CONSENT FOR A CHILD TO BE A SUBJECT IN MEDICAL RESEARCH AND AUTHORIZATION TO PERMIT THE USE AND SHARING OF IDENTIFIABLE MEDICAL INFORMATION FOR RESEARCH PURPOSES
Pediatric Cold Symptom Tracker
PRINCIPAL INVESTIGATOR :
Dr. Nader Shaikh, MD,
Division of General Academic Pediatrics,
Children’s Hospital of Pittsburgh of UPMC,
3414 Fifth Avenue, Pittsburgh, PA 15213
SOURCE OF SUPPORT :
National Institutes of Health
What is this study about and why is it being done?
The purpose of this study is the development of an iPhone application to track the duration and severity of the common cold in children, ages 2 to 11 years (prior to the 12th birthday). We ask that you complete a 9-question diary once a day while your child has a cold. The application will store your child’s information in a way that will be easy for you to review at any time. The application will help you to see whether your child is getting better or worse and you will be able to track the number of colds your child has during the year. It will alert you if your child’s cold symptoms do not follow the usual pattern of cold symptoms, if symptoms last longer than 10 days or if your child’s symptoms are becoming worse after 5 days. This information is important because colds with an abnormal duration could signify sinusitis. This information will also help researchers to learn more about the common cold.
It is important to remember that this study will not provide treatment for your child’s symptoms. This study is designed to help researchers better understand the common cold. This research study should not replace the care of your child’s primary care doctor. You should seek medical treatment for your child as you normally would.
What are my child and I being asked to do?
About 1,000 children across the country, ages 2 to 11 years (prior to the 12th birthday), and their parents are being asked to track their child’s cold symptoms using our mobile app. If you agree to participate in this research study, this is what will be asked of you:
- Download the free mobile app. You will need to have an iPhone to participate in this study.
- Complete a screening questionnaire on the iPhone.
- View the informed consent document and agree to participate in the study.
- Register for an account. Once you have provided consent, everyone who enrolls will complete an electronic registration process through the “mobile cold app” Registration will include entering an e-mail address as well as other general information about your child.
- Health surveys: If you indicate that your child currently has a cold, you will be prompted daily to complete a 9 question survey to help researchers collect more information about the common cold.
What are the benefits and risks of participating in this research study?
Risks
Confidentiality
Rarely (<1%), there is a risk of loss of confidentiality. All of the study data will be stored in locked file cabinets that are kept in the research area and computer records are password protected. Electronic diary entries will be stored on a secure server that requires an account with a password in order to obtain access. Each computer has a password only available to the study staff. Electronic diary entries will only have the patient study identification number on them. Identifying codes that could be used to link your child with this identification number will be kept in a locked file cabinet in the research office. Your e-mail address and child’s name will be collected and is required for the registration process.
Internet Communication
Although every reasonable effort has been taken, confidentiality during Internet communication activities cannot be guaranteed and it is possible that additional information beyond that collected for research purposes may be captured and used by others not associated with this study.
Mobile App Use
Risk is possible when a participant is using the app in an environment when it is not safe to do so; such as while walking or driving a car. We will urge participants to only access the app and complete tasks when they are in an environment that is safe to do so.
Benefits
It is important to know that you may not benefit from taking part in this research study. Others may not benefit either. Increased knowledge of whether mobile phones can be used to study the natural history of the common cold. We hope that the information learned from this study will benefit other patients who are experiencing a common cold or sinusitis. This may help aid in the treatment of these two ailments in the future.
What if there is new information while my child is in this study?
If any information is learned that might affect your willingness to have your child continue to be in this study, you will be informed.
What costs will be associated with permitting my child to participate in this research?
You will not be paid for participating in this research study. Being in this research study will not lead to extra costs to you other than usage of your mobile data plan if applicable. Data collected during this study will count against your existing mobile data plan but you can set up the “Pediatric Cold Symptom Tracker” to only use Wi-Fi connections to limit impact on your data plan.
How will my child’s privacy rights be protected?
Under the Health Insurance Portability and Accountability Act (HIPAA), your child's private health care information cannot be used for the research purposes of this study without your permission. You will be informed of the specific uses and disclosures of your child's medical information for the purpose of this research study and who will have access to your child’s health information.
What uses of my child's medical information will this research involve?
This research study will not involve the use of your child’s medical record information. All information collected during this research study is self-reported and will be kept on a secure server provided by the University of Pittsburgh. Your child’s gender and race will be collected through the mobile app. Your child’s name as well as the e-mail address used to log-in to the mobile application will be collected. This information will be stored in a secure database and will not be accessed by the investigators working on this study.
Who will have access to my child’s medical information related to his/her participation in this research study?
In general, research records are kept confidential. Each computer has a password only available to the study staff. Paper records are stored in locked cabinets and computerized records are password protected. There are, however, some disclosures of your child’s research-related medical information that may occur. In addition to the investigators listed on the first page of this authorization form and their research staff, the following persons may have access to your child’s information related to your child’s participation in this research study.
Authorized representatives of the University of Pittsburgh Research Conduct and Compliance Office may review your identifiable research information for the purpose of monitoring the appropriate conduct of this research study. Authorized representatives of the NIH and the Office for Human Research Protections (OHRP) may review and/or obtain your child’s identifiable medical information for the purpose of monitoring the accuracy and completeness of the research data, for performing required scientific analyses of the research data, and reanalysis of the research data at a later date and to be sure that the research is being conducted according to the guidelines of each institution. While these organizations have provided their assurance that they will not release your child’s identifiable medical information to anyone else, the Children’s Hospital of Pittsburgh cannot guarantee this. In unusual cases, the investigators may be required to release your child’s research information in response to a court order. Research investigators are required under Pennsylvania law to report any suspicion of child abuse to child protection services. If the investigators learn that your child or someone related is in serious danger of potential severe harm, they may need to warn those who are in danger and contact other agencies to ensure safety.
May I stop my child’s participation in this study and may I withdraw my permission for the use of my child’s medical information for the purpose of this research study?
You have the right to stop your child’s participation in this study at any time. You may withdraw, at any time, your permission for the use of your child’s medical information for the purpose of this research study. Of course, if you withdraw your permission for the use of your child’s health information, your child may no longer participate in this research study. To the extent that researchers have already used your child’s health information in data analysis and/or scientific publication, this information cannot be withdrawn. If you decide to withdraw your permission, you should notify your child’s study doctor in writing along with the date of your decision. Your decision to withdraw your permission for the use of your child’s participation in this research study will have no effect on your or your child’s current or future medical care at Children’s Hospital of Pittsburgh, UPMC or affiliated health provider, or the University of Pittsburgh.
Will there be any compensation if my child is injured or becomes ill as a result of participating in this study?
If you believe that the research procedures have resulted in an injury to you, immediately contact the Principal Investigator who is listed on the first page of this form. Emergency medical treatment for injuries solely and directly related to your participation in this research study will be provided to you by the hospitals of UPMC. Your insurance provider may be billed for the costs of this emergency treatment, but none of those costs will be charged directly to you. If your research-related injury requires medical care beyond this emergency treatment, you will be responsible for the costs of this follow-up care. At this time, there is no plan for any additional financial compensation.
If the study team finds your child is not eligible to participate in the study, based on the answers of to the screening questions, you may be withdrawn from the study by the study team.
Could the information I provide be used for future research?
The information collected during use of this application could be shared with other investigators in the future for research purposes. This information will be de-identified.