SUMMER INSTITUTE FOR TRAINING IN BIOSTATISTICS (SIBS)
RELEASE DATE: January 2, 2003
RFA: HL-03-010 (Requesting competing renewal application, see NOT-HL-05-118)
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov)
LETTER OF INTENT RECEIPT DATE: February 25, 2003
APPLICATION RECEIPT DATE: March 25, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research 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 Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Heart, Lung and Blood Institute (NHLBI) invites applications for
a grant to develop, conduct, and evaluate a summer course in the basic
principles and methods of biostatistics as employed in biomedical research.
The course would introduce advanced undergraduate students to the field of
biostatistics for the purpose of attracting new students into the field as a
response to the dwindling national pool of trained bio-statisticians. The
course will attract students from the entire USA and will cover the
fundamental concepts of probability, statistical reasoning and inferential
methods motivated, in part, by examples that include data collected in
studies of heart, lung, blood, and sleep disorders. The course will be
developed during the first year and taught during the summers of 2004, 2005,
2006, with appropriate modifications or refinements following each of the
first two summer sessions.
RESEARCH OBJECTIVES AND SCOPE
Background
Biostatistics is a fundamental scientific component of biomedical and public
health research. Traditional and emerging methodologies are used in clinical
trials, observational or epidemiologic studies, medical imaging, and
genomics. The current demand for biostatisticians far exceeds the supply and
the gap is expected to continue to widen. This under supply results from a
combination of burgeoning need and a relatively flat rate of graduating
doctoral- and masters-level biostatisticians. A large proportion of the
currently senior biostatisticians were trained in the late 1960's and early
1970's and were supported during the early stages of their careers by
National Institutes of Health (NIH) training initiatives. With this cohort
approaching retirement over the next decade and the tremendous needs and
opportunities, now is the time for the government and private sector to re-
invest in the training of the next generation of biostatisticians.
Objectives and Scope
The goal of this announcement is to stimulate applications for a Summer
Institute for Training in Biostatistics (SIBS) to increase interest in the
field of biostatistics among advanced undergraduate students majoring in
mathematics or another quantitatively oriented area of study. This program
is definitely not intended to provide an in-depth basic course in the subject
nor is it intended to be a standard introductory course in statistics. SIBS
would, instead, comprise an innovative introduction to some basics of
probability and elementary statistical methods motivated by a series of
examples illustrating the use of probability and statistical reasoning
applied to the design and analysis of data from studies including those of
the heart, lung, blood, and sleep disorders. There is a wealth of data from
observational cohort studies and numerous clinical trials
(http://www.nhlbi.nih.gov/resources/deca/default.htm) that can be used to
demonstrate the essential role biostatistics plays in medical research.
An essential aspect of the course will be the use of a personal computer by
each student. The PC will be an indispensable learning tool for
understanding and using some of the fundamental elements of data analysis.
For this reason, instruction in the use of a basic programming language, such
as S-plus, would comprise part of the early classroom instruction. Applicants
are encouraged to be as creative as possible, since the primary goal of the
course is to attract the interest of potential biostatistics students.
Depending on the level and interest of the students, the following are
examples of the concepts to be covered and the approach to be used in their
assignments.
o Descriptive statistics (measures of central tendency and dispersion,
histograms) are formally presented followed by a PC-based demonstration
using real data. Student assignments would repeat these calculations on
individually chosen samples from real data sets.
o Students learn to draw random samples from data sets and compute measures
of central tendency and sample proportions. With this skill they explore the
nature of the distributions of these quantities in the context of repeated
sampling from a large data set. This sets the stage for introducing the
normal, Student's t, and binomial probability distributions.
o Using an epidemiology cohort study data set, possibly from one of those
funded by NHLBI, instructors demonstrate the concept of adjusted (for age,
race, gender, etc.) rates of disease incidence and mortality. Students learn
how to compute and compare these rates in different subsets of the cohort.
o A classroom exposition of some of the details underlying the results of an
actual epidemiologic cohort study reported in the media.
o The principles underlying the randomized clinical trial are introduced
using data from one of the clinical trials related to disorders of the heart,
lung, blood, or sleep. Students learn some of the subtleties of the conduct
and interpretation of data using, for example, the Cardiac Arrhythmia
Suppression Trial as a case study.
o A review of several published studies where flawed analyses have produced
misleading results.
o Guest lectures by one or more investigators who have recently completed
studies that have attracted media attention.
The course will take a creative approach to engaging students' interest,
perhaps through data associated with topics pertaining to their own
particular interest. They should be expected to spend time outside of class
on individual assignments involving projects that address questions related
to selected data sets. Assuming a summer schedule of classes with perhaps
four hours of class and laboratory each day over a five to six week period,
the course may reasonably qualify as a one year credit course in basic
statistics that many undergraduate curricula require.
Proposals for SIBS should indicate criteria for student selection and the
number of students expected per class, and should include specific plans for
evaluating the effectiveness of the course in terms of students' perceptions
of the material and conduct of the course. In addition, there must be plans
in place to assess the longer-term impact, as measured by students'
subsequent choice of vocation and field of graduate study.
MECHANISM OF SUPPORT
This RFA will use the NIH Continuing Education Training Grant award mechanism
(T15). As an applicant you will be solely responsible for planning,
directing, and executing the proposed project. This RFA is a one-time
solicitation. 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 September 30, 2003.
This RFA uses just-in-time concepts. It also uses the non-modular budgeting
format.
FUNDS AVAILABLE
The NHLBI intends to commit approximately $250,000 in FY 2003 to fund one new
grant in response to this RFA. An applicant may request a project period of
up to 4 years and a budget for total costs of up to $250,000 per year.
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. It is anticipated that the award for the second
budget period may be issued as early as July 1, 2004, to assure sufficient
support for the first course offering in the summer of 2004. Although the
financial plans of the NHLBI 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 is a domesticc
organization and 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
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
SPECIFIC REQUIREMENTS
The proposed program must include and the applicant must address the
following issues in the application:
o The program structure enables awarding course certification and/or course
credit towards an undergraduate degree.
o Databases from published reports of clinical trials and epidemiologic
studies related to disorders of the heart, lung, blood, and sleep, including
those with a genetic focus or from the National Health and Nutrition
Examination Survey (NHANES) funded studies are the source of examples for
student exercises. Selected data bases, suitably modified to insure
subjects' anonymity, can be accessed through The Division of Epidemiology and
Clinical Applications of NHLBI.
o The course approach is based on the use of personal computers, with
individual data-oriented projects depending on the students' level.
o Proposed distribution of the course announcement will be wide, in order to
attract students from the entire US.
o Student qualifications and the criteria for their selection are specified.
o All available faculty and facilities, including student housing, personal
computers, software, and classroom facilities are described.
o A formal evaluation is conducted at the end of first and second summer
courses to improve overall quality of the program.
o A dissemination plan is included. It describes the applicant's willingness
and plans for disseminating, via an Internet website, SIBS course materials,
including syllabi, manuals or handbooks, references, data sets and
assignments, and recommendations for best practices in teaching
biostatistics. The website will be available for use by other institutions
after the grant period.
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:
Dr. James E. Norman
Division of Epidemiology and Clinical Applications
National Heart, Lung and Blood Institute
Rockledge 2, Room 8110
Bethesda, MD 20892
Telephone: (301) 435-1298
FAX: (301) 480-1862
E-mail: jn3@nih.gov
o Direct your questions about peer review issues to:
Anne Clark, Ph.D.
Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Dr., Room 7214 (MSC 7924)
Bethesda, MD 20892-7924 (20817 for express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: clarka@nhlbi.nih.gov
o Direct your questions about financial or grants management matters to:
Marsha Mathis
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7158, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 435-0170
FAX: (301) 480-3310
Email: MathisM@nhlbi.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 IC 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 Dr. Anne Clark at the
address listed under WHERE TO SEND INQUIRIES.
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
SUPPLEMENTAL INSTRUCTIONS: Applicants should employ the forms and format for
Institutional National Research Service Award, described in section V of Form
PHS 398, which can be found at
https://grants.nih.gov/grants/funding/phs398/instructions2/p1_preparing
_NRSA_app.htm. However, because section V provides instructions for
submitting a traditional training grant (T32) and the present T15 mechanism
is considerably different, applicants are encouraged to modify the format
appropriately. In addition, applicants should use form pages 4 and 5 for
preparing the budget information for this application. Forms suitable
for use in a word processor can be found at
https://grants.nih.gov/grants/funding/phs398/fp4.rtf and
https://grants.nih.gov/grants/funding/phs398/fp5.rtf, respectively.
Allowable Costs
Allowable costs must be consistent with NIH policy and be reasonable,
allocable, well documented and justified for SIBS. Grant funds may not be
used to supplant funds or resources otherwise available at the applicant
institution.
Personnel Costs - individuals participating in the design and implementation
of the SIBS program may request salary and fringe benefits appropriate for
the percent of time devoted to the program. Normally, all personnel costs
(including administrative and clerical costs) associated with directing,
coordinating, and administering the program are not expected to exceed 25% of
the total direct cost. Salaries requested may not exceed the levels
commensurate with the institution's policy for similar positions and may not
exceed the Congressionally mandated maximum ($166,700 in fiscal year 2002).
Limited administrative and clerical salary costs associated distinctly with
the program that are not normally provided by the applicant organization may
be direct charges to the grant only when specifically identified and
justified. Consultation costs, equipment, supplies, necessary travel, and
other program related expenses must be justified as specifically required by
the program proposed and not duplicate items generally available for programs
at the host institution.
Except for housing and meals expenses, undergraduate students may not receive
support for participating in the SIBS program. Funds will not be provided
for fringe benefits or health insurance for students involved in the SIBS
program.
Partial costs for off-site rental space will be considered if it is short
term and shown to be necessary for the implementation and execution of the
SIBS program ( computer lab, etc.). Matching funds from applicant
institutions or other organizations for such off-site costs are strongly
encouraged.
Facilities and Administrative (F&A) Costs, formerly known as "indirect
costs," will be reimbursed at a rate of 8% of modified total direct costs for
the applicant organization and any approved subcontract.
Normally, funds for the evaluation plan are not expected to exceed 5% of the
total direct cost.
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:
https://grants.nih.gov/grants/funding/phs398/label-bk.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
five collated sets of Appendix material must be sent to Dr. Anne Clark at the
address listed under WHERE TO SEND INQUIRIES.
APPLICATION PROCESSING: Applications must be received by 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.
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. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must
include an Introduction addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the (IC). Incomplete and/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 (IC) in accordance with the review criteria stated below. As
part of the initial merit review, all applications will:
o Receive a written critique
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 second level review by the National Heart, Lung and Blood
Advisory Council.
REVIEW CRITERIA
The proposed Summer Institute in Biostatistics program is intended to attract
students into the field of biostatistics. In the written comments, reviewers
will be asked to discuss the following aspects of your application in order
to judge the likelihood that the proposed training program will have a
substantial impact on the realization of this goal:
Training Program
o The potential effectiveness of the proposed course in training researchers
in biostatistics.
o Quality of the course content and adequacy of the syllabus.
o Criteria for selecting trainees and for awarding scholarships, for
publicizing the availability of the course to the target audience of active
researchers, and plans to reach students of both genders and all racial and
ethnic groups.
Program Leadership
o Training, experience, and competence of the faculty in biostatistics issues
applicable to this program.
Evaluation and Dissemination Plans
o Plans for conducting a formal evaluation of the course at the end of first
and second summer courses and to use the evaluation results to improve
overall quality of the program at its next offering.
o Plans for evaluating the effectiveness of
the course including longer-term impact, as measured by attendees' subsequent
activities or responsibilities in their institutions in the area of
biostatistics.
o Plans for disseminating course materials and recommendations
Institutional Commitment and Resources
o Adequacy and availability of any necessary institutional facilities, such
as the classroom and computer resources.
The scientific review group will address and consider each of these criteria
in assigning your application=s overall score, weighting them as appropriate
for each application.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans, animals,
or the environment, to the extent they may be adversely affected by the
project proposed in the application.
o INCLUSION: 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
included in the section on Federal Citations, below)
o 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: February 25, 2003
Application Receipt Date: March 25, 2003
Peer Review Date: June/July 2003
Council Review: September 2003
Earliest Anticipated Start Date: September 30, 2003
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
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 AMENDMENT "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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
https://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
https://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
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
https://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.
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.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.837, 93.838, 93.839 and is not subject to
the intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
administered under NIH grants policies described at
https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
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.