On behalf of University of Michigan's Department of Physical Medicine and Rehabilitation, we are asking permission from you to store some of your personal and contact information in the Sclero-Rehab Research Registry, a registry of volunteers who have expressed an interest in taking part in future research for people with scleroderma. We will build and maintain this registry in order for investigators to be able to contact you with information about future research.
The information below outlines all of the details associated with being included in this research registry. Should you have any questions, the Principal Investigator, Susan Murphy ScD OTR/L or a representative on the Dr. Murphy's research team are available to answer all of your questions. You can reach out to them using the contact information below. Your participation is entirely voluntary. If you choose not to participate in this study you will not be penalized or lose any benefits that you would otherwise be entitled to. Choosing not to participate won't affect the medical care you might receive at the University of Michigan Health System or elsewhere.
1. What are we asking to store?
If you agree, the following contact and personal information will be collected and stored in our participant registry:
• name
• address
• Main contact phone number (home, mobile, or work)
• Secondary contact phone number (home, mobile, or work)
• Preferred contact method
• e-mail address
• date of birth
• gender
• race
• ethnicity
• medical diagnosis of systemic sclerosis (scleroderma) and type (diffuse, limited (CREST), overlap/MCTD, sine, morphea, other)
• disease duration
2. Reason for storing your personal and contact information:
The purpose of this registry is to build and maintain a list of participants to be contacted for future research at the University of Michigan. The participant registry will contain the names and contact information and basic personal information (date of birth, gender, ethnicity, race, scleroderma diagnosis and duration) of volunteers who have expressed an interest of taking part in scleroderma-related rehabilitation research.
You are being asked to be in this registry because you are at least 18 years old, have a diagnosis of scleroderma or a scleroderma-related disorder, and are interested in being contacted when research studies are available.
3. Can you change your mind?
If you decide that your personal and contact information can be kept for future research but you later change your mind, you can contact Susan Murphy at SSc-registry@umich.edu or at 734-936-2123, who will remove and destroy any of your personal and contact information that she still has.
Otherwise, the information may be kept for the duration of the registry (5 years) and at that time, we will ask if you renew your permission to remain on the registry. You have the right to see and copy the information that is collected from you and stored in the participant registry bank. There will be no cost to you for any personal and contact information that is collected and stored.
4. Where will your personal and contact information be stored?
Your personal and contact information will be kept in a secure location in a participant registry called the Sclero-Rehab Research Registry so that investigators may contact you in the future about research participation opportunities. Once collected, you may be called from time to time to update personal and contact information that is necessary to keep the participant registry current.
5. Are there any benefits to your participation in this participant registry bank?
There is no direct benefit to participating in this registry; however, by including your information in this registry, you will find out about research participation opportunities at the University of Michigan.
6. Are there any risks to your participation in this participant registry bank?
The biggest risk to being involved in any research study is breach of confidentiality. Every effort will be made to keep your information confidential. We will keep your information in a secure encrypted database with access to your information restricted to only the people who need it for reasons related to this registry, such as to verify your medical information in your medical record or to contact you for a research opportunity. If we want to examine the characteristics of the participants in the registry as a whole, the data will be de-identified. Your information will be shown with a participant code that can only be linked back to you by our research team. There is a small risk that an unauthorized person may obtain your information. Therefore, there is a very slight risk that your personal and contact information could be linked to your identity and inadvertently disclosed to a third party.
7. Will your personal and contact information be shared with others?
Susan Murphy and representatives on Dr. Murphy's research team will be allowed to collect, use and/or give out your personal and contact information. They may give your personal and contact information to other researchers whose research is approved by an Institutional Review Board (IRB) (An IRB is a group of people who are responsible for looking after the rights and welfare of people taking part in research). Though other IRB-approved investigators may receive the information, they should not be sharing it on. With appropriate permissions, your collected information may also be shared with other researchers, here, around the world, and with companies.
8. How will the researchers benefit?
In general, presenting research results helps the career of a scientist. Therefore, the Principal Investigator may benefit if the results of this study are presented at scientific meetings or in scientific journals. Research can lead to new discoveries, such as new tests, drugs, or devices. Researchers, their organizations, and other entities, including companies, may potentially benefit from the use of the data or discoveries. You will not have rights to these discoveries or any proceeds from them.
Your identifiable private information may be stripped of identifiers and used for future research studies or distributed to another researcher for future research studies without additional informed consent. Your collected information may also be shared with other researchers, here, around the world, and with companies.
9. Will the researchers access my medical record?
By consenting to be included in this research registry, the researchers will be able to access your medical record to verify your diagnosis and characteristics of your condition and to maintain up-to-date contact information. Signing this form gives the researchers your permission to obtain, use, and share information about you for the registry, and is required in order for you to be included. Your permission expires at the end of the duration of the registry, unless you cancel it sooner. You may cancel your permission at any time by contacting Susan Murphy at SSc-registry@umich.edu.
Medical information and billing records are protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA). This type of information is called protected health information (PHI). PHI 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 identifiers
It's possible that the researchers or others will need access to information about you during or after this study. For example:
• The researchers may need the information to make sure you can take part in a specific study.
• The researchers may need the information to check your test results or look for side effects.
• University, government officials, auditors, and/or the IRB may need the information to make sure that this research is done in a safe and proper manner.
• The researchers may need to use the information to create a databank of information about your condition or its treatment.
• Information about your participation in the registry may be included in your regular UMHS medical record.
9.4 When does my permission to use my PHI expire?
Your permission will not expire unless you cancel it. We are anticipating the registry to be in place for 5 years. At the end of that time, you will be contacted again to determine whether you would like to remain on the registry or not. You may cancel your permission at any time by writing to the researchers listed in Section 10 "Contact Information" (below). If you withdraw your permission, you may no longer be eligible to participate in this study.
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 9.2, it may no longer be protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).
10. Who can I contact about this registry?
To find out more about the study, to ask a question or express a concern about the study, or to talk about any problems you may have as a study subject, you may contact one of the following:
Principal Investigator: Susan Murphy
Mailing Address: 24 Frank Lloyd Wright Drive
Lobby M, Suite 3100, Ann Arbor, MI 48105
Email: SSc-registry@umich.edu
You may also express a concern about a study by contacting the Institutional Review Board:
University of Michigan Medical School Institutional Review Board (IRBMED)
2800 Plymouth Road
Building 520, Room 3214
Ann Arbor, MI 48109-2800
734-763-4768
E-mail: irbmed@umich.edu
If you are concerned about a possible violation of your privacy or concerned about a study, you may contact the University of Michigan Health System Compliance Help Line at 1-866-990-0111.
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