INNOVATION GRANT PROGRAM: APPROACHES IN HIV VACCINE RESEARCH - UPDATE

Release Date:  April 13, 1999

PA NUMBER:  PA-98-075

P.T.

National Institute of Allergy and Infectious Diseases

THIS PROGRAM ANNOUNCEMENT (PA) REPLACES PA-98-075 PUBLISHED IN THE NIH GUIDE ON
MAY 21, 1998.  THE SOLE PURPOSES OF THIS UPDATE ARE TO (1) CLARIFY INSTRUCTIONS
AND (2) INCORPORATE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.

THIS PA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT
MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PROGRAM
ANNOUNCEMENT.

PURPOSE

This program announcement (PA) is a continuation of the Innovation Grant Program
for Approaches in HIV Vaccine Research, implemented by the National Institute of
Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), on
the recommendation of the AIDS Vaccine Research Committee (AVRC).  This program
aims to encourage the entrance of novel and innovative vaccine discovery and
development concepts into the research pipeline.  As such, the emphasis of this
program is on supporting prophylactic vaccine research projects that are
particularly innovative, novel, may be high risk/high impact, and that exhibit
the potential to advance AIDS prophylactic vaccine design or evaluation.
Applications are especially welcome from young investigators and those not
currently active in the field of AIDS research.  The Innovation Grant Program
utilizes a grant mechanism that provides funds to projects of an exploratory
nature to generate preliminary data for further studies.

Applications targeting any scientific area(s) related to AIDS prophylactic
vaccine research are encouraged, and applications are to be submitted according
to the Center for Scientific Review (CSR) AIDS-related receipt dates.  Before
each application receipt date, scientific areas of particular importance will be
posted on the NIAID website
http://www.niaid.nih.gov/daids/vaccine/innovation.htm.

These areas will be chosen based on advice received from the AIDS Vaccine
Research Committee (AVRC) as a result of its meetings and workshops.  Applicants
are encouraged to visit the website before submitting an application. 
Applications for research aimed at these targeted areas are especially
encouraged, but as explained above, will not be required to focus on those areas.

NIH SUPPORT OF RESEARCH ON THIS TOPIC

Although this Program Announcement is being issued by NIAID, other components of
NIH mentioned below also have an interest in, and support research on, the topics
covered.  Applicants may wish to contact each of the NIH components
listed in INQUIRIES to find out about other funding opportunities.

The National Institute for Dental Research (NIDR) has no set-aside funds for this
PA but will consider supporting highly meritorious applications meeting the
mission of the Institute.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This PA, Innovation Grant Program for
Approaches in HIV Vaccine Research is related to the priority areas of HIV
infection, immunization and infectious diseases.  Potential applicants may obtain
a copy of "Healthy People 2000" at http://www.crisny.org/health/us/health7.html

ELIGIBILITY

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

Research projects will be supported with the Exploratory/Developmental Research
Grant mechanism (R21).  This mechanism provides short-duration support for
preliminary studies of a highly speculative nature, which are expected to yield,
within this time frame, sufficient information upon which to base a well-planned
and rigorous series of further investigations.

However, specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.  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. 
Complete and detailed instructions and information on Modular Grants can be found
at http://www.nih.gov/grants/funding/modular/modular.htm.

Applications will request direct costs in $25,000 modules, up to a total direct
cost of $150,000 per year.  Support under the R21 grant is limited to two years
with no extensions or supplements.

A typical modular grant application requests the same number of modules in each
year.

Application budgets are simplified.  Detailed categorical budget information is
not to be submitted with the application; budget form pages of the application
kits will not be used.  Instead, total direct costs requested for each year will
be presented.  Information, in narrative form, will be provided only for
Personnel and, when applicable, for Consortium/Contractual Costs.  See section
on application instructions below.

Additional narrative budget justification is required in the application only if
there is a variation in the number of modules requested annually.

There will be no routine escalation for future years.  In determining the total
for each budget year, applicants should first consider the direct cost of the
entire project period.  Well-justified modular increments or decrements in the
total direct costs for any year of the project that reflect substantial changes
in expected future activities may be requested.  For example, purchase of major
equipment in the first year may justify a higher overall budget in the first, but
not in succeeding years.

Other Support pages of the PHS 398 are not to be submitted with the application. 
Information on research projects ongoing or completed during the last three years
by the principal investigator and key personnel must be provided as part of the
"Biographical Sketch."  This information will include the specific aims, overall
goals and responsibilities, and should include Federal and non-Federal support. 
This information will be used by reviewers in the assessment of each individual's
qualifications for a specific role in the proposed project.

Following peer review, NIH may request information about Other Research Support
from the applicant for applications being considered for award.

Additional budget information will be requested only under special circumstances.

Applicants may request up to two years of support and up to $150,000 per annum
in direct costs, although with compelling justification exceptions can be made
if specific costly reagents, animals, specimens or laboratory modifications are
needed to perform these studies.  Program staff may be able to advise prospective
applicants concerning NIAID-sponsored resources that may be available to them. 
Contact the program staff listed under INQUIRIES for further information.  This
award is non-renewable.

However, the hope is that successful grantees funded through this exploratory
phase program will elect to seek continuing support for research further along
the development pipeline through the R01 or P01 grant mechanisms.

Responsibility for the planning, direction, and execution of the proposed
research will be solely that of the applicant.

RESEARCH OBJECTIVES

Regularly, the AIDS Vaccine Research Committee identifies AIDS vaccine research
topics areas ripe for scientific advancement.  Applications targeting any area(s)
of scientific investigation in AIDS vaccine research are welcome; however, NIAID
especially encourages applications targeting the research areas identified by the
AIDS Vaccine Research Committee.  These scientific areas of particular importance
are posted on the NIAID website
http://www.niaid.nih.gov/daids/vaccine/innovation.htm.

As stated above, all pertinent areas of investigation that will contribute toward
development of an efficacious HIV/AIDS vaccine are welcome.  These might include
but are not limited to: methods to enhance antigen presentation/processing;
structural studies of HIV proteins as related to their antigenicity; nucleic acid
vaccination; non-HIV live virus vaccine vectors; pseudovirion approaches;
analysis of correlates of immunity; and, development of better assays to study
antibody neutralization, CTL or other immune responses.

To help meet the research objectives defined by NIAID and the AIDS Vaccine
Research Committee, research applications intended to produce preliminary data
or precedent for an idea or a concept are particularly encouraged.

For each receipt date, applicants may submit as many applications on as many
topics as they wish, provided separate applications do not propose identical
research.  In addition, applicants should strive to focus each application to a
single research topic.

SPECIAL REQUIREMENTS

Awardees will be expected to attend a meeting convened by NIAID to showcase the
progress of the work funded under this program.  Details of this meeting will be
provided post-award.  Thus, applicants should include in their budget request
funds for the PI to attend one two-day meeting in the Washington, DC area.

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
subpopulations 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 of 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
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research," published in the NIH Guide for Grants and Contracts, Vol. 23, No. 11,
March 18, 1994.

Investigators may obtain copies from these sources or from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.

NIH POLICY AND GUIDELINES ON THE 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 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 Contracts, March 6, 1998, and which is available at the following URL
address:  http://www.nih.gov/grants/guide/notice-files/not98-024.html

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: grantsinfo@nih.gov; and on the internet at
http://www.nih.gov/grants/funding/phs398/phs398.html.

For purposes of identification and processing the application, mark "YES" in item
2 on the face page and enter the PA number PA-98-075 and the title "Innovation
Grant Program: Approaches in HIV Vaccine Research".

The research plan will be strictly limited to 10 pages total.  Applications that
exceed the page limit will be returned without review.  An appendix may be
included in the application; however, the appendix is not to be used to
circumvent the page limit of the research plan.  Explicit instructions concerning
what may be included in an appendix can be found in Section 1B "General
Instructions" for the PHS 398 Grant Application.  Late or incomplete applications
will not be accepted and will be returned.

BUDGET 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 $150,000) 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 - Use a Modular Grant Budget Narrative page.
(See http://www.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.

o Under Personnel, List key project personnel, including their names, percent of
effort, and roles on the project.  No individual salary information should be
provided.
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 key 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.

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://www.nih.gov/grants/funding/modular/modular.htm
- Complete the educational block at the top of the form page;
- List current position(s) and then previous positions;
- List selected peer-reviewed publications, with full citations;
- Provide information, including overall goals and responsibilities, on research
projects ongoing or completed during the last three years.

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. It is important to identify all exclusions that were used 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. 

APPLICATIONS NOT CONFORMING TO THESE GUIDELINES WILL BE CONSIDERED UNRESPONSIVE
TO THIS PA AND WILL BE RETURNED WITHOUT FURTHER REVIEW.

Submit a signed, typewritten original of the application 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)

The Center for Scientific Review (CSR) will not accept any application in
response to this PA 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

Applications will be assigned on the basis of established PHS referral
guidelines.  Applications will be evaluated for scientific and technical merit
by an appropriate scientific review group convened in accordance with the
standard NIH peer review procedures.  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 Procedures

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.

Review Criteria

(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?

The initial review group will also examine: the appropriateness of proposed
project budget; the adequacy of plans to include both genders, children,
minorities and their subgroups as appropriate for the scientific goals of the
research, and plans for the recruitment and retention of subjects; the provisions
for the protection of human and animal subjects; and the safety of the research
environment.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding decisions:  the
scientific and technical merit of the proposed project as determined by peer
review, and the availability of funds.  In the final selection of applications
to be funded, consideration will be given to achieving balanced coverage of all
AIDS vaccine areas of investigation.

INQUIRIES

Inquiries are strongly encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.

The Division of AIDS now has a website:
http://www.niaid.nih.gov/daids/vaccine/default.htm for AIDS vaccine research with
an emphasis on facilitating participation in applying for AIDS vaccine research
funds and accessing other resources available to AIDS vaccine investigators
through the Division.  The website has information describing the various
programs targeting AIDS vaccine research and listings of currently active AIDS
vaccine-related program announcements and contracts and their associated
deadlines.  Updates concerning the continuing Innovation Grant Program will also
be posted there.

Applicants new to the field of AIDS research are encouraged to explore the NIH
AIDS Research and Reference Reagent Program and availability of human specimens
at http://www.niaid.nih.gov/reposit/default.htm.  These programs make available
small quantities of viruses, antibodies, HIV proteins, plasmids, and other
reagents to researchers.

Direct inquiries regarding programmatic issues to:

Dr. Steve Bende
Division of AIDS
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 2A29, MSC 7620
Bethesda, MD  20892-7620
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 435-3756
FAX:  (301) 402-3684
Email:  sb22k@nih.gov

Direct inquiries regarding fiscal matters to:

Ms Jane Unsworth
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 4B25, MSC 7610
Bethesda, MD 20892-7610
Telephone:  (301) 402-6824
FAX:  (301) 480-3780
Email:  ju3a@nih.gov

Direct inquiries about the related research interests of NIDR to:

Eleni Kousvelari, D.D.S., D.Sc.
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN 18A
Bethesda, MD  20892-6402
Telephone:  (301) 594-2427
Email:  kousvelari@de45.nidr.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.855 and 93.856.  Awards are made under authorization of the Public Health
Service Act, Sec. 301(c), Public Law 78-410, as amended.  Awards will be
administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and
45 CFR Part 74.  This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems 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.

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