and Human Services (HHS)
EXPIRED
Department of Health and
Human Services
Participating
Organizations
National
Institutes of Health (NIH), (http://www.nih.gov/)
Centers
for Disease Control and Prevention (CDC), (http://www.cdc.gov/)
Components of
Participating Organizations
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
Office of Behavioral and Social
Sciences Research (OBSSR), (http://obssr.od.nih.gov/content)
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute for Occupational
Safety and Health (NIOSH/CDC), (http://www.cdc.gov/niosh/)
Title: Limited Competition for Evaluating the Health Benefits
of Workplace Policies and Practices Phase II (U01)
Announcement Type
This is a renewal of RFA-HD-04-017 which was previously published September 24, 2004
Request For Applications (RFA) Number: RFA-HD-07-101
Catalog of Federal Domestic Assistance Number(s)
93.865, 93.866, 93.262
Key Dates
Release Date: November 27, 2007
Letters of Intent Receipt Date: December 28, 2007
Application
Receipt Date: January 29, 2008
Peer Review Date: June 2008
Council Review
Date: October 2008
Earliest
Anticipated Start Date: September 15,
2008
Expiration Date: January 30, 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(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application
Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award
Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
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 announcement will allow the Work, Family, and Health Network (hereafter referred to as WFHN or the Network ) the opportunity to proceed to an implementation and evaluation phase. In the initial developmental phase, network members conducted pilot studies and interdisciplinary projects to develop a workplace intervention in response to RFA-HD-04-017, Developing Studies Designs to Evaluate the Benefits of Workplace Policies and Practices. In Phase II, network members will implement a workplace intervention aimed at reducing work-family conflict and evaluate the health benefits for workers, workers families and children/dependents, and the employers places of business.
Background
Balancing work and family responsibilities is a frequent source of stress and strain which affects the individual, family, and workplace. In the scientific literature, this experience is generally termed work-family conflict. Work-family conflict may generate spillover, where negative consequences follow the employee from the workplace into the home, and crossover effects, where negative consequences spread from the employee to other employees in the workplace or family members (including spouses, dependent children, and adult care recipients, such as aging parents or disabled spouses) in the affected home.
It is important to understand how the multifaceted pressures of work and family form an environmental context influencing health and well-being among employees and their family members. Previous research demonstrates that control over one’s schedule and supportive supervisors are associated with lower levels of work-family conflict, but the literature does not provide evidence about how organizations can facilitate schedule control and supervisor support. Workplaces may or may not choose to provide policies to assist workers as they attempt to simultaneously handle their family and work responsibilities, and policies that exist on the books may not be accessible or may be implemented unevenly. Epidemiological evidence suggests that job and family demands each have important effects on health, but understanding their complex interactions goes beyond any single research paradigm and requires interdisciplinary theory-building and methodological development. Strategies to alleviate work-family conflicts will thus require innovative, interdisciplinary solutions.
The toll of work-family conflict has received increasing attention recently in the popular press, particularly in magazines aimed at businesses, work-life professionals, and employed parents and family caregivers. Articles in scientific journals have suggested links between working conditions and health-relevant outcomes such as stress, sleep, and parents success in scheduling health care appointments for family members. State and federal governments in Australia and the United Kingdom have established the right to request a flexible schedule in order to care for dependents. In the United States, flextime was the subject of a recent GAO report with associated testimony to Congress (http://jec.senate.gov/hearings.htm#061407). One goal of this program is to support high-quality research in the area of strategic interventions so that these public discussions can be informed by a solid scientific base of evidence.
Types of Research and Approaches Sought
Proposals responsive to this FOA should detail a specific workplace intervention protocol designed to ameliorate work-family conflict experienced by employees and address worker, family, and employer health and concerns. This intervention should involve both employees and their supervisors, and it should address both the social/temporal organization of work and the organizational culture of the workplace. The intervention proposed should allow for adaptability to the needs of different types of workers and workplaces, but the investigators should discuss plans to retain conceptual fidelity across sites.
Studies should conceptualize a mediational link between the amelioration of work-family conflict by this intervention and health outcomes. Health outcomes should be examined for multiple stakeholders: workers, their families and children/dependents, and employers. Relevant health outcomes for individual workers include self-reported health, health behaviors, known pre-disease pathways for chronic conditions, indicators of stress, and safety/injuries. Relevant outcomes for crossover effects to workers family members include pre-disease pathways, hormonal stress indicators, and family interpersonal processes. Assessments of health outcomes for the workplaces involved may include productivity, absenteeism, retention, rates of accidental injury, and crossover effects within work groups, in addition to the employers likely return on investment.
Proposals should also include a sustainability/translation component, in which the Network will continue to work with the Employer and Employee Advisory Committees, as well as communicate with other business and lay groups. This community participation will ensure the realistic and feasible nature of the intervention development and implementation and the relevance of the evaluation conducted. The ultimate goal of this Network is that the results of the research and the methodologies developed will eventually be accessible and informative to employers and employees for their own use in the implementation of work-family policy interventions.
The next phase of the Network will implement and evaluate a workplace intervention for which preliminary studies demonstrate evidence of improving work-family conflict and employee health. The intervention will address control of the daily work process and the culture in which supervisors and their reports interact. The intervention will target multiple levels of organization in the workplace. The study design will allow for randomization at the group level, with treatment and control groups. The Network will study businesses in two industries to allow for variation in the level of professionalization of workers and economic constraints facing employers, and to improve the perceived replicability of the findings. Within each industry, the Network will recruit enough worksites and employees per worksite to power hypotheses delineating the main effect of the intervention. The presence of spillover and crossover effects should be evaluated. Outcomes will include indicators of worker health (e.g., blood pressure, sleep quality), family and child health (e.g., spousal relationships, children’s stress), and employer health (e.g., productivity, absenteeism). Adhering to the standards of true external validity (e.g., random sampling to obtain a representative sample of workplaces) in not possible within the constraints of this project, so the study design should focus on internal validity with an eye to producing an intervention and evaluation methodology with the potential to be replicable across a range of workplace situations and worker populations.
Researchers will collect data from multiple respondents worker, employer, spouse, and child or other relevant dependents. Data will be collected using multiple methods, at multiple levels of the organization and across multiple points in time. The Network will conduct primary data collection with both treatment and control workers in their places of employment. The Network will also collect data from a subset of treatment workers and their family members in the home. Data collection components may include on-line surveys, interviews (in person and/or by telephone), and both objective and self-report indicators of health outcomes. With employer cooperation, the Network will take advantage of administrative sources of outcomes data that companies already collect, such as retention and productivity measures.
The intervention and evaluation should include baseline and follow-up interviews. Collection of biological specimens and objective health indicators (e.g., salivary hormones, blood spots, sleep duration, blood pressure, and height and weight) and gathering of relevant administrative records should also occur at appropriate intervals. Researchers will interview/survey respondents in languages other than English if necessary. Researchers will test the efficacy of the intervention in a population-based model and will also examine individual trajectories in substudies of specific workers and family members. Research plans will also address diversity among workers along the lines of race, ethnicity, nativity, family structure, and gender. The evaluation will include measures of implementation to assess at what level the intervention was actually implemented and utilized.
The intervention must be framed for each workplace as taking into account the existing conditions for the specific firm and not present a standardized package imposed without tailoring. Therefore, implementation will require walking a careful line between customization and the maintenance of fidelity across sites. Previous efforts in dissemination research have often assumed that interventions can be transferred into any service setting without modification and that a unidirectional flow of information (e.g., publishing a guideline) is sufficient to achieve practice change. "Success" of the transfer has been largely assessed based on structural measures (such as counts of training sessions provided or average duration of time per employee spent attending sessions) or recipient outcome measures that do not specifically assess how the intervention was implemented or whether the implementation remained faithful to the original conceptualization and intent of the intervention. Collecting information for a process evaluation will be part of the Phase II data collection.
Applicants should present a unified vision of the work to be undertaken in Phase II. Applicants should provide considerable evidence of preliminary studies contributing to the feasibility of the overall project. The initial hypothesis of this initiative, that work-family conflict impacts health, has been demonstrated through the preliminary work done in Phase I and thus should be described. Additionally, applicants should demonstrate their ability to work collaboratively within their own proposed research team, with the larger Network, and as a partner with the Federal Government in a cooperative agreement mechanism. Relevant areas of scientific expertise required by the interdisciplinary nature of this project should be covered across the entirety of the investigative teams.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity
will use the U01 award mechanism(s).
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". Plans beyond the current funding
opportunity are indefinite.
2. Funds Available
The
participating ICs and agencies, NICHD, OBSSR, NIA, and NIOSH, intend to commit
approximately 5.8 million dollars in FY 2008 to fund up to six competing continuation grants in response to this RFA.
Applicants should request a project period of five years and should request
support appropriate to the fulfillment of the responsibilities of their role in
the Network (RU, DCC, or TCC). The earliest anticipated start date is September
15, 2008.
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 ICs and agencies provide support for this program,
awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation, see NOT-OD-05-004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
Applications may only be
submitted by currently-supported investigative teams of the Work, Family, and
Health Network. Individual investigators may submit only one
application, but a given application may involve multiple sites, including
other WFHN grantees and partners.
Eligible institutions may include;
1.B. Eligible Individuals
The principal
investigator of each application must possess the skills, knowledge, resources,
and professional experience needed to carry out the proposed research and
research capacity development goals and objectives of the Work, Family, and
Health Network. In addition, they should have an established productive,
working relationship as scientific collaborators.
The
applicant(s) will be solely responsible for planning, directing, and executing
the proposed project. Individuals from
underrepresented racial and ethnic groups
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current 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
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 28,
2007
Application
Receipt Date: January 29, 2008
Peer Review Date: June 2008
Council Review
Date: October 2008
Earliest
Anticipated Start Date: September 15,
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:
Jeff
Evans, Ph.D.
Demographic and Behavioral
Sciences Branch
National Institute of
Child Health and Human Development
6100 Executive Blvd., Room
8B07, MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier or
express service)
Telephone: (301) 496-1176
Fax: 301-496-0962
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications must be
prepared using the research grant applications found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and 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).
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 program staff. 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 and HHS awards
are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The Grants Policy Statements can be found at http://grants.nih.gov/grants/policy/policy.htm and http://www.hhs.gov/grantsnet/adminis/gpd/.
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
Collaborative
Arrangements
The grantees will form a scientific partnership with NICHD, OBSSR, NIA, and NIOSH to implement and evaluate organizational policy, practice, and process interventions in workplace settings. Evidence of prior collaboration and a plan for proposed collaborations between the investigators and proposed access to relevant workplaces must be provided. The application must provide details of agreements regarding sub-contracting arrangements and the approach to conducting the team science effort, through its description of: the roles and areas of responsibility of participating scientists, the process for making decisions on scientific direction, allocation of resources, publications, intellectual property issues, procedures for resolving conflicts, and other information related to the management of the proposed project in order to demonstrate the potential effectiveness of such collaboration for the ongoing work of the Network.
Meetings
Grantees and federal staff may meet up to four times per year, usually in the Washington, D.C. area. The PI should include funds in the proposed budget for attendance at these meetings. The budget request may also include funds for up to four trips per year for other members of their research team to attend key meetings. Each meeting will be approximately two days in length.
Center Structure and Requirements
The WFHN shall have three types of components: four Research Units (RUs), one Data Coordinating Center (DCC), and one Translation Coordinating Center (TCC). The PIs of all Centers shall have equal rights and responsibilities within the governance framework of the Network.
Research Units (as a group) shall:
The Data Coordinating Center shall:
The Translation Coordinating Center shall:
Required Application Components
Applications submitted in response to this RFA should indicate whether the applicant is applying for the role of RU, DCC, or TCC. Applicants for RU and DCC grants should provide a description of the proposed intervention and evaluation in Section D. Research Design and Methods. Applicants for the TCC should substitute a description of their plans to fulfill responsibilities for translation, dissemination, and logistics.
Plan for Sharing Research Data
The precise content
of the data-sharing plan will vary, depending on the data being collected and
how the investigator is planning to share the data. Applicants who are planning
to share data may wish to describe briefly the expected schedule for data
sharing, the format of the final dataset, the documentation to be provided,
whether or not any analytic tools also will be provided, whether or not a
data-sharing agreement will be required and, if so, a brief description of such
an agreement (including the criteria for deciding who can receive the data and
whether or not any conditions will be placed on their use), and the mode of
data sharing (e.g., under their own auspices by mailing a disk or posting data
on their institutional or personal website, through a data archive or enclave).
Investigators choosing to share under their own auspices may wish to enter into
a data-sharing agreement. References to data sharing may also be appropriate in
other sections of the application.
Applicants requesting
more than $500,000 in direct costs in any year of the proposed research must
include a plan for sharing research data in their application. The funding
organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of
the data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy expects that
grant 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.
Section
V. Application Review Information
1. Criteria
Only the review criteria
described below will be considered in the review process.
RU applicants
may propose to oversee intervention worksites, analyze health outcomes, and/or
conduct substudies in specific populations, as appropriate to their
expertise. In any case, the research proposed should be integral to the
goals of the Network.
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 CSR 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 preventive interventions that drive this field? Will this study advance
knowledge of the impacts of work-family conflict and interventions to
ameliorate it on stakeholders: workers, their families and children/dependents,
and employers?
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? Is the approach well-grounded in the preliminary studies presented? Will
the study have internal validity?
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)?
Research Unit Applicants
Evidence of successful past performance: Does the applicant demonstrate high quality prior experience in the design, conduct, and data analysis of research projects and with collecting data in workplaces or from workers family members outside the workplace? Has the applicant performed successfully as a collaborator in Phase I network activities?
Qualifications and commitment of key personnel:
Does the
applicant present an effective plan to cooperate in all Network functions? Does the applicant
present an effective plan for internal leadership and collaboration? Does the
applicant propose appropriate commitment of staff time for the satisfactory
conduct of Network activities? Are the described capabilities to fulfill the
responsibilities proposed for this Research Unit in concert with the other
investigative teams adequate?
Data
Coordinating Center
Evidence of successful past performance: Does the applicant demonstrate high quality prior experience in the design, conduct, data collection, data analysis, and data management of major research projects? Has the applicant performed successfully as a collaborator in Phase I network activities?
Qualifications and commitment of key personnel:
Does the Principal Investigator present an effective plan to cooperate in all Network functions? Does the application demonstrate appropriate expertise and capability in statistics, econometrics, study design, development and support, as well as data analysis, project management, staff site training, and quality assurance procedures? Does the applicant propose appropriate commitment of staff time for the satisfactory conduct of Network activities?
Evidence of management capability: Does the applicant demonstrate the ability to estimate appropriate and reasonable resources for research studies? Does the applicant demonstrate the ability to manage research resources efficiently during study execution? Does the applicant demonstrate the ability to enhance collaboration among Research Units of the Network?
Translation Coordinating Center
Evidence of successful past performance: Does the applicant demonstrate high quality prior experience in the design, conduct, and dissemination of findings from major research projects? Has the applicant performed successfully as a collaborator in Phase I network activities?
Qualifications and commitment of key personnel:
Does the Principal Investigator present an effective plan to cooperate in all Network functions? Does the applicant demonstrate appropriate expertise and capability in communicating research findings to non-academic audiences, and in creating and maintaining relationships between non-academic stakeholders and researchers, and in the science of translation? Does the applicant propose appropriate commitment of staff time for the satisfactory conduct of Network activities?
Evidence of management capability: Does the applicant demonstrate the ability to balance the competing and coinciding needs of the research and business communities in joint efforts? Does the applicant demonstrate the ability to manage communication and logistical resources efficiently across the Network and all components (e.g., Steering Committee, Advisory Boards)? Does the applicant demonstrate the ability to enhance collaboration among Research Units of the Network?
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).
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing. Program staff will be responsible for the
administrative review of the plan for sharing research data.
2.D. Sharing
Research Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to
this funding opportunity should include a sharing research resources plan
addressing how unique research resources will be shared or explain why sharing
is not possible.
Program staff will be responsible
for the administrative review of the plan for sharing research resources.
The adequacy of the
resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not
applicable
Section VI. Award Administration Information
1. Award Notices
After the peer review of
the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms
and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the
business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm). See also Part II Terms and
Conditions of HHS Grant Awards (http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc).
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
Each PI and his or her investigative team will have primary
responsibility to carry out their portion of the intervention, as described in
their proposal.
Each investigator will have the right to publish results
from their individual research programs from Phase I, but they should
collaborate with the Steering Committee and the Translation Coordinating Center to ensure that relevant findings are communicated to the Network and to
other interested parties. Due publication credit will be given to all work done
cooperatively from Phase I and in Phase II.
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
A NICHD Program Scientist will have substantial programmatic
involvement that is above and beyond the normal stewardship role in awards, as
described below. Program staff from the co-sponsoring NIH ICs also will be
involved in the WFHN program, primarily as Staff Science Collaborators.
NICHD Staff Involvement: Program Scientist and Project Officer
NICHD Program Scientist
The NICHD Program Scientist will serve as the principal representative of NICHD and NIH and will have substantial programmatic and scientific involvement that is above and beyond the normal stewardship role in awards and will, in consultation with relevant NICHD program staff and representatives of the other NIH co-sponsors, provide overall programmatic oversight, coordination, and assistance to the Network.
Specifically, the NICHD Program Scientist will:
NICHD Project Officer
Additionally, a NICHD Project Officer will be responsible for the normal scientific and traditional programmatic stewardship of the cooperative agreement award and will be named in the award notice. This role is separate from the Program Scientist and will include the following:
NIH Staff Science Collaborators
Program representatives of the other NIH co-sponsors may serve as Staff Science Collaborators to the Network. They may participate in Steering Committee meetings as non-voting members. Specifically, the NIH Staff Science Collaborators will:
2.A.3 CDC/NIOSH Responsibilities
CDC/NIOSH Staff Involvement: Program Official and Staff Science Collaborator CDC NIOSH Program Official
A NIOSH Program Official will be responsible for the normal scientific and traditional programmatic stewardship of the cooperative agreement award(s) administered by CDC/NIOSH and will be named in the award notice. This role will include the following:
CDC/ NIOSH Staff Science Collaborator
A NIOSH intramural scientist may serve as a Staff Science Collaborator to the Network and may participate in Steering Committee meetings as a non-voting member. Specifically, the NIOSH Staff Science Collaborator will:
The NIOSH Staff Science Collaborator will not be involved in evaluation of the progress of the award or Extramural Program decisions affecting the award.
2.A.4. Collaborative
Responsibilities
In addition to the above specified rights, responsibilities,
and involvement, the WFHN components have collaborative responsibilities. These
include interaction with the Advisory Boards and membership on the Steering
Committee.
Steering Committee
The Steering Committee will serve as the Network's central point of communication; exchange of ideas; development, review and management of common protocols; research and training activities; and problem resolution. The Steering Committee, through the Publication Subcommittee, reviews all collaborative presentations and publications. The Steering Committee is composed of the PI of each Research Unit, the PI of the Data Coordinating Center, the PI of the Translation Coordinating Center, and the NICHD Program Scientist, each of whom have one vote. The Steering Committee will elect a Chair or Co-Chairs on an annual basis; in the case of a tie, the vote of the NICHD Project Scientist will not count. Representatives of other NIH and CDC co-sponsoring Institutes and Centers (ICs) may participate as non-voting members.
The Steering Committee will meet quarterly in person and will participate in telephone or video conferences as needed between Steering Committee meetings. The PI should plan to attend these meetings and may also plan for up to six trips per year for other members of their research team to attend key meetings or research conferences. Each Steering Committee meeting will be approximately two days in length. During the meetings, the Steering Committee will discuss research progress and problems for each site, refine common theoretical and analytic approaches and the research design, and discuss the implications of their research with interested parties outside of the Network who may be invited by the Steering Committee as warranted. Subcommittees will participate in face-to-face meetings and conference calls as needed.
The Steering Committee members will:
B. Employer and Employee/Union Advisory Committees
The TCC will be responsible for maintaining and communicating with these advisory bodies and for representing their interests to the Steering Committee. These advisory bodies will review proposed research plans, comment upon their feasibility and practical importance, assist in the implementation of research where appropriate, and carry out other activities determined by the Steering Committee.
2.A.5. Arbitration
Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. An
Arbitration Panel composed of three members will be convened. It will have
three members: a designee of the Steering Committee chosen without NIH staff
voting, one NIH designee, and a third designee with expertise in the relevant
area who is chosen by the other two; in the case of individual disagreement,
the first member may be chosen by the individual awardee. This special
arbitration procedure in no way affects the awardee's right to appeal an
adverse action that is otherwise appealable in accordance with PHS regulations
42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
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:
Jeff
Evans, Ph.D.
Demographic and Behavioral
Sciences Branch
National Institute of
Child Health and Human Development
6100 Executive Blvd., Room
8B07, MSC 7510
Bethesda, MD 20892
Telephone: (301) 496-1176
Fax: 301-496-0962
Email: [email protected]
Bernadine B. Kuchinski, Ph.D.
National Institute for Occupational Safety and Health
Office of Extramural Programs
4676 Columbia Parkway,
Room 152
Cincinnati, OH 45226
Telephone: (513) 533-8511
Fax: (513) 533-8564
Email: [email protected] and please copy [email protected]
Lis Nielsen, Ph.D.
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Ave., #533
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Fax: (301) 402-0051
Email: [email protected]
2. Peer Review Contacts:
Valerie L. Durrant, Ph.D.
Scientific
Review Officer
Health of
the Population (HOP) Integrated Review Group
Center for
Scientific Review, NIH
6701
Rockledge Drive, Room
3140, MSC 7770
Bethesda, MD 20892-7770 (20817 for Fed Ex/delivery)
Telephone:
301-435-3554
Fax:
301-480-1056
Email: [email protected]
3. Financial or Grants Management Contacts:
Robin
Kurtz
Grants Management Branch
National Institute of
Child Health and Human Development
6100 Executive Blvd., Room 8A01, MSC 7510
Bethesda, MD 20892
Telephone: (301) 435-6978
Fax: (301) 451-5510
Email: [email protected]
Richard Proper
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Ave., #2N/212
Bethesda, MD 20892-N9205
Telephone: (301) 402-7735
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 but will not factor the
plan into the determination of the scientific merit or the priority score.
Access to Research
Data through the Freedom of Information Act:
The Office of Management
and Budget (OMB) Circular A-110 has been revised to provide access to research
data through the Freedom of Information Act (FOIA) under some circumstances.
Data that are (1) first produced in a project that is supported in whole or in
part with Federal funds and (2) cited publicly and officially by a Federal
agency in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for applicants to
understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
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.
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 RFA 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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