane Drew
Office of Grants and Contracts Management
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD  20892-4870
Telephone:  (301) 594-2807
FAX:  (301) 451-5651
Email:  diane_drew@nih.gov 	

Ms. Grace Poe
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Ave., #212
Bethesda, MD   20892-9205
Phone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  Poeg@mail.nih.gov

Ms. Melinda Nelson 
Grants Management Officer 
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza  
6701 Democracy Boulevard, Suite 800, MSC 4872 
Bethesda, MD 20872-4872Telephone: (301) 594-3535 
FAX: (301) 480-5450 
Email: melinda_nelson@nih.gov

Mr. Christopher Myers
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Telephone: (301) 435-6996
FAX: (301) 402-0915
Email:  cm143g@nih.gov

Ms. Florence Danshes
Grants Management Specialist
National Institute of Diabetes & Digestive & Kidney Diseases
Two Democracy Plaza, Room 734 
6707 Democracy Blvd
Bethesda, MD  20892-5456
Phone: (301) 594-8861
FAX: (301) 480-3504
Email:  danshesf@extra.niddk.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. 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:
	
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. 93.361 (NINR), 93.866 (NIA), 93.846 (NIAMS), 
93.929 (NICHD), 93.121 (NIDCR) 93.847 and 93.879 (NIDDK), 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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