and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National
Institutes of Health (NIH), ( http://www.nih.gov/)
Components of Participating Organizations
National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www2.niddk.nih.gov/)
Title: Continuation and
Expansion of the Drug Induced Liver Injury Network (DILIN)[U01]
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-DK-07-012
Catalog of Federal Domestic Assistance Number(s)
93.848
Key Dates
Release Date: November
20, 2007
Letters of Intent
Receipt Date: February
26, 2008
Application
Receipt Date: March
20, 2008
Peer
Review Date: June
2008
Council Review Date: August 2008 (New Date October 2008 per NOT-DK-08-011)
Earliest Anticipated
Start Date: August
2008
Additional
Information To Be Available Date (Url Activation Date): NA
Expiration Date: March
21, 2008
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application
Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award
Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
A. Cooperative Agreement Terms
and Conditions of Award
1. Principal
Investigator Rights and Responsibilities
2. NIH
Responsibilities
3. Collaborative
Responsibilities
4. Arbitration
Process
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Nature of the research
opportunity:
The National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health of the U.S. Department of Health and Human Services is seeking applications to continue and expand the Drug-Induced Liver Injury Network (DILIN) established by NIDDK in 2003 (http://dilin.dcri.duke.edu/index.html).The DILIN has made major advances in the study of the epidemiology and clinical spectrum of hepatotoxicity due to drugs and to Complementary and Alternative Medications (CAM), mainly herbal products. RFA-DK-07-012 will seek the continuation of DILIN and the expansion of the network to enhance the enrollment of cases and controls from a diverse demographic background and a wide geographic distribution. A major aim of the network study is to pursue pharmacogenetic analyses to find predictive biomarkers as well as genetic fingerprints useful for elucidating the pathogenesis of Drug-Induced Liver Injury (DILI) and ultimately for developing specific means of treatment. The Network would be composed of up to 8 Clinical Centers with expertise in diagnosis and management of DILI and a Data Coordinating Center with expertise in the management of multicenter studies and clinical and translational datasets.
This RFA requests two separate types of applications: up to 8 Clinical Center, and a single Data Coordinating Center.
Background information
Drug-induced liver injury is an uncommon but important and challenging form of liver disease. Drugs, including prescription medications, over-the-counter preparations and herbals, must be considered during the evaluation of any patient with new-onset liver disease. Even if another cause is obvious (such as hepatitis B or C), the possible contributing role of a medication to the injury must be considered. The reason for this is that drug-induced liver injury can be severe, protracted and even fatal, but is usually promptly reversed by discontinuation of the offending agent. To continue a medication in the face of drug-induced liver disease is a major error that can have serious consequences. The exact incidence of drug hepatotoxicity is not known, but it has been estimated that serious adverse drug reactions (ADR) overall are responsible for 4.7% of hospital admissions in the United States. Two per cent of hospitalized patients suffer a serious ADR while in the hospital. In 1994 over 100,000 hospitalized patients died of an ADR, making this the fourth to sixth leading cause of death.
Drug-induced liver disease is challenging because of the ever increasing number of drugs used in the management of diseases and the growing number of individuals who take medications. Among the many thousands of drugs available today, several hundred have been linked to liver injury. But the clinical pattern of liver injury is diverse and complex, and drug-induced liver injury can mimic virtually any form of liver disease, from acute to chronic hepatitis, biliary obstruction to venous obstruction, acute fatty liver disease and even massive hepatic necrosis. To keep track of which drugs cause liver injury and what pattern is typical of which agent is challenging even for the most dedicated sub-specialist in the area. Furthermore, the literature on drug-induced liver disease is large and dispersed to publications in a great many disciplines including hepatology, gastroenterology, pharmacology, internal medicine, pediatrics, and surgery. Publications on drug-induced liver disease appear in many journals, in multiple languages and often as short reports or letters to the editor whose validity is difficult to assess. For this reason, it is a challenge to keep abreast of the literature on drug-induced liver disease, and literature searches to specific medications are often incomplete.
For many of these reasons, the Liver Disease Research Branch of the National Institute of Diabetes and Digestive Diseases in collaboration with the National Library of Medicine and the Drug-Induced Liver Injury Network plan to develop a web site dedicated to providing up-to-date, comprehensive clinical information on drug-induced liver disease for both the general physician and the subspecialist.
Although the study of drug-induced liver abnormalities has centered on the involvement of pharmacokinetic factors (absorption, distribution, metabolism and excretion) there is increasing evidence that genetic variation in drug targets (pharmacodynamic factors: receptors, channels, enzymes, immune factors) might also predispose to hepatotoxicity. In addition, environmental factors such as underlying disease, alcohol, smoking and diet might also be significant sources of variability interacting with genetic factors. To begin to analyze the pathogenesis and genetic basis of drug and toxin-induced liver disease, it is critically important to have unambiguously characterized cases of hepatotoxicity (phenotype) and carefully selected control subjects.
This FOA seeks to continue and expand the Drug Induced Liver Injury Network in order to:
Scientific knowledge to be achieved
By adding hundreds of well characterized drug Induced liver injury cases, along with the associated biological specimens, the Network will continue to expand our understanding of the epidemiology and clinical manifestations of drug-induced liver injury and facilitate the application of pharmacogenetics methodologies for the discovery of biomarkers and genetic fingerprints. With the potential to develop predictive markers for drug toxicity, this initiative is responsive to the NIH strategic vision to enhance the development of new treatments and preventive strategies that will improve the safety of drugs making personalized and predictive medicine a prompt reality (http://www.nih.gov/strategicvision.htm).
Objective of this research program
The selection of an outstanding cadre of clinicians and investigators with expertise in drug-induced liver injury able to identify cases and controls from a diverse demographic background and a wide geographic distribution is of paramount importance in accomplishing the following objectives:
Organization of the Drug Induced Liver Injury Network
The Network will continue and extend the work of the current Drug Induced Liver Injury Network (DILIN) (http://dilin.dcri.duke.edu/index.html). The organization will be a cooperative network of up to 8 Clinical Centers (CC) and one Data Coordinating Center (DCC). Clinical Centers will be responsible for proposing protocols, participating in their overall development, conducting the research, obtaining biosamples for repository storage and disseminating research findings. All individual CCs will be required to participate in a cooperative and interactive manner with one another and with the DCC in all aspects of the Drug Induced Liver Injury Network. The DCC will support protocol development, provide sample size calculations, statistical advice, questionnaires, and data analysis; support manuscript preparation; organize committee meetings; and provide overall study coordination and quality assurance, including coordination of the logistical activities of the Steering Committee and other standing committees.
The NIDDK Biosample Repository (www.niddkrepository.org) will be used as the specimen repository for the Network. This repository is not part of the RFA and is funded independently.
During the next funding period, the NIDDK will seek additional funding to support genome wide association studies (GWAS) to identify common genetic factors that influence predisposition to Drug Induced Liver Injury. It is expected that the genotype data generated for each sample, plus coded phenotype and exposure data will be deposited in a controlled access section of the Drug Induced Liver Injury Database, which will be compliant with the database of Genotype and Phenotype, a NIH database for genotype-phenotype datasets maintained by the NCBI. Data sharing procedures, data access principles, intellectual property, and issues regarding the protection of research participants through all phases of GWAS will be consistent with NIH Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS)(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html)
Governance
A Steering Committee will be the main governing body of the Drug Induced Liver Injury Network. At a minimum, the Steering Committee will be composed of the principal investigators of each Clinical Center in the Network, the principal investigator of the DCC and the NIDDK Project Scientist. The first meeting of the Steering Committee will be convened by the NIDDK Project Scientist in conjunction with the principal investigator of the DCC. By the end of the first or second meeting of the Committee, the NIDDK will name a study Chairperson from one of the Clinical Centers to oversee and guide Steering Committee activities. The Steering Committee will meet as often as three to four times per year. All major scientific decisions will be determined by a majority vote of the Steering Committee. Each Clinical Center, the DCC, and the NIDDK Project Scientist will have one vote. The Steering Committee will have primary responsibility for the general organization of the Drug Induced Liver Injury Network, finalizing common clinical protocols, facilitating the development of a standardized nomenclature, diagnostic criteria, histological definitions, and necessary components to the common database on patients. The Steering Committee will be responsible for the conduct and monitoring of studies and reporting study results.
All Clinical Center principal investigators will be strongly encouraged to fully commit their center resources and efforts to the Network protocols.
Other subcommittees of the Steering Committee will be established as necessary. For example, a Genetic Profiling Committee with additional expert advice could be formed to assess the different genome screening strategies and to propose a method suitable for future implementation. A Publications Committee would be helpful to facilitate the process for authorship selection and to supervise preparation of manuscripts.
Clinical protocols must be approved by local Institutional Review Boards and the Drug Induced Liver Injury Network Steering Committee before initiation.
The Drug Induced Liver Injury Network investigators will be encouraged to seek out separate funding for special projects and to develop collaboration with laboratory and basic research investigators to draw upon the resources (clinical data, serum, tissue, DNA) made available by the Drug Induced Liver Injury Database.
Any specific collaboration involving the resources of the Drug Induced Liver Injury Network will require approval by the Steering Committee.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity
will use the U01
cooperative agreement award mechanism.
As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
This funding opportunity
uses the just-in-time budget concepts. It also uses the non-modular budget
format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
The NIH U01 is a cooperative agreement
award mechanism. In the cooperative agreement mechanism, 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 VI. 2. Administrative
Requirements, "Cooperative Agreement Terms and Conditions of
Award".
2. Funds Available
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 ICs provide support for this
program, awards pursuant to this funding opportunity are contingent upon the availability
of funds and the receipt of a sufficient number of meritorious applications.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation, see NOT-OD-05-004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an)
application(s) if your organization has any of the following characteristics:
1.B. Eligible Individuals
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 support.
The PI of the Data Coordinating Center can be from the same institution as a Clinical Center but the PI of the Data Coordinating Center cannot serve as a PI of the Clinical Center.
Additionally, due to organizational logistic constraints, applications will be limited from institutions located within the United States. The NIH wishes to recruit a diverse patient study population and will seek geographically diverse Clinical Centers for the Network. Clinical Centers may bridge two or more hospitals or institutions in a defined geographic or metropolitan area through collaborations. Applications spanning more than one institution must document evidence of close collaboration between the PI and the collaborators.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH Grants Policy Statement. The
most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
Not
applicable.
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Telecommunications for
the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A.
Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt
Date: February 26, 2008
Application
Receipt Date: March 20, 2008
Peer Review Date: June 2008
Council Review
Date: August 2008 (New Date October 2008 per NOT-DK-08-011)
Earliest
Anticipated Start Date: September 2008
3.A.1. Letter of Intent
Prospective applicants
are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent
is to be sent by the date listed at the beginning of this document.
The letter of intent
should be sent to:
Francisco
O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452
Phone: 301-594-8897
Fax: 301-480-3505
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications must be
prepared using the research grant applications found in the PHS 398
instructions for preparing a research grant application. 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 (U.S. Postal Service Express or
regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of
submission, two additional copies of the application and all copies of the
appendix material must be sent to:
Francisco
O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452
Phone: 301-594-8897
Fax: 301-480-3505
Email: [email protected]
Using the RFA Label: The RFA label available in
the PHS 398 application instructions 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.
3.C. Application
Processing
Applications must be received on or before the
application receipt date(s) described above (Section IV.3.A.).
If an application is received after that date, it will be returned to the
applicant without review. Upon receipt, applications will be evaluated for
completeness by the CSR and responsiveness by the NIDDK. Incomplete and non-responsive applications
will not be reviewed.
The NIH will not accept
any application in response to this funding opportunity 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 a funding opportunity, it is to be prepared as a NEW
application. That is, the application for the funding opportunity 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.
Information on the status of an application should be
checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not
subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-award costs are
allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or competing continuation award if
such costs: are necessary to conduct the project, and would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Applications
for a Clinical Center (CC)
To promote development of a collaborative program, the issues discussed below need to be addressed in each application for a CC within the Drug Induced Liver Injury Network. This material is in addition to the submission of a research plan, as described in the section entitled Research Objectives.
o Qualifications and experience. Applicants for CCs must demonstrate experience and expertise to conduct clinical studies in Drug Induced Liver Injury (DILI). This must include documentation of experience in the diagnosis and management of patients with DILI. Of particular importance is a description of the strategies used for the identification of DILI cases.
o Study population. CC applicant must discuss the number of patients with DILI cases seen at the center during the previous 12 month period that might be eligible to enroll. The applicant for a CC must include a description of the pool of potential study participants by sex, age categories, and ethnic/racial distribution, as well as recruitment source. Patient access may be developed by establishing links with other groups outside the CC's institution. If outside links are proposed, there must be a well described plan to link the individual CCs with community health care providers such as HMOs, clinics, or private practice physicians to ensure adequate numbers patients.
Applicants for a CC from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources are encouraged to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC Project Coordinator or Principal Investigator should be included with the application.
o Willingness to participate in the DILIN. The principal investigator should state his/her general support of collaborative research and interaction with the NIDDK, the other CCs, and the DCC through the Network concept. Applicants should discuss their willingness, and that of the institutions involved, pursuing a per patient basis (capitation) of operational costs. CCs must be able to interact with the DCC to transmit and edit data and should discuss their capability to participate in a distributed data entry system.
o Institutional resources for patient care and follow-up including personnel, space, and special laboratory facilities should be described.
Applications for a Data Coordinating Center (DCC)
o Qualifications and experience. The applicant for a DCC must demonstrate experience in the area of coordination of multi-center clinical trials and epidemiological studies in all phases: protocol and manual of operations development, staff training in study procedures, research instrument development, data collection and management, quality assurance, data analysis, distributed data entry, electronic communications, administrative management and coordination. Specific experience in coordinating or monitoring studies of liver disease is not required, but the applicant may wish to include a hepatologist or hepatic pathologist in the application as a key collaborator and advisor.
o Study design and management. DCC proposals should discuss the applicant's familiarity and experience with various aspects of study design that would be important in developing clinical protocols, for example: eligibility criteria; baseline and outcome measures; methods of randomization; important considerations for making sample size and power calculations; methods and frequency of data collection and entry; monitoring accuracy of data collection; quality control procedures including training and certification and plans for statistical analysis..
BUDGET AND RELATED ISSUES
Applicants should complete the budget information as directed in the PHS 398 application form.
Applications for CCs
CCs should consider the following additional issues regarding budgets. The underlying concept of the DILIN is that a core effort is essential to maintain the infrastructure required to perform clinical studies. Based on this approach, it is estimated that the individual CCs will require a minimum level of effort to sustain the organizational aspects of the Network. Therefore, individual CCs should submit requests that will cover a minimum of ten percent effort for the principal investigator, and a small percent effort for other key personnel (nurse, technician, clinic coordinator, secretary), and travel costs for two people to attend up to four DILIN meetings during the first year and two to three times a year thereafter in Bethesda, MD. These costs should be justified appropriately in budgets and may be distributed into subcontracts. Applicants for CC should prepare budgets for five 12-month (not to exceed $270,000 total cost for year). In addition to the core budget, each CC will be provided funds for enrollment of patients from a Patient Care Fund administered by the DCC. Allowable total costs for each CC (core costs, costs per patient to conduct the protocols, and indirect costs) will vary.
CCs can propose two or more secondary hospitals or institutions in a defined geographic or metropolitan area through a multiple PI strategy or as a contract service. The budget for Multiple PI applications should be contained within the maximum allowable budget per center. Centers containing a contract service to secondary local institutions should discuss their willingness, and that of the institutions involved, pursuing a per patient basis (capitation) of operational costs for the secondary centers
Continuation and level of funding for each CC will be based on actual recruitment and overall performance. The CC awards will be subject to administrative review annually.
DCC Budget
Applicants for the DCC should prepare budgets for five 12-month periods (not to exceed $750,000 total cost for year) that roughly correspond with the standard coordinating center responsibilities outlined in other sections of this RFA.
Continuation and level of funding of the DCC will be based on overall performance. The DCC award will be subject to administrative review annually.
1. Criteria
Only the review criteria
described below will be considered in the review process.
The following will be
considered in making funding decisions:
2. Review and Selection Process
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 NIDDK in accordance with the review
criteria stated below.
As part of the initial
merit review, all applications will:
The
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application. Note that an 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 or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?
Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator and
other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)? For applications
designating multiple PIs, does the Leadership Plan ensure that there will be
sufficient coordination and communication among the PIs? Are the
administrative plans for the management of the research project appropriate,
including plans for resolving conflicts?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
2.A. Additional Review
Criteria:
In addition to the above
criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from
research risk relating to their participation in the proposed research will be
assessed (see the Research Plan, Section E on Human Subjects in the PHS Form
398).
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 will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan, Section E on Human Subjects in
the PHS Form 398).
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
Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing Research Data
Data Sharing Plan: 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 the priority score.
The presence of a data sharing plan will be part of the terms and conditions of
the award. The funding organization will be responsible for monitoring the data
sharing policy.
2.D. Sharing Research
Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to
this funding opportunity should include a sharing research resources plan
addressing how unique research resources will be shared or explain why sharing
is not possible.
Program staff will be
responsible for the administrative review of the plan for sharing research
resources.
The adequacy of the
resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
N/A
Section VI. Award Administration Information
1. Award Notices
After the peer review of
the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms
and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the
business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The following Terms and Conditions
will be incorporated into the award statement and will be provided to the
Principal Investigator as well as to the appropriate institutional official, at
the time of award.
2.A. Cooperative Agreement
Terms and Conditions of Award
The following special
terms of award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when State and local Governments are eligible
to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for
this program will be the cooperative agreement U01, an "assistance"
mechanism (rather than an "acquisition" mechanism), in which
substantial NIH programmatic involvement with the awardees is anticipated
during the performance of the activities. Under the cooperative agreement, the
NIH purpose is to support and stimulate the recipients' activities by
involvement in and otherwise working jointly with the award recipients in a
partnership role; it is not to assume direction, prime responsibility, or a
dominant role in the activities. Consistent with this concept, the dominant
role and prime responsibility resides with the awardees for the project as a
whole, although specific tasks and activities may be shared among the awardees
and the NIH as defined below.
2.A.1. Principal
Investigator Rights and Responsibilities
The Principal
Investigator will have the primary responsibility for all aspects of
their protocols, including any modification of study design, conduct of the
study, quality control, data analysis and interpretation, preparation of
publications, and collaboration with other investigators, unless otherwise
provided for in these terms or by action of the Steering Committee of the Drug
Induced Liver Injury Network. Awardees will be required to accept and
implement the common protocol(s) and procedures approved by the Steering
Committee. Modifications and ancillary protocols will be approved by the
Steering Committee.
Awardees will retain custody of and have primary rights to their data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. The collaborative protocol and governance policies will call for the continued submission of data centrally to the DCC for a collaborative database; the submission of copies of the collaborative data sets to each principal investigator upon completion of the study; procedures for data analysis, reporting and publication; and procedures to protect and ensure the privacy of medical and genetic data (if any) and records of individuals. The NIDDK Project Scientist, on behalf of the NIDDK, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee.
Implementing the core data collection method and strategy collectively decided upon by the Steering Committee. For a study involving multiple institutions, it is the responsibility of each awardee/site to ensure that data will be submitted in a timely way to the central Data Coordinating Center. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population.
Establishing mechanisms for quality control and monitoring. Awardees are responsible for ensuring accurate and timely assessment of the progress of each study, including development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; (2) for clinical trials, as simple as appropriate in order to encourage maximum participation of physicians and patients and to avoid unnecessary expense; and (3) sufficiently staffed across the participating institutions. For research involving multiple awards, strategies for the analyses of pooled data will be developed by the Steering Committee.
Submitting interim progress reports, when requested, to the NIDDK Program Director including as a minimum, summary data on protocol performance. For coordinated multiple awards or a multi-site single award, the Steering Committee may require additional information from individual awardees/sites. Such reports are in addition to the annual awardee noncompeting continuation progress report
Establishing procedures, where applicable, for all participating institutions in coordinated awards to comply with FDA regulations for studies involving investigational agents or devices and to comply with the requirements of 45 CFR Part 46 for the protection of human subjects, and the NIH policy requirements for the inclusion of women, minorities and children.
The Data Coordinating Center will be involved in collaborations with the NIDDK and the Clinical Centers during all phases of the study. Thus, the awardee is expected to work cooperatively with Clinical Centers and sponsoring organizations in a multicenter study and oversee the implementation of and adherence to a common protocol, as well as assure quality control of the data collected and storage of collected tissue specimens. In addition to organizing and attending regular meetings, the Data Coordinating Center will be expected to maintain close communications with the NIDDK Project Scientist and the Principal Investigators of the Clinical Centers.
Awardees are encouraged to publish and to publicly release and disseminate results, data and other products of the study, concordant with the study protocol and governance and the approved plan for making data and materials available to the scientific community and the NIDDK.
Support or other involvement of industry or any other third party in any study performed by the Network -- e.g., participation by the third party; involvement of project resources or citing the name of the project or the NIDDK support; or special access to project results, data, findings or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification to, and concurrence by, NIDDK.
Upon completion of the project, the DCC is expected to
transfer all study intervention materials and procedure manuals into the NIDDK
Data and Biorepository, which in accordance with current NIDDK and NIH
policies, will make them available to the scientific community for the conduct
of research at no charge other than the costs of reproduction and distribution.
Awardees will retain
custody of and have primary rights to the data and software developed under
these awards, subject to Government rights of access consistent with current
HHS, PHS, and NIH policies.
2.A.2. NIH
Responsibilities
An NIDDK
Program Director identified in the Notice of Grant Award will be responsible for
the normal stewardship and monitoring of the award. The NIDDK Program Director
responsibilities include:
1. Retaining overall programmatic responsibility for the award, and will clearly specify to the awardee the name(s) and role (s) of any additional individuals with substantial involvement in the project and the lines of reporting authority.
2. Interacting with the principal investigator( s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the principal investigator and staff, periodic site visits for discussions with awardee research teams, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee, data safety and monitoring board, and related meetings. The NIDDK retains the option of periodic external review of progress.
3. Reviewing and approving protocols to insure they are within the scope of peer review and for safety considerations, as required by Federal regulations. The NIDDK Program Director will monitor protocol progress, and may request that a protocol study be closed to accrual for reasons including: (a) accrual rate insufficient to complete study in a timely fashion; (b) accrual goals met early; (c) poor protocol performance; (d) patient safety and regulatory concerns; (e) study results that are already conclusive; and (f) emergence of new information that diminishes the scientific importance of the study question. The NIDDK will not permit further expenditures of NIDDK funds for a study after requesting closure (except for patients already on-study).
4. Making recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.
The NIDDK reserves the right to terminate or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable collaborative protocol, (b) substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol, (c) substantive changes in the agreed-upon protocol with which NIDDK cannot concur, (d) reaching a major study endpoint substantially before schedule with persuasive statistical significance, or (e) human subject ethical issues that may dictate a premature termination.
The NIDDK will name a Project Scientist from within the Division of Digestive Diseases and Nutrition whose function will be to assist the Steering Committee in carrying out the study. NIDDK will have one vote for all key study group subcommittees, regardless of the number of NIDDK personnel involved.
The Project Scientist will have substantial scientific programmatic involvement in quality control, interim data analysis, safety monitoring, and final data analysis and interpretation, preparation of publications, and coordination and performance monitoring. The dominant role and prime responsibility for these activities resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIDDK Project Scientist.
Other NIDDK Project Scientist responsibilities and levels of involvement in the project, as described below.
1. For multi-institutional protocols, convening the first meeting of and subsequent participation in the Steering Committee that oversees study conduct. The NIDDK Project Scientist or designee will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees.
2. Serving as a resource with respect to other ongoing NIDDK activities that may be relevant to the protocol to facilitate compatibility and avoid unnecessary duplication of effort.
3. Substantial involvement in assisting in the design and coordination of research activities for awardees as elaborated below:
2.A.3.
Collaborative Responsibilities
The
Steering Committee, composed of each of the Principal Investigators of the DCC,
the CCs and the NIDDK Project Scientist will be the main governing board of the
studies. However, only the principal investigators and the NIDDK Project
Scientist or designee will be voting members of the Steering Committee and all
major scientific decisions will be determined by a majority vote. This
committee will have the primary responsibility for approval of the common
protocols, facilitating the conduct of participant follow-up, monitoring
completeness of data collection and timely transmission of data to the DCC, and
reporting the study results. It will also be responsible for establishing
study policies in such areas as access to patient data, ancillary studies,
publications and presentations, and performance standards. A Chairperson
will be chosen from among the Steering Committee members by the NIDDK program
director from among the principal investigators (but not the NIDDK Project
Scientist or Data Coordinating Center Principal Investigator). The
Chairperson is responsible for coordinating the Committee activities, for
preparing meeting agendas, and for scheduling and chairing meetings.
Subcommittees will be established on topics such as ancillary studies,
publications and presentations, quality control, recruitment, protocol
adherence, among others.
Each Network Awardee and the DCC Awardee agree to the governance of the study through the Steering Committee. Meetings of the Steering Committee will ordinarily be held by telephone conference calls or in the Washington DC Metropolitan Area.
The NIDDK Project Director (and the other cited NIDDK
scientists) may work with awardees on issues coming before the Steering
Committee and, as appropriate, other committees, e.g., issues of recruitment,
intervention, follow-up, quality control, standards and methods, adherence to
protocol, assessment of problems affecting the study and potential changes in
the protocol, interim data and safety monitoring, final data analysis and
interpretation, preparation of publications, and development of solutions to
major problems such as insufficient participant enrollment. Regardless of
the number of NIH staff participating in technical advisory roles, the NIDDK
will be limited to one vote on the Steering Committee.
Each full member will
have one vote. Awardee members of the Steering Committee will be required to
accept and implement policies approved by the Steering Committee.
2.A.4. Arbitration
Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. An
Arbitration Panel composed of three members will be convened. It will have
three members: a designee of the Steering Committee chosen without NIH staff
voting, one NIH designee, and a third designee with expertise in the relevant
area who is chosen by the other two; in the case of individual disagreement,
the first member may be chosen by the individual awardee. This special
arbitration procedure in no way affects the awardee's right to appeal an
adverse action that is otherwise appealable in accordance with PHS regulations
42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be
required to submit the PHS Non-Competing Grant Progress Report, Form 2590
annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section
VII. Agency Contacts
We
encourage your inquiries concerning this funding opportunity 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:
1. Scientific/Research Contacts:
Jose
Serrano M.D., Ph.D.
Director, Liver and Biliary Programs
Liver Disease Research Branch
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney
Diseases
2 Democracy Plaza, Room 657, MSC 5450
Bethesda, MD 20892-5450
Phone 301-594-8871
Fax : 301-480-8300
EMAIL: [email protected]
2. Peer Review Contacts:
Francisco
O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452
Phone: 301-594-8897
Fax: 301-480-3505
Email: [email protected]
3. Financial or Grants Management Contacts:
Gene McGeehan
Senior Grants Management Specialist
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney
Diseases
National Institutes of Health
2 Democracy Plaza, Room 724
6707 Democracy Boulevard, MSC 5456
Bethesda, MD 20892-5456 (use 20817 for
express mail)
Telephone: 301-594-0417
Fax: 301-594-9523
Email: [email protected]
Section
VIII. Other Information
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). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, 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 and 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.
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 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 funding opportunity 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.
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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is 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 Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical 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 (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 applications for research involving human subjects and
individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
NIH Public Access
Policy:
NIH-funded investigators
are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central
(PMC) an electronic version of the author's final manuscript upon acceptance
for publication, resulting from research supported in whole or in part with
direct costs from NIH. The author's final manuscript is defined as the final
version accepted for journal publication, and includes all modifications from
the publishing peer review process.
NIH is requesting that
authors submit manuscripts resulting from 1) currently funded NIH research
projects or 2) previously supported NIH research projects if they are accepted
for publication on or after May 2, 2005. The NIH Public Access Policy applies
to all research grant and career development award mechanisms, cooperative
agreements, contracts, Institutional and Individual Ruth L. Kirschstein
National Research Service Awards, as well as NIH intramural research studies. The
Policy applies to peer-reviewed, original research publications that have been
supported in whole or in part with direct costs from NIH, but it does not apply
to book chapters, editorials, reviews, or conference proceedings. Publications
resulting from non-NIH-supported research projects should not be submitted.
For more information
about the Policy or the submission process please visit the NIH Public Access
Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).
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. For
publications listed in the appendix and/or Progress report, internet addresses
(URLs) must be used for publicly accessible on-line journal
articles. Unless otherwise specified in this solicitation,
Internet addresses (URLs) should not be used to provide any other information necessary for 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.health.gov/healthypeople.
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.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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