and Human Services (HHS)
EXPIRED
WORLD TRADE CENTER RESPONDER HEALTH CONSORTIUM
RELEASE DATE: November 12, 2003
RFA Number: RFA-OH-04-004 (see addendum NOT-OH-04-001)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
Centers for Disease Control and Prevention (CDC)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Institute for Occupational Safety and Health (NIOSH)
(http://www.cdc.gov/niosh)
NOTE: THE POLICIES, GUIDELINES, TERMS, AND CONDITIONS STATED IN THIS
ANNOUNCEMENT MAY DIFFER FROM THOSE USED BY THE NIH.
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): CFDA 93.262
LETTER OF INTENT RECEIPT DATE: December 22, 2003
APPLICATION RECEIPT DATE: January 23, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s)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 Supplementary Instructions
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 for Occupational Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC), invites applications for cooperative
agreements from single institutions or consortia of institutions to
investigate the health status of responders (workers and volunteers) involved
in the World Trade Center (WTC) response. The targeted study population
includes all responders including the Fire Department of New York City (FDNY)
responders, who provided rescue, recovery, clean-up and restoration of
essential services at the WTC disaster site following the September 11, 2001
attack.
RESEARCH OBJECTIVES
Background
Following the collapse of the WTC on September 11, 2001, thousands of workers
and volunteers (responders) provided rescue, recovery, clean-up and
restoration of essential services. In 2002, the Centers for Disease Control
and Prevention funded two medical screening programs for these responders. It
is anticipated that when the baseline screening programs are complete in the
winter of 2004, over 12,000 FDNY responders and over 12,000 other responders
will have been evaluated.
Results from these screening programs have found elevated rates of persistent
upper and lower respiratory and mental health conditions. Exposure
measurements from the WTC site confirm elevated levels of exposure to
combustion products and other particulate matter in the period following
September 11, 2001. Long-term follow-up of the exposed responders who have
participated in the baseline screening program will provide important
information regarding the long-term effects of these exposures and will
provide an efficient method for early determination of the need for additional
medical testing and notification of exposed responders.
Program Objectives
This RFA builds on the results of previous projects which focused on the
establishment of the patient cohort and the initial health screening. This
patient cohort has been divided into the FDNY responders and other responders
because of the unique health and exposure characteristics of the two groups.
The goal for this initiative is to establish four to eight (4-8) Clinical
Centers (CC) that will provide the follow-up health assessments for the
responders. One CC will be responsible for the FDNY responders, and a group
of CCs will be responsible for the other responder cohort. It is anticipated
that a CC would have adequate facilities to provide patient tracking, clinical
screening, basic mental health assessment, patient data management, and
referral to physicians for patients requiring follow-up care. The CC should be
able to assist both insured and uninsured responders. Data from this patient
group will help define the long term health care needs for the responder
population, and also provide important information on the consequences of air
pollutants, physical stressors, emotional stress, musculoskeletal exertions,
and other occupational and environmental measures. Each CC will be responsible
for providing data electronically to a data center (see below) in a uniform
fashion.
There will be two Data and Coordination Centers (DCC) that will provide data
management and coordination. It is envisioned that the clinical center for
the FDNY responders will be served by one DCC and the clinical centers for the
other responders will be served by the other DCC. The two Data and
Coordination Centers (DCCs) will be established to provide study coordination
functions, data management support and other services. One DCC will be
responsible for the FDNY responder data and the other DCC will be responsible
for the other responder data. The applicants selected as the data center will
be responsible for basic statistical analysis, outreach coordination, outlier
follow-up, data monitoring, quality assurance and other coordinating
functions. The DCCs will serve as a data collection resource, enabling the
consortium investigator to analyze data from the CCs. Because of the unique
characteristics of the two responder cohorts maintained by the two DCCs, a
merged data set of all responders is not part of this initiative. The two
DCCs will work together, and the Scientific Program Administrator will resolve
differences between the DCCs if any arise.
All of the CCs and the two DCCs will be coordinated through a World Trade
Center Responder Health Consortium (WTCRHC), which is to provide a
comprehensive and integrated program for the conduct of the follow-up studies
of the current responder population as well as other responders who may be
identified. It is important that data elements which will be shared between
awardees are managed in a uniform and compatible format. In addition, because
many of the shared data elements are based on clinical diagnosis, a critical
role of the WTCRHC will be to assure that clinical diagnosis are conducted and
interpreted in a uniform manner across the CCs. In order to accomplish this
goal, the WTCRHC will establish a Steering Committee (SC) which is described
under the PROGRAM ORGANIZATION section of this announcement.
Project Organization
The WTCRHC will consist of the following components: four to eight (4-8)
Clinical Centers, two Data and Coordinating Centers, NIOSH, a Steering
Committee (SC), a Data Safety and Monitoring Board (DSMB), and an External
Advisory Panel.
The Principal Investigator at each CC will have primary responsibility to
participate in the standardized study design and implementation to be used at
all clinical locations, including subject recruitment and safety. With the
assistance of Co-Investigators as appropriate, the Principal Investigator will
hire and supervise relevant personnel, obtain Institutional Review Board (IRB)
approval for WTCRHC protocols, oversee data collection and adherence to
quality assurance measures, and prepare budgets and annual reports. The
Principal Investigator (or designated alternate) will serve as a voting member
of the SC. A Clinical Coordinator at each CC will set up training systems,
certify personnel, and establish procedures to ensure adherence to protocols,
collection of high quality data, and accurate transmission of data to the DCC.
The application for a CC will be supported in two levels and should consist of
the following:
a. Administrative and Planning Core
An administrative and Planning Core will provide the basic organizational
structure for the clinical work. It will be responsible for tracking patient’s
contact information, verifying eligibility for examinations, benefits
information/patient referral, maintaining patient records, transferring core
data to DCC, informed consent, Health Insurance Portability and Accountability
Act (HIPAA) compliance, and participation in a quality assurance program. The
estimated direct cost for this component is $50-300K per year.
The Administrative and Planning Core must have a leader who is capable of
providing clinical and scientific leadership and who is willing to accept
responsibility for the administration and integration of the health assessment
program. Assessment of the ability of the program principal investigator to
lead a tightly integrated clinical program will be a significant consideration
in the evaluation of the application.
b. Clinical Services Core
The Clinical Services Core will be funded on a per patient basis (capitation),
and the current plan is for an examination of the cohort approximately every
18 months (a minimum of three examinations per patient) over the five-year
project period. Based on the fees for similar services, NIOSH anticipates a
capitation rate of $300-$800 depending on the final protocol approved by the
SC and NIOSH. Due to the unique characteristics of the fire fighter and other
responder cohorts, the capitation rates, frequency of examinations and core
elements may be different. The NIOSH Scientific Program Administrator will
establish the capitation rate and resolve any differences in the protocols for
the FDNY responders and other responders. Applicants should provide in their
application the capitation rate that their CC would require for the health
screening model described below and fully describe a patient protocol based on
this model.
The current clinical protocol model consists of four components: core medical
exam; basic mental health screening; patient referral; and data entry. The
core medical exam consists of an updating of the exposure and medical history,
a complete physical examination with emphasis on the upper and low respiratory
tract, routine blood and urine screening, a standard chest x-ray (if
indicated), and pulmonary function testing. The basic mental health screening
designed to identify those patients at risk for WTC-related mental health
disorders such as anxiety disorders, depression and post traumatic stress
disorders. Patients presenting with conditions that require medical follow-up
are to be referred to an appropriate health care provider. A CC should have
in place a system for the referral of patients whether they have insurance or
not. The data is to be stored in a standardized format that is established by
the SC, and transmitted electronically to the DCCs. The data management
system must be Health Insurance Portability and Accountability Act (HIPAA)
compliant.
Data and Coordinating Centers
A DCC will provide statistical support, a web-based or other electronic data
entry site for the clinical data, quality assurance, follow-up for patients
that do not self identify a clinical site, and coordination of follow-up for
patients outside the geographical service areas of the CCs. In general, a DCC
will operate under the guidance of the SC. It is envisioned that the clinical
centers for the FDNY responders will be served by one DCC and the other
clinical centers will be served by the other DCC. The two DCCs will work
together, and the Scientific Program Administrator will resolve differences
between the DCCs if any arise. Because of the unique characteristics of the
two responder cohorts maintained by the two DCCs, a merged data set of all
responders is not part of this initiative.
With SC guidance, the DCCs will develop data collection forms and operation
manuals; assist in defining outcomes; and develop procedures for quality
control, training, and data management. They will monitor the quality and
quantity of data received from the CCs; provide relevant reports to the NIOSH,
the CCs, and the Steering Committee; and serve as a central repository for
study data, with the exception of any individual research projects. The DCC in
consultation with the SC, will determine the appropriate capitation rates and
will arrange contracts to provide services for examinations being provided
outside of the geographic area of the CCs. The DCCs will prepare confidential
data analyses and reports for the DSMB. They will support manuscript
preparation through data analysis, statistical consultation, editorial
support, and meeting coordination. The DCCs will schedule and make
arrangements for all meetings of World Trade Center Responder Health Study’s
committees and boards. The DCCs will be subject to annual administrative
review by NIOSH.
Specifically, the DCCs will work in collaboration with the WTCRHC members and
NIOSH program staff to:
1. Coordinate with the SC on the selection of the common data collection
protocols, and standardized forms, and the data entry system for the creation
and maintenance of the Common Data Sets for measurements to be done in common
by the CCs. The two DCCs will maintain separate Common Data Sets which due to
unique characteristics of each cohort would not necessarily need to be
identical. Prepare, disseminate, and update the WTCRHC Common Data Sets,
maintain a Manual of Procedures (MOP), data collection forms, databases, and
results reporting summaries for the CC sites, and maintain and verify for
correctness the resulting Common Data Sets.
2. Provide or arrange for training to all CC site personnel as needed on data
management and analysis, HIPAA, and quality control and quality assurance.
3. Collaborate with the CC sites (conditional on approval by the Steering
Committee and the NIOSH Scientific Program Administrator) in the analysis of
common data both for internal use by the study sites and for publications.
4. Provide the NIOSH Scientific Program Administrator, the DSMB, and the
Steering Committee with reports based on statistical and other analyses of
issues related to the two core data sets (FDNY and Other responders), or other
needs arising during the course of studies.
5. Prepare detailed reports in standardized formats on progress of study-
specific recruitment, patient screenings, compliance, and adverse events, for
use by the Steering Committee and DSMB.
6. Prepare a list of all CC site-specific data items that are used.
7. Maintain a database on adverse events and responses to them.
8. Support the activities of the CC sites, the SC, and the DSMB through
provision of materials, documentation support, meeting planning and logistics,
and conference call coordination. This includes attendance at Steering
Committee, subcommittee, and DSMB meetings to perform the functions listed
above.
9. Prepare and distribute the minutes and action items from the SC and DSMB
meetings and conference calls, CC Site visits, and SC Subcommittee meetings,
and provide timelines for the completion of actions items and updates on the
status of action items as required.
10. Assist the NIOSH Scientific Program Administrator in written, telephone,
and electronic communications with the CC sites and with various committees as
requested.
11. Establish databases that catalogue and disseminate information about all
WTCRHC publications.
12. Develop and maintain a public and private (secured, password-protected)
WTCRHC Web page.
13. Translate written materials into Spanish, Polish and other required
languages.
14. Develop, maintain, and coordinate the dissemination of information on
benefits, occupational safety and health related to WTC and referrals.
NIOSH.
The Scientific Program Administrator will monitor subject recruitment and
study progress, ensure disclosure of conflicts of interest and adherence to
award policies. The NIOSH Scientific Program Administrator and CDC Grants
Management Specialist will be responsible for fiscal management of the
network, including calculation of capitation budget rates and awards. NIOSH
will appoint the Chairperson of the Steering Committee and the external
advisory committee members with advice from the SC. NIOSH will provide
technical assistance as requested.
Steering Committee
Voting members of the Steering Committee will include the Principal
Investigator from each CC (or designated alternate), the Principal
Investigator from each DCC (or designated alternate), representative for the
external advisory committee (selected by NIOSH), and a Chairperson appointed
by NIOSH. The Chairperson of the Steering Committee (who may or may not be a
Principal Investigator of a participating CC) will oversee its functions and
conduct the Steering Committee meetings. The NIOSH, National Cancer Institute
and other National Institutes of Health Components Scientific Program
Administrators will be non-voting members of this committee.
The Steering Committee will develop and ensure compliance with
clinical policies and procedures, identify and prioritize topics for
investigation, and evaluate protocols proposed by the CCs. The Steering
Committee will ensure that studies are properly conducted and monitored, that
data are appropriately analyzed and interpreted, and that study results are
reported in the scientific literature in a timely manner and disseminated to
physicians involved in the care of WTCRHC participants. Subcommittees,
consisting of qualified individuals from the CCs, the DCC, and NIOSH, may be
established by the Steering Committee to perform specific functions such as
publications and presentations or quality control. The DCC supporting the
other responder CCs will provide support for this committee. An executive
committee consisting of one FDNY CC representative, one other responder CC
representative (selected by NIOSH with advice from the SC) and the NIOSH
Scientific Program Administrator will resolve differences in the health
assessment protocols for the two cohorts and other issues that cannot be
resolved by the SC.
Data and Safety Monitoring Board. An independent group of experts in areas
such as lung disease, mental health, biostatistics, clinical trials and
ethics, who are not otherwise involved in the study, as well as lay persons,
will be selected to evaluate the protocol prior to implementation, to
review periodically the progress of the health assessments, and to ensure
patient safety. The DCC supporting the other responder CCs will provide
support for this committee.
External Advisory Committee
An external advisory committee of 10-20 members will be established for this
program. The members will be appointed by the Director, NIOSH with the advice
of the SC. The DCC supporting the other responder CCs will provide support
for this committee.
Research Projects
The clinical and analytical activities supported by this RFA may be
complemented by research projects at the clinical sites that are funded
through individual research projects submitted to the NIH or NIOSH. These
projects would be conducted by the individual CCs, and the data would be
housed at the project site. These projects will be approved by the SC with
advice from the external advisory committee.
MECHANISM OF SUPPORT
The mechanism of support for this RFA is the NIOSH U10 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 NIOSH staff being substantially involved as a partner
with the Principal Investigator. This relationship is described under the
section "Cooperative Agreement Terms and Conditions of Award", below. The
project period for studies supported through this RFA will be 5 years. The
anticipated award date is March 15, 2004.
This RFA uses just-in-time concepts. It does not use the modular budgeting
formats. Follow the instructions for a detailed budget research grant
application. This program does not require cost sharing as defined in the
current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
FUNDS AVAILABLE
NIOSH intends to commit approximately $15 million annually over a 5-year
period to the support of the World Trade Center Worker Health Study, (Total
Costs include Direct Costs and Facility & Administrative Costs, also called
indirect costs or overhead). It is anticipated that four to eight CCs and two
DCCs will be established under this program. Approximately $5 million each
year will be committed to the fire fighter CC and DCC and $10 million to the
other responder CCs and DCC. The proposed direct cost budget of a CC should
not exceed $300,000 plus capitation. As the number of patients to be seen is
uncertain, an applicant should only state a proposed capitation rate and
number of patients projected. NIOSH and the CDC Procurement and Grants Office
will determine the amount for capitation. The proposed budget of a DCC
applicant may not exceed $1,000,000 Direct Costs in the first year, and
$750,000 in the subsequent years. Applications exceeding the funding limits
detailed above in any year will be considered unresponsive and returned
without further consideration. Specific instructions for budget preparation
are in the SUPPLEMENTAL INSTRUCTIONS, below. Designated funding levels are
subject to change at any time prior to award due to unforeseen budgetary,
administrative, or scientific developments. At this time, NIOSH does not plan
to reissue this RFA.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) 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 institutions/organizations
o Faith-based and community based organizations
o Indian Tribes, Tribal Government, College and/or Organizations
Foreign institutions are not eligible to apply. An institution may apply for
both a CC and the DCC, but there must be minimal overlap of key personnel to
ensure that data acquisition is independent of data quality assurance and
analysis. Therefore, the principal investigators for a CC and DCC must be
different. The application for the DCC must be separate and independent from
the CC application.
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 their institution to develop
an application for support. Women, individuals in underrepresented racial and
ethnic groups, and individuals with disabilities are always encouraged to
apply for NIOSH programs.
SPECIAL REQUIREMENTS
The WTCRHC will be a collaborative effort that will require frequent
interactions of awardees among themselves and with NIOSH. Applicants should
explicitly indicate their willingness to
o Participate in Steering Committee meetings (expected to occur approximately
three to six times per year in or near New York, NY), site visits required by
NIOSH, and regular telephone conference calls,
o Cooperate with the Clinical Coordinators in the development and design of
health assessment protocols (however, it is anticipated that there may be some
differences between the firefighter responder and other responder protocols),
o Abide by common definitions; common methods for patient selection
and enrollment; and common protocols (as appropriate), procedures, tests, and
reporting forms as chosen by majority vote of the Steering Committee or
Executive Committee (however, it is anticipated that there may be some
differences between the firefighter responder and other responder protocols),
o Actively seek to implement approved protocols,
o Comply with study policies and quality assurance measures,
o Agree to the oversight of the study in collaboration with the NIOSH
Scientific Program Administrator,
o Accept awards for the support of clinical assessments based on per-patient
(capitated) rates and the actual numbers of patients served. (CCs only),
o Transmit study data to a DCC in a timely and accurate manner (CCs only),
o Report all adverse events in accordance with procedures established
by the Steering Committee and NIOSH policies to the DSMB,
o Cooperate with other awardees in the publication of study results
and the eventual release to the scientific community of study
procedures and other resources,
o Develop and implement plans for the dissemination of study results
to physicians involved in the care of World Trade Center workers and
volunteers from the September 11, 2003 event, and
o Accept the Cooperative Agreement Terms and Conditions of Award given
below.
Cooperative Agreement Terms and Conditions of Award
The cooperative agreement is an award instrument establishing an "assistance"
relationship (in contrast to an "acquisition" relationship) between NIOSH and
a recipient, in which substantial NIOSH scientific and/or programmatic
involvement with the recipient is anticipated during performance of the
activity. The purpose of NIOSH involvement is to support and/or stimulate the
recipient's activity by acting as a "partner", while avoiding a dominant role,
direction, or prime responsibility. The terms and conditions below, elaborate
on these actions and responsibilities, and the awardee agrees to these
collaborative actions with the NIOSH Scientific Program Administrator to
achieve the project objectives. It is anticipated that these terms and
conditions will enhance the relationship between the NIOSH staff and the
principal investigator(s), and will facilitate the successful conduct and
completion of the study. These agreements will be in addition to, and not in
lieu of, the relevant NIOSH procedures for grants administration.
The terms will be as follows:
1. The awardee(s) will have lead responsibilities in all aspects of the
study, including any modification of study design, conduct of the study,
quality control, data analysis and interpretation, preparation of
publications, and collaboration with other investigators, unless otherwise
provided for in these terms or by action of the Steering Committee.
2. The NIOSH Scientific Program Administrator will serve on the Steering
Committee as non-voting members; he/she or other NIOSH scientists may serve on
other study committees, when appropriate, but if other NIOSH scientists are
identified, they will also be non-voting members. The NIOSH Scientific
Program Administrator (and other NIOSH scientists) may work with
awardees on issues coming before the Steering Committee and, as appropriate,
other committees, e.g., recruitment, intervention, follow-up, quality control,
adherence to protocol, assessment of problems affecting the study and possible
changes in protocol, interim data and safety monitoring, final data analysis
and interpretation, preparation of publications, and development of solutions
to major problems such as insufficient participant enrollment.
3. Awardee(s) agree to the governance of the study through a Steering
Committee. Steering Committee voting membership shall consist of the
Principal Investigators (i.e., cooperative agreement awardees), and the
Chairperson. Meetings of the Steering Committee will ordinarily be held by
telephone conference call or in the metropolitan New York Area.
4. Awardees will retain custody of and have primary rights to their data
consistent with current HHS, PHS, and NIOSH policies. The collaborative
protocol and governance policies will call for the continued submission of
data centrally to the coordinating centers for collaborative databases, one
for the firefighter and one for the other responder cohort; the submittal of
copies of the collaborative datasets to each principal investigator upon
completion of the study; procedures for data analysis, reporting and
publication; and procedures to protect and ensure the privacy of medical and
genetic data and records of individuals. The NIOSH Scientific Program
Administrator on behalf of NIOSH, will have the same access, privileges and
responsibilities regarding the collaborative data as the other members of the
Steering Committee.
5. Awardees are encouraged to publish and to publicly release and disseminate
results, data and other products of the study, concordant with study protocols
and governance, and the approved plan for making data and materials available
to the scientific community and to NIOSH.
6. The NIOSH reserves the right to terminate or curtail the study (or an
individual award) in the event of (a) failure to develop or implement a
mutually agreeable collaborative protocol, (b) substantial shortfall in
participant recruitment, follow-up, data reporting, or quality control, (c)
major breach of the protocol or substantive changes in the agreed-upon
protocol with which NIOSH cannot concur, or (d) human subject ethical issues
that may dictate a premature termination.
7. These 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 part 74 and 92, and other HHS, PHS, CDC
and
NIOSH grant administration policy statements.
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/health assessment issues to:
Michael J. Galvin Jr., Ph.D.
Scientific Program Administrator
Office of Extramural Programs
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
1600 Clifton Road, N.E.
Building 24, Room 1537, MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2524
FAX: (404) 498-2571
Email: [email protected]
o Direct your questions about peer review issues to:
Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147
Email: [email protected]
o Direct inquiries about financial or grants management matters to:
Mr. John Columbia, Contract Specialist
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, Pennsylvania 15236-0070
Announcement Number OH-04-001
Telephone: (412) 386-4458
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 an application, the information that it contains is
used 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 and should be sent to:
Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147
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 DUN and
Bradstreet (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.dunandbradstreet.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].
SUPPLEMENTAL INSTRUCTIONS:
If the proposed project involves organizations or persons other than those
affiliated with the applicant organization, letters of support and/or
cooperation must be included.
Supplemental Instructions for the Data and Coordinating Center:
Applicants for the Data and Coordinating Center should address the potential
requirements of the CCs, and how they would be satisfied by the DCC.
Plans for collection and handling of data consistent with the projected needs
of the study sites should be discussed. Plans for ensuring data integrity and
quality control should be discussed.
Personnel: The application for a DCC must describe the expertise of key
scientific, technical and administrative personnel and include a mechanism for
replacing key professional or technical personnel should the need arise. The
Principal Investigator of the DCC should be a professional with experience in
directing a coordinating center for large-scale collaborative multi-site
clinical studies or other large-scale epidemiological research project
involving multiple institutions. Staff needs may be modified as the WTCRHC
studies progress; however, adequate support staff should be designated to
manage routine tasks:
o PI of the DCC should provide overall scientific and biostatistical guidance.
o Project Manager to attend to day-to-day details and communicate necessary
information to study sites and/or to the other WTCRHC organizational
components. Staff training is also a responsibility of the Project Manager.
o Statisticians to help in data analysis.
o System analysts to help with developing and managing the database programs.
o Computer programmers to develop computer database.
o Clerks and administrative assistants to help in administrative work
and data entry.
Budget: The budgets for the DCC application should be based
on the applicant's best judgment of activities likely to be involved during
the different Phases of the WTCRHC studies.
The Phase 1 budget (Year 1) should include costs of establishing the
DCC staff, as required to carry out the DCC functions (including costs of
training personnel of CC sites for management and analyses, and quality
control and quality assurance of common data). Phase 1 also will involve
development of the protocols and manuals of operations by the CC sites, in
conjunction with the Steering Committee for the CC studies and creation of a
database for the common measures between the CC sites.
During Phase 2, the budgets should include projected data handling costs,
reporting functions, meetings and other communications costs, and the
projected expense of performing any interim analyses that may be requested by
the DSMB. Budgets should also include costs of organizing three joint
meetings of the Steering and External Advisory Committees per year and
providing for attendance of necessary Data and Coordinating Center staff. For
planning purposes, the applicant should assume no travel expenses for the
Steering committee, and $5,000 per meeting for the External Advisory Committee
travel expenses.
The Phase 3 (Year 5) budget should be concerned with study closeout, analysis
of study data, and reporting of results in collaboration with the study sites.
Budgets should also include costs of organizing three joint meetings of the
Steering and External Advisory Committees
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/labels.pdf.
SENDING AN APPLICATION TO NIOSH: Submit a signed, typewritten original of the
application, including the Checklist, and three signed photocopies, in one
package to:
Center for Scientific Review (CSR)
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 also be sent to:
Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147
Email: [email protected]
APPLICATION PROCESSING: Applications must be received by the application
receipt date listed in the heading of the 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 8 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 CSR and
responsiveness by NIOSH. Incomplete applications will not be reviewed.
If the application is not responsive to the RFA, NIOSH staff may contact the
applicant to determine whether to return the application to the applicant or
submit it for review in competition with unsolicited applications at the next
appropriate NIH review cycle.
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by a scientific review group convened by NIOSH
in accordance with the review criteria stated below. As part of the initial
merit review, all applications will:
o Undergo a process in which only those applicants deemed to have the highest
scientific or technical merit, generally the top half of the applications
under review, will be discussed and assigned a priority score.
o Receive a written critique.
o Receive a second level of review by the NIOSH Secondary Review Committee.
REVIEW CRITERIA
The goals of NIOSH-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 evaluate the application in
order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. The scientific review group
will address and consider each of the following criteria in assigning the
application’s overall score, weighting them as appropriate for each
application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The 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 it may propose to carry out important work that by its nature is
not innovative but essential to move a field forward.
Clinical Center
Review Criteria for the Administrative Core/overall program are:
o Responsiveness to the objectives of the cooperative agreement program,
including the applicant's understanding of the objectives of the proposed
cooperative agreement and the relevance of the proposal to the objectives.
o Feasibility of meeting the proposed goals of the cooperative agreement
program.
o Degree to which the program design addresses the distinct characteristics,
specific populations, and needs of the target population.
o Leadership ability and scientific stature of the Clinical Center Director
and his/her ability to meet the program's demands of time and effort.
o Effectiveness of the Center in establishing or continuing a health
screening program for WTC responders.
o Institutional commitment to the Center.
Review Criteria for the Clinical Core are:
SIGNIFICANCE: Does your study address an important problem? If the aims of
your application are achieved, how do they advance scientific knowledge?
What will be the effect of these studies on the concepts or methods that drive
this field?
The final design of the protocols (site-specific and common) will be developed
collaboratively by the CC sites and the Steering Committee. In assessing
applications for the Clinical Center, the scientific review group will focus
on whether the applicant recognizes the significance of the issues involved
and has the knowledge necessary to contribute meaningfully to the final
design, including understanding of the scientific, ethical, and practical
issues underlying the studies.
APPROACH: Does the applicant provide evidence of cooperation with the target
population? Does the applicant have demonstrated support from and experience
with the target population? Are the conceptual framework, design, methods, and
analyses adequately developed, well integrated, and appropriate to the aims of
the project? Do you acknowledge potential problem areas and consider
alternative tactics? Did the applicant fully describe the health screening
model and provide the capitation rate that their CC would require their model?
Does the applicant have an appropriate patient referral program for patients
who require medical follow-up? Does the applicant describe a reasonable health
screening model for the target population? Does the applicant address patient
confidentiality and data security? Does the applicant propose appropriate
health screening approaches?
INNOVATION: Does your project employ novel concepts, approaches or methods?
Is the health screening design innovative and efficient? Does the project
challenge existing paradigms or develop new methodologies or technologies?
Does the proposal address problems that may arise during the study and provide
innovative solutions to such problems?
INVESTIGATOR: Is the principal investigator appropriately trained and well
suited to carry out this work? Does the investigator team have experience
working with World Trade Center Responders? Is the work proposed appropriate
to the experience level of the principal investigator and to that of other
researchers? Does the application provide evidence of specific competence and
relevant experience of professional, technical, and administrative staff
pertinent to the operation of a Clinical Center for multi-site studies? Prior
experience collecting patient data and should be demonstrated. Does the PI
have appropriate clinical experience to conduct the study? Is there evidence
of experience in and willingness to participate appropriately in a
collaborative study as described in this RFA? Are there adequate assurances
that the Clinical Center personnel have experience in utilizing procedures
that insure the safety and confidentiality of medical records?
ENVIRONMENT: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed protocols take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support? Has
the application documented the adequacy of the proposed facility, technical
hardware, and working relationship with a DCC? Evidence of institutional
support and commitment for the proposed program should be provided.
RECRUITMENT EXPERIENCE AND CAPABILITIES: What is the likelihood, based on
experience and patient base, that the PI will be successful in recruiting an
adequate number of responders with the desired clinical characteristics and
with an acceptable level of participation by women and individuals from racial
and ethnic minority populations? Does the CC have experience with the target
population?
Review Criteria for the Data and Coordination Center are:
SIGNIFICANCE: Does the study address an important problem? If the aims of
your application are achieved, how do they advance scientific knowledge? What
will be the effect of these studies on the concepts or methods that drive this
field?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Did the investigator acknowledge potential problem areas and
consider alternative tactics? Does the proposed approach in managing the
logistical and data coordination have scientific and technical merit? Are the
proposed plans and experience relating to data collection, management,
editing, processing, analysis, and reporting adequate? Are the plans for
coordination with the study site investigators adequate? Is the approach to
developing a cooperative relationship among the study sites and between the
various WTCRHC organizational components adequate? Are the plans for
exercising appropriate leadership in matters of study design, data
acquisition, data management, and data analysis demonstrated?
INNOVATION: Does the project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies for health data
management? Does the applicant for the DCC Center offer innovative ideas on
how to achieve the goals of the WTCRHC studies with regard to its design and
administration?
INVESTIGATORS: Is the principal investigator appropriately trained and well
suited to carry out this work? Does the principal investigator have
experience in directing a DCC for large-scale collaborative multi-site
clinical studies or other large-scale epidemiological research project
involving multiple institutions? Are the other members of the DCC appropriate
for the scope of work proposed?
ENVIRONMENT: Does the scientific environment in which your work will be done
contribute to the probability of success? Do the proposed protocols take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there an appropriate organizational and
administrative structure to the proposed DCC? Is there evidence of
institutional support?
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:
Scientific Review Criteria
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).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans
to include subjects from all 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).
(CCs only)
DATA SHARING: The adequacy of the proposed plans to share data and
disseminate study results.
BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed study.
Programmatic Review Criteria
o Experience with the target population.
o Size of target population likely to be captured.
o Geographic area and target population served.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: December 22, 2003
Application Receipt Date: January 23, 2004
Earliest Anticipated Start Date: March 15, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit
o Availability of funds
o Programmatic priorities
o Geographic balance
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 of the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I), efficacy studies (phase II), efficacy,
effectiveness and comparative trials (phase III). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the participants.
NIOSH follows the NIH Policy for Data Safety and Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html.
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, and NIOSH adheres to this policy.
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 are 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.
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998. For this announcement NIOSH follows this policy.
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: NIOSH
policy requires education on the protection of human subject participants for
al investigators submitting NIOSH 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 PA 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). Those who must comply with the Privacy Rule (classified
under the Rule as covered entities ) must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
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 NIOSH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIOSH 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.
LOBBYING RESTRICTIONS: Applicants should be aware of restrictions on the use
of HHS funds for lobbying of Federal or State legislative bodies. Under the
provisions of 31 U.S.C. Section 1352, recipients (and their subtier
contractors) are prohibited from using appropriated Federal funds (other than
profits from a Federal contract) for lobbying congress or any Federal agency
in connection with the award of a particular contract, grant, cooperative
agreement, or loan. This includes grants/cooperative agreements that, in whole
or in part, involve conferences for which Federal funds cannot be used
directly or indirectly to encourage participants to lobby or to instruct
participants on how to lobby.
In addition no part of HHS appropriated funds, shall be used, other than for
normal and recognized executive-legislative relationships, for publicity or
propaganda purposes, for the preparation, distribution, or use of any kit,
pamphlet, booklet, publication, radio, television, or video presentation
designed to support or defeat legislation pending before the Congress or any
State or local legislature, except in presentation to the Congress or any
State or local legislature itself. No part of the appropriated funds shall be
used to pay the salary or expenses of any grant or contract recipient, or
agent acting for such recipient, related to any activity designed to influence
legislation or appropriations pending before the Congress or any State or
local legislature.
Any activity designed to influence action in regard to a particular piece of
pending legislation would be considered lobbying. That is lobbying for or
against pending legislation, as well as indirect or grass roots: lobbying
efforts by award recipients that are directed at inducing members of the
public to contact their elected representatives at the Federal or State levels
to urge support of, or opposition to, pending legislative proposals is
prohibited. As a matter of policy, NIOSH/CDC extends the prohibitions to
lobbying with respect to local legislation and local legislative bodies.
The provisions are not intended to prohibit all interaction with the
legislative branch, or to prohibit educational efforts pertaining to public
health. Clearly there are circumstances when it is advisable and permissible
to provide information to the legislative branch in order to foster
implementation of prevention strategies to promote public health. However, it
would not be permissible to influence, directly or indirectly, a specific
piece of pending legislation.
It remains permissible to use NIOSH/CDC funds to engage in activity to enhance
prevention; collect and analyze data; publish and disseminate results of
research and surveillance data; implement prevention strategies; conduct
community outreach services; provide leadership and training; and foster safe
and healthful environments.
Recipients of NIOSH/CDC grants and cooperative agreements need to be careful
to prevent NIOSH/CDC funds from being used to influence or promote pending
legislation. With respect to conferences, public events, publication, and
grass roots activities that relate to specific legislation, recipients of
NIOSH/CDC funds should give attention to isolating and separating the
appropriate use of NIOSH/CDC funds from non-NIOSH/CDC funds. NIOSH/CDC also
cautions recipients of NISOH?CDC funds to be careful not to give the
appearance that NIOSH/CDC funds are being used to carry out activities in a
manner that is prohibited under Federal law.
HEALTHY PEOPLE 2010: CDC is committed to achieving the health promotion and
disease prevention objectives of "Healthy People 2010," a national activity
for reducing morbidity and mortality and improve the quality of life. This RFA
is related to one or more focus areas. Potential applicants may obtain a copy
of "Healthy People 2010" http://www.healthypeople.gov.
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. And under
the Occupational Safety and Health Act of 1970, Section 20(a) (29 USC 669(a)).
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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