and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
DYNAMIC ASSESSMENT OF PATIENT-REPORTED CHRONIC DISEASE OUTCOMES
RELEASE DATE: November 18, 2003
RFA Number: RFA-RM-04-011 (formerly RFA-AR-04-007, see NOT-OD-04-008)
(also see NOT-RM-04-002 and NOT-RM-04-004)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
This RFA is developed as an NIH Roadmap initiative (http://nihroadmap.nih.gov/).
All NIH Institutes and Centers participate in Roadmap initiatives. The RFA will
be administered by the NIAMS on behalf of the NIH.
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.846
LETTER OF INTENT RECEIPT DATE: February 22, 2004
APPLICATION RECEIPT DATE: March 22, 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 Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The Institutes and Centers of the National Institutes of Health seek proposals
for innovative approaches to measuring patient-reported outcomes (PROs) that
will meet the needs of clinical researchers across a wide variety of chronic
disorders and diseases. This RFA solicits two types of applications; (1)
individual research proposals, with added concept proposals for network-wide
collection of self-report data on specific domains of patient-reported outcomes,
symptoms, or quality of life in large and diverse samples, and (2) proposals for
a statistical coordinating center that will serve as a data repository, conduct
analyses, and develop a computerized system to administer, collect, and report
PRO data. The principal investigators of each project will become members of a
network - Patient-Reported Outcomes Measurement Information System (PROMIS)- to
be established immediately following award. Proposals will be funded as
cooperative agreements, and PROMIS investigators will work collaboratively to
refine and coordinate proposed domains to be measured, to collect, manage, and
evaluate the data, and to develop a computerized system that administers dynamic
questionnaires (i.e., computerized adaptive tests, CAT), collects and manages
PRO data, and creates reports of health-related quality of life status for
clinical researchers, patients, and health care providers. The broad objectives
of the RFA are to (1) develop and test a large bank of items measuring PROs; (2)
create a computerized adaptive testing system that will allow for efficient,
psychometrically robust assessment of patient-reported outcomes in clinical
research involving a wide range of chronic diseases, and (3) create a publicly-
available system that can be added to and modified periodically and that will
allow clinical researchers to access a common repository of items and CAT. This
initiative addresses the need, identified as a high priority in the NIH Roadmap
process, for improved assessment of symptoms and other patient-centered outcomes
in clinical research.
RESEARCH OBJECTIVES
Background
Conventional clinical and functional measures of disease status do not
fully capture the ways in which chronic diseases and their treatment affect
individuals. Many aspects of patients' subjective experience, such as symptom
severity and frequency, emotional and social well-being, and perceived level of
health and functional ability are important targets for disease intervention
that are not measured by x-rays or laboratory results. Measurement of patient-
reported outcomes is particularly important in clinical trials, in which changes
in clinical measurements or imaging results may not translate into important
benefit to the patients, or in trials in which two treatments may be comparable
in limiting or curing disease but have different adverse effect profiles
differentially affecting symptoms, functioning, or other aspects of patients’
quality of life.
The last several decades have seen a proliferation of tools to measure symptoms,
quality of life, functional status, emotional status, and general perception of
health. Although many of these instruments have good demonstrated reliability
and validity, there are many limitations to current measurement approaches. One
critical disadvantage is the inability to compare results of different studies
when different measurement tools are used, as these instruments will have non-
comparable or non-combinable scores because each scale may use a different
number of items, different response options, different reference periods, or
different item content. For example, progress in clinical pain research is
slowed by the use of various pain measurement scales that are not directly
comparable. The length and complexity of questionnaires and batteries can also
be problematic, creating a level of respondent burden that hampers recruitment,
results in too much missing data, or is detrimental to response validity and
reliability. The clinical outcomes research enterprise would be enhanced greatly
by the availability of a psychometrically validated, dynamic system to measure
PROs efficiently in study participants with a wide range of chronic diseases and
demographic characteristics. New computer technologies and advances in modern
measurement theory make it possible to develop, maintain, and add to item banks,
to compare items and conduct statistical modeling of responses, and to create
computerized adaptive testing that allows item subsets to be tailored to the
individual without loss of scale precision or content validity. Ultimately, such
a system would also be useful in clinical practice to assess response to
interventions and to inform modification of treatment plans.
This initiative will establish a collaborative (PROMIS) of investigators to
improve measurement of patient-reported outcomes. The network will focus on the
collection of self-report data from a diverse population of individuals,
including racial and ethnic minorities, having a variety of chronic diseases.
PROMIS will support a comprehensive and integrated approach to data collection,
storage, and management, and will have a Statistical Coordinating Center that
will manage analyses and generation of item banks and computerized adaptive
testing systems.
Specific research objectives are:
o To identify a core set of questions, derived primarily from existing,
commonly-used instruments and supplemented by new and revised items, that
will address the most common or salient dimensions of patient-relevant
outcomes for the widest possible range of chronic disorders and diseases, and
to collect responses to these items in a large, diverse sample. Domains of
interest include, but are not limited to, self reported: symptoms, physical
functioning, participation in activities, social functioning; cognitive
functioning, and emotional status. Of special interest are the assessment of
pain severity, frequency, and impact and the assessment of fatigue as
clinical outcomes of high importance to many people suffering from chronic
diseases.
o To compare the performance of specific items, instruments, and models across
diverse clinical populations, and to develop common metrics by which scores
on new and existing instruments can be standardized and/or linked;
o To use methods made available by modern measurement theory (i.e., item
response theory modeling), cognitive aspects of survey methodology,
qualitative research methods, and other sophisticated approaches to create an
item bank for each domain measured;
o To develop a new computerized adaptive testing (CAT) tool that can be used
across a number of delivery platforms in a variety of clinical settings and
with a wide range of chronic disease populations. The CAT will select
questions from the item banks to deliver tailored instruments with enhanced
sensitivity and precision, reduced floor and ceiling effects, and reduced
response burden;
o To develop a web-based, user-friendly repository that can be updated
periodically, and to which data can be added from additional research. This
resource, the PROMIS, will be used to administer CAT, collect and manage
data, and provide instant reports to clinical researchers and patients (and
ultimately to health care providers, as appropriate);
o To develop a plan to maximize acceptance of this new measurement tool in the
clinical research community and in health-care settings. This plan should
involve soliciting input from clinical researchers, clinicians, patients, and
others throughout the study cycle.
o To perform feasibility studies to evaluate the success of the CAT system and
public use item repository, and to use feasibility study results to enhance
the PROMIS;
o To develop a plan to establish a public-private partnership to sustain the
repository, ensure scientific excellence, improve future data collection
activities by updating items as necessary, adding new items or new domains,
testing and adapting the system in new populations, and extending the reach
of this system to be used across a variety of media as technology allows.
Approaches for training potential clinical research users should be explored.
Approximate Timetable
Year 1: The Primary Research Sites (PRSs) and the Statistical Coordinating
Center (SCC) will work collaboratively to choose the specific domains,
constructs, existing instruments, and items to be analyzed for possible
administration to diverse patient populations in later years; obtain IRB
approvals, conduct focus groups, develop new items, conduct cognitive interviews
with target populations on both existing and new items, discuss CAT development,
collect pilot data, and develop and test data collection and reporting
procedures. Interact with potential future users of the item bank and CAT
(i.e., clinical researchers, clinicians, and patients) to facilitate development
of the most useful protocols and research products.
Year 2: Adopt core items for data collection by the PRSs; develop software, as
necessary, for questionnaire administration and data collection; develop
interface for CAT; and initiate large-scale data collection.
Year 3: Continue data collection and initiate ongoing data analysis for use in
alpha version of CAT.
Year 4: Complete data analyses, including assessing the psychometric properties
of the scales, assessing measurement equivalence through tests for differential
item functioning, and conducting comparisons among existing PRO questionnaires
and developing linking metrics to combine or compare scores; conduct second test
of CAT (beta test); and then finalize the CAT system.
Year 5: Evaluate the feasibility and utility of the CAT and the public domain
item bank; pilot test clinical researchers’ use of CAT and the item bank;
develop strategies and form partnership(s) to provide for ongoing development
and maintenance of the item bank and associated CAT technology.
Organization of PROMIS
PROMIS will be a cooperative network consisting of several Primary Research
Sites (PRSs) and a single Statistical Coordinating Center (SCC). A Steering
Committee will establish the procedures for the function of the network, as
outlined in the “Steering Committee” section below. In addition, the NIH will
establish an independent Scientific Advisory Board (SAB) to provide oversight of
PROMIS and each PROMIS component.
Primary Research Sites. PRS applicants will propose both a specific, independent
research project and two concepts for projects to be adopted by the network as a
whole. Projects proposed by PRS applicants for adoption by the network should
directly address the specific RFA objectives listed above. The independent
project should address, or be related to, one or more aspects of the network
specific objectives listed above. After the network is established, the
principal investigator of the PRS may choose to revise aspects of the
independent project to take advantage of opportunities provided by the other
PROMIS sites, and/or to increase the relevance or contribution of the
independent project to the network. Examples of topics for the independent
project include, but are not limited to:
o Studies of proposed core patient-reported outcomes in special populations or
comparisons between populations differentiated by racial, ethnic, or other
sociodemographic characteristics, diagnosis, disease-related characteristics,
or treatment;
o Studies of the psychometric properties of one or more domains of patient-
reported outcomes different from those proposed by the applicant for adoption
by the entire network;
o Investigation of minimum clinically important differences in proposed core
measures and other domains of patient-reported outcomes;
o Investigation of health preferences or health utilities, including
developing the means to compare the burden associated with different health
states, to compare the relative importance to patients and the general
community of movement from one health state to another, and to create a single
health summary score to support cost-effectiveness analysis;
o Development, testing, or comparison of different methods or technologies for
collecting patient-reported outcomes;
o Studies involving translation and testing of non-English instruments,
adapting instruments for cultural sensitivity or relevance, or of adapting
instruments for low-literacy or for physical or cognitive handicaps, using
proposed core and other instruments.
o Studies relating self-report data to behavioral or physiological data,
including data collected using “real time” methods and technologies;
o Studies of longitudinal disease course and treatment outcomes using proposed
core measures and other domains of patient-reported outcomes.
Further instructions regarding elements to be included in PRS applications are
listed in the section “SUPPLEMENTAL INSTRUCTIONS.”
Statistical Coordinating Center. The SCC will provide and manage a secure,
customizable, coordinated data management system for collection, storage, and
analysis of data to be collected by the PRSs. With the guidance of the PRSs and
the Steering Committee, the SCC will create the core PRO questionnaires to be
administered across all PRS sites, in both paper and computer-based formats. The
SCC will be primarily responsible for analyzing the data using item response
theory (IRT) modeling and other sophisticated psychometric approaches, and for
creating item banks. The item banks will serve as the foundation for the further
development of tailored short-form instruments and computerized adaptive testing
techniques (CAT). The item banks, short forms, and CAT will be made widely
available to clinical researchers as a web-based application (or downloadable to
computer devices), and the SCC will develop training for clinical researchers in
the use of this resource. Instructions regarding elements to be included in SCC
applications are listed in the section “SUPPLEMENTAL INSTRUCTIONS.” In addition,
SCC applicants may propose up to two separate research plans for complementary
research projects entailing data collection techniques, advances in psychometric
or statistical methodology or measurement, or other topics related to this RFA.
Steering Committee. The Steering Committee (SC) will function as the main
governing board of all grants awarded under this RFA, and will be the committee
through which the NIH interacts and collaborates with the facilities. Voting
membership includes the NIH Science Officer(s) (no more than 40% of total votes)
and the PI of each awarded cooperative agreement. Additional committee members
may be added by action of the Steering Committee. Other NIH staff may attend
Steering Committee meetings when their expertise is required for specific
discussions.
Scientific Advisory Board. This committee ensures coordination among funded
projects and evaluates their progress in relation to the goals of this
initiative. The Scientific Advisory Board will use its knowledge of the
activities of all of the participating facilities to ensure adequate
investigation, communication, and sharing, and will evaluate and make
recommendations regarding coordination of awardee activities and regarding other
related activities that may be developed in the future.
It will be the responsibility of the Scientific Advisory Board to make
recommendations that will lead to exchanging research tools, research resources,
adopting common policies on data sharing, creating item banks, and
other activities that will make the resources developed of maximal utility to
the scientific community.
The SAB will be appointed by the NIH, and will consist of approximately 6
scientists (advisors) who are not affiliated with any of the funded sites.
These advisors will be selected for their broad expertise in relevant topics.
The SAB will meet at least once each year. A schedule for subsequent meetings
will be prepared at the first meeting.
The NIH will select one member to be the SAB chair, after considering
the SAB recommendations. The chair will schedule the first meeting, and will be
responsible for developing meeting agendas and chairing the meetings. Additional
SAB members may be added by an action of the original committee members. The SC
Chair and Science Officer(s) will attend SAB as non-voting members and will act
as representatives of SC. Other NIH staff and Steering Committee members may
attend SAB meetings when their expertise is required for specific discussions.
MECHANISM OF SUPPORT
This RFA will use the NIH U01 award mechanism. This RFA is a one-time
solicitation. Future unsolicited, competing-continuation applications based on
this project will compete with all investigator-initiated applications and will
be reviewed according to the customary peer review procedures. The anticipated
award date is September, 2004.
This RFA uses just-in-time concepts. It also uses the non-modular budgeting
formats. 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.
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 staff being
substantially involved as a partner with the Principal Investigator, as
described under the section "Cooperative Agreement Terms and Conditions of
Award". The initial period of support for a U01 will be five years.
FUNDS AVAILABLE
The NIH intends to commit approximately $5,000,000 in FY 2004 to fund three to
six new grants for Primary Research Sites and one new grant for a Statistical
Coordinating Center in response to this RFA. 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. Although the financial plans of the
NIH 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(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 or community-based organizations
o Foreign institutions are not eligible to apply
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 or 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
PROMIS will be a collaborative effort requiring frequent interactions among
awardees. All awardees will cooperate fully in the planning and implementation
of collaborative network projects designed to address the research objectives
described in this RFA. Data on core items from the collaborative projects will
be pooled for joint analysis, interpretation, and publication by PROMIS
investigators in accordance with policies and procedures established by a
Steering Committee (SC) to be formed shortly following award.
All awardees are required to participate in meetings and/or conference calls,
possibly quarterly, to discuss and review scientific and technical aspects of
implementation, analyses, and presentation of data. At least one investigator
from each award, preferably the PI, must attend these meetings. Up to three
additional key personnel from each award, if appropriate, may attend. Applicants
should plan for 4 trips per year and budget accordingly.
To address the joint interests of the government in the availability of, and
access to, the results of publicly funded research, the NIH requires applicants
who respond to this RFA to propose detailed plans for sharing the research
resources generated through the cooperative agreement. The resource-sharing
plan will include providing the wider scientific community access to the data
repository and CAT with appropriate timeliness and mileposts. For example,
software development should include plans and a timeline for alpha testing, beta
testing, production release, interface development, bug reporting, integration
with other codes, extension to multiple platforms, etc. Data sharing will be as
important as software sharing. All awards made under this RFA are subject to
the Final NIH Statement on Sharing Research Data
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html).
Intellectual Property Rights
The NIH is interested in ensuring that the research resources developed through
this RFA become readily available to the research community. The majority of
transfers to not-for-profit entities should be implemented under terms no more
restrictive than the Uniform Biological Materials Transfer Agreement (UBMTA). In
particular, recipients are expected to use the Simple Letter Agreement provided
at http://www.nih.gov/od/ott/RTguide_final.htm, or another document with no more
restrictive terms, to readily transfer unpatented tools developed with NIH funds
to other recipients for use in NIH-funded projects. Commercialization option
rights, royalty reach-through, or product reach-through rights back to the
provider are inappropriate. No fees should be collected to use the instruments
or gain access to the PROMIS.
Principles and guidelines for recipients of NIH research awards on obtaining and
disseminating biomedical research resources can be found at
http://www.nih.gov/od/ott/RTguide_final.htm. A reasonable time frame for release
of materials should be specified in the application and will be considered
during the review of the plan for sharing.
Cooperative Agreement Terms and Conditions of Award
Patient-Reported outcomes Measurement Information System (PROMIS)
The following Terms and Conditions will be incorporated into the award
statement. The following special terms of award are in addition to, and not in
lieu of, otherwise applicable OMB administrative guidelines, HHS grant
administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when
State and local Governments are eligible to apply), and other HHS, PHS, and NIH
grant administration policies:
The administrative and funding instrument used for this program is the
cooperative agreement (U01),an "assistance", rather than an "acquisition",
mechanism, in which substantial NIH scientific and/or programmatic involvement
with the awardee is anticipated during the performance of the activity. Under
the cooperative agreement, the NIH purpose is to support and/or stimulate the
recipient's activity by involvement in and otherwise working jointly with the
award recipient in a partner role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity. Consistent with this
concept, the dominant role and prime responsibility for the activity resides
with the awardees for the project as a whole, although specific tasks and
activities in carrying out the research will be shared among the awardees and
the NIH Science Officer(s) as described below.
1. Principal Investigator Responsibilities
Primary Research Sites (PRSs): The Principal Investigator will have primary
authority and responsibility for the independent project and for contributions
to the network, including research design, protocol development, setting
milestones, and analysis of data, as agreed upon by the Steering Committee. The
PI will accept and implement the common guidelines and procedures approved by
the Steering Committee. In accordance with policies and procedures established
by the Steering Committee, core data from the collaborative projects will be
pooled for joint analysis, interpretation, and publication by PROMIS
investigators; periodic progress reports will be submitted in a standard format.
During the first year of the award, the Steering Committee will discuss and
agree upon policies and procedures regarding its degree of involvement with the
independent projects (e.g., communication regarding independent project
activities and progress, publication of independent project results).
Statistical Coordinating Center (SCC): The Principal Investigator will have
primary authority and responsibility for management and analysis of data,
creating an item bank, developing a computerized adaptive testing (CAT) tool,
and developing training for clinical researchers, as agreed upon by the Steering
Committee. In accordance with policies and procedures established by the
Steering Committee, core data from the collaborative projects will be pooled for
joint analysis, interpretation, and publication by PROMIS investigators;
periodic progress reports will be submitted in a standard format, and item banks
and tools will be released according to the approved plans for sharing research
resources generated through the award.
2. NIH Science Officer(s)
The NIH Science Officer(s) named in the Notice of Award will have substantial
scientific/programmatic involvement during the conduct of this activity through
technical assistance, advice, and coordination above and beyond normal program
stewardship for grants. This involvement includes functioning as a partner with
the PIs and providing significant input in the planning and conduct of the
research, to include working with the Principal Investigators in finalizing the
set of items to be tested and the testing methodology, planning for data
analysis, interpreting data and, if warranted, in co-authoring manuscripts for
publication. The Science Officer(s) will also serve as scientific liaison
between the awardees and other NIH program staff, and retain the option to
recommend re-allocating NIH support among awardees as scientific goals evolve.
The Science Officer(s) must be informed of all major interactions of members of
PROMIS.
3. NIH Program Director
THE NIH will appoint a Program Director who will have responsibility for normal
program oversight and stewardship of the award. The Program Director will
appoint the Steering Committee chair based on recommendations from the Steering
Committee members, serve as a non-voting member of the Steering Committee, carry
out continuous review of all activities to ensure objectives are being met, and
have the option to recommend withholding support to a participating institution
if technical performance requirements are not met.
4. Collaborative Responsibilities
Steering Committee (SC): The NIH will interact and collaborate with the
facilities principally through the Steering Committee, which will function as
the main governing board. Voting membership includes the PI of each awarded
cooperative agreement and one or more NIH Science Officers(s) (no more than 40%
of total votes). Additional committee members may be added by action of the
Steering Committee. Other NIH staff may attend Steering Committee meetings when
their expertise is required for specific discussions.
The Science Officer(s) will schedule the first meeting and set the agenda,
following which the Chair of the committee will be responsible for developing
meeting agendas and chairing meetings. The Steering Committee will meet at least
twice per year, but may use video or teleconferencing rather than face-to-face
meetings, at the discretion of the committee members. The purpose of these SC
meetings is to identify core items to be used in developing item banks; share
scientific information; assess scientific progress; identify new research
opportunities; discuss strategy and potential avenues of collaborations (such as
with industry, private foundations and/or NIH intramural scientists); establish
priorities that will accelerate the transfer of item banks and CAT to the
clinical research community; reallocate resources; and conduct the business of
the cooperative research program. The Steering Committee will develop the
process and review procedures for handling proposed additional studies with the
funds reserved for this purpose. The use of these funds will be restricted and
must be reviewed and approved by the Steering Committee and then recommended to,
and approved by, the NIAMS for release from the individual U01 awards. Decisions
will be made by a majority vote of a quorum, with an attempt at consensus.
Scientific Advisory Board (SAB). The Scientific Advisory Board will be make
recommendations that will lead to exchanging research tools, research resources,
adopting common policies on data sharing, creating item banks, and other
activities that will make the resources developed of maximal utility to the
scientific community. This committee ensures coordination among funded projects
and evaluates their progress in relation to the goals of this initiative. The
Scientific Advisory Board will use its knowledge of the activities of all of the
participating facilities to ensure adequate investigation, communication, and
sharing, and will evaluate and make recommendations regarding coordination of
awardee activities and regarding other related activities that may be developed
in the future.
The SAB will be appointed by the NIH, and will consist of approximately 6
scientists (advisors) who are not affiliated with any of the funded sites.
These advisors will be selected for their broad expertise in relevant topics.
The SAB will meet at least once each year. A schedule for subsequent meetings
will be prepared at the first meeting. The NIH will select one member to be the
SAB chair, after considering the SAB recommendations. The chair will schedule
the first meeting, and will be responsible for developing meeting agendas and
chairing the meetings. Additional SAB members may be added by an action of the
original committee members. The SC Chair and Science Officer(s) will attend SAB
as non-voting members and will act as representatives of SC. Other NIH staff
and Steering Committee members may attend SAB meetings when their expertise is
required for specific discussions.
5. Milestones and Evaluations
The NIH Program Director will review the progress of the network and the
Steering Committee annually to assure that satisfactory progress is being made
in achieving objectives. During the first year of funding, and during
subsequent years if deemed necessary by the Program Director, reviews may be
more frequent. Should problems arise in the conduct of the study, the NIH
Program Director may require that the awardee submit quarterly reports on
progress and fiscal matters.
The progress report will be the standard annual NIH progress report (Form 2590).
The awardees' yearly milestones will be provided to the Steering Committee and
the SAB. The milestones should be adjusted annually at the award anniversary
dates, both to incorporate a group's scientific accomplishments and progress, as
well as to reflect Steering Committee and SAB recommendations. Following the
evaluation of milestones, NIH program staff may recommend augmenting any project
or reducing or withholding funds for any project that substantially fails
to meet its milestones or to remain state-of-the-art.
6. Arbitration
Any disagreement that may arise on scientific/programmatic matters (within the
scope of the award), between award recipients and the NIH may be brought to
arbitration. An arbitration panel will consist of one person selected by the
Principal Investigators, one person selected by the NIH, and a third person
selected by both NIH staff and the Principal Investigators. The decision of the
arbitration panel, by majority vote, will be binding. This special arbitration
procedure in no way affects the awardee's right to appeal an adverse action that
is otherwise appealable in accordance with the PHS regulations at 42 CFR Part
50, Subpart D and HHS regulation at 45 CFR Part 16.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
two areas: scientific/research and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Deborah N. Ader, Ph.D.
Director, Behavioral and Prevention Research Program
NIAMS
One Democracy Plaza
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20872-4872
Telephone: (301) 594-5032
Fax: (301) 480-1284
Email: aderd@mail.nih.gov
Lawrence J. Fine, M.D., Dr.PH
Medical Advisor, OBSSR-NIH
Room 256, Building One
One Center Drive
Bethesda, MD 20892
Telephone: 301-435-6780
Fax: 301-402-1150
Email: FineL@mail.nih.gov
o Direct your questions about financial or grants management matters
to:
Melinda Nelson
Grants Management Officer
NIAMS
One Democracy Plaza
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20872-4872 Telephone: (301) 594-3535
Fax: (301) 480-5450
Email: nelsonm@mail.nih.gov
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 IC staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. The letter of intent should be sent to:
Deborah N. Ader, Ph.D.
Director, Behavioral and Prevention Research Program
NIAMS
One Democracy Plaza
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20872-4872 Telephone: (301) 594-5032
Fax: (301) 480-1284
Email: aderd@mail.nih.gov
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) 435-0714, Email: GrantsInfo@nih.gov.
SUPPLEMENTARY INSTRUCTIONS
Specific Instructions for Primary Research Site Applications
Independent Projects: Applicants should propose objectives, hypotheses,
measures, and statistical analysis plans for their independent projects
following the usual PHS 398 instructions, and the Research Plan (Sections A-D)
for this portion of the application will be a maximum of 25 pages in length.
Applicants should explicitly discuss how the independent project is relevant and
complementary to the RFA objectives. Section E., Human Subjects, has no page
limit.
Network Projects: The independent project research plan must be followed with 2
concept proposals to be considered for adoption by PROMIS. An additional fifteen
pages, total (not including budget information), will be allowed for these
proposals and for a statement of capability to contribute to the network.
Proposals for PROMIS projects should include the following:
o Aims - hypotheses and associated proposed core measures (i.e., measures to be
used by all PROMIS sites), and additional important variables to be measured,
such as co morbidity and sociodemographic characteristics;
o Relevance – a statement of the scientific relevance and the importance of
proposed measures and related domains for improving measurement of patient-
reported outcomes in diverse populations;
o Requirements and Feasibility – e.g., need and ability to conduct focus groups
to determine constructs, instruments, and items to include; ability to carry-
out assessments of patient populations using a variety of methods and
technologies; and ability to apply cognitive aspects of survey methodology to
assess patients’ comprehension of items and response categories. Applicants
may propose development and testing of innovative systems;
o Statement of Capability - demonstration of a supportive institutional
environment and institutional commitment; past experience and/or willingness
to participate as a collaborating research partner in network activities,
including the collection of timely, consistent, standardized core data and
reporting of all de-identified information to a central SCC for the purpose
of supporting pooled analyses; additional information regarding expertise and
resources (i.e., access to existing data sets, access to large relevant
patient samples, experience in assessment methods and technologies,
institutional resources etc.) positioning the applicant to be an important
contributor to the collaborative network. Applicants may have very strong,
specific expertise – for example, in assessing a particular variable or
construct, or may have broad expertise with a wide population. Explicit
statements of the type and breadth of expertise relevant to the objectives of
this RFA are strongly encouraged
o An estimate of the budget, with justification, required for the PRS’
participation in the network activities proposed.
Applications should be flexible enough to accommodate further refinement and
integration with the other awardees. Potential applicants at single research
institutions may coordinate with each other to meet minimum accrual targets and
may submit common applications.
Budget Requirements for PRS Applications:
Investigators should prepare separate budgets for the independent and proposed
PROMIS research for their own site(s), not for the entire network. PRS
applicants should request a project period of 5 years. The total combined costs
(direct and applicable facilities and administrative costs) of the independent
and collaborative network projects may be up to $875,000 per year. Funding for
independent projects may be requested for up to $450,000 total costs per year.
PRS applicants should provide a detailed budget for the independent project, and
include the lump sum for network activities in the “Other” category of the
overall budget. Details of this estimated network budget should be included
following the Research Plan of the network concept proposals. The network
portion of awarded funds for each U01 will be restricted pending approval of
PROMIS projects by the Steering Committee. Once the Steering Committee has
approved network projects, network funds may be reallocated across years or
among sites as necessary. Continuation and level of funding for each PRS will be
based on actual recruitment and overall performance. Awards will be subject to
annual administrative review.
A minimum of 25% effort for the PI at each PRS is required, and should be
represented in the independent project budget. The budget for proposed PROMIS
collaborative project activities should include travel costs for two people to
attend approximately four trips each year to attend Steering Committee meetings
in Bethesda, MD, and other travel related to network operations (such as site
visits), with appropriate justification.
Specific Instructions for SCC Applications
A separate complete application is required from institutions applying to serve
as the Statistical Coordinating Center for PROMIS. SCC applicants are not
required to be a network PRS, but PRS applicants may submit an application to
serve as the SCC.
The sources of data for this research effort will be diverse; integrating data
from these multiple sources may require development of novel data collection and
editing systems. Therefore, one key function of the SCC will be to develop
automated systems to ensure high quality, efficient reporting of data from
individual PRS sites to the SCC for eventual use in pooled analyses. The SCC
will also support and assist the PRSs in their development of standardized,
automated data collection methods tailored to their local environments, to
ensure that data are of uniformly high quality. The SCC and the Steering
Committee will select one or more approaches to analyze data and construct item
banks. The SCC will develop and conduct pilot testing of the software for
computerized adaptive testing. In addition, the SCC will take the lead in
developing education material or approaches for clinical researchers who will
use the item banks and CAT system. SCC applicants must include a statement of
willingness to work collaboratively after award with the other funded sites to
prepare a joint dissemination plan.
Applicants for the SCC should describe how the information technology needs of
the network (data storage, curation, analysis, and retrieval) will be met and
propose plans and methods with respect to coordination activities, including:
o Plans for working with PRSs to develop quality control procedures for data
collection, storage, and transmission; plans for data management,
including formatting, and documentation of core data elements using data
dictionaries. The applicant should provide evidence of understanding and
experience in creating a central data repository;
o Plans for a process to select items and domains for inclusion in pilot
studies and in full-scale network data collection;
o Procedures to ensure data security, privacy, and confidentiality. When
relevant, specific state and/or federal laws and their impact on the
project must be fully explained;
o Plans and procedures for coordinating and maintaining regular
communications among all the PRSs on an ongoing basis;
o Software standards to be used at the data and computer level;
o Methods for reporting the status of data submitted for pooled data
analysis in terms of completeness and utility for pooled analysis;
o Plans for collaborating with PRSs as appropriate to identify or develop
psychometric and statistical methods, and commitment to providing
leadership in advancing psychometric, statistical, and outcomes
methodologies;
o Scientific data software to be used, and approach to enabling users to
visualize data, work across different platforms, collaborate, and analyze
data both within and across data files;
o Plans for a data query infrastructure to allow for data storage and query
over the lifetime of the network and beyond;
o Plans and procedures to: determine whether items perform differently in
different populations (i.e., differential item functioning, DIF) and how
to control for DIF when items are relevant for certain populations; select
items to be included in item banks; identify the most appropriate IRT
model or alternative; and develop and test a computerized adaptive testing
system using the item banks created;
o Plans to develop a PRO computerized system that administers
questionnaires, collects and summarizes data, and provides instant reports
to the respondent, researchers, and health providers;
o Plans to facilitate public access to, and support for, the PROMIS, which
includes but is not limited to: the item banks, short-form instruments,
CAT system, and supporting material.
In addition to its central role in moving the network towards comparable data
collection, the SCC is intended to accomplish several other research objectives
with this initiative, particularly the support and advancement of statistical
methodology for studies of process-outcome linkages in chronic disease care.
Statistical analysis of pooled data is the joint responsibility of investigators
from PRSs and the SCC. However, the SCC applicant should demonstrate familiarity
with key statistical concepts relating to the analysis of population-based data,
such as repeated measures analysis, missing data, hierarchical modeling, and
variability across populations, facilities, and providers. The SCC should
demonstrate psychometric expertise in the use of IRT models and other
psychometric and statistical approaches to construct item banks, and in
psychometric and software aspects of developing computer adaptive testing. The
SCC should demonstrate the ability and flexibility to model data using a variety
of IRT models to allow researchers to determine the optimal model for purposes
of this study. SCC applicants should discuss the development of an
infrastructure for supporting and furthering the development of psychometric and
statistical methods in collaboration with researchers at the PRSs. Similarly,
the SCC applicants should discuss the infrastructure for supporting, developing,
and testing the computer adaptive testing systems in patient populations at the
PRSs.
The research plan is limited to no more than 25 pages, and should use the
following topic headings:
1. Research objectives and aims
a. Item Bank Development
b. Computer Adaptive Testing Development
c. PRO Assessment, Data Collection, and Reporting System
2. Background and Significance
3. Data management, training, and quality control
4. Data analysis including psychometric and statistical methodologies
5. Communication
6. Scientific leadership and dissemination
Budget Requirements for SCC Applications:
SCC applicants should request a project period of 5 years with total costs
(direct and applicable facilities and administrative costs) of up to $1,500,000
per year. For budget purposes, applicants should assume that in the first year
all administrative aspects of PROMIS will be organized and enrollment started on
at least one protocol. For each subsequent year, applicants may assume at least
two active protocols. Costs for site visits to each of the PRSs should be
included (assume up to four PRSs). A portion of awarded funds for will be
restricted pending approval of PROMIS projects by the Steering Committee.
Continuation and level of funding will be based on actual recruitment and
overall performance. Awards will be subject to annual administrative review.
General Instructions for All Applications
Because the Terms and Conditions of Award will be included in all awards issued
as a result of this RFA, it is critical that each applicant include specific
plans for responding to these terms. Plans must describe how the applicant will
comply with NIH staff involvement as well as how all the responsibilities of
awardees will be fulfilled.
Each applicant must describe the proposed duties and attendant qualifications
for all other proposed personnel, such as project managers, psychometricians,
statisticians, survey experts, HRQOL experts, data managers, computer
programmers, and data entry clerks. Each applicant must have a defined space for
administrative activities and administrative personnel that will serve as a
focus for data management, quality control, and communication.
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 THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, and five signed
photocopies, in one package to:
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (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 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, the NIH will review applications for completeness and
responsiveness. Incomplete and/or unresponsive applications will not be
reviewed.
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 NIH 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 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 written critique
o Receive a second level review by an appropriate National Advisory
Council or Board.
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 evaluate the
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals.
For each PRS application, the independent research project will receive a score,
the concept proposals will receive a score, and the overall application will
receive a score. SCC applications will receive one overall score. 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, an investigator may propose to carry out
important work that by its nature is not innovative but is essential to
move a field forward.
SIGNIFICANCE: Does this study address the general and specific research
objectives of the RFA? If the aims of the application are achieved, how will
scientific knowledge be advanced? 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? Does the applicant acknowledge potential problem areas and
consider alternative tactics?
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?
INVESTIGATOR: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)?
ENVIRONMENT: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? 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:
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. Plans for the recruitment and retention of subjects will also be
evaluated. (See Inclusion Criteria in the sections on Federal Citations, below).
PRS Independent Projects: To deserve a high priority score, the application must
be judged clearly related to the general goal of providing clinical researchers
with better tools or methods to measure patient-reported outcomes, and relevant
or complementary to one or more of the specific objectives of this RFA.
PRS Network Concepts: The following factors will be considered in evaluating the
merit of proposed network activities:
o Are the concept proposals clearly related to the specific aims of the RFA and
the long-term goal of providing clinical researchers with better tools and
methods to measure patient-reported outcomes?
o Is a heterogeneous patient population available, and are plans to include
racial and ethnic minorities and subgroups appropriate for the scientific
goals of the research adequate?
o Does the applicant adequately address the protection of patient information
and confidentiality?
o Is there evidence of a supportive institutional environment for the proposed
PRS? Does the proposed PRS utilize available resources well? Is there support
and commitment from the institution?
o Do the research team and institution show clear promise of ability to work
effectively as part of a collaborative network?
Statistical Coordinating Center
The following additional factors will be considered in evaluating the scientific
merit of applications for the SCC:
o Do the qualifications and research experience of the Principal Investigator
and staff include a track record of collaborative interdisciplinary activity,
particularly in terms of coordinating large data collection? Does the project
team have adequate expertise in conducting pooled data analysis using IRT and
in other psychometric, statistical and survey methods?
o Is the information technology to be used adequately described and appropriate
to accomplish the objectives of the network?
o To what degree are the proposed technology and approach appropriate for
clinical research and likely to have utility in a clinical setting?
o Does the applicant adequately address the protection of patient information
and confidentiality?
o Are the plans for dissemination of the CAT tool adequate? Will this
instrument be accessible and user-friendly?
ADDITIONAL REVIEW CONSIDERATIONS
Budget: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research.
Data Sharing and Data Access: The scientific review group will evaluate the
adequacy of the proposed plan for sharing and data access. Comments on the plan
and any concerns will be presented in an administrative note in the Summary
Statement. The adequacy of the plan will be considered by NIH program staff and
will be important in determining whether the grant shall be awarded. The sharing
plan approved by program staff, after negotiation with the applicant when
necessary, will become part of the terms and conditions of the award. NIH
program staff will evaluate the compliance with the sharing plan and scientific
progress in the non-competing continuation of the grant award application.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 22, 2004
Application Receipt Date: March 22, 2004
Peer Review Date: July 2004
Council Review: September 2004
Earliest Anticipated Start Date: September 2004
AWARD CRITERIA
Award 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.
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
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. (NIH Policy for Data and Safety
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).
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
applications 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.
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 applications 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).
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 NIH GRANT APPLICATIONS OR APPENDICES: All applications and
applications 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.
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