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:  colea@nigms.nih.gov

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:  sunshinh@nigms.nih.gov

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:  hollanda@nigms.nih.gov

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:  colea@nigms.nih.gov

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) 435-0714, Email: GrantsInfo@nih.gov.
 
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.


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