and Human Services (HHS)
EXPIRED
NIDDK EDUCATION PROGRAM GRANTS (R25)
RELEASE DATE: August 19, 2004
PA NUMBER: PAR-04-148
EXPIRATION DATE: September 18, 2006
(Reissued as PAR-06-554)
(Expired September 18, 2006 per NOT-OD-06-104)
(See Notice NOT-DK-06-016 Non-Competition for NIDDK Education Program Grants (R25))
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.847, 93.848, 93.849
THIS PAR CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PAR
o Education Program Objectives and Description
o Mechanism 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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PAR
The Education Grant Program at the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK) is a flexible, curriculum-driven program
aimed to create educational opportunities that will attract undergraduate and
graduate students and postdoctoral fellows to careers in areas of biomedical
or behavioral research of particular interest to the NIDDK and to foster their
career development. The NIDDK is especially interested in attracting students
and postdoctoral fellows from scientific disciplines underrepresented in
disease-oriented biomedical research such as engineering, informatics,
computer science, and computational sciences, and encouraging them to apply
their expertise to research relevant to diabetes and other endocrine and
metabolic diseases, digestive diseases and nutrition, obesity research and
prevention, and kidney, urologic and hematologic diseases. This Program
Announcement (PAR) replaces PAR-02-063
http://grants.nih.gov/grants/guide/pa-files/PAR-02-063.html which was
published in the NIH Guide on February 14, 2002.
The NIDDK Education Program grants (i.e. R25s) support the development and
implementation of curriculum-dependent programs that may focus on educational
activities before, during or after the completion of a doctoral level degree
(e.g. Ph.D., M.D., D.P.H., D.D.S., O.D.) as long as they address a need that
is not fulfilled adequately by any other grant mechanism available from the
National Institutes of Health (NIH) and are dedicated to areas of high
priority to the NIDDK. The R25 grant may not be used to conduct traditional
biomedical research or as a research training grant. Applicants whose
programs cannot meet the Special Requirements stated in these guidelines
should refer to the traditional National Research Service Award (NRSA)
Institutional (T32) http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html
or Short-Term (T35) http://grants.nih.gov/grants/guide/notice-files/not98-027.html
Training Grants as possible alternative sources of support.
EDUCATION PROGRAM OBJECTIVES AND DESCRIPTION
A. Background: The principal objective of this PAR is to develop the means
to attract students (undergraduate and graduate) and/or postdoctoral fellows
to NIDDK-relevant research. In particular, the participation of students
from scientific disciplines that are underrepresented in many disease-
oriented biomedical research programs should be encouraged. Programs should
also focus on attracting underrepresented minority students and postdoctoral
fellows to NIDDK-relevant research. Applicants are expected to propose
unique, innovative, curriculum-based education programs that focus on
scientific areas of interest to the NIDDK. This may be in the form of a
course, seminar series, yearly symposium, or other appropriate educational
tool. Evaluation of the proposed educational program must be integral to its
design. It is anticipated that inclusion of faculty currently active in
research related to the mission of NIDDK will be necessary in order to
provide the highest quality of information and to introduce role models and
future colleagues into the educational experiences.
B. Program: The award provides support to institutions for up to 5 years for
(1) the principal investigator;(2) an Advisory Committee to manage,
coordinate and evaluate the program; (3) the faculty to design, develop,
implement and continually refine the program curriculum; and (4) for other
Program-related costs. No support will be provided for stipends or tuition
costs of students and/or postdoctoral fellows.
These Programs should provide curriculum-based, multi-disciplinary and
interdisciplinary didactic and other educational experiences for
undergraduate and graduate students and/or postdoctoral fellows. Examples of
specific Programs may include, but are not limited to:
o specific disease processes of interest to NIDDK (e.g. diabetes, cystic
fibrosis, inflammatory bowel disease, obesity, hepatitis, renal diseases or
hematological disorders);
o the translation of basic science discoveries to patient care ("bench to
bedside" research);
o the relationships of specific organ systems (e.g. digestive, renal,
endocrine, hematopoietic) to health and illness;
o the appreciation and integration of whole animal physiology in current
biomedical research;
o information on how molecular techniques may be applied to NIDDK-relevant
diseases and research;
o the development of therapeutics related to diseases relevant to the NIDDK
(e.g., how does one move from a genome sequence to health benefits?).
C. Environment: The participating institution(s) must have well-established
research programs and faculty qualified in curriculum development,
implementation, and program evaluation to organize and develop the
curriculum. Qualified faculty members must be available to participate in
the program. The environment should be team-oriented and highly
collaborative with a strong potential for a dynamic two-way exchange of
information and ideas within and across diverse and disparate disciplines
such as the physical, biomedical, behavioral, population and quantitative
(mathematics, engineering, computer sciences, etc.) sciences. The
institution must demonstrate a commitment to provide sustained leadership and
dedicated faculty time to the development, implementation, and evaluation of
the Program.
D. Allowable costs
1. Salary: The principal investigator may request salary support for his/her
role in leadership, management, coordination, and evaluation of the Program,
in accordance with the percent effort commitment to the Program, which will
usually be 10-50%. Faculty critical to the design, development,
implementation, and refinement of the specialized curriculum essential to the
didactic needs of the Program may request salary support in accordance with
the percent effort commitment to the Program. Salary support may be
requested for program faculty for their service on the Advisory Committee
(see SPECIAL REQUIREMENTS). The principal investigator and Program faculty
may derive additional compensation from other Federal sources or awards
provided the additional compensation does not exceed the maximum annual
salary level for Federal employees set at the Executive Level I of the
Federal Pay scale and their total percent effort on all awards does not
exceed 100 percent.
2. Advertising and Recruitment Costs: A small proportion of the budget may be
requested for advertising and recruitment costs in order to attract the best
possible candidates to the Program.
3. Ancillary Personnel Support and Other Costs: In general, salaries for
secretaries, administrative assistants, and other ancillary personnel are not
allowed. Requests for consultant costs, equipment, supplies, and other
project-related expenses must be justified as specifically required by the
proposed Program and must not duplicate items generally available at the
institution for educational programs.
4. Facilities and Administrative Costs: These costs, which were formerly
called indirect costs, will be reimbursed at 8 percent of modified total
direct costs.
E. Change of Institution: The NIDDK Education Project Grant cannot be
transferred from one institution to another.
F. Change of Principal Investigator: If the principal investigator moves to
another institution or resigns from the position, support of the award may be
continued provided that the current principal investigator or the awardee
institution has submitted a written request for change of principal
investigator, countersigned by the appropriate institutional business
official, to the NIDDK describing the reasons for the change. The
biographical sketch of the proposed new principal investigator, including a
complete listing of active grant support, must also be provided. The
information provided must establish that the specific aims of the original
peer reviewed education program to be conducted under the direction of the
new principal investigator will remain unchanged, and that the new principal
investigator has the appropriate educational and administrative expertise to
lead the program as well as the support of the institution. NIDDK Program
staff must approve of this change and should be contacted prior to submission
of the letter (see INQUIRIES).
G. Changes of Program: Awards are made to a specific institution for a
specific program under the guidance of a particular principal investigator.
Changes in any of these parameters require prior approval by the NIDDK.
A strong rationale must be provided for any proposed changes in the aims of
the original peer reviewed Program. NIDDK program staff will evaluate the
proposed changes to ensure that the Program remains within the scope of the
original peer-reviewed education program. If the new Program does not
satisfy this requirement, the award will be terminated.
H. Progress Reports: An Annual Progress Report for the grant is required.
This report should provide information on the development and implementation
of the program/curriculum/symposium, modifications to the Program as
originally proposed, the number of students/postdoctoral fellows
participating in the curriculum or program, and updates on the evaluation of
the Program by the Advisory Committee. These progress reports will be
closely monitored by NIDDK staff to ensure that the Program is achieving its
goals and meets the intent of the NIDDK for this specialized R25 grant
mechanism.
Progress reports are to be submitted using the Form PHS 2590, which can be
accessed directly at the following website address:
http://grants.nih.gov/grants/funding/2590/2590.htm. Adapt the application
for continuation so it contains the following information:
o Appropriate Face Page
o A detailed budget page that provides all salaries and fringe benefits and
other budgetary information.
o A brief description of the Objectives and Goals of the Program
o A list of faculty and Advisory Committee members who have left the Program
and of the new individuals who are taking their place or are being added.
For each new person include their degree and department (or equivalent) and,
if a multi-institutional consortium, their institution.
o Biographical Sketches of:
i. New faculty
ii. New Advisory Committee members
o A Report from the Advisory Committee that is separately attached and
evaluates the development of and, in future years, the effectiveness of the
Program and any recommended changes; the plans for recruitment/advertising
including outreach to students from minority groups underrepresented in
biomedical research;
o Once the Program has been implemented, a list of the participants with
their backgrounds, and their evaluation of the Program.
I. Evaluation: In carrying out its stewardship of human resource related
programs, the NIDDK may request information essential to an assessment of the
effectiveness of this program. Accordingly, principal investigators are
hereby notified that they may be contacted after the completion of this award
for periodic updates on various aspects of the participants' employment
history, publications, support from research grants or contracts, honors and
awards, professional activities, and other information helpful in evaluating
the impact of the program on their career choices.
MECHANISM OF SUPPORT
This PAR will use the NIH Education Project Grant (R25) award mechanism. As
an applicant, you will be solely responsible for planning, directing, and
executing the proposed project. R25 education grants are not typical research
instruments, but do involve experiments in education that require an
evaluation plan in order to determine the degree of success or failure.
Applicants may request up to five years of support to develop a specific
education program. Applications should propose short-term education projects
limited to five years or less, although the curriculum that is developed
should be self-sustaining. Awards are not renewable.
The total annual requested direct costs on the R25 grant are limited to
$100,000. Facilities and Administrative (F&A) costs are payable at the rate
of 8 percent of modified total direct costs. The 8 percent F&A cost rate
will also apply to all subcontracts on R25 grants
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html).
This PAR 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 Foreign institutions are not eligible to apply
Applications may include more than one institution to create a Program
through consortium agreements that includes all of the disciplines, research
environments, students and faculty needed to accomplish the proposed
educational objectives (refer to the following URL for guidelines on these
agreements:
http://grants.nih.gov/grants/policy/nihgps/part_iii_5.htm#Consortium).
However, only one of the participating institutions can be the recipient of
an award. An institution may submit more than one application in order to
support programs in different areas of scientific emphasis.
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
o A specialized NIDDK-relevant education curriculum, not otherwise available
at the institution, or a significant expansion of a pre-existing NIDDK-
relevant education program, must be developed; examples of a newly developed
Program include, but are not limited to, a single course, a portion of an
established course, a yearly conference, a seminar series, or a group of
short courses.
o The principal investigator must assemble and chair a multidisciplinary
Advisory Committee representing all of the disciplines, departments, schools,
institutions, etc. involved in the NIDDK education program. The Advisory
Committee will assist the principal investigator in the recruitment and
selection of the Program faculty; the establishment and review of the
specialized curriculum; and will monitor and evaluate the overall
effectiveness of the program;
o The program faculty should, if at all possible, be researchers or educators
actively engaged in scientific areas of interest to NIDDK; involvement of
clinicians is strongly encouraged;
o A plan must be provided for the process and outcome evaluation of the NIDDK
education program. Benchmarks should be specified, and specific plans and
procedures to capture, analyze, and report outcome measures must be
described;
o A plan to integrate the proposed NIDDK education program with the current
established curriculum of the applicant institution must be developed. Plans
to coordinate the NIDDK education program through institutional curriculum
committees must be documented in the application;
o A plan for continuing the curriculum and for the periodic updating of the
curriculum/program beyond the five-year project period should be described.
The principal investigator should provide evidence of institutional
commitment and plans to continue the Program after the period of grant
support ends when the program involves curricula development aimed at
strengthening the educational capability of the institution (e.g., a new
curriculum for researcher or health care professionals in training).
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PAR and welcome the opportunity
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
James F. Hyde, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 609
Bethesda, MD 20892-5460
Telephone: (301) 594-7692
FAX: (301) 480-3503
E-mail: [email protected]
Judith Podskalny, Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 667
Bethesda, MD 20892-5450
Telephone: (301) 594-8876
FAX: (301) 480-8300
Email: [email protected]
Terry Rogers Bishop, Ph.D.
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 619
Bethesda, MD 20892-5458
Telephone: (301) 594-7721
FAX: (301) 480-3510
Email: [email protected]
o Direct your questions about peer review issues to:
Francisco O. Calvo, Ph.D.
Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752
Bethesda, MD 20892-5452
Telephone: (301) 594-8897
FAX: (301) 480-8300
E-mail: [email protected]
o Direct your questions about financial or grants management matters to:
Denise Payne
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 733
Bethesda, MD 20892-5456
Telephone: (301) 594-8845
FAX: (301) 480-3504
E-mail: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001, updated 09/09/2003). Applications must
have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number
as the Universal Identifier when applying for Federal grants or cooperative
agreements. The D&B number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/. The D&B number
should be entered on line 11 of the face page of the PHS 398 form. 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]
The title and number of this program announcement must be typed on line 2 of
the face page of the application form and the YES box must be checked.
SUPPLEMENTARY INSTRUCTIONS
Applications for NIDDK Education Project Grants (R25) must be submitted on
Form PHS 398 using the modified instructions below, which take into account
all of the special features and requirements of this grant.
1. Description, Performance Site(s), Key Personnel: (Use Form Page 2 of the
PHS 398): Complete as directed in the form PHS 398 instruction package; this
should include the principal investigator, Advisory Committee Members, and
other faculty participating in the program. Please make sure that you denote
each individual's degree and departmental affiliation (or equivalent) AND, if
a consortia of institutions, institutional affiliation.
2. Table of Contents to be organized as follows:
a. Face Page
b. Description, Performance Site(s), Key Personnel
c. Table of Contents
d. Detailed Budget Page for First Year
e. Budget for Entire Proposed Period of Support
f. Budgets Pertaining to Consortium/Contractual Arrangements
g. Other Sources of Institutional Training and Education Support
h. Biographical Sketches (not to exceed 4 pages per individual):
o Principal Investigator
o Advisory Committee Members
o Other Participating Faculty
i. Education Program (Not to exceed 25 pages, excluding tables)
i. (If applicable) Introduction to Revised Application (Not to exceed 3
pages)
ii. Purpose and Objectives
iii. Specialized curriculum and other didactic experiences
iv. Resources and Facilities/Faculty
v. Program Leadership/Management
o Principal Investigator
o Advisory Committee
o Recruitment Strategies
o Evaluation Plan
j. Checklist
k. Appendices
3. Detailed Budget for the First Year: Use Form Page 4 of the PHS 398.
Under PERSONNEL break out the individuals as follows with percent effort,
salary and fringe benefits:
A. The Principal Investigator (PI)
B. The Faculty being paid from the Grant
If costs are requested for Advertising and Recruitment, make sure that these
costs are identified under each budget category.
4. Budget for the Entire Proposed Project Period of Support: Use Form Page
5 of the PHS 398 and provide projected future year budgets as instructed in
the PHS 398.
5. Biographical Sketches and Other Support: Provide biographical sketches
using the forms provided in the PHS 398 package for the Principal
Investigator, Advisory Committee Members, and other participating faculty.
6. Education Program Plan:
a. (If applicable) Introduction to Revised Application: If this is a revised
application, in no more that three pages summarize how you have addressed the
previous concerns of the reviewers and what new information is available that
might be important for the reviewers to evaluate. Additionally, highlight
(bold, italics, etc.) in the text of the plan changes made in response to the
concerns of the previous review of the application.
b. Purpose and Objectives: In this section provide background, purpose and
objectives of the Program.
c. Specialized Curriculum and Other Didactic Experiences: Describe the
proposed course/seminar series/symposium/or other curriculum-based program.
Explain how the development and implementation of this curriculum is
critically linked to the purpose and objectives of the Program and to the
potential research career development of enrolled individuals. Explain how
this curriculum is distinguished from other curricula within the existing
educational infrastructure and framework of the applicant/participating
institution(s). Describe the utilization of any existing curriculum within
the institution(s).
d. Resources and Facilities/Faculty:
Resources and Facilities: Briefly describe the infrastructure and facilities
that are available and accessible to this Program.
Faculty: Describe the track record in training scientists of each faculty
member participating in the Program.
e. Program Leadership/Management:
o Principal Investigator: Describe the qualifications and role of the
Principal Investigator to provide leadership and coordination of the Program.
o Recruitment Strategies: Describe the characteristics of the pool of
students/fellows who will be recruited for participation in the Program as
well as any advertising strategies to be used. Comment on the size of the
candidate pool expected, note any other institutional programs that might
compete for this pool, and describe strategies for addressing this
competition.
Separately describe the strategies for recruiting minority students/fellows.
o Advisory Committee: Describe how the Advisory Committee will function in
providing oversight of the development, implementation and evaluation of
recruitment strategies; will aid in recruitment and selection of
students/fellows for the Program; will interact with faculty to establish,
implement and evaluate the curriculum. In addition, indicate how the
Advisory Committee will function to approve individual education plans, if
appropriate (e.g., curriculum, research/methodology experiences), and monitor
the overall effectiveness of the Program;
o Evaluation Plan: Describe the information that will be collected, the
periods for, and criteria to be used in evaluating this Program;
8. Consortium/Contractual Arrangements: Refer to the following website for
guidelines on these agreements:
http://grants.nih.gov/grants/policy/nihgps/part_iii_5.htm#Consortium.
9. Appendices: follow instructions provided in the PHS Form 398 application
package.
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 also are indicated in the PHS 398 application kit.
SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and all
appendix material must be sent to:
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
The title and number of the program announcement must be typed on line 2 of
the face page of the application form and the YES box must be marked.
APPLICATION PROCESSING: The CSR will not accept any application in response
to this PAR 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 unfunded version of an application already reviewed, but such application
must include an Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed by the CSR for completeness and
by the NIDDK program staff for responsiveness in two areas: 1) Eligibility
criteria; 2) Special Requirements. Incomplete and/or non-responsive
applications will be returned to the applicant without further consideration.
Applications that are complete and responsive to the PAR will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the NIDDK in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
o Will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the NIDDK National Advisory Council
REVIEW CRITERIA
The review criteria that will be applied to the application are briefly
described below:
o The degree to which the proposed Program addresses areas that are of
importance to the NIDDK. The Program must demonstrate how its implementation
will advance the objectives of this PAR as well as the overall mission of the
NIDDK.
o Novelty, innovation, and significance of the education program to
scientific areas of importance to the NIDDK. The curriculum should include
original and unique approaches or methods for addressing the needs put forth
in the goals and objectives. Plans to develop web versions of courses
supported through the R25 grants, as well as other means to support rapidly
evolving areas of major interest to the NIDDK, will be evaluated.
o Adequacy of the justification of the need for the proposed Program relative
to other on-going education and/or training/career development activities
being sponsored within the institution(s).
o Qualifications of the Principal Investigator in terms of past track record
of achievement and experience to provide direction, coordination and
administration of the Education Program.
o Qualifications of the key personnel and/or faculty that will participate in
the Program.
o Suitability and commitment of the Advisory Committee to provide oversight
and input, and to monitor and evaluate the overall effectiveness of the
program.
o The overall quality and adequacy of the design of the Program to achieve
its objectives; the degree to which the curriculum (sequence, topics,
breadth, depth, etc.) will meet these objectives.
o Adequacy of the required "Evaluation Plan" to assess the effectiveness of
the Program in achieving its objectives, and the degree of portability of the
proposed program.
o Adequacy and appropriateness of the plan to recruit and enroll students
and/or postdoctoral fellows, including under-represented minorities, to
participate in the Program.
o Evidence of institutional commitment and plans to continue the Program
after the period of grant support ends when the program involves curricula
development aimed at strengthening the educational capability of the
institution (e.g., a new curriculum for researcher or health care
professionals in training).
o Appropriateness of the budget and duration of support needed to achieve the
stated goals and objectives.
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
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 Inclusion Criteria in the sections on
Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
AWARD CRITERIA
Applications submitted in response to a PAR 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 Relevance to program priorities
o Availability of funds
REQUIRED FEDERAL CITATIONS
ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities
involving live, vertebrate animals must comply with PHS Policy on Humane Care
and Use of Laboratory Animals
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as
mandated by the Health Research Extension Act of 1985
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA
Animal Welfare Regulations
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts
on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
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 PAR in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the Standards for Privacy of Individually Identifiable Health Information ,
the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on Am I a covered
entity? Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
PAR is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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