Parental Permission and Child Assent to Participate in a Research STUDY

AT The Children’s Mercy Hospital

Congenital Heart Surgeons’ Society (CHSS) Studies in Congenital Heart Disease

WHO IS DOING THIS STUDY?

This study is being conducted by The Children's Mercy Hospital’s Cardiovascular Surgery Department.  Dr. Gary Lofland, Primary Investigator, is in charge of this study.  Dr. Gary Lofland and Dr. James O’Brien, Jr. are the Cardiovascular surgeons involved in this study.  Lisa Barth, RN, MSN, MC-CNS; Lisa Laddish, RN, BSN; Kathleen O’Grady, RN, MSN, MC-CNS; and Stacy Reynolds, RN, CPNP, are the Cardiovascular Surgery Advanced Practice Nurses that coordinate the study activities at Children's Mercy Hospital.  Pamela Dennis, RN, MA, CRNFA, Jennifer Swihart, RN, RRT, CCRC and Marcy Tarrants assist in study related activities as assigned by the surgeons and the advanced practice nurses.   Vicki Headley, RN, RNC and Kathi Welch, RN, CPN; are nurse clinicians who may assist with the study. 
 

The Congenital Heart Surgeons’ Society (CHSS) has contracted with The Children’s Mercy Hospitals and Clinics to do this study.  The study personnel will not receive any personal financial benefits as a result of your decision. 
 

We are asking your child to be in this research study.  Please read the information below and ask questions about anything that you do not understand before you make a decision.

WHY IS THIS STUDY BEING DONE?

The Congenital Heart Surgeons’ Society (CHSS) collects information on individuals with congenital heart disease from many different centers around the United States and Canada.  This information is kept in a registry.  Because individuals with congenital heart disease have many different, and sometimes rare, conditions, compiling information from multiple centers gives us better information on how those who have congenital heart disease are doing, both in the short-term and the long-term, as well as which factors are associated with better or worse outcomes.  The CHSS data center helps surgeons and cardiologists change their practices and helps them to give families accurate information about their family member’s heart defect.

WHO CAN BE IN THIS STUDY?

We are asking your child to participate in this study because he or she was born with a specific Congenital Heart Disease.  About 70 surgeons will be enrolling children in this study at 45 different institutions.   
 

The Children’s Mercy Hospitals and Clinics will enroll approximately 2 patients per month in various CHSS studies.

WHAT WILL HAPPEN TO MY CHILD IN THIS STUDY?

If you agree for your child to participate in this study, your child’s diagnostic testing and surgery will not be altered in any way.  Information regarding your child’s hospitalization will be sent to the CHSS data center.  Information such as your and your child’s name and address, your child’s diagnosis, social security number, pediatrician’s name and address, Medical and surgical reports, copies of echocardiograms, chest x-rays, and cardiac catheterizations will be entered into a password protected computer database.  At intervals, healthcare professionals from the Children's Mercy Hospital or CHSS may call and/or mail a letter to you/your child, checking on your child’s clinical progress.  This letter is a survey that you will be asked to complete and return regarding your child’s clinical progress. They may ask questions about the medication your child is receiving, and surgery or procedures conducted during the year.  These data will be analyzed together with data from other children with the same diagnosis from centers around the country to determine the impact of patient characteristics, as well as treatment strategies on patient outcomes and to examine the overall health status and quality of life of these children.  The results will form the basis for scientific publication and will be presented at CHSS and other meetings.  Each participant will be in this study indefinitely.

WHAT ARE THE RISKS OF THE STUDY? 
 

There are no foreseeable risks in this study.  If you agree for your child to participate in this study, your child’s diagnostic testing and surgery will not be altered in any way. All records associated with your child’s participation in this study will be strictly confidential within the registry.  His or her name will not be released to any outside individuals or used in any publications. 
 

There may be risks we don’t know about right now.  We will tell you about any new information that might change your decision to keep your child in the study.

WHAT ARE THE BENEFITS OF BEING IN THIS STUDY?

Information collected by this data center may contribute to the care of children in the future who have the same heart condition as your child.  The information may also improve the future management of your child.  However, at this time there are no guarantees that your child will benefit from participation in this study. 

WHAT ABOUT EXTRA COSTS?

You will not have to pay anything extra if your child is in this study.

WHAT ABOUT CONFIDENTIALITY?

Your child has rights regarding the privacy and confidentiality of his or her health information.  When health information includes identifiers (like names, addresses, phone numbers and social security numbers) that link it directly to an individual, it is called protected health information (PHI).  Federal laws require that PHI be kept secure and private.  In certain situations, federal law also requires that you approve of how your child’s PHI is used or disclosed. A research study is one of those situations.  
 

By signing this permission/assent form, you are permitting the following people to have access to your child’s Medical record and use your child’s PHI for the research purposes described in this form:

• The research team, which includes the study personnel listed on this form and other persons involved in this study at Children’s Mercy Hospitals and Clinics;
• The Congenital Heart Surgeons’ Society and their designees;
• The Institutional Review Board at Children’s Mercy Hospitals and Clinics;
• Federal regulatory agencies such as the Office for Human Research Protections.

Information about your child that is obtained during this study will be recorded in a research record.  Information in the research record will be sent to the sponsor.  This record will

• Include your and your child’s name, address and telephone number, your child’s medical record number, hospital account number, social security number and date of birth.

The research record is separate from your child’s medical record.  Information from your child’s medical record may also be recorded in the research record. By signing this permission/assent form, you are allowing your child’s information to be recorded in the research record. You are also permitting your child’s research record to be shared with everyone listed above. 
 

We will also keep a research file that stays in the Cardiovascular Surgery research office.  That file may include documents that have your and your child’s name, address and telephone number, your child’s medical record number, hospital account number, social security number and date of birth. 
 

The persons and groups listed above are required by federal law or by contract to keep any PHI in your child’s research record secure and private.  While confidentiality cannot be guaranteed, it will be protected to the greatest extent possible.  There also may be some situations where laws require the release of your child’s PHI.  If your child’s PHI is shared with an organization that is not required to comply with federal privacy laws, your child’s health information is no longer considered protected and may be used and shared freely by that organization. 
 

You may choose not to sign this permission/assent form and not have your child participate in the study.  You may cancel your permission to use and share your child’s PHI at any time by contacting the study personnel listed on this form or The Children’s Mercy Hospital Medical Records Correspondence Department in writing.  If you cancel your permission, your child may no longer participate in this study.  If you cancel your permission, no more information will be recorded in your child’s research record for study purposes.  Your child’s PHI that has already been collected for the study may still be used, however. Unless you cancel your permission, your child’s PHI may continue to be recorded and used until the study is finished.  Some information about the study may be included in your child’s medical record.  Any study information recorded in your child’s medical record will be kept there indefinitely.  In the case of a side effect or bad event, your child’s entire medical record may need to be reviewed. Unless stated elsewhere in this form, you may not have access to your child’s research record or test results.\ 
 

Results of this study may be made public.  Your child will not be identified in any publications or presentations.

WHAT ARE THE ALTERNATIVES TO BEING IN THIS STUDY?

The alternative to this study is not to participate.  All tests and procedures will be performed regardless of participation in this study.

WHAT ARE MY CHILD’S RIGHTS AS A STUDY PARTICIPANT?

Being in a research study is voluntary.  Your child does not have to be in a study to receive care for his/her congenital heart defect.  If you choose not to have your child participate, there will be no penalty or loss of benefits to which your child is otherwise entitled.  
 

You may withdraw your child from the study at any time without penalty or loss of benefits to which your child is otherwise entitled.

WHO SHOULD I CALL IF I HAVE QUESTIONS OR PROBLEMS?

Dr. Gary Lofland is in charge of this study.  You may call him at (816) 234-3580 with questions at any time during the study.  You may also call Marcy Tarrants, the study coordinator, at (816) 234-3580 with any questions you may have. 
 

You may also call the Chair of the Pediatric Institutional Review Board (IRB) at (816) 234-3879 with questions about injury or your child’s rights as a research subject.  The IRB is a group of people who review studies to protect the rights of research subjects. 
 
 
 
 

SPONSOR AND INSTITUTIONAL RESPONSIBILITIES

It is not the policy of The Children's Mercy Hospital or the Congenital Heart Surgeons’ Society to compensate research participants if the research results in injury.  The hospital will provide facilities and medical attention to participants if needed.

PERMISSION OF PARENT OR AUTHORIZED CONSENTING PARTY

The purposes, procedures, and risks of this research study have been explained to me.  I have had a chance to read this form and ask questions about the study.  Any questions I had have been answered to my satisfaction.  I give permission for _____________________ to participate in this research study.  A copy of this signed consent form will be given to me. 
 

_______________________________________________________________________________________

Signature of Parent/Authorized Consenting Party   Date  Relationship to Participant

ASSENT OF MINOR

I have been told what I will be asked to do if I am in this study.  I have been told that I don’t have to be in this study.  I may quit the study at any time, and no one will be mad at me.  I have had a chance to discuss the study and ask questions.  My questions have been answered.  I agree to be in the study and do what I am asked to do so long as I continue in the study. 
 

________________________________________________       ____________

Signature of Minor      Date 
 

STUDY PERSONNEL

I have explained the purposes, procedures, and risks involved in this research study in detail to:

_________________________________________________________________

Print name(s) of Parents/Authorized Consenting Party, and

_________________, who in my opinion ___ IS / ___ IS NOT capable of assenting to participate in this study.

Print child’s name

________________________________________  ______________

Signature of Person Obtaining Permission/Assent  Date 
 
 

(revised 11/17/03; 3/10/04; 5/26/04; 9/29/04; 1/24/05; 12/20/05) 
 

(form template revised 3/27/03; 11/11/03; 06/07/05, 11/17/05) 
 
 
 
 
 
 
 
 
 
 

WITNESS

I witnessed the consent process and signature(s). 
 

_____________________________     _____________

Signature (Witness)       Date 
 

Non-English Speaking Participants

Short form in Spanish given to parent/legal guardian.

Name of Person Providing Oral Translation _____________________________

Relationship of Translator to Subject, Parent or Authorized Consenting Party ___________________