and Human Services (HHS)
EXPIRED
TRANSLATIONAL RESEARCH FOR THE PREVENTION AND CONTROL OF DIABETES
RELEASE DATE: August 22, 2002
PA NUMBER: PA-02-153 (Reissued as PAR-06-457)
(Expiration date extended, see NOT-DK-05-011)
(see correction NOT-DK-02-008)
EXPIRATION DATE: June 9, 2006
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov)
National Eye Institute (NEI)
(http://www.nei.nih.gov)
National Institute of Nursing Research (NINR)
(http://www.ninr.nih.gov)
Office of Behavioral and Social Sciences Research (OBSSR)
(http://obssr.od.nih.gov)
Agency for Healthcare Research and Quality (AHRQ)
(http://www.ahrq.gov)
Centers for Disease Control and Prevention Division of Diabetes Translation
(CDC)
(http://www.cdc.gov)
American Diabetes Association (ADA)
(http://www.diabetes.org)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),
the National Eye Institute (NEI), the National Institute of Nursing Research
(NINR), the Office of Behavioral and Social Sciences Research (OBSSR), the
Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease
Control and Prevention Division of Diabetes Translation (CDC-DDT), and the
American Diabetes Association (ADA) solicit research to translate recent
advances in the prevention and treatment of type 1 or type 2 diabetes into
clinical practice for individuals and communities at risk. This program
announcement expands a diabetes prevention and control program established
under PA 01-069, and seeks applications for clinical or behavioral studies to
develop and test 1) improved methods of health care delivery to patients with
or at risk of diabetes, 2) improved methods of diabetes self management, and
3) cost effective community-based strategies to promote healthy lifestyles
that will reduce the risk of diabetes and obesity. Studies should focus on
testing strategies for achieving objectives that have already been proven
beneficial, such as 1) control of glycemia and other risk factors for
diabetic complications, including hypertension and dyslipidemia and 2)
altering life style to prevent or delay the onset of type 2 diabetes in at
risk populations, including children and adolescents. Of particular interest
are interventions that focus on translating new advances into practice in
underserved and minority populations.
RESEARCH OBJECTIVES
Background
Several large, controlled clinical trials have established "gold standard"
approaches for treating type 1 and type 2 diabetes, and for preventing type 2
diabetes in individuals at high risk for developing the disorder. Programs
are needed to translate the results of these trials into widespread clinical
practice. Translational research related to obesity, a major risk factor for
type 2 diabetes, is also needed. In particular, established approaches for
treating childhood obesity, as well as programs for preventing regain of
weight after weight loss treatment, are appropriate targets for translational
research.
The Diabetes Control and Complications Trial (DCCT), for type 1 diabetes, and
the United Kingdom Prospective Diabetes Study (UKDPS), for type 2 diabetes,
established the importance of intensive diabetes control in dramatically
reducing the devastating complications that result from poorly controlled
diabetes. Both the DCCT and the UKPDS demonstrated the efficacy of intensive
glucose control in reducing the risk for the microvascular complications of
diabetes, such as retinopathy, neuropathy, and nephropathy. In addition,
results from the UKPDS and other trials demonstrate that cardiovascular
events are reduced in patients with type 2 diabetes through rigorous control
of blood pressure and LDL-cholesterol.
Unfortunately, the advances of these studies have not been successfully
incorporated into general health care practice. Prevention and treatment of
long-term micro- and macrovascular complications remain a critical problem in
the management of type 1 and type 2 diabetes mellitus. In the United States,
diabetes is the leading cause of new blindness in working-age adults, of new
cases of end stage renal disease and of non-traumatic lower leg amputations.
In addition, cardiovascular complications are now the leading cause of
diabetes-related morbidity and mortality, particularly among women and the
elderly. In adult patients with diabetes, the risk of cardiovascular disease
(CVD) is two to four fold greater than in nondiabetics. For cardiovascular
disease, comorbid conditions (hypertension, dyslipidemia and
hyperinsulinemia) combine with hyperglycemia to contribute to accelerated
atherosclerosis. These additional risk factors may also contribute the
microvascular disease. Thus, control of hyperglycemia, although critical, is
not sufficient to substantially reduce morbidity and mortality. Available
data demonstrate that patients with diabetes would benefit from more
aggressive and comprehensive risk factor management.
Underutilization of current knowledge was highlighted in recent studies of
diabetic individuals that demonstrated a low frequency of achievement of
targets for management of glycemia, blood pressure, and lipids, aspirin use,
self-monitoring of blood glucose, regular foot care, and ophthalmic
examinations, all of which markedly reduce the incidence and progression of
diabetic complications. Alarmingly, less than 2% of adults with diabetes
receive the level of care that has been recommended by the American Diabetes
Association (ADA), with self-monitoring of blood glucose following the ADA
guidelines performed by only one in five adults with diabetes. Thus, it is
clear that effective mechanisms for diabetes treatment, shown by the DCCT,
the UKPDS and other clinical trials to reduce the burden of diabetes, are not
being implemented.
The difficulties inherent in achieving good glucose control and preventing
diabetes complications make prevention a compelling strategy. This is
particularly true for type 2 diabetes, which is clearly linked to modifiable
risk factors e.g., obesity and a sedentary lifestyle. The Diabetes
Prevention Program (DPP) was designed to prevent or delay the development of
type 2 diabetes in individuals at high risk for its development by virtue of
their having impaired glucose tolerance (IGT). The study results have been
reported recently (NEJM, 346:393-403, 2002) and demonstrated that intensified
lifestyle or drug intervention in individuals with IGT, prevented or delayed
the onset of type 2 diabetes. The results were striking. Lifestyle
intervention reduced diabetes incidence by 58% and the drug metformin by 31%
compared with placebo. The effects were similar for men and women and for
all racial and ethnic groups. Similar effects of lifestyle intervention were
seen in another recent study conducted in Finland. Cost-effective strategies
for promoting lifestyle modification in high risk individuals, outside the
setting of a controlled, clinical trial, need to be established. Population-
based, as well as generalizable, clinic-based, strategies are needed to
establish cost-effective programs to 1) identify individuals at high risk who
could benefit from prevention programs, and/or 2) successfully promote
lifestyle change.
Childhood obesity, the prevalence of which has more than doubled in the past
two decades, is a major risk factor for type 2 diabetes. Indeed, the increase
in childhood obesity has been linked to an alarming rise in type 2 diabetes
in the pediatric population. Family-based behavioral interventions have been
shown to have a long-term impact on degree of overweight (Pediatrics, 96:
786-787, 1995, Health Psychol, 14:109-115, 1995). However, cost-effective
interventions in primary care and community-based settings are needed.
In addition, while behavioral treatment of obesity in adults leads to
clinically significant weight loss, prevention of weight regain remains an
elusive goal for many. Continuing care models show promise in promoting long-
term weight maintenance (Addict Behav, 24:219-227, 1999, Int J Obes Relat
Metab Disord, 24:893-898, 2000) and cost-effective means of providing such
care need to be developed.
Finally, the results of ongoing clinical trials that also address the
prevention and/or treatment of type 1 or type 2 diabetes and/or obesity
(e.g., Look-AHEAD, ACCORD, TrialNet) are likely to become available in the
near future. In the event of positive outcomes in any of these studies, it
will be even more crucial that effective translation strategies be developed
and adopted to improve adherence to accepted standards of diabetes care, and
to overcome barriers to the translation of scientific advances into clinical
practice.
Objectives and Scope
The NIDDK, the NEI, the NINR, the OBSSR, AHRQ, the CDC-DDT, and the ADA seek
to enhance diabetes prevention and control research. The overall objective of
this program announcement is to support research to develop and test
intervention strategies that will enhance health promotion, diabetes self
control and reduction in risk at the health care system level, the provider
level and the patient level. Trials proposed under this program should test
1) improved methods of health care delivery to patients with or at risk of
diabetes, 2) improved methods of diabetes self management, and 3) cost
effective community-based strategies to promote healthy lifestyles that will
reduce the risk of diabetes and obesity. Generally, these studies will take
interventions that have been demonstrated to be beneficial by controlled
laboratory or clinical investigations (e.g., intensive glycemic control,
increased physical activity in individuals at risk for diabetes), and extend
or adapt these interventions to larger populations or other settings.
The translation of new science to patient care would occur more rapidly if it
were not for the existence of certain barriers, which impede the adoption and
implementation of current knowledge. Such barriers include but are not
limited to:
o health care provider knowledge,
o communication between patient and health care provider,
o attitudes and beliefs of the patient, community/culture, health care
provider and health care system
o racial and ethnic disparities,
o variations in settings, including the health care system,
o clinical traditions,
o socioeconomic status,
o cost.
Proposed research studies should be designed to overcome these barriers.
Topics of interest include, but are not limited to:
o strategies to enhance glycemic, blood pressure, and lipid control or
reduce risk factors for the development of the complications of type 1
or type 2 diabetes,
o strategies to promote the adoption of healthy lifestyles which will
reduce obesity and diabetes,
o studies that test interventions to enhance long-term maintenance of
weight loss and prevention of weight regain after weight loss,
o studies that test interventions within the changing health care
delivery system and changing patient demographics,
o studies to determine the role of patient/provider communication on
diabetes outcomes, and strategies to facilitate such communication,
o strategies to enhance patient or provider education,
o studies of information technology and decision-support to facilitate
evidence-based prevention and management,
o the testing of community-based programs to provide education and
behavior modification at lower cost,
o studies that test interventions to treat childhood and adolescent
obesity in primary care or community settings,
o strategies to alter health care system features that reduce the
efficiency or effectiveness of patient/provider interaction and health
outcomes.
Of particular interest are studies to improve self management and enhance
health care delivery to underserved and minority populations. Such studies
may seek to improve outcomes in populations (with either type 1 or type 2
diabetes) that historically have had poor glycemic control, or promote
effective prevention strategies in minority populations known to be at high
risk for the development of type 2 diabetes and/or its complications.
These prevention and control projects should be effectiveness trials and will
generally have the same research design as a single-center randomized clinical
trial. There should be convincing preliminary data that show that the
intervention has the potential to alter behavior and that the intervention can
feasibly be carried out. The intervention should be clearly described.
Applicants should provide a detailed description of the design of the study,
including what eligibility, baseline and follow-up tests are to be done, what
surrogate markers and endpoints will be examined, the duration of follow-up,
and the statistical analysis to be employed. The process for biologic sample
collection, storage and handling needs should be included. A description of
the laboratory tests that are needed with appropriate methods for performing
them should be provided. Applicants should describe their physical facilities,
data management and computer resources, and facilities for data retrieval and
storage. Examples of data forms, questionnaires and software/computer
programs should be included and described. Methods for data collection,
management and quality control procedures must be detailed. Applicants must
include a plan for randomization of patients or settings for delivery of
interventions into protocols. Methods for assuring privacy and maintaining
confidentiality should be included. There must be a data and safety monitoring
plan.
Applicants should provide a detailed description of the target population to
be studied, with justification, including a definition of the cohort by age,
gender, sex and race/ethnicity. The ability to recruit this target population
and the methods to be used should be described, with an estimation of the
potential number of patients who fit the eligibility criteria and expected
accrual rates. Sample size needs and the assumptions and calculations used to
estimate sample size should be detailed. Applicants must state their plans
for reporting accrual by gender, race and ethnicity and for the reporting of
results that examine differences in treatment effects across these subgroups
(see below, "Inclusion of Women and Minorities in Research Involving Human
Subjects").
Studies may utilize methodology from the fields of biomedical, social or
behavioral sciences, epidemiology (including clinical trials), and health
services research. The primary outcome will generally be some form of
behavior change, health care status, or health care use. An intervention
aimed at producing a behavioral change should be grounded in behavior change
theory, which should be incorporated into the intervention. The application
will be strengthened by the inclusion of a process evaluation i.e., an
evaluation of whether the intervention is actually delivered as intended.
Investigators may wish to consider assessment of cost-effectiveness as a
secondary outcome measure.
Investigators should provide detailed evidence that the research team has the
experience and expertise to conduct the research study. Most translation
research will require a multidisciplinary research team. Thus, a variety of
researchers may be required for these studies, including, but not limited to,
endocrinologists, public health physicians, primary care physicians,
epidemiologists, statisticians, psychologists, health educators,
sociologists, nurses, nutritionists and other health related professionals.
The interdisciplinary nature of the research team should be fully described
and justified.
Investigators located at existing Diabetes Research and Training Centers
(DRTC) should include a complete description of how the research being
proposed in response to this PA will utilize the core facilities funded
through the Prevention and Control (P&C) Division of their DRTC. A central
purpose of the P&C Divisions is to support translation research into the
barriers that restrict the adoption of advances in diabetes treatment into
practice. It should therefore be made clear how the research being proposed
integrates into the DRTC, its cores and overall biomedical research focus.
Investigators who are not affiliated with a DRTC may, but are not required
to, form collaborations with such centers in order to utilize the resources
of a P&C Division, which may provide support for such aspects of the proposed
research as statistical analysis and instrument development. A list of DRTCs
is available at http://www.niddk.nih.gov/fund/other/centers.htm.
Investigators located at existing CDC-DDT supported "Translating Research
into Action for Diabetes (TRIAD)" sites should include a full description of
how the TRIAD sites will be advantageously utilized. TRIAD investigators
should also describe how they will integrate the TRIAD sites and cohort
without adversely affecting or overlapping the current and future multicenter
collaborative goals of the TRIAD Study (e.g., primary hypotheses, cohort
follow-up). The testing of interventions to prevent or treat disease among
individuals from the TRIAD cohort is encouraged.
MECHANISM(S) OF SUPPORT
This PA will use the National Institutes of Health (NIH) research
demonstration and dissemination project (R18) award mechanism. This mechanism
is designed to support the testing and evaluation of interventions and
activities that lead to application of existing knowledge to disease control
and prevention. Responsibility for the planning, direction, and execution of
the proposed project will be solely that of the applicant. The total project
period for an application submitted in response to this PA may not exceed 5
years. This PA uses just-in-time concepts.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic
o Foreign Institutions are not eligible
o Faith-based and community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
Letter of Authorization
Following notification by CSR of the Institute assignment, applicants should
submit a brief letter to the appropriate program official (see below,
"Inquiries") indicating whether or not they wish their application to be
considered for funding by the ADA, the CDC and/or AHRQ. While applicants may
request that their applications be considered only by the NIH and not by
these other agencies, it is necessary that the record indicate the
applicant"s consideration of this opportunity. For those applicants who wish
to have these agencies consider their application, all materials relating to
the application will be promptly forwarded to these agencies and the summary
statements for such applications will be shared with these agencies when
available.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity
answer questions from potential applicants. Inquiries may fall into two
areas: scientific/research and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Sanford Garfield, Ph.D. (for NIDDK-supported behavioral research)
Division of Diabetes, Endocrinology and Metabolic Diseases
NIDDK
6707 Democracy Boulevard, Rm. 685
Bethesda, MD 20892-5460
Telephone: (301) 594-8803
FAX: (301) 480-3503
E-mail: [email protected]
Barbara Linder, M.D., Ph.D. (for NIDDK-supported medical research)
Division of Diabetes, Endocrinology and Metabolic Diseases
NIDDK
6707 Democracy Boulevard, Rm. 699
Bethesda, MD 20892-5460
Telephone: (301) 594-0021
FAX: (301) 480-3503
E-mail: [email protected]
Peter Dudley, Ph.D.
Vision Research Program
NEI
Executive Plaza South, Rm. 350
Bethesda, MD 20892
Telephone: (301) 496-0484
FAX: (301) 402-0528
E-mail: [email protected]
Nell Armstrong, Ph.D., R.N.
NINR
Building 45, Room 3AN12
Bethesda, MD 20892 6300
Telephone, (301) 594-5973
FAX: (301) 480-8260
E-mail: [email protected]
Lawrence J. Fine, M.D., Dr. P.H.
OBSSR
Building 1, Room 256
Bethesda, MD 20892
Telephone: (301) 435-6780
FAX: (301) 402-1150
E-mail: [email protected]
o Direct your questions about financial or grants management matters to:
Florence Danshes
Division of Extramural Activities
NIDDK
6707 Democracy Boulevard, Rm. 734
Bethesda, MD 20892-5456
Telephone: (301) 594-8861
FAX: (301) 480-3504
E-mail: [email protected]
Margie Baritz
Division of Extramural Activities
NEI
Executive Plaza South, Rm. 350
Bethesda, MD 20892-6600
Telephone: (301) 496-5884
FAX: (301) 496-9997
E-mail: [email protected]
Robert L. Tarwater
Office of Grants and Contracts Management
NINR
Building 45, Room 3AN12
Bethesda, MD 20892-6300
Telephone: (301) 594-2807
FAX: (310) 480-8260
E-mail: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: [email protected].
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying the NIH staff member within one of NIH
institutes or centers who has agreed to accept assignment of the application.
Applicants requesting more than $500,000 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) Identify, in a cover letter sent with the application, 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.
SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be received by or mailed on or
before the receipt dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not
accept any application in response to this PA that is essentially the same as
one currently pending initial review unless the applicant withdraws the
pending application. The CSR 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.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review group
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:
o Receive a written critique
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council
or board
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following
aspects of your application in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these
goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application"s overall score, weighting them as appropriate
for each application. Your 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, you may propose to carry out
important work that by its nature is not innovative but is essential to move
a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the aims
of your application are achieved, how do they advance scientific knowledge?
What will be the effect of these studies on the concepts or methods that
drive this field?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you acknowledge potential problem areas and consider alternative
tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project challenge
existing paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
principal investigator and to that of other researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
(6)Translation: Does the intervention strategy proposed have the ability to
be translated into primary care, community, family or other patient
care/support settings?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
PROTECTIONS: The adequacy of the proposed protection for humans, animals, or
the environment, to the extent they may be adversely affected by the project
proposed in the application.
INCLUSION: The adequacy of plans to include subjects from both genders, all
racial and ethnic groups (and subgroups), and children as appropriate for the
scientific goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria included in the
section on Federal Citations, below)
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
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 AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete
copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research, updated racial and ethnic categories in compliance with the new OMB
standards, clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398, and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable,
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH proposals for research involving human subjects.
You will find this policy announcement in the NIH Guide for Grants and
Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA 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.
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 No. 93.847 (NIDDK), 93.837(NEI), 93.361 (NINR),
93.226(AHRQ), and 93.988(CDC) and is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.
Awards are made under authorization of Sections 301 and 405 of the Public
Health Service Act as amended (42 USC 241 and 284and administered under NIH
grants policies described at http://grants.nih.gov/grants/policy/policy.htm
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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