SHORT COURSE: INTEGRATIVE AND ORGAN SYSTEMS PHARMACOLOGY

RELEASE DATE:  April 26, 2004
 
RFA Number:  RFA-GM-05-006 (Reissued as RFA-GM-08-010)

EXPIRATION DATE:  June 26, 2004

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of General Medical Sciences (NIGMS) 
 (http://www.nigms.nih.gov)
Office of Dietary Supplements (ODS)
 (http://dietary-supplements.info.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.859

APPLICATION RECEIPT DATE:  June 25, 2004 
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
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 Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The purpose of this RFA is to solicit proposals for a Short Course(s) 
in Integrative and Organ Systems Pharmacology.  The National Institute 
of General Medical Sciences (NIGMS) recognizes the importance of 
studies using intact organ system and in vivo animal models in the 
conduct of research.  There is a growing need for functional analysis 
of biological systems to connect results at molecular and cellular 
levels to the expression of genetic and environmental determinants in 
the whole organism.  This RFA solicits proposals for Education Projects 
that will introduce students to the knowledge and skills needed for 
studies of integrative organ system and whole organism biological 
responses to drugs and other physiological perturbations.  The project 
should develop an appropriate, innovative curriculum to teach basic 
concepts and experimental techniques during a brief, but intensive 
short course, to be offered during the summer.  Inclusion of 
independently funded follow-up experiences at either the home 
institution or through industrial internships is encouraged.  
Interested students will likely be drawn from graduate programs in 
pharmacology, physiology, toxicology, and related disciplines.  
However, the course should be open to participation of other students 
at advanced levels of training and career stages, and to students from 
industry and government as well as from academia.  The training should 
foster their ability to assume leadership roles in all three sectors.  
The goal of these Education Projects will be to strengthen the research 
personnel base in the United States by broadening the exposure of 
students to training in integrative and organ systems sciences.
 
RESEARCH OBJECTIVES

Background:

The definition of Integrative and Organ Systems Pharmacology for the 
purpose of this RFA is as follows:  "Pharmacological research using in 
vivo animal models or substantially intact organ systems that are able 
to display the integrated responses characteristic of the living 
organism that result from complex interactions between molecules, 
cells, and tissues."

Such studies are important because isolated molecules and cells in 
vitro do not accurately display all of the properties that they possess 
in vivo.  Isolated molecules and cells do not adequately reflect the 
function of intact tissues, organs, and organ systems.  Normal 
physiology, pathology, and pharmacology reflect not only interactions 
between molecules and cells, but interactions of multiple tissues, 
organs, and organ systems as well.

Concerns have been raised by academic and industrial scientists about 
the training of current students in the area of integrative and organ 
systems sciences.  Most graduate students in the basic biomedical 
sciences receive limited training in physiology and integrative 
pharmacology.  Even within the discipline of pharmacology, not all 
students gain sufficient hands-on experience with in vivo animal models 
and organ systems.  Graduates need to have sufficient understanding of 
how to choose and use models that appropriately reflect the human 
condition under study.  Furthermore, students need the skills to 
communicate with other scientists across the breadth of science from 
isolated molecule to whole animal and human clinical research that is 
required for translation of research results into health benefits.

Several factors suggest an increasing need for students trained in 
integrative and organ systems sciences.  Bioinformatics and genomic 
approaches are suggesting new targets for study.  Hypotheses generated 
by in vitro studies or by computational biology and systems approaches 
to the integrative behavior of living systems need to be tested in the 
actual living organism.  The ability to develop genetically modified 
organisms has outstripped the ability to characterize the phenotypic 
changes in these organisms.  Interest is growing in behavioral and 
neurobiological phenomena that can only be studied in relatively intact 
systems and living organisms.  Discoveries in the areas of chemistry, 
genomics, and pharmacogenetics have accelerated the rate of research 
and have increased the demand for integrative and organ systems 
pharmacologists in the pharmaceutical industry.  Pharmacologists, 
experienced with in vivo models, form an integral part of every drug 
discovery and development project and are essential to assuring that 
only safe and efficacious lead compounds go forward to clinical trials.  
New tools, such as microdialysis and imaging methods, have become 
available that enhance the collection efficiency and value of 
pharmacological data obtained in vivo.

Academic infrastructure at many institutions may not be able to meet 
the demand for appropriate training in this area.  The success of 
reductionist approaches based on molecular and cellular methods has 
resulted in the displacement of many of the researchers formerly 
engaged in integrative and organ systems studies.  The cost of animal 
subjects research has increased and the use of animal subjects in basic 
medical and graduate instruction has been significantly curtailed.  The 
training to be provided by the solicited Education Projects will help 
restore the balance between in vitro and in vivo approaches to science.  

The above analysis is based on input that NIGMS staff has gleaned from 
several sources:

1.  Concerns in this area were raised by Jobe, et al., "The essential 
role of integrative biomedical sciences in protecting and contributing 
to the health and well being of our nation," in the Physiologist 37, 
79-86 (1994), reprinted in the Pharmacologist 40, 31-37, 1998.  Similar 
concerns at the international level are raised in "The fall and rise of 
in vivo pharmacology," Trends in Pharmacological Sciences 23, 12-18, 
2002.

2.  Public affairs briefing materials on the issues are available from 
the American Society for Pharmacology and Experimental Therapeutics and 
the American Physiological Society through their respective websites:
http://www.aspet.org and http://www.the-aps.org.  A broad coalition of 
scientists, represented by organizations including the American 
Association of Anatomists, the American Physiological Society, the 
American Society for Clinical Pharmacology and Therapeutics, the 
American Society for Nutritional Sciences, the American Society for 
Pharmacology and Experimental Therapeutics, the PHARMA Foundation, the 
Safety Pharmacology Society, and the Society of Toxicology, have 
endorsed a joint statement of support for increased research and 
training in Systems and Integrative Biology.  Input from other 
societies has included the American Association of Veterinary Medical 
Colleges, the Institute for Laboratory Animal Research, and several 
international pharmacological societies.   

3.  Meetings between NIGMS staff and representatives of academia and 
industry have occurred on multiple occasions, including but not limited 
to a meeting organized by NIGMS titled, "What IS training in the 
Pharmacological Sciences?" held on the NIH campus, August 8-9, 2002.  
Details of the meeting and an Executive Summary Report are available at 
the following URL:  
http://www.nigms.nih.gov/news/meetings/pharmscitraining/.  Additional 
summary reports were published in the journals, Molecular Interventions 
2(5), 270-275, 2002 and Pharmaceutical Research 19(12), 1773-1774, 
2002.  NIGMS staff also participated in a workshop organized by the 
Life Sciences Research Office (LSRO), "The Status and Future of 
Integrative & Organ Systems Sciences," held on October 20-21, 2002.  
See:  http://lsro.org/ioss/frames_ioss_home.html.

GOALS FOR THE PROPOSED EDUCATION PROJECT(S):

o  Establish a strong connection between in vitro, organ function in 
situ, and in vivo results.
o  Introduce students to the role of in vivo methods in translational 
research and safety and efficacy in drug discovery and development.
o  Expose students to multiple animal models and reasons for selecting 
a given model for a particular purpose.
o  Provide significant hands-on experience with small animal models and 
at least some exposure to larger animal models.
o  Provide reinforced training in responsible conduct of research, 
including improved ability to articulate the need for such work in 
health research.
o  Improve the ability of students to communicate with other scientists 
across a broad spectrum of research activities.
o  Stimulate development at institutions through the return of 
interested students and the encouragement of institutional commitment.

The project should develop an appropriate and innovative program of 
instruction in Systems and Integrative Pharmacology to be conducted 
during an intensive short course (e.g., 2-3 weeks) to be offered in the 
summer.  Other course durations and offering times may be suggested.    
This program should satisfy the needs of the students for the 
introduction of basic concepts as well as the acquisition of initial 
hands-on skills with a number of organ system and intact animal model 
methods.  A combination of lectures, laboratories, demonstrations, and 
seminars may be employed.  The development of novel educational tools 
and approaches is encouraged.  This program embraces physiology and 
other related areas of integrative and organ systems sciences as they 
form the underpinnings of in vivo pharmacology.

The target audience for the Education Project(s) includes scientists at 
all advanced levels of training and career development, although a 
concentration on students at the graduate level may be appropriate.  
These projects will not support K-12 or undergraduate education.  
Graduating seniors who expect to enter graduate school in the near 
future may be included.  Participation of students supported by NIH 
predoctoral training grants in the Pharmacological Sciences is highly 
encouraged, but the training should be available to other students as 
well.  Inclusion of students pursuing MD, PharmD, DVM, and other 
advanced degrees, as well as PhD degree students, is encouraged.  
Inclusion of postdoctoral fellows and established researchers who are 
seeking new directions is also appropriate.  The course should be open 
to students from industry and government as well as academia.

The project should develop plans for recruiting and selecting students 
to participate in the project.  These plans should be structured in a 
way that encourages integration of the proposed short course experience 
into the program of training of students at their home institutions.  
Agreements with a number of home institutions might be developed to 
encourage participation of their students, but the course should not be 
limited to institutions with whom such agreements exist. 
Projects may (but are not required to) include components that provide 
matching of students to follow-up academic or industrial experiences 
that will provide additional training in integrative and organ systems 
pharmacology.  It would be useful to establish collaborations with a 
number of industrial organizations expressing willingness to accept the 
number of students to be placed.  It would be useful to obtain 
commitments from academic mentors indicating how the student will be 
able to utilize their training after the course.
 
Projects should include plans to evaluate the effectiveness of short 
course and other activities and to further refine the program in 
subsequent years of the project period.

Projects should describe plans to disseminate the educational tools and 
approaches developed by this project to additional institutions.  
Provision of handout materials via websites and access to lectures via 
streaming video or other technologies is highly encouraged.  Access to 
archival video material is desirable.

SUGGESTED SHORT COURSE TOPICS:

The following list of topics for inclusion in a short course is 
suggestive only, not inclusive or prescriptive:

o  Care and use of animals
o  Responsible conduct of research involving animal subjects
o  Role of animal subjects in translational research
o  Selection of appropriate models for human diseases
o  Routes of drug administration and sampling
o  Pharmacokinetics and pharmacodynamics, including ADME studies
o  Small animal surgery and tissue sample recovery for histology
o  Cardiovascular, renal, and pulmonary function monitoring in 
restrained and unrestrained live animals
o  Small animal reproduction and characterization of genetically 
modified organisms
o  Small animal neuropharmacology and behavioral monitoring
o  Large animal laboratories, demonstrations, videos, and simulations
o  Primate model lectures, videos, remote data, and simulations
o  Imaging applications in pharmacology
o  Toxicological methodology
o  Integration of cellular and molecular information with organ systems 
and whole organisms data

The short course should not merely cover the necessary techniques to 
execute a particular protocol.  Rather, it should provide an 
understanding of the strengths and weaknesses of particular models and 
the important concepts needed to design meaningful experiments.  The 
course should provide not only familiarity with systems that are 
inherently integrative in their function, but should enhance the 
ability of the scientist to integrate information about systems.  
Although much attention may be focused on mouse and rat models, 
inclusion of other species in some capacity is required.

MECHANISM OF SUPPORT

This RFA will use the NIH Education Project (R25) award mechanism.  As 
an applicant you will be solely responsible for planning, directing, 
and executing the proposed project.  This RFA is a one-time 
solicitation.  (It may or may not be reissued at a future date.)  
Future unsolicited, competing-continuation applications based on this 
project will compete with all investigator-initiated applications and 
will be reviewed according to the customary peer review procedures.    
The anticipated award date is April 1, 2005, for short courses that 
will be first offered in the summer, 2005.

This RFA does not use the modular budgeting format.  A detailed 
categorical budget should be proposed.  This program does not require 
cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

FUNDS AVAILABLE 

The NIGMS intends to commit approximately $500,000 in FY 2005 to fund 2 
to 3 new grants in response to this RFA. An applicant may request a 
project period of up to 3 years and a budget for direct costs of up to 
$200,000 per year.  Because the nature and scope of the proposed 
project 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 NIGMS 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.  

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your institution has any of the 
following characteristics:
   
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,             
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic institutions/organizations
o Foreign institutions are not eligible to apply; however, foreign 
scientists may participate as instructors.  Foreign organizations may 
participate as sponsors for follow-on experiences, such as industrial 
internships, outside of the scope of the funded project.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed Education Project is invited to work with their 
organization 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  Requirement for Commitment of Principal Investigator

The Principal Investigator is expected to commit a substantial effort 
to the organization, oversight, development of materials, and 
instruction of the short course.

o  Requirement for Involvement of Multiple Participating Organizations

These Education Project awards will not support curriculum development 
projects focused on a single institution.  For administrative purposes, 
only one organization may serve as the applicant organization and 
should coordinate all activities of the project.  However, multiple 
organizations must be committed to the Education Project.  It is 
recommended that the course be run by an organizing committee and that 
multiple organizations be represented on the organizing committee.  The 
short course may make use of the facilities at multiple organization 
sites, but this is not essential--appropriate academic, government, 
independent laboratory, or industrial research facilities should be 
proposed.  Faculty should be drawn from multiple organizations.  
Inclusion of faculty members representing academia, industry, and 
government, is encouraged.  The participation of individual industrial 
sponsors or industrial organization sponsors is encouraged.  The 
inclusion of letters indicating commitment of the target community to 
the project is recommended.

o  Recruitment of Students

Advertising, application procedures, and selection of students will be 
a grantee responsibility.  The students should be drawn from multiple 
institutions, not just the grantee institution, and efforts should be 
made to insure recruitment of a diverse student pool.  Recruitment 
plans must address inclusion of disadvantaged students, including 
under-represented minorities.

o  Animal Welfare Assurances

The applicant organization must provide assurance that all students 
receive appropriate training in the Responsible Conduct of Research 
involving Animal Subjects prior to beginning any work with animal 
subjects.  If students have received such training at their home 
institutions, the organization must obtain appropriate documentation of 
this fact.  If students have not received such training at their home 
institutions, the organization must provide this training.  In either 
case, the organization should provide any additional training necessary 
for students to meet assurance requirements for use of animals at the 
host site.  Plans to meet assurance requirements should be described in 
the application.  Documentation of assurance will be requested at the 
time of award.

o  Reporting Requirements

The Application for Continuation of a Grant (PHS 2590, rev. 5/01, 
http://grants.nih.gov/grants/forms.htm) or equivalent documentation 
must be submitted to, and be approved by, NIH to noncompetitively fund 
each additional budget period within a previously approved project 
period.  The PHS 2590 application should include in the progress report 
a list of students who participated in the Education Project, their 
home institutions, department or degree program, and mentor or sponsor, 
and research project title at the home institution.  Statistical data 
should be included on the representation of disadvantaged student 
groups.  The report should indicate any known follow-on activities in 
which the students are participating.  If the coordination of such 
activities is a formal part of the Education Project, then a detailed 
summary, including information about follow-on host site, mentor, and 
specific project, should be provided.  The annual progress report must 
also include information on any changes in the Education Project 
curriculum and other activities, progress toward assessing the impact 
of the project, and activities undertaken to disseminate instructional 
methods and materials developed.  (Reference: NIH Grants Policy 
Statement, NIH Publication No. 99-8, October 1998.)

o Evaluation:  In carrying out its stewardship of human resource- 
related programs, the NIGMS may request information essential to an 
assessment of the effectiveness of this program.  Accordingly, the 
grantee should notify the Principal Investigator and participating 
students that they may be contacted after the completion of this award 
for periodic updates on various aspects of student 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.

o  Allowable Costs:  Items must be consistent with PHS policy and must 
be reasonable, allowable, and well justified for specific application 
to the proposed Education Project.  Support will be provided for a 
combination of curriculum development and short course implementation.  
Support will not be provided for curriculum development projects alone.  
Funds may be requested for principal investigator, faculty, and 
administrative staff salaries; laboratory equipment, animals, supplies, 
and other educational materials; production and dissemination of course 
content; program evaluation; travel and per diem (see below).  It is 
recommended that part of the cost be borne by the student's home 
institution, mentor, or employer as a way to assure commitment to the 
student's training.  Co-sponsorship of the course by other 
organizations, such as non-profit and industrial sponsors, should be 
mentioned in the application.  Co-funding through individual student 
registration fees and differential fee structures is permitted.  Funds 
for travel expenses to other sites that may participate in follow-on 
industrial internships and other follow-on activities should not be 
requested, but may be mentioned as industrial or other types of 
matching contributions.  Such matching contributions should be 
documented.  Student stipends, tuition, and fees (other than as 
mentioned above) should not be requested.  Facilities and 
Administration costs will be paid at 8% of the direct costs, exclusive 
of equipment.  Awards will be administered according to the NIH Grants 
Policy Statement:  
http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm

Travel and per diem expenses: Funds may be used for the travel of 
staff, speakers, participants, and attendees, if identified in the 
application and approved at the time of award. Travel expenses for 
employees of the grantee organization are governed by the grantee’s 
travel policies, consistently applied regardless of the source of 
funds.

Any U.S. foreign travel restrictions that are in effect at the time of 
the award will be followed, such as:
o limitations or restrictions on countries to which travel will be 
supported or
o budgetary or other limitations on availability of funds for foreign 
travel.

Proposed per diem or subsistence allowances must be reasonable and 
limited to the days of attendance at the conference plus the actual 
travel time to reach the conference location by the most direct route. 
Local mileage costs only may be paid for local participants. Where 
meals and/or lodgings are furnished without charge or at a nominal cost 
(e.g., as part of the registration fee), the proposed per diem or 
subsistence allowance must take this into consideration.

Transportation costs for attendees and participants at the conference 
may not exceed coach class fares. In all cases, U.S. flag carriers will 
be used where possible (see:  NIH Grants Policy Statement in Subpart B. 
“Cost Considerations—Allowability of Costs/Activities—Selected Items of 
Cost—Travel”).

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 programmatic issues to:

Peter C. Preusch, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
Building 45, Room 2AS.55E, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-5938
FAX:  (301) 480-2802
Email:  preuschp@nigms.nih.gov

o Direct your questions about peer review issues to:

Dr. Helen R. Sunshine, Chief
Office of Scientific Review
National Institute of General Medical Sciences
Building 45, 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:

Ms. Antoinette Holland
Grants Management Branch
Division of Extramural Activities
National Institute of General Medical Sciences
Building 45, Room 2AN.50B, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-5132
FAX:   (301) 480-2554
Email:  hollanda@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.
 
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:

Chief, Office of Scientific Review
National Institute of General Medical Sciences
Building 45, Room 3AN.12, 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 the NIGMS. Incomplete and/or nonresponsive 
applications will not be reviewed.

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 the NIGMS Advisory Council.
 
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. 

(1)  Innovation, appropriateness, and merit of the proposed Education 
Project curriculum, including short course and any proposed follow-on 
activities, in meeting the needs of the targeted students.

(2)  Appropriateness of proposed follow-on experiences, if proposed, 
adequacy of commitment from follow-on sponsors, and adequacy of plans 
for student placements.

(3)  Adequacy of plans to recruit and select students for participation 
in the project, including plans to encourage a diverse student 
population.

(4)  Adequacy of inclusion of institutions representing the broad 
target community and the commitment of multiple institutions to the 
participation of their students in the project.

(5)  Administrative experience, scientific expertise, and leadership of 
the principal investigator, appropriateness of faculty and other staff.

(6)  Availability and adequacy of laboratory and other resources 
necessary for the project, contribution of the environment to the 
probability of success, evidence of institutional commitment.

(7)  Merit of the measurable objectives and adequacy of the plans to 
evaluate the effectiveness of the Education Project and refine the 
program in subsequent years.

(8)  Adequacy of plans for dissemination of educational materials and 
methods developed by the project.

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. The only 
expected human subjects involvement in the Education Project(s) would 
be the collection of survey data for the evaluation of the educational 
tools to be developed.  Such activity may be exempt from human subjects 
regulations, but this should be described and Exemption E1 and/or E2 
should be noted and justified.  (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:  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

Application Receipt Date:  June 25, 2004
Peer Review Date:  November, 2004
Council Review:  January, 2005
Earliest Anticipated Start Date:  March 1, 2005

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: 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. 

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.

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).  

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 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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