Pediatric Heart Transplant Study Registry

PEDIATRIC HEART TRANSPLANT STUDY REGISTRY

PARTICIPATION AGREEMENT

(Print or Type Member’s Name Here)

I. Agreement: Member agrees to participate in the Pediatric Heart Transplant Study Registry. The Registry was established and is administered by the University of Alabama at Birmingham (UAB). By signing this Participation Agreement, Member 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 PHTS Registry: The purposes of the PHTS Registry are:

1.  Research. UAB and members may use the information submitted to the registry for research activities.

2.  Quality Improvement Activities on behalf of the Members. UAB will furnish the members with Quality Improvement reports comparing the Member’s information with the Registry’s aggregate information.

3.  Public Health Activities, including FDA-required reporting. UAB can assist members with required reporting to the FDA and other government agencies in support of public health activities.

III. Specific Purposes of the Registry:

The primary purpose of the registry is to establish and maintain an international, prospective, event-driven database for heart transplantation and to use the database to encourage and stimulate basic and clinical research in the fields of pediatric heart transplantation and to promote new therapeutic strategies.

In addition, members may choose to receive quality improvement reports and information from the Registry so that they can benchmark their performance against the Registry’s aggregate data pertaining to pediatric heart transplants.

IV. Requirements to Participate in Registry

Members must submit the following signed documents:

1.  Participation Agreement

2.  Research Approval. Evidence of current IRB Approval and Patient Consent or IRB Waiver of Consent to participate in the registry.

3.  HIPAA Approval. Evidence of Patient Authorization to Transmit PHI to Registry, or, current IRB/Privacy Board Waiver of Patient Authorization.

4.  HIPAA Business Associate Agreement authorizing the Registry to serve as the member’s business associate for purposes of quality improvement reporting.

V. Member Responsibilities:

1.  Member agrees to notify the Registry in the event of any change in the Principal Investigator and/or Site Administrator for the database.

2.  Member agrees to abide by the Registry Manual of Operations and Forms Completion.

3.  Member understands that incomplete data submissions or submissions on partial patient populations entitle the Registry, at its discretion, to discontinue Member’s participation in the database and Member’s access to the collected data.

4.  Members assume responsibility for maintaining security of its assigned login names and passwords.

5.  Member 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.

6.  Center agrees to pay the assigned annual participation fee. Failure to pay the participation fee will result in termination of the Member’s participation in the Registry.

VI. Registry’s Responsibilities:

1.  Registry 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.

2.  Registry will create, manage, maintain, and scientifically analyze a registry for pediatric patients who are listed for cardiac transplantation.

3.  Registry will create and implement strategies for ensuring high quality data in the registry.

4.  Registry will create and distribute annual quality assurance reports to each participating hospital that provides high quality data.

5.  Registry, under the direction of the PHTS committees, will analyze registry data for the purpose of advancing the field and producing publications.

MEMBER

* Signature: ______Date: ______

Printed Name: ______

Title: ______

* Signature should be made by the appropriate authority to bind the institution/center to the provisions in the agreement.

THE PEDIATRIC HEART TRANSPLANT STUDY

UAB

* Signature: ______Date: ______

Printed Name: ______

Title: ______