The information below describes how your privacy and the confidentiality of your research records will be protected in this study.
1) How will the researchers protect my privacy? We will take a number of steps to protect your privacy and confidentiality. • First, any personally-identifiable information (e.g., your name) will be removed from all of your data after the study, and the data will only be linked with your participant ID. All analyses will also use aggregate data. For example, analyses of location will only be run on categories of “Home,” “Work,” and “Other,” not actual addresses or locations. Your de-identified data will be stored separately from a file that links your personal information and your participant ID, and documents with this link will be kept in a locked filing cabinet to which only the members of the study staff will have access. These files will also be destroyed after the research is complete.
• Second, all data collected will be kept on secure, restricted access servers that have been approved by the University of Michigan for the storage of health and other sensitive information. The servers are behind a firewall, under intrusion monitoring, and will be made accessible only to the members of the study team. Similarly, all data in paper form (e.g., surveys) will be stored in locked filing cabinets that only members of the study team can access.
• Third, to help protect data on your personal mobile phone, our study team is available at the initial in-person session to help you add password-protection to your phone. Password protection makes it highly unlikely that any unauthorized person could gain access to your data, as iPhone’s security model automatically encrypts all data stored on a password-protected phone.
• Fourth, at any point during our in-person interview you may request that audio recording be turned off at any time should you have any concerns about anything you want to say being captured on tape. Similarly, you can skip any survey or phone-based self-report question or refuse to answer any interview question with which you feel uncomfortable.
2) What information about me could be seen by the researchers or by other people?
Participating in the study (Signing the consent form) gives the researchers your permission to obtain, use, and share information about you for this study, and is required in order for you to take part in the study. Information about you may be obtained from any hospital, doctor, and other health care provider involved in your care, including: • Hospital/doctor's office records, including test results (X-rays, blood tests, urine tests, etc.) • All records relating to your condition, the treatment you have received, and your response to the treatment • Demographic information • Personal information • Other information
3) Why? Who might see this information?
There are many reasons why information about you may be used or seen by the researchers or others during or after this study. Examples include: • The researchers may need the information to make sure you can take part in the study. • University, Food and Drug Administration (FDA), and/or other government officials, auditors, and/or the IRB may need the information to make sure that the study is done in a safe and proper manner. • Study sponsors or funders, or safety monitors or committees, may need the information to: o Make sure the study is done safely and properly o Learn more about side effects o Analyze the results of the study • If you receive any payments for taking part in this study, the University of Michigan accounting department may need your name, address, social security number, payment amount, and related information for tax reporting purposes. • Federal or State law may require the study team to give information to government agencies. For example, to prevent harm to you or others, or for public health reasons.
The results of this study could be published in an article, but would not include any information that would let others know who you are. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will NOT include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
4) What happens to the information collected about me after the study is over OR if I cancel my permission?
As a rule, the researchers will not continue to use or disclose information about you, but will keep it secure until it is destroyed. Sometimes, it may be necessary for information about you to continue to be used or disclosed, even after you have canceled your permission or the study is over. Examples of reasons for this include:
• To avoid losing study results that have already included your information • To provide limited information for research, education, or other activities (This information would not include your name, social security number, or anything else that could let others know who you are.) • To help University and government officials make sure that the study was conducted properly
As long as your information is kept within the University of Michigan Health System, it is protected by the Health System’s privacy policies. For more information about these policies, ask for a copy of the University of Michigan “Notice of Privacy Practices”. This information is also available on the web at http://www.uofmhealth.org/patient+and+visitor+guide/hipaa. Note that once your information has been shared with others as described under Question 3, it may no longer be protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).
5) When does my permission expire?
Your permission expires at the end of the study, unless you cancel it sooner. You may cancel your permission at any time by writing to the researchers listed in the Contact page.