Introduction:  As the parent and/or legal guardian of _______________________________ (the “Child”), you have the right to decide who may review or use the Child’s Protected Health Information ("PHI").  The type of information that may be used is described below. When you consider allowing the Child to take part in a research study, you must give permission as the parent and/or legal guardian to allow the Child’s PHI to be released from the Child’s doctors, clinics, and hospitals to the research team, for the specific purpose of this research study.  

What does this authorization relate to?	This authorization relates to the following study:

PRINCIPAL INVESTIGATOR (in charge of Research Team)	IRB PROTOCOL #	
	SPONSOR  #	
NAME OF CHILD - RESEARCH PARTICIPANT	BIRTHDATE	
		
STREET ADDRESS	CITY, STATE & ZIP CODE	

What information will be used for research purposes?	The PHI that will be used for research purposes may include some or all of the Child’s health records.  This includes, but is not limited to: information provided by you or the Child directly to the Research Team, hospital records and reports; admission histories, and physicals; X-ray films and reports; operative reports; laboratory reports; treatment and test results; immunizations; allergy reports; prescriptions; consultations; clinic notes; and any other medical or dental records needed by the Research Team.

Specific Authorizations:	I understand that this release also pertains to the Child’s records concerning hospitalization or treatment that may include the categories listed below.  I have the right to specifically request that the Child’s records NOT be released from his/her health care providers to the Research Team.  However, I understand that if I limit access to any of the Child’s records listed below, the Child may not be able to be in this research study. Check limitations, if any, below:

  Mental health records	  Sexually transmitted diseases	
  Psychotherapy Notes	  Alcohol / Substance abuse	
  HIV (AIDS)	  Other: _____________________________	

Who will be allowed to release this information?
I authorize the following persons, groups or organizations to disclose the Child’s information described in this Release of Information/Authorization for the above referenced research study:
  Treating providers	  Hospitals, clinics or other places where I have
  received treatment	
  Other:						  The Principal Investigator and the Research Staff	

Who can access your PHI for the study?  The people and entities listed above may share the Child’s PHI with the following persons or groups for the research study:  the Research Team, Institutional Review Board, Research Sponsor and its representatives, Research Organizations, the Department of Health & Human Services or other US or foreign government agencies as required by law, and to the Food and Drug Administration (FDA) or a person subject to the jurisdiction of the FDA in order to audit or monitor the quality, safety or effectiveness of the product or activity. 

The Research Team includes the Principal Investigator, his/her staff, research coordinators, research technicians and other staff members who provide assistance to the Research Team.  If there is a Research Sponsor(s), this shall include: ______________________________________________ and any Research Organizations who provided assistance to the Research Sponsor(s) including, but not limited to: __________________________________________________________________. 
Expiration date of this Authorization:  This authorization is valid until the following date or event:    

	 Specify Date ___/___/____ 		 End of the Study			 None
	Other: ______________________	 Indefinitely, or until such time as authorized by the 
						      sponsor to destroy study documents  	
	
Efforts will be made to ensure that the Child’s PHI will not be shared with other people outside of the research study.  However, the Child’s PHI may be disclosed to others as required by law and/or to individuals or organizations that oversee the conduct of research studies, and these individuals or organizations may not be held to the same legal privacy standards as are doctors and hospitals.  Thus, the Research Team cannot guarantee absolute confidentiality and privacy.  

As the Child’s parent and/or legal guardian, I have the right:
1.	To refuse to sign this form.  Not signing the form will not affect the Child’s regular health care including treatment, payment, or enrollment in a health plan or eligibility for health care benefits.  However, not signing the form will prevent the Child from participating in the research study above.

2.	To review and obtain a copy of the Child’s personal health information collected during the study.  However, it may be important to the success and integrity of the study that persons who participate in the study and their parents and/or legal guardians not be given access until the study is complete.  The Principal Investigator has discretion to refuse to grant access to this information if it will affect the integrity of the study data during the course of the study. Therefore, my request for information may be delayed until the study is complete.  

3.	To cancel this release of information/authorization at any time.  If I choose to cancel this release of information/authorization, I must notify the Principal Investigator for this study in writing at: ________________________________ (provide organization name and address).  However, even if I cancel this release of information/authorization, the Research Team, Research Sponsor(s) and/or the Research Organizations may still use information about the Child that was collected as part of the research project between the date I signed the current form and the date I cancel the authorization.  This is to protect the quality of the research results.  I understand that canceling this authorization may end the Child’s participation in this study. 

4.	To receive a copy of this form.

I have had the opportunity to review and ask questions regarding this release of information/authorization form.  By signing this release of information/authorization, I am confirming that I have the authority to execute this authorization on behalf of the Child.
		
Printed name of Parent and/or Legal Representative		
		
Signature of Parent and/or Legal Representative	Date	
*If signed by a legal representative; state the relationship and identify below the authority to act on behalf of the individual’s behalf.
*Individual is:		 a Minor		      Incompetent 	     Disabled		 Deceased
*Legal Authority:  				
	 Custodial Parent	 Legal Guardian	 Executor of Estate of the Deceased	 Power of Attorney Healthcare	 Authorized Legal Representative 		 Other: ___________