CENTERS OF EXCELLENCE IN MOLECULAR HEMATOLOGY
 
RELEASE DATE:  May 7, 2004
 
RFA Number: RFA-DK-04-015  

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

January 26, 2010 - This RFA has been reissued as (RFA-DK-09-013).
 
Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION: 
National Institute of Health (NIH)
 (http://www.nih.gov)
 
COMPONENT OF PARTICIPATING ORGANIZATION: 
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/NIH)
 (http://www.niddk.nih.gov/) 

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.849 
 
LETTER OF INTENT RECEIPT DATE: October 15, 2004
APPLICATION RECEIPT DATE: November 16, 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) 
invites grant applications for Centers of Excellence in Molecular Hematology 
(CEMH). The NIDDK anticipates the award of three competing Core Center Grants 
(P30) in Fiscal Year 2005. 

The Centers of Excellence in Molecular Hematology are part of an integrated 
program of hematologic diseases-related research support provided by the 
NIDDK.  The Centers currently funded in this program have provided a focus 
for increasing collaboration and improving the cost-effectiveness of 
supported research among groups of successful investigators at institutions 
with an established, comprehensive hematologic diseases research base. An 
open competition is invited, in order to renew and strengthen this program.
 
RESEARCH OBJECTIVES
 
The objective of these Core Centers is to bring together investigators from 
relevant disciplines to enhance and extend the effectiveness of research 
related to hematologic diseases and their complications.  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 
hematologic diseases research.  An existing program of excellence in 
biomedical research in the area of hematologic diseases and disorders is 
required.  This research base must be in the form of NIH funded research 
projects, program projects, or other peer reviewed research that is already 
funded at the time of submission of a Center grant application.  Close 
cooperation, communication, and collaboration among all involved personnel of 
all professional disciplines are ultimate objectives.

The Core Center must have a central focus of research investigation. The 
central focus must be a hematologic disease, group of diseases or functional 
studies relating to hematologic diseases; at least half of the research 
proposed for inclusion in the Core Center must relate to this central focus. 
The purpose for development of Centers as an organizational mechanism is to 
promote the joint efforts of both basic scientists and clinical researchers. 
Areas addressed by the NIDDK CEMH should relate to announced hematologic 
research emphases of the NIDDK.  The NIDDK Hematology Program's areas of 
emphasis include:

o the molecular and cellular biology of hematopoiesis and hematopoietic stem 
cell biology
o erythropoietin and hematopoietic growth factors
o use of definitive stem cells as cell therapy tools for hematopoietic 
disorders, or definitive hematopoietic stem cells as cell therapy tools for 
other disorders
o use of NIH-approved human embryonic stem cell (hESC) lines to explore the 
use of hESC as a model system, or as cell therapy tools
o expressed erythroid molecular biological components and creation of reagents 
useful for study of the erythroid cell lineages
o receptor biology and signaling
o blood cell metabolism; membrane biology and ion transport; heme metabolism
o globin biosynthesis and its genetic regulation
o iron absorption, storage and metabolism; pathophysiology of iron overload, 
and strategies for therapeutic intervention
o development of approaches and techniques for gene therapy using 
hematopoietic cells

Examples of relevant investigations include but are not limited to the study 
of gene structure and function, the structural biology of proteins and the 
complex biochemistry of protein interactions, studies of the mechanisms of 
intracellular iron toxicity; investigation of the mechanisms of hematopoietic 
gene regulation and of differential gene expression during hematopoietic cell 
maturation and differentiation, and clinical research to test the efficacy 
and safety of therapeutic strategies derived from basic investigation.  

These studies will have as their ultimate goal the development of preventive, 
curative, or intervention strategies in the treatment of hematopoietic 
diseases.  Concentration of efforts such as vector development, creation of 
animal models, and the application of advanced instrumentation will allow 
economies of scale and will generate technologies that will be broadly 
applicable to the understanding of molecular disorders.  These centers also 
will serve the function of facilitating the training of new professional 
personnel to satisfy future manpower needs.

Applicants should consult with the NIDDK Program staff listed below 
concerning plans for the development of the Center and the organization of 
the application.

Centers of Excellence in Molecular Hematology are based on the core concept.  
Three to six cores usually are included in a Center.  Cores are defined as 
shared resources that enhance productivity or in other ways benefit a group 
of investigators working in a center to accomplish the stated goals of the 
Center.  Examples of such resources include functional genomics and 
bioinformatics, transgenic animal, and cell preparation facilities.

Multi-institutional domestic applications are encouraged. Such applications 
must feature existing collaborations among investigators, and specific 
documentation of existing collaborations must be included in the application. 
Multi-institutional center applications will be required to encourage 
regional or national use of cores. 

Cores that are used as a regional or national resource may be justified by 
what might be termed an "extended research base".  Eligible investigators for 
such a core would be included in a "regional/national core investigator 
list". The extended research base for a regional or national 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, and will not be 
considered as part of the research base qualifying the institution as an 
applicant.

Two other types of activities may also be supported with Center funding: a 
pilot and feasibility (P&F) program and an enrichment program.  

The P&F program provides modest short term support for new initiatives or 
feasibility research studies.  This program is directed at new investigators, 
at investigators established in other research disciplines with expertise 
that may be applied to hematologic disease research, and, occasionally, at 
investigators already working in hematologic diseases who wish to make a 
substantial change in the direction of their research.  In some Centers, the 
P&F program could be used to encourage clinical projects or translational 
research. By establishing ties with the institution's General Clinical 
Research Center (GCRC), the P&F project funds could be leveraged effectively 
to pursue such projects. 

The Core Center grant may include limited funds for program enrichment such 
as seminars, visiting scientists, consultants, and workshops.

Most NIDDK-funded Centers are at institutions where the training of new 
investigators is a priority. The presence of a Center, with the resources it 
provides, should enrich any training experience and should be a positive 
factor when recruiting postdoctoral fellows and junior faculty. Applicants 
for a CEMH grant should present a plan for enhancing interactions with 
research training and career development programs.

MECHANISM OF SUPPORT

This RFA will use the 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.  Future competing 
continuation applications based on this mechanism will be accepted only in 
response to a separate announcement. The anticipated award date for this 
solicitation is July 1, 2005.

This RFA uses just-in-time concepts. This program does not require cost 
sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.

FUNDS AVAILABLE 

The NIDDK intends to commit approximately $3,000,000 in FY 2005 to fund three 
new and/or competing continuation grants in response to this RFA. An 
applicant should request a project period of five years and a budget for 
total costs of up to $1,000,000 per year. Although the financial plans of the 
NIDDK provides support for this program, awards pursuant to this RFA are 
contingent upon the availability of funds and the receipt of a sufficient 
number of meritorious applications.  
 
ELIGIBLE INSTITUTIONS
 
A CEMH must be an identifiable organizational unit within a single university 
medical center or within a consortium of cooperating institutions with a 
university affiliation. Foreign institutions are not eligible to apply.

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.  Women, individuals from underrepresented 
racial and ethnic groups, as well as individuals with disabilities always are 
encouraged to apply for NIH programs.   
 
SPECIAL REQUIREMENTS 

To be eligible for a CEMH award, an institution must have a significant 
research base related to hematologic diseases. At least 50 percent of the 
already funded research base in a new application must be supported by the 
NIH.  In competing continuation applications the percent may be less than 50 
percent due to, for example, a growing research base of investigators 
entering hematologic diseases from other fields.  The initial review group 
will determine the significance of the research base.

A significant NIH funded research base (FRB) is defined as: the funding 
level, in annual total cost for the NIH fiscal year (October 1 to September 
30), preceding receipt of CEMH applications.  The research base includes 
peer-reviewed grants, cooperative agreements, and research contracts 
utilizing only the following mechanisms:  P01, R01, R03, R18, R21, R24, R29, 
R33, R35, R37, U01, U10, U19, U24, U54, and K series awards, and N01 
(excluding contracts that primarily fund the production of materials or 
services for support of research). Excluded from the NIH Funded Research Base 
are all funds from any source other than NIH.  

Principal investigators, plus Core Directors, are expected to participate in 
an annual meeting of grantees, usually in Bethesda, Maryland.  The purpose of 
these meetings is to discuss scientific advances; the potential for 
collaborations, data and technology sharing; and other research 
opportunities.  Funds for travel to the meeting should be requested in the 
budget. 

In some cases, two or more institutions that can demonstrate a credible plan 
for collaborative research networks using CEMH cores may wish to submit an 
application for a single CEMH award.  Reviewers will look critically at the 
request for multi-institutional applications for the following indicators: a 
demonstration of exceptional need to establish collaboration between 
investigators at separate institutions; evidence of unique plans, such as the 
development of organized communications systems, to overcome the scientific 
and management challenges that are naturally a part of multi-institutional 
collaborations; specific plans to address anticipated budgetary issues in the 
transfer of funds and resources from one institution to another; and evidence 
of centralized authority of the CEMH Director for the purpose of management 
of the CEMH facilities at other sites.

Multi-institutional CEMH applications may combine the NIH hematology funded 
research of all the investigators at the institutions participating in the 
proposed CEMH to meet the NIH Funded Research Base (FRB) requirement.  A CEMH 
cannot use the FRB of an institution that is already part of another CEMH. A 
multi-institutional CEMH application must designate a lead institution that 
will receive the award and provide details of agreements regarding 
coordination and support of cores and activities at other participating 
institutions. 

DATA SHARING: All applications that list direct costs greater than $500,000 
in any year of the proposed research must have a data sharing plan. This plan 
will be reviewed for: statements of willingness to share information fully; 
clarity of included Material Transfer Agreements; adequate and clear 
strategies for sharing results/data, tools, and new animal models with the 
research community and/or websites maintained by the NIH.

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:

David G. Badman, Ph.D.
Hematology Program Director
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 621 
Bethesda, MD  20892-5458
Telephone:  (301) 594-7717
FAX:  (301) 480-3510
Email:  db70f@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:

Aretina Perry-Jones
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 745 
Bethesda, MD  20892-5456
Telephone:  (301) 594-8862
FAX:  (301) 480-3504
Email:  ap19s@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 program
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: Prospective applicants should obtain a copy of 
the Administrative Guidelines for Centers of Excellence in Molecular 
Hematology. The Guidelines are available from the Program Director cited 
above, or from the NIDDK web site at: 
http://www.niddk.nih.gov/fund/other/centers.htm#Hematology

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typed 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 program 
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.  

If the application is not responsive to the RFA, the application will be 
returned. 

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

All applications responding to this RFA will be evaluated according to the 
review criteria as outlined in the NIDDK CENTERS OF EXCELLENCE IN HEMATOLOGY 
ADMINISTRATIVE GUIDELINES available on the NIDDK web site at 
http://www.niddk.nih.gov/fund/other/centers.htm#Hematology or from the 
program director listed under INQUIRIES, above.
 
As part of the initial scientific review, which will result in an 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 
score for the Administrative Core. The scores for each of these 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 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 proposed Center address important hematologic issues? 
If the aims of the application are achieved, how will scientific knowledge be 
advanced? What will be the effect of this Center on the concepts or resources 
that drive this field?

APPROACH: Are the conceptual framework, design, collaborations and cores 
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 proposed Center have the potential to develop novel 
concepts, approaches or methods? Are the directions original and innovative? 
Does the proposed Center offer the prospect of challenging existing paradigms 
or develop new technologies or resources?

INVESTIGATORS: Are the Center investigators appropriately trained and well 
suited to collaborate in the proposed Center goals? Does the experience and 
track record of the Principal Investigator inspire confidence in his/her 
ability to lead this group of investigators?

ENVIRONMENT: Does the scientific environment in which the proposed Center 
will be set contribute to the probability of success? Do the proposed 
collaborations and cores take advantage of unique features of the scientific 
environment? 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:

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 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 CEMH 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 
CEMH.

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, four 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 
CEMHs 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 administering and reviewing the use 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 to 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.  Requested Total Costs are limited to $1,000,000 per year (including 
the P&F program and subcontract facilities and administrative costs). For 
competing continuation applications, requested Total Costs should not exceed 
the $1,000,000 cap.  Budgets may not be submitted in a modular format.

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. 

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:          October 15, 2004
Application Receipt Date:               November 16, 2004
Peer Review Date:                       February/March 2005
Council Review:                         May 2005
Earliest Anticipated Start Date:        July 1, 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 

WELFARE PROTECTION:  Recipients of PHS support for activities involving live, 
vertebrate animals must comply with PHS Policy on Humane Care and Use of 
Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as 
mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA 
Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

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

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

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

 
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