INTRODUCTION
You are invited to join a research study led by Dr. Jonathan D. Santoro, MD from the Division of Neurology at Children's Hospital Los Angeles.
You are invited to join this study because you have a loved one/family member with Down syndrome with a diagnosis of Alzheimer's disease, or if you have a loved one/family member with Down syndrome, or if you are an individual with Down syndrome. Participation in this study is voluntary. Please read the information below and ask questions about anything you do not understand before deciding whether or not to be in the study.
PURPOSE OF THE STUDY
The purpose and goal of this research is to define the risk factors that contribute to the development of early-onset Alzheimer's disease in patients with Down syndrome. Specifically, we will be focusing on the effects of psychological stress caused by adverse childhood events, educational history, socioeconomic status, and medical conditions.
NUMBER OF PARTICIPANTS
440 people will be asked to participate worldwide.
LENGTH OF PARTICIPATION
Participation in this research study will require approximately 20 minutes of your time.
PROCEDURES
If you volunteer to participate in this research study, your participation will involve completing a one-time, online anonymous survey that will ask some demographic questions, questions about medical history, questions about educational history, and questions about the stressful events that have occurred in your loved one/family member's life. If your loved one/family member that has Down Syndrome also has a diagnosis of Alzheimer's disease, the survey will also include some additional questions for you to answer that assess the clinical features, onset, and symptoms of your loved one/family member's diagnosis of Alzheimer's disease. The survey will take you approximately up to 20 minutes to complete.
POSSIBLE RISKS AND DISCOMFORTS
Some of the questions in the survey may make you feel uncomfortable or upset. The survey will also contain some sensitive questions, such as whether your loved one/family member has psychiatric diseases (i.e. bipolar disorder, schizophrenia), whether your loved one/family member lives with anyone who had a problem with drinking or using drugs, whether your loved one/family member's parents or adults in the home ever harm each other, whether your loved one/family member lives with anyone who went to jail or prison, whether your loved one/family member experienced unwanted sexual contact, etc. You do not have to answer any questions that you do not feel comfortable answering and can skip any questions you don't want to answer.
It is possible that a loss of confidentiality may occur as the surveys are being distributed online, but we don't expect this to happen since we are asking you to take an anonymous survey.
POSSIBLE BENEFITS TO SUBJECTS
You will not directly benefit from participation in this study.
POSSIBLE BENEFITS TO SOCIETY
This study will help researchers learn more about the risk factors that contribute to the development of early-onset Alzheimer's disease in patients with Down syndrome. Hopefully, this information will aid in the treatment of future patients with this condition.
YOUR OPTIONS IF YOU CHOOSE NOT TO BE IN THIS STUDY
This research is not a treatment study. Your alternative is not to participate in this study.
COSTS TO YOU FOR BEING IN THIS STUDY
There are no costs to you for participating in this research study.
PAYMENT FOR PARTICIPATION
You will not be paid for your participation in this research study.
CONFIDENTIALITY
All data will remain anonymous and no names or personal information will be associated with you and any data collected from this survey. Zip code will be collected from the survey as part of collecting demographic information, but zip code alone cannot be used to identify who you are since the survey responses are anonymous.
All research data will be stored electronically on a secure network with encryption and password protection to help prevent unauthorized access to personal information. The online survey system will not save IP addresses or any identifying information about you. The data will be kept on a password protected computer and will be destroyed six years after completion of research.
The research team will keep your data confidential. None of the information will be disclosed to others, except if necessary to protect your rights or welfare or if required by law (i.e., harm to self or others, reports of certain infectious diseases). The CHLA Institutional Review Board (IRB) that reviewed this research, and authorized representatives of CHLA may also have access to the study records in order to oversee the study. You will not be identified in any publications of the research results.
QUESTIONS ABOUT THIS STUDY
If you have questions, concerns, or complaints about the study, please reach out to the CHLA research team at dsresearch@chla.usc.edu and we will send you a response within approximately 1-3 business days.
RIGHTS OF RESEARCH SUBJECTS
You can agree to take part in this study and stop your participation in the study anytime. You should not select the box below indicating you agree to participate in the study if you have any questions that have not been answered or if you are unclear about any information in this form.
Your participation in the study is entirely voluntary. If you choose not to take part in the study or decide to stop your participation in this study at any time, there will be no penalty or loss of benefits to which you are otherwise entitled. Your choice about whether or not to participate will have no effect on your relationship with Children's Hospital Los Angeles.
This research is being overseen by the CHLA Institutional Review Board ("IRB"). An IRB is a group of people who perform an ethical review of research studies. You may talk to them at (323) 361-2265, or hspp@chla.usc.edu if:
- You have questions, concerns, or complaints that are not being answered by the research team.
- You are not getting answers from the research team.
- You cannot reach the research team.
- You want to talk to someone else about the research.
- You have questions about your rights as a research subject.
ELECTRONIC AGREEMENT TO PARTICIPATE
- You have read this document and understand its meaning;
- You have had a chance to ask questions and have had these questions answered to your satisfaction;
- You consent to your participation in this research study
- You may print a copy of this research information sheet for your records.