Research Authorization

[pic]

RESEARCH AUTHORIZATION
Title of Research Study: RECOVER II - A Prospective Randomized Trial Investigating the Use of IMPELLA® RECOVER® LP 2.5 System in Patients with Acute MyocardialInfarction Induced Hemodynamic Instability



Investigator: Robert Frankel, MD

Patient Name:
We understand that information about you and your health is personal, and we are committed to protectingthe privacy of that information. Because of this commitment, we must obtain your written authorization before we may use or disclose your protected health information for the research purposesdescribed below. This form provides that authorization and helps us make sure that you are properly informed of how this information will be used or disclosed. Please read the information below carefullybefore signing this form.
USE AND DISCLOSURE COVERED BY THIS AUTHORIZATION
A representative of Maimonides Medical Center (“Hospital”) must answer these questions completely before providing thisauthorization form to you. DO NOT SIGN A BLANK FORM. You or your personal representative should read the descriptions below before signing this form.
Who will disclose, receive, and/or use theinformation? The following person(s), class(es) of persons, and/or organization(s) may disclose, use, and receive the information, but they may only use and disclose the information to the other parties onthis list, to the research subject or his/her personal representative, or as required by law.
[ ] Every research site for this study, including this Hospital, and including each sites’ researchstaff and medical staff
[X] Every health care provider who provides services to you in connection with this study
[X] Any laboratories and other individuals and organizations that analyze your healthinformation in connection with this study in accordance with the study’s protocol
[X] The following research sponsors:
[X] The United States Food and Drug Administration
[X] The members and...