Appendix C ROC ^ Resuscitation Outcomes Consortium

^
Appendix C
ROC
Resuscitation Outcomes Consortium
SCHOOL OF
1u1EDfCNE
Qepartment of Emergency Medicina
MEMPPuANDUM
TO:.
Sheila Moore, CIP
Office of the IRB
FROM:
Jeffrey D. Kerby, MD, PhD, ~
Principal Investigator
PATE :
April 25, 2007
r
MAY - ? 2OG7
tab on f~~.A,a
RE:
F06032$008 - I3ypertonlc kesuscitation fbllowing
Traumatic Injury (South44--stem- . Resuscitation Research -Ceu~r);
'
This memorandum is a wriffen request to begin enrollment in the above
protocol for Omnzflight Inc., (Alabama LifeSaver),
Q}nniflight has a signed and fully executed contract on file with the UAB
Office of Grants and Contracts Administration. Omniflight has also secured
a Federal Wide Assurance number from the Office for Human Research
Protections (FWA04Q11311) . This agency has completed the training in
Good Clinical Practices . As a component of our I.RB approved Community
Consultation / Public Disclosure plan, we have presented an overview of the
above protocol to the Birmingham Community Advisory Board on 4/16/C17
at 7PM, to the Gadsden City Council on 4/17IQ7 at 10:00 AM, to the
Tuscalaasa City Council on 4/17107 at 1 :30PIUi; and to the Anniston City
Council on 4124IQ7 at 5 :3OPM. We solicited feedback at each community
meeting alid at each; the study was warmly received by the community
representatives with no negative comments expressed to UAB researchers or
IRB board members. UAB IR.B board members attended each meeting.
Thank you in advance for your consideration of this request to begin
enrollment and for your support of emergency research, If you have any
questions or need any additional information, please do not hesitate to
contact me.
266tU Jefferson TOWE)t
B25 19th Street South
205.975 .7387
Fax, 205 .975 .4662
The University of
'
Alsb8ma at BirFiftkhgharn
Mailing AddressJT 266N
B19 79TH ST S
BJRMINGHAM AL 35249-7p13
,p
!
L
SCHOOL OrMEDICINE
.
LM
An "
Department of amergerrCy Mi9di'Gine
OFFIGIr-'QF INS7lTltTaONAL
.i~
.- 18lJ Ft .
~, ~I~~
M, . "',~ ;
M
TO .-
Sheila MoQre, CIP
Office of the IRB
FROM:
Jeffrey D. Kerby,NO* PhD . ~
Principal Investigator
DATE;
Agtd' 3, 2 04'7
Injury
V{~64M0OS - Hypertanic Resweita0m fb1IomJjvtg Traa~n~:~ic
(Southeastern Aesusritatien gesearc;h Center)
This memorandum is a written request to begin enrollment, i the above prQtQool:
for Centerpaint Fire Department (CPFLJ) .
CPFD has a signed and fully executed contract on file with the UAB Office of
Grants and Contracts Administration . CPFLa has also secured a Federal Wide
Assurance number from the Office far Human Research Protections
(FWA00010918) . This agency has completed the training in Good Clinical
Practices. As a component of our IRB approved Community Consultation f Public
Disclosure plan, we have presented an overview of the above protocol at the Clay
City Council Meeting on 4l2/2007 at 7 :40 PM. We solicited feedback f'rom the
community . UA$ IRB board members attended this meeting.
_
Thank you in advance for your consideration of this request to begin enrollment
and for your support of emergency research . If you have any questions or need any
additional information, please do not hesitate to contact me.
Approved'
C / fOTChairman
r'"`
IRB
266N Jefferson Tower
625 19th Street South
205 .975 .7387
Fax 205,975,.4(362
The Univers'rty of
Alabama at Birrt'lingharn
Mailing Addro$s.
JT 266N
619 19TH ST S
BIRMINGHAM AL 3,9249-7013
obit~-&"a,~
r"W '
7
SCHOOL OF
MEDICINE.
UeF--artmQnt of Ernergexrey MAe:drcirre
.~~ORANDVM
Sheila M(3ore, CIP
Office 0f thP, IRB
FROM:
Jeffrey D. Kerby, MD, PhD. /L'
Investigator
PVritcpal
DATE :
April. 3, 200'7
RE:
F'060328OD8 - llypertonic Resusdtation foltovniog>
Traumatic Injury (Southeastern Resuscj't~~on Research,Cen*t')
This memorandum is a written request to begin enrollmer~ in the 4bove
protocol for `Iestavia Hills Fire Department (VHFD) .
'
VI-ED has a signed and fully executed contract on file with. the T.TAB Office
of Grants and Contracts Administration. VHF'D has also secured a Federal
Wide Assurance number from the Office for Human Research Pratectiaar,
(FWA00010924), This agency has completed the training in Good Cl~;i~al
Practices . As a component of our IRB approved Community Constiltatit~~ l'
Public Disclosure plan, we have presented an overview of the above
protocol at the Vestavia Hills United Methodist Church Meeting on
3/22/2007 at 7 :00 PM. We solicited feedback from the community. UAB
IRB board members attended this meeting.
Thank you in advance for your consideration of this request to begin
enrollment and fox your support of emergency research, If you have, any
questions or need any additional information, please do not hesitate to
contact me.
Approved
.
266N Jefferson Tower
625 79th Street South
205:975 .7387
Fax 203.Q7.5,4662
The unlwsity at
:
Alabama at Birmingham
Mailing Address:
gz
JT 2661V
619
19TH ST S
BIRMINGHAM AL .,35249-7013
1RB Chairman
~cu~ i~L1
~(lv4t'v
-- .:.. .:.
SCHOOL OF
UM MEDICINE ,
Department of Emergency Medicine
MEMORANDUNT
:
TO :
ShEllaMb0re,
OP.
OffiCeOftheMB
FROM .'
Jeffrey D. Kerby, MD, Pwvk-~
Principal Investigator
DATE :
June 27', 2007
:. RE:
F060328008 - 14ypertonic Resuscitat%on .following
Traumatic Injury (Southeastern Resuscitation Researeh Center)
°~
This memorandum is a written request to begin enrollment in the above
protocol for Trussvilie Fire Department ~TFD}.
TFD has a signed and fully executed contract on file with the tTAB Office: of'
Grants and Contracts Administration. TFD has also secured a Federal Wide
Assurance number from the Office for Human Research Protections
(FWA00011387). This agency has completed the tra.iriin:~ in Good Clinical
Practices . As a component of our TRB approved Community Consultation ~
Public Disclosure plan, we have presented an overview of the above
protocol at the Trussville City Council Meeting on Tuesday, June 26, 2007
at 6 . 00 p.m. We solicited feedback from the community . UAB IRB board
members attended this meeting.
Thank you in advance far your consideration of this request to begin
enrollment and for your support of emergency research . If you have any
questions or need any additional information, please do not hesitate to
contact me.
26FN Jefferson Tower
625 19th Street South
2Q5 .975 .7387'
Fax 265 .975 .4662
ThF; University ot
Alabama at 0irzrtingham
Mailing Address,
ST ?66N
619 187N 6T S
BIRMINGHAM AL 35249-7Q13
,
Z7f
1
~ GtT"
SCHOOL OF
,...~ ^~ MEDICINE
APR 21 2M7
Depiartment of Emergency Medicine
MEMORANDUM
:
Sheila Moore, CII'
(~~fice of the IRB
FROM:
Jeffrey D, Kerb'MT~, ~~1~~ ~
~~
Principal Investigator
MAY
,
DATE:
April 26, 200?`
RE~
F06 3280 8 ~pertionic Resuscitation, followirrg
Traumanc lujury (Southeastern Resuscitation Research
Center)
,
'~
.. .
.
-u~
--T------_ .
04"
This memorandum is a written request to begin enrollment :in the above
'protocol far Regional Paramedic Services (RPS),
Has a signed and fully executed contract on file with the UAB 'Office of
Grants and Contracts Administration. RPS has also secured a Federal Wide
Assurance number from the Office for Human Research Protections:
(FWA00010933') . This agency has completed the training in Good Clinical
Practices . As a component of our IRB approved Community Consultation/
Public Disclosure plan, we have presented an overview of the above
protocol at the Jasper City Council Meeting on Tuesday, April 17, 2007 at
10 :00 a.m. We solicited feedback from the community. LrAB IR.$ board
members attended this meeting.
'
Thank you in advance for your consideration of this request to begin
enrollment and for your support of emergency research. If you have any
questions or need any additional inf6rmation, please do not hesitate
to
contact me.
-
_
,
2efN Jefferson Tower
The University of
205.975,7387
Mailing Qddress:
625 i9th Street South
Fax 205 .975,4662
Alabama at Birmingham
JT 266N
6T9 19TH ST 8
67
BIFiM1140MAM AL 35249-70:13
SCHOOL OF
, MEDICINE
Department of Emergency Medicine
MEMORANDUM
TOi
Sheila Maore; CIF
Office of the MB
FROM:
Jeffrey D. Kerby, NW, PhD.
Principal Investigator
DATE .
3une 27, 200'7
^
s
. RE;
F136432800$ - 1Iyper-tvnic Rauscita.tibn followilig
Traumatic Injury (Southeastern Resusciftfioa Research Ceinter)
This memorandum is a written request to begin enrolline-at in the above,
protocol fax Chelsea Fire and Rescue Service (CFRS).
CFRS has a signed and fully executed contract on file with the TJA$ Offlce
of Grants and Contracts Administration . CFRS has also secured a Federal
Wide Assurance number from the Office for Human Research Protections
(FW.A,00011693) . This agency has completed the training in Good Clinical
Practices. As a component of our IRB approved Community Consultation ~
Public Disclosure plan, we have presented an overview of the above
protocol at the Chelsea City Council Meeting on Tuesday, :Tune 19, 2007 at
7 :04 p .m. We solicited feedback from the community . IJAB IRB board
members attended this meeting.
Thank you in advance for your consideration of this request to begin
enrollment and for your support of emergency research . If you have any
questions or need any additional infoniiatiail; please do not hesitate to
contact me.
JI,U N 2 "?i 2007
266N 18fteTson Tower
625 19th Street South
205. .975,7387
Fax 205.975.4662
The University of
Alabama at $irmingharrr
Mailing Address:
Jl 266N
~
679 19TH ST S
BIRMINGHAM AL 36249-i013
i.Li'lj.t~'~ .,~^,U
I
..~ "`
.
SCHOOL OF
MEDICINE
Department of Emergency MadiClh~
MEMORANDUM
TO :
Sheila Moore, CTP
Office of the iRB
FROM.-
Jeffiey D. Kerby, Mb, PhD.
PFincigal Investigator
DATE :
ju1y 11, 2007
RE:
FOb0328D(}f3 - 11~ypeitanit :Resuseit~t~~ ~foRowwling;
T)raumatie Injury ($outlteaffWn Resugcitatiou Reseamb Center)
This memorandum is a written request to begin, enrallment °in the 4boye
protocol for American Medical Rosgowe {.AMR} Ambulance S.er~,~~4l,
AMR has a signed and fully executed contract on file with the UAB Office
of Grants and Contracts Administration . AMR has also secured a Federal
Wide Assurance number from the Office for Human Research Protections
(UWAQ0411367) . This agency has completed the training in Good Glilea1
Practices . As a component of our IRB approved Community Consultation
Public Disclosure plan, we have presented an overview of the above
protocol at the Jefferson County Advisory Committee Meeting on
Wednesday, April 25, 2007 at 2 :D0 p .m. and the Fairfield City Council
Meeting on ;Monday, May 7, 2407 at 6: }(J p . in . In addition, AMR's coverage
area overlaps with Bessemer Fire and Rescue, There was a community
meeting held at Antioch Baptist Church in $esseiner on Monday, April 16,
2007 . We solicited feedback from the community and will attend additional
community meetings as requested by the City Council as an ongoing
process . A L7AB IRB board member attended the City CoUncil Meeting .
Thank you in advance for your consideration of this request to begin
enrollment and for your support of emergency research . It` you have any
questions ot need any additional iiifozinatxon, please do not hesitate to
contact me.
266N Jefferson Tower
625 19th Street South
205.975 .7387
Fax 205.975 .4662
APP
~D
The University of
~
Alabama at 8irmtngfiarrt
Mailing Address:
IRS REVIEWER
JT 266N
618 19TH ST S
BIRMINGHAM AL 35249=7a13
:_
,
SCHO 'L OF
MEDICINE
Department a~ Emergency Medfdne
MEMORANDUM
TO:
Sheila Moore, C1,P
Office of the !RB ,
Principal Investigator
'
DATE:
April 1.7 , .2a07
RE :
F0C03280Q8 - lRypexfionitc Re.~s.citatyon frsllvw~`g
Traumattc Injury (5oathtusftrn Resusvitaticr,rr Research
Center)
This memorandum is a written request to begin enrollment :in the above
.protocol for Bessemer Fire Department (BFD).
BFD has a signed and fully executed contract an file with the UAB Officeof
Grants and Contracts Administration. BFD has also secured a Federal Wide
Assurance number from the Office far Human Research Protections
(FWA04Q11066). This agency has completed the training in Good Clinical
Practices, As a component of our IRB approved Community Consultation I
Public Disclosure plan, we have presented an overview of the above
protocol at the Antioch Baptist Church Meeting on ~#116/'Z007 at 6 :00 PM,
We solicited feedback from the community . UAB IRB board members
attended this meeting,
Thank you in advance for your consideration of this request to begin
enrollment and for your support of emergency research . If you have any
questions or need any additional information, please do not hesitate to
contact me .
Approved
2fi6N Jefferson Tower
625 19th Street South
2A5._975.7381
Fax 205 :975 .4662
The Universit of
Alabama at &Ki'raingham
Mailing AdctreSS: :
JT 266N
619 197H ST 5
BIRMINGHAM AL 352Q9-7U13
iRB hairm~n
--
_
~~~
SCHOOL OF
MEDICINE
C ~~ . .'
MAY 1 0 2007
Department of Emergenr,yM'edidFne
ctR~~c;~ :iF~N,:1 (v.̀irO iJAL
MEMORANDUM
:
Sheila MODYB,. CIP
Office of the IRRB
FRQmt
leiff~ey D. Kerby, MD ; PbD/j~kr/
Principal' Investigator
DATE;
May 4, 200'7
RE:
FU6032~008 - Hypertoui~e ~suscixa~titu~lk~'a~v~ ;g TreumatitNury
(Southeastern Resuscitation Rosesirch Center)
This memorandum is a written request to begin enrollment in the above protowl for Birmingham
Fire and Rescue Service (BFRS) .
BFRS has a signed and fully executed c~riitraot on file with the TJAB Office- of Grants and .
Contracts Administration. BFF,.S has also secured a Federal Wide Assurance number from the
Office for Human Research Protections (FWA00011476) . This agency has completed the
training in Good Clinical Practices . As a component of our IRB approved Community
Consultation J Public Disclosure plan, we have presented an overview of the above protocol at
th.e Birmingham City Council Meeting on 8l1/2a06 and at the Birmingham Community Advisory
Board on 4l16/2007 at 7:OoPM. We solicited feedback from the community at each meeting.
UAB IItB board members attended the meeting on 4116. We have also mailed 150 IRB
approved flyers the Community and Neighborhood Leaders within the city of Birmingham in; the
weekly publication, through the Birmingham Community Development Office, These flyers
were mailed out on 4/6/2007,
Thank you in advance for your consideration of this request to begin .enroilment and for your
support of emergency research . If you have any questions or need any additional informttjoi :,
please do not hesitate to contact me.
AFFKUVtQ
MAY ~ 3 2007!
2E8N Jefferson Tower
625 19th Strea South
;
205,-975 .738,7
Fax, 205.975,4662
The University iif
Alabama at Birmingham
Mailing Address:
JT 2fi6N
619 1 9TH STS
BIFiMI.NGNAM AL 35249-TD13
fNSTITUTIDNAL (iEVI£W BOARD FOR
Ht~M?;N E1SE
+-~:r~lc.s
~ TRj5