Consent to Act as a Participant in a Research Study / Consent to Act as a Participant in a Research Registry
STUDY TITLE: CP - Community Registry
PRINCIPAL INVESTIGATOR: Stephen Wisniewski, PhD wisniew@edc.pitt.edu 412-383-4696
QUESTIONS ABOUT THE STUDY:
You can contact the study investigator if you have any questions about the study, concerns or complaints.
Contact Principal Investigator, Dr. Stephen Wisniewski at wisniew@edc.pitt.edu or the Study coordinator at marymartinez@pitt.edu
SOURCE OF SUPPORT:
This study is funded through the Cerebral Palsy Research Network.
INTRODUCTION:
We are asking you or your child to take part in this research study because you are an adult with cerebral palsy (CP) or the parent of a minor child with CP who is a member of the MyCP community.
Ask the study team to explain any words or information in this informed consent that you do not understand.
Individuals who participate in research are a volunteers. If you join the study, you can change your mind later. You can decide not to take part or you can quit at any time. There will be no penalty or loss of benefits if you decide to quit the study. There is no cost to you to be in this study.
During the study, we will tell you if we learn any new information that might affect whether you wish to continue, or you wish your child to continue to be in the study.
The purpose of this research is to create a large registry and research database of persons with CP. We are collecting this information to understand CP from a patient/caregiver perspective and understand the impact of CP over a longer period than is common in most research. The creation of the database will also allow us to identify those who might qualify for other research studies. Research questions this registry will be used to answer include:
What are the most important educational and job issues that face persons with CP and their caregivers?
What is the association of physical therapy interventions with physical functioning?
How do neurological and orthopedic surgeries during childhood affect quality of life during adulthood?
How long will you be in the study?
We want to follow you or your child throughout your/their life. Minors who turn 18 while in the study will need to re-enroll as an adult if they would like to continue participation. If you want to leave the study, please let us know why and we will attempt to address your concerns. If you still wish to leave the study you can do so at any time by contacting the Data Coordinating Center at the University of Pittsburgh by email or phone call. That contact information in on page 1 of this consent form.
STUDY PROCEDURES
If you agree to be in this research, we will obtain contact information as well as the demographic and medical information you provided from MyCP and we will ask you to do the following things:
Complete surveys about your/ your child's life, symptoms and quality of life initially, then periodically, afterward.
If you/your child join(s) this study, you should understand that you will not own your data, and should researchers use them to create a new product or idea, you will not benefit financially.
STUDY RISKS:
If there were a security breach to the CP-CORE Registry, an unauthorized person could access your information. That would result in a breach of confidentiality. We will make every effort to prevent this from happening.
For women participants: You are still eligible to continue in this study if you were to become pregnant during this study. There will not be any additional risk to you or the fetus as a result of participating in this study.
Some questions may cause emotional distress. If there are concerns, please contact the study team for assistance.
STUDY BENEFITS:
There are no benefits to you/your child for taking part in this research. However, we may obtain a better understanding of CP and this knowledge may benefit patients with CP in the future.
PRIVACY (Person) and CONFIDENTIALITY (Data):
We will do everything we can to keep your/your child's information private, but we cannot guarantee this. Study information will be stored on a secure University server. Regular backups are completed and only accessible by study team members. Information is only transferred over a secure connection. Electronic records will be password protected. We may also need to disclose information if required by law.
In order to conduct this study and make sure it is conducted as described in this form, the research records may be used and reviewed by others who are working with us on this research:
o Members of the research team and University of Pittsburgh
o The University of Pittsburgh Institutional Review Board (IRB), who reviews research involving people to make sure the study protects your rights;
o Your information shared with groups outside of University of Pittsburgh, will not include your name or identifying information. We will label your information with a code number, so they will not know your identity.
As a part of this study, your surveys will be included in the CP-CORE research database. Others may need to see or receive your information for this study. For example, the sponsor and its agents (if applicable), monitors, auditors, and IRB, will be granted direct access to the portion of your/your child's survey data which are related to this research study for verification of the research procedures and date.
University of Pittsburgh policy requires all research records must be maintained for at least 7 years following final reporting or publication of a project. For projects involving children, records must be maintained for 5 years past age of majority (age 23 per PA State law) after study participation ends.
WITHDRAWAL FROM STUDY PARTICIPATION:
You have the right to withdraw from the study. Should you choose to withdraw, you can request for reminder emails to stop from MyCP. You may also request for your data to be removed from the system.
To formally withdraw from this research study, you should provide a written and dated notice of this decision to the principal investigator of this research study at the address listed on the first page of this form. Your decision to withdraw from this study will have no effect on your/your child's current or future relationship with the University of Pittsburgh.
COSTS:
There is no cost to you to be in this study.
PAYMENTS:
You will not be paid to be in this study.
VOLUNTARY PARTICIPATION:
Your participation in this research study is entirely voluntary. You may want to discuss this study with your family and friends and your personal physician before agreeing to participate. If there are any words you do not understand, feel free to ask us. The investigators will be available to answer your current and future questions.
Whether or not you provide your consent for participation in this research study will have no effect on your current or future relationship with the University of Pittsburgh.
CONSENT FOR ADULTS WITH CEREBRAL PALSY
By clicking SUBMIT, I confirm that I understand the above information and all of my current questions have been answered. I understand that I am encouraged to ask questions, voice concerns or complaints about any aspect of this research study during the course of this study, and that such future questions, concerns or complaints will be answered by a qualified individual or by the investigator(s) listed on the first page of this consent document at the telephone number(s) given.
I understand that I may always request that my questions, concerns or complaints be addressed by a listed investigator. I understand that I may contact the Human Subjects Protection Advocate of the IRB Office, University of Pittsburgh (1-866-212-2668) to discuss problems, concerns, and questions; obtain information; offer input; or discuss situations that occurred during my participation. By signing this form I agree to participate in this research study. A copy of this consent form will be given to me.
PARENTAL PERMISSION FOR MINORS WITH CEREBRAL PALSY
I understand that only biological and adoptive parents are permitted to enroll their minor child into this research study.
I confirm that I understand the above information and all of my current questions have been answered. I understand that I am encouraged to ask questions about any part of this research study at any time. Any future questions will be answered by a qualified person or by an investigator listed on the first page of this consent document at the telephone number(s) given. I understand that I may always request that my questions, concerns or complaints be answered by a listed investigator.
I understand that I may contact the Human Subjects Protection Advocate of the IRB Office, University of Pittsburgh (1-866-212-2668) to discuss problems, concerns, and questions; obtain information; offer input; or discuss situations in the event that the research team is unavailable. A copy of this consent form will be given to me/my child.
I understand that as a minor (age less than 18 years), my child is not permitted to participate in this research study without my consent and that I am encouraged to discuss this study with them in age-appropriate language.
Therefore, by clicking SUBMIT, I give my consent for his/her participation in this research study.
This consent does not have an expiration date.