WCGME-IRB
The Wright Center for Graduate Medical Education
Institutional Review Board
Date: December 8, 2014
Submitted by: Michael F Moore, MD
Address: The Wound Institute & Research Center
Suite 106
1000 Meade Street
Dunmore Pa 18512
Telephone: 570.961.8000
Addenda/Memoranda/Editorial/Administrative Changes Template:
Protocol #
Editorial:
Administrative Changes:
001-2014
The Reduction of
Nasal Colonization of
MRSA Using an
Antimicrobial Clip.
Expand sample size to include any patient who is
PCR positive for MRSA.
001-2014
The Reduction of
Nasal Colonization of
MRSA Using an
Antimicrobial Clip.
Expand sample size to include any patient who is
PCR positive for MRSA.
ICF page one – first paragraph
Version 1 (V1) reads “The reason you are being
asked to participate in this study is because
there is a high incidence or occurrence of nasal
colonization of MRSA in patients undergoing
renal dialysis.” Version 2 (V2) will read “The
reason you are being asked to participate in this
study is because there is a high incidence or
occurrence of nasal colonization of MRSA in
patients.”
ICF page two – answer to 2nd question
V1 reads “Subjects who are undergoing renal
dialysis would sign an informed consent
agreement and then be screened for MRSA
nasal colonization using a nasal culture
specimen obtained by touching both nostrils
with sterile cotton tipped culture swab.”
V2 will read “Subjects will sign and informed
consent agreement and then be screened for
Rev 02/01/11
WCGME-IRB
The Wright Center for Graduate Medical Education
Institutional Review Board
Protocol #
Editorial:
Administrative Changes:
MRSA nasal colonization using a nasal culture
specimen obtained by touching both nostrils
with sterile cotton tipped culture swab.”
001-2014
The Reduction of
Nasal Colonization of
MRSA Using an
Antimicrobial Clip.
001-2014
The Reduction of
Nasal Colonization of
MRSA Using an
Antimicrobial Clip.
Update to reflect current contact.
ICF page 4 – V1 contact “Dr. Kenneth Rudolph”
change to “Dr. Mark V. White”
Expand sample to include any patient who is
PCR positive for MRSA.
001-2014
The Reduction of
Nasal Colonization of
MRSA Using an
Antimicrobial Clip.
Expand sample size to include any patient who is
PCR positive for MRSA.
Protocol 2.2
V1 reads “the outpatient dialysis population with
a known high incidence of nasal colonization by
MRSA would be assessed using polymerase
chain reaction (PCR) assays.”
V2 will read “the subject would be assessed
using polymerase chain reaction (PCR)
assays.”
Protocol 3.1
V1 reads “ A total of thirty dialysis patients that
are PCR positive for MRSA will undergo
quantitative cultures to determine the range of
colony forming units in asymptomatic
colonization.”
V2 will read “ A total of thirty subjects that are
PCR positive for MRSA will undergo
quantitative cultures to determine the range of
colony forming units in asymptomatic
colonization.”
Rev 02/01/11
WCGME-IRB
The Wright Center for Graduate Medical Education
Institutional Review Board
Protocol #
Editorial:
Administrative Changes:
Protocol 3.4
V1 reads “A physician would recruit subjects
who are undergoing outpatient renal dialysis.
V2 will read “A physician will recruit subjects.”
Protocol 6.3
V1 reads “Kenneth H Rudolph, M.D.
khrudolph@verizon.net”
V2 will read “Mark V White, MD, MPH
Chairman, WCGME IRB
whitemv@thewrightcenter.org
Rev 02/01/11