Manual of Operations and Procedures Version5.0

05/09/2016

Appendix C: Pediatric HIPAA Authorization Template, Version Date 05/09/16

Interagency Registry for Mechanically Assisted Circulatory Support

for pediatric patients (Pedimacs)

Authorization for the Use and Disclosure of

Protected Health Information (HIPAA)

Sponsor: The National Heart, Lung, and Blood Institute (NHLBI)Contract #HHSN268201100025C

Principal Investigator: (Insert local Principal Investigator)

Phone number: (Insert local Principal Investigator phone number)

This form is asking you to authorize the use and disclosure of your/your child’s health information for the registry named Interagency Registry for Mechanically Assisted Circulatory Support for pediatric patients (also known as Pedimacs). To do that you need to know:

  • The kind of health information about you/your child that the registry will collect and use; this information includes:
  • medical chart review
  • interviews about your/your child’s health and quality of life and
  • and laboratory test results;
  • The reasons that we are doing this registry, which have been described to you/your child earlier, can be found in the Informed Consent section “WHAT IS THE PURPOSE OF THIS REGISTRY?”
  • The persons who will collect and use your/your child’s information for this registry:
  • 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).
  • The clinical staff will send your/your child’s information through a secure website to the Pedimacs database.
  • Investigators for Pedimacs, 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/your child’s information to better understand how mechanical circulatory support devices improve or do not improve life for pediatric heart failure patients, but your/your child’s name and last 5 digits of your/your child’s social security number, social insurance number, or another identifying number, such as the last 5 digits of the transplant wait list number(if eligible for transplant) will be kept confidential to the extent permitted by law.
  • The people named earlier, see Informed Consent section “WHAT ABOUT CONFIDENTIALITY?”, who make sure that your/your child’s rights and safety are protected and that study findings are accurate, may also need to see information in your/your child’s 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 StudyMonitors).
  • This authorization willnot expire.
  • You can stop the use of your/your child’s 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 authorization:
  • No more information will be collected from you/your child or your/your child’s records for the registry from the time the written request is received;
  • The registry will only use the information it has already collected from you/your childor your/your child’s records before you sent the written request.
  • When you sign this document and authorize the use and disclosure of your/your child’s 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 can only use or disclose your/your child’s health information for purposes that are approved by an IRB/EB or as required by law or regulation.

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/your child’s health information for the purpose of this registry, please print and sign your name below.

______

Participant Name (print)Participant SignatureDate

______

Parent/Guardian (print)Parent/Guardian SignatureDate

______

Witness Name (print)Witness SignatureDate

______

PI or Designee’s Statement:

I have reviewed the authorization for the use and disclosure of protected health information with the subject/subject’s parent or legal guardian. To the best of my knowledge, he/she understands the meaning of this authorization.

______

PI or Designee Name (print) PI or Designee SignatureDate

______

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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