EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)
Components of Participating Organizations
National Institute of Allergy and
Infectious Diseases (NIAID), (http://www3.niaid.nih.gov/)
Title: HIV Vaccine Research and Design (HIVRAD) Program (P01)
Announcement Type Updates: The following updates relating to this announcement have been issued:
This is a reissuance of PAR-03-094
which was released April 3, 2003.
Program Announcement (PA) Number: PAR-06-285
Catalog of Federal Domestic Assistance Number(s)
No.
93.855, Immunology, Allergy, and Transplantation Research
No.
93.856, Microbiology and Infectious Diseases Research
Key Dates
Release/Posted Date: March 29, 2006
Letters of Intent Receipt Date(s): June 23, 2006; May 21, 2007
Application Receipt Date(s): August 17, 2006; June 21, 2007 (Additional date June 23, 2008 per NOT-AI-07-041)
Peer Review Date(s): November 2006;
October 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: June 24, 2008
Due Dates for E.O. 12372
Not applicable.
Additional Overview
Content
Executive Summary
Part
I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1.
Research Objectives
2. Special Requirements
Section
II. Award Information
1.
Mechanism(s) of Support
2. Funds
Available
Section
III. Eligibility Information
1.
Eligible Applicants
A.
Eligible Institutions
B.
Eligible Individuals
2. Cost
Sharing or Matching
3. Other
- Special Eligibility Criteria
Section
IV. Application and Submission Information
1.
Address to Request Application Information
2.
Content and Form of Application Submission
3.
Submission Dates and Times
A.
Receipt and Review and Anticipated Start Dates
1.
Letter of Intent
B.
Sending an Application to the NIH
C.
Application Processing
4.
Intergovernmental Review
5.
Funding Restrictions
6. Other
Submission Requirements
Section
V. Application Review Information
1.
Criteria
2.
Review and Selection Process
A.
Additional Review Criteria
B.
Additional Review Considerations
C.
Sharing Research Data
D.
Sharing Research Resources
3.
Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award
Notices
2.
Administrative and National Policy Requirements
3.
Reporting
Section
VII. Agency Contact(s)
1.
Scientific/Research Contact(s)
2. Peer
Review Contact(s)
3.
Financial/ Grants Management Contact(s)
Section
VIII. Other Information - Required Federal Citations
Part
II - Full Text of Announcement
1. Research Objectives
Background
Every year approximately five million people worldwide are infected with the human immunodeficiency virus (HIV), the virus 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, the NIAID has a lead role in this endeavor and supports a number of research programs using multiple grant and contract funding mechanisms. NIAID supports HIV/AIDS prophylactic vaccine research and development via three solicited grant programs ranging from early stage high risk/high impact research supported through the Phased Innovation Awards (PIA), to advanced research and vaccine design supported through the HIV Vaccine Research and Design (HIVRAD) Program, to vaccine development, optimization and production leading to human clinical trial testing supported by the Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) Program.
Objective
The HIVRAD program is designed to fund projects for research that have advanced past the exploratory stage and that address topics crucial to the design of an efficacious HIV/AIDS vaccine. To that end applicants may target any area of HIV/AIDS prophylactic vaccine research. These areas may include, but need not be limited to, correlates of immunity to HIV/AIDS or appropriate model systems, approaches to increase immunogenicity of HIV antigens, approaches to stimulate pertinent arms of the immune system as they relate to HIV/AIDS vaccine efficacy, development or improvement of vaccine vectors, HIV structural studies as they relate to designing HIV immunogens, and development of improved animal model systems to address vaccine efficacy. Extensive modeling of vaccine concepts in non-human primates may be included. Clinical studies involving human subjects and/or vaccine research focused solely on therapeutic applications are not considered responsive to this PA. For information on programs that support therapeutic vaccine development, please contact program staff.
See Section
VIII, Other Information - Required Federal Citations, for policies related
to this announcement.
2. Special Requirements
Milestones
Applicants are required to delineate in their application discrete goals with measurable milestones, and include criteria that can be used to decide when to proceed to the next phase of vaccine research or development. Based on comments from the peer reviewers, the Program Officer may negotiate milestones included in the application with the applicant. The agreed upon milestones will be included in the Terms of Award. The achievement of milestones will be the focus of discussion at the annual site visit review (as described below).
Scientific Advisory Group
It is strongly recommended that a 3-4 member Scientific Advisory Group (SAG), consisting of independent experts in the areas of research that the program project addresses, be identified soon after award of the program project. SAG 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 project. Applicants are urged not to include names of proposed SAG members in their applications.
Annual Meetings
Awardees shall host an annual site visit review for the Program Officer, NIAID Program Staff and Scientific Advisory Group. The PI and all co-investigators shall attend this meeting. An update and summary of results generated from each project shall be presented by the PI, co-investigators and/or all pertinent staff. These presentations shall include summaries of all goals and 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. It is suggested that investigators include the cost of travel and any proposed honorarium for attendance of the to-be-named members of the Scientific Advisory Group to these annual meetings in their proposed budgets.
Section II. Award Information1. Mechanism(s) of Support
This
funding opportunity will use the NIH Program Project
(P01) award mechanism. Applications must
include at least two (2) research projects and one (1) core. 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 number of 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 are required to be utilized by
two or more projects within the application. The total project period for
HIVRAD P01 grants may not exceed five years.
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.
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 will
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.
Facilities
and administrative costs requested by consortium participants are not included
in the direct cost limitation, see NOT-OD-05-004.
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:
1.B. Eligible Individuals
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
Not applicable.
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
There is no limit to the number of applications an applicant may submit under the announcement.
Section IV. Application and Submission Information1. Address to Request Application Information
Applicants for P01 grants must follow the special instructions entitled How to Prepare a Multi-Project Grant Application located at: http://www.niaid.nih.gov/ncn/grants/multi/multi_pf.htm.
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.
3. Submission Dates and Times
See
Section IV.3.A for details.
3.A. Receipt,
Review and Anticipated Start Dates
Letters
of Intent Receipt Date(s): June 23, 2006; May 21, 2007
Application Receipt Date(s): July 24, 2006; June 21, 2007
Peer Review Date(s): November 2006;
October 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:
Eugene
R. Baizman, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3125, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-1824
(for Express Couriers)
Telephone: (301) 402-1464
Fax: (301) 480-2408
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications
must be prepared using the research grant application forms 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)
At the time of submission, two additional photocopies of the grant application must be sent to:
Eugene R. Baizman, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3125, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-1824
(for Express Couriers)
Telephone: (301) 402-1464
Fax: (301) 480-2408
Email: [email protected]
Personal
deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C. Application Processing
Applications
must be received on or before the application
receipt/submission 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 CSR. Incomplete
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.
Although
there is no immediate acknowledgement of the receipt of an application,
applicants are generally notified of the review and funding assignment within
eight (8) weeks.
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
Plan for Sharing Research Data
Investigators
submitting an application in response to this announcement are required to
include a plan for data sharing or to state why data sharing is not possible. (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html).
Applicants are encouraged to discuss their data sharing plan with the program
contact prior to submission of their application. Program
staff will be responsible for overseeing the data sharing policy and for
assessing the appropriateness and adequacy of the proposed data-sharing plan.
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).
Unique research resources produced with funds awarded in response to this solicitation shall be made readily available for research purposes to qualified individuals with the scientific community no later than publication of the associated research funding. (http://www.aidsreagent.org/)
Section V. Application Review Information1. Criteria
The following will be considered in making funding decisions:
Relevance and feasibility of proposed goals, measurable milestones, and criteria that can be used to decide when to proceed to the next phase of vaccine research or development
2. Review and Selection Process
Applications
that are complete will be evaluated for scientific and technical merit by an
appropriate review group convened by NIAID
in accordance with the review criteria stated below.
As
part of the initial merit review, all applications will:
Upon receipt, applications will be reviewed for completeness by the NIH Center for Scientific Review. Incomplete applications will be returned to the applicant without further consideration. Applications that are will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID.
The review criteria listed below and presented in How to Prepare a Multi-Project Grant Application located at: http://www.niaid.nih.gov/ncn/grants/multi/multi_pf.htm will be used to assess P01 applications.
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.
Research Projects.
1. 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 concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
3. Innovation. Is the project original and innovative, e.g., does it challenge existing paradigms or clinical practice or address an innovative hypothesis or critical barrier to progress in the field? Does it develop or use novel concepts?
4. Investigator. Are the investigators appropriately trained and well suited to carry out this work? Is the work appropriate to the experience level of the PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project, if applicable?
5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the studies benefit from unique features of the scientific environment or subject populations or include useful collaborative arrangements? Is there evidence of institutional support?
Review Criteria for Evaluating an Overall Multi-Project Application
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 will 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 presence of a data
sharing plan will be part of the terms and conditions of the award. The funding
organization will be responsible for monitoring the data sharing policy.
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.
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).
3. Reporting
Awardees will be required to host, for the Program Officer, NIAID
Program Staff and Scientific Advisory Group, an annual site visit. The PI and
all co-investigators shall attend this meeting. An update and summary of
results generated from each project shall be presented by the PI,
co-investigators 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.
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.
We 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:
Dr. James Bradac
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room
5116, MSC-7620
6700-B Rockledge Drive
Bethesda, MD 20892-7620
Telephone: (301) 435-3754
FAX: (301) 480-3684
Email: [email protected]
2. Peer Review Contacts:
Eugene R. Baizman, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3125, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-1824
(for Express Couriers)
Telephone: (301) 402-1464
Fax: (301) 480-2408
Email: [email protected]
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
(20817 express)
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).
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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