INFORMAL CAREGIVING RESEARCH FOR CHRONIC CONDITIONS

RELEASE DATE:  August 26, 2002

PA NUMBER: PA-02-155

EXPIRATION DATE:  August 10, 2005, unless reissued. 

National Institute of Nursing Research (NINR)
 (http://www.ninr.nih.gov)
National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov)
National Institute of Mental Health (NIMH) 
 (http://www.nimh.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 National Institute of Nursing Research (NINR), the National Institute of 
Child Health and Human Development (NICHD), and the National Institute of 
Mental Health (NIMH) invite applications for research grants to advance the 
science in informal caregiving by focusing on the caregivers of individuals 
with chronic illness, disability, or functional impairment requiring partial 
or full dependency on others. This program announcement (PA) targets studies 
of informal caregiving to improve caregiver health and quality of life, 
caregiving processes, and caregiving effectiveness and health outcomes. A key 
aspect of this announcement is to encourage research to advance science-based 
knowledge of informal caregiving, with attention to the caregiver. Clinical 
research areas appropriate to this PA include studies: to improve the quality 
of informal caregiving; to prevent or manage caregiver physical and mental 
health problems related to caregiving; to reduce the burden of caregiving; to 
test the effectiveness of advances in caregiving processes, including new 
technologies; and to determine the impact of formal and informal support 
systems on caregiving outcomes and caregiving transitions/trajectories. 
Applicants should consider the feasibility of translation to practice and 
cost effectiveness for interventions tested. Studies investigating issues 
related to the parenting of healthy children or studies of caregiving in 
institutions are not responsive to this PA.

RESEARCH OBJECTIVES

Background

The definition of informal caregivers used by this announcement is adapted 
from Biegel, Sales, and Schulz (1) and includes those individuals who provide 
extraordinary, uncompensated care, predominantly in the home setting, 
involving significant amounts of time and energy for months or years, 
requiring the performance of tasks that may be physically, emotionally, 
socially, or financially demanding. 

The number of informal caregivers in the U.S. tripled from 1988 to 1996, 
according to a National Alliance for Caregiving/American Association of 
Retired Persons (NAC/AARP) study (2) of informal caregivers for care 
recipients aged 50 or older. In 1996, the U.S. had over 22 million households 
with English-speaking informal caregivers. The intensity of caregiving ranged 
from a few hours per week to constant care. The mean age of caregivers was 46 
with 22% under 35 years and 36% 50+ years old. Estimates of the number of 
caregivers under the age of 21 are not well documented. The prevalence of 
informal caregiving was higher among Asian and Black households (31.7% and 
29.4%) than among Hispanic (26.8%) or White (24%) households. About 73% of 
informal caregivers are female. The median household income of caregivers in 
1996 was $35,000. About two-thirds of caregivers worked either full-time or 
part-time, about 20% were not employed, and 16% were retired. Almost 70% of 
caregivers cared for more than one person, while 23% cared for two people and 
8% cared for three or more people.  

The main illness or problems experienced by care recipients in the study were 
identified, by groupings, as "aging" (15.5%), mobility problems (10.4%), 
dementia (9.7%), and 43.2% with various chronic diseases including heart 
disease, cancer, stroke, arthritis, diabetes, and pulmonary disease. Problems 
with smaller percentages were noted for mental or emotional illness and 
neurological problems. Wagner (3) compared 1988 and 1996 informal caregiving 
survey data and, on the basis of the comparison results, predicted that 
during the next decade, informal caregiving and the number of caregivers will 
continue to increase, as will issues in the workplace, the percentage of male 
caregivers, and long-distance caregiving. It is estimated that currently 4.1 
million adults aged 21 to 64 need personal assistance with one or more 
personal or instrumental activities of daily living. Approximately 6.8 
million adults over the age of 65 have daily personal assistance needs. (4,5)

The cost of informal caregiving is significant and is primarily that 
associated with caregiving of adults and older adult populations. Informal 
caregiving cost estimates range from $117 to $292 billion a year for adults 
with a disability or chronic disease, with higher costs occurring in 
caregiving for Alzheimer's disease. (6) The health issues arising from 
informal caregiving are significant and warrant attention. To illustrate, the 
NAC/AARP study (2) reports that 15% of caregivers admit to having physical or 
emotional health problems directly related to caregiving while other 
caregivers have one or more pre-existing health problems. More women than men 
caregivers report emotional stress and impaired physical health. 

The national informal caregiving surveys cited previously were targeted to 
older care recipients. With increasing numbers of children surviving birth 
defects (including genetic, neurodevelopment, and birth trauma conditions), 
developing chronic diseases, and the continuing numbers of automobile and 
other accidents resulting in traumatic injuries to adolescents and young 
adults, informal caregiving needs are, and will continue to be, present 
across the lifespan. The percentage of children ages 5 to 17 with any 
limitation in activity from chronic conditions is 8%, as reported by the CDC 
National Center for Health Statistics in 1997. Furthermore, there are 1.5 
million children and adolescents who have serous health conditions that 
impair daily functioning. (5,6) Chronic diseases that are severe require 
extraordinary caregiving. One example is the growing number of health 
outcomes of very low birth weight infants. Low birth weight infants have 
higher rates of mental retardation, cerebral palsy, blindness, deafness, and 
psychomotor problems than do normal weight infants. (7) Many of these health 
problems require a lifetime of committed informal caregiving by parents and 
family members and may have a deleterious impact on family dynamics, quality 
of life, and financial status.  
   
Informal Caregiving Recipient Populations   

Examples of care recipient populations and caregiving problems are briefly 
discussed. It is not possible, in this context, to specify all possible 
caregiving situations or care recipient groups. The following examples 
illustrate the breadth and depth of informal caregiving problems experienced 
by caregivers. 

Chronic Illnesses. The Centers for Disease Control and Prevention (CDC) 
reports that nearly three quarters of adults age 65 years and older have one 
or more chronic illnesses, and nearly half report two or more. Many chronic 
diseases are debilitating and may have a deleterious affect on self-care 
functions, requiring informal caregiving from family or friends. The moderate 
to severe forms of stroke, for example, often require sudden intense and 
frequent caregiving interventions, with caregiving needs changing over time. 
A review (8) of caregiving for stroke patients found several caregiver well-
being issues including depression, concern for future care, and caregiver 
burden. Burden was related, in various studies, to level of patient 
disability, and psychological distress. Caregiver depression was related to 
the relationship with the patient (spouse), more concern for future care, 
fewer social contacts, more physical symptoms in the caregiver, and stroke 
patient symptoms. Caregiver fatigue and sleep difficulties were found to be 
significantly greater for spousal caregivers of individuals with Alzheimer's 
Disease, Parkinson's disease, or cancer when compared with a control group of 
little or no caregiving requirements. (9) In a longitudinal cohort study (10) 
of almost 400 older spousal caregivers, caregivers who experienced mental or 
emotional strain related to caregiving had mortality risks 63% higher than 
non-caregiving controls. The findings suggest that having caregiver strain is 
an independent risk factor for mortality among older spousal caregivers.

Alzheimer's Disease. At least 5 million Americans provide care for someone 
with Alzheimer's disease (AD). (11) These informal caregivers are twice as 
likely to be providing constant care and 38% have been providing care for 
more than five years. The caregiving required is intense and includes 
assistance with activities of daily living, incontinence, feeding, and 
transfer or use of a wheelchair or walker. The majority (73%) of AD 
caregivers age 65 and over provide the highest levels of care. These 
caregivers are twice as likely to report physical strain and high levels of 
emotional stress as a direct result of caregiving responsibilities. They are 
more likely to report family conflict, to spend less time with other family 
members, and to give up vacations, hobbies, and other personal activities. A 
high level of financial strain is present for AD caregivers as well.

Technology-Dependent. Technological caregiving in the home is becoming more 
prevalent. Examples of technology use for care recipients of all ages include 
kidney dialysis, intravenous lines, electronic monitoring, nutritional tube 
feedings, and ventilators. Care recipients who are technology dependent may 
need constant vigilance and monitoring. The need for long-term technology re-
education, support, and caregiving guidance has not been adequately 
addressed. Informal technology caregiving success is related to caregiver and 
care recipient abilities to share responsibilities, to understand tasks, and 
to coordinate efforts with multiple health professionals. (12) The use of 
technology in informal caregiving remains a major problem for caregivers and 
care recipients as technological advances become more common and more 
sophisticated.     

This announcement is based on growing scientific opportunities that reflect 
the increased current and future need for informal caregiving.  These 
opportunities were summarized at an NINR-sponsored Research In Informal 
Caregiving:  State of the Science Workgroup Meeting in July 2001 at which a 
group of science experts in informal caregiving, including lay 
representatives, reviewed the current state of the science in the field. A 
summary of the workgroup meeting and research questions raised can be found 
at: http://www.ninr.nih.gov/research/dea/workgroup_chronic_conditions.html

Research Scope

Informal Caregiving Populations. All caregiving populations are of interest 
to this PA, including understudied populations such as caregivers of children 
or adolescents.  Also of interest are ethnic/racial minority, gay/lesbian, 
and highly stressed/overwhelmed caregivers. Age groups across the lifespan, 
including young or older caregivers, and both genders should be considered. 
Applications for all informal caregiving populations will be considered and 
include various conditions of care recipient illness, disability or 
functional impairment as well as different levels of severity of recipient 
health. Various levels of intensity of informal caregiving are of interest, 
ranging from a few hours per week to constant and vigilant caregiving. 
Studies of diverse populations are encouraged, including urban, inner city, 
rural, and other understudied groups.

The following research topics are provided as examples that would extend 
research currently funded by DHHS.  They 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 issues in appropriate components 
of the study.

Informal Caregiving Populations

Applicants may propose studies among an unlimited number of caregiving 
populations, including those previously studied. Understudied populations of 
interest include, but are not limited to:

o  Both genders, all sexual orientations, and all age groups, including young 
caregivers.

o  Caregivers of ethnic minorities, children or adolescent care recipients

o  Highly stressed or overwhelmed caregivers.

o  Caregiving populations by care recipient illness or disability, including 
but not limited to persons with cancer, cardiovascular disease, diabetes, 
arthritis, stroke, serious mental illness, Alzheimer's disease and other 
dementias, or physical disability (through trauma, birth defects, or 
debilitating conditions).

Caregiver Abilities, Problem Solving, and Care Decisions

o  Test interventions that improve the knowledge and abilities of caregivers 
for symptom management, caregiving procedures/activities, accessing 
appropriate health care/social services assistance, health care visits, 
symptom and medication management, prevention of complications, preventive 
care, changes in care needs when conditions improve or worsen, recipient 
health crises, troublesome behaviors, and physical and emotional dependency. 

o  Test interventions to improve caregivers' ability to problem solve and 
make care decisions.  Examples include but are not limited to: knowing who 
and when to call for health care/social services assistance, health care 
visits, symptom and medication management, changes in care needs for 
improving or worsening of condition, health crises, troublesome physical or 
psychological behaviors, physical and emotional dependency, and assessing 
necessity to institutionalize.  

o  Examine interventions for caregivers at different transitions in the 
trajectory of caregiving, for example, when the recipient's condition either 
improves or worsens, or the recipient is institutionalized or dies. Examples 
include the support needed, adaptation mechanisms, and skills to manage the 
transition for the caregiver and care recipient. 

o  Test interventions that improve the quality of caregiving behaviors and 
knowledge, and that consider the cost of informal caregiving and outcomes.
Determine the health care resources that are critical for all caregivers, 
regardless of type of care recipient.  

o  Test strategies to instill the critical knowledge and skills needed by 
caregivers for their effectiveness in guidance, psychoemotional support, and 
partnering with the care recipient.  

o  Examine in-home assistive information and communication-based 
technologies, including computers and health care equipment for its 
enhancement of informal caregiving effectiveness and easing of the stress or 
intensity of caregiving effort.

o  Assess methods for education, safety and technology skill maintenance, and 
care decisions in technology-dependent caregiving.

o  Examine interventions that improve the quality of interactions between 
formal and informal care providers and that improve both caregiver and care 
recipient health outcomes.

o  Examine best methods to provide health information about the health 
condition of the care recipient and the intervention strategies the caregiver 
must carry out, incorporating culturally competent approaches.

o  Develop and test measurements for caregiving attitudes, skills, knowledge 
and outcomes across and within different geographic regions and ethnic groups 
as well as recipient health conditions.

Impact on Caregiver  

o  Evaluate interventions that help to maintain and improve the caregiver's 
physical and mental health across and within different geographic regions, 
racial/ethnic groups, and by recipient health conditions.

o  Test interventions to assist caregivers to cope with or alleviate 
unanticipated demands of caregiving such as time required, loss of social 
interactions with others, other personal lifestyle sacrifices, insufficient 
family assistance, financial impact, and work issues. 

o  Assess methods to intervene for caregivers with dysfunctional family 
dynamics, including aggressive behaviors or abuse.

o  Determine what factors facilitate and inhibit the successful maintenance 
of healthy partnerships between the informal caregiver and their care-
recipients, other family members, and formal health care providers, while 
maintaining the caregiver's own health.

o  Study issues related to or interventions aimed at the termination dynamics 
experienced by caregivers when the care recipient dies or is placed in an 
institutional facility.

o  Explore the ethical dilemmas faced by family-member caregivers and how the 
caregiver's response to these dilemmas influence the outcomes of caregiving 
for the caregivers and recipients.

o  Test strategies that reduce the burden experienced by non-caregiving 
children or other family members and that enhance the level of their 
participation in caregiving.

o  Determine the impact on the caregiving relationship when the caregiver and 
care recipient have the same or similar illness states or when the caregiver 
has a serious health problem. 

o  Determine the physiological, mental health, and psychosocial effects on 
the caregiver when the caregiver is a child, young adult, adult, or elderly. 

o  Explore various caregiver effectiveness and satisfaction issues such as 
mental health and depression, respite or compensation, family conflict, 
health needs of the caregiver, evaluation of caregiving effectiveness, social 
isolation, distress, and emotional strain.  

Formal Health Care and Community Resources for Effective Caregiving

o  Test interventions or collaboration strategies between caregivers and 
formal health care systems that improve caregiving effectiveness and 
satisfaction.

o  Test the impact of formal (health care providers) and informal community 
resources (social services including social/financial, community 
organizations) on effectiveness in supporting the caregiver and caregiving 
processes and outcomes, including access to and utilization of formal, 
informal, and community sources of caregiving assistance. 

o  Investigate the role of telehealth or technology in improving informal 
caregiving and strategies that enable effective caregiving with new or 
advanced technologies.  

This announcement is sponsored by several Institutes, however, NICHD is 
interested in research on the caregivers of children and adults with chronic 
physical disabilities such as spinal cord injury, spina bifida, head injury 
or stroke.
 
The NIMH is interested in supporting research that will provide the basis for 
the development, validation, and implementation of strategies and 
interventions to identify, treat, prevent and/or rehabilitate depression, 
anxiety, and other mental disorders among caregivers of individuals with 
chronic care needs.  The NIMH has special interest in research that examines 
the influence of social and cultural factors on caregiving, and caregiver 
burden and mental health needs; and in the development of interventions that 
are transportable to rural and frontier populations.  In addition, studies on 
the organization and delivery of relevant services across mental health, 
general health, and other community care settings in order to improve mental 
health outcomes for caregivers are also of interest.  

References

1.  Biegel, D., Sales, E., and Schulz, R. (1991). Family caregiving in 
chronic illness: Heart disease, cancer, stroke, Alzheimer's disease, and 
chronic mental illness. Newbury Park, CA: Sage Publications.  

2.  National Alliance for Caregiving & American Association of Retired 
Persons (1997). Family caregiving in the U.S.: Findings from a national 
survey. Sponsored by the National Alliance for Caregiving, Bethesda MD, and 
the American Association of Retired Persons, Washington DC. 

3.  Wagner, DL (1997). Comparative analysis of caregiver data for caregivers 
to the elderly 1987 and 1997. National Alliance for Caregiving: Bethesda MD.

4.  Schulz, R, & Quittner, AL (1998).  Caregiving through the life-span: 
Overview and future directions. Health Psychology, 17(2), 107-111.

5.  Quittner, AL, Opipari, LC, Regoli, MJ, Jacobsen, J, & Eigen, H (1992).  
The impact of caregiving and role strain on family life: Comparisons between 
mothers of children with CF and matched controls. Rehabilitation Psychology, 
37, 289-304.

6.  Arno, PS, Levine C, Memmott, MM (1999). The economic value of informal 
caregiving. Health Affairs, 18(2):182-188.     

7   Hack, M, Klein, NK, & Taylor, HG (1995). Long-term developmental outcomes 
of low birth weight infants. In RE Behrman (Ed.), The Future of Children, 
5(1):176-196. Published by the Center for the Future of Children, The David 
and Lucile Packard Foundation.

8.  Han, B, & Haley, WE (1999). Family caregiving for patients with stroke: 
review and analysis. Stroke, July, 1478-1485.

9.  Teel CS, & Press AN (1999). Fatigue among elders in caregiving & non-
caregiving roles. West J Nurs Res, Aug;21(4):498-514.    

10. Schulz R, & Beach SR (1999). Caregiving as a risk factor for mortality: 
The caregiver health effects study. JAMA, 282:2215-2219.  

11. Alzheimer's Association and the National Alliance for Caregiving. (1999).  
Who cares? Families caring for persons with Alzheimer's disease. A report of 
the Alzheimer's Association, Washington DC, and the National Alliance for 
Caregiving, Bethesda MD.

12. Smith, C. (1996). Quality of life and caregiving in technological home 
care. In J Fitzpatrick & J Norbeck (Eds.), Annual review of nursing research 
(Vol. 14, pp. 95-118). New York: Springer Publishing.

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 informal caregiving.  
Investigators are encouraged to explore the feasibility of an innovative 
research question or approach that will provide a basis for future research 
project applications.  The NINR and NICHD limit exploratory/developmental 
grants (R21) to 2 years of support and up to $150,000 per year in direct 
costs.  The NIMH limits R21 grants to 3 years of support and up to $125,000 
per year in direct costs.  For further guidance on the NIMH R21 mechanism, 
please see: http://grants.nih.gov/grants/guide/pa-files/PA-99-134.html. 
Please contact the appropriate IC for specific guidance on the direct costs 
allowed or other questions.  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, you must 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 and 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. 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. Emeline Otey
Division of Mental Disorders, Behavioral Research and AIDS 
National Institute of Mental Health 
6001 Executive Boulevard, Room 6186, MSC 9625 
Bethesda, MD  20892-9625 
Telephone:  (301) 443-1636 
FAX:  (301) 443-4611 
Email:  eotey@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

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

Mr. Brian Albertini 
Division of Extramural Activities 
National Institute of Mental Health 
6001 Executive Boulevard, Room 6115, MSC 9605 
Bethesda, MD  20892-9605 
Telephone:  (301) 443-0004 
FAX:  (301) 443-6885 
Email:  albertinib2@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

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

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting $500,000 or more 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 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), 93.929 (NICHD) and 93.242 
(NIMH), 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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