and Human Services (HHS)
EXPIRED
DEVELOPING STUDY DESIGNS TO EVALUATE THE HEALTH BENEFITS OF WORKPLACE POLICIES
AND PRACTICES
RELEASE DATE: September 24, 2004
RFA NUMBER: RFA-HD-04-017 (Reissued as RFA-HD-07-101)
EXPIRATION DATE: December 21, 2004
Department of Health and Human Services (DHHS)
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/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov/)
Office of Behavioral and Social Sciences Research (OBSSR)
(http://obssr.od.nih.gov/)
National Institute for Occupational Safety and Health (NIOSH)
(http://www.cdc.gov/niosh/homepage.html)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865, 93.273, 93.262
LETTER OF INTENT RECEIPT DATE: November 22, 2004
APPLICATION RECEIPT DATE: December 20, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute of Child Health and Human Development (NICHD), the
National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the Office of
Behavioral and Social Sciences Research (OBSSR) of the National Institutes of
Health and the National Institute for Occupational Safety and Health (NIOSH)
of the Centers for Disease Control and Prevention invite applications for
cooperative agreements (U01) to participate in a research network that will
design model protocols for intervention studies that examine the health
consequences of workplace policies and practices. These interventions should
be designed to improve employees' abilities to more successfully meet work and
family demands, thereby improving worker and family health. The purpose of the
RFA is to support the development of research plans focused on the
interrelations among work, family, health, and well-being that are state of
the art in conceptualization and measurement techniques. The model protocols
that are developed will serve as the basis for a future initiative to support
a set of multi-site interventions to evaluate which types of workplace
policies and practices are the most beneficial for the health and well-being
of workers, their families (including their children and other dependents),
and workplaces.
The network will consist of approximately five to eight developmental centers
and one coordinating center. Developmental centers will engage in two types of
research: (1) Individual Projects proposed in applications that are developed
and implemented primarily by the applicant research team, and (2)
Collaborative Projects that are undertaken by the network as a whole. Each
developmental center will partner with a business firm or organization
("workplace site") to conduct individual and collaborative research projects.
The coordinating center will work with all developmental centers in the
network to provide guidance, support, dissemination, and coordination of
common activities.
RESEARCH OBJECTIVES
Overview
This RFA calls for multidisciplinary research to develop innovative models for
quasi-experimental research to evaluate the effectiveness of existing,
modified, or newly developed workplace policies and practices for improving
health and well-being outcomes for the individual as worker, spouse, and
caregiver; for spouses; and for children and other dependents. The policies
and practices to be examined should be aimed at improving the ability of the
worker to successfully meet both work and family demands. Examples of
potential workplace interventions include, but are not limited to, changes in
schedule flexibility, benefits, workplace atmosphere, workplace-based
counseling programs, alcohol use policies and programs, and potential for
career growth. A major goal of this solicitation is to develop a common
theoretical model to guide research design that may be operationalized
differently across different workplace settings. Another goal is to develop a
common return-on-investment model that can be adapted to different workplace
settings in order to evaluate the costs and benefits for the employer of
implementing the interventions.
The innovative models developed by the network should incorporate relevant
theories, methods, and current bodies of research in the social sciences
(e.g., sociology, economics, psychology, child development, anthropology,
demography) on work, family and health, and work-family conflict; in
occupational health on workplace illness and injury; in epidemiology on the
social gradient in health; and in business and management on organizational
change. The resulting model interventions must be well grounded in theory, but
flexible enough to be applied in a variety of workplace settings and to assess
a number of important health and well-being outcomes for workers and their
families.
Background
Demographic, sociological, technological, and economic changes occurring in
the U.S. since the 1950s have radically altered family life, the nature of
work, and the conditions of employment. The contemporary situation presents
new challenges for men and women attempting to balance the ever more complex
demands of family and work and for employers attempting to adjust to changes
in the economy, the nature of work, and the workforce. All of these changes
can act independently or in concert to positively or negatively affect the
health of the workers themselves as well as the health of their family
members. Examining the interaction of these factors and their effects on
workers, families, and employers is important for the long-term social,
economic, and physical health of our society. In particular, the health of the
current generation of children is associated with long-term implications for
their ability to function as the next generation of workers upon reaching
adulthood.
Work has a strong impact on family health and well-being. Work characteristics
that may influence family health include access to health insurance and
flexibility in the time and place work occurs. These factors can constrain or
enhance a worker's ability to provide caregiving to children and other
dependents. The nature of work - such as psychosocial characteristics,
physical exposures, and work culture (e.g., alcohol use policies, managerial
policies and practices) at the level of the individual office and the
organization as an entity - affects workers' physical health and social and
psychological well-being. Through the effects of workplaces on workers, job
characteristics and work cultures can affect the health and well-being of
children and other family members. Occupations differ in the level of
absorption - or commitment - they require on the part of the person who fills
them. Some occupations require the unpaid assistance and cooperation of family
members. The number of work hours, shifts, and schedules tend to define the
pace of family life and determine when family members can all be together.
Work provides the income for consumption and income determines how family
members allocate their time between breadwinning and home and leisure
activities. The tradeoff between income and time inputs and how it affects the
health and well-being of children is a continuing source of debate among
sociologists, economists, and developmental psychologists. Income can be
variable, too; some jobs do not pay a living wage, others are temporary, and
still others do not have steady hours. People in low-wage jobs are typically
in worse health and suffer from more chronic diseases than people in better-
paying jobs. Workers with disabilities face unique challenges in finding
employment, retaining employment, and coping with ancillary health conditions.
How successfully people organize their work and family lives can affect their
health and well-being and that of their children, spouses, and other family
members by affecting the quality and quantity of time available to meet non-
work demands and by affecting income.
But, family life also affects work. During periods of particularly intense
family demands, such as the birth of a child or the illness of a family
member, workers may tend to "scale back" their commitment to long work hours
by seeking a temporary period of reduced hours or taking family leave, or, in
the event of a lack of workplace accommodations, may end up increasing their
absenteeism, letting their work slip, or quitting and looking for a position
that provides more accommodation. The addition of a disabled or chronically
ill dependent to the family may have long-term detrimental effects on an
employee's work situation and health. Increased home demands can also affect
the worker's physical health and social and psychological well-being, as well
as increase risk for alcohol abuse or dependence and other risky behaviors.
Thus, heavy or increasing family demands can affect employer well-being, along
with the well-being of workers and their families, both directly and
indirectly through feedback loops.
The effects of work and family on health and well-being vary by the
race/ethnicity, gender, family status, disability status, and socioeconomic
status of the worker and family, as well as by industry and occupation across
businesses and within the worksite. The health and well-being of disabled
workers and workers with disabled family members are particularly vulnerable
to work-family conflict. Non-white workers disproportionately occupy jobs
with lower pay, fewer benefits, and less flexible conditions. At the same
time, minorities have, on average, larger families and thus greater levels of
family responsibility. African-American women, in particular, spend less of
their lifetimes within marriage than white women while having slightly higher
fertility rates; thus, they tend to be particularly vulnerable as sole wage
earners with multiple dependents. Women continue to shoulder a
disproportionate amount of the burden of housework and child care even as
their responsibilities in the labor market increase. The gender gap in wages
persists for all but select sectors of the labor force and women face a wage
penalty for motherhood that continues for years after childbirth. Workers with
lower levels of income and education tend to occupy jobs with fewer benefits
and have fewer financial resources with which to purchase solutions to work-
family conflict, such as child care. Workers with these characteristics tend
to experience poorer health outcomes, even within the same occupational
categories.
Individual factors and multiple levels of contextual factors may act alone or
in combination to influence health outcomes. They also affect the replication
and generalization of research results in this area. Contextual factors may
include, but are not limited to, characteristics of the industry, the
employer, the occupation, the worker's family and community, and policy at
multiple levels, including employer administrative policies and broader local,
state or federal policies that affect intervention implementation or benefits
accrued from the intervention.
The work, family, health and well-being research discussed here grows out of a
large body of literature across social science and health science disciplines.
Research in the fields of occupational and public health has demonstrated that
the settings for and activities engaged in during work hours have concrete
consequences for disease, injury, and disability among workers. Mental health
research has also linked both work conditions and the consequences of those
conditions to psychological well-being and the potential for alcohol abuse and
other risky behaviors which, in turn, can impact family health and work
performance. Social science research shows that work and family experiences
(e.g., how much time one devotes to work and family domains, how well these
schedules match, and whether these experiences are positive or negative)
affect not only physical and mental health, but also social and economic well-
being of workers and their families. The nature of the work being done and the
workplace environment can affect the health and well-being of spouses,
children, and other family members, and how well the family functions.
Stressful home conditions resulting from competing work and family demands,
unfavorable work conditions, or the ill health or disability of a parent can
affect the cognitive, social, and emotional development of children and the
workers' performance in the workplace. Workplace access to health insurance
and child care has significant consequences for family resources.
Despite this large relevant research base, gaps remain between current
knowledge and the knowledge essential for altering workplace policies and
practices and structuring workplace environments in ways that consistently
promote healthy outcomes for workers and their families. Little research that
involves systematic implementation and evaluation of interventions exists. The
tendency for high turnover in upper management affects the ability to conduct
workplace interventions; long-term agreements for conducting and completing
research are difficult to secure. Employers may also be reluctant to allow
research in their workplaces because they believe it will disrupt operations,
lead to reductions in output, or produce results that call for implementation
of interventions that can be costly. The current state of knowledge identifies
policies and practices that are thought to improve health, but have not been
tested broadly. Workplace policies and practices that affect an individual's
ability to meet work and family demands with implications for health are many
and varied. For the most part, researchers and employers use terms like
'workplace policies and practices' to refer to rules governing the time and
place in which work is conducted. For example, in an effort to enable workers
to better combine work and family responsibilities, employers may introduce
policies designed to permit greater flexibility in scheduling of work and
allow work in telecommuting centers or at home to reduce commuting time. By
contrast, facilitating workers' abilities to better combine work and family
responsibilities may also be achieved by providing needed services (e.g.,
child care, health clinic) on site or close to the worksite, assisting workers
with expenses by administering flexible spending accounts, and making
available referral services to outside providers. Research plans that will be
developed in the projects supported by this RFA should consider workplace
policies and practices as traditionally examined, but should also consider the
feasibility of more radical approaches to work redesign.
Network Scope
This RFA will support activities necessary to develop a common
interdisciplinary theoretical framework and to design model protocols for
large, multi-site interventions. Investigators will be expected to:
o Meet regularly with other investigators to contribute to the development of
a common overall conceptual model that will serve as a guide to experimental
or quasi-experimental studies;
o Work together to explore theoretical, research design, and measurement
issues involved in experimental and quasi-experimental studies of workplace
interventions, including developing recommendations regarding measurement
tools and model protocols;
o Identify important health outcomes to be studied for individuals as workers,
spouses, and parents, children, and other dependents, and develop common
measures to use across worksites;
o Identify important sources of work-family conflict leading to poor health
outcomes for individuals as workers, spouses and parents, children, and other
dependents, and develop common measures to use across worksites, as feasible;
o Foster a partnership with a workplace site and conduct exploratory research
to identify workplace-specific issues and barriers for employers and
employees, and to identify appropriate intervention models;
o Conduct pilot studies, as appropriate, and study the feasibility of
implementing the specific site-appropriate interventions;
o Work together to develop a plan for a coordinated set of interventions to be
implemented on a large scale across workplace sites; and
o Work together to design a model or models to measure employer return on
investment for the implementation of interventions.
The Network will be assembled to achieve the broadest possible coverage in
terms of disciplinary perspectives in work and family conflict; methodological
techniques; health and well-being outcomes; diversity in research concepts and
workplace sites; and experience dealing with employers and conducting research
in workplaces. Workplace populations across the network should represent a
broad range of individuals, including adolescents, older workers, disabled
workers, women, members of various racial/ethnic groups, and low-wage workers.
The focus of the Network is the United States, but the exploration of foreign
sites and data sets may be justified if it provides an insight into the
American condition.
Investigators must be able to demonstrate that they have a long-term research
agenda that addresses important questions relevant to the research goals of
this RFA. In addition, they should describe the workplace sites to which they
have access and will use in their research planning. Existing access to a
specific workplace is not a requirement for every investigative team, but each
team without a specific workplace site should provide a detailed plan for
gaining access to a workplace and a description of the desired type of
workplace. It is important to describe the extent to which the investigative
team has experience in workplace interventions relating to issues of work-
family conflict. However, because a range of levels of prior workplace
intervention experience is permissible across the Network as a whole, not
every team needs to possess this expertise. Similarly, it is desirable that
return-on-investment expertise be present within the Network, although not
every team need have it. It is also important to outline the conceptual models
that will underlie the development of the research plans and to describe the
relevant theories that will be employed.
Research Scope
Individual Project:
Each Developmental Center application must propose a research plan for an
Individual Project that is designed to produce information that in some way
informs the design of the model protocols. The plan must have the same degree
of specificity as the research plan provided in an Exploratory/Developmental
grant (R21) application (see http://grants.nih.gov/grants/guide/pa-files/PA-
03-107.html).
Examples of possible individual projects designed to produce information that
will advance the goals of the RFA include, but are not limited to:
o Studies that investigate and measure the sources of work-family conflict;
o Theoretical research to develop a model that identifies the mechanisms
through which work, family, and health are related;
o Methodological studies to develop measures of work-family conflict;
o Studies pinpointing which workplace factors contribute to work-family
conflict, and determining whether and how these factors vary across
workplaces;
o Studies that focus on the varying need for and impacts of work-family
policies across diverse populations (e.g., low-income workers, single-parent
families, workers with disabilities);
o Meta-analytic studies summarizing what is known about workplace policies and
programs and their effectiveness;
o Studies that develop an employer return-on-investment model;
o Workplace-specific studies that address any combination of the above issues;
and
o Pilot studies of workplace-specific interventions.
Collaborative Projects:
Each Developmental Center application must also describe cooperative research
plans for the proposed Collaborative Project that transcend his/her team's
individual research project. The cooperative research plans should propose
questions of substantive, theoretical, methodological, and/or public policy
significance that would contribute to the development of innovative models for
quasi-experimental research to evaluate the effectiveness of existing,
modified, or newly developed workplace policies and practices for improving
health and well-being by reducing work-family conflict. These research plans
should take advantage of the unique character of a network and the expertise
therein to allow for the development of common protocols across a variety of
workplaces. Each PI should indicate how the team's disciplinary and
methodological perspectives would contribute to the broader collaborative
research effort. Also, investigators should describe the specific workplace
sites or types of workplaces that they have familiarity with and/or access to,
and whether they could be used for collaborative research.
Examples of possible collaborative research plans designed to produce
information that will advance the goals of the RFA include, but are not
limited to:
o Development of a common multidisciplinary theoretical model that can be
adapted to guide research in a variety of workplace settings and for a variety
of populations of workers;
o Identification and measurement of the most important dimensions of work-
family conflict that are common across a variety of workplace settings;
o Identification and measurement of the most important health outcomes
affected by work-family conflict for use across a variety of workplace
settings;
o Identification of the most appropriate workplace interventions that address
the key dimensions of work-family conflict, improve health, and can be used
across a variety of workplaces; and
o Development of quasi-experimental research designs that can be used across a
variety of workplace settings.
The network as a whole will decide upon the collaborative projects to be
undertaken and these projects may be implemented across any number of research
teams, depending upon the project. It is possible that some individual
projects may eventually transition into collaborative projects, if such a
transition is agreed upon by the PI of the individual project and the
remainder of the network.
Guidance and Management Structure
The Network will be composed of four types of entities: One Coordinating
Center, multiple Developmental Centers, a Steering Committee, and Employer and
Union/Employee Advisory Committees. This section describes the role of each
group as well as the role of the Federal participants in this cooperative
agreement.
A. Coordinating Center. The Network will have a single Coordinating Center.
The Coordinating Center will facilitate communication between and among the
various components of the Network themselves, the components of the Network
and workplaces, and the components of the Network and the external research
community. The Coordinating Center will not by definition provide the primary
data management and analysis capacities for collaborative studies. Each
collaborative project will have a designated "Lead Center" that will provide
the primary support for projects conducted across sites; the Steering
Committee will determine whether it is most appropriate for the Coordinating
Center or a Developmental Center to serve in that capacity. The Coordinating
Center will not provide support to Developmental Centers for their individual
projects.
B. Developmental Centers. The Network will include five to eight Developmental
Centers. Developmental Centers will develop research designs and conduct pilot
studies in collaboration with the Coordinating Center, workplaces, and each
other. Each Developmental Center will have primary responsibility for its
individual project. For collaborative projects, a Developmental Center may
serve as the "Lead Center" if so designated by the Steering Committee, with
primary responsibility for coordinating the research across all involved
centers and for overseeing the completion of the research. If so designated by
the Steering Committee, it may also assume the role of participating center on
collaborative projects.
C. Steering Committee. The Steering Committee will constitute the primary
governing body of the Network. As such, it will make determinations as to
which projects (either proposed originally by the applicants or subsequently
developed by the network) will be carried out. In the case of collaborative
projects, the Steering Committee will designate one of the Developmental
Centers or the Coordinating Center as the "Lead Center." The Steering
Committee will consist of the Principal Investigator of each Developmental
Center, the PI of the Coordinating Center, and the NICHD Project Liaison, each
of whom will have one vote on the Steering Committee; NIH and NIOSH Staff
Science Collaborators will serve as non-voting members. This group will direct
the collaborative research conducted by the Network, coordinate the
development of design methodologies and measurement techniques across
individual and collaborative projects, develop the model research designs to
serve as the basis for future multi-site interventions, and develop rules for
collaborative publications.
At the beginning of each project year of the Network, the Steering Committee,
by majority vote, will elect a Chairperson from the group of Principal
Investigators. For this election, if the Steering Committee has an even number
of participants and the vote is evenly split (so that there is no majority
vote), the vote of the NICHD Project Liaison will be disregarded. Federal
participants may not serve as chair except to organize the first meeting and
conduct the election of a permanent Chairperson.
The Steering Committee may determine that outside experts or other members of
the Coordinating Center's or Developmental Centers' teams should attend some
or all meetings as nonvoting observers or resources. The Steering Committee
may also establish subcommittees and workgroups to assist it in carrying out
its functions, and these groups may include members of the Centers' teams and
others as the Steering Committee sees the need. The Steering Committee will
establish an advisory body consisting of senior workplace managers (e.g.,
Directors, Presidents, CEO's, Managers) from diverse types of workplaces. It
will also establish an advisory committee of employee representatives,
including, for example, senior union officials.
D. Employer and Union/Employee Advisory Committees. Because the success of
this RFA depends on the cooperation of employers and employees and because
their interests are not always well understood by researchers, the Steering
Committee will appoint Employer and Union/Employee Advisory committees.
E. Federal Participants. The NICHD Project Liaison will be a member of the
Steering Committee. Other extramural scientists from the co-funding agencies
may also attend meetings as non-voting Staff Science Collaborators.
MECHANISM OF SUPPORT
This RFA will use the NIH Cooperative Research Project Grant (U01) award
mechanism. This RFA is a one-time solicitation. The anticipated award date is
July 1, 2005.
The NIH U01 is a cooperative agreement award mechanism in which the Principal
Investigator retains the primary responsibility and dominant role for
planning, directing, and executing the proposed project, with NIH and NIOSH
staff being substantially involved as a partner with the Principal
Investigator, as described under the section "Cooperative Agreement Terms and
Conditions of Award."
It is anticipated that there will be a subsequent limited competition to build
upon the model research designs developed by this Network and that
applications will be invited from existing network participants, subject to
the availability of funds for this purpose.
FUNDS AVAILABLE
The NICHD intends to commit approximately $1 million, the NIAAA intends to
commit approximately $480,000, the NIOSH intends to commit approximately
$500,000, and the NIH OBSSR intends to commit approximately $300,000 in total
costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2005 to
support six to nine new grants in response to this RFA. An applicant for a
Developmental Center should request a project period of three years and may
request a budget for direct costs of up to $350,000 per year. Because the
nature and scope of the proposed research will vary from application to
application, it is anticipated that the size of each award will also vary. A
substantial portion of the collaborative funds will be held in reserve and
will be awarded to the Centers after the Steering Committee has decided on the
collaborative projects to be undertaken by the network. An applicant for the
Coordinating Center should request a project period of three years and a
budget for direct costs of approximately $175,000 per year. Although the
financial plans of the cosponsors provide support for this program, awards
pursuant to this RFA are contingent upon the availability of funds and the
receipt of a sufficient number of meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
o Faith-based or community-based organizations
Separate applications are being solicited for Developmental Centers and the
Coordinating Center to participate in this cooperative study. If an
institution chooses to apply for support for both a Developmental Center and
the Coordinating Center, separate applications and a different Principal
Investigator for each are required; there may be no overlap of effort in
research or support personnel between the applications.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with his/her institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
Meetings
The Steering Committee may meet up to six times during the first year, and
will meet up to four times per year thereafter, 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 six
trips per year for other members of their research team to attend key
meetings. Each meeting will be approximately two days in length.
Cooperative Agreement Terms and Conditions of Award
The following Terms and Conditions will be incorporated into the award
statement. They are to be followed in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS grant administration
regulations at 45 CFR Parts 74 and 92, and other HHS and NIH grant
administration policies.
The administrative and funding instrument used for this program will be the
U01, an "assistance" mechanism (rather than an "acquisition" mechanism), in
which substantial NIH scientific and/or programmatic involvement with the PI
is anticipated during performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and/or stimulate the PI's activities
by involvement in and otherwise working jointly with the PI 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 PI for the project as a whole, although
specific tasks and activities may be shared between the awardee and the NICHD
Project Liaison. Facilities and Administrative cost (indirect cost) award
procedures apply to cooperative agreements in the same manner as for grants.
Business management aspects of these awards will be administered by the NICHD
Grants Management Branch in accordance with HHS and NIH grant administrative
requirements.
1. Awardee Rights and Responsibilities
Each PI and his or her investigative team on a Developmental Center award will
have primary responsibility to define objectives and approaches and to
develop, conduct, analyze, and publish results, interpretations, and
conclusions of their individual projects. Each investigator will have the
right to publish results from their individual research programs, but they
should collaborate with the Steering Committee and the Coordinating Center to
ensure that relevant findings are communicated to the Network and to other
interested parties.
PIs will also propose a collaborative research plan in which they will
identify research questions, approaches, and/or protocols that they propose to
work on cooperatively. The Steering Committee will formulate a strategy for
collaborative research planning that will distill the several individual
collaborative research plans into a coherent overarching plan and may allow
for additional projects to be developed jointly. It will also formulate a
strategy for allocating resources among the participating Centers to implement
this plan. The collaborative research plan will be agreed upon by majority
vote of the Steering Committee, but each PI will have the right of approval
for any aspect of the collaborative research plan involving their individual
project and/or the workplace site used therein. Due publication credit will be
given to all work done cooperatively.
A. Coordinating Center
The Coordinating Center will fulfill a central role by coordinating the
activities of the other components of the Network, as well as conducting its
own communication and dissemination activities. It may also play a role in
research activities if so designated by the Steering Committee.
Coordinating Center responsibilities include:
o Providing special expertise in dealing with employers to facilitate the
development of workplace research strategies.
o Fostering relationships with employers and investigating the possibilities
of recruiting them as workplace sites.
o Coordinating communications and meetings with the Employer and
Union/Employee Advisory Committees and representing their interests to the
Steering Committee.
o Coordinating travel of additional experts to meetings and distributing funds
to them.
o Assessing employer needs at all participating workplace sites and assuring
that they are considered in planning research designs.
o Serving as a repository for measures developed in both individual and
collaborative projects and for pilot data collected; preparing public use
documentation.
o Developing and maintaining a Network website to facilitate and promote
dissemination of easily accessible study progress reports and program findings
to multiple audiences, including researchers, employers, work-life
professionals, and Federal government agencies.
o Coordinating logistical functions of meetings of the Steering Committee
(including any subcommittees and work groups that develop), including
production and distribution of committee minutes. The Coordinating Center will
handle funds for the travel of any outside experts whom the Steering Committee
determines should be present as a guest at a particular meeting.
o Translating publications of collaborative results and model protocols for
consumption by a variety of audiences, including employers and work-life
professionals; publishing them on the website and in other forms, as
appropriate; and assisting in development of other collaborative publications,
in accordance with Steering Committee procedures to be developed.
o Publishing collaborative findings in a timely manner. Publication or oral
presentation of work done under this agreement requires acknowledgement of
support by the co-sponsors. The Coordinating Center must agree to abide by
rules agreed upon by the Steering Committee concerning the publications of
collaborative findings.
o As appropriate, acting as a Lead Center in implementing collaborative
projects that are decided upon by the Steering Committee and are funded
cooperatively and coordinating with the Developmental Centers.
o As appropriate, participating in projects coordinated by Developmental
Centers when they are serving as Lead Centers.
o Collaborating with Developmental Centers and the Federal government in the
refinement of intervention and evaluation designs, and assisting in developing
and implementing cooperative multi-site design projects and pilot programs.
o Collaborating in the development of model research designs to serve as the
basis for future multi-site interventions.
B. Developmental Centers
Projects carried out by Developmental Centers should lead to the development
of model protocols that will serve as the basis for a future initiative to
support a set of multi-site interventions.
Developmental Center responsibilities include:
o Developing multidisciplinary scientific collaborations.
o Identifying sites and creating researcher-workplace collaborations.
o Ascertaining research populations and identifying appropriate sampling
strategies.
o Selecting, validating, developing, and piloting relevant instrumentation,
especially for use with diverse populations.
o Developing detailed conceptual models to guide research design and
hypothesis testing.
o Designing protocols for well-controlled randomized experiments and/or quasi-
experiments, to include identification of feasible strategies for: achieving
randomization where possible and establishing criteria for matching comparison
groups; minimizing selective attrition; and maintaining and evaluating the
fidelity of the intervention.
o Developing plans for data analysis to include identification of quantitative
expertise required for analyzing complex multivariate data sets and using
state-of-the-art techniques for measuring change.
o Developing plans to specify complete costs of implementing the intervention
in additional settings and plans to conduct cost-benefit analyses as
appropriate.
o Developing models to assess employers' return-on-investments.
o Identifying administrative facilities, procedures, and on-site and off-site
personnel.
o Implementing projects as a Lead Center, coordinating with other
Developmental Centers, as well as participating in projects on which another
Center has been designated as the Lead Center. Each participating
Developmental Center will have the responsibility for developing and
implementing their individual research program.
o Publishing major findings in a timely manner. Publication or oral
presentation of work done under this agreement requires acknowledgement of
support from the co-sponsors. Developmental Centers must agree to abide by
rules agreed upon by the Steering Committee concerning the publication of
collaborative findings.
o Collaborating in the development of model research designs to serve as the
basis for future multi-site interventions.
Awardees will retain custody of and have primary rights to the data developed
under these awards, subject to Government rights of access consistent with
current HHS, PHS, and NIH policies.
2. NIH Responsibilities
A. NICHD Project Liaison:
The NICHD Project Liaison will be the Work, Family, Health, and Well-Being
Coordinator of the Demographic and Behavioral Sciences Branch, NICHD. She
will:
o Assist in all functions of the Steering Committee;
o Assist with the development of common protocols;
o Assist the Steering Committee in reviewing and commenting on each stage of
the program before subsequent stages are started;
o Assist the Steering Committee in exercising the options of adding,
modifying, or terminating aspects of the program;
o Assist in the analysis, interpretation, and reporting of findings in the
scientific literature and other media to the community at large; and
o Assist in the development of the common research design to serve as the
basis for future multi-site interventions.
B. NICHD Project Officer:
The NICHD will appoint a Project Officer, apart from the Project Liaison, who
will:
o Carry out continuous review of all activities to ensure that the objectives
are being met and that all regulatory, fiscal, and administrative matters are
handled according to NIH guidelines.
o Have the option to withhold support to a participating institution if
technical performance requirements are not met.
o Perform other duties required for normal program stewardship of grants.
C. NIH and NIOSH Extramural Staff Science Collaborators
Other NIH and NIOSH staff may attend and participate as non-voting resources
to the Steering Committee and/or its subcommittees and workgroups. NIOSH and
NIH program representatives may serve as Staff Science Collaborators.
Specifically, the Staff Science Collaborators will, in consultation and
collaboration with the NICHD Project Liaison:
o Provide programmatic oversight and assistance to awardees;
o Provide advice, when needed, for optimal pilot testing of intervention
designs;
o Assist in overseeing workplace site participation and performance, as
needed, with the support of the Coordinating Center;
o Participate, as needed, in study design, data analysis, interpretation, and
publication of study results relevant to the research conducted by their
respective grantees;
o Assist in the development of the common research design to serve as the
basis for future multi-site interventions.
The above responsibilities are in addition to, not in lieu of, the levels of
involvement normally required for program stewardship of grants.
It is anticipated that, as the Network develops, other Federal agencies may
contribute money to assist with funding and/or may provide NICHD, NIAAA,
NIOSH, and OBSSR with other assistance, such as facilitating access to
workplaces or sharing expertise. The NICHD Project Liaison and the NIH and
NIOSH Staff Science Collaborators will constitute a panel of Federal
participants from those agencies having a role in the Network. They will use
this panel to ensure that other Federal agencies are kept informed of Network
progress and findings; the panel may be consulted for advice by the Steering
Committee. The NICHD Project Liaison will represent the panel's interests to
the Steering Committee.
3. Collaborative Responsibilities
A. Steering Committee
The Steering Committee will constitute the primary governing body of the
Network and have the responsibilities described below. As such, it will make
determinations as to which projects will be carried out. In the case of
collaborative projects, the Steering Committee will designate one of the
Developmental Centers or the Coordinating Center as the "Lead Center."
The Steering Committee will consist of the Principal Investigator of each
Developmental Center, the Principal Investigator of the Coordinating Center,
and the NICHD Project Liaison, each of whom will have one vote on the Steering
Committee; NIH and NIOSH Staff Science Collaborators will serve as non-voting
members. At the beginning of each project year of the Network, the Steering
Committee, by majority vote, will elect a Chairperson from the group of
Principal Investigators. For this election, if the Steering Committee has an
even number of participants and the vote is evenly split (so that there is no
majority vote), the vote of the NICHD Project Liaison will be disregarded.
Federal participants may not serve as chair except to organize the first
meeting and conduct the election of a permanent Chairperson. The Steering
Committee may determine that outside experts or other members of the
Coordinating Center's or Developmental Centers' teams should attend some or
all meetings as nonvoting observers or resources. The Steering Committee may
also establish subcommittees and workgroups to assist it in carrying out its
functions, and these groups may include members of the Centers' teams and
others as the Steering Committee sees the need.
Planning and implementation of the collaborative aspects of the study or
studies will be carried by the Steering Committee. The Steering Committee will
coordinate the development of a common theoretical framework and will work to
facilitate the comparability of research designs across workplace sites, as
feasible. The Steering Committee will coordinate the development of
measurement tools for use in the Network. The Steering Committee will also be
responsible for the development of model research designs that will serve as
the basis for future multi-site interventions. Measures specific to individual
projects will be reviewed by the Steering Committee, with final approval
reserved for the PI of that project. The Steering Committee will also develop
policies on data sharing, on access to materials and data, including making
measures and data available beyond the Network in a timely manner, and on
publication authorship for collaborative manuscripts. Collaborative
publication policies will be written and authorship decided using procedures
developed and approved by the Steering Committee.
All major collaborative scientific decisions will be determined by majority
vote of the Steering Committee. All participating Centers must agree to adhere
to the conceptual model, study designs, and policies approved by the Steering
Committee for collaborative projects. It is important to note that
collaborative research projects to be undertaken within the Network are not
limited to research concepts contained within awardees' original grant
applications, but will be determined by the Steering Committee based on input
from the workplace sites and subject to the approval of the co-sponsors.
Future research must be consistent with the scientific objectives of the RFA.
Considerations in the review of collaborative research planning projects by
the Steering Committee will include: a) potential contribution to the
development of the model protocols; b) strength of the scientific rationale
supporting the study; c) overall impact of the research; d) significance of
the question being proposed; e) avoidance of unnecessary duplication with
other research; f) approach, including appropriateness and feasibility of
study design; g) innovation; h) satisfactory projected workplace cooperation
and follow-up period; i) worker, family, and organization health implications,
and diversity therein; j) compliance with NIH, CDC, and Federal regulatory
requirements; and k) appropriateness of workplace site selection,
intervention, response to pilot study, and/or follow-up.
Steering Committee responsibilities include:
o Developing a common theoretical framework to guide research design;
o Planning the design, and any testing, of collaborative research protocols;
o Participating in decision-making regarding allocation of funds for
collaborative research protocols;
o Publishing results, conclusions, and interpretations of the collaborative
planning protocols;
o Formulating publication policy and appointing a Publication Subcommittee, as
judged necessary by the Steering Committee;
o Establishing Employer and Union/Employee Advisory committees; and
o Agreeing to accept the coordinating role of the committee and the
cooperative nature of the group process.
B. Employer and Employee/Union Advisory Committees
The Coordinating Center will be responsible for communicating with these
advisory bodies and for representing their interests to the Steering
Committee. These advisory bodies will review proposed research concepts and
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.
C. Meetings
The Steering Committee may meet up to six times during the first year, and
will meet up to four times per year thereafter, usually in the Washington,
D.C. area. 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. Each meeting will be approximately two days in length. During
these meetings, the Steering Committee will decide upon the operating policies
of the Network, discuss their individual research programs and other ongoing
research, formulate common theoretical approaches and the collaborative
research plan, and discuss the implications of their research with interested
parties outside of the Network who may be invited by the Steering Committee as
warranted.
D. Communications
There will be a much greater level of communication among Network members than
is normal for individual research project grants. Individual PIs must plan
appropriately for greater telephone usage, more copies of research papers, and
greater mailing costs than in a developmental grant (R21). The use of e-mail
is strongly encouraged.
E. Expectation of Cooperation
There will be high expectations of the members of the research Network to
interact with other members of the Network, share research insights, cooperate
in the design and implementation of a collaborative research plan, be
responsive to needs of the cooperative work of the Network, and be sensitive
to the public policy significance of this endeavor. Awardees must agree to
participate in these stated aspects of the Network.
4. Arbitration Process
Any disagreements that may arise in scientific or programmatic matters within
the scope of the award between grantees and the NIH may be brought to
arbitration. 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 regulation
at 45 CFR Part 16. An Arbitration Panel will help resolve both scientific and
programmatic issues that develop during the course of work that restrict
progress. The Arbitration Panel will be composed of three members: a member
selected by the Steering Committee without NIH staff voting, a member selected
by the co-sponsors, and a member with expertise in the relevant area selected
by the other two members.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA 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:
o Direct your questions about scientific/research issues to:
Lynne M. Casper, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8B07, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6983
FAX: (301) 496-0962
Email: [email protected]
Marcia S. Scott, Ph.D.
Division of Epidemiology and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2080, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 402-6328
Fax: (301) 443-8614
Email: [email protected]
Deborah H. Olster, Ph.D.
Office of Behavioral and Social Sciences Research
Office of the Director
National Institutes of Health
One Center Drive, Room 256, MSC 0183
Bethesda, MD 20892-0183
Telephone: (301) 451-4286
Fax: (301) 402-1150
Email: [email protected]
Susan B. Board, M.S.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Building 24, Room 1415, MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2512
FAX: (404) 498-2571
Email: [email protected]
o Direct your questions about peer review issues to:
Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: [email protected]
o Direct your questions about financial or grants management matters to:
Rashawn Farrior
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-5482
FAX: (301) 402-0915
Email: [email protected]
Judy Fox (formerly, Simons)
Chief, Grants Management Branch
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Rockville, MD 20852 (for (express/courier service)
Telephone: (301) 443-4704
FAX: (301) 443-3891
Email: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
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 NICHD 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:
Lynne M. Casper, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8B07, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6983
FAX: (301) 496-0962
Email: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). 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 DUNS number can be obtained by calling
(866) 705-5711 or through the web site at http://www.dnb.com/. The
DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS
398 document is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: [email protected].
SUPPLEMENTARY INSTRUCTIONS:
To promote the development of a collaborative program among award recipients,
a number of issues must be addressed in applications. Applicants should
discuss the scientific and substantive rationale for their choice of research
planning approach and methodologies, should document their ability or
potential to recruit a workplace, and should demonstrate their ability and
willingness to work collaboratively with the co-sponsors, the Coordinating
Center, and other Developmental Center awardees, to follow common research
plans, and to carry out an individual developmental project, if applying for a
Developmental Center.
The application must conform to the instructions for form PHS 398, with the
modifications described below:
o On line 2 of the application face page, the Network component applied for
must be clearly identified as either "Coordinating Center" or "Developmental
Center." This information is in addition to the RFA number and title that must
be provided on line 2. If an institution intends to apply for more than one of
the components, the institution must submit separate applications for each
component.
o Names of all personnel should be included in the application with their
specific responsibilities in support of the research effort outlined and with
their percent time and effort specified. Alphabetized biographical sketches
for all personnel (limited to four pages each) should follow the budget
justification. Key personnel do not include employees of the workplace site
unless the workplace site itself is the applicant; otherwise, if the proposed
projects require administrative or research staff positions at the workplace
site, those staff members are to be employed through the awardee institutions.
Specific content must be present in the application to document the technical
and scientific merit of the applicant's plan for a Developmental Center or a
Coordinating Center that will address the fundamental goals and collaborative
nature of the Network. Sections A-D should not be organized according to
Specific Aims, Background and Significance, etc. as stated in the PHS 398
application instructions. Replace sections A-D with the following sections
numbered 1-4. In total, Sections 1-4 should not exceed 40 pages for
Developmental Centers and 25 pages for the Coordinating Center.
1. Understanding of the Mission of the Network
(For Coordinating Center and Developmental Centers Applications)
This section should establish the applicant's understanding of the goals of
the RFA and of the Network and present a vision of how the applicant Center
could uniquely contribute to the Network.
In addition, applicants must indicate their willingness to participate in the
cooperative aspects of the Network. The statement of willingness to cooperate
should be included in this section.
2. Research Concepts
(For Developmental Centers Applications)
Applications should include a description of an individual research project of
up to 10 pages to occur in their Center. In addition, the applicant should
provide two research concepts for collaborative projects, consistent with the
goals of the RFA, that take advantage of the unique capabilities of the
Network. Applicants are allowed up to five pages to describe each concept.
Because these are developmental grants, the expectation is that research
concepts are not as thoroughly developed as they would be for an NIH research
project grant. Nevertheless, applicants should provide evidence that they have
given considerable thought to what has been done in this area, what could be
done in this area, and how their individual project will contribute to
research in this area and to the success of the network as a whole.
The plan should document the Center's relevant expertise with regard to work,
family, health, and well-being research, workplace policies and practices,
quasi-experimental designs, interventions, health outcomes, and organization-
level issues related to the goals of the RFA. Because pilot studies with
common protocols may be conducted at workplaces, applicants should discuss any
relevant expertise on cross-study meta-analyses or other research requiring
integration of data across studies. If appropriate, applicants should also
provide a plan for developing models to assess employers' return on investment
for intervention implementation. The application should demonstrate
anticipation of problems and challenges in conducting the research and plans
for resolving them.
Applicants should address these questions as appropriate:
o On which social and health science disciplines will your investigative team
draw, and why?
o What theoretical approaches are most likely to guide your research design?
o What methodological approaches are most likely to guide your research
design?
o Which health and well-being outcomes are most likely to be the focus of your
research design?
o Which workplace policies and practices that affect individuals' work and
family lives are most likely to be the focus of your research design?
o Which types of workplaces are most likely to be the focus of your research
design? What are the characteristics of these workplaces that enhance their
usefulness for this project?
o Which workers are most likely to be the focus of your research design?
o How will you incorporate family into your research design?
The research concepts for the proposed studies should include, as applicable:
a statement on the significance and innovation of the research planning
program; justification for the individual or collaborative nature of the
project; how it contributes to or utilizes the types of resources that are
available in a research network; how anticipated findings from the individual
or collaborative projects will be developed into a common research design to
be used in future multi-site, large-scale intervention studies; (potential)
access to worksites and subjects; procedures for data management, quality
control and follow-up; procedures for monitoring and reporting adverse events;
and information on human subjects protections.
The concepts for collaborative projects are included in the application to
provide evidence of the applicant's conceptualization of and approach to
Network research; they will not necessarily be implemented by the Network.
Concepts for individual projects may be transitioned to collaborative
projects, subject to the approval of the PI and the Steering Committee, as
described above.
3. Internal Administration and Collaborative Plans
The administrative and managerial qualifications and experience of the PI must
be described to provide evidence of skills in managing and coordinating
research endeavors. The skills of other personnel involved in administration
and management of the research should also be clear, as should plans for
decision-making procedures internal to the center. The Principal Investigator
must commit 25 percent or greater effort to the Network. This section should
also cover plans (in terms of responsibilities and effort) for project
management, coordination, communication, and data management. The application
should explain how communications with other Centers and the Steering
Committee would occur.
(For Developmental Centers Applications)
Plans for functioning as a "Lead Center" and as a participating center should
be addressed. An approach for coordinating the development of protocols and
monitoring progress should be given. Plans for interacting with employers and
employees at workplace sites should also be provided.
The application should address how the Developmental Center would collaborate
with the Steering Committee to develop theoretical models; refine design
methodologies, measurement techniques, analytic techniques, and pilot studies
of interventions; and assist the Steering Committee in designing and
implementing collaborative, multi-site pilot studies that would be led by
itself or another Developmental Center. Plans for developing and evaluating
ideas for cross-site protocol development should be clear.
(For Coordinating Center Applications)
Plans for fulfilling the facilitating role of the Coordinating Center should
be provided. Potential needs of other Centers and participants in the Network
should be anticipated and addressed, as should the challenges in fulfilling
those needs.
Plans for interacting with employers and employees at workplace sites and the
Employer and Union/Employee Advisory Committees, and for representing their
interests to the Steering Committee should be provided.
This section should also include plans for addressing the logistical needs of
the Network, including coordinating meetings of the Steering Committee,
subcommittees, and workgroups and travel of experts to these meetings, as well
as distributing preparatory and post-meeting documents. Plans for serving as a
repository for design methodologies and measurement techniques, including
results from pilot studies, should be clear.
Coordinating Center applicants should provide plans for disseminating the
information of Network activities to the public, work life professionals and
program providers, policy makers, researchers, employers, and others who may
be interested. Coordinating Center applicants should also provide the proposed
content of a Network website and structure of that website.
4. Research Capacity
(For Developmental Centers Applications)
The plans should document the availability of appropriate scientific expertise
within the Developmental Center to contribute to theory building, research
design, and implementation of the pilot studies that the Network develops.
They should also describe the Developmental Center's research capacities and
how they would contribute to the aims of the RFA.
The application should provide detailed descriptions of any workplace sites
that have already been recruited to participate or plans for recruiting a
workplace site and a description of preferred workplace site if no workplace
site has been recruited. The appendix should contain letters of agreement from
the institution, agency, or program directors for recruited sites. The plan
should also provide evidence, where possible, of successful collaborations
with these groups or plans for the development of successful collaborations.
Plans for assuring adequate staffing of research activities should be
presented.
(Coordinating Center Applications)
The plans should describe the Center's experience in coordinating research
projects across institutions. Evidence of a good history of working
relationships with unions, employees, and employers at senior levels of
management should be provided. Plans for recruiting additional workplace sites
should be provided. Plans for assuring adequate staffing of activities should
be presented. Coordinating Center personnel should have expertise in workplace
policies and practices; knowledge of work-life policies in the context of
organizational settings; familiarity with the needs of workers and employers
across a range of industries, occupations, organizations, and regions; and
experience in communicating with academic, corporate, and government
audiences.
Human Subjects
Human Subjects Research (PHS 398 Research Plan section E) instructions have
been revised and must be addressed in the application; no specific page limits
apply, but the plans must be complete and concise. The application should
describe plans for human subject protections, for data safety monitoring, and
for representation among workplace populations.
Budget
The budget instructions provided in the application form PHS 398 must be
followed. Budgets will be reviewed on the basis of appropriateness and
reasonableness for the work proposed. Allowable costs and policies governing
the research grant program of the NIH will prevail. The budget and
accompanying justification are not part of the 40-page (Developmental Centers)
and 25-page (Coordinating Center) limits.
(For Developmental Center Applications)
All applicants should prepare budgets for three years of funding. Proposed
budgets may not exceed $350,000 in direct costs per year. Principal
Investigators should be budgeted for a total commitment to the Network of at
least 25 percent, including participation in the individual and collaborative
projects for each of the three years. Applications should include budget
estimates and plans for research planning projects, including separate budgets
for individual and collaborative research planning, and for participating in
the Network.
The budget for an individual project should not exceed $150,000 per year in
direct costs and should be commensurate with the work being planned; that is,
an individual project involving pilot studies and data collection would likely
command a larger portion of the funds to be awarded to a Developmental Center
than an individual project involving measure development or secondary data
analysis. Applicants are encouraged to be mindful that the effort devoted to
individual projects is expected to decline over the award period as the effort
devoted to collaborative projects is expected to increase over the award
period. Budgets must be proposed accordingly.
For budget purposes for the collaborative planning projects, Developmental
Center applicants should estimate a budget for their center's participation in
the two collaborative projects they have proposed and should assume that they
will be the "Lead Center" for one of the projects and a collaborating center
for the other one. Applicant centers should not include project costs for
other collaborating centers in their budgets.
For the budget corresponding with network participation, applicants should
include funds for travel to the Washington, D.C. area to provide for
participation in Network-related meetings that are expected to span two days
(six trips in the first year and four trips thereafter). Applicants may also
budget for other members of their research teams to attend meetings in the
Washington, D.C. area; no more than six trips per year may be budgeted for
this purpose regardless of the size of the research team. Applicants should
ensure that adequate provisions are made to allow Principal Investigators to
participate fully in activities of the Steering Committee and its
subcommittees/workgroups. If more meetings are necessary, individual awards
will be supplemented with appropriate monies from the funding for
collaborative research projects. This portion of the budget should also
include funds for personnel costs and basic administrative costs to support
participation in the network.
Funds for individual projects will be awarded directly to the proposing
Developmental Centers along with funds for participating in the Network.
Funds for collaborative projects will be held in reserve and will be
distributed after the Steering Committee has approved the collaborative
projects to be undertaken by the Network and has determined the allocation of
funds across centers. The support recommended for future years is an estimate
only for the purpose of NICHD budgeting across this network of cooperative
agreements. Therefore, the level of support for each non-competing year is
subject to change (up or down) with each non-competing award.
The applicant should prepare separate budgets for:
1) the individual project (e.g., personnel, facilities, equipment, supplies,
training costs, logistic support, travel and communications with other
centers, staff for data collection, management, and analysis, etc.);
2) a collaborative project as a Lead Center (e.g., personnel, facilities,
equipment, supplies, training costs, logistic support, travel and
communications with participating centers, staff for data collection,
management, and analysis, etc.);
3) a collaborative project as a participating center (e.g., personnel,
facilities, equipment, supplies, training costs, logistic support, travel and
communications with the Lead Center and any other participating centers, staff
for data collection, management, and analysis, etc.); and
4) a network participation budget (e.g., personnel costs, travel to meetings,
and basic administrative costs).
(For Coordinating Center Applications)
Applicants for the Coordinating Center may apply for up to $175,000 per year
in direct costs and should apply for three years of funding. They should
budget for personnel, facilities, equipment, supplies, travel, and
communications with employers at workplace sites and with the Developmental
Centers. Budgets should also include funds for communications with the
Employer and Union/Employee Advisory Committees and for members of these
advisory committees to attend meetings. For planning purposes, assume up to
five members for each committee who will attend two meetings in the first year
and one meeting per year in the second and third years. Applicants should
also budget for experts who are not PIs or co-PIs to attend Network meetings
as needed. For planning purposes, assume four to five experts per meeting per
year.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form 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/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed photocopies, in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and all
copies of appendix material must be sent to:
Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an application
is received after that date, it will be returned to the applicant without
review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within eight weeks.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA 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 an RFA,
it is to be prepared as a NEW application. That is, the application for the
RFA 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.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the co-sponsors. Incomplete and/or non-responsive
applications will be returned to the applicant without further consideration.
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 NICHD in accordance with the review criteria stated below. As part of the
initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Child Health and
Human Development Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In the
written comments, reviewers will be asked to address the criteria below in
order to judge the likelihood that the proposed work will have a substantial
impact on the pursuit of these goals.
1. Understanding of the Mission of the Network
(Coordinating Center and Developmental Center Applications)
o How well does the application demonstrate an understanding of the scientific
agenda of the Network? How innovative is the vision the application presents
for utilization of the Network?
2. Research Project and Concepts
(Developmental Center Applications)
Reviewers will focus their evaluation on the conceptual framework, the level
of innovation, and the potential to significantly advance our knowledge or
understanding. Reviewers will place less emphasis on methodological details
and certain indicators traditionally used in evaluating the scientific merit
of R01 applications including supportive preliminary data. Appropriate
justification for the proposed work can be provided through literature
citations, data from other sources, or, when available, from investigator-
generated data. Preliminary data are not required.
o How well do the concepts take advantage of the unique capabilities of the
Network and the role of a Developmental Center? How significant are the
research questions being proposed? How strong is the scientific rationale
supporting the study? Do the plans evidence reasonable methodologies and
approaches?
Research Project
o Have the investigators justified why this project is best done on an
individual rather than a collaborative basis and how it fits within the
broader mission of the RFA? What would this project add uniquely to the
knowledge generated under the auspices of the Network? How would this project
lay the foundation for use of the workplace site involved (or proposed) as a
site for intervention and evaluation in a second phase of the Network?
Concepts
o Have the investigators justified why this project is best done on a
collaborative rather than an individual basis? How will this project draw on
the unique resources of a network that are unavailable to individual
investigative teams working in this area? How would this project move the
field forward toward common protocols?
3a. Internal Administration and Cooperative Plans
(Coordinating Center and Developmental Center Applications)
o How strong are the administrative and managerial qualifications of the PI
and key staff? Is there evidence of sufficient dedication of time and other
resources to the work? How clear and feasible are plans for project
management, coordination, and communication? How well developed are the plans
for data management? Are intra-center decision-making procedures specified and
workable? How well are likely challenges anticipated and potential solutions
articulated?
3b. Internal Administration and Cooperative Plans
(Developmental Center Applications)
o How well developed are the plans for functioning as a "Lead Center" and as a
participating center? How sufficient and efficient is the infrastructure for
project management, study design and development, and pilot study activities?
If appropriate, are plans for interacting with employers and employees at
workplace sites well-delineated and reasonable? How well developed are the
plans for cross-Center communication and communication with the Steering
Committee? How well developed are the plans for interaction between the
Developmental Center and the Coordinating Center? Are plans for protocol
sharing and other research plan development needs appropriate?
3c. Internal Administration and Cooperative Plans
(Coordinating Center Applications)
o What is the quality of the plans for serving as a facilitating center to the
Network? How well developed are the plans for interaction between the
Coordinating Center and the Developmental Centers? What is the quality of the
plans for interacting with employers and employees at workplace sites and the
Employer and Union/Employee Advisory Committees, and for communicating these
interactions with the Steering Committee? How well are other needs and
challenges addressed?
o How well are repository and dissemination needs addressed? What is the
quality of the plan for serving as a methodological repository? How feasible
and developed are the logistic support and operational support plans? How well
developed are the plans for developing a Network website, for disseminating
findings to various groups, and for using appropriate technological resources?
How strongly does the record of experience in these areas support the
application?
4a. Research Capacity
(Developmental Center Applications)
o What is the quality of the scientific expertise and productivity within the
Developmental Center, especially with respect to studies relating to work-
family conflict, work, family, and health, complex multi-site or single
studies of workplace interventions, workplace policies and practices, and
health and well-being outcomes? (Note that expertise in all or even most of
these areas is not necessary within one Developmental Center.) If applicable,
what is the quality of and how appropriate are the participating workplace
sites, especially in regard to providing sufficient variation in site or
population characteristics to the Network? If no specific workplace site is
proposed, how good are the proposed plans for recruiting a workplace site? How
well does the application document the ability of the Center to develop a
variety of traditional and innovative interventions, to model organizational
change, and to study organization-level issues relevant to the goals of the
RFA? If applicable, how appropriate is the plan to develop employer return on
investment models? How well does the application evidence anticipation of
problems and challenges in developing research designs and plans for resolving
them?
4b. Research Capacity
(Coordinating Center Applications)
o Does the application provide evidence of prior experience coordinating
collaborative projects across more than one institution? Is there evidence of
a good history of working relationships with employers at senior levels of
management? What is the quality of the plan for recruiting additional
workplace sites? Do the project personnel have the proper expertise to fill
the role that this center will play in the Network?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will 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 criteria included in the section
on Federal Citations, below.)
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 Inclusion Criteria in the sections on
Federal Citations, below.)
ADDITIONAL CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: November 22, 2004
Application Receipt Date: December 20, 2004
Peer Review Date: March/April 2005
Council Review: June 2005
Earliest Anticipated Start Date: July 01, 2005
AWARD CRITERIA
Criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities
An attempt will be made to balance the network so that it will have a multi-
disciplinary composition, a diversity of research concepts, workplace sites
and proposed interventions, and broad coverage of relevant health outcomes for
workers and their families, including children. Awards will be made on the
basis of the scientific merit of the grant application and the need to create
a balanced network.
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).
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 -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts
on October 9, 2001 (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 RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects 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 that is available at
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 proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC 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 RFA 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.
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://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore, we
caution reviewers that their anonymity may be compromised when they directly
access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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