RELEASE DATE:  November 20, 2003

RFA Number:  RFA-NS-05-001 

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

January 21, 2010 - This RFA has been reissued as (RFA-NS-11-001).

Department of Health and Human Services (DHHS)
National Institutes of Health (NIH)

National Institute of Neurological Disorders and Stroke (NINDS) 
National Institute of Environmental Health Sciences (NIEHS) 

93.114, 93.115



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


The National Institute of Neurological Disorders and Stroke (NINDS) 
invites cooperative agreement applications from qualified institutions 
for support of a Parkinson’s Disease Data Organizing Center (PD-DOC), 
designed to serve as a shared research resource to facilitate research 
in Parkinson’s disease (PD).  This resource is intended to compile 
clinical data, as well as to provide virtual catalogues for both basic 
scientific and clinical research in PD.

Parkinson’s disease research would benefit from analysis of combined 
data collected systematically from existing PD Centers (Udall Centers, 
NIEHS centers, NIA Alzheimer’s Disease Centers) and, eventually, from 
other sources where longitudinal data are collected.  Such data on 
patients and unaffected, age-matched controls would support 1) 
clinical, molecular and pathological research on disease natural 
history, heterogeneity, diagnosis, and clinical-pathological 
correlations; and 2) epidemiological research related to the 
identification of risk factors, neuroprotective factors or biomarkers.  
As clinical components are built into the Morris K. Udall Parkinson’s 
disease Centers of Excellence and other PD Centers, the advance funding 
of this data coordination initiative will function to systematize data 
collection and analysis across centers. In addition, existing databases 
should be assessed as to their relevancy and incorporation into this 
national resource. Data from all PD center resources can thus be 
combined, coordinated, and made available to researchers from PD 
centers as well as the wider PD research community.  

The primary objectives will be to: 

1) Establish, maintain, and disseminate a data base of clinical, 
pathological and biochemical information collected at Udall Centers, 
Collaborative Centers for Parkinson’s Disease Research (CCPDER), or 
other PD centers, from persons with Parkinson’s disease and related 
disorders and from unaffected age-matched controls;

2) Assess availability and potential use of existing databases and how 
they could be incorporated or made compatible, as well as provide 
training and data quality control across all participating sites.

3) Provide assistance to investigators in planning and conducting 
research studies using the database; 

4) Make available virtual data and a catalog of tissues and other 
biological samples collected from PD patients and controls for use in 
epidemiological, clinical, molecular and pathological studies by 
qualified investigators, and

5) Coordinate annual meetings of its steering committee and the annual 
Udall (and other) PD Centers’ meeting to discuss progress and 

With the establishment of this data coordinating center, important and 
novel research issues can be addressed which would not be possible with 
the individual resources available at any one individual center.  
Research activities that use PD-DOC resources may be supported through 
the usual National Institutes of Health (NIH) and other federal and 
non-federal sources for the funding of investigator-initiated 


A.  Background

Since March of 2000, the National Institutes of Health (NIH) has 
expended tremendous effort and has made significant progress on the 
implementation of the Parkinson's Disease Research Agenda. As part of 
the implementation process, NIH convened a summit with several 
outstanding scientists in late July 2002 - to gain a better sense of 
where the field of PD research stands internationally, and to collect 
information on the "roadblocks" that may still be impacting progress.  
(The results of the summit meeting are articulated the Parkinson’s 
disease Matrix:  
Recommendations made at this meeting included the integration and 
clinical expansion of the Udall centers. The ultimate goal of improving 
the integration of centers is to create a patient-centric system in 
which community physicians, research centers, and NIH are all part of a 
cohesive network. With such a system, information on patients can be 
better captured and managed, and research can be integrated at both the 
basic and clinical levels.  Clinical expansion of the network of 
integrated centers could link basic, translational, and clinical 
research, further the development of outcome tools, brain banks, and 
biomarkers, and would necessarily include cores for clinical pathology 
and tissue banks. This will require formal coordination, thus it was 
recommended that a coordinating center facilitate the continuing 
development of standards for data collection, centralize the systematic 
collection of patient data, provide this data to the PD research 
community, and manage joint centers meetings where progress and 
collaborations could be addressed.

B.  Research Goals and Scope

Applications should present a plan for a data coordinating center which 
includes approaches to the following activities and any others that 
would complement the functions outlined here:

1)  Data Coordination

a. assume responsibility for the minimum common data set (tracking 
multiple variables) currently in existence on basic clinical and 
pathological information about patients in a standard format. In 
anticipation of this process, NINDS convened a workshop to explore 
potential features of a minimum data set for PD.  The resultant draft 
minimum data set for clinical and pathological features of PD can be 
found at: 
It is hoped this will serve as a useful starting point for potential 

b. to gradually expand and/or modify the minimum data set to include 
information of greater depth and breadth about the clinical, 
pathological, genetic status, exposure histories, and risk factors of 
the patients and controls. 

c. perform surveys of existing PD database structures and propose ways 
to integrate common variables and index non-conforming variables in a 
central database, and continue to identify sites from which data should 
be collected.

d. develop protocols and methods for data collection and its 
transmission to and from individual centers and the PD-DOC, as well as 
to ensure quality control and uniform collection of data across 
participating sites.

e. prepare a virtual catalog of all tissues, biological specimens, cell 
lines, reagents and molecular probes, relevant neurotoxicants, etc, and 
make it available to investigators both within and outside of the PD 

f. coordinate with the NINDS genetic repository for PD when 

g. develop and maintain a comprehensive set of procedures to assure 
confidentiality of subjects.

2)  Consultation on study design and statistical analysis

a. provide advice and consultation  to investigators planning studies 
which utilize the database to encourage its maximum and most efficient 

b. provide guidelines and information to investigators planning 
prospective epidemiological, genetic or clinical studies

c. provide advice and consultation to investigators planning or 
conducting pooled or secondary analyses of exposure histories or 
existing risk factor databases;

3) Coordination of meetings and reports

a. establish a steering committee with NINDS to oversee PD-DOC 
operations made up of the Principal Investigator of the PD-DOC, NINDS 
and NIEHS staff, representatives from the PD research community, and 
special consultants; The steering committee must be kept informed and 
approve of any changes in policy.

b. organize regular meetings or teleconferences of the PD-DOC Steering 
Committee to allow the steering committee to monitor operations and 
approve changes in procedures; provide administrative support to the 
annual Udall Center’s meeting.

c. prepare guidelines for publications that use the PD-DOC, as well as 
prepare annual reports for the steering committee.

4) Staff Requirements (see also “Description of Capabilities and 
Experience” under application content)

a. The Principal Investigator and/or other key staff must have 
appropriate expertise and capability in biostatistics, data management, 
data analysis, and project management; prior experience in complex 
large-scale collaborative studies is desired.

b. The Principal Investigator and/or other key staff should have 
experience in Parkinson's disease and related disorders research (for 
example in the form of publications) and have familiarity with the PD 
research literature including genetics, epidemiology, molecular 
pathogenesis and clinical course of the disease.

c. The Center staff must have the ability to assist in designing 
protocols, study manuals and data collection systems, including 
distributed data entry and plans for data analysis.

d. The Center staff must have experience in developing and maintaining 
data quality control, including accurate collection of the minimum data 
set across sites. 

e. The Center staff must demonstrate successful experience in assisting 
clinical investigators prepare manuscripts for publication that utilize 
data gathered from collaborative research.


This RFA will use NIH U01 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 earliest 
award date is December 1, 2004.

This RFA uses just-in-time concepts.  The NIH U01 is a cooperative 
agreement award mechanism in which the Principal Investigator retains 
the primary responsibility and dominant role for planning, directing, 
and executing the proposed project, with NIH staff being substantially 
involved as a partner with the Principal Investigator, as described 
under the section "Cooperative Agreement Terms and Conditions of 


NINDS intends to commit approximately $1 million and NIEHS 
approximately $300,000 in FY05 to fund one award for a Data 
Coordinating Center in response to this RFA. An applicant may request a 
project period of up to 5 years and a budget for total costs of up to 
$1.3 M per year. Although the financial plans of the NINDS and NIEHS 
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. 


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

The applicant organization should have experience in functioning as a 
data coordinating center for clinical studies of a medical and/or 
behavioral nature, or in other large-scale data management and analysis 
projects and have knowledge about the unique characteristics of 
Parkinson’s disease and related disorders, the various NIH PD Centers 
Programs, and the status of current PD research, including important 
unanswered questions that could be addressed using the larger data 


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.   


Cooperative Agreement Terms and Conditions of Award

These terms are in addition to, not in lieu of, otherwise applicable 
Office of Management and Budget (OMB) administrative guidelines, HHS 
Grant Administration Regulations at 45 CFR Part 74 and 92, and other 
HHS, PHS, and NIH Grants Administration policy statements.
The administrative and funding instrument used for the PD-DOC is the 
cooperative agreement (U01), an "assistance" mechanism (rather than an 
"acquisition" mechanism) in which substantial NIH scientific and/or 
programmatic involvement with the awardee is anticipated during 
performance of the activity. Under the cooperative agreement, the NIH 
purpose is to support and/or stimulate the recipient's activity by 
involvement in and otherwise working jointly with the award recipient 
in a partner role, but it is not to assume direction, prime 
responsibility, or a dominant role in the activity. Consistent with 
this concept, the dominant role and prime responsibility for the 
activity resides with the awardee(s) for the project as a whole, 
although specific tasks and activities in carrying out the studies will 
be shared among the awardees and the NINDS Project Scientist.
A.  Awardee Rights and Responsibilities
The awardee will have substantial and lead responsibilities in all 
tasks and activities.  These include data collection, database design, 
training, quality control, data analysis, and assistance with 
preparation of publications. The awardee agrees to work cooperatively 
with PD research centers and agrees to accept guidance from the PD-DOC 
Steering Committee.
B.  NINDS/NIEHS Staff Responsibilities
The NINDS will name a Program Official whose function will be to assist 
the Principal Investigator and the Steering Committee in oversight of 
the Coordinating Center.  The Program Official will have substantial 
scientific-programmatic involvement, above and beyond normal program 
stewardship, including being a voting member of the steering committee 
and all key study group subcommittees, participation in database 
development, budget monitoring, identification of relevant research 
questions, modification of protocols, quality control, data analysis 
and interpretation, preparation of publications, and coordination and 
performance monitoring.  The prime responsibility for these activities 
resides with the awardee although specific tasks and activities in 
overseeing the studies will be shared between the awardee and the NINDS 
Program Official.

An NINDS Program Director will be responsible for normal program 
stewardship and monitoring of the award.  The Program Director may also 
serve as the Program Official described above.

The NINDS reserves the right to terminate or curtail the award in the 
event of a lapse in data reporting, quality control, or other major 
breach of the protocol.
C.  Steering Committee
The PD-DOC Steering Committee will include the PD-DOC Principal 
Investigator, the NINDS and the NIEHS Program Officials, three Udall 
Center Directors, one CCPDER director and three additional members 
selected from the PD research community. Other outside members with 
data center expertise may be appointed by the Steering Committee.  A 
Chairperson will be elected from the membership of the Steering 
Committee.  The functions of the Steering Committee are to oversee the 
creation of the data center and the expansion of the minimum database; 
approve operating procedures and changes in operating procedures; 
identify, prioritize, and review study topics; consider the relevant 
research questions and available resources; review proposals submitted 
to the PD-DOC for feasibility; consult with and advise the leadership 
of the PD-DOC and the NINDS and monitor the data center's progress in 
meeting goals; help the PD-DOC analyze and interpret data from studies 
associated with the PD-DOC; and approve the composition of a 
publications committee.
D. Arbitration

Any disagreement that may arise on scientific/programmatic matters 
(within the scope of the award), between award recipients and the NINDS 
may be brought to arbitration.  An arbitration panel will be composed 
of three members, one member selected by the PI, one member selected by 
the PO, and one member selected jointly. The arbitration Panel will 
recommend a course of action to the Director of Extramural Activities, 

This special arbitration procedure in no way affects the awardee’s 
right to appeal an adverse action that is otherwise appealable in 
accordance with the PHS regulations at 42 CFR Part 50, Subpart D and 
HHS regulation at 45 Part 16 or the rights of NINDS under applicable 
statutes, regulations and terms of the award.


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:

Dr. Diane D. Murphy
Neurodegeneration Group
National Institute for Neurological Disorders and Stroke
Neuroscience Center Room 2223
6001 Executive Blvd.
Rockville, MD 20852
Telephone:  (301) 496-5680
FAX:  (301) 480-1080

Dr. Cindy Lawler
Cellular, Organ, Systems Pathobiology Branch
National Institute of Environmental Health Sciences
Box 12233  MD EC-23
Research Triangle Park, NC 27709
Telephone: (919) 316-4671
FAX: (919) 541-5064

Dr. Annette Kirshner
Cellular, Organ, Systems Pathobiology Branch
National Institute of Environmental Health Sciences
Box 12233  MD EC-23
Research Triangle Park, NC 27709
Telephone: (919) 541-0488
FAX: (919) 541-5064

o Direct your questions about peer review issues to:

Alan Willard, Ph.D.
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke 
6001 Executive Blvd., Room 3208
Bethesda, MD  20892
Telephone:  (301) 496-9223
FAX: (301) 402-0182

o Direct your questions about financial or grants management matters 

Michael J. Loewe
Chief, Grants Management Branch
National Institute of Neurological Disorders and Stroke 
6001 Executive Blvd., Suite 3290, MSC 9537
Bethesda, MD  20892-9537
Telephone:  (301) 496-9231
FAX: (301) 402-0219


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 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 is to be sent to Dr. Diane 
Murphy at the address listed above.


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 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 in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:


See also B. Research Goals and Scope above for additional information 
on application instructions and requirements.

The application should include:

1) a description of capabilities and experience of the key personnel, 
2) a research plan for the first five years of the data center, and 
3) a budget with justification of expenses.  

1. Description of Capabilities and Experience (as outlined above under 
staff requirements)

a. Describe the applicant organization's facilities, resources, and how 
the staff's strengths in biostatistics, data management, data analysis, 
and project management skills have been used in previous, successful 
large-scale collaborative research.

b. Describe the knowledge and experience of the Principal Investigator 
and/or other staff in research on Parkinson’s disease and related 

c. Describe the experience of the key personnel in assisting protocol 
design, data entry procedures and manual preparation, and in data 
collection and data quality control for previous large-scale, complex 
research projects.

d. Present the applicant's record in generating reports on data 
collection and performance in previous large-scale collaborative 
projects, including preparation of manuscripts.

e. Describe how logistical services and organizational support have 
been utilized in managing resources and monitoring performance in 
previous large-scale, collaborative research.

2.  Research Plan

a. Describe the applicant's conception of the role of the Data 
Coordinating Center in furthering Parkinson’s disease research using 
large data sets.

b. Describe examples studies on Parkinson’s disease etiology, 
pathogenesis and clinical course that would be feasible using an 
expanded data set. Describe the statistical methods to be used, the 
unique analytic challenges these studies may face, and strategies for 
dealing with these challenges.

c. Provide a statement of intent to collaborate with all recognized PD 
research Centers as well as the NINDS Genetic Repository when 
appropriate. Also describe leadership role of the PD-DOC in developing 
clinical programs at new centers.

d. Describe the platform for the database and procedures for 
maintaining data integrity across centers and assuring confidentiality 
of subjects.

e. Describe the nature of additional data, over a proposed minimum data 
set (see, 
that may be collected in future.

f. Describe the importance of having prospective hypotheses for each 
set of data and an ordered and well-considered process for adding 
additional hypotheses to test. 

g. Propose an administrative and management structure that would 
support the PD-DOC.

h. Describe procedures and guidelines for access, use and publication 
of data.

i. Describe involvement of human subjects and human specimens in the 
Research Plan, Section e. Human Subjects.  Applications must include 
documentation of the ability to properly acquire human samples and 
clinical data for the proposed studies.  The NIH brochure entitled 
"Research on Human Specimens: Are You Conducting Research Using Human 
Subjects?" ( and OHRP 
guidance on Repositories, Tissue Storage Activities and Data Banks 
( are available for 
guidance on these topics.

3.  Budget Considerations

All PD-DOC proposals should request and provide justification for five 
years of support.  The total costs (direct plus indirect) requested for 
applications for the PD-DOC may not exceed $1,000,000. These costs may 
include those for logistical arrangements (e.g., meeting room rental, 
audio video expenses, speaker expenses, etc.) of meetings each year for 
the PD-DOC Steering Committee and the Annual Udall Center’s meeting.  
Funds should be budgeted for regular teleconferences for the Steering 

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:

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and three signed, 
photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
At the time of submission, two additional copies of the application 
must be sent to:

Dr. Alan L. Willard, Ph.D.
Chief, Scientific Review Branch, NINDS
6001 Executive Blvd, Room 3201
Rockville, MD 20852 (couriers)
Bethesda, MD 20892-9529 (for US Mail)

APPLICATION PROCESSING: Applications must be received by 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.


Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NINDS. Incomplete and/or nonresponsive 
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 NINDS in 
accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will:

o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications 
under review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by an appropriate national advisory 
council or board. 


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? 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 

INVESTIGATOR: Is the investigator appropriately trained and well suited 
to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)?

ENVIRONMENT: Does the scientific environment in which the work will be 
done contribute to the probability of success? Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
evidence of institutional support?  

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

1.  The organizational and administrative structure of the proposed 
program including evidence of the degree of commitment and support of 
the organization/institution for the proposed program.

2.  The scientific merit of the proposed approach to data collection, 
management and coordination, as outlined in the RFA. Documentation of 
the specific competence and previous experience of professional, 
technical, and administrative staff pertinent to the data center. Prior 
experience should be demonstrated in similar studies, for the 
collection of data from multiple locations, as well as experience in 
monitoring the quality and timeliness of such data.

3.  Documentation of the specific competence and previous experience of 
professional staff with the unique features of Parkinson’s disease and 
related disorders research.  The extent to which proposed uses for data 
collected in the Center demonstrate an understanding of this complex 
disease process and logical approaches to answering questions 
fundamental to the disease.

4.  Suitability of proposed data management and data analysis plan, the 
adequacy of the proposed facility and technical hardware and 
appropriateness of the budget for the work proposed.

5.  Suitability of plans for managing meetings of the steering 
committee and the annual Udall meetings.

6.  Understanding of human subject research protection issues as 
demonstrated in the Human Subjects section of the application.

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).
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).
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.  

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.


Letter of Intent Receipt Date:  December 22, 2003
Application Receipt Date:  January 22, 2004
Peer Review Date:  Summer, 2004
Council Review:  September, 2004
Earliest Anticipated Start Date:  December 1, 2004


Applications will be considered for award based upon (1) scientific and 
technical merit; (2) program balance, including in this instance 
sufficient compatibility of features to make a successful collaborative 
program a reasonable likelihood; and (3) availability of funds.


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.

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:  

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking $500,000 or more in 
direct costs in any single year are expected to include a plan for data 
sharing or state why this is not possible.  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.

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 

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 
a complete copy of the updated Guidelines are available at 
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 

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, 

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

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

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of 
research on hESCs can be found at 
and at
Only research using hESC lines that are registered in the 
NIH Human Embryonic Stem Cell Registry will be eligible for Federal 
funding (see   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. 

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

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.

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 
( 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

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 

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

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance at 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

The Public Health Service (PHS) strongly encourages all grant 
recipients to provide a smoke-free workplace and promote the non- 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

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