Docstoc

Radiology_Consent0107

Document Sample
Radiology_Consent0107 Powered By Docstoc
					  STANFORD UNIVERSITY - Research Consent Form
  Protocol Title: Development of an International Database of Patients with Holoprosencephaly and Related Brain
  Malformations
  Protocol Director: Jin Hahn, MD
  IRB Approval Date: April 10, 2007                                          IRB Expiration Date: April 9, 2008



          INFORMED CONSENT TO USE RADIOLOGY IMAGES FOR RESEARCH



FOR QUESTIONS ABOUT THE STUDY, CONTACT: Jin Hahn, MD, 300 Pasteur Dr. Room
A345, Stanford, CA 94305, 650-723-6841.

DESCRIPTION: The purpose of this study is to create a database of radiology images and reports.
We hope to learn more about the structures of the brain and the development of brain malformations.
By signing this consent, you authorize and grant permission to Stanford Medical Center and the Carter
Centers for Brain Research in Holoprosencephaly and Related Malformations to interpret, store and
study your child's radiology images, reports and to copyright, use and/or publish the images, excluding
any identifying information such as name or address, for research or medical education. You also
agree that such images and information may be published on websites, in newspapers, magazines,
journals, textbooks, or other printed materials, and that such images may be shown or played at
presentations. Physicians, other healthcare professionals, students, and scientists may ultimately view
these images. For example, an image of your child may appear in a scientific or medical publication,
but without any identifying information. Therefore, there is a chance that the images could be
revealed to others besides physicians, other healthcare professionals, students, or scientists and no
longer protected. Your participation in this study is entirely voluntary.

RISKS AND BENEFITS: You may experience psychological stress upon learning that your child has
a brain malformation. There are no direct benefits to you by participating. The information that we
collect may help others, just as the information collected from others may benefit you. We cannot and
do not guarantee or promise that you will receive any benefits from this study. Your decision whether
or not to participate in this study will not affect your child’s medical care.

TIME INVOLVEMENT: The time involved includes time required to submit the images to us.

PAYMENTS: You will NOT receive payment for participation.

SUBJECT'S RIGHTS: If you have read this form and have decided to participate in this project,
please understand your participation is voluntary and you have the right to withdraw your consent or
discontinue participation at any time without penalty or loss of benefits to which you are otherwise
entitled. You/your child have the right to refuse to answer particular questions. Your child’s individual
privacy will be maintained in all published and written data resulting from the study.

                          Authorization To Use
             Your Health Information For Research Purposes
Because information about your child and your child’s health is personal and private, it



  Page 1 of 4
  STANFORD UNIVERSITY - Research Consent Form
  Protocol Title: Development of an International Database of Patients with Holoprosencephaly and Related Brain
  Malformations
  Protocol Director: Jin Hahn, MD
  IRB Approval Date: April 10, 2007                                          IRB Expiration Date: April 9, 2008



generally cannot be used in this research study without your written authorization. If
you sign this form, it will provide that authorization. The form is intended to inform
you about how your child’s health information will be used or disclosed in the study.
Your child’s information will only be used in accordance with this authorization form
and the informed consent form and as required or allowed by law. Please read it
carefully before signing it.

What is the purpose of this research study and how will my health information be
utilized in the study?

The purpose of this study is to collect radiology images/reports for research.

Do I have to sign this authorization form?

You do not have to sign this authorization form. But if you do not, you will not be able
to participate in this research study. Signing the form is not a condition for receiving
any medical care outside the study. Your child’s images would be evaluated without
being a part of the research study.

If I sign, can I revoke it or withdraw from the research later?

If you decide to participate, you are free to withdraw your authorization regarding the
use and disclosure of your child’s health information (and to discontinue any other
participation in the study) at any time. After any revocation, your child’s health
information will no longer be used or disclosed in the study, except to the extent that the
law allows us to continue using your child’s information (e.g., necessary to maintain
integrity of research). If you wish to revoke your authorization for the research use or
disclosure of your child’s health information in this study, you must write to: Jin Hahn,
MD, 300 Pasteur Dr. Room A345, Stanford, CA 94305, 650-723-6841.

What Personal Information Will Be Used or Disclosed?

Your child’s health information related to this study, may be used or disclosed in
connection with this research study, including, but not limited to, clinical information
and imaging scans (MRI, CT, Ultrasound, etc.).

Who May Use or Disclose the Information?



  Page 2 of 4
  STANFORD UNIVERSITY - Research Consent Form
  Protocol Title: Development of an International Database of Patients with Holoprosencephaly and Related Brain
  Malformations
  Protocol Director: Jin Hahn, MD
  IRB Approval Date: April 10, 2007                                          IRB Expiration Date: April 9, 2008



The following parties are authorized to use and/or disclose your child’s health
information in connection with this research study:

    The Protocol Director, Dr. Jin Hahn, and his personnel
    The Neuroradiologist, Dr. Patrick Barnes
    The Stanford University Administrative Panel on Human Subjects in Medical
     Research and any other unit of Stanford University as necessary.

Who May Receive / Use the Information?

The parties listed in the preceding paragraph may disclose your child’s health
information to the following persons and organizations for their use in connection with
this research study:

    The Office for Human Research Protections in the U.S. Department of Health and
     Human Services
    The Carter Center Research Affiliates
    Texas Scottish Rite Hospital
    Rutgers University
    Kennedy Krieger Institute
    The National Institutes of Health
    University of California in San Francisco
    Massachusetts General Hospital
    The Food and Drug Administration

Your child’s information may be re-disclosed by the recipients described above, if they
are not required by law to protect the privacy of the information.

When will my authorization expire?

Your authorization for the use and/or disclosure of your/your child’s health information
will expire December 31, 2030.

Will access to my medical record be limited during the study?
To maintain the integrity of this research study, you may not have access to any health
information developed as part of this study until it is completed. At that point, you
would have access to such health information if it was used to make medical or billing


  Page 3 of 4
   STANFORD UNIVERSITY - Research Consent Form
   Protocol Title: Development of an International Database of Patients with Holoprosencephaly and Related Brain
   Malformations
   Protocol Director: Jin Hahn, MD
   IRB Approval Date: April 10, 2007                                          IRB Expiration Date: April 9, 2008



decision about you (e.g., if included in your official medical record).

________________________________                                                 ______________
Signature of Subject                                                             Date

________________________________
Signature of Legally Authorized Representative

_____________________________________________________________
Description of Representative's Authority to Act for Subject

CONTACT INFORMATION:
If you have any questions, concerns or complaints about this research study, its procedures, risks and
benefits, or alternative courses of treatment, you should ask the Protocol Director, Jin Hahn, MD at
650-723-6841. You should also contact him at any time if you feel you have been hurt by being a part
of this study.
Independent Contact: If you are not satisfied with how this study is being conducted, or if you have
any concerns, complaints, or general questions about the research or your rights as a participant, please
contact the Stanford Institutional Review Board (IRB) to speak to someone independent of the
research team at (650)-723-5244 or toll free at 1-866-680-2906. You can also write to the Stanford
IRB, Stanford University, Stanford, CA 94305-5401.
 The extra copy of this consent form is for you to keep.

SIGNATURE _____________________________ DATE ____________

(When consent is obtained from legally authorized representative(s) (e.g., parent(s), guardian or conservator), include
signature lines for representatives and a description of their authority to act for the participant.)

________________________________             ____________                  ______________________________
Signature of Parent, Guardian or Conservator     Date                         Authority to act for participant


________________________________                      ____________         ______________________________
(If available) Signature of Other Parent                  Date                Authority to act for participant

Signatures of both parents are requested, unless the person obtaining consent has determined that the
other parent is not reasonably available.




   Page 4 of 4