Full Text DE-95-006

SHORT-TERM TRAINING FOR ORAL HEALTH CLINICAL TRIALS

NIH GUIDE, Volume 24, Number 18, May 19, 1995

RFA:  DE-95-006

P.T. 34

Keywords: 
  Oral Diseases 
  Clinical Trial 


National Institute of Dental Research

Letter of Intent Receipt Date:  August 15, 1995
Application Receipt Date:  September 11, 1995

PURPOSE

The National Institute of Dental Research (NIDR) invites new
applications for National Research Service Award (NRSA) Short-Term,
Institutional Training Programs in the design and conduct of dental,
oral and craniofacial clinical trials.  The objective of the programs
to be supported through this Request for Applications (RFA) is to
provide short-term training for oral health research personnel
interested in becoming active members of teams that conduct clinical
trials sponsored by government and industry.

Background

The need for an increased number of appropriately trained personnel
in clinical or patient-oriented research (POR) has been highlighted
in numerous recent reports and studies.  POR is defined as "research
conducted with human subjects (or on material of human origin such as
tissues, specimens and cognitive phenomenon) for which the
investigator (or colleague) directly interacts with human subjects in
either an outpatient or an inpatient setting" (NIH, 1994).  The
personnel need for POR is especially great in oral health research.
The responsibility for ensuring the availability of sufficient
numbers of competent POR clinical scientists to meet the expanding
opportunities resulting from dental, oral, and craniofacial basic and
clinical research rests with the government, academia, and industry.
Strong recommendations that the NIDR encourage the training and
career development of clinical investigators, and specifically of
personnel knowledgeable about clinical trials, have been made by the
NIDR Dental Research Programs Advisory Committee, the National
Advisory Dental Research Council, the Institute of Medicine (IOM)
task force on clinical research in dentistry (which was part of the
1994 study by the IOM Committee on Addressing Career Paths for
Clinical Research), and at an NIDR  meeting in 1993 on training
requirements for dental, oral, and craniofacial clinical trials.

This RFA is one of several NIDR initiatives to address these critical
needs in POR.  The objective is to help develop a cadre of
well-trained investigators who are knowledgeable about the design and
conduct of clinical trials in oral health research, and who can
function as effective members of clinical trial teams.

Training must be relevant to the goals of the NIDR.  These include
research on: the causes, epidemiology, prevention, diagnosis and
treatment of dental caries, periodontal and soft tissue diseases,
salivary gland disorders, oral cancer, oral manifestations of AIDS
and HIV infection, and craniofacial anomalies including dentofacial
malrelations; fluorides and nutrition; orofacial pain;
temporomandibular disorders; behavioral, social, economic and
cultural factors related to oral diseases and disorders;
biomaterials; and research on older Americans, gender differences,
minorities, those with medical problems and disabilities, and
individuals and groups at high-risk for oral health problems.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Short-Term Training for Oral Health Clinical Trials, is related to
the priority area of oral health.  Potential applicants may obtain a
copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0 or Summary:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202/783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, public and private
institutions such as dental schools, dental research institutions,
schools of public health and universities.  Consortia arrangements
are encouraged.

An institution may have no more than three concurrent NRSA short-term
training grants from the NIDR: one conventional grant for dental
students; one for training of women and minority dental students; and
one resulting from this RFA.

Trainee Eligibility

Preference for training must be given to individuals who: (1) have
received a D.D.S./D.M.D., Ph.D., both an R.D.H. and Master's degree,
or equivalent degrees from an accredited domestic or foreign
institution; (2) hold postdoctoral, resident, or faculty appointments
in dental, dental hygiene, medical, or public health schools,
advanced dental education/research institutions, or universities, or
private industry positions that are involved with clinical trials;
and (3) demonstrate a commitment to clinical oral health research.
Consideration also may be given to those who recently have completed
a graduate program related to oral health or a clinical dental
specialty program, but have not yet obtained a full-time research
position.

Trainees must be citizens or non-citizen nationals of the United
States or have been lawfully admitted for permanent residence (i.e.,
in possession of the Alien Registration Receipt Card I-551 or I-151)
at the time of appointment.  Non-citizen nationals, although not
citizens of the United States, owe permanent allegiance to the U.S.
They are generally born in lands that are not states, but are under
U.S. sovereignty, jurisdiction, or administration.  Individuals on
temporary or student visas are not eligible.

MECHANISM OF SUPPORT

Awards made as a result of this RFA will be the National Institutes
of Health (NIH), NRSA Short-Term Institutional Research Training
Grant (T35).  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the program
director.  The total project period for applications submitted in
response to this RFA must be five years.  This RFA is a one-time
solicitation.  Awards may be renewable depending on program needs,
availability of funds, and submission of a successful competing
application.  The anticipated award date is July 15, 1996.

FUNDS AVAILABLE

The NIDR expects to make up to five new awards, each with five
positions, at a total first year cost of approximately $150,000 for
all awards, in response to this RFA.  This level of support is
dependent on the receipt of a sufficient number of applications of
high scientific and educational merit.  Although this program is
provided for in the financial plans of the NIDR, these awards are
contingent upon the availability of funds.

RESEARCH OBJECTIVES

The program must provide opportunities for individuals with a variety
of training, research, and clinical backgrounds to develop skills in
the design and conduct of clinical trials for dental, oral, and
craniofacial conditions.  There is no expectation that these
short-term training programs will allow participants to serve as
principal investigators or directors of clinical trials immediately.
The courses are expected to enable trainees to become active and
integral members of clinical trials teams, be able to evaluate and
interpret published reports of clinical trials critically, and be
able to communicate these skills to predoctoral and postdoctoral
students, oral health professionals, and scientists in private
industry.

The program must include a core curriculum of formal instruction in
the design, conduct, analysis, and presentation of results from
single center and multicenter clinical trials.  Topics such as the
following should be included: study organization and administration,
including roles and responsibilities of team members; developing
specific aims and primary and secondary endpoints for the trial;
principles of hypothesis testing; importance and use of preliminary
studies; preparing a detailed clinical protocol (containing at least
inclusion and exclusion criteria, patient assignment procedures,
study designs and potential biases, randomization, sample size
calculations); issues related to patient availability, recruitment,
and retention; data integrity, management, quality control, and
analysis; appropriate use of oral, dental, and craniofacial indices
and measures; quality assurance of biological specimens and other
individual measures, such as radiographs; protection of human
participants, biohazard safety of employees and subjects, informed
consent and assent, ethics in research and scientific integrity,
responsible conduct of research; statutory mandates, such as the
inclusion of women and minority subjects in trials funded by the NIH;
the need for and purposes of a data and safety monitoring board;
government regulatory issues, especially from the Food and Drug
Administration; and issues related to trials performed by private
industry.  There should be opportunities for practical experiences
such as observing and participating in various phases of ongoing
clinical trials.

The training program director will be responsible for the selection
and appointment of trainees and for the overall direction of the
program.

Each applicant may request up to five positions for each year over
the five-year period.  The number of positions awarded will be
determined by the initial review group's assessment of scientific and
educational merit, program needs, and the availability of funds.  The
length of the short-term training experience and of trainee support
may vary from one to three months per year and the training must be
full-time, during this period.  Successful trainees may be
reappointed for a continuing course of training, not to exceed two
appointments.

Program directors and potential trainees should be aware that an
individual may receive up to three years of NRSA support at the
postdoctoral level, including any combination of support from
institutional training awards and individual fellowship awards.
Appointments on these short-term training programs will be included
in the calculation of the total period of NRSA support.  Extensions
beyond the three year period require a waiver from the NIDR.
However, well-qualified potential trainees may anticipate favorable
consideration of a waiver request.  People receiving support under
individual or other institutional NRSA training grants are not
eligible for appointment to these short-term programs.

Training grants may not be used to support studies leading to a
D.D.S./D.M.D. or other similar professional degrees, or to support
residencies, or other training for dentists providing care to
patients where the majority of their time is spent in non-research
clinical training.  However, if a specified period of full-time
research training is creditable toward specialty board certification,
the training grant may support such research training if the trainee
has shown a clear interest in a research career.

Applicants are reminded of the importance the NIDR places on
recruitment and retention of women and underrepresented minorities to
sponsored training and career development programs.  Where feasible,
women and minority mentors should be involved as role models.

Additional information regarding NRSA Institutional Research Training
Grants is given in the NIH Guide for Grants and Contracts (NIH
Guide), Vol. 23, No. 21, June 3, 1994.  Copies of the NIH Guide are
usually available in the office of sponsored research of most
academic institutions and from the Office of Grants Information,
Division of Research Grants, at the address below.

Stipends and Other Training Costs

For postdoctoral trainees, the annual stipend is determined by the
number of years of relevant postdoctoral experience at the time of
appointment.  Relevant experience may include research, including
industrial; teaching; internship; residency; clinical practice; or
other time spent in a health-related field beyond that of the
qualifying doctoral degree.  Stipends will be prorated on a monthly
or weekly basis.  The postdoctoral annual stipends are as follows:

Years of Relevant Experience            Stipend

     Less than 1 year                   $19,608
     1                                   20,700
     2                                   25,600
     3                                   26,900
     4                                   28,200
     5                                   29,500
     6                                   30,800
     7 or more                           32,300

Stipends may be supplemented by an institution from non-Federal
funds.  Other NIH funds may not be used to supplement stipends.
Non-NIH Federal funds may not be used for stipend supplementation
unless specifically authorized under the terms of the program from
which the supplemental funds are derived.  An individual may make use
of Federal educational loan funds or Department of Veterans' Affairs
benefits when permitted by those programs.  Under no circumstance may
the condition of stipend supplementation detract from or prolong the
training.

Institutional costs of $2,500 per year per postdoctoral trainee
($1,500 per year per predoctoral trainee), prorated on a weekly or
monthly basis, may be requested to defray the cost of training
related expenses, such as tuition, fees, supplies, consultant costs,
equipment, and other expenses.  Fringe benefits are not provided by
this award.  No allowance will be provided for dependents or for an
individual's travel to the training site.

An indirect cost allowance based on eight percent of total allowable
direct costs or actual indirect costs, whichever is less, may be
requested.

Payback Provisions

All postdoctoral trainees must sign an agreement to fulfill NRSA
payback requirements.  They incur one month of payback obligation for
each month of support in the first twelve months of support.  This
obligation will be satisfied by continuing on a NRSA training grant
for an additional 12 months.  For payback obligations which are not
satisfied in this way, trainees must engage in biomedical or
health-related behavioral research and or teaching for a period equal
to the period of support up to 12 months.  The obligated service must
be undertaken continuously within two years after termination of
support.  Individuals who fail to fulfill the obligation through
service must pay back the total amount of funds paid to the
individual for the obligation period plus interest at a rate
determined by the Secretary of the Treasury.  Financial payback must
be completed within three years of the date the United States becomes
entitled to recover such amount.

Under certain conditions, the Secretary of Health and Human Services
may extend the period for starting service or for repayment, permit
breaks in the period of service or repayment, or otherwise waive or
suspend the payback obligation of an individual.

Officials of the applicant organization responsible for recruitment
of trainees should familiarize themselves with the terms of the
payback service requirement and explain them carefully to prospective
trainees before an appointment to the training grant is offered.

For additional information, including the grounds for approving
extensions of support and payback provisions, refer to the
announcements in the NIH Guide, "National Research Service Awards -
Guidelines for Individual Awards - Institutional Grants," Special
Edition, Volume 13, No. 1, January 6, 1984, and "Modification of the
NRSA Service Payback Obligation," Volume 22, No. 27, July 30, 1993.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some new
provisions that are substantially different from the 1990 policies.
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508- 14513), and
reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18,
1994, Volume 23, Number 11.

Investigators may obtain copies from these sources or from the
program staff or contact person listed under INQUIRIES.  Program
staff may also provide additional relevant information concerning the
policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by August 15, 1995, a
letter of intent that includes a descriptive title of the proposed
short-term training program, the name, address, and telephone number
of the Program Director, the identities of other key personnel and
participating institutions, and the number and title of the RFA in
response to which the application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is helpful in planning for the review of
applications.  It allows NIDR staff to estimate the potential review
workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to James A. Lipton, D.D.S., Ph.D.
at the address under INQUIRIES.

APPLICATION PROCEDURES

It is strongly recommended that prospective applicants contact Dr.
Lipton early in the planning phase of application preparation.  Such
contact may help ensure that applications are responsive to this RFA.
Applications must be submitted on form PHS 398 (rev. 9/91).
Application forms are available at most institutional offices of
sponsored research and from the Office of Grants Information,
Division of Research Grants, National Institutes of Health, 6701
Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892-7762,
telephone (301) 435-0714; and from Dr. Lipton at the address listed
under INQUIRIES.

Each applicants may request up to five positions for each of the five
years of the award.  The exact length of the proposed training
experience is left to the discretion of the applicant and may vary
from one to three months.  The budget request must correspond to the
proposed training period(s).

A plan must be included for the recruitment of women and individuals
from minority groups that are nationally underrepresented in these
sciences.  No awards will be made to applications lacking this
component.

Applications must include a description of formal and or informal
activities related to instruction about the responsible conduct of
research to be incorporated into the proposed research training
program.  Information must be provided on the rationale, subject
matter, appropriateness, format, and the frequency and duration of
instruction; and the amount and nature of faculty participation.  No
award will be made if an application lacks this component.

Information regarding, "Modification of Existing Review Criteria for
NRSA Institutional Research Training Grants," is given in the NIH
Guide, Vol. 21, No. 11, March 20, 1992.

To identify the application as a response to this RFA, check "YES" on
item 2a of the face page of the application and enter "RFA:
DE-95-006, Short-term Training for Oral Health Clinical Trials."  The
RFA label available in the application form PHS 398 must be affixed
to the bottom of the face page.  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.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed, photocopies, in one package to:

DIVISION OF RESEARCH GRANTS
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
also must be sent to:

H. George Hausch, Ph.D.
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN-44F
45 Center Drive, MSC 6402
Bethesda, MD  20892-6402
Telephone:  (301) 594-2372

This RFA is for a single competition.  Applications must be received
by September 11, 1995.  If an application is received after that date
it will be returned to the applicant without review.

REVIEW CONSIDERATIONS

Applications will be reviewed for completeness and responsiveness to
the RFA by DRG and NIDR staff.  Incomplete or nonresponsive
applications will be returned to the applicant without further
consideration.  Remaining applications may be subjected to triage by
a special grants review committee, convened by the NIDR Scientific
Review Section, to determine their merit, relative to others received
in response to the RFA.  The NIDR will withdraw applications judged
to be noncompetitive and notify the applicant.  Applications judged
to be competitive will be evaluated for scientific and technical
merit by the review committee.

The following review criteria will be applied:

o  The proposed research training and program design; the core
curriculum; the opportunities for observing and participating in
various phases of ongoing clinical trials; the quality of such
practical experiences; the appropriateness of the length of the
proposed training program; the unique or innovative aspects of the
training program.

o  The qualifications of the program director and participating
faculty including the roles of specific instructors or preceptors,
their time commitment, ability to compete for research support,
current clinical trials activities and experience in graduate
clinical research training.

o  Procedures for recruitment and selection of trainees, including
women and minorities; availability of high-quality candidates; and
how the trainees will be mentored and their progress monitored.

o  Training environment: institutional commitment, the quality of the
facilities, and the availability of research support; level of
ongoing clinical research activity; availability of equipment,
facilities, and clinical resources.

o  The quality of instruction in the responsible conduct of research
and scientific integrity.

Secondary review will be by the National Advisory Dental Research
Council.  Among the information the Council considers will be the
report of the special review committee on the plans for recruiting
women and individuals from underrepresented minority groups.

The NIDR will notify the applicant of the Council's action shortly
after its meeting.

Review and Award Schedule

Applications will be processed according to the following schedule:

Letter of Intent Receipt Date:  August 15, 1995
Application Receipt Date:       September 11, 1995
Initial Review Group Meeting:   February 1996
Council Meeting:                June 1996
Earliest Date of Award:         July 15, 1996

AWARD CRITERIA

Funding decisions will be based on the recommendations of the special
review committee and the National Advisory Dental Research Council.
The earliest award date is July 15, 1996.

The NIDR appreciates the value of complementary funding from other
public and private sources, including foundations and industrial
concerns, for activities that will complement and expand those
supported by the NIDR.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues to:

James A. Lipton, D.D.S., Ph.D.
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN-18J
45 Center Drive, MSC 6402
Bethesda, MD  20892-6402
Telephone:  (301) 594-2618 or 594-7710
FAX:  (301) 480-8318
Email:  LIPTONJ@DE45.NIDR.NIH.GOV

Direct inquiries pertaining to grants management issues to:

Mr. Martin Rubinstein
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN-44A
45 Center Drive, MSC 6402
Bethesda, MD  20892-6402
Telephone:  (301) 594-4800

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.121.  NRSA Institutional Research Training Grants
are made under the authority of Section 487 of the Public Health
Service (PHS) Act as amended (42 USC 288), Title 42 of the Code of
Federal Regulations, Part 66, is applicable to this program.  This
program is not subject to the intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-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 routing 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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