This Program Announcement expires on December 15, 2003, unless reissued.
DRUG ABUSE ASPECTS OF HIV/AIDS AND OTHER INFECTIONS
Release Date: November 30, 2000
PA NUMBER: PA-01-023
National Institute on Drug Abuse
(http://www.nida.nih.gov)
THIS PROGRAM ANNOUNCEMENT (PA) USES THE "MODULAR GRANT" AND "JUST-IN-TIME"
CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION
INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO
THIS PA.
PURPOSE
The National Institute on Drug Abuse (NIDA) supports research on the natural
history, epidemiology, etiology, pathogenesis, prevention, and treatment of
drug abuse and drug abuse aspects of HIV/AIDS and other infectious agents
[e.g., hepatitis B virus (HBV), hepatitis C virus (HCV), other sexually
transmitted diseases (STDs), and tuberculosis (TB)]. AIDS was first
recognized as a growing epidemic among men who have sex with men (MSM) and
injection drug users (IDUs) and their sexual partners in the early 1980s.
While considerable scientific progress has been made since then in
understanding, preventing, and treating the intertwined epidemics of drug
abuse and HIV/AIDS, much remains unknown or poorly understood today.
Emerging drugs of abuse, such as the club drugs ecstasy, GHB, ketamine, and
methamphetamine, as well as more potent supplies of heroin, cocaine, and
marijuana, are rapidly changing the profiles of populations at risk. In the
United States, over 48,000 women have been diagnosed with AIDS attributed to
injection drug use, and more than a third of AIDS cases in adult/adolescent
women diagnosed from July 1998 through June 1999 reported injection drug use
as their risk exposure. Racial and ethnic minority populations of both
genders have been deeply affected by drug abuse, HIV/AIDS, and other
infectious diseases in recent years, with new HIV infections continuing at an
alarming rate in the U.S. and in other nations. This PA seeks to stimulate a
range of investigator-initiated studies to advance the scientific knowledge
base on drug abuse aspects of HIV/AIDS and other serious infections.
Researchers are invited to address diverse and cross-cutting issues in
multiple disciplines, including virology, etiology, therapeutics and
vaccines, ethnography and epidemiology, and the behavioral and social
sciences.
HEALTHY PEOPLE 2010
The Public Health Services (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, "Drug Abuse
Aspects of HIV/AIDS and Other Infections," 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/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government. Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as principal
investigators.
MECHANISM OF SUPPORT
This PA will use the National Institutes of Health (NIH) research project
(R01), small grant (R03), and exploratory/developmental (R21) award
mechanisms. Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant. The total project
period for an application submitted in response to this PA may not exceed
five years for the R01, two years for the R03, and three years for the R21.
RESEARCH OBJECTIVES
Background and Significance
In the early 1980s, HIV and AIDS were first identified in the U.S. among MSM,
IDUs, and the sexual partners of IDUs. It later became clear that the same
risk behaviors for HIV (i.e., injecting drug use and unprotected sex) are
associated with other blood-borne and sexually transmitted infections, such
as HBV and HCV, and with the spread of TB. Sharing syringes and other
equipment for drug injection is a primary route of HIV transmission, yet
injection drug use contributes to the spread of HIV/AIDS beyond the circle of
those who inject, e.g., to persons who have sex with an IDU and to children
born to HIV-infected mothers who acquired the infection from sharing needles
or having sex with an infected IDU. IDU-associated AIDS accounts for a
larger proportion of cases among women than among men. Since the epidemic
began, 59% of all AIDS cases among women have been attributed to injection
drug use or sex with partners who inject drugs, compared with 31% of cases
among men. Racial and ethnic minority populations in the U.S. have
experienced a disproportionate burden of HIV/AIDS cases, most profoundly from
IDU-associated AIDS. In 1998, IDUs accounted for 36% of all AIDS cases among
both African American and Hispanic adults and adolescents, compared with 22%
of all cases among White adults/adolescents.
Since the start of the epidemic, injection drug use has directly or
indirectly accounted for more than 36% of the AIDS cases in the U.S., and the
trend continues today. The Centers for Disease Control and Prevention (CDC)
reports that 15,024 (31%) of the 48,269 new cases of AIDS in the U.S. in 1998
were associated with injection drug use. IDUs also have one of the highest
HBV seroincidence rates compared to other risk groups, and at least 60% of
incident HCV cases are among IDUs. Acquisition of HBV and HCV can occur
rapidly following initiation of injection, with reported prevalence rates of
50% for HBV and 65% for HCV among persons injecting for less than one year.
Co-infections of HBV, HCV, and HIV often cluster in IDUs and are endemic
among experienced IDUs. IDUs are at very high risk for pneumonia, septic
pulmonary emboli, and TB. In 1998, for example, CDC estimated that 50% of
HIV-infected persons with TB had injection drug use as an HIV exposure.
Other infectious diseases pose major risks to IDUs, including Human T-
Lymphotropic Viruses (HTLV) and hepatitis D virus (HDV). Combined HBV and
HDV infection is associated with hepatitis outbreaks and high mortality among
IDUs. IDUs are at risk for other serious health complications, such as
rhabdomyolysis and delirium, as well as a variety of bacteremic infections,
including endocarditis, skin/soft tissue infection, mycotic aneurysm, septic
arthritis, septic thrombophlebitis, respiratory infections, and
osteomyelitis. Risks for these infections are particularly high among IDUs
exposed to infected blood from multiperson use of syringes and other
injecting equipment.
Noninjecting drug use, particularly the use of crack cocaine, is another
major transmission risk for HIV and other infectious diseases. Research has
shown that crack smokers may be three or more times more likely to be
infected with HIV than non-smokers. The context of risk, including crack use
and drug-for-sex exchanges or risky, unprotected sex with multiple partners,
is significantly associated with the rapid spread of HIV through drug and sex
networks. Age-discrepant relations also have implications for HIV
transmission, young women and adolescents who use crack and other drugs are
at high risk for HIV infection at an early age, especially when they use
drugs and have sex with older, HIV-infected partners.
Largely because of substantial gains in early diagnosis and therapeutic care,
there are now more people living with HIV in the U.S. than ever before.
Moreover, today’s HIV prevention programs have benefited considerably from
the empirical knowledge accrued over more than 15 years of NIDA-supported
research on preventing the spread of HIV and other infections among drug
users. While the number of new HIV infections in the U.S. has declined
significantly from the 150,000 a year in the late 1980s, there are still an
estimated 40,000 new infections every year. In addition, the CDC estimates
that, of the 900,000 people currently living with HIV in the U.S., up to a
third are unaware that they have the infection. Today, the profile of the
individual at risk in the U.S. is largely urban and involves multiple and
simultaneous risk-taking behaviors, including injecting and noninjecting drug
use (particularly use of crack cocaine), unprotected sex with multiple
partners, and exchange of sex for drugs or money.
The intertwined epidemics of drug abuse, HIV/AIDS, and other infectious
diseases have evolved over time. HBV and HCV have become more prevalent in
injecting and noninjecting drug-using populations, as have drug-resistant
strains of gonorrhea and TB. HCV is now considered an opportunistic
infection in HIV-positive persons, according to the U.S. Public Health
Service (1999). An estimated 80% of HIV-infected persons in the U.S. today
are co-infected with HCV. Although no vaccine is available for HIV or HCV,
epidemiological data on the HBV vaccine indicate that successful immunization
of injecting and noninjecting drug users is possible. Multidisciplinary,
biomedical, and behavioral research is critically needed today to address the
public health challenges of these intertwined, drug use-associated epidemics
in all ethnic and racial groups, adolescents and young adults, and persons of
all sexual orientations.
Areas of Interest
NIDA seeks multi-disciplinary, cross-cultural research studies on drug abuse
aspects of HIV/AIDS, other blood-borne and sexually transmitted infections,
and TB. Included are studies that inform our understanding of the causes and
consequences of differentials in HIV-associated risks, morbidity, and
mortality in men and women, adolescents and adults, and in majority and
minority populations. Researchers are encouraged to utilize and integrate
complementary methodological approaches in their study designs, including
epidemiology, ethnography, behavioral and prevention science, virology, and
clinical medicine.
This PA envisions a range of national and international research projects
within and across the priority areas for NIH research on HIV/AIDS
(http://www.nih.gov/od/oar/index.htm), including but not limited to the types
of studies and issues described below.
Natural History and Epidemiology
o Studies of the epidemiology and natural history of HIV and blood-borne
infections, STDs, and TB in injecting and noninjecting drug users and their
sexual partners, including studies of women, racial and ethnic minorities,
specific subpopulations (e.g., adolescents and young adults, runaways, street
youth, men who have sex with men and use drugs), and the risk, peer, and
social networks of drug users and their sexual partners. Studies are
encouraged to understand potential cofactors and mediators of these diseases,
their progression, and their outcomes in active drug users.
o Studies of new and improved approaches to access and recruit hard-to-
reach, active drug users to participate in biomedical and behavioral
interventions to reduce drug use-related risk behaviors, disease
transmission, comorbidity, and mortality. Researchers are encouraged to
develop new strategies to link community-based outreach to drug users with
referrals and access to services for HIV counseling and testing, diagnostic
screening for other diseases, drug treatment, and medical care.
o Research involving the development and evaluation of (a) new study
protocols, sampling and survey methods, and biostatistical techniques, and
(b) rapid diagnostic assays to measure and monitor drug abuse and sex-related
risk behaviors, seroincidence and seroprevalence rates for HIV, HBV, HCV,
other blood-borne and sexually transmitted infections, and TB, and disease
progression and outcomes.
Etiology and Pathogenesis
o Studies of viral and host mechanisms involved in the transmission,
establishment, and spread of HIV in IDUs, noninjecting drug users, and their
sexual partners, including research on the mechanisms by which viral
hepatitis, STDs, and other infections may influence HIV transmission in drug
users. Research is encouraged to identify the etiologic and interactive
biologic, behavioral, environmental, sociocultural, and gender-related
factors that determine the relative transmission efficiency of HIV and other
diseases in diverse populations of drug users and others at risk.
o Studies that define the role of drugs of abuse and related compounds
(including adulterants and contaminants of drugs of abuse) or drug abuse
treatment medications on susceptibility, onset, and progression of HIV
disease, latent HIV infection, pharmacotherapy-resistant HIV strains, AIDS-
associated opportunistic infections, TB, and other blood-borne and sexually
transmitted diseases in drug-abusing populations.
o Research on drug abuse-related risk factors associated with nutritional,
metabolic, endocrine, and gastrointestinal disorders and their underlying
pathophysiology in persons infected/co-infected with HIV, HIV/AIDS-associated
opportunistic infections, TB, viral hepatitis, and other blood-borne and
sexually transmitted infections.
o Basic and clinical research on the neuropathogenesis of HIV and the
relationship of nervous system infection to disease progression in drug
users, including studies of the relationship(s) of virologic, host,
pharmacologic, and environmental factors to HIV-associated central nervous
system dysfunction and AIDS dementia complex.
Therapeutics
o Clinical trials research which reflects the changing demographics of drug
abuse, HIV/AIDS, TB, viral hepatitis, and other blood-borne and sexually
transmitted infections, including studies that recruit and retain multi-
ethnic/racial populations of injecting and noninjecting drug users, their
sexual partners, and their children in the evaluation of potential therapies
for the treatment of drug abuse, HIV infection, serious HIV-associated
complications, and other diseases.
o Basic and applied research to advance therapeutic entities and strategies
to prevent and treat HIV, HIV/AIDS-related complications, and potential co-
infections in drug users and their sexual partners. Of interest are studies
of drug interactions among commonly used treatments for HIV and HIV-related
disease and other substances that may be used by HIV-infected drug users
(such as drug addiction treatment medications and over-the-counter drugs).
Investigators are encouraged to evaluate the acceptability and use of new
compounds (e.g., topical microbicides and other agents) to reduce and prevent
sexual transmission of HIV and other infectious diseases in high-risk,
sexually active, drug-using populations.
o Studies that select and investigate biologic markers, surrogates, and/or
other outcomes to evaluate the safety and clinical efficacy of new agents and
approaches in the treatment of HIV-associated opportunistic infections and
neurologic complications of HIV disease in injecting and noninjecting drug
users. In particular, clinical research is needed to develop and evaluate
interventions that facilitate better adherence to therapies among drug users
infected with HIV and other diseases in drug abuse treatment.
o Studies of adherence to multidrug regimens in HIV-infected injecting and
noninjecting drug users, including the development of improved methods to
assess adherence to therapeutic regimens in this diverse and changing
population. Better methods are also needed to compare and validate adherence
measures in the context of linked HIV care/drug abuse treatment services for
HIV-infected drug users, and to evaluate the impact of improved adherence on
the clinical effectiveness of HIV care/drug abuse treatment (and,
potentially, of therapeutic regimens for other infectious diseases, such as
HBV and HCV).
Vaccines
o Basic research to advance the design and development of candidate vaccines
and other biomedical interventions to prevent the spread of HIV in at-risk,
drug-using populations, including studies that, for example, monitor and
model effects on immune activation from drug abuse and STDs in HIV-infected
and seronegative injecting and noninjecting drug users and their sexual
partners.
o Basic virologic and immunologic research to model, develop, and evaluate
safe and effective HIV vaccine strategies and passive immune interventions to
interrupt HIV transmission from mother to infant, with special focus on high
risk, sexually active and/or pregnant women who use drugs or are the sexual
partners of IDUs.
o Epidemiologic and behavioral research to monitor changes in the risk
behaviors and HIV seroincidence rates of persons participating in vaccine
clinical trials and to improve methods for identifying and evaluating
emerging risk groups likely to participate in HIV vaccine efficacy trials.
Behavioral and biomedical intervention studies are needed to improve the
recruitment, adherence, and retention of high-risk populations in HIV vaccine
efficacy trials and to minimize potential adverse social, economic,
behavioral, and legal consequences of participation.
o Multidisciplinary research to improve the design and efficiency of HIV
vaccine efficacy studies involving high-risk drug-using populations,
including research to establish and strengthen linkages between HIV vaccine
preparedness and other prevention and treatment research activities (e.g.,
research on HIV outreach interventions that integrate counseling and testing
for HIV with screening and medical services for viral hepatitis and other
STDs, and with referrals and access to drug abuse treatment).
Behavioral and Social Sciences Research
o Research to design and test single components (and/or their combinations)
of prevention interventions for HIV and other diseases in sexually active,
drug-using populations, including evaluation studies to determine the
effectiveness, cost-effectiveness, and sustainability of interventions in
demographically and culturally diverse community contexts. This may include
developing interventions that have linkages to a variety of ancillary
services (e.g., rapid diagnostic assays, HIV counseling and testing, and
medical and drug treatment) or that are adapted to special populations, such
as drug injecting women, the sex partners of drug injectors, or men who use
drugs and have sex with men.
o Interdisciplinary research on the behavioral, cultural, and social
determinants of injection drug use and risky sex as they relate to the
transmission of HIV and other infections. Studies are needed to understand
the diverse and dynamic contexts of risk associated with the transmission of
blood-borne infections and STDs, including HIV. Such studies may address,
for example, relationships between peer influences, beliefs about gender
roles, the composition of social networks, and transitions from noninjecting
to injecting drug use or from unsafe drug use and unsafe sex.
o Intervention studies to improve outreach, recruitment, adherence, and
retention of HIV-infected drug users, especially hard-to-reach IDUs, in
clinical trials on HIV/AIDS and drug abuse prevention and treatment.
Research is encouraged on improving strategies to prevent and minimize
adverse social, psychological, and physical consequences of HIV/AIDS and drug
abuse addiction, including the stigmatization so often associated with these
diseases.
o Research that advances qualitative and quantitative methodologies in
behavioral and social science investigations of drug abuse, HIV/AIDS, and
other infectious diseases. This may include studies to: improve measurement
instruments for special populations (e.g., HIV-infected drug injecting women,
prisoners), refine techniques for measuring the social mixing patterns of
high-risk networks, develop outcome measures and indicators for evaluating
the social impact of HIV prevention interventions, and formulate new
strategies that facilitate multisite, intercultural, and international
research projects.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS -
UPDATED AUGUST 2, 2000
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 biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are provided 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 research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html),
a complete copy of the updated Guidelines is available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to 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) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age 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 was published in the NIH Guide for
Grants and Contract, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning these policies.
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 the recommendations before submitting an
application that will administer compounds to human subjects. The guidelines
are available on the NIDA Home Page at http://www.nida.nih.gov/
or may be obtained by calling 301-443-2755.
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, clinics, 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 services. Persons at risk for HIV infection
include IDUs, crack cocaine users, and sexually active drug users and their
sexual partners.
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. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
APPLICATION PROCEDURES
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated
in the application kit. Application kits are available at most institutional
offices of sponsored research and may be obtained from the Division of
Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov.
Applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version of the preceding grant application types requesting $500,000 or more
in direct costs for any year are advised that he or she must contact the
Institute or Center (IC) program staff before submitting the application,
i.e., as plans for the study are being developed. Furthermore, the
application must obtain agreement from the IC staff that the IC will accept
the application for consideration for award. Finally, the applicant must
identify, in a cover letter sent with the application, the staff member and
IC that agreed to accept assignment of the application. This policy requires
an applicant to obtain agreement for acceptance from both for any such
application and any such subsequent amendment. Refer to the NIH Guide for
Grants and Contracts, March 20, 1998 at
http://grants.nih.gov/grants/guide/notice-files/not98-030.html.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS
The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets. Only
limited budgetary information is required under this approach. The just-in-
time concept allows applicants to submit certain information only when there
is a possibility for an award. It is anticipated that these changes will
reduce the administrative burden for the applicants, reviewers, and NIH
staff. The research grant application form PHS 398 (revised 4/98) is to be
used in applying for these grants, with the modifications noted below.
BUDGET INSTRUCTIONS
Modular Grant applications will request direct costs in $25,000 modules, up
to a total direct cost request of $250,000 per year. (Applications that
request more than $250,000 direct costs in any year must follow the
traditional PHS 398 application instructions.) The total direct costs must
be requested in accordance with the program guidelines and the modifications
made to the standard PHS 398 application instructions described below:
PHS 398
o FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs
(in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular
Total Direct plus Facilities and Administrative (F&A) costs] for the initial
budget period. Items 8a and 8b should be completed indicating the Direct and
Total Costs for the entire proposed period of support.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398. It is not required and will not be accepted with the
application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required
and will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for
sample pages.) At the top of the page, enter the total direct costs
requested for each year. This is not a Form Page.
Under Personnel, list all project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should
be provided. However, the applicant should use the NIH appropriation
language salary cap and the NIH policy for graduate student compensation in
developing the budget request.
For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the
nearest $1,000. List the individuals/organizations with whom consortium or
contractual arrangements have been made, the percent effort of all personnel,
and their role on the project. Indicate whether the collaborating
institution is foreign or domestic. The total cost for a
consortium/contractual arrangement is included in the overall requested
modular direct cost amount. Include the Letter of Intent to establish a
consortium.
Provide an additional narrative budget justification for any variation in the
number of modules requested.
o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual"s qualifications for a
specific role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for
all key personnel, following the instructions below. No more than three
pages may be used for each person. A sample biographical sketch may be
viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm.
- Complete the educational block at the top of the form page,
- List position(s) and any honors,
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years,
and
- List selected peer-reviewed publications with full citations.
o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the
type of agreement and the date. All appropriate exclusions must be applied
in the calculation of the F&A costs for the initial budget period and all
future budget years.
The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.
The title and number of the program announcement must be typed on line 2 of
the face page of the application form and the YES box must be marked.
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)
REVIEW CONSIDERATIONS
Applications will be assigned on the basis of established PHS referral
guidelines. An appropriate scientific review group, convened in accordance
with the standard NIH peer review procedures, will evaluate applications for
scientific and technical merit. As part of the initial merit review, all
applications will receive a written critique and undergo a process in which
only those applications deemed to have the highest scientific merit,
generally the top half of applications under review, will be discussed,
assigned a priority score, and 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. Each
of these criteria will be addressed and considered in assigning the overall
score, weighting them as appropriate for each application. Note that 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: 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?
(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?
In addition to the above criteria, in accordance with NIH policy, all
applications also will be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects also will be
evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research.
o The adequacy of the proposed protection for humans, animals, or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
AWARD CRITERIA
Applications will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:
quality of the proposed project as determined by peer review, availability of
funds, and program priorities.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Elizabeth Lambert, M.Sc. or
Helen Cesari, M.Sc.
Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5198, MSC 9593
Bethesda, MD 20892-9593
Telephone: (301) 402-1933 or 402-1918
FAX: 301-443-4100
Email: HC30X@nih.gov or EL46i@nih.gov
Direct inquiries regarding fiscal matters to:
Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX : (301) 594-6847
E-mail: gf6s@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.279. Awards are made under authorization of sections 301 and 405 of the
Public Health Service Act as amended (42 USC 241 and 284) and administered
under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts
74 and 92. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Department of Health and Human Services (HHS)
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