ESTABLISHING THE PRECURSORS OF THE METABOLIC SYNDROME IN CHILDREN

RELEASE DATE:  November 17, 2003

RFA Number:  RFA-HD-03-033

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 Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.865; 93.847 

LETTER OF INTENT RECEIPT DATE:  February 16, 2004
APPLICATION RECEIPT DATE:  March 16, 2004 

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism 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 goal of this initiative is to understand and identify the precursors of 
the metabolic syndrome in children and adolescents. The metabolic syndrome 
(also known as the dysmetabolic syndrome, syndrome X, or the insulin 
resistance syndrome) represents a clustering of metabolic disorders--central 
obesity, impaired fasting glucose, dyslipidemia and hypertension--that in 
adults predicts the development of type 2 diabetes and/or coronary artery 
disease. Research is needed to determine whether the precursors of the 
metabolic syndrome are different in children than in adults and whether there 
are unique pathophysiological factors operating in the pediatric population. 
Elucidating the precursors of the metabolic syndrome in children and 
adolescents may lead to new therapies to prevent the development of the 
metabolic syndrome or to mitigate the consequences of the metabolic syndrome 
later in life. 

RESEARCH OBJECTIVES

Background

Although the origins of obesity are complex, the condition results ultimately 
from an imbalance of energy intake and energy expenditure. The metabolic 
consequences of obesity operate at biochemical and molecular levels and may 
manifest clinically as insulin resistance, hypertension and dyslipidemia. The 
clustering of these metabolic derangements has been termed the metabolic 
syndrome. The metabolic syndrome in adults is defined according to the 
National Cholesterol Education Program Adult Treatment Panel III by the 
presence of at least three of five components:  increased abdominal girth; 
hypertension; hypertriglyceridemia; low levels of high density lipoprotein 
cholesterol; and impaired fasting glucose. These metabolic derangements have 
been targeted in the adult population because they confer risk for type 2 
diabetes mellitus, atherosclerosis and premature cardiovascular disease.

Overweight has tripled in the pediatric population over the last three 
decades, and current data indicate that at least 15 percent of children six to 
19 years of age are overweight. As overweight has increased in the pediatric 
population, so, too, have its metabolic consequences. Recently published data 
indicate that nearly 30 percent of overweight adolescents in the U.S. meet 
criteria for the metabolic syndrome. As in adults, overweight in children may 
threaten their future health by contributing to type 2 diabetes, 
steatohepatitis, hypertension, atherosclerosis, cerebrovascular disease, and 
several kinds of cancer. Indeed, many of the complications of overweight have 
been increasing, particularly among adolescents. The incidence of type 2 
diabetes in adolescents has increased by a factor of ten in the past 15 years, 
according to epidemiologic studies in southwestern Ohio. Recent studies also 
have identified non-alcoholic steatohepatitis (NASH) in 15-25 percent of 
overweight children between the ages of 10 and 16, and impaired glucose 
tolerance in 25 percent of overweight children. 

The disease burden engendered by overweight falls disproportionately on 
African American, Hispanic, and American Indian minorities, especially those 
in impoverished circumstances. Recent evidence among the Pima tribe shows that 
overweight and its attendant states of insulin resistance, hypertension, and 
dyslipidemia may be transmitted from mother to daughter, thus contributing to 
a vicious cycle of ever-increasing prevalence of these disorders. 

Studies are needed in children and adolescents to define better the metabolic 
consequences of overweight and to gain an understanding, at the cellular and 
molecular levels, of how overweight in children and adolescents engenders 
insulin resistance, altered glucose homeostasis, hypertension, and 
dyslipidemia. A related goal is to develop biomarkers and/or genetic markers 
to identify children at risk for various components of the metabolic syndrome 
later in life. Elucidating the precursors of the metabolic syndrome in 
children and adolescents may lead to new therapies to prevent the development 
of the metabolic syndrome or to mitigate the consequences of the metabolic 
syndrome later in life.

Research Scope

The goal of this initiative is to identify and understand the precursors of 
the metabolic syndrome in children and adolescents. Studies submitted in 
response to this RFA should focus on determining whether the precursors of the 
metabolic syndrome are different in children than in adults and whether there 
are unique pathophysiological factors operating in the pediatric population. 
Epidemiologic studies that involve the long-term follow-up of previously 
established and well-characterized cohorts are also of interest. Although 
descriptive epidemiology in the pediatric population is recognized as an 
important need, applications seeking to establish new cohorts will not be 
considered responsive to this RFA.

Appropriate topics for investigation under this RFA include, but are not 
limited to:

o State-of-the art, hypothesis-driven studies in children designed to 
ascertain the pathogenesis of and the molecular links between overweight and 
its metabolic complications, including insulin resistance, hypertension, 
dyslipidemia, glucose intolerance, and non-alcoholic steatohepatitis. 

o Studies designed to understand racial and ethnic differences among children 
in the precursors of the metabolic syndrome; 

o Studies designed to understand the role of puberty in the development of 
overweight and the metabolic syndrome, including studies to explore, at the 
molecular level, changes observed in insulin resistance during puberty, 
including racial and ethnic differences;

o Studies to elucidate the temporal appearance in children of the precursors 
of the metabolic syndrome;

o Studies to understand risk and to develop markers to predict which 
overweight children are at risk for metabolic complications of overweight;

o Epidemiologic studies, in well-established cohorts, to examine the long-term 
consequences of overweight and other components of the metabolic syndrome in 
children in order to better understand the factors that accurately predict the 
future development of type 2 diabetes and/or cardiovascular disease.

MECHANISM OF SUPPORT

This RFA will use the NIH Research Project Grant (R01) and the NIH 
Exploratory/Development Research Grant (R21) award mechanisms.  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 be 
reviewed according to the customary peer review process. The anticipated award 
date is September 30, 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.

The R21 mechanism is intended to encourage new exploratory/developmental 
research projects by providing support for the early stages of their 
development. Awards are made to demonstrate feasibility of a subsequent 
project and to obtain preliminary data testing innovative ideas. Therefore, 
these grants are not renewable. Continuation of projects developed under this 
program will be through the regular research project grant mechanism (for 
example, R01).  These grants are not intended to support or supplement ongoing 
funded research of an established investigator or to serve as an alternative 
mechanism of support for projects not receiving funding as competing 
continuation applications.  Information on the NIH Exploratory/Developmental 
Grant is available at http://grants.nih.gov/grants/guide/pa-files/PA-03-107.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/archive/grants/policy/nihgps_2001/part_i_1.htm.

FUNDS AVAILABLE

The NICHD intends to commit approximately $1.5 million and the NIDDK intends 
to commit approximately $500,000 in total costs [Direct plus Facilities and 
Administrative (F & A) costs] in FY 2004 to support two to six new and/or 
competing continuation grants in response to this RFA.  An applicant for an 
R01 may request a project period of up to five years and a budget for direct 
costs of up to $500,000 per year.  An applicant for an R21 may request a 
project period of up to two years and a combined budget for direct costs of up 
to $275,000 for the two-year period.  No more than $200,000 may be requested 
in any single 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 
participating ICs 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 his/her institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   

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:  

Gilman Grave, M.D.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B11, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 496-5593
FAX: (301) 480-9791
Email: graveg@mail.nih.gov

Barbara Linder, M.D., Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Dmeocracy Boulevard, Room 699
Bethesda, MD 20892-5460
Telephone: (301) 594-0021
FAX: (301) 480-3503
Email: bl99n@nih.gov

o Direct your questions about peer review issues to:  

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: stretchr@mail.nih.gov

o Direct your questions about financial or grants management matters to:  

Dianna Bailey
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 496-5482
FAX: (301) 402-0915
Email: dn11r@nih.gov

Kathleen J. Shino, M.B.A.
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Dmeocracy Boulevard, Room 708
Bethesda, MD 20892-5460
Telephone: (301) 594-8869
FAX: (301) 480-3504
Email: ks48e@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 NICHD 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:  

Gilman Grave, M.D.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B11, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 496-5593
FAX: (301) 480-9791
Email: graveg@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 
document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS:  Applications for the R21 should be prepared 
according to the instructions presented in the NIH Exploratory/Developmental 
Research Grant Program Announcement 
(http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). 

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/label-bk.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 must be 
sent to:  

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an application 
is received after that date, it will be returned to the applicant without 
review.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within eight 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 NICHD and NIDDK.  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 NICHD 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

Please note:  The NIH R21 exploratory/developmental grant is a mechanism for 
supporting novel scientific ideas or new model systems, tools or technologies 
that have the potential to significantly advance our knowledge or the status 
of health-related research.  Because the research plan is limited to 15 pages, 
an exploratory/developmental grant application need not have extensive 
background material or preliminary information as one might normally expect in 
an R01 application.  Accordingly, reviewers will focus their evaluation of R21 
applications on the conceptual framework, the level of innovation, and the 
potential to significantly advance our knowledge or understanding.  Reviewers 
will place less emphasis on methodological details and certain indicators 
traditionally used in evaluating the scientific merit of R01 applications 
including supportive preliminary data. Appropriate justification for the 
proposed work can be provided through literature citations, data from other 
sources, or, when available, from investigator-generated data.  Preliminary 
data are not required for R21 applications.    

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 discuss the following aspects 
of the application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals:

o Significance
o Approach
o Innovation
o Investigator
o Environment 

The scientific review group will address and consider each of these criteria 
in assigning the application's overall score, weighting them as appropriate 
for each application.  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 will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below.)

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 CONSIDERATIONS 

SHARING RESEARCH DATA:  Applicants requesting more than $500,000 in direct 
costs in any year of the proposed research must include a data sharing plan in 
their application.  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.

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 16, 2004
Application Receipt Date:  March 16, 2004
Peer Review Date:  June/July 2004
Council Review:  September 2004
Earliest Anticipated Start Date:  September 30, 2004

AWARD CRITERIA

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 is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that:  a) 
all applications or 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.

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.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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