PKD RESEARCH AND TRANSLATION CORE CENTERS
 
RELEASE DATE:  May 28, 2004
 
RFA Number:  RFA-DK-04-012  

Update: The following update relating to this announcement has been issued:

December 22, 2009 - This RFA has been reissued as (RFA-DK-09-007).

EXPIRATION DATE:  March 16, 2005

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)
 (http://www.niddk.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.849  
  
LETTER OF INTENT RECEIPT DATE:  February 15, 2005
APPLICATION RECEIPT DATE:  March 15, 2005  
 
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) 
invites applications for Polycystic Kidney Disease (PKD) Research and 
Translation Core Centers to support both basic and clinical research on PKD.  
The goal of this program is to improve the lives of patients with polycystic 
kidney disease by improving therapies for this condition.   Core Centers 
should provide shared institutional and national resources to facilitate 
basic and clinical research on PKD and improve its effectiveness in 
translating insights from basic biology to clinical practice.  The Centers 
will also support pilot and feasibility studies to develop and test new 
approaches to therapy.
 
RESEARCH OBJECTIVES
 
A.  Background

PKD is the fourth leading cause of chronic kidney disease (CKD) in America, 
affecting approximately 500,000 people.  A striking feature of PKD is the 
variability with which it affects the patient.  Some develop only a modest 
number of renal cysts during their lifetime and may not be aware of being 
affected by this disorder.  Others develop a massive number of renal cysts 
and may reach renal failure at an early age.  It is not unusual for cysts to 
develop in the liver and within the systemic vasculature.  Evidence also 
indicates that in addition to documented cyst enlargement and interstitial 
fibrosis, apoptotic loss of non-cystic nephrons is a significant component of 
the pathology of PKD and may contribute to the progressive loss of renal 
function.

Much progress has been made since the initial solicitation for PKD centers in 
1999. Examples include: improved animal models of disease due to increased 
understanding of the underlying molecular processes that result in cyst 
formation and growth; progress in understanding the role of the primary 
cilium in kidney tubule cyst formation; progress in understanding aneurysmal 
development in PKD. The NIDDK is now further enhancing the PKD Centers 
program to allow for regional, national and even international collaboration.

The NIDDK has also funded two complementary multicenter clinical studies. In 
1999, the NIDDK funded the Consortium for Radiologic Imaging Studies of 
Polycystic Kidney Disease (CRISP) (RFA-DK-99-003) to determine whether 
changes in anatomic characteristics of the kidneys of patients with PKD will 
be useful in providing surrogate measures for disease progression.  
Preliminary findings from this group over the next several years might inform 
the designs of clinical trials in patients with PKD in the near future. Then, 
in 2001, the NIDDK established the PKD Clinical Trials Network to design and 
implement clinical trials to determine which pharmacologic agents might slow 
the progressive loss of function in PKD. The first large interventional 
clinical trial in this network, called HALT-PKD, will be a randomized trial 
of renin-angiotensin axis blockade in patients with PKD.

Despite the progress noted above, many challenges remain in determining the 
genetic and pathophysiologic mechanisms of PKD that could potentially be 
targeted for therapeutic interventions.

B.  Research Goals and Scope

The goal of these PKD Research and Translation Core Centers is to provide 
resources for communication and collaboration between basic and clinical 
researchers in the field of polycystic kidney disease. Core Centers will 
provide shared resources to enhance the efficiency of research and foster 
collaborations within and among institutions with strong existing bases of 
research on PKD.  Centers may be located in a single institution or in 
multiple institutions with complementary research bases.

Project Organization

A biomedical research core is defined as a shared resource that provides 
essential services, techniques, or instrumentation to Center participants 
enabling them to conduct their funded individual research projects more 
efficiently and/or more effectively.  Cores provide specialized technologies 
and expertise needed to accomplish the stated goals of the Center. Each core 
should provide services to multiple funded research projects.  Centers may 
propose either Institutional Cores or Regional/National/International Cores. 
Whereas Institutional Cores support research at a single institution or a set 
of cooperating institutions, Regional/National/International Shared Resources 
serve specific scientific communities on a regional, national, or 
international level. A new category of research base for cores that are used 
as a regional, national, or international resource should be considered the 
"extended research base". The extended research base for a regional, national 
or international core could include all investigators who might expect to use 
the core in some way. This might include investigators who would be expected 
to fully compensate the core service through a charge-back, and thus would 
not be obtaining direct financial assistance from the Center. The list could 
include investigators who use the core services but otherwise have no 
collaborative interactions with other Center investigators. The extended 
research base should be defined as an entity separate from the institutional 
research base. For review purposes, it should be evaluated as part of the 
core, in order to distinguish it from the local institutional research base.  
Examples of types of biomedical core resources that would be considered 
responsive to this Request for Applications include:

o Collection, analysis, storage and distribution of data and samples;
o Provision of specialized tools and technologies or access to specialized 
expertise; 
o Development, standardization and distribution of reagents and/or protocols;
o Provision of technical assistance, training, and enrichment programs; 
o Recruitment of patients and coordination of patient studies;
o Development, beta-testing and dissemination of specialty assays, methods, 
and services on an institutional level;
o Increase interdisciplinary interactions at the institution through cross-
project/laboratory exchange; 
o Sharing of specialized tools, technologies and expertise between 
collaborating investigators.

In addition to biomedical cores, an administrative core must be described which 
will be responsible for allocation of resources within the Center and 
distribution of resources to Center participants.  The Administrative core will 
also be responsible for planning the Educational Enrichment Program consisting 
of a seminar series, guest lectures, and workshops, and convening a Committee 
to oversee the solicitation, review and selection of the pilot projects.  
Although funds are not provided directly for training purposes, the core 
laboratories and program enrichment activities should provide training 
opportunities for Center members.

Each Core Center must develop a cohesive Pilot and Feasibility Program to 
develop new research directions or provide an opportunity for new 
investigators or established investigators to enter the field of PKD 
research.  A pilot and feasibility project is intended to provide modest 
support that will allow an investigator the opportunity to develop sufficient 
preliminary data as a basis for an application for independent research 
support.  Pilot and feasibility projects are not intended to support or 
supplement ongoing research of an established investigator.  This Program 
should be integrated into the overall research goals of the Center and make 
use of the resources provided by the cores.  Pilot and Feasibility projects 
could include clinical projects to investigate basic research findings in a 
clinical setting. Each Core Center application must include a minimum of two 
up to a maximum of five pilot projects.  Each pilot project may request a 
maximum of $50,000 direct costs per year (excluding Fiscal and Administrative 
costs) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html) 
for up to two years. A comprehensive description of the Pilot and Feasibility 
Program can be found in the Administrative Guidelines 
(http://www.niddk.nih.gov/fund/other/centers/P30guidelines.pdf).

The National Center for Research Resources (NCRR) supports approximately 80 
General Clinical Research Centers (GCRC) nationwide, which provide services 
and resources to enhance clinical research  
(http://www.ncrr.nih.gov/clinical/cr_gcrc.asp).  Research Centers supported 
by the NIDDK are encouraged to collaborate with GCRCs to avoid duplication of 
effort and enhance utilization of services and resources.

MECHANISM OF SUPPORT
 
This RFA will use NIH Core Center (P30) award mechanism.  As an applicant you 
will be solely responsible for planning, directing, and executing the 
proposed project.  This RFA is a one-time solicitation.  The anticipated 
award date is October 2005. 

This RFA uses just-in-time concepts. It uses the non-modular budgeting 
formats. 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 NIDDK intends to commit approximately $1.5 million in FY 2005 to fund two 
new grants in response to this RFA. An applicant may request a project period 
of up to five years and a budget for direct costs of up to $750,000 per year 
(excluding Fiscal and Administrative costs) 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html ). 
Because the nature and scope of the proposed research will vary from 
application to application, it is anticipated that the size and duration of 
each award will also vary. Although the financial plans of the IC(s) provide 
support for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 
applications.  
 
ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:   
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges,             
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic institutions/organizations
o Foreign institutions are not eligible to apply as the applicant 
organization; however, consortia agreements with foreign institutions are 
permitted. 
 
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 

An existing program of biomedical research in polycystic kidney disease is 
required. This research base must consist of NIH and other peer-reviewed 
funded research projects and be substantial to justify the requested Core 
support. A clinical research base is not required but would be considered a 
strength. Suggestions for describing and presenting this research base in the 
application are included in the Administrative Guidelines.

Successful applicants, during the second year of the award and each year 
thereafter, may be expected to attend a yearly meeting of PKD Centers 
Directors convened by the NIDDK.  Funds for this activity may be requested in 
the budget proposed for the respective center.
 
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:

Marva M. Moxey-Mims, M.D.
Pediatric Nephrology & Renal Centers Programs Director
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 639
Bethesda, Maryland 20892-5458
Telephone:  (301) 594-7717
FAX:  (301) 480-3510
Email:  mm726k@nih.gov

o Direct your questions about peer review issues to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes, Digestive, and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, Maryland 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:

Carolyn Kofa
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 727
Bethesda, Maryland 20892-5452
Telephone:  (301) 594-7687
FAX:  (301) 480-3504
Email:  ck104i@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 NIDDK 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: Applicants should consult the “Administrative 
Guidelines for PKD Research and Translation Core Centers” located at: 
http://www.niddk.nih.gov/fund/other/centers/P30guidelines.pdf.
 
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.  
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 applications will not be reviewed.  

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 Diseases Advisory Council.
 
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 The scientific excellence of the Center's research base (its strengths, its 
breadth and depth) as well as the relevance and interrelation of these 
separately funded research projects to the PKD 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 PKD 
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. 

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 
PKD 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 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, two to five 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 competing continuation 
applications, data should be supplied on the success of previously funded P&F 
projects in obtaining outside support. Applicants should refer to the 
Administrative Guidelines for PKD Research Core and Translation Centers for 
specific details regarding the P&F program and its review by the IRG.

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 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 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 are 
capped at $150,000), and for enrichment in relation to the total Center 
program. Total requested direct costs are limited to $750,000 (including the 
P&F program). For both new and competing continuation applications, total 
requested direct costs should not exceed the $750,000 cap.

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. http://grants.nih.gov/grants/policy/data_sharing

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 15, 2005
Application Receipt Date:               March 15, 2005
Peer Review Date:                       June 2005
Council Review:                         September 2005
Earliest Anticipated Start Date:        October 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: 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:  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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


H H S Department of Health
and Human Services

 
  N I H National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892