MOLECULAR MARKERS AND MECHANISMS OF HIV-ASSOCIATED DEMENTIA
RELEASE DATE: March 12, 2004
RFA Number: RFA-MH-05-002 (see addendum NOT-MH-04-004)
EXPIRATION DATE: May 12, 2004
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov/)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.242, 93.279
LETTER OF INTENT RECEIPT DATE: April 12, 2004
APPLICATION RECEIPT DATE: May 11, 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 Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute of Mental Health (NIMH) and the National Institute on Drug
Abuse (NIDA) invite applications proposing to identify and characterize novel
molecular and genetic markers associated with distinct stages of progression of
HIV-associated nervous system disease in the context of highly active anti-
retroviral therapy (HAART). Research on the role of unique molecular and genetic
markers in defining mechanisms of neuropathogenesis, host genetic susceptibility to
development of central nervous system (CNS) disease and response to treatment are
also important areas of focus of this Request for Applications (RFA). The use of
state-of-the-art microarray technology, proteomics, molecular genetics, and
neuroimaging techniques to define and characterize novel molecular and genetic
markers associated with HIV-induced nervous system disease are encouraged.
RESEARCH OBJECTIVES
The introduction of HAART has resulted in significantly improved survival of AIDS
patients and decreased incidence of HIV-associated dementia (HAD). HAD is
estimated to constitute about 5% of new AIDS-defining illnesses in the USA.
Although HAART has resulted in a decline in the incidence of HIV dementia, the
improved survival has resulted in increased cumulative prevalence of nervous system
complications of AIDS. HAART does not provide full protection against neurological
damage in HIV/AIDS in part, because the blood-brain barrier is only partially
permeable to anti-retroviral agents. The frequency of HIV-associated encephalitis
observed in post-mortem tissue has remained constant, suggesting that HAART does
not eliminate HIV-1 infection in the central nervous system. Furthermore, while
improvements in treatment for AIDS have occurred in the developed world, a
significant number of new infections are being reported in the developing countries
including China, India, Eastern Europe, and Sub Saharan Africa. The neurologic and
neuropsychiatric complications resulting from new infections in the developing
world are likely to cause significant morbidity and mortality.
Extensive research is underway to better understand the underlying mechanisms of
neuropathogenesis of HIV-1. Currently there is limited consensus on the pathways
leading to neurologic and neuropsychiatric disease in the setting of HAART. While
HAART has resulted in increased prevalence of HIV dementia, the neurologic disease
has been reported to be milder. It has been suggested that in the era of HAART,
distinct subtypes of HAD are observed. The proposed subtypes include the following:
a) subacute progressive dementia; b) chronic active dementia; and c) chronic
inactive dementia.
A critical gap in the field of neuroAIDS research is the identification of reliable
molecular markers linked with progression as well as distinct subtypes of HIV-
associated CNS disease. Currently available clinical and laboratory markers of
HIV/CNS disease may be less reliable in the HAART era. The identification of
molecular markers would be beneficial to track HIV/CNS disease progression in the
era of HAART and also provide insights into mechanisms of neuropathogenesis. Such
markers may also lead to defining common pathways in the pathophysiology of HAD and
other neurodegenerative diseases such as Parkinson’s disease, Huntington’s disease,
Alzheimer’s disease, amyotrophic lateral sclerosis, and multiple sclerosis.
The goal of this RFA is to stimulate research to identify and characterize novel
molecular and genetic markers associated with HIV-associated nervous system
disease. Research on the role of unique molecular and genetic markers in defining
mechanisms of neuropathogenesis, host genetic susceptibility to development of CNS
disease, and response to treatment are also relevant to this initiative.
Studies to be funded in response to this RFA could include, but are not limited to:
o Microarray analysis of HIV-infected human CNS tissue or animal models of
neuroAIDS at various stages of disease progression to identify modulation of unique
genes. Genes of interest can be further characterized to delineate their molecular
identity as well as their functional role in neuropathogenesis.
o Use of proteomics to uncover protein signatures associated with HIV infection in
various peripheral and CNS cell populations and biological fluids of patients at
various stages of disease progression. Protein chip technologies may be utilized
to identify unique protein profiles associated with neurological and
neuropsychiatric manifestations of HIV infection.
o Use of neuroimaging approaches such as proton magnetic resonance spectroscopy (1H
MRS) and functional MRI (fMRI) to delineate key biological markers that correlate
with disease symptoms and progression. Neuroimaging studies are also useful to
establish relationships between spectroscopic markers and histopathologic markers
of neuronal health and inflammation. Studies of the role of unique inflammation-
related markers identified by neuroimaging, in the pathophysiology of neuroAIDS,
are relevant.
o Role of novel markers of immune activation and tissue damage (chemokines,
cytokines, and other inflammatory mediators) as prognostic indicators of HIV-
induced nervous system disease progression and response to therapy. Mechanistic
studies of novel immune activation markers and their contribution to
neuropathogenesis are of particular interest.
o Studies of markers on microglial cells, endothelial cells, astrocytes, and
neurons, reflecting HIV-induced cellular dysfunction or apoptosis, that not only
serve as useful indicators of disease progression but also provide insights into
mechanisms of development of nervous system disease.
o Identification of novel markers of oxidative stress resulting from HIV infection
of brain and interrelationship with neuronal injury as well as response to therapy.
o Studies of molecular markers and signatures linked with HIV-associated
opportunistic infections and co-infections in domestic and international settings.
o Studies of actions of abused drugs on neurologic disease states using the
techniques and approaches described herein to understand drug actions. Also,
studies of endogenous drug systems (e.g., opioid or cannabinoid systems) in the
manifestations of HIV and related diseases are appropriate.
o Studies of host genetic factors and markers that are associated with
susceptibility and progression of HIV-associated nervous system disease.
o Pharmacogenomic studies to identify genetic markers and polymorphisms linked
with host response to anti-retroviral therapy. For example, polymorphisms in the
mdr gene are associated with differences in protease inhibitor levels and magnitude
of CD4+ count recovery under therapy.
MECHANISM OF SUPPORT
This RFA will use NIH research project grant (R01) and exploratory developmental
grant (R21) award mechanisms. As an applicant you will be solely responsible for
planning, directing, and executing the proposed project. The R21 mechanism (see
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html) is intended to
encourage new exploratory/developmental research projects by providing support for
the early stages of their development. For example, such projects could assess the
feasibility of a novel area of investigation or a new experimental system that has
the potential to enhance health-related research. These studies may involve
considerable risk but may lead to a breakthrough in a particular area, or to the
development of novel techniques, agents, methodologies, models or applications that
could have a major impact on a field of biomedical, behavioral, or clinical
research.
Applications for R21 awards should describe projects distinct from those supported
through the traditional R01 mechanism. For example, long-term projects, or
projects designed to increase knowledge in a well-established area will not be
considered for R21 awards. Applications submitted under this mechanism should be
exploratory and novel. These studies should break new ground or extend previous
discoveries toward new directions or applications.
R21 applications may request a project period of up to two years with a combined
budget for direct costs of up $275,000 for the two-year period. For example, you
may request $100,000 in the first year and $175,000 in the second year. The
request should be tailored to the needs of your project. Normally, no more than
$200,000 may be requested in any single year.
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 December 1, 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 budgeting as 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 NIMH intends to commit approximately $1 million and NIDA intends to commit
$500,000 in FY 2005 to fund 3 to 5 new and/or competitive continuation grants in
response to this RFA. An applicant may request a project period of up to 5 years
for R01 and 2 years for R21. 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 IC(s)
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 or foreign institutions/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.
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:
Jeymohan Joseph, Ph.D.
Chief, HIV Neurovirology, Genetics and Molecular Therapeutics Program
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6202
Bethesda, MD 20892
Telephone: (301) 443-3012
FAX: (301) 443-9719
Email: jjeymoha@mail.nih.gov
Charles Sharp, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 443-1887
FAX: (301) 594-6034
Email: cs107m@nih.gov
o Direct your questions about peer review issues to:
Michael Kozak, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9609
Bethesda, MD 20892-9608
Telephone: (301) 443-1340
FAX: (301) 443-4720
Email: kozakm@mail.nih.gov
o Direct your questions about financial or grants management matters to:
Mr. Brian Albertini
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115
Bethesda, MD 20892
Telephone: (301) 443-0004
FAX: (301) 443-0219
Email: albertib2@mail.nih.gov
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6101 Executive Boulevard, Suite 270, MSC 8403
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: gf6s@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:
Jeymohan Joseph, Ph.D.
Chief, HIV Neurovirology, Genetics and Molecular Therapeutics Program
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6202
Bethesda, MD 20892
Telephone: (301) 443-3012
FAX: (301) 443-9719
Email: jjeymoha@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) 710-0267, 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 copies
of the appendix material must be sent to:
Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9663
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: jnoronha@mail.nih.gov
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 participating ICs. Incomplete applications will not be
reviewed. If the application is not responsive to the RFA, NIH staff may contact
the applicant to determine whether to return the application to the applicant or
submit it for review in competition with unsolicited applications at the next
appropriate NIH review cycle.
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by the
NIMH and NIDA 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 the National Advisory Councils of the
participating ICs.
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 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 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
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: April 12, 2004
Application Receipt Date: May 11, 2004
Peer Review Date: June 2004
Council Review: September 2004
Earliest Anticipated Start Date: December 1, 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).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking $500,000 or more in direct
costs in any single year are expected to include a plan for data sharing or state
why this is not possible. http://grants.nih.gov/grants/policy/data_sharing
Investigators should seek guidance from their institutions, on issues related to
institutional policies, local IRB rules, as well as local, state and Federal laws
and regulations, including the Privacy Rule. Reviewers will consider the data
sharing plan but will not factor the plan into the determination of the scientific
merit or the priority score.
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.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health Systems
Agency review. Awards are made under the authorization of Sections 301 and 405 of
the Public Health Service Act as amended (42 USC 241 and 284)and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the
terms and conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm
The PHS strongly encourages all grant recipients to provide a smoke-free workplace
and discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some
cases, any portion of a facility) in which regular or routine education, library,
day care, health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and advance the
physical and mental health of the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Department of Health and Human Services (HHS)
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NIH... Turning Discovery Into Health®
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