WOMEN'S MENTAL HEALTH IN PREGNANCY AND THE POSTPARTUM PERIOD

RELEASE DATE:  June 6, 2003

PA NUMBER: PA-03-135

March 2, 2006 (NOT-OD-06-046)   Effective with the June 1, 2006 submission 
date, all R03, R21, R33 and R34 applications must be submitted through 
Grants.gov using the electronic SF424 (R&R) application. This announcement 
will stay active for only the May 1, 2006 AIDS and AIDS-related application 
submission date for these mechanisms. The non-AIDS portion of this funding 
opportunity for these mechanisms expires on the date indicated below. Other 
mechanisms relating to this announcement will continue to be accepted using 
paper PHS 398 applications until the stated expiration date below, or 
transition to electronic application submission. A replacement R21 (PA-06-377) 
funding opportunity announcement has been issued for the submission date of 
June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter.

EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 
EXPIRATION DATE for All R01 Applications: March 2, 2009

National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)
National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)
National Institute of Drug Abuse (NIDA)
 (http://www.nida.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.242, 93.279, 93.865

THIS PA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of the PA
o  Research Objectives
o  Mechanism(s) of Support
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Where to Send Inquiries
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS PA

In this PA, the National Institute of Mental Health (NIMH), the National 
Institute of Drug Abuse (NIDA), and the National Institute of Child Health 
and Human Development (NICHD) encourage research on women's mental health in 
relation to pregnancy and the postpartum period.  As illustrated by a few 
highly publicized cases, the consequences of severe untreated postpartum 
depression and psychosis can be devastating for individuals, families, and 
communities.  In July 2002, NIMH held a major interdisciplinary conference to 
identify research needs in the areas of pregnancy-onset and postpartum 
depression and postpartum psychosis (hereafter referred to collectively as 
perinatal mood disorders).  In February 2003,’s 450 and HR 846 were introduced 
in the 108th Congress.  The bills call for the Secretary of Health and Human 
Services, working through the Director of NIMH to provide for basic, 
epidemiological, diagnostic, clinical, and intervention research on 
postpartum depression and psychosis.

RESEARCH OBJECTIVES

Perinatal mood disorders are potentially devastating conditions that affect 
many women during pregnancy (often referred to as gestational or antepartum) 
and after pregnancy (often referred to as postpartum, puerperium or postnatal).  
Perinatal mood disorders are broadly termed maternal depression. Perinatal mood 
disorders are classified into three groups: the (postpartum) blues, which is a 
common and less severe form of postpartum depression; clinical mood and anxiety 
disorders, which can occur during pregnancy and following childbirth, usually 
within six months to a year later (depending on the definition used) and often 
necessitating treatment; and postpartum psychosis, which is the most extreme 
form of perinatal mental illness, usually occurring within a few weeks of 
childbirth and constituting a medical emergency.  The causes of these 
conditions are complex and most likely heterogeneous, with putative distinct 
and shared risk factors.  Biologically oriented explanations are likely to 
consider changes in levels of estrogen and progesterone following delivery, 
genetic vulnerability factors sensitive to hormonal changes, and hypothyroidism 
as possible triggering events.  Environmental factors associated with perinatal 
mood disorders include difficult delivery, marital stress, and lack of social 
support.  A personal or family history of mood disorders, particularly bipolar 
disorder or prior postpartum psychosis, is also a major risk factor for a 
perinatal mood disorder.  A subset of women with perinatal mood disorders may 
also manifest mood disorders particularly in relation to other reproductive 
transitions such as those that occur during the premenstrual period.  It is 
estimated that 8-15 percent of women having children suffer from a clinically 
significant postpartum mood disorder; of these women, many experienced 
depressive symptoms as well during pregnancy.  An estimated .5 to 1 percent of 
women will experience a postpartum psychosis.  There are limited 
epidemiological data on postpartum psychosis because of the low incidence.

Perinatal mood disorders are under-diagnosed and under-treated.  It is 
estimated that health care providers identify only 20-30 percent of these 
conditions.  Maternal depression, anxiety, and stress during pregnancy are 
associated with a variety of poor physical and emotional outcomes in offspring.  
Untreated perinatal mood disorders can have a range of poor maternal functional 
outcomes, from substance abuse, loss of employment, and divorce to suicidal 
behavior or death by suicide.  Untreated perinatal depression also impacts 
society through its effect on a mother's ability to promote the infant's 
cognitive and emotional development.  Maternal depression has been associated 
with poorer child cognitive and psychological development.  In extreme cases, 
such as postpartum psychosis, it has been associated with poorer neonatal 
outcomes, even infanticide.

In addition to the mood disorders, many women enter the perinatal period with  
active and/or relapsing/recurring drug or alcohol use disorders as well as 
mental illness (anxiety disorders, eating disorders, schizophrenia) and with 
medical conditions related to substance abuse such as infectious disease 
(HIV, HBV, HCV).  These conditions and other co-occurring conditions of higher 
prevalence in women such as autoimmune disorders must be explored at the level 
of basic, epidemiological, diagnostic, clinical, and intervention research in 
relation to maternal perinatal health.

This PA encourages research on perinatal mood and other mental disorders in 
four areas:  (1) clinical course, epidemiology and risk factors; (2) basic and 
clinical neuroscience; and (3) interventions; and (4) services.  Research is 
encouraged both on perinatal non-psychotic mood disorders and on psychotic 
disorders.

Clinical Course, Epidemiological and Risk Factors Research

Current national epidemiology studies have paid surprisingly little attention 
to the postpartum period and even less attention to pregnancy in terms of risk 
for different kinds of perinatal mental disorders and distinguishing risk 
factors.  This critical gap must be addressed, as clinical and epidemiology 
studies form the basis of intervention research.  The prevalence of perinatal 
depression in different racial/ethnic groups of women is undetermined, with 
some reports of much higher rates in low-income and/or ethnic minority women 
and other reports of comparable rates among women.

Below are examples of clinical, epidemiological, and risk factors research 
encouraged by NIMH:

o  Epidemiological studies to identify risk and protective factors for 
postpartum non-psychotic depression and anxiety disorders, especially in women 
with different clinical patterns and histories (e.g., reproductive-related mood 
changes, recurrent depression).

o  Clinical and epidemiological studies to identify the characteristics of 
pregnancy-onset depression and to examine its functional impact and course.

o  Studies of health disparities in perinatal depression, other peri-natal 
mental disorders, and in co-occurring behavioral and medical conditions.

o  Clinical and epidemiological studies of women with bipolar disorder or 
schizophrenia to identify risk factors for perinatal mood disorders onset; 
studies to aid in the early identification and treatment of serious perinatal 
psychosis among high-risk women.

o  Clinical and epidemiological studies of pregnancy complications and birth 
and neonatal outcomes in women with perinatal mood or anxiety disorders or 
psychosis. 

o  Clinical and epidemiological studies of treated versus untreated perinatal 
mood, anxiety, and other mental disorders during pregnancy and lactation in 
relation to child outcomes such as development and mental health.

o  Research on psychiatric and social functional status associated with 
infertility, miscarriage, stillbirth, and elective abortion.

NIDA encourages research in the following area:

o  Studies exploring the effects of current or lifetime drug abuse, including 
treatment status and comorbid conditions, on onset and course of mental 
disorders during the perinatal period.

Basic and Clinical Neuroscience

Very little basic neuroscience research is currently aimed specifically at 
addressing the neurobiology of perinatal mood disorders.  There is a need to 
apply the knowledge of hormone-sensitive brain circuits and neurotransmitter 
systems to developing an understanding of the neurobiology of perinatal mood 
disorders in clinical populations.  The development of appropriate models of 
the peripartum period will be essential for understanding the neurobiology of 
perinatal mood disorders.  Consideration of combined genetic and environmental 
influences on postpartum hormonal status, emotionality, and maternal behavior 
is also appropriate for model development.  Finally, new tools are needed to 
advance the understanding of neuroendocrine control of mood and cognition in 
humans, non-human primates, and other species.

The following are examples of clinical neuroscience research encouraged by NIMH:

o  Studies aimed at identifying neurobiological, endocrine, and behavioral 
characteristics that distinguish perinatal mood disorders from perinatal 
psychotic disorders and from mental disorders occurring at other times across 
the lifespan.

o  Neuroimaging studies of normal and patient populations of women during 
different perinatal intervals to identify functional changes in brain 
neurochemistry in relation to hormonal transitions.

o  Studies to identify unique hormone sensitivities in women with histories of 
perinatal mental disorders in order to predict risk of subsequent perinatal 
mood disorders and to identify subsets of women vulnerable to developing mood 
disorders following other hormonal events (e.g., menstruation; menopause).

o  Studies to identify genetic polymorphisms/markers of vulnerability in women 
at high risk for the development of perinatal mood disorders or postpartum 
psychosis. The inclusion of subsets of women with more homogeneous psychological 
symptoms during pregnancy and post-partum is particularly encouraged.

o  The inclusion of women with a history of perinatal mood disorders in genetic 
studies of depression and bipolar disorder in order to identify additional 
vulnerability markers for the disorders in relation to perinatal triggers. 

Below are examples of model development research encouraged by NIMH:

o  The development of models of hormone changes occurring during and after 
pregnancy for neurobiological and behavioral studies.

o  The development of models to examine the combined environmental and genetic 
influences of resilience and vulnerability to mood and cognitive disorders 
during the perinatal period.

o  The development of models to study the impact of perinatal disorders during 
pregnancy and lactation and pharmacological treatments for the disorders on the 
behavioral and neural development of offspring.

o  Identification of relevant objective and quantitative measures including 
assessment of neuroendocrine activity (pituitary, gonadal, thyroid hormone 
systems), brain activation (EEG, PPI, ERP), and the development of simplified 
behavioral measures with parallel application across species including humans, 
non-human primates, and/or rodents.

Below are examples of tool development research encouraged by NIMH:

o  Development of research tools to visualize the influence of post-partum 
hormonal changes on brain gene expression and on activation of brain circuits 
regulating mood and cognition.

o  Development of more selective hormone receptor ligands and radioligands 
(e.g., estrogen receptor   agonists and thyroid receptor ligands) for basic and 
clinical research.

o  Development of novel tools and approaches to visualize activation of steroid 
hormone receptors in brain imaging studies across the reproductive cycle and 
throughout pregnancy.

NIDA encourages research in the following area:

o  Studies elucidating the effects of drug abuse or drug abuse history and 
other comorbid conditions (e.g., HIV infection, hepatitis) on maternal 
neurobiology during the perinatal period.

NICHD encourages research in the following area:

o  Mechanistic studies of the impact of perinatal mood disorders on human fetal 
and infant nervous system development.

Interventions Research

There is a need to develop more systematic knowledge about the impact of known 
pharmacological and psychosocial depression treatments for perinatal mood 
disorders.  There is also a need to develop new behavioral interventions for 
these conditions, in particular interventions that can be adapted to general 
medical or group settings.

The following are examples of the kinds of intervention studies encouraged by 
NIMH:

o  Studies of the efficacy, safety, pharmacokinetics, and pharmacodynamics of 
pharmacotherapies for treatment of perinatal mood disorders, especially those 
occurring during pregnancy and lactation. 

o  Maintenance studies to develop effective non-pharmacological interventions 
to prevent postpartum relapse.

o  Studies of pharmacological maintenance treatments during pregnancy and 
postpartum for women with serious mental illnesses such as psychosis and 
studies of pharmacological prophylaxis strategies for these conditions in women 
at high risk for a recurrence of psychotic perinatal conditions. 

o  Controlled studies of non-pharmacological interventions, such as psychosocial 
therapies or light therapy for perinatal depression.

o  Development of innovative non-pharmacological interventions as alternatives 
to traditional one-on-one interventions for identifying, preventing, and 
treating perinatal mood disorders (e.g., self-help; support groups; Web-based 
approaches to reduction of subsyndromal symptoms before they become disorders).

o  Development of outcome measures of maternal functioning and/or child 
functioning, which can be incorporated into assessments of the effectiveness of 
interventions.

o  The development of innovative interventions for preventing and treating 
perinatal mood disorders, which are aimed at the reduction of risk for poor 
parenting and child psychopathology and that can be easily adapted to medical 
and other real-world settings (e.g., community-based mental health centers).

NIDA encourages research in the following area:

o  Studies of the effects of current or lifetime diagnosis of drug abuse and 
comorbid conditions on behavioral and pharmacological treatment of maternal 
mental disorders during the perinatal period.

Services Research

Increased screening and referral to accurate, accessible, and sustainable 
mental health assessment, treatment, and needed services is a public health 
strategy with the potential to improve outcomes in perinatal mood disorders. 
To determine the effectiveness of such an approach, a variety of factors must 
be evaluated at the individual, practitioner, organizational, community, and 
systems levels.

The following are examples of services research encouraged by NIMH:

o  Studies dealing with clinical decision-making in personal-encounter care 
for individual patients with perinatal mood disorders; research to identify 
risk factors for the development of such disorders in clinical settings; 
factors that are important in the natural history of these disorders, including 
co-morbid conditions.

o  Studies that elucidate the critical components of effective collaborative 
models for screening/referral partnerships within and across systems of care 
(e.g., between primary care and mental health care, between public and private 
health care systems, or between health care providers/systems and employers).  
Such studies should seek to understand issues relevant to successful 
implementation of effective models.

o  Research on the impact of various forms of managed care and physician 
payment methods on the detection, assessment, referral and treatment of 
perinatal mood disorders, and performing economic analyses of practice patterns 
of different health providers and systems in addressing such disorders.

o  The development of community collaborative models for screening/referral 
partnerships between researchers and public and private health care systems 
and between health care providers/systems and employers. 

o  Studies of the mechanisms by which stigma associated with perinatal mental 
illness affects the behavior of providers and consumers in terms of creating 
barriers to recognition, help-seeking, or referral for or acceptance of 
treatment.

o  Studies that provide insights into differences in quality and outcomes of 
care in various practice types, and analysis of the appropriateness of 
treatment, including medications.

o  Studies to determine the need for and barriers to utilization of mental 
health services for mothers with postpartum mood disorders, including 
assessment and rehabilitation of functional disability.

o  Studies exploring the feasibility and efficacy of parenting-related 
services that address special issues of parenting and illness management for 
women with serious mental illnesses.

o  Research related to issues of culture, social systems, and social networks 
as they relate to help-seeking, use and provision of services, and 
effectiveness, quality, and outcomes of services.

MECHANISM(S) OF SUPPORT

This PA uses the NIH Research Project Grant (R01), Small Grant (R03), and 
Exploratory/Developmental Grant (R21) mechanisms.  As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed project.

The Small Grant (R03) provides two years of funding with a maximum of $50,000 
direct costs for each year.  Instructions for the R03 application can be found 
at (http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html).  The 
Exploratory/Developmental Grant (R21) provides two years of funding with a 
maximum of $275,000 direct costs over the entire budget period with no one 
year exceeding $200,000.  It is intended for development and pilot testing of 
novel models, sensitive neurochemical measurements, interventions and other 
aspects of intervention development.  Instructions for R21 applications can be 
found at (http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html).

The total project period for an R01 application submitted in response to this 
PA may not exceed five years.

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 or 
less, use the modular format.  Otherwise follow the instructions for 
non-modular research grant applications.  This program does not require cost 
sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

Applicants are strongly encouraged to consult with program staff listed under 
INQUIRIES.

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:

Mary C. Blehar, Ph.D.
Chief, Women's Mental Health Program
National Institute of Mental Health
6001 Executive Boulevard, Room 8125, MSC 9659
Bethesda, MD  20892-9659
Telephone:  (301) 443-2847
FAX:  (301) 4438552
Email:  [email protected]

Catherine Y. Spong, M.D.
Chief, Pregnancy and Perinatology Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03E, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6894
FAX:  (301) 496-3790
Email:  [email protected]

Deborah M. Smith, MD, MPH, FACOG
Special Expert and Chief, Medical Consequences Unit
Center on AIDS and Other Medical Consequences of Drug Abuse (CAMCODA)
National Institute of Drug Abuse
6001 Executive Boulevard, Room 5198 MSC 9593
Bethesda, MD  20892-9593
Telephone:  (301) 402-0924 
FAX:  (301) 480-4544 
Email:  [email protected]

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

Joy R. Knipple
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-8811
FAX:  (301) 443-6885
Email:  [email protected]

Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17M, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-5482
FAX:  (301) 480-4782
Email:  [email protected]

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  [email protected]

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) 710-0267, 
Email: [email protected].

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 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.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of established 
PHS referral guidelines.  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 
the 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 the application's overall score, weighting them as appropriate for 
each application.  The application does not need to be strong in all categories 
to be judged likely to have major scientific impact and thus deserve a high 
priority score.  For example, an investigator may propose to carry out 
important work that by its nature is not innovative but is essential to move a 
field forward.

SIGNIFICANCE:  Does this study address an important problem? If the aims of the 
application are achieved, how will scientific knowledge be advanced? What will 
be the effect of these studies on the concepts or methods that drive this field?

APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project? Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

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

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

ENVIRONMENT:  Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements? Is there evidence of institutional support?

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK:  The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed. (See criteria included in the section 
on Federal Citations, below).

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  The adequacy of plans 
to include subjects from both genders, all racial and ethnic groups (and 
subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of subjects 
will also be evaluated. (See Inclusion Criteria in the sections on Federal 
Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH:  If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 398 
research grant application instructions (rev. 5/2001) will be assessed.

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:

o  Scientific merit of the proposed project as determined by peer review
o  Availability of funds
o  Relevance to program priorities

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and others, 
and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

MONITORING PLAN AND DATA AND SAFETY 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 and Safety 
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 "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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable health 
information, and is administered and enforced by the DHHS Office for Civil 
Rights (OCR). Those who must comply with the Privacy Rule (classified under the 
Rule as "covered entities") must do so by April 14, 2003  (with the exception 
of small health plans which have an extra year to comply).

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution.  The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH processes 
involving the review, funding, and progress monitoring of grants, cooperative 
agreements, and research contracts can be found at http://grants.nih.gov/grants/
guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they directly 
access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to achieving 
the health promotion and disease prevention objectives of "Healthy People 
2010," a PHS-led national activity for setting priority areas.  This PA is 
related to one or more of the priority areas.  Potential applicants may obtain 
a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of Federal 
Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All awards 
are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, Public 
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities (or in some cases, any portion of a facility) in which regular or 
routine education, library, day care, health care, or early childhood 
development services are provided to children.  This is consistent with the 
PHS mission to protect and advance the physical and mental health of the 
American people.

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