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 on Aging
(NIA), (http://www.nia.nih.gov)
Title: National Study of Disability Trends and Dynamics (U01)
Announcement Type
New
Related Notices
Request For Applications (RFA) Number: RFA-AG-08-007
Catalog of Federal Domestic Assistance Number(s)
93.866
Key Dates
Release Date: November
15, 2007
Letters of Intent
Receipt Date: December 20, 2007
Application
Receipt Date: January 18, 2008
Peer Review Date: June/July 2008
Council Review
Date: August 2008
Earliest
Anticipated Start Date: September 30, 2008
Additional
Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: January 19, 2008
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism 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
A. Cooperative Agreement Terms
and Conditions of Award
1. Principal
Investigator Rights and Responsibilities
2. NIH
Responsibilities
3. Collaborative
Responsibilities
4. Arbitration
Process
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
Section I. Funding Opportunity Description
1. Research Objectives
This
funding opportunity announcement (FOA) solicits Cooperative Agreement (U01)
grant applications from applicant organizations that propose to design and
conduct a longitudinal, nationally-representative survey of disability trends
and dynamics among the U.S. older population residing in community and
institutional settings that is linked to Centers for Medicare and Medicaid
Services (CMS) Medicare claims records.
Background
The multiple dimensions of an individual’s health and functional ability evolve continuously over the course of later life sometimes gradually, sometimes abruptly, sometimes uni-directional in decline, sometimes in complex patterns of decline and recovery, sometimes with a clearly dominant and identifiable health condition, sometimes with multiple precipitating conditions. People live with and adapt to their evolving health applying health interventions, medications, and assistive technologies, as needed; using environmental, social and family support systems, if they help; living independently to the extent they can, and relying on assistive care, both formal and informal, to the extent they need. Nationally-representative, longitudinal data are needed to help us understand the complexity of health-related conditions as they evolve over the course of later life, and how they relate to functional ability, independence and the use of assistive care at older ages.
To date, one of the leading resources for studying changes in health and functional status and for tracking health expenditures, Medicare service use, and the availability of personal, family and community resources for caregiving has been the National Long-Term Care Survey (NLTCS) which collected 6 waves of data in 1982, 1984, 1989, 1994, 1999 and 2004. There are no additional waves of data collection currently planned. The data are publicly archived at the National Archive of Computerized Data on Aging (NACDA), a component of the Inter-University Consortium for Political and Social Research (ICPSR) at the University of Michigan (see http://www.icpsr.umich.edu/NACDA/welcome.html ).
RFA Goals
Applicants are invited to offer designs and plans for a longitudinal, nationally-representative study of disability trends and dynamics among the U.S. older population residing in community and institutional settings that is linked to CMS Medicare claims records. Although applications are limited to a maximum period of five years, study designs should include the potential for a longer term study. Applicants may propose completely new samples, supplements to existing samples, or may propose to conduct another wave of the NLTCS, or a successor study using the NLTCS sample. Applicants proposing to continue the NLTCS longitudinal sample in any way are directed to the section below entitled Special Requirements. Applicants are referred to two National Academy of Sciences (NAS) workshops (see http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/ConferencesAndWorkshops.htm ). While the NAS workshops were convened to discuss the NLTCS specifically, the workshop summaries contain information that is relevant for planning new surveys or supplements to existing surveys as well. For example, see the section below entitled General Characteristics of Responsive Applications which summarizes design and content issues discussed in the workshops. Proposed studies must detail plans to make the data publicly available (see Section 6).
This solicitation is for study design and conduct of the resulting study. It is not anticipated that final analyses will be supported by this solicitation. Funds for analyses are permitted only for the purpose of study development, e.g. data cleaning, validation, pilot questions, etc., and should not delay or hamper public release of the data. Significant substantive analyses are expected to be conducted under separate grant mechanisms.
Applicants are encouraged to design a study that: 1) provides estimates of disability rates for 5 year age groups (including ages 85+), and major racial/ethnic groups within the 65+ population; 2) permits analyses of transitions among different living situations and the determinants and consequences of transitions (i.e., disability dynamics); 3) permits estimation of national disability prevalence (by age, racial/ethnic group, physical and cognitive status) that, for the purpose of trend analyses, is as comparable as possible to estimates for previous years from the National Long-Term Care Survey. Applicants might also consider options to calibrate incidence and prevalence estimates (for analysis) to those from other relevant sources such as the National Health Interview Survey, Medicare Current Beneficiary Survey, Health and Retirement Study, etc. Applicants will have to balance the desirability of comparability with costs and other constraints, including the development of improved measures of disability.
The broad goals of this RFA are that the awarded survey will:
1. Facilitate the study of causes and consequences of disability and disability trends.
2. Facilitate the analysis of disability dynamics and individual pathways to disability at the population level.
3. Create a database infrastructure of important medical, behavioral, social and environmental risk factors for disability.
4. Improve the measurement of disability by incorporating additional approaches beyond traditional Activities of Daily Living (ADL)/Instrumental Activities of Daily Living (IADL) measures.
5. Facilitate the analysis of health disparities.
6. Facilitate the comparison of population-level intervention strategies to reduce disability.
7. Facilitate the analysis of the long term economic impact of changes in functioning on families, personal finances, and on public programs such as Medicare and Medicaid.
8. Consider coordination of measurement with other social science studies of the aging process. For example, measurement of cognitive and economic status and other variables might be harmonized with measures in, e.g., the Health and Retirement Study, the Panel Study of Income Dynamics, or the Medicare Current Beneficiary Survey.
Applications are not expected to address all the competing scientific goals evenly. Applicants are encouraged to balance among these and justify their overall priority and focus.
General Characteristics of Responsive Applications
1. The following options for designing a longitudinal, nationally-representative study on disability trends and dynamics among the U.S. older population were discussed at two meetings of the National Academy of Sciences (see meeting summaries at http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/ConferencesAndWorkshops.htm ).
2. Convenient access to the data by the scientific community is an important element of this RFA, as are state-of-the-art processes for maintaining the security of sensitive data and sample confidentiality. Applicants must propose a plan for rapid public release of well-documented and user-friendly research files, and plans for user support and user training. Applicants should consider successful approaches to the dissemination of large-scale survey data including confidential elements and linked administrative data or geographic detail. Examples are NACDA or other sites that meet scientific standards of documentation, openness and access (e.g., the Health and Retirement Study, Panel Study of Income Dynamics, Wisconsin Longitudinal Study, etc.), while scrupulously safeguarding confidentiality. The plan for dissemination of publicly-available data must be justified in the application. Applicants are also referred to Section 6.
3. Prior to award, a Data Safety and Monitoring Board, whose purpose will be to monitor the study and advise NIA, will be established. Scientific experts and representatives of relevant federal agencies will be appointed to the DSMB prior to the award by NIA.
4. After award, the study should appoint an advisory panel, made up of experts in the scientific community, to broadly advise the PD/PI throughout the survey design and implementation process. Names of advisory group members should not be given in the application; rather, guidelines for how they will be selected (e.g., what substantive areas would be covered) should be briefly discussed in the application. Potential advisory group members should not be approached until after the application has undergone peer review and the application is awarded. If desired, funds may be requested for this activity in the application (see Section VI.2, Administrative and National Policy Requirements).
5. A timeline for the development of the proposed survey, data collection, and public use file production is required in the budget justification section of the application.
6. Limited funds for analyses are permitted for the purpose of study development only, e.g. data cleaning, validation, pilot questions, preparing for future waves, etc., and substantive analyses of major outcomes should not delay or hamper public release of the data. A timeline for making the data publicly available must be proposed. Substantive analyses are expected to be conducted under separate grant mechanisms.
References
Summaries of two National Academy of Sciences expert meetings on the future of the NLTCS. http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/ConferencesAndWorkshops.htm
Freedman VA, Schoeni RF, Martin LG, Cornman JC. Chronic conditions and the decline in late-life disability. Demography. 2007 Aug;44(3):459-77.
Manton KG, Gu X, Lamb VL. Change in chronic disability from 1982 to 2004/2005 as measured by long-term changes in function and health in the U.S. elderly population. Proc Natl Acad Sci U’s A. 2006 Nov 28;103(48):18374-9. Epub 2006 Nov 13.
Freedman VA, Martin LG, Shoeni RF. Recent trends in disability and functioning among older adults in the United States: a systematic review. JAMA. 2002. 288(24):3137-46.
Special Requirements
Applicants who wish to propose conducting additional waves of the NLTCS or a successor study using the NLTCS sample must budget for a sub-contract with Duke University. Due to consent agreements under which NLTCS participants were solicited in the 2004 wave, access to identifiable information about panel members is restricted to Duke University. Therefore, Duke University has agreed to collaborate with any awardee who proposes using the NLTCS sample. Minimally, this collaboration is for the purpose of reconsenting previous survey respondents to permit reinterview by a different institution. Thus, Duke University collaboration is minimally required only until the reconsent process for the next wave, and any data transfers, are complete.
When developing the informed consent procedures for the next wave of the NLTCS, applicants must consent panel members in a manner that protects their confidentiality, but that permits their identifiable information to be released from Duke University to the applicant for the purpose of conducting the proposed survey. In addition, consent must be obtained to permit panel members identifiable information to be transferred to another institution at a later date, should another institution in the future (not the applicant) be authorized to continue the study. In the Protection of Human Subjects section of the Research Plan, applicants should specify their proposed informed consent form and procedures and discuss how they propose to handle cases that decline to consent or that consent to be surveyed by the applicant but do not consent to have their identifiable information transferred to another institution at a later time.
Applicants should not contact Duke University to negotiate directly regarding budget or scope of work. Applicants wishing to use the NLTCS sample in any way should budget for one-year estimated funds of $862,000 in Total Costs to Duke University. This includes an estimated $162,000 in costs to Duke University (which will negotiate necessary reconsenting agreements with Duke University’s Institutional Review Board, the Census Bureau, the Centers for Medicare and Medicaid Services, the Research Data Assistance Center (ResDAC), and the Office of Management and Budget) and an estimated $700,000 in costs to the data collection organization Duke University contracts with to obtain the NLTCS sample person s consent for Duke University to release their records for use in subsequent rounds of the survey. These are estimated costs only and the final budget will depend on whether or not an opt-out or opt-in approach for reconsent is used. These total estimated costs include any data transfers required. Depending on the design proposed, the estimated costs may or may not be merged with the full costs of the next interview wave. In other words, if applicants propose using the same data collection agent as the one contracted by Duke University to conduct the reconsenting operation, the estimated $700,000 for reconsenting would be merged with costs for data collection, and it would be possible to combine reconsenting with the next wave of data collection. If applicants propose another survey organization for the data collection, the estimated $700,000 would be just for the reconsenting procedure and the next wave of data collection would be done separately from the reconsenting.
Historically, the US Census Bureau has served as the data collection agency for the NLTCS. Applicants who wish to use the Census Bureau as the data collection agency for the next interview should contact the NIA Scientific/Research Contact named in Section VII.
After a funding decision is made, and if the award requires NLTCS identifiable information, final budgets will be decided after direct negotiations among the selected awardee, Duke University, and the NIA. Also, NIA must approve the proposed informed consent form and procedures prior to award.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding opportunity
will use the Cooperative
Agreement (U01) award mechanism.
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 U01 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". NIA
does not expect to reissue this FOA. The successful applicant is encouraged to apply for competing
supplements and/or competing renewals for subsequent waves of data
collection/data processing using the U01 mechanism.
2. Funds Available
The nature and scope of the
proposed research will vary from application to application. The size of
the expected award is not fully determined at this time (see Special
Requirements ). The duration of the award is 5 years.
Although the financial plans of the National Institute on Aging provides
support for this program, the award pursuant to this funding opportunity is
contingent upon the availability of funds and the submission of a sufficient
number of meritorious applications.
The National Institute on Aging intends to commit approximately $2.4 - $3.6 million direct costs in FY2008 to fund one application. The total cost budget over the 5 year grant period is expected to range from $12 - $18 million direct costs.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.
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 support.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the NIH Grants Policy Statement.
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
A PD/PI may submit only one
application to this FOA.
Section
IV. Application and Submission Information
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.
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: December 20, 2007
Application
Receipt Date: January 18, 2008
Peer Review
Date(s): June/July 2008
Council Review
Date: August 2008
Earliest
Anticipated Start Date: September 30, 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:
Georgeanne E. Patmios, M.A.
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, MSC 9205
Gateway Building, Suite 533
Bethesda, MD 20892-9205 (use 20814 for express mail)
Telephone: (301) 496-3138
Fax: (301) 402-0051
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, appendix material and five signed photocopies of the
application in one package to:
Center for Scientific Review (CSR)
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).
Using the RFA Label: The RFA label available in
the PHS 398 application instructions must be affixed to the bottom of the face
page of the application. Type the RFA number on the label. Failure to use this
label could result in delayed processing of the application such that it may
not reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form and
the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
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 National
Institute on Aging.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 review, unless the applicant withdraws
the pending application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to a funding opportunity, it is to be prepared as a NEW
application. That is, the application for the funding opportunity must not
include an Introduction describing the changes and improvements made, and the
text must not be marked to indicate the changes from the previous unfunded
version of the application.
Information on the status of an application should be
checked by the Principal Investigator in the eRA Commons at: 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
Not applicable.
Plan for Sharing Research
Data
This FOA requires a data sharing plan
for the storage and dissemination of publicly-available and user-friendly data
for research use. The precise content of the data-sharing plan will
vary. Applicants are expected to describe the expected schedule for data
sharing, appropriate data cleaning, file construction, the documentation to be
provided, whether or not any analytic tools also will be provided, special
protections for linked administrative data and data with geographic
identifiers, and procedures to safeguard confidentiality. Applicants
should consider successful approaches to the dissemination of large-scale survey
data such as the National Archive of Computerized Data on Aging (NACDA) or
other sites that meet scientific standards of documentation, openness and
access (e.g., the Health and Retirement Study, Panel Study of Income Dynamics,
Wisconsin Longitudinal Study, etc.). The plan for dissemination of
publicly-available data must be justified in the application. If a
continuation of the NLTCS is proposed, the data sharing plan should describe
how the 1982-2004 files will be incorporated. Applicants should also describe
their track record of producing timely and user-friendly public-use data files
from prior data collection activities.
This FOA also requires that the data sharing plan describe plans to service user requests and for appropriate data user training workshops.
The data sharing policy is available at http://grants.nih.gov/grants/policy/data%5Fsharing/ .
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.
Sharing Research Resources
Not applicable.
Section
V. Application Review Information
1. Criteria
Only the review criteria
described below will be considered in the review process.
The following will be
considered in making funding decisions:
2. Review and Selection Process
Applications that are
complete and responsive to the RFA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by the Center for Scientific
Review in accordance with the review criteria stated below.
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)? Has the PD/PI
successfully directed and managed large-scale, complex longitudinal
studies? Is the PD/PI a recognized leader in the scientific areas
proposed? Do the PD/PI and the proposed data collection agency have a
positive record of producing and disseminating timely and user-friendly public
data files? Does the proposed data collection agency have a record of
producing high quality data and achieving high response rates?
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 and Minorities in Research: The adequacy of plans to include subjects from both
genders and all racial and ethnic groups (and subgroups), 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).
2.B. Additional Review
Considerations
Data Sharing Plan: Is the data sharing plan sound and innovative, in terms of
quality and timeliness?
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
This FOA requires a data sharing plan for the storage and dissemination
of publicly-available and user-friendly data for research use. Applicants
are expected to describe the expected schedule for data sharing, appropriate
data cleaning, file construction, the documentation to be provided, whether or
not any analytic tools also will be provided, special protections for linked
administrative data and data with geographic identifiers, and procedures to
safeguard confidentiality. Applicants should consider successful
approaches to the dissemination of large-scale survey data such as the National
Archive of Computerized Data on Aging (NACDA) or other sites that meet
scientific standards of documentation, openness and access (e.g., the Health
and Retirement Study, Panel Study of Income Dynamics, Wisconsin Longitudinal
Study, etc.). The plan for dissemination of publicly-available data must
be justified in the application. If a continuation of the NLTCS is
proposed, the data sharing plan should describe how the 1982-2004 files will be
incorporated. Applicants should also describe their track record of
producing timely and user-friendly public-use data files from prior data
collection activities.
This RFA also requires that the data sharing plan describe plans to service user requests and for appropriate data user training workshops.
The data sharing policy is available at http://grants.nih.gov/grants/policy/data%5Fsharing/.
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.
2.D.
Sharing Research Resources
Not applicable.
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
NIA must approve the proposed informed consent form and
procedures prior to award.
A Data Safety and Monitoring Board (DSMB) whose purpose will be to monitor the study and advise NIA will be established prior to award. The NIA will appoint independent scientific experts and representatives of relevant federal agencies to a DSMB prior to award and the final choice of membership will be the NIA s.
After award, the study should appoint an advisory panel, made up of experts in the scientific community and not connected with the study except in this capacity, to advise the PD/PI throughout the survey design and implementation process. The DSMB will report to the NIA and to the study’s advisory panel. Names of advisory group members should not be given in the application; rather, guidelines of how they will be selected (e.g., what substantive areas would be covered) should be discussed in the application. Also, potential advisory group members should not be approached until after the application has undergone peer review. If desired, funds may be requested for the advisory panel (Also see below, 2.A.3., Collaborative Responsibilities).
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 (U01), 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 below.
2.A.1. Principal
Investigator Rights and Responsibilities
The Principal
Investigator will have the primary responsibility for the design and
details of the study, and will retain primary responsibility for performance of
the activity including analyzing and publishing results, negotiating required
Data Use Agreements with the Centers for Medicare and Medicaid Services and
other administrative data as required, and maintaining ownership over data
collected. The awardee agrees to accept assistance from the designated
NIH/NIA Project Scientist in aspects of the scientific and technical management
of the study and in coordinating with other Federal agencies (see below under
2.A.2., NIH Responsibilities and 2.A.3., Collaborative Responsibilities).
After award, the PD/PI should appoint an advisory panel, made up of experts in the scientific community, to advise the PD/PI throughout the survey design and implementation process (also see below under 2.A.3., Collaborative Responsibilities).
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
An NIH Project Scientist
will have substantial programmatic involvement that is above and beyond the
normal stewardship role in awards, as described below.
The NIH/NIA project scientist will provide assistance to the PD/PI and project team in coordinating survey design and operations with participating federal agencies. If the awardee will continue the NLTCS, the NIA role will additionally include coordination among the awardee, Duke University and the contractor selected by Duke University for the purposes of reconset.
The NIH/NIA project scientist will serve as a nonvoting member of the advisory panel appointed by the PD/PI and will provide assistance in establishing, and in providing operational support for, the federal coordinating group described under 2.A.3., Collaborative Responsibilities.
Additionally, an agency
program official or IC program director will be responsible for the normal
scientific and programmatic stewardship of the award and will be named in the
award notice. The program
official will also monitor the progress of the data sharing plan.
2.A.3.
Collaborative Responsibilities
In addition to the Advisory Panel to be selected by the PD/PI, the PD/PI, the NIH/NIA Project Scientist, relevant sub-contractor organizations, and representatives of participating federal agencies will meet as a federal coordinating group at least twice during the first year of the award and at least once a year in subsequent years. Meetings of the federal group may be coordinated with meetings of the external advisory group. The federal group will exchange information on data needs, data collection, data quality, available federal resources and methodological issues.
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 Advisory Panel 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
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 Contacts
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:
Georgeanne
E. Patmios, M.A.
Behavioral and Social Research
Program
National Institute on Aging
7201 Wisconsin Avenue, MSC 9205
Gateway Building, Suite 533
Bethesda, MD 20892-9205 (use 20814 for express mail)
Telephone: (301) 496-3138
Fax: (301) 402-0051
Email: [email protected]
2. Peer Review Contacts:
Not
applicable
3.
Financial or Grants Management Contacts:
Ms. Deborah Stauffer
Grants and Contracts
Management
National Institute on
Aging
Gateway Building, Suite
2N212
Bethesda, MD
20892-2292
Telephone: (301) 496-1472
Fax: (301) 402-3672
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Human Subjects
Protection:
Federal regulations
(45CFR46) require that applications and proposals involving human subjects must
be evaluated with reference to the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to be gained
(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 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 public access to
research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided
guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this 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.
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.
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.
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. For
publications listed in the appendix and/or Progress report, internet addresses
(URLs) must be used for publicly accessible on-line journal
articles. Unless otherwise specified in this solicitation,
Internet addresses (URLs) should not be used to provide any other information necessary for 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 FOA 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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