Download HIPAA Authorization Template

Manual of Operations and Procedures Version 5.0
05/09/2016
Appendix C: Adult HIPAA Authorization Template, Version Date 05/09/16
Interagency Registry for Mechanically Assisted Circulatory Support
for adult patients (Intermacs®)
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
(Intermacs®). 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 local PI) (or whoever may replace this doctor) and the clinical staff are
responsible for collecting this information here at (insert institution name).
o The clinical staff 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, the Food and Drug
Administration, and the Center for Medicare and Medicaid Services, or their
agents, will use your information to better understand how mechanical
circulatory support devices improve or do not improve life for heart failure
patients. However, your name and last 5 digits of your social security number,
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Manual of Operations and Procedures Version 5.0
05/09/2016
Appendix C: Adult HIPAA Authorization Template, Version Date 05/09/16
social insurance number, or another identifying number such as the last 5 digits
of your transplant wait list number (if you are transplant-eligible) will be kept
confidential to the extent permitted by law.
o The people named in the Informed Consent section “WHAT ABOUT
CONFIDENTIALITY?”, 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)/Ethics Board (EB), the National Heart, Lung, and Blood Institute, and
the Intermacs® organization or their representatives (including 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 registry, the information disclosed may no longer be protected by
the federal privacy regulations found at 45 CFR Part 164. However, the investigators for
this registry only use or disclose your health information for purposes that are approved
by an IRB/EB 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 investigators 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 and Procedures Version 5.0
05/09/2016
Appendix C: Adult HIPAA Authorization Template, Version Date 05/09/16
___________________________
Legally Authorized 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/subject’s Legally Authorized Representative. To the best of my
knowledge, he/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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