What other choices do I have? This is not a treatment study. You can choose not to be in the safety monitoring activity. How will my privacy be protected? The researchers will protect your information, as allowed by law. Absolute confidentiality cannot be guaranteed because persons outside the study team may need to look at your study records. Your health information is protected by a federal privacy law called HIPAA. By signing this consent form, you are giving permission for KUMC to use and share your health information. If you are not a patient of The University of Kansas Medical Center, you might be required to complete additional paperwork in order to obtain your medical records. If you decide not to sign the form, your information will not be collected and you cannot be in the safety monitoring activity. The researchers will only use and share information that is needed for the safety monitoring activity. To do the safety monitoring activity, they will collect health information from the safety monitoring activities and from your medical record. You may be identified by information such as name, address, phone, date of birth, social security number, or other identifiers. Your health information will be used at KUMC by Dr. __________, members of the research team, The University of Kansas Hospital Medical Record Department , the KUMC Research Institute and officials at KUMC who oversee research, including members of the KUMC Human Subjects Committee and other committees and offices that review and monitor research studies. By signing this form, you are giving your doctor and the research team permission to share information about you with persons or groups outside KUMC. Your information will be shared with representatives of [Sponsor] (the sponsor of the study), the monitoring company that inspects study data, other business partners of the sponsor who help with the study, the U.S. Food and Drug Administration (FDA) and similar agencies in foreign countries (including Health Canada and the European Medicines Agency), the Department of Health and Human Services (DHHS),and U.S. agencies that oversee human research (if a study audit is performed). These groups or agencies may make copies of study records for audit purposes. The purpose for using and sharing your information is to evaluate if the study treatment affects you and your baby. The HIPAA privacy law may not apply to everyone who receives your health information. Your information might not be protected by HIPAA if persons outside KUMC disclose it. In some cases, there may be other laws that protect your information from improper use.
What other choices do I have? This is not a treatment study. You can choose not to be in the safety monitoring activity. How will my privacy be protected? The researchers will protect your information, as allowed by law. Absolute confidentiality cannot be guaranteed because persons outside the study team may need to look at your study records. Your health information is protected by a federal privacy law called HIPAA. By signing this consent form, you are giving permission for KUMC to use and share your health information. If you are not a patient of The University of Kansas Medical Center, you might be required to complete additional paperwork in order to obtain your medical records. If you decide not to sign the form, your information will not be collected and you cannot be in the safety monitoring activity. The researchers will only use and share information that is needed for the safety monitoring activity. To do the safety monitoring activity, they will collect health information from the safety monitoring activities and from your medical record. You may be identified by information such as name, address, phone, date of birth, social security number, or other identifiers. Your health information will be used at KUMC by Dr. __________, members of the research team, The University of Kansas Hospital Medical Record Department , the KUMC Research Institute and officials at KUMC who oversee research, including members of the KUMC Human Subjects Committee and other committees and offices that review and monitor research studies. By signing this form, you are giving your doctor and the research team permission to share information about you with persons or groups outside KUMC. Your information will be shared with representatives of [Sponsor] (the sponsor of the study), the monitoring company that inspects study data, other business partners of the sponsor who help with the study, the U.S. Food and Drug Administration (FDA) and similar agencies in foreign countries (including Health Canada and the European Medicines Agency), the Department of Health and Human Services (DHHS),and U.S. agencies that oversee human research (if a study audit is performed). These groups or agencies may make copies of study records for audit purposes. The purpose for using and sharing your information is to evaluate if the study treatment affects you and your baby. The HIPAA privacy law may not apply to everyone who receives your health information. Your information might not be protected by HIPAA if persons outside KUMC disclose it. In some cases, there may be other laws that protect your information from improper use.