and Human Services (HHS)
EXPIRED
CURRICULUM DEVELOPMENT AWARD IN INTERDISCIPLINARY RESEARCH
RELEASE DATE: October 29, 2003
RFA Number: RFA-RM-04-007 (formerly RFA-GM-04-003, see NOT-OD-04-008)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
THIS RFA IS DEVELOPED AS AN NIH ROADMAP INITIATIVE
(http://nihroadmap.nih.gov/). ALL NIH INSTITUTES AND CENTERS
PARTICIPATE IN ROADMAP INITIATIVES. THE RFA WILL BE ADMINISTERED BY THE
NIGMS ON BEHALF OF THE NIH.
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.859
LETTER OF INTENT RECEIPT DATE: January 27, 2004
APPLICATION RECEIPT DATE: February 24, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Training Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The Curriculum Development Award in Interdisciplinary Research supports
the development of innovative courses, curricula and educational
approaches designed to train interdisciplinary scientists in emerging
areas of biomedical, behavioral and quantitative sciences. These
programs are focused on preparing undergraduate, predoctoral, or
postdoctoral candidates, or combinations of these, to conduct research
in team settings that are highly interdisciplinary and collaborative
and to train future leaders who can catalyze the integration of
multiple disciplines. The courses and curricula may be organized
around an interdisciplinary research theme which will form a framework
for integrating education and training across disciplines. To achieve
the breadth and diversity of courses and curricula needed to meet these
goals, applicants must include multiple departments and may also
include multiple centers, schools or institutions. This award is
intended to a) support the development of new didactic programs in
interdisciplinary research training at institutions that do not
currently offer them, or b) support the improvement or expansion of
curricula at institutions with existing programs. As part of this
program, awardees will be expected to develop and implement the courses
or curricula in their institution(s). It is expected that such courses
and curricula will be models that could be transferable to other
institutions in whole or in part. Applicants interested in applying
for interdisciplinary research training support through other
mechanisms should refer to the related roadmap initiatives on
interdisciplinary training at
http://nihroadmap.nih.gov/interdisciplinary/grants.asp.
TRAINING OBJECTIVES
Background and Description
The National Institutes of Health (NIH) is engaged in a series of
activities collectively known as the NIH Roadmap, whose goal is to
accelerate both the pace of discovery in the life sciences and the
translation of therapies from bench to bedside. In the course of
developing the NIH Roadmap, it has become increasingly clear that
scientific advances are being made at the interfaces of traditional
disciplines, and approaches to science are becoming more integrative.
This requires a cooperative effort, typically in the form of
investigators from diverse research backgrounds working collectively
across traditional disciplinary boundaries to answer scientific
questions and achieve specific endpoints. This also requires a
workforce capable of crossing disciplinary boundaries and leading and
participating in integrative and team approaches to complex biomedical
problems. Building research teams for the future has therefore emerged
as one of the major themes in Roadmap implementation. Additional
information about the NIH Roadmap can be found on the NIH website at
http://nihroadmap.nih.gov/.
Biomedical research encompasses a large number of scientific
disciplines in addition to the biological sciences, including but not
limited to the behavioral, quantitative, engineering and computer
sciences. Distinct disciplinary perspectives represent significant
sources of strength to the overall research enterprise because each
discipline has its own intellectual history, experimental and analytic
approaches, and theoretical context that produce a unique way of
thinking about a problem. Nevertheless, as scientific capabilities
move forward, increasingly complex questions arise, and these often
require the convergence of perspectives from multiple disciplines.
Over the years, the Institutes and Centers (ICs) at NIH have developed
many initiatives, mechanisms and programs to support multidisciplinary
research-that is, research that brings together researchers from
different disciplines to focus on a circumscribed problem.
It is becoming apparent that, in some cases, the collaborative nature
of disciplines that characterizes multidisciplinary research is not
sufficiently sustained to address, in a comprehensive way, challenging
problems in biomedical and behavioral research. Rather,
interdisciplinary research, which integrates several disciplinary
approaches in a more sustained and systematic fashion, may be required
to tackle these more complex problems. Integrating different
disciplines in this way holds the promise of opening up currently
unimagined scientific avenues of inquiry, and in the process, may form
whole new disciplines. Historical examples of this include the
development of genomics, which was formed from genetics, molecular
biology, analytical chemistry, and informatics. Neuroscience is
another example in which multiple disciplines have, in a less directed
way, blended and evolved into a new discipline. Thirty years ago,
students of the brain might have identified themselves as anatomists,
physiologists, or psychobiologists, but today they would consider
themselves neuroscientists.
Combining particular aspects of different disciplines to develop
entirely new ways to approach biomedical and behavioral research
problems is daunting in many ways. NIH recognizes the value and
enormous contributions that existing interdisciplinary approaches have
made and are making to biomedical research. However, the Roadmap is
focused on stimulating the development of new and innovative
interdisciplinary approaches and training. NIH is proposing a series
of initiatives that aim to provide investigators with the training to
effectively lead and engage in integrative and team approaches to
complex biomedical problems. Collectively, the initiatives provide
opportunities for integration of disciplines at all stages of
investigators careers, facilitate communication among the disciplines,
and ensure the development of necessary infrastructure to build the
workforce for the research teams for the future. Additional
information on initiatives associated with building research teams of
the future can be found on the NIH website at
http://nihroadmap.nih.gov/interdisciplinary/index.asp.
The Interdisciplinary Curriculum Development Awards are expected to
support the development of innovative courses and curricula designed to
train interdisciplinary scientists in emerging areas of biomedical and
behavioral science. These curricula can be designed for undergraduate,
predoctoral or postdoctoral students, or combinations of these. The
NIH is particularly interested in programs that encourage the
integration of quantitative, physical, behavioral, or social sciences
with the traditional biomedical sciences that will lead to the creation
of a new interdisciplinary research area.
MECHANISM OF SUPPORT
This RFA will use the NIH K07 mechanism, using the Leadership provision
of this award to support curriculum development (see
http://grants.nih.gov/grants/guide/pa-files/PA-00-070.html).
Planning, direction, and execution of the program will be the
responsibility of the principal investigator. However, the institution
must demonstrate a commitment to the purposes of this award for course
or curriculum development in the specified area. The project period is
for up to five years. Competing renewals to continue the development
of courses/curricula developed under this award will not be considered.
At this time, plans for reissuing the RFA are indefinite. The
anticipated award date is 09/30/2004. In most cases, these awards will
be made to develop new educational approaches for which the institution
will subsequently assume support. This RFA uses just-in-time concepts.
FUNDS AVAILABLE
The participating ICs intend to commit approximately $1.5 million in
FY04 to fund approximately 5-10 new grants in response to this RFA. An
applicant may request a project period of up to five years. Because the
nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award
will also vary. Although the financial plans of the ICs provide
support for this program, awards pursuant to this RFA are contingent
upon the availability of funds and the receipt of a sufficient number
of meritorious applications. The Institution may contribute resources
in terms of released time for the Principal Investigator and support
for clerical and administrative personnel, travel, consultants and
meetings, faculty support, core facilities and space and equipment.
ELIGIBLE INSTITUTIONS
You may submit an application 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 institutions/organizations
o Foreign institutions are not eligible to apply.
An institution may submit more than one application if it proposes the
development of distinctly different interdisciplinary
curricula/courses. Proposed educational experiences must be distinct
from those training programs currently receiving NIH support or other
federally funded support. There must be a commitment from the
nominating institution that the course(s) or curricula will become an
integral part of the academic offerings of the institution.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to
carry out the proposed curriculum development is invited to work with
their institution to develop an application for support. The Principal
Investigator should possess the research and training expertise, and
leadership and administrative capabilities required to develop and
implement an interdisciplinary course/curriculum of this scope. The PI
must be willing to spend between 25-50% of his/her full-time
professional effort on course(s) and curriculum development for the
period of the award, and must identify appropriate collaborator(s) from
the relevant disciplines who will agree to collaborate on the
development of the course(s) and curricula. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.
Principal Investigators must be U.S. citizens or noncitizen nationals,
or must have been lawfully admitted for permanent residence and possess
an Alien Registration Card or some other verification of legal
admission as a permanent resident.
All potential applicants are strongly encouraged to contact the NIH
staff listed below to discuss their eligibility and the specific
provisions of this award.
SPECIAL REQUIREMENTS
Program: The Principal Investigator is expected to develop courses or
curricula at the undergraduate, graduate or postdoctoral level (or
combinations of these) that integrate the principles and conceptual
approaches of multiple, diverse disciplines in emerging areas of
biomedical research, including but not limited to the behavioral,
quantitative, engineering and/or computer sciences. The curricula may
be organized around an interdisciplinary theme that provides a
framework for merging concepts and approaches from multiple disciplines
into an integrated course/curriculum. These efforts should also
encourage collaboration and interaction across departments, schools
and/or institutions.
Environment: The institution must have strong training program(s) in
the individual disciplines which are being integrated through the
interdisciplinary course(s) or curricula that are being developed. The
institution must demonstrate a commitment to the further development
and implementation of these courses and curricula following the award.
The institution must provide assurance that the Principal Investigator
is an integral part of its research and academic programs.
Allowable costs:
Salary: This award will provide salary and fringe benefits for the
recipient for levels of effort between 25 and 50 percent. The total
salary requested must be based on the Principal Investigator’s full-
time, 12-month staff appointment. It must be consistent both with the
established salary structure at the institution and with salaries
actually provided by the institution from its own funds to other staff
members of equivalent qualifications, rank, and responsibilities in the
department concerned. If full-time, 12-month salaries are not
currently paid to comparable staff members, the salary proposed must be
appropriately related to the existing salary structure. The salary
will always be pro-rated for the percentage of time/effort of a full-
time position, based on the institutional salary scales, keeping the
DHHS salary cap as a maximum for which the amount is determined.
The institution may supplement this award contribution up to a level
that is consistent with the institution's salary scale; however,
supplementation may not be from Federal funds unless specifically
authorized by the Federal program from which such funds are derived.
In no case may DHHS funds be used for salary supplementation.
Institutional supplementation of salary must not require extra duties
or responsibilities that would interfere with the purpose of the
Curriculum Development Award.
Research Support: A maximum of $50,000 per year may be requested for
ancillary needs, such as collaborators, consultants, equipment,
computer time, etc. All requests for ancillary support must be
justified. In no case will the allowance provided exceed $50,000.
Salaries for mentors or for secretarial, technical and/or
administrative assistance are not allowed.
Facilities and Administrative (F&A) Costs: F&A costs will be reimbursed
at 8 percent of modified total direct costs, or at the actual indirect
cost rate, whichever is less.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA 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:
o Direct your questions about scientific/research issues to:
Alison E. Cole, Ph.D.
Division of Pharmacology, Physiology and Biological Chemistry
National Institute of General Medical Sciences
Building 45, Room 2AS-49K
Bethesda, MD 20892
Telephone: (301) 594-3349
FAX: (301) 480-2802
Email: [email protected]
o Direct your questions about peer review issues to:
Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences, NIH
45 Center Drive, Room 3AN.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
FAX: (301) 480-8506
Email: [email protected]
o Direct your questions about financial or grants management matters
to:
Antoinette Holland
Grants Administration Branch
National Institute of General Medical Sciences
45 Center Drive, Room 2AN.50B, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-5132
FAX: (301) 480-3423
Email: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows NIH staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. The letter of intent should be sent to:
Alison E. Cole, Ph.D.
Division of Pharmacology, Physiology and Biological Chemistry
National Institute of General Medical Sciences
Building 45, Room 2AS-49K
Bethesda, MD 20892
Telephone: (301) 594-3349
FAX: (301) 480-2802
Email: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). 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 DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. The PHS 398 document 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].
SUPPLEMENTARY INSTRUCTIONS
The application must address the following issues:
Principal Investigator:
Describe the Principal Investigator's commitment to developing and
implementing an interdisciplinary course(s) or curricula, which meet
the scientific and educational requirements of the interdisciplinary
fields and the institution.
Provide evidence that the Principal Investigator has the capacity to
develop and implement course(s) or curricula that are based on sound
research concepts and educational principles.
Course or Curriculum Development Plan:
Describe the plan and how it fits into the institutional plans and
goals. Explain how this curriculum is distinguished from other
curricula within the existing educational infrastructure and framework
of the applicant/participating institution(s). Describe the immediate
and long-term objectives of the award and how those objectives will
meet the needs for expansion or enhancement of the academic or research
capacity of the institution in interdisciplinary research.
Environment and Institutional Commitment:
The institution must provide evidence of commitment and support for the
proposed program. There must be evidence of support for the Principal
Investigator and his/her course and/or curricula development and
implementation plans and for the further enhancement of the
interdisciplinary scientific area.
Collaborator's Statement:
Principal Investigators must include information about any
collaborator(s) including her/his research and training qualifications.
The application must also include information describing the nature and
extent of collaboration that will occur during the proposed award
period.
Budget:
Budget requests must be provided according to the instructions in form
PHS 398. The request for ancillary support, i.e., essential books,
travel, consultants, equipment, computer time, etc., must be justified
and specified by category.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
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 copies of the appendix material must be sent to:
Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences, NIH
45 Center Drive, Room 3AN.12F, MSC 6200
Bethesda, MD 20892-6200
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
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.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA 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 an RFA, it is to be prepared as a NEW
application. That is, the application for the RFA 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.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by NIGMS. Incomplete or non-responsive applications
will be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIGMS in accordance with the review
criteria stated below. As part of the initial merit review, all
applications will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications
under review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by an appropriate National Advisory
Council or Board.
It is strongly recommended that prospective applicants contact the
staff person listed under INQUIRIES early in the planning phase of the
application. Such contact will help ensure that applications are
responsive to the overall intent of this award.
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 evaluate the
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The
scientific review group will address and consider each of the following
criteria in assigning the application’s overall score, weighting them
as appropriate for each application. The application does not need to
be strong in all categories to be judged likely to have major impact
and thus deserve a high priority score.
Principal Investigator:
o Evidence of the Principal Investigator’s excellence in research and
academic activities, and the quality and breadth of prior scientific
training experience.
o Commitment to developing and implementing academic course(s) or
curricula which meet the scientific and educational requirements of the
interdisciplinary field and the institution.
o Evidence of the capacity to develop and implement course(s) or
curricula that are based on sound research concepts and educational
principles.
o Evidence of potential to become a leader in developing educational
interdisciplinary scientific programs at the institution(s).
Course/Curricula Development Plan:
o Quality, feasibility and innovation of course or curricula
development and implementation plans for interdisciplinary research
training.
o Appropriateness of the plan to the goals of this program. Adequacy
of the justification provided for the need for the proposed curriculum
relative to other on-going education and/or training activities being
sponsored within the institution(s).
o Immediate and long-term objectives of the award and how those
objectives will meet the needs for expansion or enhancement of the
academic or research capacity of the institution in the
interdisciplinary research area.
o Quality of plan to disseminate the materials nationwide through such
means as Web postings, presentations at meetings, workshops, etc.
Environment:
o Commitment of the institution to strengthening interdisciplinary
research and education activities in areas of interest to the NIH. For
example, an institutional commitment to create a new degree program, at
either the undergraduate or graduate level, in the proposed
interdisciplinary area, would be regarded as compelling evidence of
institutional support.
o Merit of the institution's plan to strengthen their interdisciplinary
training.
o Scope and nature of collaboration among participating schools and
departments.
Collaborator(s):
o The collaborator's capabilities to contribute to the goals of the
program.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
following items will be considered in the determination of merit and
the priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. (See criteria
included in the section on Federal Citations, below.)
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. 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.
ADDITIONAL REVIEW CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: January 27, 2004
Application Receipt Date: February 24, 2004
Peer Review Date: June-July 2004
Council Review: September 2004
Earliest Anticipated Start Date: September 30, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required
for all types of clinical trials, including physiologic, toxicity, and
dose-finding studies (phase I); efficacy studies (phase II); efficacy,
effectiveness and comparative trials (phase III). The establishment of
data and safety monitoring boards (DSMBs) is required for multi-site
clinical trials involving interventions that entail potential risk to
the participants. (NIH Policy for Data and Safety Monitoring, NIH
Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
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, 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.
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. 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: (if
applicable) 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.
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 (see 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.
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.
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).
Those who must comply with the Privacy Rule (classified under the Rule
as covered entities ) must do so by April 14, 2003 (with the exception
of small health plans which have an extra year to comply).
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 RFA 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 284and 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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