PREDOCTORAL RESEARCH TRAINING IN BIOSTATISTICS   

RELEASE DATE: July 27, 2004

PA NUMBER:  PAR-04-132

EXPIRATION DATE:  September 12, 2006, unless reissued. 

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION: 
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of General Medical Sciences (NIGMS)
 (http://www.nigms.nih.gov)

APPLICATION RECEIPT DATE: October 14, 2004; September 10, 2005 and September 
10, 2006

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:  93.859 (NIGMS)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose
o Training Program Objectives
o Special Program Considerations
o Mechanism of Support 
o Eligible Institutions
o Eligible Training Program Directors
o Eligible Trainees
o Allowable Costs
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Additional Review Considerations
o Award Criteria
o Required Federal Citations

PURPOSE  

The National Institute of General Medical Sciences (NIGMS) announces a new 
predoctoral institutional training grant program in biostatistics.  The 
purpose of the program is to provide support for predoctoral training in 
biostatistical theory and evolving methodologies related to basic biomedical 
research, including, but not limited to, bioinformatics, genetics, molecular 
biology, cellular processes, and physiology, as well as epidemiological, 
clinical and behavioral studies.  The goal is to ensure that a workforce of 
biostatisticians with a deep understanding of statistical theory and new 
methodologies is available to assume leadership roles related to the Nation’s 
biomedical, clinical, and behavioral research needs.  Implementation will 
depend on the integration of biostatistics and basic biological sciences to 
create effective interdisciplinary training grant programs.  The 
Biostatistics Training Grant Program is administrated by NIGMS with funds 
contributed by the National Cancer Institute, the National Institute of 
Allergy and Infectious Diseases, the National Heart, Lung and Blood 
Institute, the National Human Genome Research Institute, the National 
Institute of Dental and Craniofacial Research, the National Institute of 
Deafness and Other Communication Disorders, and the National Institute of 
Neurological Disorders and Stroke.

TRAINING PROGRAM OBJECTIVES

Biostatistics is an essential discipline in advancing and integrating 
biomedical, behavioral, and clinical research.  In 2001, the National 
Institutes of Health (NIH) sponsored a workshop to evaluate future needs and 
opportunities in biostatistics research and training.  The Workshop 
documented that the demand for biostatisticians exceeded the supply and 
recommended the establishment of a new training program in biostatistics that 
would provide in-depth training in statistical theory and methodologies and 
offer a broad scope of research opportunities for future biostatisticians.  
In response to NIH-wide discussions, NIGMS, with support from other NIH 
institutes and centers, hosted a workshop in December of 2003 to assess the 
need for training in biostatistics and to identify the important elements 
that would characterize a multidisciplinary training program in 
biostatistics.  

The outcome of the 2003 Workshop, which included leading researchers in 
biostatistics, biomedical research, clinical research, and bioinformatics, 
was a reiteration of the biomedical workforce need for biostatisticians 
trained in more than one discipline.  Specifically, the Workshop participants 
recommended establishing a predoctoral training program that is grounded in 
rigorous training in biostatistics and includes training in other 
disciplines. Successful training programs would be interdisciplinary, 
connecting biostatistics to basic biomedical, epidemiological, clinical, and 
behavioral research. The participants noted that to be effective members of 
the biomedical research community the next generation of biostatisticians, in 
addition to mastering traditional statistical theory and methods, will need 
to be trained in basic biological sciences (e.g., genetics, molecular 
biology, biochemistry, cell biology, evolution, bioinformatics, and 
computational biology).  One recommendation to achieve this integration is 
for biostatistics graduate students to train in experimental laboratories in 
order to gain first-hand experience and insight into the nature of problems 
faced by biomedical researchers.  The goal is to produce broadly trained 
biostatisticians with expertise in research areas that enable them to be 
integrated members of multidisciplinary teams at all levels of research and 
to play key roles in hypothesis development, experimental design, data 
gathering and analysis, and formulation of models and conclusions.

The NIGMS predoctoral biostatistics training program differs from existing 
NIH biostatistics training programs, which are focused primarily on specific 
diseases, by emphasizing the integration of statistical theory and 
methodologies with basic biomedical research, as well as clinical and 
behavioral studies.  This new program complements the more focused training 
programs, providing balance between the need for biostatistics tailored to a 
specific disease and developing biostatistical formalisms for emerging areas 
of research.  The aim is to provide opportunities for students with strong 
quantitative talents to pursue a wide range of opportunities in biostatistics 
research.  

This is the 10th institutional predoctoral training grant program created by 
NIGMS over the past 25 years.  The goal of the NIGMS training programs is to 
provide graduate students with access to research opportunities across 
disciplinary and departmental lines by supporting the development of 
comprehensive interdisciplinary and multidisciplinary graduate training.  
Further information about NIGMS training grant programs, including 
descriptions of the individual institutional training grant programs and 
special requirements, can be found at the NIGMS website: 
(http://www.nih.gov/nigms/funding/trngmech.html). 

SPECIAL PROGRAM CONSIDERATIONS

Applicants for a predoctoral institutional training grant in biostatistics 
need to describe an interdisciplinary program that is built on a strong 
foundation in statistical theory and methodology and that provides a clear 
understanding of basic biological research, including bioinformatics, 
computational biology, and the relationship of these scientific domains to 
epidemiological, clinical, and behavioral research.  One of the main 
challenges in this training program is to bridge cultural differences between 
disciplines.   

To promote these aims, NIGMS asks all applicants to address the following 
items and challenges:

o Description of the mission and objectives of the program.

o Creation of a collaborative infrastructure for training faculty:  To 
develop a vital collaborative infrastructure that provides interdisciplinary 
training, faculty must be recruited from more than one department.  Evidence 
for this infrastructure could include collaborative research projects, co-
authored publications, joint service on dissertation committees, 
collaborative teaching, and regular interactions in journal clubs and seminar 
series.

o Training of graduate students from diverse scientific backgrounds:  The 
application should address at least two scenarios for student success, one 
involving students coming from a biological background and the other 
involving students coming from a quantitative or computational science 
background.

o Degree requirements:  While it is recognized that biostatistics depends on 
a theoretical formalism that requires an essential core of didactic courses, 
this requirement must be balanced with training in other disciplines. 
Applicants must identify the key ideas and skills that are essential to 
multidisciplinary training in biostatistics and monitor the impact of core 
requirements on time to degree. 

o Institutional commitment:  Successful training programs depend on strong 
institutional support.  The application must provide statements from the 
appropriate administrators and/or deans outlining how the proposed training 
program contributes to the broader vision of the institution with respect to 
faculty recruitment, curriculum development, and the integration of 
undergraduate, graduate and postdoctoral training.

o Applicant pool:  It is important to identify and recruit students with 
strong quantitative skills from biological backgrounds, and students from 
statistical, mathematical, physical, and computational backgrounds with an 
interest in biological problem solving.

o Rotations: A major goal of this new program is to train biostatisticians 
who are conversant in experimental biology, computational implementation, and 
application of new methodologies.  Students should be exposed to the 
realities of daily life in these very different research environments.  One 
way to accomplish this objective is through research rotations in which 
students with predominantly quantitative training rotate in biology 
laboratories, and conversely, students with predominantly biological 
backgrounds rotate in quantitative/computer science laboratories.  Rotations 
are widely recognized as effective means to introduce students to the 
broadest choice of potential thesis laboratories and cultures.

o Emphasis on team research:  The solution for many biomedical research 
problems depends on the effective collaboration of researchers from different 
disciplines.  To advance the field of statistical research and its 
application to biomedical, epidemiological, clinical, and behavioral 
research, it is important that biostatisticians acquire the skills and 
knowledge necessary to become intellectual collaborators from initial 
experimental design through data analysis and interpretation.  To achieve 
this, students should participate in a variety of interdisciplinary training 
activities that will enable them to bring together knowledge from different 
domains to solve important problems.  One way to promote interdisciplinary 
training is to arrange for co-mentorship.  
 
o Statistics, biology, and computer science courses: Students must be able to 
understand the theoretical and methodological literature in statistics to be 
able to develop new methods appropriate for biomedical problems. It is 
incumbent on the applicant to define a set of core concepts that all students 
in the program will master. Core courses in statistics might include 
mathematical statistics, including theory of estimation and inference; 
probability theory; linear models, including regression analysis of variance 
and generalized linear models; non parametric methods; and data analysis.  
Core courses in biology should be designed to provide fundamental knowledge 
in basic biomedical research, whereas core computational courses should focus 
on understanding the foundations of bioinformatics and computational biology.  
Courses in these areas might include, but are not limited to, basic concepts 
in molecular biology, genetics, computer algorithms, and databases, including 
algorithms developed in computational biology and bioinformatics.    

o Student interactions:  It is important to provide forums that enable 
predoctoral and other students in biostatistics to interact with one another 
and with visiting scholars in their field.  The aim is to help students 
develop a sense of identity within their field and expose them to successes 
and challenges in biostatistics research.  Mechanisms for fostering student 
interactions may include seminar series with presentations from students, 
faculty and outside speakers; retreats; and journal clubs.

o Teaching skills: To produce a workforce that can assume faculty positions 
at academic institutions, trainees should be given the opportunity to learn 
teaching methods and be provided with opportunities to teach.

o Involving industry in creative ways:  Industry provides significant 
research opportunities for biostatisticians.  Affiliate programs should be 
considered that provide exposure to industrial research and development 
through internships and other activities.

o Academic and career advising: Early mentoring of students concerning their 
academic and career options is an important factor in the success of all 
training programs.  The special considerations involved in deciding between 
careers in industry and academia should be discussed, as should methods for 
developing skills for obtaining research funding.

o Monitoring students:  Students should be monitored throughout their 
graduate careers with close attention paid to time to degree and retention in 
the program.

MECHANISM OF SUPPORT 

This program announcement will use the National Research Service Award (NRSA) 
Institutional Training Grant mechanism (T32).  Predoctoral institutional 
training grant funds are intended to support trainee stipends; partially 
cover tuition, fees, and health insurance; and provide modest sums for 
equipment, supplies, and travel to scientific meetings.  Predoctoral trainees 
may receive up to five years of support under the NRSA provisions. However, 
the normal period of support for trainees on NIGMS institutional predoctoral 
training grants is between one and three years, and is typically offered in 
the early years of training to provide students with flexibility to select 
courses, laboratory rotations, and mentors. 

Institutional training grants are awarded for project periods of up to five 
years and are renewable. Awards within an approved competitive segment are 
normally made in 12-month increments with support for additional years based 
on satisfactory progress and the continued availability of funds.  
Information on the policies governing the institutional predoctoral training 
grant awards, including notification, tenure, trainee eligibility, and other 
provisions, may be found on the NIH home page at 
http://grants.nih.gov/training/extramural.htm. 

ELIGIBLE INSTITUTIONS 

Applications may be submitted by domestic, non-profit, private and public 
institutions with established programs leading to the Ph.D. degree.  The 
applicant institution must have a strong research program in the areas 
proposed for research training. 
   
ELIGIBLE TRAINING PROGRAM DIRECTORS

Any individual with the skills, knowledge, and resources necessary to 
organize and implement a high-quality research training program is invited to 
work with his/her institution to develop an application for support.  
Individuals from underrepresented racial and ethnic groups as well as 
individuals with disabilities are always encouraged to apply for NIH 
programs.  The research training program director at the institution will be 
responsible for selection and appointment of trainees to the NRSA research 
training grant and for the overall direction, management, and administration 
of the program.    

ELIGIBLE TRAINEES

Predoctoral students appointed to the training program must have the 
opportunity to carry out supervised biomedical research with the primary 
objective of developing or extending their research skills and knowledge in 
preparation for a research career.  Predoctoral trainees must have received a 
baccalaureate degree by the beginning date of their NRSA appointment, and 
must be training at the post-baccalaureate level and enrolled in a program 
leading to a Ph.D. in science or in an equivalent research doctoral degree 
program.

A trainee must be a citizen or non-citizen national of the United 
States or must have been lawfully admitted for permanent residence. 
Individuals on temporary or student visas are not eligible. 

ALLOWABLE COSTS 

Details about allowable costs and current stipend levels are available at 
http://grants.nih.gov/training/nrsa.htm.

Stipends:  National Research Service Awards provide funds to graduate student 
trainees in the form of stipends.  A stipend is provided as a subsistence 
allowance to help trainees defray living expenses during the research 
training experience.  It is not provided as a condition of employment with 
either the Federal Government or the awardee institution.  Stipends must be 
paid to all trainees at the levels approved by the Secretary of the 
Department of Health and Human Services.  

The training institution may not alter established stipend levels.  Further, 
stipend amounts are not to be changed in the middle of an appointment period.  
Stipends may be adjusted only at the time of appointment or reappointment.  
Finally, stipends must be based on the levels established for the current 
fiscal year of the grant.  

Tuition, Fees, and Health Insurance:  The NIH will offset the combined cost 
of tuition, fees, and health insurance (either self-only or family as 
appropriate), currently at the following rate: 100 percent of all costs up to 
$3,000 and 60 percent of costs above $3,000.  Costs associated with tuition, 
fees, and health insurance are allowable only if they are applied 
consistently to all persons in a similar research training status at the 
institution regardless of the source of support.  A full description of the 
tuition policy is contained within the Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2003/index.htm. 

Other Trainee Costs: Trainee travel, including attendance at scientific 
meetings that the institution determines to be necessary to the individual's 
research training, is an allowable trainee expense.

Training Related Expenses: Currently, institutional costs of $2,200 a year 
per predoctoral trainee may be requested to defray the costs of other 
research training related expenses, such as staff salaries, consultant costs, 
equipment, research supplies, and travel expenses for the training faculty.  
Training related expenses may be adjusted in future fiscal years. 

Facilities and Administrative Costs:  A facilities and administrative 
allowance (indirect cost allowance) based on 8 percent of total allowable 
direct costs (this excludes amounts for tuition, fees, health insurance, and 
equipment) may be requested.  Applications from state and local government 
agencies may request full indirect cost reimbursement. Information on 
Facilities and Administrative Costs is available in the Grants Policy 
Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm.
 
WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA 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:

John Whitmarsh, Ph.D.
Center for Bioinformatics and Computational Biology 
National Institute of General Medical Sciences
Building 45, Room 2AS.55F
Bethesda, MD  20892
Telephone:  (301) 451-6446
FAX:  (301) 480-2802
Email: Whitmarj@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
Building 45, Room 3AN.12F
Bethesda, MD  20892
Telephone:  (301) 594-2881
Fax:  (301) 480-8506
Email: sunshinh@nimgs.nih.gov

o Direct your questions about financial or grants management matters to:

Grace Olascoaga
Grants Management Analyst
National Institute of General Medical Sciences
Building 45, Room 2AN.32E
Bethesda, MD  20892
Telephone:  (301) 594-5520
FAX:  (301) 480-2554
Email: olascoag@nigms.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using institutional NRSA section of 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 is available at: 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

Helpful information for preparing applications and organizing required 
materials for NIGMS institutional training grant applications can be found 
at: http://www.nigms.nih.gov/training/nrsatablesintro.html.

The Center for Scientific Review (CSR) will not accept any application in 
response to this PA that is essentially the same as one currently pending 
initial review unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of a substantial 
revision of an unfunded version of an application already reviewed, but such 
an application must include an Introduction addressing the previous critique.  

Applications must be mailed on or before the receipt date listed on the first 
page of this PA.  

Submit a signed, original application, including the checklist, and five 
signed copies of the application in a single package to:

Mailing Address:

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)

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the Center 
for Scientific Review and responsiveness by NIGMS.  Incomplete and/or 
nonresponsive applications will not be reviewed.  Applications that are 
complete and responsive to the PA 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 selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Advisory General Medical 
Sciences Council

REVIEW CRITERIA

Applications will be reviewed according to the review criteria outlined in 
the “NIH NRSA Institutional Research Training Grants” 
(
http://grants1.nih.gov/grants/guide/pa-files/PA-02-109.html) and on the 
NIGMS website (http://www.nigms.nih.gov/training/nrsatablesintro.html).   

Review criteria related to this PA include:

Program Direction/Administrative Structure

o Research, training, and leadership ability of the program director
o Adequacy of the program administration and advisory structure

Training Faculty

o Composition of the faculty (by rank and distribution in different 
fields/departments)
o Mechanisms and criteria for inclusion/exclusion of faculty
o Current independent research grant support (obtained through peer-reviewed 
competition)
o Publication records
o Nature and breadth of research conducted
o Evidence of collaboration and cooperation among faculty members
o Experience in the supervision of research training (related to the proposed 
program)

Training Program

o Aims of the program in relation to this program announcement
o Program components (nature and extent of courses, research/rotation 
opportunities, seminars, examinations, teaching opportunities, other), 
including any innovative features
o Opportunities for interdisciplinary training and collaborative research
o Provisions/activities to promote cohesiveness of the program
o Integration of biostatistics and basic biomedical research
o Mechanisms to monitor and guide trainees (e.g., by the Ph.D. degree 
departments/programs, training program, mentors, thesis committees)

Applicant Pool

o Size and distribution (regional or national, proportion eligible for 
training grant support)
o Quality (based on academic credentials and other factors, e.g., research 
experience)

Trainees and Candidates for Training

o Mechanisms and criteria for the recruitment and selection of trainees
o Number; distribution in departments, programs, and among training faculty
o Caliber of current and/or potential trainees and others identified with the 
program
o Racial and ethnic diversity of the trainee pool (including participation of 
underrepresented minority students)
o Quality of research; postdoctoral and career plans

Research and Training Environment

o Institutional support for the training program
o Other sources of training support available
o Facilities and resources available to the program (including clinics, where 
relevant)
o Numbers of predoctoral and postdoctoral students affiliated with 
participating laboratories

Outcomes (where relevant for existing programs)

o Record of completion of training
o Average time to completion of Ph.D. degree
o Publication records of past and current trainees
o Success of graduates:  nature, quality, and research relevance of 
subsequent positions--e.g., postdoctoral, academic, industrial, clinical

ADDITIONAL REVIEW CONSIDERATIONS 

MINORITY RECRUITMENT PLANS:  Plans to recruit and retain minority trainees is 
a factor in the assessment of the quality of the trainee pool and thus will 
be included within the priority score.  In addition, peer reviewers will 
separately evaluate the minority recruitment plan after the overall score has 
been determined.  Reviewers will examine the strategies to be used in the 
recruitment of minorities, and whether any prior experience in recruitment of 
minorities has been incorporated into the formulation of the plan for the 
next award period.  The evaluation will be included in an administrative note 
in the summary statement.  If the plan for minority recruitment and retention 
is judged to be unacceptable, funding will be withheld until a revised plan 
that addresses the deficiencies is a received.  Staff within the NIGMS, with 
guidance from the National General Medical Sciences Advisory Council, will 
determine whether amended plans and reports submitted after the initial 
review are acceptable. Additional information on this requirement was 
published in the NIH Guide for Grants and Contracts, Volume 22, Number 25, 
July 16, 1993 (see 
http://grants.nih.gov/grants/guide/notice-files/not93-188.html). 

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH:  Every predoctoral NRSA 
trainee supported by an institutional research training grant must receive 
instruction in the responsible conduct of research. Applications must include 
a description of a program to provide formal or informal instruction in 
scientific integrity or the responsible conduct of research.  Applications 
without plans for instruction in the responsible conduct of research will be 
considered incomplete and may be returned to the applicant without review.  
Although the NIH does not establish specific curricula or formal 
requirements, all programs are encouraged to consider instruction in the 
following areas: conflict of interest, responsible authorship, policies for 
handling misconduct, policies regarding the use of human and animal subjects, 
data management, and data sharing. (For more information on this provision, 
see the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 
27, 1992 at: 
(http://grants.nih.gov/grants/guide/notice-files/not92-236.html). 
The plans for responsible conduct of research will be discussed 
after the overall determination of merit, so that the review panel's 
evaluation of the plans will not be a factor in the determination of the 
priority score.  Plans will be judged as acceptable or unacceptable.  The 
acceptability of the plan will be described in an administrative note on the 
summary statement.  

AWARD CRITERIA

Applications submitted in response to this PA will compete for available 
funds with all other recommended applications.  The following will be 
considered in making funding decisions:  

o Quality of the proposed training program as determined by peer review
o Availability of funds 
o Relevance to program 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 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.)

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 subject 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.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.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.


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and Human Services (HHS)
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