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) 435-0714, 
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.


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