PARTNERSHIPS BETWEEN BASIC AND CLINICAL RESEARCHERS IN OBESITY
RELEASE DATE: February 27, 2004
RFA Number: RFA-DK-04-010
EXPIRATION DATE: July 22, 2004
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institute of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/NIH)
(http://www.niddk.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.847 and 93.848
LETTER OF INTENT RECEIPT DATE: June 21, 2004
APPLICATION RECEIPT DATE: July 21, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK)
invites applications supporting the development of close collaborations
between basic and clinical researchers focused on obesity. The goal of this
Request for Applications (RFA) is to encourage productive partnerships between
basic and clinical researchers to investigate the biological mechanisms
controlling energy balance in humans. The ultimate goal of these
investigations is to obtain the necessary knowledge of the different
biological pathways regulating energy homeostasis so that new biomarkers of
overweight, obesity, and associated metabolic changes can be identified, and
novel therapeutic targets developed.
RESEARCH OBJECTIVES
Background
The obesity epidemic has been well documented in the scientific literature
and in the lay press. Recent data from the National Health and Nutrition
Examination Survey demonstrate that almost two thirds of Americans are
overweight, and over 30% are obese (BMI > 30). Obesity is associated with a
host of co-morbid conditions, including diabetes, cardiovascular disease,
certain cancers, osteoarthritis, and gallbladder disease. Despite the
enormous health impact of obesity and the recent progress in our
understanding of the condition at the molecular level, many aspects of the
basic pathophysiology of obesity remain to be investigated. In addition, the
interrelationships of factors that contribute to energy balance and to the
difficulties associated with maintenance of weight loss over the long term
are not well understood.
The development of close collaborations between basic and clinical researchers
holds great promise for the advancement of the study of obesity and associated
conditions. Clinical researchers are likely to benefit from the fact that
various aspects of obesity research endeavors can be more readily or
practically performed in animals then in humans. Closer collaborations may
result in a more knowledgeable assessment of which areas of research show the
greatest promise for further consideration in humans. In addition, both
clinical and basic researchers are likely to benefit from improvements of
methodologies and techniques whenever the basic or clinical are of study is
lacking these methods.
With the trend in research toward greater specialization in recent years, it
has become apparent that a collaborative approach needs to be fostered,
especially with the investigation of multi-faceted health issues like
obesity.
Research Scope
Determining the underlying mechanisms that link overweight, obesity and
associated metabolic changes continues to be a critical research question.
Studies to identify new biomarkers of obesity-associated disease risk should
yield novel targets for therapeutics to disrupt the development of
overweight, obesity and associated metabolic changes, and to help identify
those in whom preventive strategies might be implemented. Biological factors
that contribute to the development of obesity and to the ability to lose
weight and to sustain weight loss also need to be explored, as do physiologic
pathways of the neuroendocrine and endocrine systems, GI tract, adipocyte
tissue, liver, and muscle that contribute to appetite regulation and energy
expenditure.
Applications should propose collaborative research partnerships between a
clinical and a basic researcher. Each research partner should be a
successful independent investigator with a track record of successful
research accomplishments.
Each of the research partners will serve as a principal investigator on an
R01 grant application within a collaborative R01 project. The level of
effort proposed by the collaborating independent investigators should be
appropriate for the scope of the project.
The collaborating investigators need not be at the same institution. If at
separate institutions, the application should document how the collaboration
will be achieved. One potential mechanism for collaboration between two
independent laboratories might be a shared postdoctoral fellow or other
research staff position. Funds for travel between the collaborating
laboratories may be included in the budget proposal, and each research partner
should request funds to attend one meeting in Bethesda, MD.
For this RFA studies carried out exclusively in animals are NOT considered
responsive. R01 applications submitted in response to this RFA should
propose studies investigating the biologic pathways and mechanisms regulating
energy balance in humans.
The following are examples of research activities that might be pursued
through close partnerships between basic and clinical researchers. These are
examples only and are not meant to be limiting.
o Explore weight loss models (e.g., diet, surgery, physical activity) to
understand the biological factors and pathway(s) contributing to weight
maintenance and/or regain in humans
o Identify novel predictive biomarkers in serum, urine and/or particular fat
depots or tissues that contribute to the development of type 2 diabetes or
the metabolic syndrome in overweight or obese subjects
o Determine the metabolic, bio-behavioral or physiological mechanisms behind
weight gain during critical periods (e.g. during peri-menopause or following
smoking cessation)
o Investigate the impact of bariatric surgery on long-term energy balance
through mechanistic studies of the pathways regulating appetite, nutrient
absorption, nutrient metabolism, energy expenditure, fitness, or body
composition
o Develop human studies to elucidate the biologic basis of behavioral or
environmental correlates of long term weight maintenance
o Investigate the biological basis behind resistance to weight gain in
individuals who remain lean despite huge calorie intake
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) research project
grant (R01) award mechanism to support collaborative research projects between
basic and clinical investigators. For collaborative R01 projects, a group of
investigators must submit simultaneously at least two, but typically not more
than three, R01 grant applications with a collaborative research project. R01
grant applications may be from a single institution or several institutions,
and may include shared resources. Collaborative R01 research projects must
demonstrate the interdependence of the individual components. As an applicant
you will be solely responsible for planning, directing, and executing the
proposed project. Applicants should pay close attention to the SUPPLEMENTARY
INSTRUCTIONS (see below points 1-3) for submitting application that describes
in detail how the work is to be coordinated. 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 April 1, 2005. Projects that are not funded in the
competition described in this RFA may be re-structured and designed as
traditional R01s, and submitted as NEW applications using the standard receipt
dates for NEW applications described in the instructions to the PHS 398
application at: http://grants.nih.gov/grants/funding/phs398/phs398.html
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 NIDDK intends to commit approximately $2 million in FY 2005 to fund 3 to
4 new projects in response to this RFA. Applicants for collaborative R01
grants may request a project period of up to 4 years. The combined budgets
for all the R01 applications within a collaborative group may not exceed
$400,000 in direct costs per year. We anticipate that a future solicitation
will provide an opportunity for expanded support for successful partnerships
between basic and clinical researchers funded through the current RFA.
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 NIDDK provides
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.
SPECIAL REQUIREMENTS
Applicants from institutions that have a Diabetes Endocrinology Research
Center (DERC), a Diabetes Research and Training Center (DRTC), a Clinical
Nutrition Research Unit (CNRU), an Obesity/Nutrition Research Center (ONRC)
or a General Clinical Research Center (GCRC) funded by the NIH National
Center for Research Resources may wish to identify the Center(s) as a
resource for conducting the proposed research. In such a case, a letter of
agreement from either the principal investigator or the GCRC program director
should be included with the application.
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:
Carol Renfrew Haft, Ph.D.
Program Director, Adipocyte Biology
Division of Diabetes, Endocrinology and Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 605
Bethesda, MD 20892-5460
Telephone: (301) 594-7689
FAX: (301) 480-3503
E-mail: cr84g@nih.gov
o Direct your questions about peer review issues to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov
o Direct your questions about financial or grants management matters to:
Denise Payne
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 733
Bethesda, MD 20892-5456
Telephone: (301) 594-8845
Fax: (301) 480-3504
E-mail: dp43b@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(s)
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:
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
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.
SUPPLEMENTARY INSTRUCTIONS: All application instructions outlined in the PHS
398 application kit are to be followed, with the following requirements for
R01 applications:
1. For these collaborative R01 projects, the individual components must be
submitted as one packet accompanied by a cover letter that lists each
principal investigator, his/her institution, and the shared project title.
To facilitate proper processing and review, include this same cover letter
with each of the individual R01s. In each R01 grant application list the
collaborating projects and principal investigators on page 2, under
"Performance Sites." In addition, the DESCRIPTION (page 2) for each R01
grant application within a collaborative R01 project should be the same and
the applicants should define in the DESCRIPTION how and why the individual
participants propose to collaborate.
2. The RESEARCH PLAN section should be included in ONLY one of the R01 grant
applications. All of the remaining R01 grant applications within the
collaborative R01 project should refer to the RESEARCH PLAN from the
designated R01 application, rather than duplicate the RESEARCH PLAN.
Applicants should elaborate on the significance and nature of the
collaboration in an Introduction section of the "Research Plan" of the
designated R01.
3. Those collaborative R01 applications that do not include, but only refer
to, the RESEARCH PLAN must include the following information in their
application: face page, DESCRIPTION, Performance Sites, and Key Personnel
for his/her laboratory’s part of the project, Research Grant Table of
Contents, modular budget, budget justification, biographical sketches of PI
and other key personnel, resources and environment, and checklist. Sections
for Human Subjects Research and/or Vertebrate Animals must also be completed,
if appropriate.
4. Collaborative R01 applications will use the "MODULAR GRANT" and "JUST-IN-
TIME" concepts, with direct costs requested in $25,000 modules. The combined
budgets for all of the research projects in a collaborative R01 application
may not exceed $400,000 in direct costs per year. For these collaborative
R01 projects, each R01 grant application must include its own budget. The
total direct costs for a collaborative R01 project are limited to $400,000 in
direct costs per year, and these funds should be distributed, as appropriate,
among the PIs within the collaborative project. In addition, each research
partner should request funds to attend one meeting in Bethesda, MD.
5. R01 appendix materials should be limited, and should not be used to
circumvent the page limit for the research plan. Copies of appendix
material will only be provided to the primary reviewers of the application
and will not be reproduced for wider distribution. The following materials
may be included in the appendix of the designated application:
o Up to five publications, including publications, abstracts, patents, or
other printed materials directly relevant to the project. These may be
stapled as sets.
o Surveys, questionnaires, data collection instruments, and clinical
protocols. These may be stapled as sets.
o Original glossy photographs or color images of gels, micrographs, etc.,
provided that a photocopy (may be reduced in size) is also included within
the 25 page limit of items a-d of the research plan.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Collaborative
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
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:
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
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 NIDDK. Incomplete and/or non-responsive applications
will be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the NIDDK 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 Diabetes and Digestive and
Kidney Advisory Council.
Collaborative R01 grant applications will NOT be reviewed individually, but
as components of a single research project, and, as such, the individual R01
applications within a collaborative R01 project will be assigned the same
priority score and receive the same reviewers comments within the individual
summary statements.
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 in obesity
research? 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?
INVESTIGATORS: Are the investigators appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the principal investigators and other researchers? Is the research
partnership innovative? Does the partnership include at least one
independent basic obesity researcher and one independent obesity clinical
investigator? Does the research partnership merge scientific expertise based
on strong experimental rationale and sound project goals?
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 for each R01 application within a collaborative R01
project in the determination of the 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.
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: June 21, 2004
Application Receipt Date: July 21, 2004
Peer Review Date: November/December 2004
Council Review: February, 2005
Earliest Anticipated Start Date: April, 2005
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: Research components involving Phase I and II
clinical trials must include provisions for assessment of patient eligibility
and status, rigorous data management, quality assurance, and auditing
procedures. In addition, it is NIH policy that all clinical trials require
data and safety monitoring, with the method and degree of monitoring being
commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH
Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).
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 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 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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