Before you agree to be in any study, you must be told and should understand certain things about the research. You should be told about things like:

• the reason the study is being done
• what will be done in the study
• how long the study will last
• what parts of the study are experimental
• risks, discomforts, and benefits of the study
• other things you can do instead of being in the study
• how your information will be protected
• what the study will pay for and what you might need to pay for
• when you might be stopped from being in the study
• that you don’t have to be in the study and that you can stop at any time
• when you will be told about new information that may make you want to change your mind about being in the study, and
• how many people will be in the study.

As required by law, study-related records with your identifying information will be kept confidential. Safety measures for the access, security, and privacy of your information have been put in place by law. Unless the law requires it, your name, email address, or any other direct identifying information will not be used to identify you.

Purpose of Authorization
We have rules to protect information about you. Federal and state laws also protect your information. By signing the consent form or a separate “HIPAA” form, you are giving your permission, called your “authorization,” for the use and disclosure of information protected by the law.

You must sign a Protected Health Information Authorization if you want to be in a study. When you sign the form, you give permission for the use and sharing of your Protected Health Information “PHI” for the study. PHI is health information that identifies you. Your authorization is beneficial and important for each study. Without your authorization, you will not be able to be in a study.

Using and Sharing PHI
Each study will collect information about you. This information may include your email address, or date of birth. These are examples of identifiable information. The people doing the research may keep a copy of the information, but it cannot be shared without telling you in the form first.

Study results without the identifiable information may be shared in medical journals and at scientific meetings. Your records will be confidential. No one will share your identity in a medical journal or at a scientific meeting. Results from each study may or may not be sent to you, but you will be told in the form.

Who Can Receive and Use Your Study Information?
It is possible that people outside the Jaeb Center may need to see or receive your information from this study. Some examples include the government, committees that monitor safety, other sites in the study, and companies that sponsor the study. In most cases the information will have a code number with it instead of your name or email address.

There are some situations where the information will not have a code number but may include your name, email address, or phone

Other Considerations
The information collected in a study may be used in future studies without additional permission from you. This may include research done by other researchers. The information that may be shared will not contain any information that could identify you. There may still be a chance that someone could identify you, but this is not likely. The study results may also be made public. These results will not have any information that could identify you.

Can You Cancel Your Authorization?

You may cancel your permission for the use and sharing of your study PHI at any time. You will need to contact the JCHR IRB to cancel this. When you cancel your permission or when you withdraw from a study directly, you are no longer part of the study. No new information about you will be gathered for that study. The Jaeb Center will receive all the information that was collected for that study up to the time that you cancel or withdraw from the study.

When Will the Use and Sharing of Your PHI Stop?
Some of your study PHI does not have a code number with it. Your permission for the use and sharing of your PHI lasts 50 years from the date that you sign this form or until the end of the study, whichever comes first. The rest of your study information does have a code number with it. When it is collected, it becomes part of a research report. Your permission for the use and sharing of this coded information will never end. This coded data does not have your name or email address.

A Legally Authorized Representative can agree to participation in a research study on behalf of another adult who cannot consent for themselves. If you are deciding for another person whether that person will take part in the study, it is important that you understand who is a legally authorized representative “LAR”. A LAR for an adult who lacks capacity to consent can be an attorney in fact, a court appointed guardian, or an individual’s spouse, adult child, or parent (in that order). This means that if an adult who lacks capacity to consent has a court-appointed guardian, then the spouse would not be permitted to serve as the LAR.

A Legally Authorized Representative “LAR” can agree to participation in a research study on behalf of a minor. A LAR for a minor (person under the age of 18) is a natural or adoptive parent, a legal custodian, or a legal guardian. Depending on the age of the child, they may also be given information about a study in easy language to help them understand why they are being asked to be in the study. This information is given on an Assent Form. The minor and their LAR will be asked to sign the Assent Form if they decide that it is in the best interest of the minor to participate. When a minor turns 18 years old while they are in a study, then they will be consented again with the adult version of the Informed Consent Form.

If you have concerns about something that has happened in the study, like a side effect, or have health-related questions, then you should contact the study doctor with the information on your Informed Consent Form.

If you want to talk to someone about your rights, safety or welfare, or about research in general, then you can always contact the Jaeb Center IRB at IRB@wordpress-416094-1308241.cloudwaysapps.com, or by calling (813) 975-8690 and asking for the IRB Administrator.

It is up to you to decide if you want to stay in this study. No one can make you continue. You may stop being in the study now or at any time. You will not be treated differently as a person if you decide to stop being in the study. Everything in the consent form that you last signed is still valid, including the potential benefits, risks, and the use and disclosure of your health information. If you would like the information in the previous consent form to be reviewed with you, please let your study team know. They will review the form with you if you would like. You can also request another copy if you want one.

If you would like to withdraw your participation, you can download this JCHR IRB Withdraw Letter and provide it to your study team.