Manual of Operations Version 4.0
02/27/2014
Appendix C: Adult HIPAA
Interagency Registry of Mechanically Assisted Circulatory Support
Authorization for the Use and Disclosure of
Protected Health Information (HIPAA)
Sponsor:
The National Heart, Lung, and Blood Institute (NHLBI)
Contract #HHSN 268201100025C
Principal Investigator:
(Insert local Principal Investigator)
Phone number:
(Insert local Principal Investigator phone number)
This section is asking you to authorize the use and disclosure of your health information for the
registry named Interagency Registry for Mechanically Assisted Circulatory Support. To do that
you need to know:

The kind of health information about you that the registry will collect and use; this
information includes:
o Medical chart review,
o interviews about your health and quality of life and
o laboratory test results.

The reasons that we are doing this registry, which have been described to you earlier,
can be found in the Informed Consent section “WHAT IS THE PURPOSE OF THIS
REGISTRY?”

The persons who will collect and use your information for this registry:
o Dr. (insert site PI) (or whoever may replace this doctor) and the research staff
are responsible for collecting this information here at (insert institution name).
o This clinical site will send your information through a secure website to the
INTERMACS database.
o Investigators for INTERMACS, including representatives from device
manufacturers, the National Heart Lung and Blood Institute (NHLBI), the Food
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Appendix C: Adult HIPAA
and Drug Administration (FDA), and the Center for Medicare and Medicaid
Services (CMS), or their agents, will use your information to better understand
how MCSDs improve or do not improve life for heart failure patients, but your
name and last 5 digits of your social security number (or in the event that your
social security number is not available, the last 5 digits of the transplant wait list
number) will be kept confidential to the extent permitted by law.
o The people named in the Informed Consent section “WHAT ABOUT
CONFIDENTIALY?”, who make sure that your rights and safety are protected and
that study findings are accurate may also need to see information about you in
your records including the (name of Institution’s) Institutional Review Board
(IRB), the National Heart, Lung, and Blood Institute (NHLBI), INTERMACS study
monitors


This authorization will not expire.

You can stop the use of your information in this registry by sending a written request to
Dr. (insert name of PI) (or whoever may replace this doctor). If you decide to withdraw
your authorization:
o No more information will be collected from you or your records for the registry
from the time the written request is received;
o The registry will only use the information it has already collected from you
before you sent the written request.

When you sign this document and authorize the use and disclosure of your health
information for this research, the information disclosed may no longer be protected by
the federal privacy regulations found at 45 CFR Part 164. However, the researchers for
this registry only use or disclose your health information for purposes that are
approved by an IRB or as required by law.
STATEMENT OF CONSENT
(NOTE: This is only a suggested signature format. Sites may use their own signature page.)
The details of this authorization have been explained to you and you have been given the
opportunity to ask any questions you wish.
If you voluntarily agree to allow the researchers to use and disclose your health information
for the purpose of this registry, please print and sign your name below.
___________________________ _
Participant Name (print)
__________________________
Participant Signature
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____________
Date
Manual of Operations Version 4.0
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Appendix C: Adult HIPAA
__________________________ _
Legally Authoirzed Representative
(LAR) Name (print)
__________________________
LAR Signature
____________
Date
_____________________________
Witness Name (print)
____________________________
Witness Signature
____________
Date
PI or Designee’s Statement:
I have reviewed the authorization for the use and disclosure of protected health
information with the subject. To the best of my knowledge, she understands the meaning of
this authorization.
______________________
PI or Designee Name (print)
____________________
PI or Designee Signature
_____________
Date
_____________________________________________________________________
Note: This consent form with the original signatures MUST be retained on file by the
principal investigator. A copy must be given to the volunteer. A copy should be placed in the
volunteer’s medical record, if applicable.
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