VPREG Privacy Information
Vasculitis Pregnancy Registry (VPREG)
The primary objective of the Vasculitis Pregnancy Registry (VPREG) is to understand pregnancy characteristics and outcomes among women with vasculitis.
VPREG is run through the Vasculitis Patient-Powered Research Network (VPPRN). The goal of the VPPRN’s research program is to conduct high-quality studies that will improve the care and health of patients with vasculitis by exploring research questions and advancing medical knowledge.
What information will VPREG collect and how will it be used?
- Information about yourself, your vasculitis and pregnancy will be collected, which is categorized as personal health information. This information will be stored in our secure database and kept confidential to the extent permitted by law.
- Your personal health information may help identify ways to improve pregnancy outcomes for patients with vasculitis. All information will be used only for research purposes and all responses will be kept private and confidential.
- Provided information may be used in research analyses and the results of these analyses may be presented in scientific conferences and published in medical literature. These presentations and publications will never reveal information that individually identifies you or any other individual in VPREG.
- VPREG may need to contact you to obtain additional information or clarification related to your participation in this study.
- While you participate in VPREG, you may be notified of research studies for which you may be eligible. You are not obligated to enter any studies.
- The regulations of the federal Health Insurance Portability and Accountability Act (HIPAA) protect your identifiable health information. By agreeing to participate in this study, you authorize us to use your information we will protect it as required by the law.
- The VPPRN Team follows the security guidelines of the U.S. Health Insurance Portability and Accountability Act of 1996 (HIPAA). All collected data is transmitted, stored, and processed in a secure environment.
Data Protection and Privacy Notice
As part of this clinical study, we will collect and process your personal data in accordance with the General Data Protection Regulation (GDPR). This means:
- Purpose of Data Collection: Your personal data will be collected and used solely for the purposes of the VPREG research study.
- Data Controller: The data controller responsible for your personal data is the Health Informatics Institute (HII) at the University of South Florida (USF).
- Data Processing: Your data will be processed in a manner that ensures appropriate security and confidentiality. This includes measures to prevent unauthorized access, disclosure, alteration, or destruction of your data.
- Data Sharing: Your data may be shared with participating VPREG researchers as noted above, but only for the purposes of this study and in compliance with GDPR.
- Your Rights: Under GDPR, you have the right to:
Access your personal data.
Request correction of any inaccurate data.
Request deletion of your data (where applicable).
Object to or restrict the processing of your data.
Withdraw your consent at any time without affecting the lawfulness of processing based on consent before its withdrawal.
- Data Retention: Your data will be retained as required by local and federal law and will be securely deleted thereafter.
- Contact Information: If you have any questions about your data or your rights under GDPR, you can contact the HII Data Protection Officer (DPO), Dr. Kenneth Young at gdpr@epi.usf.edu.
What if I change my mind?
- Participation in VPREG is completely voluntary and no cost to you.
- You have the ability to withdraw from VPREG at any time. You may withdraw or take away your permission to use and disclose your information at any time by emailing vpreg@vpprn.org. Once you have withdrawn, you will no longer be a participant in VPREG, and new information will not be collected. Deidentified information collected prior to withdrawing consent will be used.
Does VPREG share my information?
Protection Against Involuntary Disclosure of Your Information: To help us protect your privacy, we have applied for a Certificate of Confidentiality from the United States Department of Health and Human Services (DHHS). This certificate protects against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant. The VPREG study staff can’t be forced to disclose study information that identifies you, even if ordered by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the certificate to resist any demands for information that would identify you, except to prevent serious harm to yourself or others. Click HERE to review the VPREG Certificate of Confidentiality.
- All information collected as part of VPREG will be stored in our secure database and kept confidential to the extent permitted by law.
- VPREG and the VPPRN will not sell, rent, lease, or voluntarily share your personal or contact information without your permission.
- VPREG is a study of the Vasculitis Patient-Powered Research Network (VPPRN). By joining this study, you are permitting the VPPRN to use your health information for research purposes and you agree to allow the study team to link your VPREG and VPPRN study records if you are enrolled in the VPPRN. You are also allowing us to share your health information with individuals or organizations who are also involved in the research and listed below:
- University of Pennsylvania:
- Investigators and staff involved in this research study
- Staff responsible for data collection and storage. The data collected for this study will be stored on secure servers within the University of Pennsylvania firewall and only be accessible to the PI, co-investigators, and authorized study personnel.
- Institutional Review Board (IRB) staff who have oversight responsibilities for this study
- Duke University:
- Investigators involved in this research study
- Institutional Review Board (IRB) staff who have oversight responsibilities for this study
- University of South Florida (USF):
- Institution responsible for the data security and privacy of VPREG and the VPPRN and ensuring regulatory compliance with the Health Insurance Portability and Accountability Act (HIPAA) and General Data Protection Regulation (GDPR). Click HERE to review the VPPRN Privacy Pledge.
- Institutional Review Board (IRB) staff who have oversight responsibilities for this study
- University of Pennsylvania:
- VPREG will not share information that may individually identify you with researchers or organizations who will review research data. Deidentified information may be shared with researchers outside of VPREG and the VPPRN. This deidentified information will be used for research purposes only and will never reveal information that individually identifies you or any other individual in VPREG.
- Your identifiable information may only be reviewed by members of the VPREG team and local, state, and federal regulatory bodies that oversee the safety of the network, as required by law.
What if I have questions?
If you have any questions or concerns about this research study, the VPREG privacy policy and/or how your information is protected, or experience an unanticipated problem, please contact:
CHRISTINE YEUNG, VPPRN NETWORK MANAGER
If you have questions about your rights as a participant in this research, general questions, or have complaints, concerns or issues you want to discuss with someone outside the research, please contact:
University of South Florida Institutional Review Board
University of South Florida College of Medicine
12901 Bruce B. Downs Blvd., MDC35
Tampa, FL 33612-4799
United States
Telephone: +01 (813) 974-5638
The VPPRN, and the studies conducted under the VPPRN umbrella, is supported by the Vasculitis Clinical Research Consortium (VCRC), the Vasculitis Foundation, the Penn Vasculitis Center, and Biopharmaceutical Industry Partners.