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Appendix D: Participation Agreement - Page 1 of 3
Appendix D Version 3.1, Revised 11/20/13
The Interagency Registry for Mechanically Assisted Circulatory Support
PARTICIPATION AGREEMENT
(Print or Type Center’s Name Here)
I.
Agreement: Institutions performing mechanical circulatory support device (MCSD)
implantation (hereinafter “Center”) are invited to participate in the Interagency Registry for
Mechanically Assisted Circulatory Support (INTERMACS®), an observational registry of clinical
events occurring in MCSD recipients. INTERMACS® serves as the North American quality
improvement system for assessing the characteristics, treatments, and outcomes of patients
receiving Food and Drug Administration (FDA)-approved (or Health Canada-approved for
Canadian sites) MCSDs. The Registry, which includes pediMACS (the pediatrics portion of
INTERMACS®), was established and is maintained by the University of Alabama at Birmingham
(UAB) pursuant to a federal research contract from the National Heart, Lung and Blood Institute
(NHLBI), National Institutes of Health (NIH), Department of Health and Human Services (HHS).
UAB serves as the Data Coordinating and Analysis Center (DCC). By signing this Participation
Agreement, Center agrees to the terms and conditions outlined in the Agreement. Failure to
abide by the terms and conditions will result in exclusion from further participation in the
registry.
II.
General Purposes of the Registry: The Registry is maintained for the following purposes
related to the implantation of MCSDs and assessing the quality of care and outcomes for
patients receiving MCSDs.
1. Quality Improvement Activities on behalf of the Centers. UAB will furnish the centers
with Quality Improvement reports comparing the Center’s information with the
Registry’s aggregate de-identified information.
2. Public Health Activities, including FDA and CMS-required reporting. UAB can assist
Centers with required reporting to the FDA, CMS and other government agencies in
support of public health activities.
3. Research. UAB and Centers may use de-identified information submitted to the registry
for research activities.
III.
Specific Purposes of the Registry: The primary purpose of the registry is to understand
and advance the application of mechanical circulatory support to improve the lives of patients
with advanced heart failure. The registry will use information collected to:

Facilitate the refinement of patient selection to maximize outcomes with current
and new device options.
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





Improve and expedite new device clinical trials by providing historical control data,
reliable enough to serve as Objective Performance Criteria (OPC) standards for FDA.
Develop consensus “best practice” guidelines to improve clinical management by
reducing short and long term complications of MCSD therapy.
Improve economic outcomes by identifying and optimizing factors affecting costeffectiveness.
Guide improvements in technology, particularly as next generation devices evolve.
Promote research into the underlying pathophysiologic substrate of advanced heart
failure in order to define and promote the conditions necessary for myocardial
recovery.
Evaluate parameters of quality of life before and after device implantation.
As stated in Section II (above), Centers will receive quality improvement reports and
information from the registry so that they can benchmark their performance against the
Registry’s aggregate de-identified data.
IV.
Requirements to Participate in Registry
Centers must submit the following signed documents to participate in the registry:
1. Participation Agreement
2. Approvals.
a. Evidence of current IRB Approval and Patient Consent to participate in the
registry.
b. The Center’s Federal Wide Assurance number.
c. Evidence of Patient Authorization to Transmit Protected Health Information
(PHI) to Registry.
3. HIPAA Business Associate Agreement authorizing the Registry to serve as the member’s
business associate for purposes of quality improvement reporting.
V.
1.
2.
3.
4.
5.
6.
Center Responsibilities:
Center agrees to designate a Principal Investigator and appoint a Site Administrator as
the Designated Contact for INTERMACS® communications and will maintain current mail,
phone, and fax and email contact information for those individuals.
Center agrees to notify INTERMACS® in the event of any change in the Principal
Investigator and/or Site Administrator for the database.
Center agrees to abide by the INTERMACS® Protocol and applicable Manual(s) of
Operations and Procedures.
Center understands that incomplete data submissions or submissions on partial patient
populations entitle INTERMACS®, at its discretion, to discontinue Center’s participation
in the registry and Center’s access to the collected data.
Center assumes responsibility for maintaining security of its assigned login names and
passwords.
Center agrees to comply with all federal and state regulations governing research and
with all applicable HIPAA laws and regulations pertaining to the submission, use and
disclosure of information reported to the Registry.
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7. Center agrees to pay the assigned annual participation fee, payable on July 1st of each
year. Failure to pay the participation fee will result in termination of the Center’s
participation in INTERMACS®.
VI.
1.
2.
3.
4.
INTERMACS® Responsibilities:
INTERMACS® will comply with all applicable federal and state regulations governing
research and with all applicable HIPAA laws and regulations pertaining to the
submission, use and disclosure of information reported to the Registry.
INTERMACS® agrees to provide Center with quarterly reports of center-specific data and
aggregate de-identified data.
INTERMACS® grants Center permission to submit data analysis requests to the
INTERMACS® Data Access, Analysis and Publications Committee for consideration.
INTERMACS® agrees to publish an annual report of all aggregate de-identified data and a
listing of all centers participating in the Registry.
CENTER
* Signature: ________________________________________ Date: _____________________
Printed Name: __________________________________________________________________
Title: _________________________________________________________________________
* Signature should be made by the appropriate authority to bind the institution/center to the
provisions in the agreement.
INTERMACS REGISTRY
* Signature: _________________________________________ Date: _____________________
Printed Name: __________________________________________________________________
Title: _________________________________________________________________________
Appendix D Version 3.1
Revised Date: 11/20/2013