Consent To Participate In A Research Study

Title: Duke Autism Research Volunteer Registry

Principal Investigator:
Geraldine Dawson, Ph.D.
Duke Center for Autism and Brain Development, Pavilion East at Lakeview
2608 Erwin Road, Suite 300, Durham, N.C. 27705
919-684-3165


INTRODUCTION:

You have expressed interest in being part or having your child be part of the Duke Center for Autism’s research volunteer registry. Please read this consent form carefully. The nature of the registry, including its risks and benefits and other important information, is described below. Please ask the staff member who provided this consent form to explain any words or information that you do not clearly understand. If you are enrolling using our online form, and have any questions about this consent form, please contact us at autismresearch@duke.edu or 1-888-691-1062 so we can explain the project before you make a decision and enter your information.

Importantly, any services that you or your child receives through a Duke University-affiliated (or non-Duke affiliated) clinic, primary care provider, or the Duke Center for Autism and Brain Development, will not be affected by your decision about your or your child’s participation in this registry. Furthermore, your decision regarding participation in the research registry will not affect your or your child’s ability to participate in other research studies at the Duke Center for Autism or Duke. If you do agree to participate or have your child participate, you may withdraw yourself or your child from the registry at any time. The Duke Autism Research Volunteer Registry is overseen by Dr. Geraldine Dawson, Professor and Director of the Duke Center for Autism and Brain Development (DCABD) at Duke University Medical Center (DUMC).

What is this the purpose of this registry?

The purpose of this registry is to maintain a database that will allow staff at the DCABD to inform potential participants about upcoming or existing studies for which they may be eligible. Those participants or their parents or legal guardians will then be contacted to determine their interest in participating in the current study. In addition, participants are provided with information about events and activities sponsored by the DCABD and receive periodic newsletters describing activities and events at the DCABD.

What is involved in this project?

If you agree for you or your child to participate in registry, you may enroll yourself or your child in person, over the phone, or through our online enrollment form. If you enroll online, we will maintain a record in our database that you provided consent electronically. If you enroll over the phone, we will make a note that you provided your verbal consent to participate in this study. If you enroll in person, you will be asked to sign and date this consent form. We may also ask you a few questions (online, over the phone, or in person) to make sure you understand the project.

We will collect the following information, which may be completed verbally, electronically, or on paper. This information will be entered directly into the registry database.

  • We will collect your contact information including home address, cellphone number, alternate phone numbers, and email address. You will be asked to provide only the contact information you prefer.
  • Your or your child’s gender, age, date of birth, and demographic information, medical and developmental diagnoses you or your child has received, and other questions related to your or your child’s health.
  • Your full name and biological relationship to your child (if you are enrolling him/her).

If you or your child is enrolled in the Duke Autism Research Volunteer Registry, you may also receive the following information occasionally:

  • Information cards via email (or mail, with pre-stamped envelope) to inform us of any changes in your contact information (address, e-mail address, and/or phone number),
  • Newsletters to update you on ongoing activities of the Duke Center for Autism and Brain Development,
  • Holiday and birthday cards,
  • Invitations to special community events hosted by the Center (such as sports clinics and artwork contests),
  • Information about other research-related opportunities.

What are the risks of the project?

There are no known physical risks for enrolling yourself or your child in the database. Although your information will be strictly confidential and kept in a highly secure database, there is always a potential risk to your privacy. Every effort will be made to maintain this privacy. However, this cannot be guaranteed.

Are there benefits to taking part in the project?

Benefits include being informed about opportunities to participate in research and invitations to activities and events at the DCABD. There is the possibility that a future study for which you are contacted may also provide benefits.

Will my information be kept confidential?

Study records that identify you or your child will be kept strictly confidential as required by law. Federal Privacy Regulations provide safeguards for privacy, security, and authorized access.

Except when required by law, you or your child will not be identified by name, address, telephone number, or any other direct personal identifier in records disclosed outside of Duke University Health System (DUHS). All data can only be accessed by a secure password which will be locked away by authorized personnel. The database will be stored on a secure server at the Duke School of Medicine. Any paper records will be stored in locked offices.

If you or your child is currently a Duke patient (or becomes a Duke patient), we will use and record your or your child’s Medical Record Number, and access your or your child’s medical chart to review information as needed to make relevant updates to your or your child’s registry record. The medical chart review will include diagnosis, procedures, encounter type (sick or well visit), and information regarding the type and severity of medical conditions.

Your or your child’s records may be reviewed in order to meet federal or state regulations. Reviewers may include representatives from the Duke University Health System Institutional Review Board. If this information is disclosed to outside reviewers for audit purposes, it may be further disclosed by them and may not be covered by the federal privacy regulations.

If enrolling your child: When your child turns 18, he/she will be given the opportunity to verbally consent or sign an adult consent form to remain in the database. If you remain your child’s legal guardian after he/she turns 18, you may consent on behalf of your child. There is no obligation to remain in the database. If he/she or you do not re-consent, your and your child’s information will be deleted.

What are the costs?

There are no costs to you for your or your child’s participation in this database.

What about compensation?

You will not receive financial compensation for choosing to participate in this database.

What about my rights to decline participation or withdraw from the study?

You may choose not to participate or not to allow your child to participate. If you do agree to participate or to allow your child to participate in this project, you are free to withdraw or to withdraw your child from the database at any time. If you withdraw or you withdraw your child from the database, no new data about you or your child will be collected for study purposes other than data needed to keep track of the withdrawal.

If you do decide to withdraw or to withdraw your child from the registry, contact us in writing and let us know that you are withdrawing. Our mailing address is: Duke University Medical Center Box 3527, Durham, NC 27710 or you may write to us by email at autismresearch@dm.duke.edu.

Your decision not to participate or for your child not to participate or to withdraw will not involve any penalty or loss of benefits to which you and/or your child are entitled, and will not affect your or his/her access to health care at Duke or any other clinic or health care system. You may still choose to participate in studies conducted at DCABD or Duke even if you do not agree to participate in the registry.

Whom do I call if I have questions or problems?

For questions about the project, or if you have problems, concerns, or suggestions about the project, contact us at 1-888-691-1062 or by email at autismresearch@dm.duke.edu. You may also contact the Principal Investigator, Geraldine Dawson, at geraldine.dawson@duke.edu.

For questions about your or your child’s rights as a project participant, to discuss problems, concerns or suggestions related to the project, or to obtain information or offer input about the project, contact the Duke University Health System Institutional Review Board (IRB) Office at (919) 668-5111.

STATEMENT OF CONSENT

“The purpose of this database, procedures to be followed, risks, and benefits have been explained to me. I have been allowed to ask the questions I have, and my questions have been answered to my satisfaction. I have been told whom to contact if I have questions, to discuss problems, concerns or suggestions related to the project or to obtain information or offer input about the project. I have read this consent form and agree to participate or to allow my child to participate in this project with the understanding that I may withdraw myself or my child at any time. I have been told that I will be given copy of this consent form or will be able to download a copy of consent form.”

Protocol ID: Pro00054178 | Continuing Review Before: 6/23/2017 | Reference Date: 5/15/2017

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