Health Resuscitation Outcomes Consortium
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MEMORANDUM
May 31,2006
TO:
The Honorable Mayor and City Council Members
FROM:
Michael C. Van Milligen, City Manager
SUBJECT: Resuscitation Outcomes Consortium (ROC)
On March 20, 2006, the City Council approved an agreement with Zoll Corporation for
participation in a National Institute of Health Resuscitation Outcomes Consortium. Prior
to participating in this Consortium, it is necessary to file for a Federalwide Assurance
number.
Fire Chief Dan Brown recommends City Council approval to file for a Federalwide
Assurance number.
I concur with the recommendation and respectfully request Mayor and City Council
approval.
. (l tl L:./1LL/
Michael C. Van Milligen
MCVM/jh
Attachment
cc: Barry Lindahl, Corporation Counsel
Cindy Steinhauser, Assistant City Manager
E. Daniel Brown, Fire Chief
CITY OF DUBUQUE, IOWA
MEMORANDUM
May 17, 2006
TO: Michael C. Van Milligen, City Manager
FROM: E. Daniel Brown, Fire Chief t 0 8
SUBJECT: Resuscitation Outcomes Consortium (ROC)
The next step for the Fire Department in participating in the Resuscitation Outcomes
Consortium (ROC) is filing for a Federalwide Assurance (FWA) number. An FWA
number is required anytime a research is done on human subjects. The FWA guides
the research activities and ensures that ethical principles will be followed and
Institutional Review Board (IRB) is also required to oversee and review this research.
The IRB is an administrative body established to protect the rights and welfare of
human research subjects that participate in the study. The IRB has the authority to
approve, modify or disapprove all research activities conducted. Both Finley and Mercy
HospitallRB's have agreed to administer our participation in the ROC Study.
Fire Department staff consulted with Barry Lindahl and he recommended that the City of
Dubuque be used as the institution name and that you as City Manager be listed as the
signatory official. He also recommends the City Council approve of the FWA application
prior to you signing the application.
Attached is the application for the Federalwide Assurance (FWA) number. The
signatory official signature space is provided in item 7 of the application. I respectfully
request that this item be put on the next council agenda for their approval of your
signature in order to move forward with the Resuscitation Outcomes Consortium Study.
EDB/jl
Submission Number: 7511
Institution Name: CITY OF DUBUQUE
OMB No. 0990-0278
Approved for use through 1/31/2008
5/17120063:05:41 PM
U.S. Department of Health and Human Services (DHHS)
Federalwide Assurance (FWA) for the Protection of Human Subjects
For Domestic (U.S.) Institutions
1. Institution Filing Assurance
Legal Name: CITY OF DUBUQUE
City: DUBUQUE
State: IA
HHS Institutional Profile Code:
Federal Entity Identification Number (EIN):
This Assurance replaces:
2. Institutional Components
List below all components over which the Institution has legal authority that operate under a different
name. Also Ust with an asterisk (*) any alternate names under which the Institution operates, The
Institution should have available for review by the Office for Human Research Protections (OHRP) upon
request a brief description and line diagram explaining the interrelationships among the Assurance
Signatory Official, the Institutional Review Board (IRB), IRB support staff, and investigators in these
various components.
NOTE: The Signatory Official signing this Assurance must be legally authorized to represent the
Institution providing this Assurance and all components listed below. Entities that the Signatory Official
is not legally authorized to represent may not be listed here without the prior approval of OHRP.
None Selected
3. Statement of Principles
This Institution assures that all of its activities related to human subjects research, regardless of funding
source, will be guided by the ethical principles in the following documents:
THE BELMONT REPORT
Submission Number: 7511
Institution Name: CITY OF DUBUQUE
OMS No. 0990-0278
Approved for use through 1/31/2008
4. Applicability
(a) This Institution assures that whenever it engages in human subjects research conducted or
supported by any federal department or agency that has adopted the Federal Policy for the Protection of Human
Subjects, known as the Common Rule, the Institution will comply with the Terms of the Federalwide Assurance
for Institutions Within the United States (contained in a separate document on the OHRP
website), unless the research is othelWise exempt from the requirements of the Common Rule or a department
or agency conducting or supporting the research has determined that the research shall be covered
by a separate assurance.
(b) Optional: This Institution elects to apply the following to all of its human subjects research regardless
of the source of support, except for research that is covered by a separate assurance:
No Selection Made
5. Designation of Institutional Review Boards (lRBs)
This Institution designates the following IRB(s) for review of research under this Assurance (if the IRB has not previously
registered with HHS or has not provided a membership roster to HHS, please submit to OHRP the
appropriate IRS registration materials which are available on the OHRP website).
NOTE: Reliance on the IRB of another institution or organization or an independent IRB must be documented
by a wriUen agreement that is available for review by OHRP upon request. OHRP's sample IRS
Authorization Agreement may be used for this purpose, or the parties involved may develop their own agreement.
Future designation of other IRBs requires an update of the FWA.
HHS IRS Registration Number
Name of IRS As Registered with HHS
IRS00004475
IRS00005117
FINLEY HOSP IRS #1
MERCY HEALTH SERVICES - IOWA DSA MERCY MEDICAL CENTER IRS #1
5/1712006 3:05:41 PM
$\.Jbmission Number: 7511
Institution Name: CITY OF DUBUQUE
OMB No. 0990-0278
Approved for use through 1/31/2008
5/17120063:05:41 PM
6. Human Protections Administrator (e.g., Human Subjects Administrator or Human Subjects Contact Person)
First Name: WAYNE Middle Initial: R
Degrees or Suffix (e.g., MD, PhD):
Institution: DUBUQUE FIRE DEPARTMENT
Last Name: DOW
Institutional Title: EMS SUPERVISOR
Telephone: (563) 589-4194
FAX: (563) 589-0894
E-mail: WDOW@CITYOFDUBUQUE.ORG
Address: 11 WEST 9TH ST.
City: DUBUQUE
State: IA
Zip Code: 52001
Submission Number: 7511
Institution Name: CITY OF DUBUQUE
OMB No. 0990-0278
Approved for use through 1/31/2008
5/17/2006 3:05:41 PM
7. Signatory Official (i.e., Official Legally Authorized to Represent the Institution
-- cannot be IRB Chairperson or IRB member)
I understand that the Assurance Training Modules on the OHRP website describe the responsibilities of the Signatory Official,
the IRB Chair(s), and the Human Protections Administrator under this Assurance. Additionally, I recognize that providing
research investigators, IRB members and staff, and other relevant personnel with appropriate initial and continuing
education about human subject protections will help ensure that the requirements of this Assurance are satisfied.
Acting officially in an authorized capacity on behalf of this Institution and with an understanding of the Institution's
responsibilities under this Assurance, 1 assure protections for human subjects as specified above. The IRB(s)
designated above are to provide review for all research to which this Assurance applies. The designated IRB(s) will
comply with the Terms of the Federalwide Assurance for Institutions Within the United States and possess appropriate
knowledge of the local context in which this Institution's research will be conducted.
All information provided with this Assurance is up.to-date and accurate. I am aware that false statements
could be cause for invalidating this Assurance and may lead to other administrative or legal action.
Signature:
Date:
Michael C Van Milligen
First Name: MICHAEL
Degrees or Suffix (e.g" MD, PhD):
Institution: CITY OF DUBUQUE
Telephone: (563) 5894110
Middle Initial: C
Last Name: VAN MILLlGEN
Institutional Title: CITY MANAGER
FAX: (563) 589-0894
E-mail: CTYMGR@CITYOFDUBUQUE.ORG
Address: 50 WEST 13TH ST.
City: DUBUQUE
State: IA
Zip Code: 52001
NOTE: Institutions operated by the U.S. Government may need to obtain department or agency
clearance prior to submission of the FWA to OHRP. Please contact the relevant department or
agency Human Subject Protections Officer before forwarding this Assurance to OHRP.
.
~ SUbmission Number: 7511
Institution Name: CITY OF DUBUQUE
OMS No. 0990-0278
Approved for use through 1/31/2008
5/1712006 3:05:41 PM
8. FWA Approval
The Federalwide Assurance for the Protection of Human Subjects for Institutions Within the United States
submitted to HHS by the above Institution is hereby approved.
Assurance Number:
Expiration Date:
Signature of HHS Approving Official:
Date:
Public burden for this collection of information is estimated to average two hours for a new FWA filing and less than an hour for an FWA renewal or
update. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid
OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for
reducing this burden to: OS Reports Clearance Officer, Room 503, 200 Independence Avenue, SW., Washington, DC 20201.
Do not return the completed form to this address.