National Child Traumatic Stress Initiative (NCTSI) Evaluation Sample Informed Consent—Caregiver (Suggested Content and Wording)
Purpose
The Substance Abuse and Mental Health Services Administration (SAMHSA) in the United States Department of Health and Human Services is studying the National Child Traumatic Stress Network funded by the National Child Traumatic Stress Initiative (NCTSI). The NCTSN program is funded to improve access to quality care for children who have experienced trauma and their families. The (NCTSN Center Program Name) where your child has received services is a part of this project. This project will be used to help make services for traumatized children and their families better.
Description of Participation
As a part of this project, you will be interviewed initially at intake, every 3 months until treatment ends, and then at the end of treatment with (NCTSN center program name). We will talk with you at the clinic, home, or at any other place that is best for you. In the interviews, we will be asking you about your child’s symptoms and behaviors, and about the services your child has received. This will take about 2 hours.
If your child reaches age 11 at any time during this project, we will ask your child if we can interview him or her. At that time, we will ask for your permission to talk to your child. We will also describe the interview process to your child.
Risks and Benefits
There are no direct benefits to you being a part of this project. Your child may benefit from the treatment he/she receives. You may also learn new things about your child. As a result of this project, services for traumatized children with mental health needs may get better. You may feel uncomfortable when talking about personal matters. We have taken steps to protect your privacy and information regarding this will be provided later in the consent process.
Compensation
If you agree to participate in this project, you will receive a thank you gift. You will receive $XX for your first interview and $XX for each follow-up interviews.
If you have any questions about this evaluation project, you can call (evaluator) to have your questions answered. You can call him/her collect at (555) 555-5555. To contact the Institutional Review Board that reviewed this project, call (555) 555-5555.
Protection of Information
Special precautions will be taken to protect your child’s and your privacy. No agency that you are involved with, including schools, will have access to the information you provide. All forms in the project will be coded so that they cannot be associated with individual names. In reports, the information summarized will never mention individual names.
Rights Regarding Decision to Participate
I understand that if I agree to take part in this project, I can change my mind and quit at any time. If I change my mind and quit, any information I gave to the project will be destroyed, if this is what I want. If I decide not to be in this project, it will not affect services for my child and family. It also will not affect services that we might want in the future.
I have read this form or, it has been read to me, and I understand what it says. My questions have been answered. A copy of this form will be given to me. By signing my name below, I freely agree:
to be interviewed every 3 months, until treatment ends ____
Caregiver/Guardian (Type or Print Full Name): ______________________________________
Signature of Caregiver/Guardian:
________________________________________ Date: ___/___/____
Name of Child/Youth (Print) ___________________________________
Date: ___/___/____
Funding
source
Local
NCTSN center/program name
Description
of why the study will be conducted
Participant
responsibilities
Description
of data collection methods: interviews--frequency, duration; record
review; observation, etc.
Description
of child/youth involvement
Other
guidelines (e.g., possible data sources, age, changes in
participation over time, etc.
Potential
risk factors associated with participation
Potential
benefits that may be gained through participation
Type
and amount of compensation participant will receive for
participation
Process
or schedule for payment
Contact
information for someone working on the study who will be available
to answer participant questions
Protocol
for maintaining participant privacy
Description
and purpose of the Federal Certificate of Confidentiality
Mandated
reporting requirements
Rights
Regarding Decision to Participate
Statement
of participant rights to terminate participation at will
Statement
that the termination of participation will not lead to adverse
consequences
Statement
of participant understanding of the consent form
Statement
that participant has had all of his or her questions answered
Permission
to be interviewed
Permission
to access service provider records for 12 months previous to
service and 24 months after the first service
Signature
line for participant to sign, thus granting consent to participate
Date
Key
Components of a Consent Form
Elements
to Include:
Purpose
of the Study
Description
of Participation
Risks
and Benefits
Compensation
for Participation
Contact
Information
Protection
of Information
Voluntary
Consent
February 2010 NCTSI Evaluation-Caregiver
Consent Page
| File Type | application/msword |
| Author | Bhuvana.Sukumar |
| Last Modified By | bbarker |
| File Modified | 2011-12-09 |
| File Created | 2011-12-09 |