TARGETED INTEGRATIVE RESEARCH IN DRUG ABUSE AND HIV/AIDS IN PREGNANCY

RELEASE DATE:  December 23, 2003

RFA NUMBER:  RFA-DA-04-010

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION: 
National Institute on Drug Abuse (NIDA) 
 (http://www.nida.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279

LETTER OF INTENT RECEIPT DATE:  February 17, 2004
APPLICATION RECEIPT DATE:       March 17, 2004

THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION:

o Purpose of this RFA
o Research Objectives
o Mechanisms of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The National Institute on Drug Abuse (NIDA) invites targeted 
integrative research on epidemiological, prevention, and treatment 
service approaches that focus on drug abuse, HIV/AIDS and other medical 
consequences of drug abuse, specifically relevant to pregnant women and 
females of childbearing age. Pregnancy is a clinical and psychosocial 
phenomenon that presents public health, clinical care and drug 
treatment services with challenges for effective drug abuse prevention 
and treatment services.  Pregnancy also poses challenges to the overall 
health care, including therapies for HIV/AIDS and other medical 
consequences of drug abuse. Research and clinical experience have given 
rise to a burgeoning knowledge base about important gender differences 
in addiction treatment for females.  However, among drug abusing 
pregnant females of childbearing age, patterns of drug use and effects 
of use from various drugs have not been adequately characterized or 
addressed.  This is particularly true of emerging and re-emerging drugs 
of abuse such as ecstasy and methamphetamine.  Substance using females 
who are pregnant often have inadequate or no prenatal care, have 
greater infant morbidity and mortality in the postnatal period, and 
significant deficiencies in child health care utilization.  In addition 
the new mother is likely to have significantly lower levels of maternal 
postpartum visits, primary care visits, contraceptive use and, most 
importantly, exposure to prevention intervention strategies. 

Studies are sought that target pregnant and postpartum drug-using 
females as they move through the health care and drug abuse services 
continuum, and on overall health outcomes specific to this population. 
A key focus of these studies with respect to this population is 
integration and application of knowledge and models of care that can 
blend for improved outcomes targeting drug abuse (consequences, 
epidemiology, prevention intervention and treatment approaches) and 
clinical care (therapeutics, diagnostic tools).  Specifically, NIDA 
seeks innovative research that targets, integrates and informs 
scientific knowledge on unique aspects of clinical care, prevention 
interventions, and drug abuse treatment for drug-using pregnant females 
and females of childbearing age.  Applicants are encouraged to compare 
models of care addressing certain of the many factors involving this 
population, such as medical, behavioral, social and service system 
issues.  Results of these studies are expected to inform the 
development and design of models of care for pregnant females and 
females of childbearing age that blend significant components to create 
optimal outcomes.  Studies could for example investigate integrative 
strategies for intervention, treatment, prevention with clinical care 
and pre- or post-natal service approaches that best target this 
population over the health care, drug abuse and behavioral risk 
continuum.  

RESEARCH OBJECTIVES

Background

Over the years NIDA initiatives have reflected the changing scientific 
and clinical landscape and thus provide resources for timely 
investigations of issues as they related to drug abuse, HIV/AIDS and 
other medical consequences of drug abuse and pregnancy.

Research and clinical experience have shown important differences in 
addiction treatment for women.  Reframing theoretical questions, 
conceptual frameworks, assessment technique modifications, and new 
treatment approaches are some of the general attributes of female-
centered or gender-specific models of care.  Characteristics of these 
models include empowerment approaches, training and supervision 
protocols for treatment staff, increased flexibility in treatment 
planning and program structure, peer counseling and therapeutic 
relationships and comprehensive integrated services (e.g. GED, 
vocational counseling, nutrition, child care) oriented toward special 
needs of women.  Of interest are programmatic activities that include 
spiritual and culturally relevant traditions, attention to exposure to 
interpersonal violence and physical and sexual abuse and primary care 
giving roles traditionally for females.

Over the last decade perspectives have evolved on the conduct of 
research involving females of childbearing potential and those who are 
pregnant.  Maternal-fetal physiology is understood as representing bi-
directional interactions with the placenta as an interposed modulating 
organ system.  Along with the advancements in basic science, new 
methods for clinical assessment of maternal and fetal physiologic 
events such as ultrasonography are available to be applied in research 
settings.  

Often an attenuation of all substance use occurs with pregnancy but 
there are differentials with respect to age, pregnancy history and the 
substance being used.  Data from the 2002 National Survey on Drug Use 
and Health (formerly known as the National Household Survey on Drug 
Abuse) reports the past month prevalence of any illicit drug use, 
cigarette smoking, and marijuana and binge alcohol use to be higher 
among 18-25 year old pregnant women as compared to 26-44 year old 
pregnant women.  Additional analyses performed on the NPHS data reveal 
that an association exists between report of illicit drug use in the 
index pregnancy and a higher order number of previous pregnancies after 
controlling for age.  This same relationship holds for tobacco use.

A research network is currently funded by NIDA to explore developmental 
outcomes of infants prenatally exposed to methamphetamine but there is 
limited research on methamphetamine use and pregnancy.

In the United States, hospital delivery is virtually universal and 
almost all women have some interface with the medical care system prior 
to labor and delivery.  Pregnancy has been characterized as an 
opportune time for screening and detection of drug use, initiation of 
behavior change and acceptability of clinical interventions.  However, 
considerable variability exists among populations and participation in 
prenatal care or experience with drug abuse treatment.  It is well 
documented that substance-abusing women have a high likelihood of 
inadequate prenatal care.  

In a prospective cohort analysis of 6673 women delivering in the 
District of Columbia, mothers with illicit drug exposure in pregnancy 
were significantly more likely to begin prenatal care later and to have 
fewer prenatal visits.  The highest risk for prematurity, a 12-fold 
increased risk, occurred in infants born to mothers with no prenatal 
care and illicit drug use.  The impact of illicit drug use, frequency 
of use or specific drug of abuse on maternal health and variations of 
effects are not well addressed in drug treatment interventions.  
Elevated risk estimates have been observed for syphilis, gonorrhea, 
pregnancy-related hypertensive disorders, chorioamnionitis, asthma and 
postpartum hemorrhage. Substance-abusing women who become pregnant and 
have inadequate or no prenatal care have greater infant morbidity and 
mortality in the postnatal period with significant deficiency in the 
pattern of child health care utilization.  Equally significant by some 
standards are lower levels of maternal postpartum visits, primary care 
visits, and adoption of effective contraception for family planning. 
There is virtually no information on health or drug use outcomes for 
substance-abusing women who do not complete a pregnancy, either 
voluntarily or secondary to pregnancy complications such as miscarriage 
or ectopic pregnancy.

Controversies persist regarding detoxification and the use of 
pharmacotherapies as part of drug abuse treatment and the treatment of 
co-occurring disorders in pregnant and lactating women.  In addition, 
the availability of drug treatment for pregnant and newly parenting 
women is very limited.  Many prenatal care programs are designed to 
provide for the multiple needs of the pregnant woman and her family 
such as psychological, social, vocational and legal services in 
addition to medical care.  However, in most locations the inclusion of 
drug treatment into these comprehensive programs is also limited. Women 
residing in rural areas are particularly limited in treatment options. 
A limited number of studies in pregnant women have been undertaken to 
evaluate the office-based model of opiate substitution therapy with 
buprenorphine.

The circumscribed duration of clinical obstetrical care may be at odds 
with the necessity of remaining in drug treatment for an adequate 
period of time to reach the threshold for recovery. Severity of 
addiction related problems and prior treatment experience have been 
both positively and negatively associated with involvement in drug 
treatment during pregnancy.  Lack of coordination after delivery for 
the provision of aftercare predicts poorer prognosis for recovery.  
Multiple studies have demonstrated the lack of durability and 
sustainability beyond six months of abstinence or drug use reduction 
achieved during pregnancy.  Gender and racial and ethnic diversity in 
relapse prevention needs has been reported but not specifically 
explored in relation to pregnancy.

Community level prescription and proscription of certain behaviors in 
pregnancy are an important influence on pregnancy outcome and function 
outside of the clinical services realm.  Peer group deviance, licit and 
illicit substance use by a male partner, significant other or family 
member, familial social support and mandated treatment are factors that 
have been described to influence acceptance of and compliance with drug 
treatment by pregnant women.

Knowledge, attitudes and practices within the health care provider 
community have an influence on prenatal care and drug treatment.  
Substance-abusing women who become pregnant are stigmatized and many 
clinicians have limited knowledge of the nature of addiction and its 
medical consequences.  There are specialty differences in screening, 
assessment and referral of women for substance use.  Surveys have 
reported attitudes on the part of perinatal providers that do not 
foster reciprocal approaches to optimizing maternal and fetal/infant 
health outcomes.  Negative attitudes coupled with the intensity of 
high-risk perinatal care may create dissonance for health care 
providers who are presented with a woman actively using drugs who also 
seeks to have a parenting and mothering role.

Finally, one of the most significant individual and public health 
consequences of drug use: acquisition and transmission of HIV infection 
and other infectious diseases, has added a new dimension to drug abuse 
treatment in pregnancy.  Among AIDS cases diagnosed in women and 
adolescent girls through 2001, injection drug use was the exposure 
category in 32 percent.  Heterosexual transmission by way of sex with 
an injection drug user accounted for 16 percent of cases.  Over fifty 
percent of all cases are classified as “other exposure/not identified” 
and “sex with men of other or unspecified risk.”  Research is emerging 
on the indirect role of injection and non-injection drug use as 
facilitators of sexual risk behaviors. The heterosexual transmission 
category is now the predominant exposure category in the Midwest, South 
and West as compared to the Northeast.  There has been a significant 
decline in the incidence of perinatal transmission of the HIV virus 
since the adoption of the results of ACTG 076 (using zidovidine) and 
other protocols. There are emerging issues in the provision of 
antiretroviral therapy to women of childbearing potential, as more 
women become candidates for indicated antiretroviral therapy as well as 
prophylaxis. There is evidence that women, who use illicit drugs during 
pregnancy, as well as tobacco and alcohol, are significantly less 
likely to receive prophylactic antiretroviral regimens. Substance-
abusing women with limited prenatal health care contribute to the 
residual risk for maternal to child transmission in the United States.  

Areas of Research Interest

Applicants are encouraged to propose targeted integrative research 
addressing females of childbearing age and unique aspects of drug 
abuse, HIV/AIDS and other medical consequences of drug abuse and 
pregnancy.  Multidisciplinary approaches are encouraged as appropriate, 
derived from the clinical, behavioral, biomedical, and social sciences 
and utilizing both qualitative and quantitative measures and 
methodology. Focal issue areas include epidemiology, prevention, 
behavioral and other interventions, drug treatment, clinical care and 
services. Research proposals that address any of the following are 
encouraged:

o Variations in conceptual models of gender-based drug abuse treatment 
and its applicability and transferability across the continuum of care 
provided to substance-abusing pregnant females and females of child 
bearing age.  Examples of potential variables involved in models of 
care may include:
Factors associated with prevention, intervention, treatment strategies 
as integrated into clinical care including, as appropriate, 
consideration of those receiving prenatal care late in pregnancy, 
intermittently or not at all and possibly involving issues such as 
detoxification, lactation, drug interactions, continued drug use, 
abstinence, provider practices, access and utilization of care, 
associations between entry into prenatal and other care and initiation 
into drug treatment and continuation in such services.

o Epidemiology studies on incidence and prevalence of HIV acquisition 
and care throughout the preconception, pregnancy and postpartum cycle 
in drug abusing females.

o Drug use trends and use patterns in drug-using pregnant women and 
females of child bearing age who have or are at risk for HIV/AIDS; for 
example, use of emerging drugs of abuse and nontherapeutic use of 
prescription drugs, including issues such as pharmacotherapy, drug 
interactions, pain management, comorbidity.

MECHANISM OF SUPPORT

This RFA will use the NIH research project (R01) and the 
exploratory/developmental (R21) award mechanisms 
(http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html).  As an 
applicant you will be solely responsible for planning, directing, and 
executing the proposed project.  This RFA is a one-time solicitation.  
Future unsolicited, competing-continuation applications based on this 
project will compete with all investigator-initiated applications and 
will be reviewed according to the customary peer review procedures.  
The anticipated award date is September 30, 2004.  Applications that 
are not funded in the competition described in this RFA may be 
submitted as NEW investigator-initiated applications using the standard 
receipt dates for NEW applications described in the instructions to the 
PHS 398 application.

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

FUNDS AVAILABLE 

NIDA intends to commit approximately $1,500,000 in FY 2004 to fund 2-5 
new and/or competitive continuation grants in response to this RFA.  
For the R01, an applicant may request a project period of up to 5 
years.  For the R21, the project period is 2 years and up to $275,000 
in direct costs for the two-year period 
(http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html).  Because 
the nature and scope of the proposed research will vary from 
application to application, it is anticipated that the size and 
duration of each award will also vary.  Although the financial plans of 
NIDA provide support for this program, awards pursuant to this RFA are 
contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications.

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed research is invited to work with their 
institution to develop an application for support.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.   

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity 
to answer questions from potential applicants.  Inquiries may fall into 
three areas:  scientific/research, peer review, and financial or grants 
management issues:

o Direct your questions about scientific/research issues to:

J.C. Comolli, B.S.N., M.B.A.
Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5194, MSC 9593
Bethesda, MD 20892-9593
Telephone: (301) 402-0630
Fax: (301) 594-6566 or (301) 480-4544
Email: Jcomolli@nida.nih.gov

o Direct your questions about peer review issues to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, Maryland  20892-8401
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@mail.nih.gov

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

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 242, MSC 8403
Bethesda, MD  20892-8403
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
Email:  gf6s@nih.gov

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed research
o Key areas of proposed research including major methodologies
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does 
not enter into the review of a subsequent application, the information 
that it contains allows NIDA staff to estimate the potential review 
workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning 
of this document.  The letter of intent should be sent to:

Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001). Applications must 
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) 
number as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on 
line 11 of the face page of the PHS 398 form. The PHS 398 document 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.

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.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and three signed, 
photocopies, in one package to:
 
Center For Scientific Review
National Institutes Of Health/DHHS
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application and 
all copies of the appendix material must be sent to:

Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)

APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignments within 8 weeks.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  However, when a previously unfounded application, 
originally submitted as an investigator-initiated application, is to be 
submitted in response to an RFA, it is to be prepared as a NEW 
application.  That is, the application for the RFA must not include an 
Introduction describing the changes and improvements made, and the text 
must not be marked to indicate the changes from the previous unfunded 
version of the application.  

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by NIDA.  Incomplete applications will not be 
reviewed.  If the application is not responsive to the RFA, NIH staff 
may contact the applicant to determine whether to return the 
application to the applicant or submit it for review in competition 
with unsolicited applications at the next appropriate NIH review cycle.
 
Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by NIDA in accordance with the review criteria 
stated below.  As part of the initial merit review, all applications 
will:

o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications 
under review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Advisory Council on 
Drug Abuse

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to evaluate the 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  The 
scientific review group will address and consider each of the following 
criteria in assigning the application's overall score, weighting them 
as appropriate for each application. 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The application does not need to be strong in all categories to be 
judged likely to have major scientific impact and thus deserve a high 
priority score.  For example, an investigator may propose to carry out 
important work that by its nature is not innovative but is essential to 
move a field forward.

(1) SIGNIFICANCE:  Please assess the extent to which the study aims are 
consistent with the goals of the RFA.  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?  Does 
the study address an important problem consistent with the goals of 
this RFA?

(2) 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?

(3) 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?

(4) 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)?

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

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and the priority score:  

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.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the 
sections on Federal Citations, below).

ADDITIONAL REVIEW CONSIDERATIONS

Sharing Research Data 

Applicants requesting more than $500,000 in direct costs in any year of 
the proposed research must include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the 
rationale for not sharing research data will be assessed by the 
reviewers. However, reviewers will not factor the proposed data sharing 
plan into the determination of scientific merit or priority score.  
(See 
http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm.)

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    February 17, 2004 
Application Receipt Date:         March 17, 2004
Peer Review Date:                 July/August 2004
Council Review:                   September 2004
Earliest Anticipated Start Date:  September 30, 2004

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

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

DATA SAFETY AND MONITORING PLAN: Data and safety monitoring is required 
for all types of clinical trials, including physiologic, toxicity, and 
dose-finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III).  The establishment of 
data and safety monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to 
the participants. (NIH Policy for Data Safety and Monitoring, NIH Guide 
for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $500,000  
in direct costs in any single year are expected to include a plan for 
data sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing. Investigators should 
seek guidance from their institutions, on issues related to 
institutional policies, local IRB rules, as well as local, state and 
Federal laws and regulations, including the Privacy Rule. Reviewers 
will consider the data sharing plan but will not factor the plan into 
the determination of the scientific merit or the priority score.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the 
policy of the NIH that women and members of minority groups and their 
sub-populations must be included in all NIH-supported clinical research 
projects unless a clear and compelling justification is provided 
indicating that inclusion is inappropriate with respect to the health 
of the subjects or the purpose of the research. This policy results 
from the NIH Revitalization Act of 1993 (Section 492B of Public Law 
103-43).

All investigators proposing clinical research should read the 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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of 
research on hESCs can be found at 
http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  
Only research using hESC lines that are registered in the NIH Human 
Embryonic Stem Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov).   It is the responsibility of the applicant to 
provide, in the project description and elsewhere in the application as 
appropriate, the official NIH identifier(s) for the hESC line(s)to be 
used in the proposed research.  Applications that do not provide this 
information will be returned without review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom 
of Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

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

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

HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON 
DRUG ABUSE:  Researchers funded by NIDA who are conducting research in 
community outreach settings, clinical, hospital settings, or clinical 
laboratories and have ongoing contact with clients at risk for HIV 
infection, are strongly encouraged to provide HIV risk reduction 
education and counseling.  HIV counseling should include offering HIV 
testing available on-site or by referral to other HIV testing service 
for persons at risk for HIV infection including injecting drug users, 
crack cocaine users, and sexually active drug users and their sexual 
partners.  For more information see 
http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE 
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS:  The National Advisory 
Council on Drug Abuse recognizes the importance of research involving 
the administration of drugs to human subjects and has developed 
guidelines relevant to such research.   Potential applicants are 
encouraged to obtain and review these recommendations of Council before 
submitting an application that will administer compounds to human 
subjects.  The guidelines are available on NIDA's Home Page at 
http://www.nida.nih.gov under the Funding, or may be obtained by 
calling (301) 443-2755.

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 RFA 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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