and Human Services (HHS)
EXPIRED
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number: PAR-06-286
Catalog of Federal Domestic Assistance Number(s)
93.855,
Immunology, Allergy, and Transplantation Research
93.856, Microbiology and Infectious Diseases Research
Key Dates
Release/Posted
Date: March 28, 2006
Letters
of Intent Receipt Date(s): June 23, 2006; June 22, 2007
Application Receipt Dates(s): July 24, 2006; July 24, 2007, (Additional date July 24, 2008 per NOT-AI-07-042)
Peer Review Date(s): November,
2006; November 2007
Council Review Date(s): January 2007; January 2008
Earliest Anticipated Start Date: January, 2007; January, 2008
Additional Information To Be Available Date (Url
Activation Date): Not Applicable.
Expiration Date: July 25,
2007 (Extended to July 25, 2008 per NOT-AI-07-042)
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
1. Research Objectives
Background
Every year approximately five million people worldwide are infected with the human immunodeficiency virus (HIV), the vir us that causes the Acquired Immunodeficiency Disease Syndrome (AIDS). Almost 14,000 people become infected each day and 45 million additional infections are projected to occur by 2010 unless more effective measures are taken to prevent new infections. The human and economic toll of HIV/AIDS requires an accelerated effort to develop a preventive HIV vaccine. The development of a safe and effective prophylactic vaccine against HIV/AIDS is one of the highest priorities of the National Institutes of Health (NIH). Within NIH, NIAID has a lead role in this endeavor and supports a number of research programs using multiple grant and contract funding mechanisms. NIAID supports the progressive stages of AIDS vaccine research and development from basic research through iterative product development and clinical trials. NIAID supports HIV/AIDS prophylactic vaccine research and development via three solicited grant programs ranging from (1) early stage high risk/high impact research through the Phased Innovation Awards (PIA) (http://grants.nih.gov/grants/guide/pa-files/PA-06-109.html) , to (2) advanced research and vaccine design supported through the HIV Vaccine Research and Design (HIVRAD) Program (PAR-06-285), to (3) vaccine development, optimization and production leading to human clinical trial testing supported by the Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) Program (this announcement).
Research Objectives and Scope
The goal of the IPCAVD program is to support the translation of meritorious HIV/AIDS prophylactic vaccine candidates from the bench to clinic. As such, initiation of human studies during the term of funding must be a feasible and established goal. Consistent with these goals, the IPCAVD Program is designed to support more advanced later stages of vaccine research and development and applications must include Phase I human studies. Projects responsive to this announcement include but are not limited to:
Preclinical research alone is not responsive to this announcement.
See Section
VIII, Other Information - Required Federal Citations, for policies related
to this announcement
Section
II. Award Information
As
an applicant, you will be solely responsible for planning, directing, and
executing the proposed project.
This funding opportunity uses the just-in-time budget
concepts. It also uses the non-modular budget format described in the PHS 398
application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
The
NIH U19 is a cooperative agreement award
mechanism. In the cooperative agreement mechanism, 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
VI. 2. Administrative Requirements, "Cooperative Agreement Terms and
Conditions of Award".
The NIAID intends to re-issue this program announcement. NIAID anticipates that awardees will complete their research during the period of performance of their awards. Acceptance of competitive renewals will be considered on a case by case basis.
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award may also vary. Although the financial plans of the NIAID provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
You
may submit (an) application(s) if your organization has any of the following
characteristics:
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.
2. Cost Sharing or Matching
Cost sharing is not required.
The
most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
An Institution may submit only one application annually; however,
applications may include investigators from more than one institution if such
arrangements enhance the scientific strength of the proposed research program.
In addition, a Principal Investigator may serve as a Project Leader in another
multi-project application if there is no scientific overlap with the
application submitted by the Principal Investigator.
1. Address to Request Application Information
The
PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html
in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Telecommunications
for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications
must be prepared using the most current PHS 398 research grant application
instructions and forms. Applications must have a D&B Data Universal
Numbering System (DUNS) number as the universal identifier when applying for
Federal grants or cooperative agreements. The D&B number can be obtained by
calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number
should be entered on line 11 of the face page of the PHS 398 form.
The title and number
of this funding opportunity must be typed on line 2 of the face page of the
application form and the YES box must be checked.
Foreign Organizations
Several special
provisions apply to applications submitted by foreign organizations:
Proposed research should provide a unique research opportunity not available in the U.S.
Multi-Project Applications
Applicants for U19 cooperative agreements must follow special application guidelines as described in the NIAID’s How to Prepare a Multi-Project Grant Application which is available at: http://www.niaid.nih.gov/ncn/grants/multi/multi_pf.htm .This document presents specific instructions for sections of the PHS 398 application form that should be completed differently than usual. For all other items in the application, follow the usual instructions in the PHS 398.
Essential elements of the multi-project cooperative agreement mechanism (U19) include: 1) a minimum of two interrelated individual research projects organized around a central theme; 2) collaborative efforts and interaction among independent projects and their investigators to achieve a common goal; 3) a single Principal Investigator who will be scientifically and administratively responsible for the group effort; 4) a single applicant institution what will be legally and financially responsible for the use and disposition of funds awarded; 5) an Administrative Core; and 6) where necessary, support for scientific core resources or facilities, each of which shall be utilized by at least two research projects in order to facilitate the research effort.
3. Submission Dates and Times
Applications
must be received on or before the receipt date described below (Section IV.3.A).
Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): June 23, 2006; June 22, 2007
Application Receipt Dates(s): July 24, 2006; July 24, 2007
Peer Review Date(s): November,
2006; November 2007
Council Review Date(s): January 2007; January 2008
Earliest Anticipated Start Date: January, 2007; January, 2008
3.A.1.
Letter of Intent
Prospective
applicants are asked to submit a letter of intent that includes the following
information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent
by the date listed at the beginning of this document.
The
letter of intent should be sent to:
Roberta Binder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3130, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-1824
(for Express Couriers)
Telephone: (301) 496-7966
FAX: 301-480-2408
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications
must be prepared using the research grant applications found in the PHS 398
instructions for preparing a research grant application. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817
(for express/courier service; non-USPS service)
Personal
deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of submission, two additional copies of the
application and all copies of the appendix material must be sent to:
Roberta Binder, Ph.D.
Division
of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room
3130, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-1824 (for Express Couriers)
Telephone:
(301) 496-7966
FAX:
301-480-2408
Email:
[email protected]
3.C. Application Processing
Applications
must be received on or before the application receipt date(s) described
above (Section IV.3.A.). If an application is received after that date, it will
be returned to the applicant without review. Upon receipt, applications will be
evaluated for completeness by the CSR and responsiveness by the NIAID. Incomplete
and non-responsive applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH 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.
Applicants may
obtain status information about their applications via the eRA Commons (https://commons.era.nih.gov/commons/).
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All
NIH awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The Grants Policy
Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-Award Costs are allowable. A grantee may, at its own
risk and without NIH prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new or competing continuation award if such costs: are necessary to
conduct the project, and would be allowable under the grant, if awarded,
without NIH prior approval. If specific expenditures would otherwise require prior
approval, the grantee must obtain NIH approval before incurring the cost. NIH
prior approval is required for any costs to be incurred more than 90 days
before the beginning date of the initial budget period of a new or competing
continuation award.
The
incurrence of pre-award costs in anticipation of a competing or non-competing
award imposes no obligation on NIH either to make the award or to increase the
amount of the approved budget if an award is made for less than the amount
anticipated and is inadequate to cover the pre-award costs incurred. NIH
expects the grantee to be fully aware that pre-award costs result in borrowing
against future support and that such borrowing must not impair the grantee's
ability to accomplish the project objectives in the approved time frame or in
any way adversely affect the conduct of the project. See NIH Grants Policy
Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Applicants for U19 cooperative agreements must follow special application guidelines as described in the NIAID’s How to Prepare a Multi-Project Grant Application which is available at: http://www.niaid.nih.gov/ncn/grants/multi/multi_pf.htm .This document presents specific instructions for sections of the PHS 398 application form that should be completed differently than usual. For all other items in the application, follow the usual instructions in the PHS 398.
Special requirements of this PAR include:
1. Research Plan
- Primary and secondary objectives of the clinical trial
- Clinical trial designImmunogenic/virologic assays to be performed
- Requisite qualifications of the clinical trial director
- Time schedule for the clinical trials
The concept proposal also must provide: 1) a plan for the management of the clinical trial that Includes collection, storage, management, quality control, and reporting of study data and a system for adverse event reporting; 2) a description of the procedures and timeline for protocol development and implementation, including preparation of the manual of operations; 3) a description of the assistance to be provided in the preparation of Investigational New Drug applications; and 4) a plan for the recruitment and retention of study participants. In addition, the application must describe the overall approaches to overcoming obstacles and limitations with respect to these activities.
2. Scientific and Technical Expertise: Documentation of the scientific and technical expertise required to design, conduct and analyze the proposed studies and development activities, including GMP vaccine production.
3. External Advisory Committee. It is strongly recommended that a 3-4 member External Advisory Committee (EAC), consisting of independent experts in the areas of research that the program project addresses, be identified soon after award. EAC members will be requested to attend annual meetings sponsored by the grantee to assist the grantee with interpretation of results and planning of future studies, and to assist Program Staff with assessing progress during the course of the award. Applicants are strongly urged NOT to include names of proposed EAC members in their applications..
4. Requirement of a Manufacturing Project. The applicant must, as one of the projects of the NIH Multi-Project Cooperative Agreement (U19), have a Manufacturing Project; relegation of the GMP manufacturing to a Core Project will not be acceptable. The Manufacturing Project should contain all the information that describes the infrastructure, facilities, and resources for production of the vaccine under cGMP (Good Manufacturing Practices as defined in the US Code of Federal Regulations 21 CFR Part 211) conditions and GLP (Good Laboratory Practices 21 CFR Part 58) performance of IND-enabling preclinical animal studies. Release of funds for initiation of this Project will be contingent upon the successful completion of a DAIDS-contracted GMP audit of the manufacturing facility.
5. Administrative Core. A plan, under the direction of the Principal Investigator, that addresses Program oversight, daily operations, promotion of collaborations, participation in meetings, and other IPCAVD Program activities. The Administrative Core budget request should include funding for: 1) overall administration (e.g. secretarial and other administrative services), expenses for publications for collaborative efforts, and communication expenses; and 2) travel funds and any proposed honorarium for External Advisory Committee (EAC) members to attend annual site visit review meetings.
Plan for Sharing
Research Data
The
precise content of the data-sharing plan will vary, depending on the data being
collected and how the investigator is planning to share the data. Applicants
who are planning to share data may wish to describe briefly the expected
schedule for data sharing, the format of the final dataset, the documentation
to be provided, whether or not any analytic tools also will be provided,
whether or not a data-sharing agreement will be required and, if so, a brief
description of such an agreement (including the criteria for deciding who can
receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting
data on their institutional or personal website, through a data archive or
enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be
appropriate in other sections of the application.
Applicants
requesting more than $500,000 in direct costs in any year of the proposed
research must include a plan for sharing research data in their application.
The funding organization will be responsible for monitoring the data sharing
policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness
of the data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
Sharing Research
Resources
NIH
policy requires that grant awardee recipients make unique research resources
readily available for research purposes to qualified individuals within the
scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the
resources sharing plan and any related data sharing plans will be considered by
Program staff of the funding organization when making recommendations about
funding applications. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section
VI.3. Reporting.
2. Review and Selection Process
Applications that are complete will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
NIAID.
As part of the initial merit review, all applications will:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria 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 an 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.
Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators. Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
Review Criteria specific to this PAR: Are the milestones and timelines proposed feasible? Is the candidate vaccine feasible for further preclinical and clinical development? What is the adequacy of the facilities for cGMP manufacturing? Are all the necessary skill sets of the Principal Investigator/co-investigators sufficient to accomplish the goals of this proposal?
Additional information related to the
review of this PAR are stated in NIAID’s How to Prepare a Multi-Project
Grant Application which is available at: http://www.niaid.nih.gov/ncn/grants/multi/multi_pf.htm.
2.A.
Additional Review Criteria:
In
addition to the above criteria, the following items will continue to 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 the Research
Plan, Section E on Human Subjects in the PHS Form 398).
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 the Research Plan, Section E on Human Subjects in the PHS Form
398).
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 Form 398 research grant application instructions
will be assessed.
Biohazards: If
materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is
adequate.
2.B. Additional
Review Considerations
Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing
Research Data
Data Sharing Plan: The reasonableness of the data
sharing plan or the rationale for not sharing research data may be assessed by
the reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or the priority score. The
funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing
Research Resources
NIH
policy requires that grant awardee recipients make unique research resources
readily available for research purposes to qualified individuals within the
scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr
and http://www.ott.nih.gov/policy/rt_guide_final.html).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program
staff will be responsible for the administrative review of the plan for sharing
research resources. The adequacy of the resources sharing plan will be
considered by Program staff of the funding organization when making
recommendations about funding applications. Program staff may negotiate
modifications of the data and resource sharing plans with the awardee before
recommending funding of an application. The final version of the data and
resource sharing plans negotiated by both will become a condition of the award
of the grant. The effectiveness of the resource sharing will be evaluated as
part of the administrative review of each non-competing Grant Progress Report
(PHS 2590). See Section
VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not
applicable.
Section
VI. Award Administration Information
1. Award Notices
After
the peer review of the application is completed, the PD/PI will be able to
access his or her Summary Statement (written critique) via the eRA Commons.
If the application
is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal
notification in the form of a Notice of Award (NoA) will be provided to
the applicant organization. The NoA signed by the grants management officer is
the authorizing document. Once all administrative and programmatic issues have
been resolved, the NoA will be generated via email notification from the
awarding component to the grantee business official (designated in item 12 on
the Application Face Page). If a grantee is not email enabled, a hard copy of
the NoA will be mailed to the business official.
Selection of an
application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. These costs may
be reimbursed only to the extent considered allowable pre-award costs. See Also
Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All
NIH grant and cooperative agreement awards include the NIH Grants Policy
Statement as part of the NoA. For these terms of award, see the NIH Grants
Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A:
General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The
following Terms and Conditions will be incorporated into the award statement
and will be provided to the Principal Investigator as well as to the
appropriate institutional official at the time of award.
2.A.
Cooperative Agreement Terms and Conditions 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
(U19), an "assistance" mechanism (rather than
an "acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it 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, although specific tasks
and activities may be shared among the awardees and the NIH as defined above.
2.A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary
responsibility for defining the research objectives, approaches, and details of the
projects within the guidelines of the PAR and for performing the scientific
activities.
Annual Site Visit Review
All awardees are required to host for the NIAID/DAIDS Program Officer and NIAID Program Staff, an annual site visit review. The PI, all co-Investigators, and the External Advisory Committee (see below under Collaborative Responsibilities) members shall attend this meeting. An update and summary of the results generated on each project shall be presented by the PI, Co- Investigators, and/or pertinent staff. These presentations should include summaries of all goals or milestones (refer to Other Submission Requirements section of the PAR) and a description of all problems encountered that may have an impact on the achievement of future goals and milestones.
Mid-Point Progress Report
In addition to the annual site visits, the PI will be required to submit a written mid-point progress report delineating progress on each of the stated milestones, the immunologic parameters of the vaccine candidate as a efficacious HIV/AIDS prophylactic vaccine, the feasibility for GMP manufacture, and a clear plan for the initiation of a clinical study. All supplemental information must be provided no later than 1 month before the 2.5 year anniversary of the award.
Monitoring Clinical Studies
INIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. The 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).
Intellectual Property
The successful development of tools for the evaluation of a prophylactic HIV/AIDS vaccine will require substantial investment and support of private sector industries and may also involve collaborations with multiple organizations, including academic and/or non-profit research institutions. It is the intent of this initiative to support the formation of the appropriate public-private partnerships that are essential to meet this critical public health need. NIAID recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program. To this end, all awardees understand and acknowledge the following:
Data
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject
to Government rights of access consistent with current HHS, PHS, and NIH
policies.
2.A.2. NIH Responsibilities
NIAID
staff assistance will be provided by an NIAID Scientific Coordinator who will
have substantial scientific/programmatic involvement during the conduct of this
activity through technical assistance, advice, and coordination above and
beyond normal program stewardship for grants as described below:
Additionally, an NIAID Program Official will be responsible for the normal stewardship of the award and will be named in the award notice.
Based on the comments from the peer reviewers, the Program Official may wish to revise the milestones included in the application through negotiation with the awardee. The agreed milestones will be included in the Terms of Award. Funding for the final 2 years of the grant will be contingent upon the successful completion of negotiated milestones and the feasibility of clinical testing within the funding period as determined by a mid-point review.
2.A.3. Collaborative Responsibilities
External Advisory Committee
In
addition to the interactions defined above, awardees and NIAID staff shall
share responsibility for the organization of an External Advisory Committee
(EAC). The composition and membership of the EAC shall be determined by consensus between the PI and the NIAID Scientific Coordinator. The EAC will consist of a minimum of 3
members not directly affiliated with the research being conducted by the
awardee. The EAC, together with the PI, will be responsible for determining
progress of the PI/co-investigators during the annual site visit. The EAC
will participate in the mid-point review.
Each full member
will have one vote. Awardees will be required to accept and implement policies
approved by the External Advisory Committee.
2.A.4. Arbitration Process
Any
disagreements that may arise in scientific or programmatic matters (within the
scope of the award) between award recipients and the NIH may be brought to
arbitration. An Arbitration Panel composed of three members will be convened.
It will have three members: a designee of the Steering Committee chosen without
NIH staff voting, one NIH designee, and a third designee with expertise in the relevant
area who is chosen by the other two; in the case of individual disagreement,
the first member may be chosen by the individual awardee. This special
arbitration procedure in no way affects the awardee's right to appeal an
adverse action that is otherwise appealable in accordance with PHS regulations
42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
In addition to the
annual site visits, the PI will be required to submit a written mid-point
progress report delineating progress on each of the stated milestones, the
immunologic parameters of the vaccine candidate as a efficacious HIV/AIDS
prophylactic vaccine, the feasibility for GMP manufacture, and a clear plan for
the initiation of a clinical study. Any such supplemental information must be
provided no later than 1 month before the 2.5 year anniversary of the grant
award.
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency ContactsWe encourage your inquiries concerning this funding
opportunity 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:
1. Scientific/Research Contacts:
Michael Pensiero,
Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room
5136, MSC-7628
6700B Rockledge Drive
Bethesda, MD 20892-7628
Bethesda, MD 20817 (for express mail)
Telephone:
(301) 435-3749
FAX: 301-402-3684
Email: [email protected]
2. Peer Review Contacts:
Eugene R. Baizman, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3130, MSC-7616
6700 B
Rockledge Drive
Bethesda , MD 20892-7616
Bethesda, MD 20817 (for express mail)
Telephone:
(301) -402-1464
FAX: (301)-480-2408
Email: [email protected],gov
3. Financial or Grants Management Contacts:
Chanee Williams
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2248, MSC-7614
6700-B Rockledge Drive
Bethesda, Maryland 20892-7614
Bethesda, MD 20817 (for express mail)
Telephone: 301.496.7075
FAX: 301.480.3780
Email: [email protected]
Required Federal Citations
Use of Animals in Research:
Recipients
of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
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 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data
and safety monitoring is required for all types of clinical trials, including
physiologic toxicity and dose-finding studies (phase I); efficacy studies
(Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety
monitoring boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for Data
and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should
seek guidance from their institutions, on issues related to institutional
policies and local IRB rules, as well as local, State and Federal laws and
regulations, including the Privacy Rule. Reviewers will consider the data
sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
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 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 funding opportunity 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.
Sharing of Model Organisms:
NIH
is committed to support efforts that encourage sharing of important research
resources including the sharing of model organisms for biomedical research (see
http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit
other researchers to benefit from the resources developed with public funding.
The inclusion of a model organism sharing plan is not subject to a cost
threshold in any year and is expected to be included in all applications where
the development of model organisms is anticipated.
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 "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is 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 Clinical Research:
The
NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
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 (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 applications for research involving human
subjects and individuals designated as key personnel. The policy is available
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://stemcells.nih.gov/index.asp
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 (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the application
as appropriate, 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.
NIH Public Access Policy:
NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS)
system (http://www.nihms.nih.gov/) at
PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part
with direct costs from NIH. The author's final manuscript is defined as the
final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH
is requesting that authors submit manuscripts resulting from 1) currently
funded NIH research projects or 2) previously supported NIH research projects
if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award
mechanisms, cooperative agreements, contracts, Institutional and Individual
Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For
more information about the Policy or the submission process please visit the
NIH Public Access Policy Web site at http://publicaccess.nih.gov/
and view the Policy or other Resources and Tools including the Authors' Manual
(http://publicaccess.nih.gov/publicaccess_manual.htm).
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).
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 Catalog of Federal Domestic Assistance at http://www.cfda.gov/ in the following
citations: No. 93.855, Allergy, Immunology and Transplantation Research and No.
93.856, Microbiology and Infectious Diseases Research, and is not subject to
the intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The NIH
Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
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.
Loan Repayment Programs:
NIH
encourages applications for educational loan repayment from qualified health
professionals who have made a commitment to pursue a research career involving
clinical, pediatric, contraception, infertility, and health disparities related
areas. The LRP is an important component of NIH's efforts to recruit and retain
the next generation of researchers by providing the means for developing a
research career unfettered by the burden of student loan debt. Note that an NIH
grant is not required for eligibility and concurrent career award and LRP
applications are encouraged. The periods of career award and LRP award may
overlap providing the LRP recipient with the required commitment of time and
effort, as LRP awardees must commit at least 50% of their time (at least 20
hours per week based on a 40 hour week) for two years to the research. For
further information, please see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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