Title: GCRC news
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Title: GCRC news
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Language: English
Creator: General Clinical Research Center, University of Florida
Publisher: General Clinical Research Center, University of Florida
Place of Publication: Gainesville, Fla.
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Inside This Issue

From the Director

GCRC Core Lab

Scatterbed Research

User-Friendly GCRC

NCRR Opportunities

~K23 Grant

~K24 Grant

GCRC Courses

Points of Interest

* UF GCRC awarded $19
million from NIH
* DNA Bank plans under-
* GCRC announces new
course in bioethics


The life of a clinical or basic scientist is one of delayed gratification, and this
fact of life certainly has been in evidence while the GCRC waited for its com-
petitive renewal award notice and its new budget. Those have recently come to
pass, and the Center has just embarked on the first year of a five-year cycle of
funding to the tune of over $19 million--the largest extant federal grant at the
University of Florida. The award is a tribute to so many individuals throughout
the University and Shands Hospital that it would take the entire newsletter to
list them. However, particular thanks go to the Center's dedicated staff and to
our faculty and trainees who utilize the GCRC and whose protocols reflect the
high praise and meritorious review accorded them by the NIH. On these long
coattails, yours truly recently became President-Elect of the national GCRC
Program Director's Association.

With the new budget come new resources, some of which have been detailed in
previous issues of the GCRC News. Several of these deserve renewed attention
here, as do two GCRC-sponsored courses coming up this summer and fall for
interested faculty and trainees.

By the way, this new format for our newsletter reflects the creativity of Douglas
Theriaque, Informatics Manager, and Nevil Parker, Program Assistant, of the


The Sample Processing and DNA
Bank portions of the Core Laboratory
are in the process of becoming CLIA-
certified. The Sample Processing
Laboratory will be certified for the
purpose of glucose, lactate, P-HCG,
and routine urine analyses. This
year, the lab will also implement a
bar coding strategy to help anony-
mize samples that will also aid in tri-
aging and storing samples of body
fluids and tissues from subjects stud-

ied on the GCRC. This will be an im-
portant advance in providing sample
identifiers that meet current federal
guidelines for maintaining patient
confidentiality and data integrity.

The DNA Bank, under the direction
of GCRC Associate Director, Mark
Brantly (brantml@medicine.ufl. edu),
will be hiring an individual to assist
in the isolation, coding, and storage
of peripheral blood cells, serum, and


9, No 1


plasma for current and future genetic
investigations. These samples will be
linked to a brief, disease-specific ques-
tionnaire. All subjects (volunteers or
patients) who enroll in a GCRC study
will be asked by a Center representative
to sign a consent form distinct from and
in addition to the traditional Informed
Consent that accompanies their enroll-
ment in a specific study. The separate
consent form will relate to the database
questionnaire and blood products, all of
which will be owned by the GCRC.
Investigators who wish to access this
genetic information subsequently may
do so, provided that their hypothesis-
driven protocol is approved by the IRB
and the GCRC Advisory Committee.

For example, Investigator A has a pro-
tocol to enroll patients with type 1 dia-
betes. Some of those subjects will pro-
vide consent (or assent) to donate a
small amount of blood to the GCRC for
the DNA Bank. A year later, Investiga-
tor B, who works principally in the area
of hypertension, may wish to search for
disease-specific genes using the stored
leukocyte DNA from the type 1 diabe-

tes patients. Accordingly, Investigator B
submits a protocol to the IRB and the
GCRC's Advisory Committee that, if ap-
proved, provides him or her with the
relevant patient databases and a portion
of each subject's DNA.

Once the DNA bank is fully operational,
we anticipate that the Center may obtain
up to 1,500 new samples per year. With
time, we hope this will provide a unique
and diverse repository for genetic inves-

We are also in the process of hiring a
new laboratory director and a senior re-
search chemist for the Biomedical Mass
Spectrometry Laboratory of the Core
Lab. These searches are being coordi-
nated by Core Lab Director George Hen-
derson (hendegn@medicine.ufl.edu) and
by Mark Brantly. Filling these skilled
positions will be essential to provide
GCRC investigators with timely exper-
tise in methods-development and appli-
cation for the analysis of xenobiotics and
naturally occurring compounds, from
small molecules to proteins.


Associate Program Director, Des
Schatz (schatda@peds.ufl.edu) heads
this important resource. A scattered
protocol is one that, either because of
its complexity, the medical state of the
subjects, or the logistical challenges of
conducting the research, cannot appro-
priately be conducted in the GCRC per
se. Accordingly, studies are under-
taken, solely or in part, under the so-
called scatterede" designation. This
applies to protocols conducted in inten-
sive care units, emergency or operating

rooms, imaging suites, off-campus clin-
ics, and so on.

The GCRC has research nurses whose
time is dedicated fully to scattered re-
search. Moreover, scattered protocols
may be benefited by support from the
GCRC for ancillary laboratory costs,
core laboratory analyses and biostatisti-
cal support. We are anxious to increase
the number and diversity of scattered
protocols, and interested individuals
should contact Des.

"Once the DNA
bank is full
operational, we
anticipate that the
Center may obtain
up to 1,500
samplesper year."

Page 2

Volume 9, No 1



Anyone interested in learning more
about the resources and opportunities
associated with research and training in
the GCRC should access its Web site
(http://www.gcrc.ufl.edu/). The site also
provides step-by-step instructions on
providing a GCRC protocol submission
to the Advisory Committee. Investiga-
tors who wish to conduct GCRC re-
search can avail themselves of one-stop

shopping, i.e., the same protocol sub-
mission, coupled with the IRB question-
naire and consent form, may be submit-
ted to both the IRB and the GCRC Ad-
visory Committee for review, either
concurrently or consecutively.

For specific issues about proposed or
pending GCRC studies, please contact
the following individuals:

* Fiscal matters: Ann Coutu--Administrative Manager (265-8909;

* Nursing resources and inpatient/outpatient/scatterbed resource avail-
ability and scheduling: Maureen Surdez, RN--Nurse Manager (265-
0680 x43717; surdemr@shands.ufl.edu)

* Biostatistical issues and data management: Doug Theriaque--
Informatics Manager (265-0680 x06233; theriaqu@gcrc.ufl.edu)

* Federal Guidelines for Patient Safety and Data Monitoring: Barbara
Frentzen, ARNP-- Research Subject Advocate (265-0680 x43715;
frentzen@gcrc.ufl. edu)

* Mass Spectrometry Laboratory and general Core Laboratory ques-
tions: George Henderson, PhD (265-0680 x26193;
hendegn@medicine.ufl. edu)

* DNA Bank: Mark Brantly, MD (846-0752; brantml@medicine.ufl.

* Scatterbed research: Des Schatz, MD (265-0680 x20330;

* Gene therapy protocols: Terry Flotte, MD (846-2739; flotttr@peds.

* When all else fails: Peter Stacpoole, PhD, MD--GCRC Director
(265-0680 x46791; stacpool@gcrc.ufl.edu)

Letter D-Physician holding a
S urine. From the Isagoge
Johannita in Tegni Galeni by
Hunayn ibn Ishaq al-'Ibadi,
809?-873 (known as Joannitius).
Folio 42v. Oxford, 13th century.
Online exhibition: Medieval
Manuscripts in the National
Library of Medicine: The Arti-
cella (http://www.nlm.nih.gov/

Page 3

Page 4 Volume 9, No 1


For more
information on the
opportunities, visit
the Grants
Information page
at http: /
grants 1. nih.gov/
grants/index. cfm

The NCRR is the NIH Institute that
funds all eighty GCRCs. Its Director,
Judy Vaitukaitis, has visited UF twice
through the Center's GCRC Visiting Sci-
entist Program. The NCRR's budget,
currently over $1 billion, supports sev-
eral divisions, one of which is the Clini-
cal Research Division that has a budget
of over $327 million. The new director
of this division is Anthony Hayward, a
pediatric immunologist formerly at the
University of Colorado. Dr. Hayward
oversees the three branches of the Clini-
cal Research Division: the GCRC pro-
gram; the Clinical Research Resources
program; and the Career Development

The Clinical Research Resources branch
supports two grant programs for groups
of investigators, centers or other aca-

K23 New Investigator Awards

The NCRR funds more K23 awards than any other NIH institute. These are five-
year, mentored awards that provide up to $75,000 per year salary support and up to
$25,000 per year in research-related expenses (supplies, equipment, travel). It is
strongly recommended that physicians or other eligible trainees whose research at
least partly involves the GCRC consider submitting their K23 proposal to the
NCRR, whose study section is comprised of reviewers expert in and highly dis-
posed toward funding patient-oriented investigations.

To do this, the potential applicant must undertake the following:

Identify one or more mentors with an acknowledged track record in mentoring in
the same or a related scientific field of interest. It is highly recommended that at
least one of these individuals has current peer-reviewed federal funding in the
general area of the applicant's research proposal.

Obtain a written commitment of at least 75% protected time from the applicant's
division chief and department chair.

demic entities, with or without GCRC af-
filiation: The traditional Shared Instru-
mentation Program for one or more re-
lated pieces of equipment that cost be-
tween $100,000 and $500,000 and a new
"High End" Instrumentation Program
for purchases between $750,000 and $2
million. No institutional matching funds
are required to be eligible for this latter
program, and no indirect costs are pro-
vided for this one-year award. The
NCRR budgeted $10 million in FY '02
for this program. Most applications sub-
mitted involved equipment for imaging or
mass spectrometry.

Further information on these instrumenta-
tion programs may be obtained through
the NCRR's Website (http://www.ncrr.

Page 4

Volume 9, No 1

GCRC News Page 5

In addition to outlining a feasible research plan, describe his or her strategy for ca-
reer development during the award period. It would therefore behoove the applicant
to apply to become a fellow in the University's Advanced Post-graduate Program for
Clinical Investigation (APPCI). This is a federally funded institutional grant under
the K30 program that provides infrastructure support for trainees embarking on ca-
reers in clinical investigation. Among other benefits, it offers complete tuition sup-
port for graduate-level courses that are deemed highly desirable for K23 awardees.
Indeed, K30 fellowship programs were designed, in part, to embellish the training
and career development of federally-funded recipients of mentored research awards,
such as K23s. Further details can be obtained by contacting Marian Limacher
(limacmc@medicine.ufl.edu), the principal investigator for the APPCI.

At least six months prior to the anticipated date of the K23 submission (June 1, Oc-
tober 1, February 1), the applicant and mentor(s) must contact either Peter Stacpoole
or Larry Edwards, Chairmen of the GCRC Advisory Committee, about their interest
in submitting the proposal to the NCRR. The GCRC Advisory Committee will then
select two or three individuals from its membership to help the applicant develop an
appropriate application to the NCRR. The GCRC portion of that application must
be reviewed and approved by the entire Advisory Committee prior to submission of
the grant, which can then be accompanied by glowing letters of endorsement by the
Center's Program Director and Advisory Committee Chairman.

During the past fiscal year, the national success rate for NCRR-funded K23 applica-
tions was approximately 46% (399 applications; 184 awards) and reflected over $64
million in award dollars. For more information, access NCRR Grants Information

K24 (Midcareer Investigator) Awards

These are for established faculty who
wish to engage in, and receive salary
support for, mentoring in patient-
oriented research. Candidates are usu-
ally within fifteen years of their specialty
training, but exceptions are made.
Awards are for five years and provide
for up to 50% protected time, up to
$62,950 in salary support, and up to
$25,000 per year for research-related ex-
penses. Dan Driscoll, a professor in the
Division of Pediatric Genetics and a
member of the GCRC Advisory Com-
mittee, and Mark Brantly, GCRC Asso-
ciate Program Director, are UF's K24
recipients to date, and those interested in
considering this opportunity should con-
tact them.

During the last fiscal year, the NCRR
provided over $23 million to fund 45% of
the proposals received (128 applications;
58 awards). For more information, access
NCRR Grants Information (http://grantsl.

Important Reminder!
Publications resulting from research conducted
in part or wholly on the GCRC should include
the acknowledgement: Supported in part by
General Clinical Research Center grant RR00082.

'Physicians or
other eligible train-
ees whose research
at leastpartly in-
volves the GCRC
[should] consider
submitting their
K23 proposal to
the NCRR, whose
study section is
comprised of re-
viewers expert in
and high disposed
toward fundingpa-
tient-oriented inves-
tigations. "


Page 5

Page 6 Volume 9, No 1


During the first two weeks of October,
the GCRC will sponsor its sixth annual
Science of Clinical Research (SCR)
course (GMS 6181). This one credit,
graduate level course-the first required
course in the APPCI curriculum-is
open, at no charge and on a first-come-
first-served basis, to fellows and faculty
of any clinical department in the Health
Science Center who may be interested
in pursuing a career in clinical research.
The SCR provides a broad overview of
various topics relevant to the conduct
of clinical research. It consists of
three-hour sessions that meet five days
a week for two weeks. Sessions are
headed by a diverse group of senior UF
faculty, and a syllabus is provided.
Some time during mid to late summer,
the GCRC will announce the forthcom-
ing SCR course to the Health Science
Center community and will provide
ample opportunity to enroll in the
course, either for credit or through au-
dit. In addition to offering the course at
no charge, the GCRC even provides
snacks to maintain blood sugars and

This spring, we inaugurated a new

course entitled Ethical and Policy Issues
in Clinical Research (GMS 6931). This
course, for which two graduate credit
hours may be obtained, was developed by
Barbara Frentzen, the GCRC's Research
Subject Advocate, and Bill Allen, Profes-
sor ofBioethics, Law and Medical Pro-
fessionalism. The course will be given
annually and is currently offered on Mon-
day, 9 to 11 a.m., in Room CG-56 and on
Wednesday, 2 to 4 p.m., in Room C2-42.
It provides the requisite educational infor-
mation for any individual who wishes to
be certified under current federal guide-
lines in patient-oriented research. Addi-
tionally, it can be taken to fulfill require-
ments for training programs in clinical
subspecialties in which didactic course-
work in issues pertaining to the ethical
aspects of human and animal investiga-
tion are obligatory. Ethical and Policy
Issues in Clinical Research is also a re-
quired part of the APPCI curriculum. De-
tails about this course can be obtained by
contacting Barbara Frentzen
(frentzen@gcrc.ufl. edu).

(Program descriptions for last year's SCR
course and the current bioethics course

GCRC Course Descriptions

The Science of Clinical Research: 2001 Course Outline

Course Introduction Challenges and Opportunities for the Physician-Scientist
(Terry Flotte)
*Goals and overview of course Terry Flotte *Integration with UF's Advanced Postgradu-
ate Program in Clinical Investigation Ron Marks Perspective of a junior investigator -
Jeffrey Skimming *Description of student project Ron Marks

Our new course,
Ethical and Policy
Issues in Clinical
Research, '7rorid(s,
the requisite educa-
tional information
for any individual
who wishes to be
certified under cur-
rent federal guide-
lines inpatient-
oriented research."

Page 6

Volume 9, No 1


Grants and Grantsmanship, Part 1 Where the Money Is and How to Keep It
(Frederick Southwick)
*Alternatives to NIH Michele Tennant *Funding opportunities for junior investigators -
Frederick Southwick *GCRC-based research and awards Larry Edwards

Grants and Grantsmanship, Part 2 How and What To Write
(Frederick Southwick)
*Perspectives of a medical college dean Kenneth Berns *Elements of good writing Ed
Block *Optimizing chances for an award and its renewal Frederick Southwick

Study Design and Analysis in POR, Part 1 Clinical Trials
(Alan Hutson)
*Types of trials and protocol development Alan Hutson *Blinding and placebos Alan
Hutson *Study design Alan Hutson *Multiple significance testing Alan Hutson
*Randomization Alan Hutson *Sample size/power Alan Hutson

Study Design and Analysis in POR, Part 2 Clinical Trials
(Alan Hutson)
*Intention to treat analysis Alan Hutson *Missing data Alan Hutson *Diagnostic accu-
racy Alan Hutson

Study Design and Analysis in POR, Part 3 Observational Studies
(Ron Marks)
*Cohort studies Ron Marks *Case-control, cross-sectional studies Ron Marks
*Causality, evidence-based medicine Ron Marks *Epidemiological case studies Judy

Statistical Methods in Data Analysis in POR
(Ron Marks)
*Overview of statistical methods Ron Marks *Introduction to Web-based research ap-
proach to clinical research Ron Marks

Federal Guidelines and Scientific Integrity in POR Rules to Know Up Front
(Peter lafrate)
*IRBs and informed consent Peter lafrate *Data and safety monitoring for clinical trials -
Barbara Frentzen *Gender and minority representation and "ownership" of human tissues
and fluids Barbara Frentzen *FDA governance of new product development Susan Beltz

Special Topics in POR Diversions from the Standard Paradigms
(Mark Brantly)
*Structure and function of NIH Kirsten Madsen *How grants are triaged and reviewed -
Kirsten Madsen *Biotechnology Shelly Schuster *Pharmacogenetics Julie Johnson
*DNA arrays Henry Baker

Grants and Grantsmanship, Part 3 How and What to Write
(Peter Stacpoole)
*Critique of student POR proposals Mark Brantly, Alan Hutson, Ron Marks, Peter
Stacpoole *Critique of course Peter Stacpoole

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. -

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l... ^ '-I ,'-"" .' L--h

Vermont MS.2 -Illustrations
from an Italian Herbal from
1500. Division of the Louise M.
Darling Biomedical Library,
UCLA. Cataloged in the Graphi-
cal Index of Medieval Medical
Images (IMMI). [ http:/www.


Page 7

General Clinical Research
Box 100322
University of Florida
Gainesville FL 32610
Phone: 352-265-8909
Fax: 352-338-8910
Email: coutua@gcrc.ufl.edu


Ethical and Policy Issues in Clinical Research: 2002 Syllabus

Class 1: May 13

Class 2: May 15

Class 3: May 20

Class 4: May 22

Class 5: May 27

Class 6: May 29

Class 7: June 3

Class 8: June 5

Class 9: June 10

Class 10: June 12

Class 11: June 17

Class 12: June 19

* History of Research Ethics
* Basic Ethical Principles

* Overview of Major Issues in Human Subjects Research
* Ethics and the Scientist

* Epidemiological Research
* Genetics
* Tissue Banking

* Research Involving Vulnerable Subjects

Holiday-No Class

* Clinical Trials

* Research and the Drug/Device Approval Process

* Research Involving Women and Members of Minority Groups

* Research on Animals

* Managing Conflicts of Interest

* Ownership of Data and Intellectual Property

* Authorship and Peer Review

Volume 9, No 1

Page 8

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