and Human Services (HHS)
EXPIRED
PLANNING GRANTS FOR HIV/AIDS PREVENTION AND TREATMENT INTERVENTION IN
MIDDLE-AGED AND OLDER POPULATIONS
Release Date: January 8, 2001
RFA: RFA-AG-01-004
National Institute on Aging
(http://www.nih.gov/nia/)
National Institute on Mental Health
(http://www.nimh.nih.gov/)
Letter of Intent Receipt Date: February 23, 2001
Application Receipt Date: March 26, 2001
THIS RFA 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 RFA.
PURPOSE
The National Institute on Aging (NIA) and National Institute of Mental
Health (NIMH) invites qualified researchers to submit applications for
planning grants (R21) to assist in the design, testing and preliminary
evaluation of prevention and treatment interventions for HIV/AIDS in the
middle-aged and older population. Effective strategies for AIDS
prevention and treatment through behavior change interventions for the
major populations at risk have been identified but not yet applied to
the fifty plus population.
This announcement solicits planning applications for one-time grants to
support pilot and feasibility research important for 1) the
implementation and evaluation of behavioral and primary social
prevention interventions targeted toward the identification and
reduction of risk factors or enhancement of protective factors
associated with HIV/AIDS among middle-aged and older people, and/or 2)
for the implementation and evaluation of effective secondary prevention
interventions that address the needs of HIV-infected middle-aged and
older people. The R21 mechanism supports exploratory and open trial
studies that will lead to the development of a phase 2 clinical trial
testing the efficacy of different intervention approaches for this
population. While this RFA is intended to encourage innovation and
high impact research upon which significant future research may be
built, and while no preliminary data are expected to be described in
the application, applications should make clear that the proposed
research and/or development is scientifically sound, that the
qualifications of the investigators are appropriate, and that resources
available are adequate (see review criteria).
Because of the lack of randomized controlled studies in this
population, there is a need for a planning phase to conduct preliminary
research on the application and adaptation of previously successful HIV
intervention strategies utilized in younger populations or those used
to prevent or minimize other diseases/conditions among older adults.
The planning grant application and review process is intended to
provide a mechanism for initial peer review of the rationale and basic
design of an intervention study which requires further development and
testing before a full fledged study is appropriate. This award
mechanism is appropriate for interventions whose rationale and basic
design are considered sufficiently meritorious, but where sufficient
information is lacking to move directly to more formal efficacy trials.
This planning grant is intended to provide support for the development
of a refined study design, organizational plan, detailed intervention
and assessment protocol, preliminary data collection and analysis,
manual of procedures, and budget. While the focus of this solicitation
is on the application and testing of intervention techniques to the
fifty plus population, additional information may also need to be
gathered to understand older people’s unique risks as well as settings
and situations that place this population at risk.
Applicants should be aware that the award of a Planning Grant does not
guarantee NIA or NIMH acceptance of the full-scale clinical trial for
peer review, nor subsequent funding of the trial following peer review.
However, it is expected that the applicant will develop a full-scale
clinical trial for submission to a public or private agency if the
Clinical Trial Planning Grant is funded.
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 Request for
Applications (RFA), PLANNING GRANTS FOR HIV/AIDS PREVENTION AND
TREATMENT INTERVENTIONS, 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 foreign and domestic 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
The mechanism of support will be the NIH Exploratory/Developmental
Grant (R21). The award cannot be renewed. Applicants should note that
the funding of a planning grant does not imply a commitment by the
sponsoring organizations to fund the proposed full-scale study, nor
even to accept a subsequent application for such a study.
Specific application instructions have been modified to reflect
"MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined
by NIH. Complete and detailed instructions and information on Modular
Grant applications can be found at:
http://grants.nih.gov/grants/funding/modular/modular.htm
FUNDS AVAILABLE
These planning grants will provide up to $150,000 in direct costs per
year (with a total cost cap of $250,000 per year) for up to two years.
The participating Institutes (NIA and NIMH) will contribute up to $1.6
million in FY 2001 to fund a total of 5 to 7 meritorious applications
that are relevant to the Institutes missions. Although the financial
plans of the Institutes 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 applications of outstanding
scientific and technical merit.
Direct costs will be awarded in modules of $25,000, less any overlap or
other necessary administrative adjustments. Facilities and
Administrative costs will be awarded at the negotiated rate.
RESEARCH OBJECTIVES
Background
HIV/AIDS prevention research has shown that interventions that target
risk behaviors, improve knowledge, develop and practice skills, and
support maintenance of behavior change can be effective in reducing the
behaviors associated with the spread of HIV(NIH Consensus Development
Conference Panel, Interventions to Prevent Risk behaviors. AIDS 2000,
14 (suppl 2): 85-96). Despite data showing that the proportion of
adults fifty and older with HIV/AIDS has remained steady at
approximately 10% since the beginning of the epidemic, interventions
for primary and secondary prevention have been targeted to younger
persons, generally neglecting older adults. There is some suggestion
that the HIV/AIDS caseload may be aging, due both to new treatments
that improve survival for those already infected and to the growth in
new cases among those over age 50. For example, the rate of new AIDS
cases is rising twice as fast in the older population compared with the
younger population, particularly among specific older populations at
risk, including men who have sex with men, substance users, and older
women. The majority of older persons do not identify themselves as at
risk, even those who engage in drug- or sex-related activities that
increase the likelihood of contracting HIV. Thus, it is not surprising
that, compared to younger adults, older people know less about HIV
infection and are often misinformed about HIV/AIDS risks, that symptoms
are often attributed to other causes, including aging, that physicians
often under-diagnose older people, and that there is a widening
survival gap for older people with HIV/AIDS relative to their younger
counterparts.
Research efforts are needed that apply and expand interventions with
science-based effectiveness to the reduction of risk behaviors among
middle-aged and older people and for improvement in the diagnosis and
treatment of older adults with HIV/AIDS. While the older population as
a whole may be at relatively low risk of contracting HIV, findings show
that practices engaged in by some groups of middle-aged and older
adults may place them at risk of infection. Due to delays attributable
to both patient and health care provider factors, older persons come to
medical attention at later stages and experience shorter post-diagnosis
survival times and may be at special risk because of age-related and
HIV-related immune changes. Moreover, the presence of co-morbidities
in older people may complicate adherence to and the effectiveness of
HIV/AIDS drug treatments and may have important consequences such as
the necessity for multiple therapies, increased disability, increased
burden on clinical care and service delivery systems and increased
associated costs.
An intensified research effort is needed to understand the
effectiveness of behavioral and social interventions aimed toward older
people. However, intervention efforts need to be informed and
targeted by current epidemiological information, both nationally and
locally, on incidence and prevalence of HIV at older ages. In order to
translate research to practice, intervention research needs to build on
existing basic knowledge of HIV, the unique aspects of aging with
HIV/AIDS, and settings and situations in which older people are at
risk. The merits of individual, social and community level
interventions for targeting specific behaviors and persons at risk need
to be considered. Other important intervention factors that may vary
in effectiveness for older populations include type of intervention
facilitator, setting in which the intervention is delivered, duration
of the intervention, intervention delivery methods, incentives and
compensation, as well as the specific content related to reducing risk
behaviors. Prevention programs must be initiated as early as
feasible, must consider developmental level of target population,
should be delivered at levels with maximum impact and must be based on
long-term strategic planning.
Specific Objectives
HIV/AIDS is a public health problem affecting Americans of all ages.
Research on preventing HIV/AIDS or its consequences in the middle and
later years is increasingly important. Aging populations need to be
integrated into ongoing prevention related studies, and researchers need
to focus studies on how age interacts with other behavioral, social, and
biological factors to affect the likelihood of middle-aged and older
people contracting HIV, transmitting it to others, and living with
HIV/AIDS. Drawing on knowledge from the behavioral sciences about HIV
transmission and its prevention in younger populations, the research
objectives in this RFA focus on preliminary research and background
documentation needed to design and implement intervention methods that
may increase knowledge and perceived risk, improve skills related to
risk reduction (such as needle-cleaning for injection drug users, or
negotiating condom use), identify risk settings and situations (life
transitions or crises), achieve earlier testing and diagnosis of
HIV/AIDS and enhance delivery of, and adherence to, treatment and
medical regimens among middle-aged and older adults. The planning grant
application should describe the conceptual basis for the proposed
intervention study, the basic design characteristics, and preliminary
information to be gathered in this initial feasibility phase.
Specifically the application should include information on:
o Study rationale and hypothesis. Address significance of research
area and the principal hypotheses to be tested.
o Preliminary studies. Outline of preliminary studies (including
analyses of existing data) to guide selection of, and/or refine,
intervention strategies targeted to middle aged and older populations.
o Study design. Outline the major design elements of preliminary
studies to be conducted during this planning phase. These might include
topics such as sample size, identification of any control groups, and
strategies for assuring recruitment and retention.
o Study population. Specify who will be included in preliminary
studies, including general eligibility and exclusionary criteria and the
sources of recruitment.
o Assessment and measurement. Outline covariate, mediating and outcome
measures to be employed or pilot tested in this phase, strategies for
assessment, and rationale for selection.
o Intervention strategy. Describe the conceptual basis for the
proposed intervention, outline the major intervention components and
implementation plans; and discuss strategies for assuring treatment
fidelity and adherence.
o Data analytical approaches. Outline methods for data management and
analysis with attention to strategies for assuring data quality.
o Future Directions. Outline how the proposed research in this
planning phase would lead to phase 2 efficacy studies which in turn
would lead to phase 3 multi-site controlled trials and phase 4
effectiveness/dissemination research.
In addition to characterizing proposed new intervention research,
information should be included on organizational and logistical aspects
of this planning process:
o Timeline. Outline timeline and tasks to be accomplished during each
year of the planning grant.
o Personnel. Identify participants in the planning process, their
roles in the development of the plan, and their experience in related
studies.
o Liaison /Collaborations. Describe other persons or other groups you
will be interacting within the planning phase.
o Manual of Operations. Identify the study elements to be planned or
refined if the planning grant is awarded. Outline factors to be
included in the draft Manual of Procedures that awardees are expected to
produce at the end of the planning grant award period in order to move
to the next stage of intervention research.
o Human subjects protection. Identify plans for establishing an
external data and safety monitoring board for any randomized controlled
studies to be initiated in the planning or future stages of this
research.
In addition to addressing generic research design and methodological
issues, the planning grant activities should indicate what information
will be examined in relationship to factors that are specific to the
design and implementation of effective prevention and treatment HIV/AIDS
interventions among middle-aged and older adults. The bullets
underneath the four major categories described below illustrate the type
of issues that might be included to indicate an understanding of the
complexities involved in designing, testing and evaluating HIV/AIDS
prevention and treatment interventions in this targeted population.
Population and social context characteristics: The application should
discuss population characteristics that may be unique to middle-aged and
older people, or people at risk of HIV as they age and that will affect
intervention responsiveness and outcomes. These include, for example:
o Population diversity. This includes factors such as chronological
age, gender, HIV serostatus and care status, and other biopsychosocial
factors such as frailty or level of cognitive function.
o Social and cultural factors. This includes factors that influence
behaviors related to risk of HIV as well as access to and delivery of
medical care such as socio-economic status, marital status, social
networks, living arrangements, and cultural attitudes and expectations.
o Contexts, settings, and situations. The context in which risk
behaviors occur may vary by age. For example, research shows that older
drug users are less likely than younger drug users to use illicit drugs
in shooting galleries .
o Life course events and experiences. HIV risk may change as a
function of life transitions and life course events, such as changing
work or family relationships, separation or divorce, and death of a
loved one or partner.
HIV/AIDS Knowledge, Skills, Attitudes and Behaviors. These factors
define persons at risk as well as serve as major intermediary
intervention outcomes. Factors to consider include:
o Knowledge, skills, and attitudes. Prevention interventions for
older people need to consider knowledge of HIV transmission and AIDS
among the targeted older population, as well as attitudes regarding
adoption of safer sex- and drug-related behaviors. For example, older
women may lack the skills or confidence to negotiate safe-sex practices
with their partners. In addition, prevention efforts should address the
issue of AIDS stigma.
o Risk behaviors. The type and frequency of risky activities or
behaviors may also vary by age, or be modified by factors related to
aging. For example, there is evidence that older men in retirement
communities have multiple female sex partners and do not perceive that
their sexual behavior places them at risk. Behavioral determinants and
correlates of risky behavior may also be important to consider.
o Adjustment to diagnosis and treatment. Other factors to consider
include the psychosocial needs of older HIV-infected individuals, with
particular attention to coping with the chronic and fatal nature of the
disease.
Intervention Characteristics: The application should address factors in
the actual design of optimal interventions. For example, in what way
will the proposed research be based on models of behavioral change and
target the risk reduction needs of the specific population, use the most
effective delivery techniques, and be linked to desired outcomes through
appropriate methodology and measurement. Of particular concern is the
degree to which effective interventions and intervention strategies work
for reducing HIV risk among middle-aged and older adults, or whether
modifications related to aging are warranted. The following factors
should be addressed in the application:
o Consideration of covariates. Several factors unique to an aging
population may act as covariates in intervention effectiveness. These
include factors such as: comorbidity (medical, mental, psychiatric),
functional status (social, cognitive, psychiatric), pharmacology
(polypharmacy, interactions, side effects), the type and extent of risky
behaviors (e.g., illegal drug use or unprotected sexual behaviors with
high risk partners), etc.
o Models of behavior change. Researchers should also consider the
multiplicity of factors that influence behavior change, and integrate
biological, cognitive, psychological, and social perspectives to explain
and predict the acquisition and maintenance of preventive HIV-related
behaviors among middle- aged and older people. Pathways of influence
specifying mediators linking interventions to hypothesized outcomes
should be delineated.
o Specificity of content. A plan for standardizing the treatment
fidelity of interventions should be developed with attention to
treatment adherence . Intervention intensity, duration and frequency
should be addressed.
o Delivery channels of the intervention: The effectiveness of the
intervention message may vary depending on how the intervention is
delivered to participants and the particular delivery channel specified.
It will be important to specify whether the intervention is delivered to
individuals, couples, small or large groups, to a community, or to the
general population.
o Community advisory boards. A strategy for obtaining appropriate
community input and participation should be outlined.
Measurement, Outcomes, and Evaluation: This area focuses on the need to
link our understanding of HIV-related behaviors and behavior change to
the appropriate measurement of relevant outcomes for middle-aged and
older adults. Topics to consider include factors such as:
o Attrition: The ability to evaluate intervention effectiveness is
affected by loss of intervention participants. Thus, strategies for
recruiting and retaining samples of middle-aged and older adults are
needed .
o Measurement selection: Researchers should identify methods for
obtaining accurate self-report of HIV-related behaviors and behavior
change, considering the sensitivity of the information for many older
persons, and the diversity of backgrounds, languages, and cultures.
Researchers at this stage may not have final assessment batteries and
can propose assessment for examining the reliability and validity of
assessments as part of the design.
o Outcomes: Factors affecting selection of study outcomes should be
identified. For example outcomes are likely to vary by targeted risk
behavior as well as the type of intervention (individual, social,
community), setting (general population, clinic sample, retirement
community, drug treatment facility), and the specific hypothesis being
evaluated. The use of biological outcomes may also be appropriate.
The spectrum of outcome measures might also include cost-effectiveness
factors, HIV-specific health outcomes and general health outcomes.
SPECIAL REQUIREMENTS
Awardees should budget for three trips a year for up to three
investigators to Bethesda, Maryland in order to come and discuss common
aspects of their protocol development with other awardees and share
solutions to common problems in conducting intervention research in
middle-aged and older populations. Additionally investigators will be
expected to participate in workgroups that will meet electronically and
by phone between meetings to discuss issues common to the different
intervention studies (e.g., recruitment and retention; developing
strategies for cross site assessments; treatment fidelity). This
planning phase should provide the necessary information to develop
detailed protocols and a Manual of Procedures for subsequent Phase 2
studies to be proposed by the investigative team. The resultant Manual
of Procedures is a key product of this planning phase and should be
submitted in the final report.
Applicants for planning grants for human intervention studies should
review the NIA document "Implementation of Policies for Human
Intervention Studies". This is available in the "Grants and Contracts"
section of the NIH Home Page
(http://www.nih.gov/nia/funding/policy/humint.htm). Persons without
access to the NIH Home Page may obtain copies of the policy from: Office
of Extramural Affairs, National Institute on Aging; Gateway Building,
Suite 2C218; Bethesda, MD 20892-9205. Phone (301) 496-9322).
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
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
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 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 are 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.
Investigators also may obtain copies of these policies from the program
staff listed under INQUIRIES. Program staff may also provide additional
relevant information concerning the policy.
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.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the
identities of other key personnel and participating institutions, and
the number and title of the RFA in response to which the application
may be submitted. 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 IC staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent to the program staff listed under
INQUIRIES by the letter of intent receipt date listed in the heading of
this RFA.
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants, with the modifications noted below.
These forms are available at most institutional offices of sponsored
research; 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:
[email protected]; and on the internet at:
http://grants.nih.gov/grants/funding/phs398/phs398.html.
The RFA label available in the PHS 398 (rev. 4/98) 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 sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been
modified to allow for this change. Please note that this sample label
is in pdf format.
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 Institute staff. The research grant
application form PHS 398 (rev. 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. 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 $150,000 which is the direct cost
cap of this RFA) 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.
o 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
current 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 the 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;
- 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.
o 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.
Submit a signed, typewritten original of the application and three
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)
At the time of submission, send two additional copies of the
application to:
Mary Nekola, Ph.D.
Chief, Scientific Review
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Room 2C212
Bethesda, MD 20892-9205
It is important to send these copies at the same time as the original
and three copies are sent to the Center for Scientific Review. These
copies are used to identify conflicts and to help ensure the
appropriate and timely review of the application.
Applications must be received by 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.
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. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude
the submission of substantial revisions of applications already
reviewed, but such applications must include an introduction addressing
the previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by CSR and
for responsiveness by the NIA and NIMH. Incomplete and/or
nonresponsive applications will be returned to the applicant without
further consideration.
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 NIA and NIMH in accordance with the review
criteria stated below. As part of the initial merit review, a process
may be used by the initial review group in which applications 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
the applications under review, will be discussed, assigned a priority
score, and receive a second level review by the National Advisory
Council on Aging and the National Advisory Council on Mental Health.
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
method? 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?:
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 will also
be evaluated.
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.
The personnel category will be reviewed for appropriate staffing based
on the requested percent effort. The direct costs budget request will
be reviewed for consistency with the proposed methods and specific
aims. Any budgetary adjustments recommended by the reviewers will be
in $25,000 modules. The duration of support will be reviewed to
determine if it is appropriate to ensure successful completion of the
requested scope of the project.
Several criteria specific to this RFA have been identified. These
include:
o Demonstrate an understanding of the special needs of the HIV/AIDS
and aging population and relevant research issues
o Show knowledge of intervention research principles and processes in
the proposed population
o Likelihood that planning grant will yield findings upon which to
build a subsequent clinical trial
Schedule:
Letter of Intent Receipt Date: February 23, 2001
Application Receipt Date: March 26, 2001
Date of Initial Review: June 2001
Review by Advisory Council: August 2001
Anticipated Award Date: September 2001
AWARD CRITERIA
The following will be considered in making funding decisions:
o Quality of the proposed project as determined by peer review
o Availability of funds
o Program priority and balance.
Inquiries concerning this RFA are encouraged. Additional information,
including sample budget narratives and biographical sketch, may be
found at this site:
http://grants.nih.gov/grants/funding/modular/modular.htm. The
opportunity to clarify any issues or questions from potential
applicants is welcome. Email queries are preferred.
Further information about Institute priorities and procedures can be
found on the Institute Home Pages: NIA (http://www.nih.gov/nia); NIMH
(http://www.nimh.nih.gov/).
Direct inquiries regarding programmatic issues related to HIV/AIDS
research focused on understanding the role of aging processes and aging
populations in HIV/AIDS intervention research to:
Marcia Ory, Ph.D., M.P.H.
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 533 MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
FAX: (301) 496-3136
Email: [email protected]
Direct inquiries regarding NIA fiscal matters to:
Carol Lander
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: [email protected]
Direct inquiries regarding programmatic inquiries focused on mental
health aspects of HIV intervention research to:
David M. Stoff, Ph.D.
HIV/AIDS and Mentally Ill Research Program
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6210, MSC 9619
Bethesda, MD 20892-0619
Telephone: (301) 443-4625
FAX: (301) 443-9719
Email: [email protected]
Direct inquiries regarding NIMH fiscal matters to:
Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email: [email protected]
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance
No. 93.866 (NIA) and No. 93.242 (NIMH). 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 and contract 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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