PREVENTION RESEARCH FOR THE TRANSITION TO ADULTHOOD

RELEASE DATE:  December 4, 2003
 
RFA Number:  RFA-DA-04-013 (see addendum NOT-DA-04-005)

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 20, 2004
APPLICATION RECEIPT DATE:       March 23, 2004

THIS 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 Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The period spanning late adolescence and young adulthood (roughly from 18 
through 25 years of age), is characterized by various developmental tasks 
and life changes and choices; it also is the period when use and abuse of 
drugs peak.  The National Institute on Drug Abuse (NIDA) seeks research 
grant applications focused on this transitional period that test the 
efficacy of interventions to prevent and/or reduce drug use, abuse, and 
related problems including HIV-risk behaviors.  Interventions should be 
based on existing knowledge of the etiology and patterns of drug use and 
abuse. Studies focusing solely on alcohol use will not be considered as 
responsive to this RFA. A related NIDA RFA (DA-04-009), 
Behavioral and Cognitive Processes Related to Adolescent Drug Abuse 
(http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-04-009.html), is 
designed to focus on the entire period of adolescence and on basic 
cognitive and biobehavioral processes related to drug abuse. 

RESEARCH OBJECTIVES

Background and Significance

The initiation of drug use and escalation from use to abuse are most 
likely to occur during critical developmental and social transitions.  
While much attention has been given to initiation of drug use during the 
transitions that occur during early adolescence (e.g., from elementary to 
middle school and changes related to the onset of puberty), far less 
research has focused on illicit drug use and abuse (except the use of 
alcohol) during the transition from adolescence to adulthood.  That 
developmental period, recently identified as a separate life stage labeled 
“emerging adulthood,” is characterized by a variety of unique life changes 
and choices that occur roughly between the ages of 18 and 25.  While 
previously the late teens and early twenties was a period of intensive 
preparation for imminent entry into adult roles, the new norm is for these 
emerging adulthood years to be set aside for experimentation and 
exploration of life possibilities and decisions.  Transitions, including 
leaving home, embarking on careers, establishing intimate relationships 
including marriage, and parenthood characterize this stage of development 
and may affect substance abuse.  

Additional developmental transitions (i.e., actual change processes rather 
than the outcomes) also occur.  These include further cognitive 
development (e.g., continued brain development, the emergence of personal 
beliefs and values), changes in one’s identity or self-definition (e.g., 
exploration of career roles), and affiliative transitions (e.g., shifts in 
relationships with parents and peers). These changes provide new 
opportunities for growth as well as new demands that can result in 
frustration and stresses that may lead to initiation or exacerbation of 
substance abuse, as well as antisocial behaviors and comorbid psychiatric 
disorders.  While most young adults mature out of drug use as they move 
into adult roles, some do not. Thus, it is important to understand how 
drug involvement affects or is affected by developmental task completion 
and the mechanisms through which individuals “age out” of problem 
behaviors in order to facilitate the successful mastery of such tasks. 
Applying a developmental perspective to this life stage suggests looking 
at the interactions of individual characteristics and processes and 
environmental factors in the development of age-specific preventive 
interventions.

During the period of emerging adulthood substance use increases, peaks, 
and then declines for most young people.  According to the 2002 National 
Survey on Drug Use and Health (NSDUH) (SAMHSA, 2003), rates of past month 
illicit drug use climbed steadily for youth from 12 to 17, peaked among 18 
to 20 year olds, remained high for those between 21 and 25 before dropping 
for persons 26 through 29. About a quarter of smokers and one third of new 
marijuana users start using after age 17 as do about 70% of cocaine users 
(almost all of whom progress from using other drugs). Emerging adults vary 
widely in their rates of use, and these rates depend, in part, on 
diverging intrapersonal, sociodemographic and life choice factors related 
to education, employment, living arrangements, marital status, and life 
style.  For example, in 2002, 22% of full-time college students and 27% of 
their high-school-graduate age peers had used at least one illicit drug in 
the past 30 days. In addition, 15% of college students and 33% of other 
high school graduates were daily cigarette smokers and 41% of students and 
37% of other respondents had consumed 5+ drinks in a row (i.e., binge 
drank) in the past 2 weeks (Johnston, Bachman & O’Malley 2003).  These 
high rates of drug use suggest the need to focus on preventing initiation 
and escalation of drug use among this age group.  Subpopulations at 
greatest risk include males, those with a high school education or less, 
the unemployed, persons with past year co-occurring serious mental 
illness, and criminal justice populations. Increasing substance use after 
high school also is associated with leaving the parental home and 
acquiring freedom from adult supervision; declining substance use is 
associated with entry into marriage and parenthood.  Drug use is somewhat 
contingent on earlier patterns of use. However, drug use patterns continue 
to change with fluctuations often related to life changes. For example, 
while parenthood and marriage may initially be protective, divorce may 
provoke substance use initiation or escalation. 

Areas of Interest

The complexity of the issues related to drug use/abuse and associated 
consequences across the transition to adulthood indicate the need for a 
multidisciplinary, developmental approach to prevention research.  Studies 
of interest under this RFA may focus preventive interventions at the 
intrapersonal, family, school/work, peer and broader social context levels 
and examine them alone or in combination. Studies might develop and test a 
variety of innovative preventive interventions targeting emerging adults 
at the universal, selective, or indicated levels for implementation in 
diverse settings.  All such interventions need to be sensitive to cultural 
and gender differences.  Investigators representing a broad array of 
academic disciplines and engaged in cross-cutting fields of science are 
encouraged to consider designing hypothesis-driven studies that use 
rigorous methodologies from epidemiological, basic, clinical, behavioral 
and social research.  Competing continuations of ongoing longitudinal 
studies will not be considered.

Intrapersonal Level Studies

Personal characteristics associated with elevated risk for use or abuse of 
drugs include those that cannot be modified (e.g., gender) and others that 
are more malleable including expectancies related to use of specific 
drugs, interpersonal skills, emotional control, and physical health.  
Better understanding of how such factors interact and are affected by the 
social context (e.g., drug availability, job stress) would provide a basis 
for tailoring messages and interventions.  For example altering alcohol 
expectancies has proven effective in reducing heavy drinking among college 
students.  Similarly, determining expectancies then crafting prevention 
messages to specific groups of drug users might prove effective.  Studies 
might include but are not limited to the following:

o Implementation and assessment of culturally-tailored adaptations of 
interventions to emerging patterns of use among racial/ethnic groups with 
respect to drug use and drug-related problems.  
o Tests of preventive interventions designed to foster reduction or 
termination of drug use by altering drug expectancies and/or increasing 
the sense of adult responsibility associated with the subjective meaning 
of adulthood.

Family and Intimates

During emerging adulthood most youth move both physically and emotionally 
away from their family of origin. Yet researchers have ignored the 
changing nature of family ties throughout the young adult transition and 
their associations with drug use. Features of the leaving home transition 
vary with respect to timing or age at which it occurs, reasons for leaving 
home, and the young person’s affective reactions to leaving. The 
circumstances under which the young adult leaves home may be both a 
trigger for substance use initiation or progression or may have been 
triggered by substance use/abuse. Adolescent research shows that parents 
remain an important source of advice on the most important life decisions, 
such as those around college and work.  Moreover, a salient feature of 
emerging adulthood for many young people is the continued economic 
dependence on parents, which generally has some social, psychological and 
perhaps later economic cost attached.  Thus, research on the family of 
origin might explore impact of continuing parental influence and design 
interventions involving parents.  Many young adults live in quasi-family 
settings during this transitional period (e.g., with a roommate, a group, 
or a romantic partner). Some create new families, by marrying and/or 
becoming parents during this age of transition.  Studies of familial, peer 
and romantic ties and early parenthood may include, but are not limited 
to, the following: 

o Design and test interventions that involve parents in communicating 
about drugs as they prepare their child for college or full-time entry 
into the work force. 
o Develop a prenatal intervention to end or reduce use of drugs among 
high-risk pregnant women in the emerging adulthood age range.  The 
intervention may be at the selective or indicated levels and might be 
implemented in primary care or non-traditional settings (e.g., worksite 
wellness programs; community recreation centers). 
o Design interventions to address the negative influence of one intimate 
partner on the drug use of the other, based on assessment of the factors 
that account for the patterns of influence on the other and on their 
relationship. 
o Test HIV prevention components for inclusion in drug abuse prevention 
interventions for the young adult population.

Education, Work and Drugs

Recent research has focused on “binge” drinking among college students. A 
number of those students that abuse alcohol also use illicit drugs.  
However, there has been limited preventive intervention research on 
college students’ use of illicit drugs and even less research designed to 
intervene with non-college young adults who have higher rates of illicit 
drug use or with specific subpopulations in this group.  Explanations for 
these differential patterns include sociocultural theories that emphasize 
the influence of the work group and the work environment, and 
psychological theories that emphasize individual variables.  However, few 
interventions aside from drug testing, Employee Assistance Programs 
(EAPs), and health-oriented preventive interventions have been used to 
address these problems and these interventions have generally not been 
rigorously tested. Thus, researchers might test the effectiveness of 
tailored wellness programs as part of apprenticeship programs operated by 
labor unions or formalized mentoring by other employers.  In addition, 
intervention studies for young adults in college or job tracks might:  
need to add “include but not limited to….”

o Examine the establishment, publication, and enforcement of college and 
university drug use policies and implementation of those policies on rates 
of alcohol and other drug use on campus and the local community to 
identify effective procedures and approaches to reducing substance abuse 
among students. 
o Develop preventive interventions for workplaces and college campuses 
that address drug use norms, work-related stress, and occupational group 
pressures to use drugs. 

Peers and Broader Social Contexts 

Some subpopulations of youth and contexts specific to young adult culture 
are extremely high-risk and probably contribute to drug use patterns, to 
the uptake of practices associated with particular drugs, and to 
consequences of these behaviors.  The problems encountered and potential 
modalities for intervention among high-risk subpopulations of young adults 
are not well understood.  The informal social contexts in which young 
adults “hang out” and may use drugs also have not been fully explored.  
These include including bars and social clubs, street gangs, and gyms and 
organized athletic activities.  The broader social environment (e.g., 
community factors, mass media) can also contribute to both substance abuse 
problems and to amelioration of problems.  Environment includes features 
of contexts in which individuals live and can be either positive features 
(e.g., anti-drug norms with college or workplace contexts; high density of 
anti-drug media messages) or negative features (e.g., high availability of 
drugs; lack of enforcement of rules or policies) and most of these 
features are malleable.  For example, it is possible to focus on changing 
group social norms, public and organizational policies and practices, and 
sanctions for violating them through environmental interventions. Studies 
focusing on various contexts and circumstances of drug use may include the 
following, but not limited to:

o Test the efficacy of existing preventive interventions and strategies  
(e.g., mentoring, job training and challenge activities) for very high-
risk late adolescents (e.g., youth with comorbid psychiatric disorders, 
high school dropouts, persons under the supervision of the criminal 
justice system).
o Examine ways to effectively communicate preventive messages to late 
adolescent and early adult populations using both traditional media (TV 
and radio messages) and non-traditional approaches (including DVDs and 
computer-based websites).   
o Examine processes that could facilitate the implementation of drug abuse 
prevention programs through novel delivery systems such as computer dating 
services, dance clubs, faith-based activities, and private fitness 
facilities. 
o Assess the impact of environmental and/or systems level interventions 
such as organizational policies and practices on illegal drug use.  Such 
studies might examine the effectiveness of student health services and 
counseling services, or test the effectiveness of peer mentoring as ways 
to reduce new worker stress and facilitate integration.
o Assess applications of brief interventions (e.g., feedback interviews) 
aimed at preventing drug use among young people in varied contexts (e.g., 
gynecological services, STD treatment clinics or student health center 
settings).

MECHANISMS OF SUPPORT

This RFA will use the NIH research project (R01), the small grant (R03) 
and the exploratory/developmental (R21) award mechanisms.  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/archive/grants/policy/nihgps_2001/part_i_1.htm .

FUNDS AVAILABLE 

NIDA intends to commit approximately $1.5 million in FY 2004 to fund 3 
to 5 grants in response to this RFA.  An applicant may request for the 
R01 project period of up to 5 years. For the R03, the project period is 
2 years and direct costs up to $50,000 for each of those years.  For 
the R21, the project period is 2 years and up to $275,000 in direct 
costs for the two-year period.  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 the 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:

Susan E. Martin, Ph.D.
Prevention Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5163, MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 402-1533
FAX: (301) 480-2542
Email:  smartin@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 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 20, 2004 
Application Receipt Date:         March 23, 2004
Peer Review Date:                 June/July 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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