Registry FAQ

 

Participant - refers to a person who has been diagnosed with PSC.

Consent - is a process that informs you how your participation in the registry could affect you, explains information that you need to consider carefully before participating and provides a written record of what you have and have not agreed to. Your consent can be withdrawn at any time, as your participation is voluntary.

You - refers to the person entering the information into the registry. This may be the affected individual, a friend, family member or guardian of the affected individual (the person legally responsible for the care of the affected individual) acting on the affected individual's behalf.

De-identified data - means that all information that can identify you has been removed.

Other definitions can be found in the Glossary. 

 
Understanding the Patient Registry

A registry is a place to store detailed information about affected individuals and their families with a specific disease or syndrome or group of diseases. In this case, the PSC Partners Patient Registry is for affected individuals with PSC. When you join the registry, you will create your own personal health record. Your personal record, combined with those of many other people with PSC, creates a registry that meets several critical needs.

    1. You can track information that helps you work with your doctor and other healthcare providers to facilitate management of your personal health.
    2. It is a place where you can include information about your health, including PSC diagnosis, test results (including genetic testing in the future), and information on the progress of your disease, so you have access to the most accurate and up-to-date information.
    3. It will enable PSC Partners to provide you with the most up-to-date information about research that may be of specific interest to you and other people with PSC, including clinical trials to evaluate possible new treatments.
    4. Researchers studying PSC need accurate information from many people to understand how PSC affects people, information only you and your doctor can provide.
    5. Researchers who are ready to start research studies or clinical trials can use information in the registry to help identify people that may be eligible to participate in studies. If an affected individual looks like a good match for a scientist's research or a clinical trial, the scientist or clinical trial coordinator will contact the registry. A member of the PSC Partners’ registry team will then contact you and other individuals identified by the investigator. Scientists cannot contact you directly, as they only have access to de-identified data.

Primary Sclerosing Cholangitis (PSC) is a poorly understood disease for which there are currently no effective therapies and no known cure. The disease is rare, which makes it difficult to gather information and develop treatments.  The registry will collect information from PSC patients all over the world to help researchers have a better understanding of PSC.  The rarity of the disease makes it difficult to conduct large clinical trials. To address these deficiencies, PSC Partners has developed a patient registry to collect detailed medical information on PSC patients to help discover possible factors contributing to disease causes and progression and to help find and evaluate new therapies.

The purpose of the PSC Partners Patient Registry is to collect and store medical and other information from individuals with PSC. Information from the registry will be used to better understand PSC and to develop new treatments. This information will be helpful to understand how PSC affects those living with the disease. The registry may lead to studies that help to better understand the natural history (progression) of PSC and/or environmental factors that may contribute to the disease. The registry may also be used by the PSC Partners’ registry team to contact patients about clinical trials for which they may be eligible, including those investigating new treatments.

By collaborating with other rare disease registries, the goal is to bring together information coming from other registries and to find similarities and patterns among diseases. This collaboration may speed up the discovery of new treatments for PSC.

The data is collected from individuals who have a diagnosis of PSC, including data about those who have passed away. The diagnosis must be confirmed by MRI or other PSC diagnostic test results.

 
Rights, Risks and Benefits of Participation

You have the right to know about the procedures, risks, and benefits of participating in the PSC Partners Patient Registry. To participate in this registry, you will need to give your consent. If you decide to participate, you can change your mind later and leave the registry. Please take your time to make your decision and discuss it with your family, friends, and caregivers. The consent process will be proved to you when you register for an account on this site.

After joining the registry, a participant may be invited to participate in a clinical trial. Participation in a clinical trial, if the participant qualifies, will be based solely upon the voluntary consent of the patient.

There is minimal risk in taking part in the registry. The registry includes questions that can be sensitive, and you may feel uncomfortable answering. You do not have to share any information you do not want to share.

There may be risks to your privacy. The PSC Partners patient registry will store study records and other information about you in a secure location and will grant access only to personnel authorized by PSC Partners. Compliance to Glossary Link HIPAA and Glossary Link FISMA rules and standards and an annual review of the registry by an Institutional Review Board (IRB) serve to minimize risks to the patient. However, just like other personal information kept by your health care providers, your banks, and others, even these safeguards cannot guarantee absolute protection of the data. If private information gets into the wrong hands, it can cause harm. Although rare, there are reported cases of breaches that have resulted in discrimination in insurance or employment. In the event there is a breach in the registry’s computer system, all participants will be notified. If you would like more detailed information regarding the security of the PSC Partners patient registry, please contact the registry coordinator at registrycoordinator@pscpartners.org.

Providing your information to the registry and participating in this registry is voluntary.  Participation may not benefit you personally, medically, or financially.  However, your participation may help all those with PSC by increasing the understanding of the disease. Collected data may help speed up research by collecting information scientists can use.  Researchers may learn whether and how treatments work. Medical professionals may be able to improve how they treat the disease.  Participants may receive information about opportunities to participate in research, clinical trials, medical advances and other news from the registry. Participants will also have instant access to de-identified patient questionnaire responses.

Participating in this registry is your choice, is completely voluntary, and will not affect your healthcare.

If you decide to participate in the registry, you can decide to stop at any time. Simply contact the registry at the email address or telephone number listed on the first page of this form, and all of your data will be removed from the PSC Partners patient registry. However, pre-authorized de-identified data cannot be retrieved from researchers that have already accessed it prior to your request for removal.

PSC Partners may withdraw you from the registry if circumstances arise which warrant doing so even if you would like to continue.

We will tell you about new information or changes in the registry that may affect your willingness to continue your participation.

 
Confidentiality of Data

The goal of the PSC Partners patient registry is to share detailed medical and other information with scientists and other researchers while still protecting your privacy.  All of the information you provide will be maintained in a safe (“secure”) HIPAA- and FISMA- compliant environment (please see Glossary), and any information that could identify you and your family members will not be shared without your approval.

Your privacy will be protected by hiding the name, address, and other “identifying” information from researchers. We call this information “de-identified” because all personal identifiers have been removed.  Your personal information such as your name, address, or other information that identifies you or your family will be labeled with a code number, encrypted (coded), stored and protected with a password. Only authorized people who work on the registry will know the code and be able to identify you if needed. Any individual authorized by PSC Partners to work on the registry has completed HIPPAA awareness certification. The PSC Partners Patient Registry is the guardian of the information contained within the registry.

Your identifiable information will not be shared with anyone outside the registry. Approved scientists, researchers, and clinicians will be allowed to see only the de-identified data for their studies. Your identifiable information will not be shared with anyone outside the PSC Partners Patient Registry unless you give your permission to share it.

You may request PSC Partners at any time that the de-identified data about you collected and compiled by the registry be removed.

During the consent process, you may agree to share a subset of de-identified information collected from your profile with global registries that collect data from other rare diseases.

The registry has to follow US federal and state rules to protect your privacy.

Only authorized members of the PSC Partners registry team, who have a need to, will know that you have registered and answered the enrollment questionnaire. Only they will see your personal information with a few exceptions that are listed below.

PSC Partners will make every reasonable effort to assure that your personal information, in our possession, will be kept confidential. However, we cannot guarantee total privacy. Your personal information may be released if required by law. If information from the registry is published or presented at scientific meetings, your name and other personal information will NOT be used.

PSC Partners owns the registry data. This registry will be managed by Invitae, a company that manages other rare disease registries like the PSC Partners Patient Registry. Invitae is hosted in a HIPAA and FISMA compliant infrastructure with dedicated firewalls and advanced intrusion detection to secure the participant's data. All registry network transmissions are encrypted for an added level of protection. All transmissions are sent via encrypted SSL (Secure Sockets Layer, i.e. a system of codes that provide communication security over the internet), and personal health information will be encrypted in the database.

Invitae strictly follows the rules and standards provided by HIPAA and FISMA (see Glossary). The Food and Drug Administration (FDA) and Western IRB may also inspect the registry records. An IRB is a formally recognized, qualified team that reviews and monitors research studies to protect the rights and welfare of research participants.

In the event PSC Partners Seeking a Cure ceases to exist (this is not likely), all attempts will be made to find another suitable entity to take ownership of the registry. You will be asked to give your consent to the transfer of your data (identifiable and de-identifiable information).  The data of those not consenting for such a transfer will be destroyed. If all attempts fail to find a suitable entity, then all data collected by the PSC Partners Patient Registry will be destroyed, thus protecting your privacy. You will be contacted and informed of this action.

If you would like more detailed information regarding the security of the PSC Partners Patient Registry, please contact the registry coordinator at registrycoordinator@pscpartners.org.

 
Costs and Compensation

There is no charge for you to participate in this registry.  Neither you nor your insurance carrier will be charged for participating in the registry. 

You will not be paid for taking part in this registry.  PSC Partners Seeking a Cure maintains ownership of the de-identified data collected and compiled by the registry and is the guardian of the information contained within the registry. You will have no property ownership or interest in such data derived from the registry and no right or entitlement in any research or research product using or derived from the data.  However, on the registry site, you will have access to statistics on how others with PSC have responded to questions, and if you would like to, you will have access to view new PSC studies. 

 
Joining the Registry

  1. You, or your authorized representative, should read "Understanding Your Participation," and then decide if you want to participate in the registry.
  2. If you choose to participate, you, or your authorized representative, will need to complete and sign the Consent Form, affirming that you understand the risks and benefits of participation, and that you agree to participate in the registry.
  3. The next step is to provide basic information about you to create an account with a login user name and password.
  4. Once you create this account, your name and email address will be sent to our administrator who will confirm to you that you are now a member of the registry.

Once you create an account, you will be able to access the registry survey. The questions in the survey will include your personal information. You do not have to complete the entire survey at one time. All your answers will be saved, and you can go back to complete the questions as well as change your answers if you make a mistake or update your information at any time. If you need more than three days to fill out the survey, please notify us by writing to registrycoordinator@pscpartners.org .

If more than one family member has PSC, you can create a single-family account. First register one individual with PSC and answer the survey. Then you will be able to add other family members with PSC to the same account. Each individual family member must provide his or her own consent and enter his or her own data. The value of the family account is to link records from multiple family members.

You will be asked to update your registry information at least once a year. The registry will automatically send you a reminder each year, but you can also update your information when you have new information. The registry may also ask you to fax, mail or upload your test results, and any other relevant reports or testing results. Your registry account can be updated whenever there is a change in the patient’s health, change in medication, or new symptoms. If the registry cannot contact you, your account may become inactive.

In the future, the registry may be linked to a biobank which is a place that stores tissue, blood or other samples from patients.  If a biobank is created for people with PSC, you may be asked to donate samples to the biobank. If you decide to donate your samples, you will be asked to provide separate consent for the biobank.  

Yes, the legally authorized representative of an adult patient, legal guardian of a minor or parent of the patient can give consent for the patient to join and can complete the patient survey on behalf of that patient. When the patient turns 18, consent for continued participation will be obtained directly from the patient if they do not have a legally authorized representative. Those minors who choose not to re-enroll as adults will have their records deleted from the registry.   

PSC patients over the age of 18 who understand the consent form (and who do not have a legal guardian) are eligible to join the registry and must sign the consent form. Otherwise, the legally authorized representative of an adult patient, legal guardian of a minor or parent of the patient must give consent for the patient to join. When the patient turns 18, consent for continued participation will be obtained directly from the patient if they do not have a legally authorized representative. Those minors who choose not to re-enroll as adults will have their records deleted from the registry.   

Yes, it is okay. It is important that you join other registries. Your information may be used differently, for different purposes, and by different researchers looking for different aspects of PSC. This does not affect the care you are given by your physicians.

The registry will take somewhere between 30 minutes and an hour to join and complete the first survey. You will be asked to provide documentation of your diagnosis. You can start the registration process and return to it.   

 
Clinical Trial Opportunities

Although one of the main goals of the registry is to make it easier for PSC patients to participate in research, there is no guarantee that you will be eligible for a trial. Even if you are eligible for a trial based on the data you store in the registry, it is possible that you do not meet the trial requirements. In order to participate in any trial, you will need to discuss the trial with the research staff and fill out a separate informed consent form specific to the trial. Informing you about the existence of a trial does not imply that PSC Partners endorses it. Before you consent to be in a clinical trial, you should discuss your participation with your physician.

Even if you do not want to take part in a clinical trial, your information will still be useful to researchers who are trying to learn more about patients with PSC. By joining the registry, you will be helping to better understand the geographical spread of the PSC population, the progression of disease, evaluation of treatments and tests, monitoring the safety of medications, and more.

 
Additional Information

If you have any questions about the registration process, about participation in the registry, or about reporting problems that result from your participation in the registry, please contact the registry coordinator at registrycoordinator@pscpartners.org.

This research is being overseen by an Institutional Review Board (“IRB”). An IRB is a group of people who perform independent review of research studies. You may talk to them at New England IRB by emailing info@neirb.com or by (800) 562-4789 if (1)You have questions, concerns, or complaints that are not being answered by the research team (2)You are not getting answers from the research team (3)You cannot reach the research team (4)You want to talk to someone else about the research or (5)You have questions about your rights as a research subject.

If there are questions in the registry that you do not understand, first go to the Glossary for more information. If you have further questions, please contact the Registry Coordinator at registrycoordinator@pscpartners.org .

For additional information regarding the terms and conditions of this website or the privacy policy, please go to Privacy Policy and Terms and Conditions.