COOPERATIVE AGREEMENT FOR EXPLORATORY/DEVELOPMENTAL GRANTS FOR MINORITY
INSTITUTIONS ALCOHOL RESEARCH PLANNING (U01)
RELEASE DATE: May 2, 2002
RFA: RFA-AA-02-013
National Institute on Alcohol Abuse and Alcoholism
(http://www.niaaa.nih.gov/)
LETTER OF INTENT RECEIPT DATE: July 1, 2002
APPLICATION RECEIPT DATE: July 30, 2002
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of This RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks
applications for cooperative agreement grants (U01 mechanisms) to support
research planning and research development at Minority Serving Institutions
(MSIs). The purpose of these grants is to promote alcohol research
expertise and infrastructure development at MSIs, and thereby ultimately to
identify, characterize, and reduce alcohol-related health disparities in
American ethnic and cultural populations and their subpopulations. Grant
planning activities should address health disparities in the following target
populations but are not limited to persons of African heritage,
Hispanic/Latino culture, American Indians/Alaskan Natives, Asian Americans,
and Native Hawaiian and Pacific Island populations.
An essential characteristic of the programs funded in response to this RFA is
that it will require long-term committed partnerships between the recipient
MSI and one or more established alcohol research investigators at research
intensive institution(s). The NIAAA encourages a multidisciplinary approach
to research, and it is expected that at least one project will address
questions related to alcohol-related health disparities. It is also
expected that these grants will develop and sustain preliminary research
studies that will lead to the submission of competitive grant applications
from MSIs.
The NIAAA is committed to increasing and strengthening efforts to address
health disparities related to a wide range of alcohol related problems
including alcohol and alcohol abuse and dependence (alcoholism). This RFA is
related to one or more of the priority areas found in the strategic plan.
Potential applicants may obtain a copy of "Strategic Plan to Address Health
Disparities" (February 8, 2001) at
http://www.niaaa.nih.gov/about/DisparitiesIntro-text.htm.
OBJECTIVES AND SCOPE OF THE PLANNING GRANT
Background:
Alcohol consumption is associated with a wide range of adverse health and
social consequences, both acute (e.g., traffic deaths, other injuries) and
chronic (e.g., alcohol dependence, liver damage, stroke, cancers of the mouth
and esophagus). The scope and variety of these problems are attributable to
differences in the amount, duration, and patterns of alcohol consumption;
differences in genetic vulnerability to particular alcohol-related
consequences; and differences in economic, social, and other environmental
factors. Ethnic and cultural disparities in alcohol-related problems vary
with the problem under consideration and are of pressing public health
concern. Alcohol-related death rates (for all categories of alcohol- related
mortality combined) are higher among Blacks than whites. Recent research
indicates that cirrhosis death rates are higher among white men and women of
Hispanic origin than among non-Hispanic black and white Americans. Alcohol-
related traffic deaths are many times more frequent (per 100,000 population)
among American Indians or Alaska Natives than among other minority
populations.
The incidence of fetal alcohol syndrome (FAS) appears to be several times
higher in some African American and American Indian communities than in the
general population. Research also reveals that although African American
teenagers typically drink less than their white or Hispanic counterparts,
their mortality from cirrhosis is substantially higher as they approach
middle age. Other adverse health consequences associated with alcohol
consumption such as cirrhosis, alcoholic liver disease, HIV/AIDS,
cardiomyopathy, pancreatitis, and alcohol-related sleep disorders are also
more prevalent in some minority populations. Finally, increases in risky
drinking behavior (i.e., drinking and driving) have been reported among
Hispanics. Since ethnic minority groups have differing genetic backgrounds,
it is possible that some of the disparities in disease incidence and
prevalence are due to differences in genetic predisposition. In addition,
genetic and biological factors may interact with behavioral, cultural and
environmental factors to manifest health disparities.
MSIs conduct high quality programs for educating students from minority
cultures for treating patients and providing outreach to minority
communities. They represent a rich source of talent with appropriate cultural
sensitivity and perspectives needed in alcohol research. However, few MSIs
have developed and sustained programs in alcohol research, and there is a
need to increase the number of minority scientists who are pursuing
successful biomedical and behavioral alcohol research careers. More
specifically, there remains a serious shortage of funded minority scientists
who conduct independent alcohol research, who focus research efforts on the
disproportionate incidence, mortality and morbidity rates in minority
populations and who bring the cultural perspectives that are essential to the
successful conduct of many forms of research involving minority patients and
populations.
Continued support of MSIs and minority scientists in alcohol research is
essential to developing a stronger national understanding of the disparities
of alcohol related incidence and mortality in minorities compared to majority
populations. The potential for identifying and training minority students and
faculty in areas of alcohol research have not been fully explored. One
piloted and potentially powerful approach for addressing these issues is to
create and sustain collaborations between scientists and faculty of MSIs and
established alcohol investigators in ways that integrate and take maximum
advantage of their respective expertise and experience into mutually
beneficial activities.
TOPICS AND AREAS FOR CONSIDERATION
Development in at least three of the following four broad areas is required
and must include activities linked to achieving NIAAA objectives through
focused planning and implementation of pilot studies. The four planning grant
areas include:
1) Alcohol Research Training and Career Development:
While the primary purpose of each planning grant is preparation for the
conduct of alcohol research, an important component related to planning for
research is the training of research and clinical personnel. The applicant
institution should demonstrate or give reasonable assurances that it has:
- the potential for collaborative career development programs jointly
organized and conducted by scientists and faculty of both MSI and the
established collaborating research program specifically designed for
training and mentoring minority scientists. Focus should be on training
minority scientists in clinical, behavioral, and population research that can
address health disparity issues among minority and under served populations.
Career development programs for minority scientists must represent true
collaborations that function across institutional boundaries of the MSI and
the collaborating alcohol research program; or
- the potential to develop programs designed to train predoctoral and/or
postdoctoral students for careers in alcohol research; or
- the capacity to establish and conduct programs of continuing education in
the medical, behavioral, epidemiological, or other health service fields
relevant to alcohol abuse and alcoholism.
While the applicant institution need not necessarily have formal training
programs of its own, there must be specific provision for coordination
between the MSI and the training programs of the collaborating institution
and/or other affiliated institutions. Planning grant funds may not be used
to pay stipends or other training related costs. However, grant resources
may be made available for payment for services rendered, such as research
assistance, teaching, or laboratory support. MSI staff should be actively
involved in the development of training programs.
2) Research
Collaborative alcohol research projects, including pilot studies, must build
and stabilize the collaborative alcohol research capabilities of minority
institutions to address the impact of alcohol on populations experiencing
negative alcohol-related consequences. Projects should enhance development of
collaboration of partner investigators, scientists, and clinicians in
minority serving institutions with established alcohol investigators. These
grants will support the planning, partnership development, and implementation
of mutually beneficial collaborations between applicant institutions and
collaborating research intensive institutions that support productive alcohol
research programs. Approaches to planning are encouraged to address
essential elements including: a focus on interdisciplinary alcohol and health
disparities research; institutional commitment; administrative capabilities
and facilities; and interdisciplinary coordination and collaboration. Single
or multi-site pilot or feasibility research projects that address health
disparities are appropriate.
Topics listed below are examples of some research areas that might be
considered for planning and piloting. They are not comprehensive,
restrictive nor in priority order.
- Studies of the patterns of alcohol consumption and alcohol related problems
within specific minority populations.
- Research to determine specific genetic or biological factors that may
increase risk for alcohol dependence or organ damage.
- Biomedical studies that examine the association between alcohol abuse or
dependence and enhanced progression of AIDS-defining opportunistic
infections.
- Research among high-risk minority populations that develops and tests
interventions to prevent maternal drinking, fetal alcohol syndrome and
alcohol related neurological disorders.
- Research to determine biological, genetic, and environmental risk factors
that lead to disproportionately high incidence of adverse pregnancy outcomes.
- Research to identify social and cultural factors that influence motivation
for alcohol treatment, adherence to treatment and treatment outcomes.
- Studies to identify and characterize those aspects of minority drinking
environments (problems, patterns, community norms, values, etc.) that are
likely to influence the outcomes of prevention and intervention studies.
- Research to evaluate the effectiveness of screening and brief interventions
in high risk minority health care, education or other settings.
3) Science Education
Education programs can include activities augmenting existing curriculum or
creating new curricula in the MSI and/or the collaborating alcohol research
program. NIAAA encourages the development of educational programs designed
to motivate minority students to pursue careers in research at earlier stages
of their educational experience (e.g., high school, undergraduate). A
successful planning effort in this area is expected to result in the
submission of a competitive R25 application. All educational programs and
activities must include plans for ongoing assessment and evaluation and
demonstrate processes for linking evaluation results to improving training
curriculum and related educational tools.
4) Outreach and Research Dissemination
The dissemination of alcohol research results to health care professionals,
and the minority community must include a comprehensive process for linking
information to the target audience and provide strategies for developing
ongoing outreach and research services. The MSI and collaborating alcohol
research program are required to develop an outreach strategic plan.
Dissemination and outreach activities must be based on accurate, current, and
culturally competent information and detail methods for translating alcohol
research knowledge to minority communities. NIAAA encourages the development
of coordinated outreach strategies with community and local groups. All
outreach and dissemination activities must include plans for ongoing
assessment and evaluation and demonstrate processes for linking evaluation
results to improving outreach and dissemination activities.
The expectation is that these U01 alcohol planning grants will become the
basis for generating competitive research grant applications including:
research project grant (R01); exploratory /development grant (R21);
educational project grant (R25); training grant applications (T32, F31, F32);
and career development grant applications (K awards) for submission to NIAAA.
MECHANISM OF SUPPORT
This RFA will use a Cooperative Agreement (U01) mechanism. The NIH U01 is a
cooperative agreement award mechanism in which the Principal Investigator
retains the primary responsibility and dominant role for planning, directing,
and executing the proposed project, with NIH staff being substantially
involved as a partner with the Principal Investigator, as described under the
section "Cooperative Agreement Terms and Conditions of Award". At present,
the plans for extending the cooperative agreement projects beyond the initial
award period are indefinite. Future plans will be based on evaluation of
scientific progress achieved by awardees during the initial funding period.
FUNDS AVAILABLE
The NIAAA anticipates making up to six three-year (U01) awards and plan to
set aside a total of $2.0 million for first year funding. The maximum total
annual direct cost budgets for these cooperative planning grants is $250,000
annually. Applications exceeding this limit will be considered unresponsive
to this RFA and will be returned without further consideration. Although the
financial plans of the NIAAA 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. At this time, it
is not known if this RFA will be reissued.
Applicants should request funds to attend an annual meeting on alcohol-
related health disparities research to be arranged by NIAAA.
Allowable costs for the three-year U01 alcohol research-planning grants
include:
- Administrative costs for managing the effort, such as salaries for key
personnel, travel for key personnel, equipment and supplies to support an
administrative structure.
- Developmental costs for: for workshops, seminars, retreats and other forms
of communication to explore potential opportunities in research, training and
career development or education. These costs must be for the purpose of
selecting the areas of greatest promise for implementation as specific types
of pilot projects or programs based on merit and potential to result in a
successful grant application.
- Costs related to implementing pilot research projects or pilot programs in
training and career development or education for the explicit purpose of
obtaining preliminary data for the submission of a specific grant
application(s).
ELIGIBLE INSTITUTIONS
Applications will only be accepted from Minority-Serving Institutions (MSIs)
[e.g., Historically Black Colleges and Universities (HBCUs), Hispanic-Serving
Institutions (HSIs) and Tribal Institutions (e.g., Colleges)], either in the
United States or in territories under U.S. jurisdiction, and from
institutions or organizations that can demonstrate organized, integrated
research efforts focused on alcohol.
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, hospitals and health
maintenance organizations
o Domestic
Racial/ethnic minority individuals, women, and persons with disabilities are
encouraged to apply as principal investigators. To be responsive to this RFA,
eligible institutions must have documented collaborative agreements with
established alcohol investigators. It is anticipated that in most instances
the collaborating scientists will be located at one or more research
intensive institutions.
The definitions below are intended to clarify concepts that are expressed in
this RFA.
- Minority Serving Institution (MSI) is an academic, health care or research
institution with an enrollment and/or faculty predominately of ethnic
minorities, or an institution that qualifies as a Historically Black
College/University (HBCU), a Hispanic-Serving Institutions (HSI), a Tribal
College or University (TCU), or a Hispanic-Serving Health Professional
Institution (HSHPI), comprise a significant proportion of the enrollment s
and that have a track record of commitment to the special encouragement of
minority faculty, students and investigators. Both MSIs with medical schools
and MSIs with more focused research and education programs (e.g., Masters and
Ph.D. programs) are invited to participate in this initiative. MSIs that
offer only baccalaureate degrees and Tribal Institutions (e.g., Colleges) are
encouraged to participate in this initiative as full collaborators,
especially in the development of educational programs aimed at motivating
students to enter careers in alcohol research. A partial list of eligible
MSIs can be found at the following website address:
http://www.sciencewise.com/. Other institutions that meet MSI
qualifications may not be listed at this website, but they are also eligible
to apply.
- The collaborating research intensive institution is the institution with
which the applicant institution has partnered. A "research intensive
institution" is an academic, health care or research institution which is
currently the recipient of substantial NIH research support.
An "established alcohol research investigator" is an individual who is
currently the recipient of independent research support from the NIAAA
through one or more of the following mechanisms: regular research grant (R01,
R37, U01 or U10) or a component director within an Alcohol Research Center.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
The principal investigators must be U.S. citizens, non-citizen alien
nationals, or permanent residents of the United States. The principal
investigator must have his/her primary appointment at the applicant MSI
institution.
SPECIAL REQUIREMENTS AND PROVISIONS
There are a number of Special Requirements and Provisions that are required
of each alcohol research planning grant application. Requirements bulleted
here are more fully explained under the heading "Supplemental Instructions"
in the SUBMITTING AN APPLICATION Section, below.
- Each planning grant application must be focused on three of the four of the
following targeted areas: a) alcohol research training and career
development; b) research; c) science education; and d) dissemination and
outreach.
- Appropriate letters of support.
- Demonstration of a collaborating partnership with an active alcohol
research program.
- Description of the collaborative process, methods and means of
communication.
- Pilot projects and pilot programs must not overlap in purpose or intent
with existing funded grants.
- Recipients to participate in an annual meeting.
- The Principal Investigator with consultation of the NIAAA Science
Collaborator will establish a unique Project Advisory Committee (PAC)
Cooperative Agreement Terms and Conditions of Award
The following Terms and Conditions will be incorporated into the new award
statements and will be provided to the principal investigators and to the
appropriate institutional officials at the time of award. The following
special terms of award are in addition to, and not in lieu of, otherwise
applicable OMB administrative guidelines, HHS grant administration
regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and
local Governments are eligible to apply), and other HHS, PHS, and NIH grant
administration policies.
The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIAAA programmatic involvement
with the awardees is anticipated during performance of the activities. Under
the cooperative agreement, the NIAAA supports and stimulates the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role. The NIAAA is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this
concept, the dominant role and prime responsibility resides with the awardees
for the project as a whole.
1. Principal Investigator Rights and Responsibilities
The PI Awardee has primary authorities and responsibilities to define
objectives and approaches, and to plan, conduct, analyze, and publish
results, interpretations, and conclusions of their research, career
development and other activities. The PI will:
- Create a Program Advisory Committee (PAC) in consultation with the NIAAA
Scientific Collaborator.
- Coordinate a regular schedule of PAC meetings for review and consultation.
- Implement the approved three year plan for the planning effort, with
periodic updates as needed.
- Coordinate project activities within their institution, with outside
collaborators, and with the NIAAA Scientific Collaborator.
- Maintain collaboration and partnership with an established NIAAA
investigator and collaborating alcohol research program.
- Accept assistance from the NIAAA Staff Scientific Collaborator in pursuing
project goals.
- Awardees will retain custody of and have primary rights to the data
developed under these awards, subject to Government rights of access
consistent with current HHS, PHS, and NIH policies.
2. NIAAA Staff Rights and Responsibilities
As per the terms of the cooperative agreement arrangement, the NIAAA will
appoint a Program Official and a Staff Scientific Collaborator to participate
in the conduct of each of U01 Planning Cooperative Program.
- The NIAAA Program Official provides normal program stewardship and reviews
the scientific progress of individual research project components, and the
use of the core resource facilities among the research projects within each
Cooperative Agreement. The Program Official also monitors compliance by the
Cooperative Agreement with the operating policies of this RFA. The NIAAA
Program Official may recommend withholding of support, suspension, or
termination of an award for lack of scientific progress or failure to adhere
to policies established by the RFA or the Award Statement.
- The NIAAA Scientific Collaborator will have substantial scientific-
programmatic involvement with the awardees through providing technical
assistance, advice and coordination above and beyond normal program
stewardship of research grants. The NIAAA Scientific Collaborator will: a)
facilitate the coordination necessary to manage this complex project; b)
participate as a non-voting member of the PAC; c) participate in monitoring
progress of ongoing studies; d) participate in planning and implementing
efforts to disseminate information; e) provide instruction in faculty
development activities; f) participate in data interpretation and, when
appropriate, in the preparation of publications and presentations. The NIAAA
Scientific Collaborator is subject to the same publication/authorship
policies governing all participants in the study, as well as to the official
NIH Publication Policy governing extramural employees.
3. Arbitration Process
Any disagreement that may arise on scientific or programmatic matters between
U01 awardees and the NIAAA may be brought to arbitration before an
arbitration panel. The arbitration panel will be composed of three members.
One member will be chosen by the awardee. A second member will be selected by
the NIAAA. The third member, having expertise in the relevant scientific
area, will be chosen by the two selected members. This special arbitration
procedure in no way affects the awardee's right to appeal an adverse action
that is otherwise appealable in accordance with the PHS regulations at 42 CFR
Part 50, Subpart D and HHS regulation at 45 CFR Part 16.
INQUIRIES
Written, telephone, fax and e-mail inquiries concerning this RFA are strongly
encouraged, especially during the planning phase of these applications.
Below is a listing of program (i.e., scientific management), grants
administration (i.e. fiscal management) and review (i.e., management of peer
review process) staff of the NIAAA who are available for inquiries:
Direct inquiries regarding programmatic issues to:
Ernestine Vanderveen, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 301
6000 Executive Boulevard MSC 7003
Bethesda, MD 20892-7003
(Rockville, Maryland 20852 for express/courier service)
Telephone: (301) 443-2531
FAX: (301) 480-2358
Email: tvander@willco.niaaa.nih.gov
Direct inquiries regarding fiscal matters to:
Judy Fox Simons
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 505
6000 executive Blvd. (MSC-7003)
Bethesda, MD 20892-7003
(Rockville, Maryland 20852 for express/courier service)
Telephone: (301) 443-2434
Email: jsimons@willco.niaaa.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 NIAAA 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:
RFA-AA02-013
Extramural Project Review Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 409-MSC 7003
Bethesda, MD 20892-7003
(Rockville, Maryland 20852 for express/courier service)
Telephone: (301) 443-4375
FAX: (301) 443-6077
SUBMITTING AN APPLICATION
The following procedures apply to submitted applications:
Applications are to be submitted using the Form PHS 398 (rev. 4/01) using the
SUPPLEMENTAL INSTRUCTIONS provided below. The PHS 398 is available at
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267;
FAX: (301) 480-0525; Email: grantsinfo@nih.gov.
NOTE: The RFA label available in the PHS 398 application form (or at
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf) must be affixed to
the bottom of the face page of the application and the RFA number AA02-013
written on the label. Failure to do so could result in delayed processing of
the application such that it may not reach the review committee in time for
the review. On Line 2 of the Face page the YES box must be checked and the
number and title of the RFA typed in.
Submit the complete signed application with the checklist, and three
photocopies without the checklist to:
Center for Scientific Review
Division of Research Grants
National Institutes of Health
6701 Rockledge Drive, Room 1040
MSC 7910
Bethesda, MD 20892-7710
(Bethesda, MD 20817 for express/courier service)
At the time of submission, two additional copies of the application must be
sent to:
RFA: AA-02-013
Extramural Project Review Branch
National Institute on alcohol Abuse and alcoholism
Willco Building, Room 409
6000 Executive Boulevard, MSC 7003
Bethesda, Maryland 20892-7003
(Rockville, Maryland 20852 for express/courier service)
Supplemental Instructions
This RFA requires Supplemental Instructions as follows:
- Each three-year alcohol research planning grant application must be focused
on three of the four of the following targeted areas: a) alcohol research
training and career development b) research c) science education and d)
dissemination and outreach. A three-year plan, jointly proposed by the MSI
and the collaborating alcohol research scientists, must be presented. The
plan must describe the activities and the process through which the MSI will
reach the goal of developing competitive projects and preliminary research
results in support of applications for further grant support. The plan, must
include a chronological table of collaboration development listing the
specific first year and second year objectives. For each objective, a brief
statement should be made about the separate contributions of the MSI and the
collaborating alcohol research scientist or program in order to achieve
success. The final objective must be the submission of a grant application
to NIAAA-.
- When the Principal Investigator from the MSI is not an independent
investigator, the application must include: 1) a letter of support from
senior members of the MSI (e.g., Department Chair, Dean, President,
Chancellor, or Center Director) to indicate full support for the activity. 2)
a letter of support from the prospective mentor(s) to assure appropriate
mentoring and maximum probability of success. The letter of support should
describe mentoring activities and support to ensure success of the
collaborative effort. The support must include release or protected time to
enable faculty to participate in and focus on achievement of the objectives
in application and institutional discretionary resources that will be made
available to the Principal Investigator. Evidence of significant
institutional commitment is required of applications that propose PIs with
minimal experience in alcohol research (e.g., a training program or an
education program that provides commitment from appropriate institutional
officials of the MSI (Dean or President) and the collaborating alcohol
research program institution.
- The collaborative activities must demonstrate a clear partnership between
the MSI and the collaborating alcohol research program. This must be done
through collaboration in preparing the planning grant application for
submission by the MSI. The application must describe how the MSI and the
collaborating alcohol research program will complement each other in
achieving clearly stated goals and common objectives. The collaborating
institution and scientist must provide evidence of commitment to the project
and expectations for interactions and performance by each partner should be
clearly presented.
- For interactions and progress in planning, the application must clearly
describe a collaborative process outlining: methods for appropriate means of
communicating and identifying areas of potential collaborations; areas of
focused collaboration and strategies selected for implementation; and pilot
projects/programs through which preliminary data is acquired to be as basis
for submitting a specific competitive grant application in one or two of the
target areas referenced or specified above to the NIAAA.
- The use of funds to support pilot projects and pilot programs must be for
totally new activities that do not overlap in purpose or intent with existing
funded grants (e.g., P30, P50, P01, R01, R03, R21, R25 Research Resources,
Research Infrastructure Grants, NRSA Grants, and other peer-reviewed funded
programs).
- Recipients of these cooperative planning awards and their collaborators
will be expected to participate in an annual meeting. Travel costs for this
purpose should be included in the grant application from the MSI.
- The Principal Investigator with consultation of the NIAAA Science
Collaborator will establish a unique Project Advisory Committee (PAC)of four
to six members. At least one PAC member should be from a relevant community
group and two members should be experienced alcohol researchers. The NIAAA
Scientific Collaborator will be an additional non-voting member of the PAC.
The PAC will meet at least annually to review activities and make
recommendations on all project functions. The role of the PAC is provide
advice to the Principal Investigator on scientific and related issues
pertinent to the operation of the CMIARD. Among its duties, the PAC will
assess interim progress of all projects within the CMIARD, and review
projects proposed for future implementation.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIAAA. Incomplete applications will be returned to the
applicant without further consideration. And, if the application is not
responsive to the RFA, CSR 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 the NIAAA in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
o Receive a written critique
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 second level review by the NIAAA National Advisory Council on
Alcohol Abuse and Alcoholism.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIAAA. Incomplete applications will be returned to the
applicant without further consideration. And, if the application is not
responsive to the RFA, CSR 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 the NIAAA in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
o Receive a written critique
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 second level review by the NIAAA National Advisory Council on
Alcohol Abuse and Alcoholism.
REVIEW CRITERIA
This initiative is quite broad in scope and includes alcohol research,
alcohol research training and career development and alcohol research
education objectives. Under these circumstances, the review criteria are not
organized under the traditional headings of Significance, Approach,
Environment, Investigator and Innovation typically used for NIH research
grants. Reviewers will have to use considerable flexibility in determining
the merit of a broad range of possibilities that can expand research,
training and career development
opportunities for minority scientists and students.
Applicants can apply for three years of support and should include
information on their experience, interactions and planning history,
consequently reviewers must evaluate the following:
1. Strength of the evidence that the researchers and faculty of the MSI and
the collaborating alcohol research program worked closely together in the
preparation of the application.
2. As applicable, the degree to which the letters of support from senior
faculty and/or institutional/center leaders address the need for mentoring of
inexperienced Principal Investigators or for specific institutional/center
commitments to ensure the success of the collaboration.
3. As applicable, the adequacy of provisions made for day-to-day oversight,
coordination, support and logistical services needed to make the
collaboration successful.
4. Planning Activities:
a. The adequacy of the different planning methods proposed by the MSI and
collaborating alcohol research program to fully explore areas of opportunity
and to ensure highly interactive and integrated efforts between individual
scientists (e.g., research project) and/or between faculty and scientists
(e.g., training program, education program).
b. The adequacy and duration of the initial planning stage needed to identify
areas of potential collaboration.
c. The quality and merit of the documented planning process used for
identifying areas ready for prioritization and/or for pilot testing.
d. The appropriateness and adequacy of the specific faculty and scientists
identified from the MSI and the collaborating alcohol research program to
contribute effectively to each aspect of this planning effort.
5. Pilot Projects/Programs
a. The qualifications of the Co-leaders to implement a pilot project/program.
b. The merit of the project/program and its feasibility to acquire the
necessary preliminary data to become competitive for specific grant support
(e.g., R03, R01, P01, P50, K12, T32, R25).
6. Applicants must choose three of the four planning grant areas. Review
criteria for each of the four areas follow the objectives described in the
Topics and Areas for Consideration section. In addition, reviewers should
take into account the planning grant level of these objectives. Briefly, the
criteria for each area include:
a. Alcohol Research Training and Career Development:
- The potential for collaborative career development programs jointly
organized and conducted by scientists and faculty of both MSI and the
established collaborating research program.
- The potential to develop programs designed to train predoctoral and/or
postdoctoral students for careers in alcohol research.
- The capacity to establish and conduct programs of continuing education in
the medical, behavioral, epidemiological, or other health service fields
relevant to alcohol abuse and alcoholism.
b. Research
- Feasibility of establishing collaborative alcohol research projects based
on the research capabilities of the MSI.
- Likelihood of the research to address health disparities related to the
impact of alcohol on minority populations.
- Expectation that pilot research projects will enhance the development of
collaborations between MSI investigators, scientists, and clinicians and
their counterparts among established alcohol investigators.
- Evaluation of opportunities to encourage additional desirable elements such
as interdisciplinary coordination; institutional commitment; and the
development of administrative capabilities and facilities.
c. Science Education
- Feasibility of education programs to augment existing curriculum or create
new curricula at the MSI.
- Feasibility of strategies to motivate minority students to pursue careers
in research.
- Likelihood that a successful planning effort in this area may result in the
submission of a competitive R25 application.
d. Outreach and Research Dissemination
- Feasibility of creating a plan for the dissemination of alcohol research
information to health care professionals and the minority community.
- Feasibility of a process for linking alcohol information to the target
audience and providing strategies for developing ongoing outreach and
research services.
- Feasibility of developing a strategic plan for dissemination and outreach
activities based on accurate, current, and culturally competent information
and effective methods for information transfer to minority communities.
- Possibilities for the development of coordinated outreach strategies with
community and local groups.
- Inclusion of plans to develop strategies for ongoing assessment and
evaluation of all outreach and disseminating activities.
7. Other Considerations:
The initial review group will also examine the appropriateness of the
proposed budgets and duration; the adequacy of plans to include both genders
and minorities and their subgroups as appropriate for scientific goals of the
research and plans for recruitment and retention of subjects; the adequacy of
plans for including children as appropriate for the scientific goals of the
research, or the justification for exclusion; the provisions for the
protection of human and animal subjects; and the safety of the research
environment.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: July 1, 2002
Application Receipt Date: July 30, 2002
Peer Review: August-September 2002
Review by NIAAA Council: September 2002
Earliest Anticipated Award Date: September 28, 2002
AWARD CRITERIA
Applications recommended by the NIAAA Advisory Board will be considered for
award based upon (a) scientific and technical merit as determined by peer
reviewers; (b) the program priorities of the NIAAA, and (c) availability of
funds.
REQUIRED FEDERAL CITATIONS
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 is provided indicating that inclusion
is inappropriate with respect to the health of the subjects or the purpose of
the research. This policy is based on 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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-
048.html); a complete copy of the updated Guidelines is available at
https://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 of 21)
must be included in all human subjects research, conducted and supported by
the NIH, unless there are clear and compelling scientific and ethical reasons
not to include them. This policy applies to all initial (Type I) 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 Contracts, March 6, 1998, and is available at the following URL
address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html.
REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
All investigators proposing research involving human subjects should read the
policy that was published in the NIH Guide for Grants and Contracts, June 5,
2000 (Revised August 25, 2000), available at the following URL address
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
Cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA 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.
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.
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 the
priority area of Alcohol Research. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople/ and the NIAAA
"Forecast for the Future: Strategic Plan to Address Health Disparities" at
http://www.niaaa.nih.gov/
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.398, Alcohol Research Manpower 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 Parts 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.