HomeMy WebLinkAbout2010-06-02 PACKET 04.E.REQUEST OF CITY COUNCIL ACTION COUNCIL AGENDA
MEETING ITEM #
DATE 06/02/10
PREPARED BY Public Safety Craig Woolery
ORIGINATING DEPARTMENT STAFF AUTHOR
COUNCIL ACTION REQUEST
City Council pass a motion to approve the HealthPartners Research Foundation (HPRF)
Agreement and authorize execution of the subaward agreement between the City of Cottage
Grove Department of Public Safety and HealthPartners Research Foundation to participate in
the IMMEDIATE study and authorize Director of Public Safety Craig Woolery to execute such
an agreement on behalf of the City of Cottage Grove and Public Safety Department.
STAFF RECOMMENDATION
City Council pass a motion to approve the HealthPartners Research Foundation (HPRF)
Agreement and authorize execution of the subaward agreement between the City of Cottage
Grove Department of Public Safety and HealthPartners Research Foundation to participate in
the IMMEDIATE study and authorize Director of Public Safety Craig Woolery to execute such
an agreement on behalf of the City of Cottage Grove and Public Safety Department.
SUPPORTING DOCUMENTS
® MEMO /LETTER: from Director of Public Safety Craig Woolery
RESOLUTION:
❑ ORDINANCE:
❑ ENGINEERING RECOMMENDATION:
❑ LEGAL RECOMMENDATION:
OTHER: HealthPartners Research Foundation IMMEDIATE Study Agreement
ADMINISTRATORS COMMENTS
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City Administrator Date
COUNCIL ACTION TAKEN: M APPROVED ❑ DENIED ❑ OTHER
Date: May 26, 2010
Subject: REQUEST AUTHORIZATION TO ENTER INTO AN AGREEMENT WITH
HEALTHPARTNERS RESEARCH FOUNDATION (HPRF) AND
PARTICIPATE IN THE IMMEDIATE STUDY
Cottage Grove EMS has been requested to participate in a National Institute of Health (NIH)
study by our Medical Director at Regions Hospital. The research study is called the
IMMEDIATE Trial (Immediate Myocardial Metabolize Enhancement During Initial
Assessment and Treatment in Emergency Care). This research study uses an intravenous
solution of glucose, insulin and potassium (GIK) to reduce the amount of damage to the
heart from a heart attack. Cottage Grove Paramedics would receive training on the
protocols of this study and the enrollment of qualifying consenting patients suffering from
acute myocardial infarction (AMI) in the pre - hospital setting.
As a participant in the study, all of Cottage Grove's MRX monitor /defibrillators would receive
state of the art software upgrades that can accurately diagnose potentially life threatening
heart arrhythmias. The value of the software upgrades is approximately $18,000.00 for our
six (6) monitor /defibrillators. All paramedic training required to participate in this study will
be reimbursed through HealthPartners (Regions Hospital). Also as an incentive, Regions
Hospital has agreed to provide additional advanced life support training to Cottage grove
personnel such as Rapid Sequence Induction (RSI) training.
The enclosed sub award agreement between HealthPartners Research Foundation (HPRF)
and the City of Cottage Grove has been reviewed by our City Attorney. There will also be a
public notification process that will inform citizens of the study. The sample press release is
enclosed.
RECOMMENDATION
The Cottage Grove Department of Public Safety, on behalf of the City of Cottage Grove, is
requesting authorization from Council to enter into an agreement with the HealthPartners
Research Foundation to participate in a one (1) year research study called the IMMEDIATE
Trial, beginning in June 2010,
CAW /cce
Encl.
DPS10 -016
PRESS RELEASE:
In close collaboration with the team at the National Coordinating Center, the
Cottage Grove Public Safety Department is participating in the IMMEDIATE Trial.. The
East Metro St. Paul IMMEDIATE Trial Team is under the direction of RJ Frascone, MD,
Regions Hospital Medical Director.
Heart Attack Studv to Start in June
Cottage Grove Public Safety along with Regions and St. Josephs Hospitals are
participating in the IMMEDIATE Trial.
This National Institutes of Health sponsored research study will test if an
intravenous "GIK" solution of glucose, insulin, and potassium can reduce the
amount of damage to the heart from a heart attack. Patient enrollment starts in
M'ay and will continue for 1 years.
If you have symptoms of a heart attack and, are at least 30 years old and have
positive findings on an EKG done by an EMS paramedic, you may be enrolled in
the Trial. People with signs of heart failure, and those receiving dialysis will not
be enrolled. If you participate in the study you will receive either a standard IV
solution or GIK solution for up to 12 homy. Which solution you receive is
determined by chance. Neither you nor the medical staff will know which one
you are assigned to receive. You will continue to receive all the standard care
you would normally receive.
Previous studies have shown that giving GIK as early as possible may protect the
heart from damage until further therapies are available. However, if you
participate there is no guarantee of benefit. Possible side effects include redness
or inflammation at the IV site; change in blood sugar levels that may cause
weakness, dizziness, or thirstiness; change in potassium levels that may result in
a rapid heartbeat or dizziness. You will be monitored for side effects and treated
if needed.
Due to the emergency nature of a heart attack, informed consent will not be
obtained prior to starting the study drug. In the ambulance, the paramedics will
notify you of the study and you can decide to accept or decline participation.
More detailed information will be provided to you at the hospital, at that time
you can provide informed consent to continue or withdraw. You may withdraw
from the study at any time, with no disruption in care. For more information,
visit the Trial website at
... ... ... 1 11P P fl I I 1 A T r T
EMS Unit Agreement
Name of Institution with the Federal Wide Assurance (FWA):
HealthPartners Research Foundation
Applicable FWA #: 00000106
EMS Unit Name: (_ 0 eya a e C% r�/ V e C
Research Covered by this Agreement:
41.0-013 -"IMMEDIATE Trial: Immediate Myocardial Metabolic Enhancement During Initial Assessment and
Treatment in Emergency Care"
Principal EMS Unit: RJ Frascone, MD
(1) The above -named EMS Unit has reviewed: 1) The Belmont Report: Ethical Principles and
Guidelines for the Protection of Human Subjects of Research (or other internationally
recognized equivalent; see section B.1. of the Terms of the Federalwide Assurance (FWA)
for International (Non -U.S.) Institutions); 2) the U.S. Department of Health and Human
Services (HHS) regulations for the protection of human subjects at 45 CFR part 46 (or other
procedural standards; see section B.3. of the Terms of the FWA for International (Non -U.S.)
Institutions); 3) the FWA and applicable Terms of the FWA for the institution referenced
above; and 4) the relevant institutional policies and procedures for the protection of human
subjects.
(2) The EMS Unit understands and hereby accepts the responsibility to comply with the
standards and requirements stipulated in the above documents and to protect the rights and
welfare of human subjects involved in research conducted under this Agreement.
(3) The EMS Unit will comply with all other applicable federal, international, state, and local
laws, regulations, and policies that may provide additional protection for human subjects
participating in research conducted under this agreement.
(4) The EMS Unit will abide by all determinations of the Institutional Review Board (IRB)
designated under the above FWA and will accept the final authority and decisions of the
IRB, including but not limited to directives to terminate participation in designated research
activities.
(5) The EMS Unit will complete any educational training required by the Institution and/or the
IRB prior to initiating research covered under this Agreement.
(b) The EMS Unit will report promptly to the IRB any proposed changes in the research
conducted under this Agreement. The EMS Unit will not initiate changes in the research
without prior IRB review and approval, except where necessary to eliminate apparent
immediate hazards to subjects.
(7) The EMS Unit will report immediately to the IRB any unanticipated problems involving
risks to subjects or others in research covered under this Agreement.
(8) The EMS Unit acknowledges and agrees to cooperate in the IRB's responsibility for initial
and continuing review, record keeping, reporting, and certification for the research
referenced above. The EMS Unit will provide all information requested by the IRB in a
timely fashion.
(9) The EMS Unit will not enroll subjects in research under this Agreement prior to its review
and approval by the IRB.
(10) Emergency medical care may be delivered without IRB review and approval to the extent
permitted under applicable federal regulations and state law.
(11) This Agreement does not preclude the EMS Unit from taking part in research not covered by
this Agreement.
(12) The EMS Unit acknowledges that it is primarily responsible for safeguarding the rights and
welfare of each research subject, and that the subject's rights and welfare must take
precedence over the goals and requirements of the research.
EMS Unit Signature:
Printed Name:
Address:
City
State
Signature, FWA Institutional Official:
Printed Name: Andrew F. Nelson, MPH
Institutional Title: Executive Director, HealthPartners Research Foundation
Early EMS and ED Use of GIK for ACS: The IMMEDIATE Trial
Subaward Agreement
Between
HealthPartners Research Foundation
And
The City of Cottage Grove
This Subaward Agreement ( "Agreement ") is entered into by and between HealthPartners
Research Foundation (hereinafter referred to as "HPRF ") and the City of Cottage Grove,
by and through its Public Safety Department (hereinafter referred to as "EMS Agency ").
HPRF and EMS Agency are sometimes referred to herein as "parties" or individually as a
"party" in this Agreement.
WHEREAS, HPRF is the recipient of a subaward from Tufts University Medical Center for
51-101 HL077821 -03 ( "Award ") and CFDA# 93.837 from the National Institutes of Health,
( "Sponsor "), for the conduct of a project entitled "Early EMS and ED Use of GIK for ACS:
The IMMEDIATE Trial ", ( "Study ") as detailed in the study protocol;
WHEREAS, the parties acknowledge that the mission of the parties is health care and the
advancement of scientific knowledge and education. The parties acknowledge that this
Study will be performed in a manner best suited to carryout that mission.
WHEREAS, HPRF desires EMS Agency's participation in the research activities under
this Study;
WHEREAS, EMS Agency would like to participate in the research activities in support of
the Study; and,
WHEREAS, HPRF and EMS Agency desire to enter into a Subaward Agreement under
the Award for research support services
NOW, THEREFORE, in consideration of the mutual promises and covenants contained
herein, HPRF and EMS Agency agree as follows:
•' • Ty
The EMS AGENCY shall perform those services described in Exhibit A, the Scope of
Work, which is attached hereto and incorporated herein by reference. Any changes to
the Study proposed by EMS AGENCY shall require the prior written approval of HPRF,
which shall include IRB review and approval if appropriate. EMS AGENCY shall adhere
to all conditions of approval as discussed or documented in the approval process by the
IRB of record. The IRB of record will be the HPRF IRB. Any significant changes in the
performance of this Agreement as outlined in the Scope of Work set forth in Exhibit A
require the express written approval of both HPRF and EMS AGENCY in an amendment
to this Agreement.
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The term of this Agreement shall begin on April 15, 2010, and shall terminate on January
31, 2011. This Agreement shall not extend beyond the termination date unless agreed to
in writing by both parties.
Future periods are contingent upon programmatic requirements, satisfactory progress
and Tuft's receipt of a continuation award under the NIH Grant. Accordingly, it is the
intention of HPRF to continue this contracting relationship through the project period
provided that ongoing funding from Sponsor is awarded at requested levels and that EMS
AGENCY meets project performance and reporting requirements including, but not
limited to, OMB A -133, Section 400 (d) regulations.
3. ESTIMATED COST AND PAYMENT:
Payment for work performed by EMS AGENCY is not to exceed $ 8,100.00 unless
amended by written mutual agreement.
EMS AGENCY will be paid by HPRF for services rendered under the terms of this
Agreement, provided that:
1. Such costs are allowable by terms of this Agreement;
2. The applicable governmental cost principles were followed, including obtaining prior
written approval from HPRF for all areas requiring prior approval of the awarding
agency as outlined in applicable governmental cost principles and in accordance with
the NIH Grants Policy Statement.
EMS AGENCY shall submit one invoice within one month following the end of training on
or around May 7, 2010. Invoices must clearly delineate expenditures by expense
category as shown in the budget attachment (Exhibit B — Budget). Additionally, individual
invoices must correctly reference: HPRF Agreement Number X1001300. Invoices
without such references will be returned to EMS AGENCY.
The invoices for each project must be submitted within 30 calendar days after the
termination of training, and must be signed and marked "Final" by the EMS AGENCY
with the following statement:
"The EMS AGENCY has an approved financial accounting management system
designed to assure that all expenditures were incurred in full compliance with OMB
Circular A -133 or its own applicable audit regulations. Disallowed costs, if found during
the retention period of this Agreement, will be promptly refunded to HPRF."
Failure to sign the final invoice and provide such a statement will not relieve the EMS
AGENCY from this requirement. Execution of this Agreement will be considered to be
acceptance by the EMS AGENCY of these terms.
If during the record retention period of this Agreement, a finding or questioned cost is
found related directly to this Agreement, then the EMS AGENCY will promptly notify
HPRF in order to proceed with resolution of such matter, as may be required by HPRF's
prime sponsor or applicable Federal regulations.
Invoices and questions concerning invoice receipt or payments should be directed to the
HPRF's Administrative Contact as shown in Exhibit C.
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HPRF shall make payments in accordance with HPRF's accounts payable policies but in
no event later than 45 days after receipt of an accurate invoice from EMS AGENCY.
4. BUDGET
Any expenditures or charges beyond the specified training reimbursement requires
prior approval of the HPRF's Authorized Institutional Official as provided in
Exhibit C or his /her designee
The EMS AGENCY may not deviate significantly from the major line items of the budget
attachments (Exhibit B), as defined by the Sponsor's guidelines, unless specifically
authorized by the HPRF.
5. PROGRESS REPORTS:
Upon written request, EMS AGENCY will provide progress reports to HPRF within thirty
(30) days of receipt of HPRF's written request. All progress reports shall be directed to
HPRF's Principal Investigator and sent to HPRF's Administrative Contact as identified in
Exhibit C.
6. PRINCIPAL INVESTIGATOR /SITE PRIMARY CONTACT
The Principal Investigator for HPRF and Primary Contact for EMS AGENCY are noted in
Exhibit C. EMS AGENCY's Primary Contact shall be responsible for the technical and
administrative conduct of the Study covered by this Agreement. In the event that a
change in EMS AGENCY's Primary Contact is necessary, HPRF must be notified in
writing immediately.
7. NOTICES:
For either party, all notices required or permitted under this Agreement shall be effective
only if given in writing and delivered by personal service (including email), or by express
or registered mail, to the appropriate institutional officials identified in Exhibit C. All
notices and requests for approvals from HPRF on financial or administrative matters shall
be submitted to the HPRF's Administrative Contact identified in Exhibit C.
8. FEDERAL STATE AND LOCAL TAXES:
Except as may be otherwise provided in this Agreement, the Agreement price includes all
applicable Federal, State and local taxes and duties.
9. COMPLIANCE WITH LAW
Each party shall comply with any and all applicable State and Federal laws, regulations
and policies applicable to this Agreement, and shall ensure that any of its contractors and
subcontractors also complies with such requirements.
10. HIPAA COMPLIANCE:
The parties may receive from each other certain health or medical information in the
performance of this Agreement ( "Protected Health Information" or "PHI," as defined in 45
C.F.R. Section 160.103). Use or disclosure of PHI is subject to the terms of the Data Use
Agreement associated with this Study.
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11. REVIEW OF HUMAN SUBJECTS IN RESEARCH PROJECTS:
As applicable, EMS AGENCY shall comply with Department of Health and Human
Services (DHHS) policies and regulations regarding the Protection of Human Subjects
(Title 45 Code of Federal Regulations, Part 46, Subpart A, as amended) and with 21 CFR
50 and 21 CFR 56, as applicable.
12. USE OF NAME
HPRF and EMS AGENCY mutually each agree to not use the name of the other, or the
name of any staff of the other in any commercial or non - commercial advertising or other
public communication concerning this Study without the prior written permission of a duly
authorized party hereto and individual whose name is planned to be used.
13. CONFIDENTIALITY:
(a) Each party shall keep confidential that information received from the other party that is
confidential or proprietary in nature, whether received directly or indirectly, during or
otherwise in connection with projects governed by this Agreement. "Confidential
Information" includes but is not limited to the following:
i) study participant medical records, research data, and other identifiable personal
health information;
ii) any other patient - identifiable information;
iii) provider - identifiable information;
iv) any nonpublic Information about the business operations of each party;
v) any other nonpublic information of each party including but not limited to health
care delivery practices, utilization data, pharmacy data, membership or other
health plan information; and.
(vi) Confidential Information of other participating sites.
(b) Each party shall make reasonable efforts to mark Confidential Information clearly,
or so identify Confidential Information that is disclosed orally provided however,
that items described in Section (a), (i), (ii) and (iii) above shall be automatically
deemed Confidential Information without further identification. If a party
determines it has made an oral disclosure of Confidential Information, the party
making the disclosure shall be responsible for clearly informing the other party, in
writing within thirty (30) days that the information disclosed is confidential. Except
for items described in Section (a), (i), (ii) and (iii), which confidentiality shall be
maintained as required by law, the parties shall use reasonable efforts to maintain
the confidentiality of the items described in Section (a), (iv) and (v) for a period of
five (5) years after termination of the Agreement.
(c) The obligation to keep information confidential shall not apply to:
i) information that is shown to have been in the possession of the receiving party
before being disclosed by the disclosing party;
ii) information which is now, or later becomes, generally available to the public
through no fault of any party to this Agreement;
iii) information which is received from a third party who is not under an obligation
of confidentiality;
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iv) information which is independently developed by the receiving party without
access to the confidential information of the disclosing party; or
v) information required to be released by law provided that the other party is
notified prior to making such release of information and has the opportunity, if it
chooses, to contest such release.
(d) Confidential Information provided from one party ( "disclosing party ") to the other
( "receiving party ") under this Agreement shall be maintained by the receiving party in
a secure and confidential manner, and used by the receiving party solely in the
conduct of the Study and in accordance with this Agreement, the consent documents,
if any, and the Study as approved by the applicable IRBs. Any other use or disclosure
is prohibited except as expressly authorized by applicable law or elsewhere in this
Agreement. A receiving party shall disclose Confidential Information only to such
persons (employees, agents, contractors, and vendors) having a need to know such
information necessary for the receiving party to conduct the Study.
The parties to this Agreement agree that any Confidential Information received from
the other party and retained by either Party must be recorded in such a manner that it
cannot be directly or indirectly linked through identifiers to any patient, enrollee,
employee, provider, or other individual related to the party from whom the information
was received.
The parties agree to advise each of their investigators, subcontractors, employees
and agents who have access to Confidential Information received from the other party
under the terms of this Agreement from using or disclosing that Confidential
Information in a manner contrary to the terms of this Agreement.
The disclosing party may require the other party's agents, contractors and vendors to
sign confidentiality agreements acceptable to the disclosing party before providing
such individuals access to its Confidential Information.
Notwithstanding anything in this Section 13 to the contrary, HPRF and EMS Agency will
comply with the requirements of the Minnesota Data Practices Act (the "Act ") in
performing its duties under this Agreement. No private or confidential data collected,
maintained or used in the course of performance of this Agreement will be disseminated,
except as authorized or required by the Act either during the term of this Agreement or
thereafter, Any data supplied to EMS AGENCY by HPRF during this Agreement will be
administered in accordance with the provisions of the Act.
14. TERMINATION
Notwithstanding the provisions of Section 2 above, either party may terminate this
Agreement for any reason upon thirty (30) days prior written notification to the other
parry, effective on the date the other party receives such notice, and with cause thirty (30)
days after an uncured material breach described in a written notification to the breaching
party.
In the event of early termination, EMS AGENCY shall take all reasonable steps to
minimize further costs, and shall be entitled to reimbursement for costs and non -
cancelable obligations incurred prior to the effective date of such early termination,
except in no event shall such reimbursement exceed the amount set forth in Section 3. If
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this Agreement is terminated early, then EMS AGENCY shall deliver such information
and items completed up to the early termination date to the HPRF.
The following Sections shall survive the expiration or termination of this Agreement:
Section 10, 11, 12, 13, 15, 17, and 23.
15. DISPUTE RESOLUTION:
a) Equitable Relief. Nothing in this Agreement shall prevent either party from seeking
equitable relief.
b) Meet and Confer. No party shall initiate legal action under or in relation to this
Agreement unless it has first complied with the process described in this
subsection (b), excluding actions for which equitable relief is sought. Should a
dispute arise under or in relation to this Agreement or to a specific Study
Agreement governed by this Agreement and equitable relief is not sought, a party
shall issue a written notice to the other party describing the dispute and the
remedy sought. The disputing parties shall meet and confer in person or by
telephone within five business days of receipt of such notice, or such other time
period as the parties may mutually agree in writing. If such dispute is not resolved
through such conference within five business days, the matter shall be
immediately referred to the persons to whom each such individual reports within its
organization who shall attempt to resolve the dispute. If the dispute is not resolved
within twenty business days after receipt of the notice, or such other time period as
the parties may mutually agree in writing, either party may seek any remedy
available under law including, without limitation, immediate termination of this
agreement.
16. FORCE MAJEURE:
No party shall be liable for any delays or failures in performance resulting from
circumstances or causes beyond its reasonable control, including, without limitation, fire
or other casualty, act of God, war or other violence, or any law, order or requirement of
any governmental agency or authority, provided that the party claiming the force majeure
event shall use reasonable efforts to continue to perform on any specific study governed
by this Agreement.
17. INDEMNIFICATION:
Each party shall be responsible for the negligent or willful acts or omissions of itself and
its agents to the extent allowed by law.
Financial records, supporting documents and other records pertinent to this Agreement
shall be retained by EMS AGENCY for a period of three (3) years from the date of
submission of the final expenditure report, except that records pertaining to audits,
appeals, litigation or settlement of claims arising out of performance of this Agreement
shall be retained until such audits, appeals, litigation or claims have been disposed of.
The retention period starts from the date of the submission of the EMS AGENCY's final
invoices.
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The retention periods set forth in this section 18 are minimum retention periods; the EMS
AGENCY will retain records for longer periods if required by its record retention schedule
as required by state law.
All research records, including but not limited to original data and primary data - yielding
materials, secondarily derived tables and figures, and statistical tabulations and other
summaries, pertinent to this Agreement shall be made available to HPRF upon its
reasonable request during business hours and shall be retained by EMS AGENCY for a
period of three (3) years from the termination date of this Agreement, except (a) to the
extent a Party has requested the return of such records, or (b) that records pertaining to
any allegation of scientific misconduct or investigation, appeal, administrative proceeding
or litigation relating to any charge arising out of the scientific performance of this
Agreement shall be retained until three (3) years after the later of the conclusion of the
allegation, investigation, appeal, administrative proceeding, litigation or acceptance by
Public Health Service of a final report pertaining thereto.
Administration of this Agreement shall be in accordance with generally accepted
accounting principles, with Office of Management and Budget (OMB) Circular A -110, A-
122, A -133 and with applicable provisions of the NIH Grants Policy Statement (NIHGPS).
EMS AGENCY acknowledges and agrees that, as part of HPRF's implementation of
OMB Circular A -133 HPRF will monitor EMS AGENCY's performance under this
Agreement and, in the event of incomplete performance, HPRF may require EMS
AGENCY to obtain, at EMS AGENCY's sole expense, an independent audit of costs
claimed under this Agreement.
If EMS AGENCY expends $500,000 or more in federal funds in any one year, EMS
AGENCY will arrange for an annual examination by an independent accountant in order
to ascertain the effectiveness of the EMS AGENCY's financial management systems and
internal procedures established to meet the terms of this Agreement.
If the EMS AGENCY is subject to the uniform administrative requirements of OMB
Circulars A -110 and arranges for audits that comply with OMB Circular A -133 or
equivalent guidelines, the EMS AGENCY shall provide its independent accountant's or
firm's written report upon execution of this Agreement. Any subsequent audit report shall
be sent to the HPRF within thirty (30) days of receipt by the EMS AGENCY. The
report(s) shall be sent to the HPRF's Financial Contact address referenced in Exhibit C.
EMS AGENCY shall monitor other entities that receive funding through the EMS
AGENCY as a result of this Agreement and shall adhere to all applicable regulations
outlined in OMB Circular A -133 including requirements of Subpart D-- Federal Agencies
and Pass - Through Entities.
If any audit report or other significant accounting errors in invoicing or budgeting reflect
major shortcomings in EMS AGENCY's internal control systems, HPRF may seek to
impose more stringent prior approval requirements for certain types of expenditures
and /or rebudgeting and may require detailed supporting documentation for all claims for
reimbursement until EMS AGENCY has reasonably demonstrated that necessary
corrective action has been, or will be taken.
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Within six months of receipt of a report or statement identifying an instance of
noncompliance with Federal laws and regulations, the EMS AGENCY shall provide to
HPRF its plan for corrective action and shall cooperate with HPRF in resolving questions
HPRF may have. All such records and reports or statements prepared in accordance
with the requirements of OMB Circular A -133, as applicable, shall be available for
inspection by representatives of HPRF or the government during normal business hours.
The EMS AGENCY shall ensure that other subcontractors, as well, who receive funding
or perform work through the EMS AGENCY as a result of this Agreement adhere to the
terms of this section.
Failure to comply with the terms of this paragraph may lead to Agreement termination in
accordance with Section 16, Termination.
The Comptroller General of the United States, the U.S. Department of Health and Human
Services, the HPRF and any of their duly authorized representatives shall have access at
any reasonable time after prior written notification to pertinent books, documents, papers
and records of EMS AGENCY in order to make audits, examinations, excerpts and
transcripts. In the event that any payment made to the EMS AGENCY is determined on
the basis of such audits to be unallowable the EMS AGENCY shall promptly refund the
unallowable amount to HPRF upon demand.
19. INDEPENDENT CONTRACTOR
EMS AGENCY is deemed at all times to be an independent contractor and shall be
wholly responsible for the manner in which it performs the services required of it by the
terms of this Agreement. Nothing contained herein shall be construed as creating the
relationship of employer and employee between HPRF and EMS AGENCY or its officers,
agents, and employees.
20. SEVERABILITY
If any provision of this Agreement or any provision of any document incorporated by
reference shall be held invalid, the parties will try to construe the provision in a manner
that eliminates the offending language but maintains the overall intent of the Agreement.
If that is not possible, the provision will be excised from this Agreement. The remainder
of the Agreement will remain in full force and effect only if the excised provision does not
relate to payment or obligations and enforcing this Agreement would not result in
substantial unfairness to a party. Otherwise, either party may terminate this Agreement
upon thirty (30) days advance written notice.
21. MODIFICATIONS:
No modification, amendment, supplement to, or waiver of this Agreement shall be binding
upon the parties unless made in writing and duly signed by the authorized institutional
officials of both HPRF and EMS AGENCY as identified in Exhibit C.
22. ASSIGNMENT/TRANSFER
EMS AGENCY may not assign, subcontract, delegate, cede or otherwise transfer any of
its rights or obligations under this Agreement without the prior written consent of HPRF,
which consent will not be unreasonably withheld; provided, however, without HPRF's
consent EMS AGENCY may assign this Agreement in connection with the transfer or
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sale of all or substantially all of its assets or business or its merger or consolidation with
another company but in such event, the assigning party shall provide the other party with
no less than 30 days prior written notice of the assignment, and the other party may
terminate this agreement pursuant to Section 16, herein. This Agreement shall inure to
the benefit of and be binding upon each party hereto, its successors and permitted
assigns. No assignment shall relieve either party of the performance of any accrued
obligation which such party may then have under this Agreement.
23. SPECIAL CONDITIONS FOR FEDERALLY FUNDED GRANTS
EMS AGENCY shall comply with the Special Conditions for Federally Funded Grants as
identified in Exhibit D, attached hereto and incorporated herein by reference.
24. ENTIRE AGREEMENT:
This Agreement, including exhibits and attachments, constitutes the entire agreement
between the parties regarding the subject matter herein and supersedes all prior
agreements between the parties.
25. APPROVALS
Any written approvals required under this Agreement may be made via email.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement on the
month, day and year specified below.
HealthPartners Research Foundation Agency:
Beverly A. Prawalsky Chief, EMS AGENCY Date
Sr. Mgr., Financial Reporting &
Grants Management
Date
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EXHIBIT A
SCOPE OF WORK
Members of Cottage Grove Public Safety will attend four hours of training on the IMMEDIATE trial
study protocol and two hours of required NIH Human Subjects Protection online training. They will
identify and recruit participants for the trial according to the eligibility criteria and the recruitment
and enrollment protocol developed under the Exception from Informed Consent regulations (21
CFR 50.24).
The IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial Assessment and
Treatment in Emergency Care) Trial will determine if an intravenous glucose, insulin and
potassium (GIK) solution can reduce the incidence of acute myocardial infarction (AMI) as
assessed by biomarker and electrocardiogram evidence of myocardial necrosis within the first 24
hours of enrollment. A randomized placebo - controlled double - blinded clinical trial of immediate
GIK will be conducted as early as possible in the prehospital emergency medical services (EMS)
setting.
This subcontract is part of the overall IMMEDIATE Trial Federal grant number UOI HL077821.
HealthPartners Research Foundation (HPRF) serves as the subcontractor for the St. Paul Site.
The funding period for this site is anticipated to begin on 03/15/10 assuming all Pre - Funding
Period deliverables are met. Funding is expected to continue through enrollment plus one month
close -out support. The budget provided to Cottage Grove Public Safety under this agreement is
for the funding period 02/01110 through 01/31/11.
Wes Halvorsen of EMS Agency is the subcontract Co- Investigator responsible for the
organization and implementation of the IMMEDIATE Trial at EMS AGENCY. EMS AGENCY
contact will work with Dr. Frascone [HPRF Site PI] to supervise the EMS AGENCY staff
responsible for the overall implementation of the Trial that will include enrollment in the EMS
setting. He will supervise research staff, obtain all necessary institutional approvals for human
subjects research, ensure completion of training at the EMS agency, overall compliance of the
Protocol, and adherence to the budget and timeline. Dr. Frascone is responsible for the
implementation of all study - related components involving the EMS system and paramedics and
will work closely with EMS AGENCY.
It is anticipated that approximately two to three study subjects per month will be enrolled at the St.
Paul Site. Enrollment will be monitored on an on -going basis by the IMMEDIATE Trial CC at Tufts
Medical Center (Tufts MC) using the electronic data collection and reporting systems.
Study resources will be provided directly by Tufts MC to the St. Paul Site, including study protocol
and training manuals, the study drug, IV pumps and tubing, study drug supply cases, online
paramedic training system, and the electronic data capture system.
Pre - Funding Period:
• Site Visit - The CC leadership conducts a site visit during this time as part of the site
assessment process. It is expected that that the site visit is attended by key representatives from
the following: EMS system (medical director, paramedic leadership, fire chief, paramedic
educator, state and /or local authority); receiving hospitals (emergency department physicians,
cardiology department physicians, nursing, pharmacy); and others such as pharmacists,
institutional review board members, and other regulatory or quality assurance staff. The CC
leadership will present an overview of the study, answer questions, and view the facilities.
® Institutional Review Board (IRB) Submission and Approval - The CC will work closely with the
site.
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• Determine the EMS system's governing IRB
• Ensure that a Federal Wide Assurance (FWA) is in place for the EMS system. If
not, CC will lead application process for obtaining an FWA.
• CC will provide assistance and guidance with IRB application and related
processes. The CC will complete the primary IRB application and provide it to the
EMS Site for review and signature, and for submission to the IRB.
• CC will provide community consultation plan for submission to the IRB; CC will pay
for the approved implementation of the community consultation plan.
• IRB fees will be paid by the CC if incurred.
• CC will attend IRB meeting if requested.
• Conflict of Interest form signed and returned to CC (Site PI and Investigators)
• Investigator's CV, license and human subject protection certification provided to
CC
• Protocol Signature Page signed and returned to CC
o FDA form 1572
Start -Up Period:
• Onsite orientation and training of research team
• Schedule and convene meeting with all staff and CC Program Manager
• Manual of Operations, policies and procedures
• Electronic data capture (EDC) data collection system
• Staff training on the study drug tracking system
• IRB processes
• Complete community consultation
• Complete public disclosure
• IRB submission and approval from EMS system's receiving hospital
• Paramedic training
• Complete Human Subjects Protection certification program
• Complete all IMMEDIATE Trial study modules
• Complete hands -on practicum
• Electronic data systems
• Predictive instrument software upgrade to the electrocardiographs
® Transfer of data to the Trial's Data Coordinating Center (DCC)
• Report distribution and monitoring
• Staff training on the study drug tracking system
• Materials and study drug distribution
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1x1'11-1 ...
Prior to the onset of the Enrollment Period, paramedics within the St. Paul Site will be fully
prepared to participate in the screening and enrollment process and all receiving hospitals will be
ready. Enrollment in the EMS setting will be monitored on an ongoing basis, providing daily,
weekly and monthly reports to ensure that all patients evaluated for a cardiac event have an ECG
done, and subsequently a Screening Form completed (for every ECG). All Screening Forms will
be entered into the EDC system within 24 hours to allow for close monitoring and ensuring that
the minimum requirements for study subject enrollment are met.
The expectations are that screening and enrollment will occur 24 hours a day, 7 days a week and
365 days a year. The assigned CC Program Manager and the Site Team will review reports
weekly to monitor the paramedics' performance based on study subjects who are correctly
enrolled, incorrectly enrolled, and those who are missed. This will allow close monitoring of the
Site's false positive rate, and if the false positive rate exceeds 10% on a continual basis then
continued payment for study subjects who do not have ACS will not be provided. During this
period, the Site Team will be responsible for adhering to the Protocol requirements and as
specified in the Manual of Operations.
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PRITUTHM
Reimbursement for Paramedic attendance at study training session
Total Costs $ 8,100.00
Paramedic Training
We estimate that 30 staff members of EMS AGENCY will be trained to participate in the Trial with
four hours of didactic training each. Staff members will also be completing two hours of on -line
training. EMS AGENCY will be reimbursed for their staff's training time at six hours times their
individual hourly rate to a maximum reimbursement of $ 8,100.00.
Invoice must include the following detail:
Date of Training, Attendee name, rate of pay, # of hours = total reimbursement
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Exhibit C
HPRF Contacts
EMS AGENCY Contacts
Administrative Contact (STUDY PI Office)
Administrative Contact
Name: Josh Salzman
Name:
Address: 680 Hale Ave. N, Ste. 230
Address:
Oakdale, MN 55128
Telephone: 651 - 254 -7749
Fax: 651- 778 -3778
Telephone:
Email: Joshua .g.salzman @healthpartners.com
Fax:
Email:
Principal Investigator
Site Primary Contact
Name: R.J. Frascone, MD
Name:
Address: Regions Hospital
Address:
640 North Jackson Street MS13801B
Saint Paul, MN 55101
Telephone: 651.254.7750
Telephone:
Fax:
Fax:
Email: Ralph .J.Frascone @HealthPartners.com
Email:
Financial Contact
Financial Contact
Name: Kristin Simonson
Name:
Address: HealthPartners Research Foundation
PO Box 1524
Minneapolis, MN 55440 -1524
Address:
Telephone: 952 - 967 -5028
Telephone:
Fax: 952 - 967 -5022
Fax:
Email: Kristin .J.Simonson @HealthPartners.com
Email:
Authorized Institutional Official
Authorized Institutional Official
Name:
Name: Beverly Prawalsky
Address: HealthPartners Research Foundation
PO Box 1524
Address:
Minneapolis, MN 55440 -1524
Telephone: 952 - 967 -5003
Telephone:
Fax: 952 - 967 -5022
Fax:
Email: Beverly .A.Prawalsky @HealthPartners.com
Email:
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Exhibit D
Special Conditions for Federally Funded Grants
General terms and conditions:
1. The restrictions on the expenditure of federal funds in appropriations acts are
applicable to this Subaward Agreement to the extent those restrictions are pertinent.
2. 45 CFR Part 74 or 45 CFR Part 92 as applicable. [This is the CFR governing NIH]
Including 45 CFR Part 46, 45 CFR Part 50, Subpart F, 45 CFR Part 52, and 45 CFR
Part 76.
3. The NIH Grants Policy Statement, including addenda, in effect as of the beginning
date of the period of performance and found at
http: // grants. nih .gov /grants /policy /policy,htm, except for the payment mechanism and
final reporting requirements are replaced with Reporting Requirements and Terms
and Conditions on the front page of this agreement.
4. EMS AGENCY assures, by signing this Subaward Agreement, that all of EMS
AGENCY's personnel who are responsible for the design and conduct of projects
involving human research participants have successfully completed their institutional
training in accordance with the NIH Guide, Notice OD -00 -039.
5. Title to equipment costing $5,000 or more that is purchased or fabricated with
research funds or collaborator cost sharing funds, as direct costs of the project or
program, shall unconditionally vest in the collaborator upon acquisition without further
obligation to the Federal Awarding Agency subject to the conditions specified in the
NIH Grants Policy Statement.
6. All prior approvals are to be sought from the HPRF and not the Federal Awarding
Agency.
Agency- Specific Certifications /Assurances
1. The following assurances /certifications are made and verified by Collaborator's
Authorized Official Signature on this Subaward Agreement. Descriptions of individual
assurances /certifications are provided in Section III of the PHS 398. 1) Human
Subjects; 2) Research Using Human Embryonic Stem Cells; 3) Research on
Transplantation of Human Fetal Tissue; 4) Women and Minority Inclusion Policy; 5)
Inclusion of Children Policy; 6) Vertebrate Animals; 7) Debarment and Suspension; 8)
Drug -Free Workplace; 9) Lobbying; 10) Non - Delinquency on Federal Debt;
11)Research Misconduct; 12) Civil Rights (Form HHS 441 or HHS 690); 13)
Handicapped Individuals (Form HHS 641 or HHS 690); 14) Sex Discrimination (Form
HHS 639 -A or HHS 690); 15) Age Discrimination ( Form HHS 680 or HHS 690); 16)
Recombinant DNA and Human Gene Transfer Research; 17) Financial Conflict of
Interest; 18) Smoke Free Workplace; 19) Prohibited Research; 20) Select Agent
Research; 21) PI Assurance.
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