Your Privacy and Security are Very Important to Us
Who will use or share protected health information about me?
VCU and VCU Health are required by law to protect your identifiable health information. By consenting to this research program, you authorize VCU/VCU Health to use and/or share your health information for this research only with those who are approved to do so to conduct, monitor, and oversee the research.
To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health, which will offer the protections described here. A Certificate of Confidentiality helps the researchers keep your information private. For example, researchers can refuse to give out your information in a court case. Researchers may have to give your information if the study is audited, or if the information is required by the Food and Drug Administration (FDA). The researchers cannot prevent you or others, for example a member of your family, from sharing information about you or your involvement in this research. If you give an insurer, employer, or other person permission to receive research information, then the researchers may not use the Certificate to withhold that information.
What happens with my data?
Your personally identified information will be kept confidential as required by law. Federal Privacy Regulations provide safeguards for privacy, security, and authorized access. Every effort will be taken by VCU to protect your information, including:
- Electronic information will be saved as password encrypted files and stored on a secured server behind firewalls at the VCU School of Medicine.
- Paper surveys and other study paperwork will be locked in locked file cabinets, which only the study PI and approved research staff can access.
- Data collected through the Vibrent platform/app and accelerometer will be stored securely on commercial databases, outside of VCU.
Except when required by law or for your care and safety, you will not be identified. The results of future research studies conducted using your information in the registry may be published in scientific journals or presented at medical meetings, but you will not be personally identified.
What information will you get from me?
If you decide to join the research program, you will:
- Complete two surveys. You will be asked to complete an initial survey and a follow-up survey approximately 9-12 months later. The surveys will ask you some basic information like your name, date of birth, phone number, and email address. The surveys will also ask about your health, including medical history and medication use, behavioral factors (tobacco and alcohol use, diet and physical activity), cancer treatment history, and symptom burden.
- Allow research staff to access your medical records and use information from your medical record for this study.
- Be asked to wear an watch-like device (Actigraph Watch) for 7 days that will monitor your sleep and physical activity.
- You may also choose to provide a saliva sample.
- Researchers may add data from other sources to the information you provide us, for example, environmental data and pharmacy records. This will allow researchers to assess more factors that might affect your health. Based on your residential address and/or other information that you have provided us, we can add data from other sources to your study records. For example, we may add data about how many people live in your community and how close you live to the nearest clinic.
Will my information be shared with insurance companies?
No, the information you provide will not be shared with your insurance company.
Will you sell my personal information?
No, we will never sell any of your information.
Do I have to reveal my protected health information (PHI)?
No, you can skip any questions that you do not wish to answer that may reveal your PHI. You may also change your mind and revoke (take back) the right to use your protected health information at any time. If you decide to revoke this authorization, you must write to the study team. Please address this request to: THRIVE Health Study, Attn: Dr. Bernard Fuemmeler, Box 980430, Richmond VA, 23298-0430.
Will taking part in the research program affect my health care?
No, taking part in this research program is unrelated to the type and quality of health care you receive.
Is the study approved by an ethics review board?
This research program has been approved by an institutional review board (IRB) at VCU. To ask questions, express concerns, report problems, obtain information, or offer input about your rights as a research participant, you may contact: Office of Research and Innovation, Virginia Commonwealth University, 800 East Leigh Street, Suite 3000 Box 980568, Richmond, VA 23298 Telephone: (804) 827-2157. https://research.vcu.edu/human-research/hrppirb/research-participants/
Does this study have a Certificate of Confidentiality?
Yes, this research program has a Certificate of Confidentiality (CoC), which has been granted by the National Institutes of Health (NIH). This means that CoC’s protect the privacy of research participants by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research except when the participant consents or in a few other specific situations. Information protected by a CoC is immune from the legal process and is not admissible as evidence (unless participant consents to this disclosure). CoC protections also last in perpetuity. Learn more here: https://grants.nih.gov/policy/humansubjects/coc/information-protected-coc.htm
