and Human Services (HHS)
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
Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov)
National
Institute on Aging (NIA), (http://www.nia.nih.gov)
National
Institute of Nursing Research (NINR), (http://www.ninr.nih.gov/)
Title: Research On The Cognitive Sequelae Of
Parkinson's Disease (R21)
Announcement Type
This is a reissue of
PAS-02-107 which was previously released May 8, 2002.
Update: The following updates relating to this announcement have been issued:
Looking Ahead: As part of the Department of Health and Human Services'
implementation of e-Government, during FY 2006 the NIH will gradually
transition each research grant mechanism to electronic submission through
Grants.gov and the use of the SF 424 Research and Related (R&R) forms.
Therefore, once the transition is made for a specific grant mechanism, investigators
and institutions will be required to submit applications electronically using
Grants.gov.. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/.
NIH will announce each grant mechanism change in the NIH Guide to Grants and
Contracts (http://grants.nih.gov/grants/guide/index.html).
Specific funding opportunity announcements will also clearly indicate if
Grants.gov submission and the use of the SF424 (R&R) is required.
Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm)
for the most current information when preparing a grant application.
Program Announcement (PA) Number: PA-06-107
Catalog of Federal Domestic Assistance Number(s)
93.853, 93.866, 93.361
Key Dates
Release Date: December 22, 2005
Letters of Intent Receipt Date(s): Not Applicable
Application
Submission Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Peer
Review Date: Standard
dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Council Review
Date: Standard
dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Earliest
Anticipated Start Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Additional
Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: March 2, 2006
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
This PA is one of three coordinated programs being released by NINDS to promote research on the non-motor aspects of Parkinson’s disease, including Research On The Cognitive Sequelae Of Parkinson's Disease (R01) (PA-06-105), and Research On The Cognitive Sequelae Of Parkinson's Disease (R03) (PA-06-106).
Table of ContentsPart
I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1. Research Objectives
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. Submission, 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
1. Research Objectives
Background:
Parkinson's disease (PD) is commonly viewed as an extrapyramidal motor disorder. Hence, a substantial body of research has focused on understanding the neural mechanisms underlying the most apparent symptoms (tremors, slowness, initiation of movements) and on treatment of these debilitating clinical manifestations. However, PD is more than a motor disease; it also affects thinking, reasoning, learning, processing speed, and other cognitive abilities. Consequently, Parkinson's patients exhibiting motor and cognitive symptoms present unique challenges for the assessment and treatment of psychopathology in their disease process. In such patients, both quality of life and treatment outcome are severely compromised. The cognitive changes seen in PD patients are less understood and studied than parkinsonian motor symptoms.
In June 2005, NINDS organized the second Parkinson s Disease Research Summit, focused on the advancement of therapeutics in PD. For reasons listed above, a special breakout session on the non-motor complications of PD was convened. The group discussed a wide range of non-motor aspects of PD, identifying behavioral and cognitive impairment as particularly important for future research studies; the participants made a number of high priority recommendations in this area. The first of these priority recommendations involves expanding our understanding of the non-motor manifestations such as cognitive impairment in PD - an improved base of scientific knowledge would be a substantial contribution to therapeutics and intervention development. A second priority recommendation was the development of animal models that reproduce non-motor features of PD for research, drug discovery, and testing. A third priority recommendation was the incorporation of the non-motor manifestations of PD, such as cognitive impairment, into clinical trials, which the group agreed would aid in the testing of both pharmacological and non-pharmacological interventions for these complications. The last priority recommendation involves the development of improved methods for characterizing the non-motor complications, including standardized methods for clinical assessment.
In addition to these priority recommendations, the group also suggested a number of other strategies to move this field forward, including studies of how the cellular changes in PD lead to non-motor symptoms; the incorporation of studies of non-motor manifestations into the development of risk factor criteria; and further studies of the impact of these aspects of the disease on disability.
In order to address these recommendations, this PA encourages research on all aspects of cognition in the context of the diagnosis and treatment of PD, the progression of the disease, and its co-morbidity with dementia or other non-motor or neuropsychiatric complications.
The purpose of this initiative is to:
1) focus the attention of neuroscientists on the underlying neurodegenerative processes that affect cognition in Parkinson's disease;
2) promote research on potential therapeutics for cognitive impairment in PD; this includes the development of relevant animal models which can provide greater understanding of cognitive changes in PD, or the development of screens in such models which could test the potential use of therapeutics for cognitive impairments in PD;
3) promote studies of improving diagnostic assessment of cognitive impairments in PD;
4) promote the interaction of cognitive neuroscientists and clinical scientists conducting research in Parkinson's disease patients;
5) develop integrative research programs that advance our understanding of the substrates of cognitive function in health and in Parkinson's disease.
Applications that demonstrate the establishment of collaborative research programs with researchers at existing Udall Centers of Excellence for Parkinson's disease research are particularly encouraged.
Objectives of this research program include, but are not limited, to the following:
In addition to the above objectives, the NINR places a high priority on promoting research on potential biobehavioral interventions to maintain, support, or enhance the cognitive function of persons with PD. Such research may include:
Applicants specifically interested in these additional research topics are encouraged to speak with the NINR contact (see Section VII.) prior to submitting an application.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information1. Mechanism(s) of Support
This funding opportunity
will use the NIH
Exploratory/Developmental Research Grant (R21; please see http://grants.nih.gov/grants/funding/r21.htm;
and http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html) award
mechanism(s).
This PA is one of three coordinated programs being released
by NINDS to promote research on the non-motor aspects of Parkinson’s disease,
including Research On The Cognitive Sequelae Of Parkinson's Disease (R01) (PA-06-105),
and Research On The Cognitive Sequelae Of Parkinson's Disease (R03) (PA-06-106).
As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
This funding opportunity
uses just-in-time concepts. It also uses the modular budget format described in
the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/modular/modular.htm).
The Exploratory/Developmental Grant (R21) provides up to two years of funding with a maximum of up to $275,000 in direct costs for the two year period. As an Exploratory/Developmental mechanism, the R21 Grant is intended to support projects that: 1) assess the feasibility of a novel avenue of investigation 2) involve high risk experiments that could lead to a breakthrough in a particular field or 3) demonstrate the feasibility of new technologies that could have major impact in a specific area. To be eligible for consideration, proposals must be distinct from those traditionally submitted through the R01 mechanism. For example, projects designed to produce incremental advances in knowledge in a well-established area will not be considered. Proposals submitted under this mechanism should be limited to those with the potential for truly ground-breaking impact.
Investigators seeking to carry out pilot studies of therapies in preparation for a clinical trial that are specifically relevant to the mission of the NINDS should apply under the auspices of the Preliminary Investigations Leading To Optimal Trials In Neurology program announcement PAR-03-174. This announcement can be found at http://grants.nih.gov/grants/guide/pa-files/PAR-03-174.html.
Investigators seeking to develop milestone-driven translational therapeutics programs for Cognitive Impairment in PD that are specifically relevant to the mission of the NINDS should apply under the auspices of either 1) the NINDS Exploratory/Developmental Projects in Translational Research Program Announcement (for translational R21 applications); or 2) NINDS Cooperative Program in Translational Research Program Announcement (for U01 or U54 applications). These announcements can be found at http://grants.nih.gov/grants/guide/pa-files/PAR-05-157.html or http://grants.nih.gov/grants/guide/pa-files/PAR-05-158.html, respectively.
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 IC(s) 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 Information1. 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
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
Not Applicable
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.
Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. No preliminary data is required but may be included if it is available. A Progress Report is not needed; competing continuation applications for an exploratory/developmental grant will not be accepted.
Use the instructions for
the appendix except that no more than 5 manuscripts, previously accepted for
publication, may be included.
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.
Submission, Review and Anticipated Start Dates
Letter
of Intent Submission Date: Not applicable
Application Submission Date(s): Standard
dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Peer Review Date: Application
Receipt Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Earliest Anticipated Start Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
3.A.1. Letter of
Intent
A letter of intent is
not required for the funding opportunity.
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 five
signed photocopies in one package to:
Center for Scientific
Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (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).
3.C.
Application Processing
Applications
must be submitted on or before the application
receipt/submission dates described above (Section
IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
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
Specific Instructions for Modular Grant applications.
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Plan for Sharing
Research Data
Not Applicable
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.
1. Criteria
Only
the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted
for this funding opportunity will be assigned to the ICs on the basis of
established PHS referral guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
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?
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
Not
Applicable
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
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 14 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 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:
Debra J. Babcock, Ph.D.,
M.D.
National
Institute of Neurological Disorders and Stroke
6001
Executive Blvd., Room 2108, MSC 9521
Bethesda, MD 20892-9521
Rockville, MD 20852 (for UPS, FedEx, etc.)
Phone:
301-496-9964
Fax:
301-402-2060
Email: [email protected]
Diane D.
Murphy, Ph. D.
National Institute of Neurological Disorders and Stroke
NSC, Room 2222
6001 Executive Blvd.
Rockville, MD 20892
Telephone: (301) 496-5680
FAX: (301) 480-1080
Email: [email protected]
Judith A. Finkelstein, Ph.D.
National Institute on Aging
Gateway Building, Suite 350
7201 Wisconsin Avenue
Bethesda, MD 20892
Telephone: 301-496-9350
FAX: 301-496-1494
Email: [email protected]
Kathy Mann Koepke, Ph.D.
National Institute of Nursing Research
6701
Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone:
(301) 496-9623
FAX:
(301) 480-8260
Email: [email protected]
2. Peer Review Contacts:
Not
Applicable
3. Financial or Grants Management
Contacts:
Ms. Maxine Davis-Vanlue
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001
Executive Blvd, Suite 3254
Bethesda, Maryland 20892
Telephone:
(301) 496-9231
Fax:
(301) 402-0219
Email: [email protected]
Ms. Linda Whipp
Grants and Contract Management Office
National Institute on Aging
Gateway Building, 2N212
Bethesda, MD 20892
Telephone: 301-496-1472
FAX: 301-402-3672
Email: [email protected]
Ms. Kelly
Oster
Office of
Grants and Contracts Management
National Institute of Nursing Research, NIH
6701
Democracy Blvd,
Room 710
One Democracy Plaza
Bethesda, MD 20892-4870 (courier use 20817)
Telephone:
(301) 594-2177
FAX:
(301) 402-4502
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).
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/ 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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