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: Limited
Competition: The Studies to Treat or Prevent Pediatric Type 2 Diabetes
(STOPP-T2D) (U01)
Announcement Type
This is a re-issue of RFAs DK-01-010 and DK-01-011.
Update: The following update relating to this announcement has been issued:
Key Dates
Release Date: April 18, 2008
Application Receipt Date: July 31, 2008
Peer
Review Date: October 2008
Council Review Date : January 2009
Earliest Anticipated Start Date: March 1, 2009
Expiration
Date: August 1, 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, Review and
Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
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
The purpose of this funding opportunity announcement (FOA) is to continue the support for the maintenance of the DCC and centers that have been conducting the TODAY and HEALTHY studies, as part of the STOPP-T2D (Studies to Treat or Prevent Pediatric Type 2 Diabetes) consortium. NIDDK invites applications for this limited competition Request for Applications (RFA) from eligible applicants. The program will fund, up to a maximum of 4 years, one U01 cooperative agreement award to complete the TODAY and HEALTHY studies and analyze collected data.
Background
Type 2 diabetes has traditionally been viewed as a disease of adults; however, recent epidemiological data reveal an increasing number of cases of type 2 diabetes in the pediatric population, especially among adolescents and in certain minority populations. The increase of type 2 diabetes in children and adolescents is presumed to be a consequence of widespread obesity.
Clinical trials to develop effective primary prevention strategies, as well as effective treatment strategies are needed in the pediatric population. The Diabetes Prevention Program (DPP) demonstrated that intensified lifestyle or drug intervention in individuals with impaired glucose tolerance prevented or delayed the onset of type 2 diabetes. However, interventions designed for adults may not be directly applicable to the pediatric population. The majority of children with type 2 diabetes or at risk for type 2 diabetes are in the pre-adolescent or adolescent age range. The adolescent period presents special challenges to health care providers and families when attempting to promote behavior and life style changes.
When children develop diabetes, efficacious therapy is needed to maintain euglycemia in order to prevent the development of complications. Diabetes is currently estimated to cost the U.S. health care system approximately $174 billion annually. Much of the cost is related to the micro- and macrovascular complications of diabetes. Since the development of complications is related, in part, to the duration of diabetes, children represent a population at high risk. Indeed, studies have documented that from 30-50 percent of children with type 2 diabetes already have adverse cardiovascular risk profiles at the time of diagnosis. Unfortunately, the drugs currently approved for use in adults with type 2 diabetes have not been systematically studied in children. Thus, treatment options for those children diagnosed with type 2 diabetes are restricted by the lack of data on the use of such pharmacological agents.
Prevention and treatment programs must also consider cultural differences among racial and ethnic groups that may influence acceptance of medical or lifestyle regimens. This is especially important for type 2 diabetes in children, which disproportionately affects minority groups.
In response to these concerns, the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health funded the STOPP-T2D consortium. In response to a competitive RFA issued in 2000, awards to the DCC and 7 clinical sites were made in 2002 (U01 DK61230; U01 DK61231; U01 DK61223; U01 DK61249; (U01 DK61230; U01 DK61212; U01 DK61239; U01 DK61242; U01 DK61254). Investigators at these sites developed two studies: TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth), a treatment trial, and HEALTHY, a primary prevention study. Both studies utilize the same DCC and have benefited by being part of the STOPP-T2D consortium, because of the overlapping expertise required for the two studies.
TODAY
A consortium of 4 clinical centers (CC) and a coordinating center began protocol development. During protocol development, it was appreciated that additional CC would be required in order to be appropriately powered to conduct the intervention. An additional 11 CC were added in 2002 as subcontracts to the DCC by a competition comparable to NIH peer review. Following publication of a notice of opportunity to compete, full applications were peer reviewed by an external committee set up by the DCC using processes similar to an NIH review.
The TODAY study seeks to identify the best treatment for type 2 diabetes in children and teens. Participants will be randomly assigned to one of three treatment groups: metformin alone; metformin and rosiglitazone in a fixed dose combination; and metformin plus intensive lifestyle change aimed at losing weight and increasing physical activity. The TODAY study will enroll 750 children and teens 10 to 17 years old diagnosed with type 2 diabetes in the past 2 years. All subjects will be followed for a minimum of two years. All subjects will receive standard diabetes education. TODAY is testing the hypothesis that initial aggressive therapy will provide better glycemic control than traditional, step-wise therapy. This could potentially have long-lasting benefits in adolescents who may be thrown into diabetes by pubertal insulin resistance.
The TODAY study's main goal is to determine how well and for how long each treatment approach controls blood glucose levels. The primary outcome will be time to treatment failure, defined as a hemoglobin A1c > 8.5% for 6 months. Secondary outcomes include measures of beta cell function and insulin resistance, body composition, nutrition, physical activity and fitness, microvascular complications, cardiovascular risk factors, side effects, quality of life, and psychological outcomes. The influence of individual and family behaviors on treatment response and the relative cost effectiveness of the treatment arms are also evaluated.
The TODAY study group has been successful in establishing the infrastructure required to conduct a complex, multi-center clinical trial. Recruitment networks have been set up so that youth with type 2 diabetes who are being cared for outside of a specific funded academic medical center can be recruited to the study. To date, approximately 600 children have been enrolled in TODAY. The TODAY cohort is 35% Hispanic American, 33% African American and 5% American Indian.
The TODAY study started later than expected because of the need to add additional sites to have adequate power and because of delays in acquiring study drug. Recruitment began in May 2004. Recruitment has been challenging because the majority of families targeted are extremely disadvantaged. Currently, enrollment is proceeding at a steady pace of 15 subjects/month, and is expected to be completed November 2008. The current awards end February 2009. The study will need to be extended to complete the minimum 2-year follow-up of the last subjects randomized and conduct data analysis.
The protocol has been approved at the IRBs of all participating sites.
HEALTHY
A consortium of 3 field centers and a coordinating center collaborated in a series of feasibility and pilot studies in preparation for the HEALTHY study. During protocol development, it was appreciated that additional field centers would be required in order to be appropriately powered to conduct the intervention. An additional 4 field centers were added in 2004 as subcontracts to the DCC by a competition comparable to NIH peer review. Following publication of a notice of opportunity to compete, full applications were peer reviewed by an external committee set up by the DCC using processes similar to an NIH review.
The HEALTHY study will determine if changes in school food services and physical education classes, along with activities that encourage healthy behaviors, lower risk factors for type 2 diabetes in middle school children. The study is being conducted in 42 middle schools (6 per field center). Participating schools have been randomly assigned to a program group, which implements the changes, or to a comparison group, which continues to offer food choices and PE programs typically seen in middle schools across the country. Students in the program group will have:
The study focuses on reducing three modifiable risk factors related to adiposity and glycemic dysregulation: BMI percentile > 85 (indicating overweight), fasting glucose, and fasting insulin.
Following the completion of pilot testing from 2003-2005, the HEALTHY study began in the fall 2006. The HEALTHY study group was successful in recruiting the required number of schools with the characteristics delineated in the protocol, and was successful in recruiting the cohort of students needed to conduct the study. Over 6400 6th graders participated in the baseline assessment. The cohort is 80% minority. Following baseline assessment in fall 2006, the intervention began in January 2007. The HEALTHY program is implemented in the 6th grade and continues for the 6th grade cohort as they progress through 7th and 8th grade. Final data collection occurs in the 2nd semester of 8th grade.
All students are exposed to the intervention since the HEALTHY program becomes part of the school curriculum. Students must provide parental consent and their own assent for data collection procedures. The protocol has been approved at the IRBs of all participating sites. At baseline and after 2.5 years, students will be tested for diabetes risk factors, including blood levels of glucose, insulin, and lipids. They will also be measured for fitness level, blood pressure, height, weight, and waist circumference.
The HEALTHY study is currently being implemented in the 7th grade. Because of the need to
add additional field centers, and because the funding cycle and the school year are not matched, the current grants will end after the fall semester of 8th grade. Therefore, extension of the HEALTHY study is required to complete the intervention and data collection, and to analyze the collected data.
Objectives and Scope
The overall objective of the solicitation is to allow completion of the TODAY and HEALTHY studies.
For TODAY, this FOA will allow: 1) the clinical centers to complete the TODAY study and conduct outcomes assessment; 2) the DCC to continue to coordinate the activities of the TODAY research consortium, and clean and analyze the collected data; and 3) the TODAY investigators to write manuscripts describing the intervention and reporting the results of the TODAY study. It is expected that the TODAY study will provide important information about the best ways to treat type 2 diabetes in youth. In addition, the TODAY cohort will provide invaluable information about the natural history of type 2 diabetes in children and adolescents. Finally, ancillary studies to TODAY may enhance knowledge of the etiology and pathogenesis of early-onset type 2 diabetes.
While the project period for applications solicited under the invitation will be 4 years, it is anticipated that there may be an opportunity for extension of the consortium to allow additional follow-up of the cohort under study for an appropriate duration to better understand the natural history of type 2 diabetes in youth, particularly changes in beta cell function over time and the development of complications.
For HEALTHY, this FOA will allow: 1) the field centers to complete the intervention in the 8th grade and conduct the post-intervention outcomes assessment; 2) the DCC to continue to coordinate the activities of the HEALTHY research consortium, and clean and analyze the collected data; and 3) the HEALTHY investigators to write manuscripts describing the intervention and reporting the results of the HEALTHY study.
In addition to assessing the efficacy of a school-based primary prevention program for diabetes risk factors, it is expected that the HEALTHY study will provide important epidemiologic data about the health of middle school youth, especially is it relates to the presence and natural history of obesity and other risk factors of type 2 diabetes and cardiovascular disease.
Study Design
TODAY
The TODAY cooperative study group, comprised of investigators from the clinical centers, the DCC and the NIDDK, has jointly developed the standardized protocol. The three treatment regimens are: (1) metformin alone, (2) metformin plus rosiglitazone, and (3) metformin plus an intensive lifestyle intervention called the TODAY Lifestyle Program (TLP). Patients are randomized within two years of the diagnosis of T2DM. The study is a randomized, controlled, partly double-blinded clinical trial. The intensive lifestyle arm is not blinded to either subject or investigator; however, the two medication arms are double-blinded.
The primary objective of the TODAY trial is to compare the three treatment arms on time to treatment failure in 750 patients (250 per arm) enrolled from 10 to 17 years of age with T2DM. The study is powered to allow all three possible comparisons between the treatment groups while maintaining the overall significance level at 0.05.
The primary objective of the TODAY trial is to compare the efficacy of the three treatment arms on time to treatment failure based on glycemic control. The secondary aims are to: compare and evaluate the safety of the three treatment arms; compare the effects of the three treatments on the pathophysiology of T2DM with regards to beta cell function and insulin resistance, body composition, nutrition, physical activity and aerobic fitness, cardiovascular risk factors, microvascular complications, quality of life, and psychological outcomes; evaluate the influence of individual and family behaviors on treatment response; and compare the relative cost effectiveness of the three treatment arms.
The primary outcome of treatment failure is defined in terms of HbA1c, because it correlates with glycemic control and long-term diabetes outcome. There are a number of secondary outcomes in this trial. The results of these secondary outcomes help interpret the primary effect of the treatment regimens on HbA1c. These secondary aims have been chosen because they provide insight into the mechanism by which the treatment regimens affect durable glycemic control (e.g., effects on insulin resistance, sensitivity, diet and physical fitness) or because they provide information concerning the differential risks and benefits of the three treatment arms (e.g., studies of microvascular complications and cardiovascular risk).
The TODAY consortium will jointly analyze data from the study, and disseminate this information through presentations at scientific meetings and manuscripts in scholarly, peer-reviewed journals. The study group has also developed mechanisms to solicit research proposals from investigators outside the consortium who may have novel hypothesis they wish to test in the TODAY cohort or by using TODAY samples and/or data. TODAY is collecting specimens that include sufficient material for measurements to be made based on the hypotheses developed by the TODAY study group and also for storage of sufficient specimens so that materials will be available in the future when new technology or approaches to type 2 diabetes research may become available.
Study Components
One award will be made to the DCC, which will include subcontracts to each of the 15 clinical centers conducting the TODAY study, and to the central laboratory, reading centers, and cores.
1. Clinical Centers
Up to 15 subcontracts to the DCC will be made for the clinical centers that are responsible for conducting the intervention and for collecting outcomes in TODAY subjects.
The CC will be expected to implement the intervention, according to the established TODAY protocol. The CC will collect data in accordance with established study procedures and submit all samples and data to the DCC and central laboratory and central reading centers, as appropriate and required by the protocol.
Investigators at the CC will conduct analyses in conjunction with the DCC. The TODAY consortium will have exclusive access to data from the TODAY study population for a period of time, in accordance to a timetable determined by the TODAY Steering Committee in conjunction with NIDDK. The TODAY study group will then share data and patient specimens derived from the TODAY study through the NIDDK repository. The TODAY Steering Committee has already established policies under which ancillary studies may be conducted while the study is ongoing.
2. Data Coordinating Center (DCC)
There will be a single DCC. The DCC is responsible for the collection, management and analysis of all clinical and laboratory data. The DCC will continue to be responsible for ensuring subject confidentiality and safety, and quality control. The DCC will conduct training and certification of study staff, and maintain and update the manual of operations. The DCC will continue to oversee implementation of and adherence to the study protocol. The DCC will coordinate communication among and with the CC.
The DCC will continue to coordinate movement of biologic samples from the CC to the central laboratory and, subsequently, to the NIDDK repository, where samples will be stored for future analysis. The DCC will similarly continue to coordinate the flow of radiographic tests and other collected data to the appropriate central reading center. The DCC will also coordinate with the NIDDK Data Repository to prepare all TODAY data for eventual archiving and distribution.
The DCC will provide biostatistical, data management and analytic expertise. The DCC will continue to prepare appropriately detailed reports to the Steering Committee and to the TODAY DSMB, and to the NIDDK staff at regular intervals. The DCC will be responsible for the planning and logistics of meetings of the Steering Committee and its subcommittees.
3. Steering Committee
The primary governing body of the study will continue to be the Steering Committee, comprised of the Principal Investigators of the DCC and each CC, and the NIDDK Project Scientist.
The Steering Committee will continue to develop policies and procedures for the TODAY study group, and ensure that these policies are properly implemented. These may include procedures for modification of study design, use of study samples and data, approval of ancillary studies, publication and presentation of study findings, monitoring study progress, determining completeness and quality of data collection, and other performance measures.
4. Project Scientist
The NIDDK Project Scientist will continue to assist the Steering Committee in carrying out the TODAY study. The Project Scientist will provide scientific support to awardees activities, including protocol development, quality control, interim data monitoring, final data analysis, preparation of publications, and overall performance monitoring.
HEALTHY
The HEALTHY cooperative study group, comprised of investigators from the 7 field centers, the DCC and the NIDDK, has jointly developed the standardized protocol. The study is a primary prevention cluster design trial. The focus is on the public health impact of the intervention. The school is the unit of sample size determination, randomization, intervention, and analysis. Observations are made and data collected at the school, grade, class, and student levels.
The study started at the beginning of school year 2006-2007 gathering baseline data collection on 6th graders. The students attended a health screening to collect height, weight, waist circumference, and blood pressure. Fasting blood was drawn and shipped to a central laboratory for analysis of insulin, glucose, and lipids (total cholesterol, HDL, LDL, triglycerides). The students also completed self-report questionnaires on pubertal development (Tanner stage), health utility index (HUI), visual-analog health thermometer (EuroQoL), 2-day self-administered physical activity checklist (2D-SAPAC), and food frequency questionnaire (Block FFQ). Other data collected are: student fitness (20-meter shuttle test) and behavior self-assessments; economic cost-effectiveness; school food environment production, sales, servings, and item-based nutrient analysis; school academic performance (standard test scores, attendance, comportment); and environmental influences on student health above and beyond the study intervention. Interim data collection of height and weight occurs at the end of 7th grade and end of study data collection occurs at the end of 8th grade (repeat of baseline). All students must provide parental consent and their own assent for data collection procedures.
In those schools randomized to intervention, the intervention started in the second half of 6th grade and continues as the students progress through their 7th and 8th grades. The four intervention components are integrated to deliver the theme each semester. The intervention components are:
1. Nutrition. This component is designed to change the nutritional quality of food and beverage offerings throughout the total school food environment, including cafeteria meals and after school snacks offered through federal programs such as the National School Lunch Program (NSLP) and School Breakfast Program (SBP), a la carte (snack bars and student stores) sales, and vending machines.
2. Physical Education. This component makes changes in the physical education (PE) program and equipment to increase both participation and number of minutes spent in moderate-to-vigorous physical activity when implemented by PE teachers as part of classroom lesson plans.
3. Behavior. This component is comprised of brief classroom activities designed to increase knowledge, enhance decision-making skills, promote peer involvement and interaction, and enhance social influence. It uses individual and group behavior change initiatives aimed at promoting healthier behaviors through self monitoring, goal setting, and problem solving. Parents and family members are provided with information and strategies to support youth in accomplishing behavioral goals.
4. Communications. School-wide campaigns enhance and promote changes in nutrition, activity, and behavior. The campaigns provide core materials and actions. Events are designed to offer sites regional, cultural, and operational flexibility.
Study Components
One award will be made to the DCC, which will include subcontracts to each of the 7 field centers conducting the HEALTHY study, and to central laboratory and cores.
1. Field Centers
Up to 7 subcontracts to the DCC will be made for the field centers that are responsible for conducting the intervention at the 21 HEALTHY intervention schools and for collecting outcomes and process data at all 42 HEALTHY schools.
The field centers will be expected to implement the 8th grade intervention, according to the established HEALTHY protocol. The field centers will collect data in accordance with established study procedures and submit all samples and data to the DCC and central laboratory, as appropriate and required by the protocol.
Investigators at the field centers will conduct analyses in conjunction with the DCC. The HEALTHY consortium will have exclusive access to data from the HEALTHY study population for a period of time, in accordance to a timetable determined by the HEALTHY Steering Committee in conjunction with NIDDK. The HEALTHY study group will then share data and patient specimens derived from the HEALTHY study through the NIDDK repository. The HEALTHY Steering Committee has already established policies under which ancillary studies may be conducted while the study is ongoing.
2. Data Coordinating Center (DCC)
There will be a single DCC. The DCC is responsible for the collection, management and analysis of all clinical and laboratory data. The DCC will continue to be responsible for ensuring subject confidentiality and safety, and quality control. The DCC will conduct training and certification of study staff, and maintain and update the manual of operations. The DCC will continue to oversee implementation of and adherence to the study protocol. The DCC will coordinate communication among and with the field centers.
The DCC will continue to coordinate movement of biologic samples from the field centers to the central laboratory and, subsequently, to the NIDDK repository, where samples will be stored for future analysis. The DCC will also coordinate with the NIDDK Data Repository to prepare all HEALTHY data for eventual archiving an distribution.
The DCC will provide biostatistical, data management and analytic expertise. The DCC will continue to prepare appropriately detailed reports to the Steering Committee and to the HEALTHY DSMB, and to the NIDDK staff at regular intervals. The DCC will be responsible for the planning and logistics of meetings of the Steering Committee and its subcommittees.
3. Steering Committee
The primary governing body of the study will continue to be the Steering Committee, comprised of the Principal Investigators of the DCC and each field center, and the NIDDK Project Scientist.
The Steering Committee will continue to develop policies and procedures for the HEALTHY study group, and ensure that these policies are properly implemented. These may include procedures for modification of study design, use of study samples and data, approval of ancillary studies, publication and presentation of study findings, monitoring study progress, determining completeness and quality of data collection, and other performance measures.
4. Project Scientist
The NIDDK Project Scientist will continue to assist the Steering Committee in carrying out the HEALTHY study. The Project Scientist will provide scientific support to awardees activities, including protocol development, quality control, interim data monitoring, final data analysis, preparation of publications, and overall performance monitoring.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This
funding opportunity will use the NIH cooperative
Agreement (U01) award mechanism(s).
The Project
Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) 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". It is not known whether this cooperative agreement will be continued beyond the initial award period.
2. Funds Available
The NIDDK
intends to make one award to the STOPP-T2D coordinating center for up to $26
million in FY2009. This award will include subcontracts to the 15 TODAY clinical
sites and the 7 HEALTHY field centers. The applicant may request a project
period of 4 years. Future year amounts will depend on annual
appropriations.
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.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
This FOA is a limited competition for the continuation of the TODAY and HEALTHY studies, as part of the STOPP-T2D consortium, which was previously reviewed in response to RFAs DK-01-010 and 01-011. Only the STOPP-T2D DCC is eligible to submit an application.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Resubmission applications are not
allowed in response to this FOA.
Competing renewal applications are allowed in response to this FOA.
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 in item (box) 2 only of the
face page of the application form and the YES box must be checked.
Additional information is available in the PHS 398 grant application instructions.
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
Application Receipt Date: July 31, 2008
Peer Review Date: October 2008
Council Review Date: January 2009
Earliest
Anticipated Start Date: March 1, 2009
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 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 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
Calvo, Ph.D.
Review Branch
National Institute of
Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room
752
Bethesda, MD 20892
Telephone: (301) 594-8885
FAX: (301) 480-3505
Email: [email protected]
For
express/courier service use 20817
3.C. Application
Processing
Applications must be received on or before the
application receipt date described above (Section
IV.3.A.). If an application is received after that date, the application
may be delayed in the review process or not reviewed. Upon receipt,
applications will be evaluated for completeness by the CSR and for
responsiveness by the reviewing Institute Incomplete and/or 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 NIH Grants
Policy Statement.
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 renewal award if such costs: 1) are
necessary to conduct the project, and 2) 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 renewal 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 and Information
The awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".
Appendix Materials
All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application. Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
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 that are
complete and
responsive to the FOA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by NIDDK and in accordance with NIH
peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the scientific peer 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 meritorious 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 rating:
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 on Human Subjects in the PHS
398 instructions).
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 on Human Subjects in the
PHS 398 instructions).
Care
and Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five points described in the Vertebrate Animals
section of the Research Plan 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.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
3. Anticipated Announcement and Award
Dates
Not applicable
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.
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 Notice of Award 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 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 development and implementation of the
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.
Modifications of 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. The
NIDDK expects that biologic samples and associated clinical data will be made
available to the broader scientific community at an appropriate juncture to
support further studies related to the prevention and etiology of type 2
diabetes and obesity. The study will be expected to put all study materials and
procedures manuals in the public domain and/or make them available to other
investigators. 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 and other
co-sponsors.
Support or other involvement of industry or any other third party in any study performed by the Consortium 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.
The NIDDK has established Central Biosample,
Genetic and Data Repositories for the archival and storage of data and
biosamples. All samples and data transferred to the repositories will be under
the custodianship of the NIDDK, although the study’s Steering Committee
will have proprietary control of and exclusive access to the samples and data
for an agreed-upon period of time. The clinical and field centers will submit
the samples and data to the NIDDK repository via the DCC and the study is
expected to put all study design materials and procedure manuals into the
public domain and/or make them available to other investigators, according to
the approved plan for making data and materials available to the scientific
community and the NIDDK, 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 NIH Project
Scientist will
have substantial programmatic involvement that is above and beyond the normal
stewardship role in awards, as described below.
The NIDDK Project Scientist will have one vote on the Steering Committee and on all key study group subcommittees. 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 Project Scientists.
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.
Additionally, an agency
program official or IC program director will be responsible for the normal
scientific and programmatic stewardship of the award and will be named in the
award notice. The assigned program director may also serve as an NIH
Project Scientist.
2.A.3. Collaborative Responsibilities
The Steering Committee for each study, composed of each of the Principal Investigators of the clinical centers (TODAY) or field centers (HEALTHY) and the DCC, and the NIDDK Project Scientist, and the Chairman of the Steering Committee, will be the main governing board of the study. 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. Each member of the Steering Committee will have one vote and all major scientific decisions will be determined by a majority vote of the Steering Committee. A Chairperson will subsequently be chosen from among the Steering Committee members (but not the NIDDK Project Scientist). Subcommittees will be established for specific purposes as needed, such as for ancillary studies, publications and presentations, quality control, recruitment, protocol adherence, among others.
Each Consortium awardee agrees to the governance of the study through the Steering Committee. The Steering Committee voting membership shall consist of the Principal Investigators of the field centers (HEALTHY) or clinical centers (TODAY) and the DCC, and the NIDDK Project Scientist. Meetings of the steering Committee will ordinarily be held by telephone conference calls or be face to face.
The NIDDK Project Scientist may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees, e.g., to address 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 or retention.
An independent DSMB convened by the NIDDK and composed of experts in relevant medical, psychological, statistical, operational, and bioethical fields who are not otherwise involved in the study will be established to review periodically the progress of the study. The committee will oversee participant safety, evaluate study progress and results, monitor data quality, and provide operational and policy advice to the Steering Committee and the NIDDK regarding the status of the study. The Principal Investigator of the Data Coordinating Center, the NIDDK Project Coordinator, and the Director of the Division of Diabetes, Endocrinology and Metabolism may participate as ex-officio, non-voting members of the DSMB. DSMB members will be appointed by the Director, NIDDK. The NIDDK named Project Coordinator will serve as executive secretary of the External Advisory Board.
The NIDDK expects that biologic samples and associated clinical data will be made available to the broader scientific community at an appropriate juncture to support further studies related to the prevention and etiology of type 2 diabetes and obesity. The NIDDK expects that STOPP-T2D will put all study materials and procedures manuals in the public domain and/or make them available to other investigators via the NIDDK central repository according to the timetable determined by the steering committee in concordance with NIDDK.
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 Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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:
Barbara Linder, M.D., Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney
Diseases
6707 Democracy Boulevard, Room 699
Bethesda, MD 20892
Telephone: (301) 594-0021
FAX: (301) 480-3503
Email: [email protected]
2. Peer Review Contacts:
Francisco Calvo, Ph.D.
Review Branch
National Institute of Diabetes and Digestive and Kidney
Diseases
6707
Democracy Boulevard, Room 752
Bethesda , MD 20892
Telephone: (301) 594-8885
FAX: (301) 480-3505
Email: [email protected]
3. Financial or Grants Management Contacts:
Chris
Davis
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney
Diseases
6707
Democracy Boulevard, Room 700
Bethesda, MD 20892
Telephone: (301) 594-2115
FAX: (301) 594-9523
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.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic associations
with observable traits (such as blood pressure or weight), or the presence or
absence of a disease or condition. All applications, regardless of the amount
requested, proposing a genome-wide association study are expected to provide a
plan for submission of GWAS data to the NIH-designated GWAS data repository, or
provide an appropriate explanation why submission to the repository is not
possible. Data repository management (submission and access) is governed by the
Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide
Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
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 Requirement:
In
accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
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 FOA 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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NIH... Turning Discovery Into Health® |
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