and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
INTER-RELATIONSHIPS OF SLEEP, FATIGUE, AND HIV/AIDS
RELEASE DATE: October 27, 2003
RFA Number: RFA-HL-04-010
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.233, 93.853,
93.837, 93.838, 93.839
LETTER OF INTENT RECEIPT DATE: February 13, 2004
APPLICATION RECEIPT DATE: March 15, 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 primary goal of this initiative is to elucidate the etiology of
sleep disturbances and fatigue associated with human immunodeficiency
virus (HIV) infection and acquired immunodeficiency disease syndrome
(AIDS). An improved understanding of this etiology will help in the
development of approaches to improve the sleep and quality of life of
HIV-infected patients and improve our fundamental understanding of the
relationship between sleep and chronic infections in particular and
chronic diseases in general.
RESEARCH OBJECTIVES
Between 850,000 and 950,000 Americans are living with HIV infection and
suffering from devastating effects on health, performance, and overall
quality of life (QOL). As new therapies extend life expectancy of HIV
patients, long term adverse impacts on QOL become increasingly
important. Although relatively unstudied, sleep disturbance and fatigue
are highly prevalent and disabling symptoms in a majority of
individuals infected with human immunodeficiency virus (HIV). Sleep
complaints are among the first symptoms of HIV infection and correlate
with decreasing CD4+ lymphocyte counts in otherwise asymptomatic HIV
seropositive individuals. Fatigue symptoms are associated with
increased napping, diminished alertness, difficulty falling asleep, and
frequent awakening during sleep. Polysomnographic studies indicate
that HIV infection disrupts the normal cycle of alternating rapid eye
movement (REM) and non-REM periods associated with restorative sleep;
advanced HIV infection is associated with a loss of normal sleep
patterns. These impairments in sleep quality may diminish
immunological and cognitive-motor function. The onset of these
disturbances in sleep architecture occurs early in the course of HIV
disease and appears to be a characteristic of the long clinical latency
preceding the development of acquired immunodeficiency disease syndrome
(AIDS). For patients with HIV infection, sleep disturbance and
fatigue interfere with daily activities, diminish the quality of life,
and contribute to a greater risk of unemployment. Advanced HIV
infection is associated with a loss of normal sleep patterns.
Common complications of advanced HIV infection, such as peripheral
neuropathy, can also be a source of sleep disturbance and exacerbate
fatigue symptoms. Some findings suggest that symptoms of sleep
disturbance and fatigue are independently associated with survival
among people with HIV infection. Although relatively little is known
about the pathophysiology or etiology of sleep disturbances and fatigue
in patients with HIV disease, it is known that there are reciprocal
interactions between sleep and neuroendocrine and immune factors. For
example, immune molecules alter sleep architecture, sleep deprivation
alters neuroendocrine and immune responses, immune system activation
and neuroendocrine responses alter sleep, and sleep quality appears to
affect the course of and susceptibility to infectious diseases in
general.
Clarification of the relationships among sleep, fatigue, and HIV/AIDS
may yield novel possibilities for new ways to study and manage this
disease. Studies are needed to elucidate mechanisms associated with
both the presence of HIV infection and decrements in sleep and
wakefulness. Early immunological responses to peripheral HIV infection
are known to alter the profile of circulating cytokines implicated in
the regulation of physiological sleep. These acute phase response
cytokines are elevated in the blood of HIV-infected individuals, and
produce fatigue when administered in human and animal models. Studies
are needed to determine whether blood brain barrier permeability to
these cytokines is compromised after HIV infection, and to elucidate
central mechanisms by which increased cytokine levels alter sleep, the
biological clock, body temperature, and other regulators of sleep and
wakefulness. Recent findings from animal studies suggest that shedding
of the HIV envelope-coat glycoprotein gp120 may mediate at least some
sleep abnormalities. Central mechanisms by which HIV gp120 leads to
disturbance of sleep and wakefulness need to be elucidated. Sleep
disturbances also produce abnormalities in hypothalamic-pituitary-
adrenal (HPA) axis hormone secretions such as cortisol and growth
hormone. It is not well understood, however, to what extent these
sleep-related abnormalities contribute to the acute phase response of
HIV infection, the progressive decline in humoral and cellular
immunity, the decline of neuropsychological function in AIDS-related
dementia, and the wasting syndrome associated with late-stage AIDS.
The severity of sleep disturbance and potential developmental
consequences of pediatric and especially infant HIV have also not been
studied. Research is needed to elucidate the relationship of
peripheral neuropathy and other symptoms of advanced HIV infection to
sleep disturbance and fatigue.
HIV infection may also increase the risk of sleep disordered breathing.
Adenotonsillar hypertrophy is an early manifestation of HIV infection
and can lead to reductions in upper airway dimensions that increase the
risk for sleep-disordered breathing in HIV-infected adults compared to
the general population. Accumulating evidence indicates that mild to
moderate sleep-disordered breathing may be an independent risk factor
for hypertension, cardiovascular disease, and stroke. Whether HIV
infection modifies these risks is unknown. Studies are needed to
determine the epidemiological risks, natural history, and causal
mechanism(s) linking HIV-related infections, lymphadenopathy, and other
complications of HIV infection to an increased risk of sleep-disordered
breathing. Screening instruments and optimal treatment regimens for
airway obstruction also need to be developed since available surgical
treatment approaches indicated in selected patients present significant
added risks for HIV-infected adults.
Insomnia, independent of drug or alcohol use, appears to be a highly
prevalent and under-diagnosed disorder in patients with HIV-infection.
It is also a common side-effect of anti-retroviral therapies used in
HIV treatment. Epidemiological and clinical research are needed to
elucidate the neurological and neurobehavioral characteristics of
insomnia in HIV-infected individuals, the role in the progression of
HIV infection, and the relationship to other symptoms of HIV infection
including pain, anxiety, and depression. Developing biomarkers and
imaging techniques that define brain sites associated with insomnia may
lead to indicators alerting to potential HIV infection.
There are a number of research directions that could be pursued to
elucidate the etiology of sleep disturbances and fatigue associated
with HIV infection and AIDS. Clinical and animal model based research
using mechanistic neurophysiological, neuroanatomical, and
pharmacological approaches are encouraged. Examples of studies that
would be responsive to this program include but are not restricted to
the following:
o Elucidate mechanisms underlying sleep abnormalities and circadian
dysrhythmia in human HIV/AIDS, or in animal models infected with
viruses comparable to HIV.
o Elucidate the cellular or neural basis for changes in the regulation
of biological clock and homeostatic sleep mechanisms responsible for
entrained and free running circadian rhythms as a function of infection
with viruses comparable to HIV.
o Identify potential exacerbating effects of sleep and circadian
disturbance on the severity of HIV infection and progression to AIDS,
or in animal models infected with viruses comparable to HIV.
o Identify abnormalities in restorative functions of sleep contributing
to symptoms of fatigue and excessive daytime sleepiness as a function
of HIV infection and AIDS.
o Elucidate mechanisms linking sleep and circadian disturbances in
HIV/AIDS to cardiopulmonary, endocrine, immunological, and other
pathophysiological sequalae of HIV infection and AIDS.
o Elucidate sleep abnormalities contributing to HIV-related
neurocognitive dysfunction and excessive daytime sleepiness.
o Identify differences in sleep/alertness among HIV/AIDS patient groups
that vary with respect to peripheral nerve pathology.
o Elucidate biological, cellular, and molecular mechanisms by which HIV
or HIV viral proteins interact with the host to disturb normal sleeping
patterns, and the interactions between the HIV proteins and primary and
secondary targets in the central nervous system.
o Elucidate the effects of sleep disturbance and fatigue on HIV disease
progression, as indicated by immunological and clinical indicators of
disease progression, and identify biological mediators and biomarkers
of such interactions.
MECHANISM OF SUPPORT
This RFA will use NIH R01 award mechanism. As an applicant you will be
solely responsible for planning, directing, and executing the proposed
project. 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. Applications that are not funded in the
competition described in this RFA may be resubmitted as NEW
investigator-initiated applications using the standard receipt dates
for NEW applications described in the instructions to the PHS 398
application.
This RFA uses just-in-time concepts. It also uses the modular
budgetingas well as the non-modular budgeting formats (see
http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in
each year of $250,000 or less, use the modular budget format.
Otherwise follow the instructions for non-modular budget research grant
applications. 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
The NHLBI intends to commit approximately $2,000,000 and NIMH
approximately $500,000 in FY 2004 to fund four to five new and/or
competitive continuation grants in response to this RFA. An applicant
may request a project period of up to four years and a budget for
direct costs of up to $350,000 per year. Because the nature and scope
of the proposed research will vary from application to application, it
is anticipated that the size and duration of each award will also vary.
Although the financial plans of the Institutes provide support for this
program, awards pursuant to this RFA are contingent upon the
availability of funds and the receipt of a sufficient number of
meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations
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. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
In order to be considered responsive to this announcement, applications
must propose hypothesis-driven studies that focus on elucidating the
etiology of sleep disturbances and fatigue associated with HIV
infection and AIDS. Studies of sleep disorders must be closely coupled
to the goal of elucidating pathophysiology associated with HIV
infection and AIDS in order to be considered responsive to this RFA.
Applications focused on the transfer of established methods or
overcoming technical barriers such as the measurement of sleep will not
be accepted. Applications centered on developing large cohorts for
epidemiology or interventions for HIV/AIDS or sleep disorders would not
be appropriate.
Collaborations and consortia promoting interdisciplinary approaches
between scientists studying the pathophysiology of HIV infection and
AIDS and sleep or circadian researchers are strongly encouraged. In
such cases, each participant's contribution should be identified and
well-integrated into the overall experimental design. Applications
proposing to include data collection from normal human subjects or
animal models must provide a strong rationale that is clearly relevant
to the goal of elucidating the etiology of sleep disturbance and
fatigue associated with HIV infection and AIDS.
Upon initiation of the program, the sponsoring Institutes may organize
periodic meetings to encourage the exchange of information among
investigators who participate in this program. Travel funds for a two
day meeting each year, most likely to be held in Bethesda, Maryland,
must be included in the budget calculation. Applicants must include a
statement indicating their willingness to participate in these
meetings.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
three areas: scientific/research, peer review, and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Michael J. Twery, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Bethesda, MD 20892-7952
Telephone: (301) 435-0202
FAX: (301) 480-3557
Email: twery@nih.gov
Kathy Kopnisky, Ph.D.
Center for Mental Health Research on AIDs
National Institute of Mental Health
6001 Executive Boulevard, Room 6199
Bethesda, MD 20892-9619
Telephone: (301) 443-7726
FAX: (301) 443-9719
Email: Kkopnisky@NIH.gov
o Direct your questions about peer review issues to:
Anne Clark, Ph.D.
Chief, Review Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD 20892 (20817 for express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-3541
Email: clarka@nhlbi.nih.gov
o Direct your questions about financial or grants management matters
to:
Robert Pike
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Bethesda, MD 20892-7926
Telephone: (301) 435-0171
FAX: (301) 480-3310
Email: piker@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 by mail or E-mail
to Anne Clark at the above address.
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.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in
a modular grant format. The modular grant format simplifies the
preparation of the budget in these applications by limiting the level
of budgetary detail. Applicants request direct costs in $25,000
modules. Section C of the research grant application instructions for
the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants. Additional information
on modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
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 three signed,
photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and
all five collated sets of appendix material must be sent to Anne Clark
at the above address for peer review questions.
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, applications will be reviewed for completeness by the CSR
and responsiveness by the NHLBI and NIMH. Incomplete and/or
nonresponsive 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 the National Heart, Lung, and Blood Institute
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. The
scientific review group will address and consider each of the following
criteria in assigning the application’s overall score, weighting
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 an important problem? 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).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in the project, the five items described under Section f
of the PHS 398 research grant application instructions (rev. 5/2001)
will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
SHARING RESEARCH DATA: The reasonableness of the data sharing plan or
the rationale for not sharing research data will be assessed by the
reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or priority
score.
http://grants.nih.gov/grants/policy/data_sharing/index.htm
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 13, 2004
Application Receipt Date: March 15, 2004
Peer Review Date: May-June, 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 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.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at
http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide, in the project description and elsewhere in the application as
appropriate, the official NIH identifier(s) for the hESC line(s)to be
used in the proposed research. Applications that do not provide this
information will be returned without review.
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 NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information
necessary to the review because reviewers are under no obligation to
view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet
site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be
found at http://grants.nih.gov/grants/policy/policy.htm
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
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Department of Health and Human Services |
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National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |