CLINICAL NUTRITION RESEARCH UNIT CORE CENTERS

RELEASE DATE:  May 13, 2004
 
RFA Number:  RFA-DK-04-016  

EXPIRATION DATE:  November 19, 2004

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION:  
National Institutes 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: 93.848
 
LETTER OF INTENT RECEIPT DATE: October 18, 2004
APPLICATION RECEIPT DATE:  November 18, 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 Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
invite applications for Clinical Nutrition Research Unit (CNRU) grants. Three 
existing CNRUs are expected to submit competitive renewal applications. 

The Clinical Nutrition Research Unit grants are core centers (P30) that are 
part of an integrated program of nutrition and obesity-research support 
provided by NIDDK. The Centers currently funded in this program 
(http://www.niddk.nih.gov/fund/other/centers.htm#ClinicalNutrition) have 
provided a focus for increasing collaboration and improving cost 
effectiveness of supported research among groups of successful investigators 
at institutions with an established, federally supported, comprehensive 
nutritional sciences and obesity and related disorders research base.

RESEARCH OBJECTIVES

The objective of the Core Centers is to bring together basic science and 
clinical investigators from relevant disciplines to enhance and extend the 
effectiveness of research related to nutritional sciences, obesity, and 
related disorders, with clinical and/or translational applications in these 
areas. A Core Center must be an identifiable unit within a single university 
medical center or a consortium of cooperating institutions, including an 
affiliated university. The overall goal of the Core Center is to bring 
together clinical and basic science investigators in a manner that will 
enrich the effectiveness of nutritional sciences, obesity, and related 
disorders research.  An existing program of excellence in biomedical basic 
and clinical research in the areas of nutritional sciences, obesity, and 
related disorders is required. The research must be in the form of research 
project grants (R01), program project grants (P01), or other peer-reviewed 
research that is already funded by NIH, other Federal Agencies, or non-
federal groups at the time of submission of the Center grant application.  It 
is required that at least fifty percent of the nutritional sciences and 
obesity or other related disorders research comprising the research base be 
supported by Federal Agencies. Close cooperation, communication, and 
collaboration among all involved personnel of various professional 
disciplines are ultimate objectives.  A CNRU should be comprised of the 
following components: 

Required Components: (These are the fundamental components that a responsive 
application must include.)
 
1. Biomedical or behavioral clinical research with human subjects or 
populations; 
2. Basic laboratory investigations;
3. Research training (funds to be derived from other sources*);  
4. Shared facilities and research services;

Encouraged Components: (The presence of these components demonstrates the 
institutional commitment and the recognition of clinical nutritional sciences 
and obesity within the Institution(s)).

5. Education programs emphasizing the nutritional sciences and obesity and 
related conditions or disorders for medical students, house staff, practicing 
physicians, and allied health personnel (funds to be derived from other 
sources*);
6. Research components of nutritional support services; and
7. Public information activities (funds to be derived from other sources*).

*Funds to support these components may not be requested as part of an 
application in response to this announcement.

The CNRUs are based on the core concept. Cores are defined as shared 
resources that enhance productivity or in other ways benefit a group of 
investigators working in the nutritional sciences, obesity and related areas 
to accomplish the stated goals of the Center. It is appropriate and may be 
beneficial to have one or more central themes around which core center 
research investigations are focused. 

CNRU applications must include an administrative core that will be 
responsible for oversight and allocation of Center resources. The 
Administrative core will also be responsible for planning an enrichment 
program and for implementing a process for solicitation, review, and 
selection of projects for the CNRU Pilot and Feasibility Program (P/F).

A clinical component or core that deals with patients is often helpful. This 
clinical component can exist as a stand-alone core or as a part of another 
core such as the administrative core. 

Besides leading to a better understanding of disease etiology and natural 
history of disease, such cores might provide biostatistics support; enhance 
clinical study design; foster collaboration among researchers; aid in 
recruitment of subjects for clinical studies; support epidemiological studies 
in areas of nutritional sciences and obesity; or provide modest funding for 
tissue, DNA, or serum storage. In addition, a clinical or epidemiology core 
may help more effectively address NIH policies concerning the participation 
of women, children, and ethnic minority populations in clinical studies. The 
cores listed here do not represent a comprehensive list of possibilities. In 
responding to the RFA, applicants are encouraged to propose cores that 
address specific objectives based on the unique requirements of investigators 
and the research comprising the research base at the applicant institution. 

The P/F program provides modest support for new initiatives or feasibility 
research studies. This program is directed at new investigators and at 
investigators established in other research disciplines with expertise that 
may be applied to nutritional sciences or obesity research. Established 
clinical nutrition or obesity investigators pursuing high impact/ high risk 
projects or projects that are a significant departure from their usual work 
are also eligible for support under the CNRU P/F program. In addition, 
temporary salary support for one Named New Investigator in a specified area 
of research with a defined P/F study may be requested for up to 24 months. 
Subsequent individuals for this slot will be named by the Center Director and 
approved by the Center's External Advisory Board and the NIDDK. 

The Core Center grant may include limited funds for program enrichment such 
as seminars, visiting scientists, consultants, and workshops. Although funds 
are not provided directly for training purposes, applicants may wish to 
describe how the core laboratories and program enrichment activities will 
provide training opportunities for center members.

MECHANISM OF SUPPORT
 
This RFA will use the NIH Core Centers grant (P30) award mechanism.  As an 
applicant, you will be solely responsible for planning, directing, and 
executing the proposed center grant. The NIDDK accepts P30 applications only 
when submitted in response to an RFA. The receipt of competing continuation 
applications from three P30 CNRUs is anticipated in response to this 
solicitation. These applications will compete for the three anticipated 
awards along with other applications received in response to this RFA. The 
anticipated award date is July 1, 2005.  

This RFA uses just-in-time concepts.  It also uses the non-modular budgeting 
formats. 

FUNDS AVAILABLE
 
The NIDDK intends to commit approximately $ 4,000,000 in FY 2005 to fund a 
total of 3 new and/or competitive continuation grants in response to this 
RFA. An applicant may request a project period of up to 5 years and a budget 
for direct costs of up to $ 750,000 per year. Because the nature and scope of 
the proposed research will vary from application to application, it is 
anticipated that the size of each award may also vary. Although the financial 
plans of the IC(s) provide support for this program, awards pursuant to this 
RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications.  
 
ELIGIBLE INSTITUTIONS
 
You may submit an application 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 institutions/organizations
o Foreign institutions are not eligible to apply. 
 
For the purpose of the RFA, the NIDDK will not support more that one CNRU 
center grant (P30) in an applicant institution. More details on the CNRU 
program are available in the Clinical Nutrition Research Units Guidelines 
available on the internet at 
http://www.niddk.nih.gov/fund/other/centers/introcnru.htm or from the Program 
Director listed under INQUIRES, below
 
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, women, and individuals with disabilities are always 
encouraged to apply for NIH programs. 

SPECIAL REQUIREMENTS 

The CNRU Director, who is the Principal Investigator on the P30 application 
and Director of the Administrative Core, should be a scientist who can 
provide effective administrative and scientific leadership and can 
demonstrate proficiency in managing a large, multi-component project. The 
Director will be responsible for the organization and operation of the CNRU 
and for communication with the NIDDK on scientific and operational matters. 
Center Directors are required, and their administrators are strongly 
encouraged, to attend an annual meeting to be held at a location to be 
determined by the NIDDK. Funds for travel to this meeting should be included 
in the budget for the Administrative Core of the Center.

Successful CNRU applications require an existing program of excellence in 
biomedical research in the areas of basic and clinical research related to 
the nutritional sciences, obesity, and related disorders. To justify Core 
Center support, the CNRU must serve a strong research base that has a 
consistent and outstanding record in NIH and other peer-reviewed funding. The 
research base grants must be summarized in accordance with the Administrative 
Guidelines for NIDDK Clinical Nutrition Research Units (CNRU). (See 
Application Procedures.)

At lease 50 percent of the nutritional sciences and obesity-related research 
comprising the research base must be supported by Federal Agencies.

Scientific personnel and institutional resources capable of supporting the 
research base must be available. In addition, the institution and pertinent 
departments must show a strong commitment to the Center’s support. Such 
commitment may be provided as dedicated space, staff recruitment, salary 
support for investigators, dedicated equipment, or other financial support 
for the proposed Center.

Each core unit proposed for funding under the CNRU must be utilized by a 
minimum of two federally funded research projects. A detailed description of 
each core unit proposed as part of the Center must be provided, with a 
detailed budget and budget justification. A Core director must be named for 
each core proposed. The description of each core unit proposed should include 
a rationale, indicating how it will support the research effort in a cost-
effective manner. Facilities must be available for the primary needs of the 
CNRU Program because funds for new construction are not available.

Promoting interdisciplinary and multidisciplinary collaboration among 
scientists working within a Center is a major goal of the CNRU Program. Each 
Center application should describe how continuing and new interactions will 
be fostered and encouraged by the CNRU.

Another goal of the CNRU is to attract scientists to the field of nutritional 
sciences and obesity research. Therefore, a Pilot and Feasibility (P/F) 
program as well as an Enrichment Program may be supported within the CNRU 
program.

Because P30 funds do not directly support research projects, the issues of 
minority/gender representation, inclusion of children as participants in 
research involving human subjects, required education on the protection of 
human subject participants, and the use of human embryonic stem cells will 
have been addressed at the individual project level (i.e., R01 level). 
However, the application must specifically address these issues for any P/F 
projects or cores, as appropriate.

All applications that list direct costs greater than $500,000 in any year of 
the proposed research must have a data sharing plan.

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:

Carolyn W. Miles, Ph.D.
Clinical Obesity and Nutrition Program Director
National Institutes of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 665
Bethesda, MD 20892-8876
Telephone: (301) 451-3759
FAX: (301) 480-8300
Email: cm294e@nih.gov

o Direct your questions about peer review issues to:

Francisco O. Calvo, Ph.D. 
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 752
Bethesda, MD  20892-5452
Telephone:  (301) 594-8897
Email: fc15y@nih.gov

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

Ms. Sharon Bourque
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 719
Bethesda, MD 20892-5456
Telephone: (301) 594-8846
FAX: (301) 480-3504
Email: sb114m@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 (Associate Directors, Core Directors)
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: The Clinical Nutrition Research Unit Guidelines 
provide more detailed information on the Centers and on preparing the 
application. The guidelines are accessible at 
http://www.niddk.nih.gov/fund/other/centers/introcnru.htm
or from the program director listed under INQUIRES.
 
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the Checklist, and three signed, photocopies, in 
one package to:
 
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application and all 
copies of the appendix material must be sent to:

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. The 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of substantial 
revisions of applications already reviewed in response to a previous Centers 
RFA, but such applications must include an introduction addressing the 
previous critique.
  
PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness to the RFA 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. No 
site visits are planned in the review of these applications; all information 
required for evaluation must be contained in the application. As part of the 
initial merit review, all applications will:

o Undergo a process in which all applications will be discussed and assigned 
a priority score
o Receive a written critique
o Receive a second level review by the National Diabetes, Digestive and 
Kidney Diseases Advisory Council. 
 
REVIEW CRITERIA

All applications responding to this RFA will be evaluated according to the 
review criteria as outlined in the Clinical Nutrition Research Units 
Administrative Guidelines available on the Internet at 
http://www.niddk.nih.gov/fund/other/centers/introcnru.htm for from the 
Program Director listed under WHERE TO SEND INQUIRIES, above.

As part of the initial scientific review, which will result in one overall 
priority score for the P30 application, reviewers will rate each individual 
research core and, if requested, the clinical component, as well as the P/F 
program. The evaluation of the Enrichment program will be reflected in the 
adjectival score of the Administrative Core. The merit descriptors for each 
of these components will appear in the summary statement. The review group 
will assign a descriptor, rather than a score, for the research base, the P/F 
program, and the Center Director.

Review Criteria

The most important component of a CNRU is an ongoing, strong base of 
nutritional sciences and obesity-related research.

Specific review criteria for CNRU Core Centers are:

o the scientific excellence of the Center's research base (its strengths and 
depth) as well as the relevance and interrelation of these separately funded 
research projects to the central theme(s) or focus of the Center and the 
likelihood for meaningful collaborations among Center investigators. The 
existence of a base of established, independently supported biomedical 
research of high quality is a prerequisite for the establishment of a CNRU 
Core Center and is the most important component of the review. (The results 
of previous peer reviews of its content will weigh heavily in the assessment 
of the application's overall strength as a potential recipient of an award.)

o the strength of the clinical research components of the center 

o the qualifications, experience, and commitment of the Center 
investigators responsible for the individual research projects, and their 
willingness to interrelate with each other and contribute to the overall 
objectives of the CNRU Core Center.

o the appropriateness and relevance of the proposed Cores and their modes of 
operation (such as how usage will be prioritized), facilities, and potential 
for contribution to ongoing research.  Competing continuation applications 
must document the use, utility, quality control, and cost effectiveness of 
each Core requested to continue as part of the Center.  Progress will be 
judged in part by the list of publications arising from the utilization of 
the cores.  At least two users are required to establish a core.  However, a 
greater number of users will be considered to be more cost effective.

o for all applications, a description of current or proposed P/F studies 
should be submitted for evaluation as part of the review of the P/F program. 
In general for new applications, the proposed P/F projects will be examined 
to assess the eligibility of the P/F applicant and the adequacy of the 
selection process by which the individual studies were selected. For 
competitive renewal applications emphasis is accorded to the program as a 
whole, including past track record and management of the program. Applicants 
should refer to the Administrative Guidelines for CNRUs for specific details 
regarding the P/F program and its review.

o a Named New Investigator, if requested, will be considered separately.

o the scientific and administrative leadership abilities of the proposed 
Center Director and Associate Director and their commitment and ability to 
devote adequate time to the effective management of the program.

o the administrative organization proposed for the following:

(a) Coordination of ongoing research between the separately funded projects 
and the Center, including mechanisms for internal monitoring;

(b) Establishment and maintenance of internal communication and cooperation 
among the Center investigators;

(c) Mechanism for selecting and replacing professional or technical personnel 
within the Core Center;

(d) Mechanism for reviewing the use of and administering of funds for the P/F 
program;

(e) Management capabilities that include fiscal administration, procurement, 
property and personnel management, planning, budgeting, and other appropriate 
capabilities;

o The institutional commitment to the program, including lines of 
accountability regarding management of the Center grant and the institution's 
contribution to the management capabilities of the Center;

o The academic environment and resources in which the activities will be 
conducted, including the availability of space, equipment, facilities, and 
the potential for interaction with scientists from other departments and 
institutions;

o Efficient and effective use and/or planned use of the limited enrichment 
funds, including the contribution of these activities in enhancing the 
objectives of the Center;

o Although the CNRUs do not specifically support research training, it should 
be a training environment, and demonstration of accomplishments and future 
plans related to the training of investigators necessary to conduct research 
in clinical nutrition and obesity will be considered in assessing the 
potential to meet Center objectives. The integration of these efforts into 
the overall Center, including core facilities, is of particular importance. 
Efficient and effective use and /or planned use of the limited enrichment 
funds, including the contribution of these activities in enhancing the 
objectives of the Center will also be considered.

o The appropriateness of the budgets for the proposed and approved work to be 
done in Core facilities, for P/F studies (these are restricted funds), and 
for enrichment in relation to the total Center program.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated. (See Inclusion Criteria in the sections on Federal Citations, 
below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS

Sharing Research Data

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:          October 18, 2004
Application Receipt Date:               November 18, 2004
Peer Review Date:                       March 2005
Council Review:                         May 2005
Earliest Anticipated Start Date:        July 2005

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Relevance to research areas of high programmatic interest to the Division 
of Digestive Diseases and Nutrition, NIDDK and research areas targeted by 
Congress
o Availability of funds
o Geographic distribution
 
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: 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: Investigators submitting an NIH application seeking 
$500,000 or more in direct costs in any single year are expected to include a 
plan for data sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing  Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm  
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects' research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. 

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, the official NIH 
identifier(s) for the hESC line(s) to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) cited 
publicly and officially by a Federal agency in support of an action that has 
the force and effect of law (i.e., a regulation) may be accessed through FOIA.  
It is important for applicants to understand the basic scope of this 
amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The 
Department of Health and Human Services (DHHS) issued final modification to 
the “Standards for Privacy of Individually Identifiable Health Information”, 
the “Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR).  

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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