and Human Services (HHS)
EXPIRED
NOVEL HIV THERAPIES: INTEGRATED PRECLINICAL/CLINICAL PROGRAM
Release Date: May 24, 2000
PA NUMBER: PAR-00-098
National Institute of Allergy and Infectious Diseases
National Institute of Mental Health
Application Receipt Dates: October 10, 2000, 2001, 2002
APPLICATIONS IN RESPONSE TO THIS PROGRAM ANNOUNCEMENT (PA) MUST BE PREPARED
USING A MULTI-PROJECT GRANT APPLICATION FORMAT. SPECIFIC INSTRUCTIONS FOR
COMPLETING THE APPLICATION ARE IN THE NIAID BROCHURE ENTITLED "INSTRUCTIONS
FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (April 1999) -
http://www.niaid.nih.gov/ncn/grants/multibron.htm.
PURPOSE
The National Institute of Allergy and Infectious Diseases (NIAID), National
Institutes of Health (NIH), invites applications for the discovery,
preclinical evaluation, development, and pilot clinical studies of novel
agents and strategies to suppress HIV replication, interfere with HIV
transmission or disease progression, or ameliorate the consequences of
infection. The National Institute of Mental Health (NIMH), NIH, invites
applications to identify and treat the nervous system complications of HIV
infection that result in CNS dysfunction. The Integrated Preclinical/
Clinical Program (IPCP) described in this Program Announcement (PA) supports
a continuum of diverse research activities from multidisciplinary groups.
Accordingly, applications may emphasize one of the following: (1) research
involving preclinical discovery and development of new therapeutics; (2)
preclinical research that transitions to clinical studies during the award
period; or (3) clinical research of novel, pilot treatment strategies. In
combining these activities into a single PA, the IPCP provides a spectrum of
research opportunities to collaborative groups interested in any aspect of
the discovery and development of new modalities for the treatment of HIV
disease. The participation of the private sector is strongly urged.
Responsive applications will involve creative and original therapeutic
research that targets diverse facets of HIV infection. Excluded from this PA
are targets and approaches already under extensive investigation at academic
or private sectors, non-targeted random screening of potential inhibitors,
and research on AIDS-associated opportunistic pathogens and malignancies.
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 Program Announcement
(PA), NOVEL HIV THERAPIES: INTEGRATED PRECLINICAL/CLINICAL PROGRAM, is
related to the focus area of HIV Infection. Potential applicants may obtain
a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic 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. While foreign institutions are not eligible for to
apply for Program Project Grant (P01) awards as the principal institution,
they may participate under this PA as research projects or cores. However,
these components will not receive support for indirect costs. Racial/ethnic
minority individuals, women, and persons with disabilities are encouraged to
apply as Principal Investigators.
The involvement of the private sector is strongly urged because of the
infrastructure and capital resources it brings to the program and its
potential to rapidly marshal resources and move therapeutic leads through the
development pathway. Investigators from the private sector are eligible to
participate as Principal Investigators, Project or Core Leaders, or
informally as collaborators.
MECHANISMS OF SUPPORT
The mechanism of support is the Program Project grant (P01). Program Project
grants support broadly based, multi-disciplinary 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. The total project period
for P01 grants may not exceed four 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.
Research groups supported by this PA include: (1) groups focusing exclusively
on preclinical discovery and development of novel therapeutic entities and
strategies; and (2) groups positioned to implement a proposed pilot clinical
study during the award period. P01 applications submitted in response to
this PA may not request in excess of $725,000 first-year total (direct and
indirect) costs for research involving preclinical studies, or $1,500,000
first-year total (direct plus indirect) costs for research involving clinical
studies. Budgets exceeding these levels must be strongly justified and pre-
approved for submission by the Program contact person listed under
"INQUIRIES". Groups proposing to transition from preclinical to clinical
studies during the award period should submit a budget for each phase that
reflects the limits given above.
The level of support for clinical research under this PA may be insufficient
to provide all the funds necessary to conduct the proposed clinical study.
Prospective groups should therefore develop plans to use existing
infrastructure and organizational support to complement the award [including
NIH sponsored General Clinical Research Centers (GCRC) and Centers for AIDS
Research (CFAR)].
Responsibility for the planning, direction, and execution of the proposed
research for all applicable mechanisms of support will be solely that of the
applicant.
Applicants for P01 grants must follow special application guidelines in the
NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT
AWARDS (April 1999); this brochure is available via the WWW at:
http://www.niaid.nih.gov/ncn/grants/multibron.htm.
RESEARCH OBJECTIVES
Background
Research advances in recent years have yielded a wealth of information on HIV
molecular biology, the pathogenesis of HIV disease, and the impact of disease
progression on immune function. Concomitantly, seminal technological
advances have been realized. Together, these advances offer exciting
opportunities to develop and translate new therapeutic concepts to clinical
application and complement current FDA approved therapies. To assist in
assembling the diverse scientific expertise and ancillary resources needed to
translate basic discoveries to applied entities, this PA is designed to
support multi-disciplinary preclinical and clinical research groups.
Research Objectives and Scope
The objectives of the IPCP are: (1) to maintain a strong and diverse base in
preclinical discovery and development of new therapeutics; and (2) to support
the translation of innovative treatment concepts from preclinical studies to
pilot clinical proof-of-concept studies. The ultimate goal of this PA is the
discovery, development, and exploratory clinical evaluation of new and
effective therapeutic approaches for the treatment of HIV disease and
prevention of HIV sexual transmission. Such research is expected to yield
long-term therapeutic returns as well as identify and open new research
directions. In line with this objective, the PA will support diverse and
creative strategies of sound scientific rationale that are new or under-
studied, and provide a continuous spectrum of research opportunities from
preclinical to pilot clinical studies. Interdisciplinary research groups
will conduct this comprehensive effort.
Examples of preclinical and clinical research areas of interest to the IPCP
include:
1. Development of under-explored/new drugs and therapeutic concepts that
target elements (viral or host) essential for HIV replication and/or
pathogenic manifestation(s)
2. Development of strategies or entities that target viral reservoirs
(cellular, tissue, organ)
3. Development of cytoreductive strategies as adjunct immune-therapies
(e.g., to induce repopulation of immune components) or as preparative
regimens for transplantation (hematopoietic stem cells, lymphoid cells,
organs)
4. Design and testing of therapeutic vaccines (e.g., DNA-based; vector-
based)
5 Identification of topical microbicide inhibitors of HIV sexual
transmission (e.g., blockers of HIV fusion and/or entry; gene- and cell-based
inhibitors)
6. Evaluation of novel therapeutic strategies in combination with treatment
paradigms [e.g., HAART plus cell-based therapy; structured treatment
interruption (STI) in conjunction with a therapeutic vaccine, cytokines,
others]
7. Identification of molecular and cellular mechanisms underlying HIV-
associated CNS dysfunction and development of targeted therapeutics
[Current research areas supported by funded groups under the IPCP can be
viewed at: http://www.niaid.nih.gov/daids/pdatguide/ipcp.htm.]
Preclinical Research
The preclinical portion of the IPCP supports the discovery and development of
specific therapeutic approaches or strategies. The new therapeutic strategy
should have relevance and future application to clinical evaluation. The
inclusion of an animal model for proof-of-concept is strongly encouraged.
Preclinical groups seeking to transition from preclinical to clinical
research during the award period must detail the goals and milestones
considered necessary to enter the clinical phase. These goals and milestones
should also include plans and a timetable for obtaining the required
institutional and government approvals [Institutional review Board (IRB),
Institutional Biosafety Committee (IBC), Food and Drug Administration (FDA),
NIH Recombinant Advisory Committee (RAC)]. The peer review group will review
the appropriateness of the goals and milestones. When a request to
transition to the clinical phase is made, these goals and milestones will be
also be used to determine the successful completion of the preclinical
development phase. Release of funds for clinical research will be contingent
upon the documented successful completion of the proposed and peer-reviewed
goals and milestones.
Clinical Studies
The clinical portion of the IPCP supports interdependent, iterative
clinical/laboratory research designed to evaluate and optimize a clinical
therapeutic approach. Relative to the preclinical portion of the IPCP, human
subjects concerns and regulatory issues substantially increase under the
clinical phase. These safety and clinical proof-of-concept studies of
innovative therapeutic strategies may involve greater scientific risk than
that practiced in larger clinical trials. A successful group will develop
and optimize a therapeutic strategy to a point at which it can be determined
whether the strategy merits further clinical evaluation. Moreover, analysis
of outcome should explore reasons for failures as well as successes as part
of an overarching objective to further advance the knowledge base and
development of new therapeutic modalities.
A clinical application must be based on a strategy in an advanced stage of
preclinical development that is suitable for evaluation in a small number (6-
12) of patients. [When merited by the study, a larger number of patients may
be considered; prior approval by the Program Officer (see INQUIRIES, below)
is required.] The application should include (1) a detailed plan of the
iterative clinical and laboratory research to be conducted to optimize the
proposed strategy; (2) a timetable to be followed; (3) plans for the clinical
studies including the clinical protocol; and (4) institutional and government
approvals (IRB, FDA, RAC).
SPECIAL REQUIREMENTS
IPCP Group Scientific Advisory Panel
Each IPCP group will designate a Scientific Advisory Panel ("Panel") of 2-3
investigators, not affiliated with any of the institutions comprising the
group. The Panel will attend one or more of the IPCP group meetings each
year, review the group's activities, and evaluate progress, adherence to the
original time frame of activities, and the continued relevance of each
project to the group's overall goals. The Panel will recommend new
directions as appropriate and will provide the PI with a comprehensive
written evaluation of the group's activities and recommendations after each
meeting. A copy of the report is to be sent to the DAIDS Coordinator within
30 days of the meeting. [The DAIDS Coordinator for each group will be the
equivalent of a Project Officer, having either medical or scientific research
expertise depending on the clinical or preclinical focus of the project.]
Meetings and travel
The NIAID organizes small meetings/workshops throughout the year on topics of
interest to IPCP investigators. Awardees are strongly encouraged to
participate in these meetings held in the Washington DC area. Applicants
should include estimated travel expenses for one such meeting per year in the
application budget. Estimated expenses for travel of the Scientific Advisory
Board members should be based on one group meeting per year and should be
included in the budget. No additional travel funds will be provided to attend
other domestic or foreign meetings.
TERMS AND CONDITIONS OF AWARD
Patent Coverage
Since an application may include several institutions, including the private
sector, complex patent situations may arise. To avoid delays related to
intellectual property issues in implementing new therapies for HIV, each
multi-project group is required to provide a plan as part of the application,
detailing (1) the approach, agreed to by all parties, to be used for
obtaining patent coverage and for licensing, where appropriate; and (2) the
procedures to be followed for the resolution of legal problems that
potentially may develop. Attention is drawn to the reporting requirements of
35 U.S.C. Parts 200-212 and 37 CFR Part 401 or FAR 55.227-11. Instructions
were also published in the NIH GUIDE FOR GRANTS AND CONTRACTS, Vol. 19, No.
23, June 22, 1990. Note that non-profit organizations (including
universities) and small business firms retain the rights to any patent
resulting from Government grants or cooperative agreements.
It is also noted that a Presidential memorandum of February 18, 1983 extended
to all business concerns, regardless of size, the first option to the
ownership of rights to inventions as provided in P.L. 96-517. As a result of
this memorandum, the relationships among industrial organizations and other
participants are simplified, since all group members can now be full partners
in the research and in any inventions resulting there from. The specific
patenting arrangements among the institutions may vary and could include
joint patent ownership, exclusive licensing arrangements, etc. Applicants
are encouraged to develop an arrangement that is most suitable for the
group’s particular circumstances.
The patent agreement among the institutions comprising the group, signed and
dated by the organizational officials authorized to enter into patent
arrangements for each group member and member institution, must be submitted
with the application, and a copy submitted to Dr. Nava Sarver (address under
INQUIRIES). If the group wishes to place all inventions and discoveries
resulting from these studies within the public domain, a letter to that
effect must be submitted to Dr. Sarver in lieu of the patent agreement. The
letter must be co-signed by the Principal Investigator, each of the Project
Leaders, and each of the business officials representing the respective
institutions.
Federal regulation clause 37-CFR-401 and HHS Inventions regulations at 45 CFR
Parts 6 and 8 require that NIH be informed of inventions and licensing
occurring under NIH funded research. Invention and licensing reports must be
submitted to the Extramural Invention Reports Office at (301) 435-1986.
For awards including clinical studies
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. Terms
and Conditions of Award will be included with awards. NIAID policy was
announced in the NIH Guide on February 24, 2000 and is available at:
http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html. The full
policy including terms and conditions of award is available at:
http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf
Terms of awards specific to this PA may also apply.
Groups seeking to transition from preclinical to clinical studies during the
award period must include a long-range development plan that details the
preclinical, transitional, and clinical phases of the proposed studies and a
budget appropriate to each phase. Funds to accommodate the potentially more
costly clinical study should be budgeted in the application. The group must
articulate a set of objectives and milestones to be completed prior to the
transition to clinical research and include the clinical site and clinical
investigators to be involved. For purposes of peer review, the application
must include a clinical protocol based on research findings available at the
time of submission (although it is understood that the protocol may change as
work progresses). All the above components - the development plan,
objectives and milestones, clinical site and clinical investigators - will be
essential elements of the initial review by the peer review group. The NIAID
and/or NIMH will review requests to transition to clinical research and will
use outside expertise to review the revised clinical protocol and budget and
to assist in determining whether the group requesting transition is
positioned to proceed to clinical studies.
Release of funds for clinical research will be contingent on successful
accomplishment of milestones and criteria stated in the original application
as reviewed and approved by the peer review group, and include compliance
with all applicable laws and regulations. To initiate clinical studies
awardees must have IRB, FDA and RAC (if applicable) approvals. Funds for
clinical studies will be withheld until the required approvals are obtained
and copies provided to NIAID (Dr. Nava Sarver, address under INQUIRIES).
Additional details for applications including a clinical component are listed
as follows.
The Principal Investigator is responsible for:
1. Assuming responsibility for developing protocols and monitoring study
performance; participant recruitment and follow-up; interim data and safety
analysis and monitoring. All protocols will be submitted by the Principal
Investigator to the NIAID (Dr. Nava Sarver, address below) for review for
safety issues by the DAIDS Clinical Science Review Committee (CSRC) prior to
implementation. The Principal Investigator will be responsible for reporting
recruitment, retention, and other similar information to DAIDS/NIAID at six-
month intervals, on January 1 and July 1 of each year. Adverse event reports
will be forwarded to Dr. Sarver at the same time as to the FDA.
2. Establishing procedures to comply with FDA regulations for studies
involving investigational agents and strategies and to comply with the
requirements of 45 CFR Part 46 for the protection of human subjects. Terms
of award for any human clinical trial component will be developed to ensure
volunteer safety and monitoring of compliance with regulations and Good
Clinical Practices. NIAID staff will provide guidance and technical advice
on meeting FDA requirements for investigational substances.
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,
compelling rationale, and justification are provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research", published in the Federal Register of March 28, 1994 (FR 59 14508-
14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18,
1994 which is available via the WWW at:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html
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://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators may obtain copies from these sources or from Dr. Nava Sarver
(listed in INQUIRIES below) who may also provide additional relevant
information concerning the policy.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
APPLICATION PROCEDURES
Applicants for P01 grants must follow special application guidelines in the
NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT
AWARDS (April 1999); this brochure is available via the WWW at:
http://www.niaid.nih.gov/ncn/grants/multibron.htm
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated
in this Program Announcement. Application kits are available at most
institutional offices of sponsored research and from the Division of
Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-
0714, email: [email protected].
In addition, applications are available at the following URL:
http://grants.nih.gov/grants/forms.htm.
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. 4/98)
Application Kit (as modified in, and superseded by, the NIAID BROCHURE
ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR -PROJECT AWARDS"
(http://www.niaid.nih.gov/ncn/grants/multibron.htm) will be judged non-
responsive and will be returned to the applicant.
Applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version of the preceding grant application types requesting $500,000 or more
in direct costs for any year are advised to contact the Institute or Center
(IC) program staff before submitting the application, i.e., as plans for the
study are being developed. Furthermore, the application must obtain
agreement from the IC Staff that the IC will accept the application for
consideration for award. Finally, the applicant must identify, in a cover
letter sent with the application, the staff member and Institute or Center
who agreed to accept assignment of the application.
This policy requires an applicant to obtain agreement for acceptance of both
any such application and any such subsequent amendment. Refer to the NIH
Guide for Grants and Contracts, March 20, 1998 at
http://grants.nih.gov/grants/guide/notice-files/not98-030.html.
For purposes of identification and processing, item 2a on the face page of
the application must be marked "YES" and the PA number listed on the face
page of this PA and the words "NOVEL HIV THERAPIES: INTEGRATED
PRECLINICAL/CLINICAL PROGRAM" must be typed in.
Submit a signed, typewritten original of the application, including the
checklist, and three signed, exact, single-sided 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 mail or 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 to Dr.
Dianne Tingley at the address listed under INQUIRIES.
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.
Applicants from institutions that have a General Clinical Research Center
(GCRC) funded by the NIH National Center for Research Resources may wish to
identify the GCRC as a resource for conducting the proposed research. If so,
a letter of agreement from either the GCRC program director or principal
investigator could be included with the application.
REVIEW CONSIDERATIONS
Review Procedures
Applications will be assigned on the basis of established NIH referral
guidelines. Upon receipt, the NIH Center for Scientific Review will review
applications for completeness. Incomplete applications will be returned to
the applicant without further consideration.
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.
Review Criteria
Applicants are urged to become familiar with the NIAID brochure "INSTRUCTIONS
FOR APPLICATIONS FOR MULTI-PROJECT AWARDS
http://www.niaid.nih.gov/ncn/grants/multibron.htm (April 1999) for specific
review criteria for P01 applications. This brochure details the review
criteria applicable to the individual projects, individual cores, and the
overall application as a whole. These criteria are contained in instructions
provided to the peer review panel and will be used as the working frame by
which the applications will be evaluated.
Specifically, the reviewers will be asked to comment on specific criteria as
detailed in the brochure for multi-project 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 review criteria will be addressed and
considered by the reviewers 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 a 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.
In addition to (not in lieu of) the review criteria detailed in the
instruction brochure (see above), review criteria specific to this PA (mainly
bearing to the review of the individual preclinical and clinical projects)
include, as follows:
1. The medical significance and originality of the project.
2. The likelihood that the research will open new directions in the treatment
of HIV disease or containment of HIV infection, demonstrate a capacity to be
reduced to clinical practice, or merit evaluation in clinical studies for
safety and proof-of-concept.
3. Appropriateness of the experimental approach, development plan, and
methodology proposed, including laboratory capabilities (preclinical and/or
clinical) in immunology, virology, cell biology; assays to detect changes in
parameters related to HIV infection based on state-of-the-art methods, and
choice of end-points. For previously funded preclinical groups: evidence of
significant progress in the previous award (e.g. design, formulation, or
development of therapeutic entities/strategies that merit clinical
evaluation).
4. The Principal Investigator's and Project Leaders' commitment to devote
substantial time and effort to the program. [Due to the complexity and time
required to maintain a well-coordinated and productive research effort, a
minimum 20% (time) commitment by the PI and PLs is strongly suggested unless
there are compelling arguments to the contrary.]
5. For groups focusing on preclinical research:
o Choice of the therapeutic target or strategy, its contribution to the
diversity of potential therapeutics, and the likelihood that the
target/strategy can be developed (e.g., following a prescribed preclinical
development plan; selecting a clinical candidate compound) during the award
period.
6. For groups proposing clinical research:
o Adequacy and validity of the proposed milestones for determining the
readiness of the group to transition to clinical research; iterative research
plan to develop and optimize the proposed strategy; protocol design (clinical
and scientific); short and long term development plans; contingency plans
addressing the specific objectives; plans to guard the safety of subjects;
plans to evaluate outcome even if negative; and provisions to obtain the
required institutional and regulatory approvals (IRB, FDA, RAC) to conduct
the clinical study.
o Experience of the Principal Investigator and Project Leaders in the
planning, design, and conduct of small clinical studies in HIV-infected
patients; availability of a General Clinical Research (GCRC), Center for AIDS
Research (CFAR), or other additional source of institutional support and/or
statistical support; the infrastructure required for the conduct of safe and
efficient clinical research; and short and long range plans that will result
in the successful implementation of clinical studies during the award period.
o If a previously funded clinical group: a clinical concept that is new,
substantially improved, or that represents a new opportunity/direction
resulting from the preceding funding period.
5. In addition to evaluating the scientific merit of the application, all
multi-project applications are also assessed for the soundness of the
administrative and organizational structure that facilitates attainment of
the objective(s) of the program.
Thus, the Administrative Core should detail the short and long term
management of the Program such as: communication, group meetings, sharing and
transmission of information and reagents, awareness of development at other
projects within the program, progress, problems and how will they be
addressed, engagement of the Scientific Advisory Panel and NIAID in the
group's research activities/meeting, consideration and integration of
scientific input/recommendation from the Scientific Advisory Panel and NIAID
into scientific direction and decision-making, timely reporting as required
in the Terms of Award (provided at the time of award), HHS, NIH Office of
Biotechnology Activities - Recombinant Advisory Committee (OBA-RAC), and FDA
as applicable, and other aspects relevant to the cohesiveness and interactive
nature of group activities
The initial review group will also examine: the adequacy of plans to include
children and both genders and 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 recommended
applications. The following will be considered when making funding
decisions: quality of the proposed project as determined by peer review,
overall program balance among research areas of the announcement, balance of
preclinical and clinical studies, and availability of funds.
INQUIRIES
Written and telephone inquiries are encouraged. The opportunity to clarify
any issues or questions from potential applicants is welcome.
Requests for the NIAID brochure INSTRUCTIONS FOR APPLICATIONS FOR MULTI-
PROJECT AWARDS
http://www.niaid.nih.gov/ncn/grants/multibron.htm.
(April 1999) as well as inquiries regarding programmatic (research scope,
eligibility and responsiveness) issues may be directed to:
Nava Sarver, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4216, MSC 7626
6700-B Rockledge Drive
Bethesda, MD 20892-7626
Telephone: 301-496-8197
Fax: 301-402-3211
EMAIL: [email protected]
Programmatic issues specific to CNS-related applications may be directed to:
Dianne Rausch, Ph.D.
Center for Mental Health Research on AIDS
National Institute of Mental Health
Room 6209
6001 Executive Boulevard, MSC 9619
Bethesda, MD 20892-9619
Telephone: 301-443-7281
Fax: 301-443-9719
EMAIL: [email protected]
Direct inquiries regarding review to:
Dianne Tingley, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2148, MSC 7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: 301-496-0818
Fax: 301-402-2638
EMAIL: [email protected]
Direct inquiries regarding NIAID fiscal matters to:
Ms. Linda Shaw
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2125, MSC 7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: 301-402-6611
Fax: 301-480-3780
EMAIL: [email protected]
Direct inquiries regarding NIMH fiscal matters to:
Ms. Diana S. Trunnell
Division of Extramural Activities
National Institute of Mental Health
Room 7C-08
Parklawn Bldg
5600 Fishers Lane
Rockville, MD 20857
Telephone: 301-443-2805
Fax: 301-443-6885
EMAIL: [email protected]
AUTHORITY AND REGULATIONS
This program is described in the Catalogue of Federal Domestic Assistance No.
93.856. 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 Public Health Service strongly encourages all grant and contract
recipients to provide a smoke-free workplace and promote the non-use of all
tobacco products. In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or, in some cases, any portion
of a facility) in which regular or routine education, library, day care,
health care or early childhood development services are provided to children.
This is consistent with the PHS mission to protect and advance the physical
and mental health of the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||