and Human Services (HHS)
EXPIRED
HIV VACCINE RESEARCH AND DESIGN PROGRAM
RELEASE DATE: April 3, 2003
PA NUMBER: PAR-03-094 (See amendment, NOT-AI-05-033)
(see addenda NOT-AI-04-004, NOT-AI-03-038)
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. Replacement P01 (PAR-06-285) funding
opportunity announcement has been issued for the
submission date of June 1, 2006 and submission dates thereafter.
EXPIRATION DATE: November 15, 2005, unless reissued.
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov)
CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research
APPLICATION RECEIPT DATE: November 13, 2003, November 15, 2004, November 14,
2005
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
The National Institute of Allergy and Infectious Diseases (NIAID) of the
National Institutes of Health (NIH) invites applications for research aimed
at obtaining a safe and efficacious vaccine against HIV or AIDS. NIAID
supports the progressive stages of AIDS vaccine research and development from
basic research through iterative product development, and clinical trials.
NIAID supports AIDS prophylactic vaccine research and development via three
solicited grant programs. The Innovation Grant Program for AIDS Vaccine
Research supports high risk/high impact early stage concept evaluation for
projects with limited preliminary data. The HIV Vaccine Research and Design
(HIVRAD) Program supports a multi-project HIV vaccine design and development
research application. The Integrated Preclinical/Clinical AIDS Vaccine
Development (IPCAVD) Program, also a multi-project Program, supports
iterative product development and later stage vaccine optimization and must
include limited human studies.
NIH Support of Research on this Topic
Applications submitted in response to Program Announcements are assigned
according to established PHS referral guidelines. When the subject of an
application is of interest to more than one component of NIH, dual
assignments are made.
RESEARCH OBJECTIVES
Background
Vaccine research requires contributions from multiple fields including
immunology, virology, molecular biology, viral disease pathogenesis, and
animal modeling. The HIVRAD program supports multidisciplinary AIDS vaccine-
related studies. As summarized in PURPOSE above, HIVRAD is designed to
accept projects too advanced for the exploratory Innovation Grant Program,
but not yet sufficiently advanced for the product/clinically-oriented IPCAVD
program.
Research Objectives and Scope
The overall objective of the HIVRAD program and this program announcement is
to advance vaccine concepts further towards the development of an AIDS
vaccine. To that end, applicants may target any area of AIDS vaccine
research. These areas include, but are not limited to: development of viral
and bacterial vector systems, development of improved animal model systems to
address vaccine efficacy, and studies of immune responses from existing
vaccine cohort samples. Other areas may include studies of HIV immunogen
structure as it relates to improving immunogenicity, or approaches to
increase the immunogenicity of HIV antigens. Extensive modeling of vaccine
concepts in non-human primates may also be included. The safety evaluation of
immunogens in infected animals may be included if these studies directly
support the development of a prophylactic vaccine. Applicants are required
to delineate in their application discrete goals with measurable milestones
and include criteria that can be used in deciding when to proceed to the next
phase of vaccine development. Clinical studies involving humans and/or
vaccine research focused solely on therapeutic applications would not be
considered appropriate for this PA. For information on programs that support
therapeutic vaccine development, please contact program staff.
MECHANISM OF SUPPORT
This PA will use the NIH program project grant (P01) award mechanism. As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project. Program project grants support broadly
based, multidisciplinary research programs that have a well-defined, central
research focus or objective. An important feature is that the
interrelationships of the individual scientifically meritorious projects will
result in a greater contribution to the overall program goals than if each
project were pursued individually. The program project grant consists of a
minimum of three interrelated individual research projects that contribute to
the program objective. This type of award also can provide support for
certain common resources termed cores. Such resources should be utilized by
two or more projects within the award. An exception to standard policy has
been granted for this program announcement such that fundable applications
may have at least two (2) projects and one (1) core. The total project
period for P01 grants may not exceed five years. At this time, the NIAID is
administratively limiting the duration of P01 grants to four years; this
administrative limitation may change in the future. In addition, P01 grant
applications submitted in response to this PA may not request in excess of
$750,000 first-year total (direct and FFacilities and Administrative (F&A)
costs.
Applicants for P01 grants must follow special application guidelines in the
NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT
AWARDS; this brochure is available via the WWW at:
http://www.niaid.nih.gov/ncn/grants/multibron.htm.
ELIGIBLE INSTITUTIONS
The applicant may submit (an) application(s) if the institution has any of
the following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
Milestones
Based on comments from the peer reviewers, the Program Officer may wish to
revise the milestones included in the application through negotiation with
the applicant. The finalized milestones will be included in the Terms of
Award. The achievement of the milestones will be the focus of discussion at
the annual site visit review (as described below).
Annual Meetings
All awardees are required to host, for the Program Officer and NIAID Program
Staff, an annual site visit. The PI and all co-PIs shall attend this
meeting. An update and summary of results generated from each project shall
be presented by the PI, co-PI and/or all pertinent staff. These
presentations shall include summaries of all goals or milestones achieved
during the review period and a description of all problems encountered that
may have an impact on the achievement of future goals and/or milestones.
Patent Coverage
Since applications may involve several institutions, including the private
sector, complex patent issues may arise. To avoid delays in the
implementation of new vaccines for HIV-related intellectual property issues,
each multi-project group is required to provide a plan as part of the
application that details: (1) the approach for obtaining patent coverage and
licensing, where appropriate, (2) a statement demonstrating acceptance of the
approach signed by all parties, and (3) the procedures to be followed for the
resolution of legal problems that may potentially develop.
When clinical studies or trials are a component of the research proposed,
NIAID policy requires that studies be monitored commensurate with the degree
of potential risk to study subjects and the complexity of the study. AN
UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is
available at: http://grants.nih.gov/grants/guide/notice-files/
NOT-AI-02-032.html. The full policy, including terms and conditions of
award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a letter of intent identifying the NIAID staff member who has agreed
to accept assignment of the application.
Specifically, applicants requesting more than $500,000 must carry out the
following steps:
1) Contact the NIAID program staff person listed in this PA at least 6 weeks
before submitting the application, i.e., as applicant is developing plan for
the study.
2) Obtain agreement from the NIAID contact that the IC will accept the
application for review and potential consideration for award, and
3) Identify in the letter of intent, the NIAID staff member contacted, a
proposed first year budget with the number of Projects, PIs and Institution
for each project, specific aims for each project, and a projected budget for
the proposed funding period.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised
version of these grant application types. Additional information on this
policy is available in the NIH Guide for Grants and Contracts, October 19,
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct questions about scientific/research issues to:
Dr. Michael Pensiero
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room Number 4109, MSC-7628
6700-B Rockledge Drive
Bethesda, MD 20892-7628
Telephone: (301) 435-3749
FAX: (301) 402-3684
Email: [email protected]
o Direct questions about peer review issues to:
Dr. Dianne Tingley
Division of Extramural Affairs
National Institute of Allergy and Infectious Diseases
Room Number 2148A, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 496-2550
FAX: (301) 402-2638
Email: [email protected]
o Direct questions about financial or grants management matters to:
Victoria P. Connors
Division of Extramural Affairs
National Institute of Allergy and Infectious Diseases
Room Number 2121, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-6579
FAX: (301) 480-3780
Email: [email protected]
SUBMITTING AN APPLICATION
Applicants for P01 grants must follow special application guidelines in the
NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT
AWARDS; this brochure is available via the WWW at:
http://www.niaid.nih.gov/ncn/grants/multibron.htm. This brochure presents
specific instructions for sections of the PHS 398 (rev. 5/01) application
form that should be completed differently than usual. For all other
instructions for sections of the PHS follow the usual instructions in the PHS
398.
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: [email protected].
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted on or before the receipt dates noted at the
heading of this Program Announcement.
Applications that are not received as a single package on the receipt date or
that do not conform to the instructions contained in PHS 398 (rev. 5/01)
Application Kit (as modified in, and superseded by, the NIAID BROCHURE
ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS") will be
judged non-responsive and will be returned to the applicant.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and three signed photocopies in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional exact copies of the grant
application and all five sets of any appendix material must be sent:
Dr. Dianne Tingley
Chief, AIDS Preclinical Research Review Branch
Division of Extramural Affairs
National Institute of Allergy and Infectious Diseases
Room Number 2148A, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 496-2550
FAX: (301) 402-2638
Email: [email protected]
APPLICATION PROCESSING: The application must be received by the date listed
on the first page. The 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 a substantial revision of an
application already reviewed, but such application must include an
Introduction addressing the previous critique.
Concurrent submission of an R01 and a Component Project of a Multi-project
Application: Current NIH policy permits a component research project of a
multi-project grant application to be concurrently submitted as a traditional
individual research project (R01) application. If, following review, both the
multi-project application and the R01 application are found to be in the
fundable range, the investigator must relinquish the R01 and will not have
the option to withdraw from the multi-project grant. This is an NIH policy
intended to preserve the scientific integrity of a multi-project grant, which
may be seriously compromised if a strong component project(s) is removed from
the program. Investigators wishing to participate in a multi-project grant
must be aware of this policy before making a commitment to the Principal
Investigator and awarding institution.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the NIH
Center for Scientific Review and for responsiveness to the goals of this PA
by NIAID staff. Incomplete or non-responsive applications will be returned to
the applicant without further consideration. Applications that are complete
and responsive to this PA will be evaluated for scientific and technical
merit by an appropriate peer review group convened by the NIAID. As part of
the initial merit review, all applications will:
P01 applications that are complete and responsive to this PA will be
evaluated for scientific and technical merit by an appropriate peer review
group convened by the NIAID.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Allergy and
Infectious Diseases Council
REVIEW CRITERIA
The general review criteria for P01 grant applications are presented in the
NIAID brochure entitled "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT
AWARDS" at http://www.niaid.nih.gov/ncn/grants/multibron.htm.
ADDITIONAL REVIEW CRITERIA: In addition, the following review criteria items
will be considered in the determination of scientific merit and the priority
score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the sections on
Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL CONSIDERATIONS
DATA SHARING: The adequacy of the proposed plan to share data.
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
The NIAID gives special consideration for funding, including award of grants
beyond the established NIAID percentile and priority score paylines, to
scientifically meritorious applications in response to Program Announcements.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-02-001.html); a complete copy of the updated Guidelines are
available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. This policy announcement is in the NIH Guide for Grants and
Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the "Standards for Privacy of Individually Identifiable Health Information",
the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on "Am I a covered
entity?" Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS
This program is described in the Catalogue of Federal Domestic Assistance at
http://www.cfda.gov/ in the following citations: No. 93.855, Immunology,
Allergy, and Transplantation Research and No. 93.856, Microbiology and
Infectious Diseases Research. 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 NIH Grants Policy Statement is available at
http://grants.nih.gov/grants/policy/policy.htm. This document includes
general information about the grant application and review process;
information on the terms and conditions that apply to NIH Grants and
cooperative agreements; and a listing of pertinent offices and officials at
the NIH. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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