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://www.niddk.nih.gov)
Title: Ancillary Studies of Kidney Disease Accessing Information from Clinical Trials, Epidemiological Studies, and Databases (R01)
Announcement Type
This is a reissue of PA-03-091
previously issued on March 23, 2003.
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number:
PA-06-163
Catalog of Federal Domestic Assistance Number(s)
93.849
Key Dates
Release Date: March 2, 2006
Letters of Intent Receipt Date(s): N/A
Application Submission
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
for details
Peer Review Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
for details
Council Review Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
for details
Earliest Anticipated Start Date: Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
for details
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites investigator-initiated research project applications for ancillary studies to ongoing or completed clinical trials and epidemiological studies of kidney disease as well as clinical trials and epidemiological studies for other diseases or populations that lend themselves to the study of kidney disease. These studies may range from new analyses of existing datasets of completed studies to additional collection of data and biological specimens in ongoing investigations. The goal of these studies should be to extend our understanding of the risk factors for developing kidney disease and their associated co-morbid illnesses such as malnutrition and cardiovascular disease, factors associated with rapid decline in kidney function among persons with chronic kidney disease, and the impact of these diseases on quality of life and mental and physical functioning. Studies of biomarkers for patients with acute renal failure and other kidney diseases, for example, are also appropriate topics for further investigation. Studies ancillary to both government and non-government supported clinical trials and epidemiological studies are encouraged. Analysis of large public access databases and other databases is also encouraged.
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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, 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
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
Background
The public health and economic burden of chronic kidney disease in the United States is substantial. Diabetes and hypertension are the main causes of chronic kidney disease in this country. The number of new cases of end-stage kidney disease in 2000 was over 96,000 and the number of patients undergoing treatment was over 370,000. As the United States population continues to age it is anticipated that the number of new cases of end-stage kidney disease will also increase. It has been estimated that approximately 20,000,000 people have chronic kidney disease in this country.
Acute renal failure in hospitalized patients is also a significant problem in the United States, ranging from 1-15% of hospitalized patients. Medical management of acute renal failure has traditionally consisted primarily of supportive care, with renal replacement therapy for the most severe cases. Despite such interventions in acute renal failure, however, mortality rates in affected patients remain very high (>50% in some series).
Over the past two decades the NIDDK has conducted a number of multi-center clinical trials studying potential factors that ameliorate the progression of chronic kidney disease. For example, a clinical trial completed in 1994, The Modification of Diet in Renal Disease (MDRD) Study examined the effects of a low-protein diet and a lower than usual level of blood pressure. Recently, the African American Study of Kidney Disease (AASK) Trial reported the results of treatment with a low blood pressure goal and three different anti-hypertensive drug regimens on the progression of hypertensive kidney disease among nearly 1,200 African Americans. (The AASK Trial participants are now part of a 5-year prospective cohort study). Likewise, clinical trials of diabetic kidney disease, most recently the Reduction in Endpoints in NIDDM with the A2 Receptor Antagonist Losartan (RENAAL) and the Irbesartan Diabetic Nephropathy Trial (IDNT), have been supported by the private sector. Large-scale multi-center clinical trials supported by the NIDDK with patients with end-stage kidney disease have also been completed (The Hemodialysis Study) or have been recently initiated (The Dialysis Access Consortium). A major clinical trial of type II diabetes supported by the NIDDK, the Look AHEAD, is ongoing whereas the Diabetes Prevention Program, also supported by the NIDDK and completed in 2001, continues as a prospective study. A multi-center randomized clinical trial among patients with acute renal failure, co-sponsored by the Department of Veterans Affairs and the NIDDK, is now underway.
A number of epidemiological studies conducted among patients with chronic kidney disease have focused on patients who have reached end-stage kidney disease. Many of these studies have been conducted through the United States Renal Data System (USRDS) supported by the NIDDK. Some insight about selected risk factors for chronic kidney disease prior to end-stage has been obtained through epidemiological studies conducted to characterize other diseases or examine other populations not selected for chronic kidney disease which included measures of kidney function, primarily serum creatinine, or permitted the linking of medical records to ascertain death and/or end-stage renal disease treatment. Only recently, the NIDDK established a prospective cohort study, the Chronic Renal Insufficiency Cohort (CRIC) Study, to examine the risk factors for progression of chronic kidney disease and to identify risk factors for cardiovascular disease in adult patients with reduced kidney function. Similarly, the NIDDK plans to establish a prospective cohort study of children with chronic kidney disease this year.
Scope and Objectives
The studies noted above and others provide the potential to learn more about risk factors for progression of chronic kidney disease and associated co-morbid illnesses and factors associated with mortality for acute renal failure. In many cases these studies have large databases and patient samples, lending themselves to new analyses and assays. While study investigators have been actively working on the NIDDK-supported databases and samples as well as developing ancillary studies for ongoing studies, this funding opportunity seeks to increase the number of ancillary studies and stimulate use of existing government supported databases and samples by a wider community of investigators. It is also envisioned that this funding opportunity will encourage investigators to conduct ancillary studies in non-government supported studies as well as permit analyses of large public and private databases.
While it is anticipated that there will be a wide range of opportunities for basic and clinical/epidemiological research by accessing data and biological samples from these studies at least the following types of investigations are possible:
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 National Institutes
of Health (NIH) research project grant (R01) award mechanism.
As an applicant, you will be solely
responsible for planning, directing, and executing the proposed project.
This funding opportunity uses just-in-time concepts.
It also uses the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less, use the modular budget format described in the PHS
398 application instructions. Otherwise follow the instructions for non-modular
research grant applications.
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 IC(s) 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 awards.
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 programs.
2. Cost Sharing or Matching
N/A
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
Applicants may submit more than one application, provided
they are scientifically distinct.
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, Phone (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.
Foreign Organizations
Several special provisions apply to applications submitted
by foreign organizations:
Proposed research should provide
a unique research opportunity not available in the U.S.
3. Submission Dates and Times
See SectionIV.3.A for details.
3.A. Submission, Review and Anticipated
Start Dates
Application Submission Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
for details
Peer Review Date: Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm
for details
Council Review Date: Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
for details
Earliest Anticipated Start Date: Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
for details
3.A.1. Letter of Intent
A letter of intent is not required
for the funding opportunity.
3.B. Sending an Application to the NIH
Applications must be prepared using the research grant application forms found
in the PHS 398 instructions for preparing a research grant application. Submit
a signed, typewritten original of the application, including the checklist,
and five 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).
3.C. Application Processing
Applications must be submitted on or before the application receipt/submission dates described
above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt applications will be evaluated for completeness
by CSR. Incomplete 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 merit review unless the applicant withdraws the pending application.
The NIH will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of a substantial revision
of an application already reviewed, but such application must include an Introduction
addressing the previous critique.
Although there is no immediate acknowledgement of
the receipt of an application, applicants are generally notified of the review
and funding assignment within eight (8) weeks.
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
It is required that each applicant provides documentation
at the time of grant submission that he/she has received approval from the
appropriate governing body of the respective study to conduct the proposed
ancillary study. In cases where large public access databases are proposed
for investigation, applicants must indicate that the database is available
for their use.
Specific Instructions for Modular Grant applications.
Applications requesting up to $250,000 per year in direct costs must be submitted
in a modular budget format. The modular budget format simplifies the preparation
of the budget in these applications by limiting the level of budgetary detail.
Applicants request direct costs in $25,000 modules. Section C of the research
grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html
includes step-by-step guidance for preparing modular budgets. Applicants must
use the currently approved version of the PHS 398. Additional information
on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Specific Instructions for Applications Requesting $500,000
(direct costs) or More per Year.
Applicants requesting $500,000 or more in direct costs for any year must carry
out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the application,
i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will
accept your application for consideration for award; and,
3) Include a cover letter with the application that identifies the staff member
and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated
new (type 1), competing continuation (type 2), competing supplement, or any
amended or revised version of these grant application types. Additional information
on this policy is available in the NIH Guide for Grants and Contracts, October
19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
Plan for Sharing Research Data
N/A
Sharing Research Resources
NIH policy requires that grant awardee recipients
make unique research resources readily available for research purposes to
qualified individuals within the scientific community after publication (NIH
Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan
for sharing research resources addressing how unique research resources will
be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans
will be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each non-competing
Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered
in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity
will be assigned to the ICs on the basis of established PHS referral guidelines.
Appropriate scientific review groups convened in accordance with the standard
NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications will:
The following will be considered in making funding decisions:
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)?
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 may 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 funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research Resources
NIH policy requires that grant awardee 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 NIH 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).
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:
John W. Kusek, Ph.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 617
Bethesda, Maryland 20892-5458
Phone: (301) 594-7735
Fax: (301) 480-3510
Email: [email protected]
2. Peer Review Contacts:
N/A
3. Financial or Grants Management Contacts:
Teresa Farris Marquette
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 728
Bethesda, Maryland 20892-5456
Phone: (301) 594-7682
Fax: (301) 4803504
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
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). 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.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research
resources including the sharing of model organisms for biomedical research
(see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors
to elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the application/proposal
a description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers
to benefit from the resources developed with public funding. The inclusion
of a model organism sharing plan is not subject to a cost threshold in any
year and is expected to be included in all applications where the development
of model organisms is anticipated.
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.
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 (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.
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. 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 PA 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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