Continence in Children with Cerebral Palsy

Subject Consent

I AM BEING ASKED TO READ THE FOLLOWING MATERIAL TO ENSURE THAT I AM INFORMED OF THE NATURE OF THIS RESEARCH STUDY AND OF HOW I WILL PARTICIPATE IN IT, IF I CONSENT TO DO SO. CLICKING "NEXT" BELOW WILL INDICATE THAT I HAVE BEEN SO INFORMED AND THAT I GIVE MY CONSENT. FEDERAL REGULATIONS REQUIRE INFORMED CONSENT PRIOR TO PARTICIPATION IN THIS RESEARCH STUDY SO THAT I CAN KNOW THE NATURE AND RISKS OF MY PARTICIPATION AND CAN DECIDE TO PARTICIPATE OR NOT PARTICIPATE IN A FREE AND INFORMED MANNER.

Purpose
I am being invited to participate voluntarily in the Continence in Children with Cerebral Palsy survey research project. We are collecting information about what age children with cerebral palsy become toilet-trained and what type of therapies children get to work on toileting skills. We hope to establish a timeline for toilet training in children with cerebral palsy and see how therapies might affect this process.

Selection Criteria
I am being invited to participate because my child has cerebral palsy.

Standard Treatment(s)
This is a survey based study. You are being asked to complete a survey that will ask about your child’s functional level, previous treatments, and amount of continence mastery. The survey should take about 30-60 minutes to complete

Procedure(s)
If I agree to participate, I will be asked to consent to the following: Participate in a survey regarding my child’s continence development.

Risks
The risks of taking this survey are nearly nil. You may have an emotional reaction to the survey questions.

Benefits
We cannot promise any benefits to you or others from your taking part in this research. However, you may be interested in what we find out about children with cerebral palsy and toliet training in the future. The results of this study will help us figure out when children with cerebral palsy become toliet-trained and what therapies may be helpful in helping these children become toliet-trained.

Confidentiality
Dr. Roberta OShea will maintain all data locked in her office at Governors State University.

I understand that my name will not be used on any reporting or writing completed as a result of this study.

Participation Costs and Subject Compensation
It does not cost anything to be in this study. I also understand I will not be compensated for participating in the study.

Liability I understand that side effects or harm are possible in any research program despite the use of high standards of care and could occur through no fault of mine or the investigator involved. There are no known side effects to completing the survey. I do not give up any of my legal rights by signing this form.. I can obtain further information from Roberta OShea, PhD, PT, DPT at roshea@govst.edu or 708-235-3994. If I have questions concerning my rights as a research subject, I may contact Dr. Renee Theiss, Chair of the IRB at 708-235-2147 or irb@govst.edu or Dr. Roberta O’Shea, Principal Investigator, at roshea@govst.edu or 708-235-3994 with any questions or concerns regarding this project.

Authorization

Before giving my consent by beginning the survey, the methods/ inconveniences/ risks/ and benefits have been explained to me and my questions have been answered. I understand that I may ask questions at any time and that I am free to withdraw from the project at anytime without causing bad feelings. My participation in this project may be ended by the investigator for reasons that would be explained. New information developed during the course of this study which may affect my willingness to continue in this research project will be given to me as it becomes available. I understand that this consent form will be filed in an area designated by the IRB with access restricted to the principal investigator, Roberta OShea. I understand that I do not give up any of my legal rights by signing this form.

Checking “Next” below documents your permission to take part in this research.