This notice describes how medical information about you may be used and disclosed and how you can get access to this information. Please review it carefully.
Data to be Collected and Processed
The study team will collect data about your child for the study. This data may include your child’s name and/or initials, full date of birth, gender, contact details, and information needed for payment processing. In addition, the following Special Category personal data about your child may be collected: race, ethnic origin, and health data. Your child’s study records will be kept in a research file that is separate from their medical chart.
How Your and Your Child’s Personal Data Will be Used
The personal data collected about you or your child by the study team or Sponsor assigned vendor during their visit to the site or on the phone will be recorded in your child’s study records by the study team to run the study and to monitor your child’s safety as a participant. Your or your child’s personal data will be processed on a computer and/or on paper. The collection of this data is necessary to conduct the study and comply with applicable laws. Your child will not be able to participate in the study if you fail or refuse to provide your child’s information to the study team.
There are laws about the recording, forwarding, storage, and analysis of your/your child’s personal data. These laws require your voluntary and explicit consent before your child can participate in the study. If you do not consent to the collection and use of your or your child’s personal information, your child will not be able to participate in the study.
Results of this study may be presented at meetings or in publications; however, your and your child’s identity will never be shared. Your and your child’s personal data will not be used for any direct marketing purposes.
Storage of Your and Your Child’s Personal Data: According to legal requirements, your and your child’s personal data will be stored in the study databases, paper and/or electronic files for whichever time period is longer, as required by applicable laws:
- at least 25 years after the study ends, OR
- at least 2 years after the drug being studied has received its last approval for sale, OR
- at least 2 years after the drug’s development has stopped.
Transferring the Personal Data to a Third Party
To keep your and your child’s identity private, all data that is sent or provided outside of the research clinic will show only a coded identification number instead of your child’s name. Only the study doctor and authorized personnel will be able to connect this code to your child’s name. They will use a list called a participant identification list, that will be kept in a secure place, to link this code to your child’s name in case of an emergency. None of the study systems will store data from the participant identification list allowing for the code to be linked with your or your child’s identity. This list is confidential and can be retained at the research clinic only. Uncoded personal data will not leave the research clinic and can be reviewed on-site only.
The coded data from the study showing your child’s involvement will be provided to the Sponsor and other individuals and/or companies that act on the Sponsor’s behalf, including Medpace. Also, your child’s study records (including uncoded personal data) may be reviewed by the Sponsor and other individuals and/or companies that act on the Sponsor’s behalf, including Medpace; government agencies in the U.S. and other countries where the study drug may be considered for approval (such as the U.S. FDA); the Institution Review Board (IRB), which is a group that look out for the rights of research participants, for the purpose of reviewing and approving the study; other doctors, health care professionals, or research staff who are involved in the study; and independent auditors for the purposes of confirming your child’s participation in the study, monitoring their safety during the study, and monitoring the conduct of the study. Further, your or your child’s personal information may be disclosed in response to lawful requests by public authorities, including those to meet national security or law enforcement requirements.
Your child’s study records may be released to the groups listed above. If your child’s study records are reviewed by these people, they may need to see their entire medical record. Because of this, it cannot be assured that your child’s confidentiality will always be protected. It is possible that your child’s information will be shared (re-disclosed) in a way that it would no longer be protected. However, this access to your child’s study records will be granted without violating your confidentiality to the extent allowed by applicable laws and regulations. By signing this Privacy Notice, you are authorizing this access to your child’s study records.
With your permission, the study doctor will tell your child’s primary doctor about their role in this study.
You may also take away (or withdraw) your permission for the use and disclosure of your child’s study records at any time. If you choose to withdraw your permission, you must write the study doctor a letter. The study doctor’s mailing address is listed on the first page of this informed consent form.
If you withdraw your permission, your child’s health information will no longer be used for this study, except to the extent the parties to the research have already taken action based upon your authorization.
If you withdraw your permission, your child can no longer take part in the study. If you refuse to give permission or withdraw your permission, your child’s medical care and your and your child’s relationship with the health care providers at the research clinic will not be affected.
You have a right to see your child’s study records. However, you will not be able to see your child’s study records until after the study has ended.
A description of this clinical trial will be available on https://clinicaltrials.gov/, as required by U.S. Law. This Web site will not include information that can identify you or your child. At most, the Web site will include a summary of the results. You can search this Web site at any time.