PROTOCOL NUMBER & TITLE______________________________________________

When we use “you” or “I” in this consent form, we mean you or your child; “we” means the doctors and other staff.

DESCRIPTION OF RESEARCH -(Items 1 thru 6 must be in third person)

1. (Omit if not applicable.) IF DRISCOLL CHILDREN’S HOSPITAL IS BEING PAID TO CONDUCT THE STUDY:
   The sponsor of this study, [Sponsor Name], is paying Driscoll Children's Hospital (DCH) {and Dr. [PI] if relevant} to perform this research. This study is being sponsored by a grant from (Sponsor Name). Portions of Dr. {PI}'s and [his/her] research team's salaries are being paid by this grant.
   
   
2. PURPOSE OF STUDY: (A statement that this is a clinical research study, and an explanation of the purpose of the clinical research (explanation not limited to this space).
   
   
3. DESCRIPTION OF RESEARCH: (A detailed description in lay language of the procedures to be followed. Experimental or investigational drugs, devices, procedures, etc. to be used in the clinical research study must be specifically identified. State the estimated number of participants to be included in the clinical research study and expected duration of the participant's involvement. State which of the drugs or devices used is FDA approved for commercial use. If any specific cost information or waiver of cost information is available, it should be included in this section (explanation not limited to this space).
   
   
4. RISKS, SIDE EFFECTS AND DISCOMFORTS TO PARTICIPANTS: A description of any reasonably foreseeable risks, side effects or discomforts to the participant and a statement as to unforeseen risks or side effects must be stated. Identify any special factors involved in the research that may influence the decision to participate. Also applicable, add, “This clinical research study may involve unforeseeable risks to the participant" (explanation not limited to this space).
   
   4a. Add if applicable: "This clinical research may involve unforeseeable risks to unborn children. Subjects who are of child bearing age should discuss birth control issues with their treating physician.
   
   
5. POTENTIAL BENEFITS: A description of any benefits to the participant or to others that may reasonably be expected from the clinical research study. If there are no potential benefits then this should be stated (explanation not limited to this space).
   
   
6. ALTERNATE PROCEDURES OR TREATMENTS: (A notification of appropriate alternative procedures or treatments, if any, and their risks, benefits and or alternatives that might be advantageous to the participant (explanation not limited to this space).
   
   
7. Statement about voluntary participation and right to withdrawal
   Taking part in this study is your choice. You can change your mind and leave the study at any time. If you decide you do not want to be part of the study, it will not affect your medical care at Driscoll Children's Hospital. You should talk to your doctor before making a final decision. If you withdraw from the study, no new information will be collected for the study unless there is a bad effect related to the study. In that case; your entire medical record may need to be reviewed by the study sponsor. If you decide to withdraw from the study, notify
   Dr.________________________________ at (address) in writing.
   
   
   

   Driscoll Children’s Hospital 3533 S Alameda Corpus Christi TX 78411 Form [ 812 ] Date: [ 11/03/05 ]

   Patient Label

   
   
   
   
   
   
   
   For withdrawal of samples
   
   If you agree to allow your tissue/blood/cells to be kept for future research, you are free to change your mind at any time. If you change your mind, notify Dr.__________________ [PI] in writing at ___________ (address).
   
   Discontinuation of the study
   Your study doctor may decide to take you off this study if it is in your best interest, if the treatment is not effective, or if another treatment would be better for you.
   
   
8. Confidentiality:
   If you take part in this research study, every effort will be made to keep your personal information private. Your name will not be used when the research results are published.
   
   
9. Who will have access to study records and to whom information may be disclosed?
   Organizations that may look at and copy your medical records for research, quality assurance, and data analysis include the Food and Drug Administration, sponsors who furnish the drugs/devices being utilized in this study, representatives of the DCH IRB (and NCI Pediatric Central IRB). Your name will not be revealed in any reports or publications resulting from this study, without your expressed consent.
   
   
10. Expiration date for retention of records The study results will be retained in your research record for at least 6 years or until the study is complete.
    
    
11. If you feel you have been injured as a result of taking part in this research study, tell your study doctor. You will get medical treatment if you are injured as a result of taking part in this study. You or your health plan may be charged for this treatment. The study will not pay for your medical treatment.
    
    
12. You or your insurance company will be responsible for all the costs of your treatment. You will not be paid for taking part in this study. You will be informed if any medications, investigational agents, or devices will be provided by the study sponsor. In some cases if the investigational agent becomes commercially available during the course of this study, you may be responsible for the cost of later doses.
    
    
13. (This statement will apply to all clinical and laboratory protocols).
    You will not receive payment for any new products that might be developed because of research done on your specimens.
    

    You may discuss questions or problems during or after this study with (name of investigator) at (phone number). In addition, you may discuss any problems or any questions regarding your research rights during or after this study with one of the Co-Chairpersons of the DCH Institutional Review Board (IRB) at (361) 694-4619.
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    

CONSENT

I have been given a chance to ask all of my questions about the study and the investigator answered them to my satisfaction. I authorize Dr.___________________________ to (administer/perform) the survey/procedure/treatment/investigational drug regimen. I will receive a copy of this signed consent form.

CHILD ASSENT

This research study has been explained to me in words I can understand. Someone will answer all my questions about this study. I also know that I can refuse to participate if I wish.

I was present during the explanation of the research to be conducted under this protocol. The child participant was also present. I feel that the child assented to participation in the research.