What is a Patient Registry?
A patient Registry is an electronic database of information about individuals with a specific disease or medical condition that is provided by those individuals or their caregivers.
What is the NephCure Kidney Network Patient Registry?
The NephCure Kidney Network (NKN) is a patient registry for people with the rare kidney diseases that lead to Nephrotic Syndrome, including Focal Segmental Glomerulosclerosis, Minimal Change Disease, Membranous Nephropathy and IgA Nephropathy. The goal of the NKN Patient Registry is to encourage, promote and facilitate research for those who suffer from primary Nephrotic Syndrome. Patient information in the NephCure Kidney Network Patient Registry is de-identified (a code instead of your name) or made anonymous (all identification removed) to share with researchers developing new knowledge, clinicians treating patients, epidemiologists analyzing disease data, and industry investigators seeking patients to evaluate new treatments using clinical trials. Participants who choose to receive information about clinical trials will be provided with the most up-to-date information about each study. It is the participant’s choice whether to contact the study coordinator (study staff) to get more information, including their eligibility to participate.
Commitment to Participate
Please read this information carefully. Take as much time as you need. If you have questions, please ask them.
You can send your questions via email to firstname.lastname@example.org or call 610-540-0186 ext. 19. You may choose to wait until your question is answered before deciding to participate in the Registry.
You are a volunteer. You are being asked to participate because you are an individual (or a caregiver, family member, or guardian of an individual) with a diagnosis of a rare kidney disease that causes primary Nephrotic Syndrome. To participate in this registry, you will:
Need to give your consent after reading this document that is called "Understanding your Participation".
Patients over the age of 18 who understand the consent form (and who do not have a legally authorized representative) are eligible to join the Registry on their own. Patients between the ages of 7 and 17 years of age should read the Assent Form and agree to participate or the legal guardian or parent of the patient must give consent for the patient to join. For children ages 7 and younger, the legal guardian or parent of the patient must give consent. If you answer "yes" to the questions regarding participation, you will have "consented". Please take your time to make your decision and discuss it with your family, friends and caregivers.
If you agree to participate in the Registry, you will be asked to complete a series of surveys about your life and health.
The surveys will ask about such things as demographic information, disease progression, medications, family history, and how the disease affects your life (i.e., Patient Reported Outcomes). Patients report that the surveys take between 30-45 minutes to complete.
You will be asked to update your Registry information at least twice per year or as your health changes.
In order to complete your profile, you may also be asked to login and respond to unanswered questions in the survey or fax/upload relevant lab or physician reports. If Registry study staff is unable to reach you for updates, your account may become inactive.
Participation in the NephCure Kidney Network Patient Registry may not benefit you personally, medically or financially. However, your participation may help you and others with Nephrotic Syndrome by supporting researchers to improve their understanding of these rare and debilitating diseases. All participants are able to see aggregate (de-identified) group data collected from registrants that may help inform their care decisions. In addition, participants can choose to receive updates about clinical research for which they may be eligible, and may help influence what research is conducted with NephCure Kidney Network Patient Registry data.
Risks, Inconveniences and Discomfort
The risks of taking part in the NephCure Kidney Network are very low. If you are not comfortable answering or do not want to answer a question in the Registry, you may skip questions or select the ‘Prefer Not to Answer’ response. By participating in the Registry and looking at summarized data contributed by all participants, you may learn information that is difficult or upsetting to you. It is important to recognize that each person with Nephrotic Syndrome is unique.
Loss of private or confidential information is also a risk. In the unlikely situation where there is a loss of security, we will let you know right away. To keep this risk low, we will store your information in a secure computer database. This database uses a security system with many safeguards and protections. Compliance to HIPAA security standards serves to minimize risks to the patients.
Also to minimize the risk of loss of private or confidential information, we will allow only NephCure Kidney Network Registry designated study staff to access information that identifies you.
Information that might identify you or tell people who you are, such as your name and address, will not be shared with anyone else. Only information that cannot
be used to identify you (“de-identified data”) will be shared with researchers (a code instead of your name). If you would like more detailed information regarding
the security of the NephCure Kidney Network Patient Registry, please contact the Registry Manager at: email@example.com
Alternatives to Registry Participation
Taking part in the NephCure Kidney Network Patient Registry is completely voluntary—it is your choice. You do not have to join this Registry. There is no penalty or loss of benefits to you.
What happens to the information collected in the NephCure Kidney Network?
NephCure Kidney International is the guardian of the information contained within NephCure Kidney Network Patient Registry. Scientists, health care providers, and other appropriate professionals can request access to the de-identified data stored in the Registry. Approval of such requests are made by the NephCure Kidney Network Steering Committee. The Steering Committee is made up of patients, family caregivers, patient advocates, and medical and scientific professionals who guide the policies of the Registry. The Registry will never release any personal information such as name, address, email, or phone number without your permission. Before your information is shared, we “de-identify” it; that is, remove information that would allow someone to locate or identify you.
The NephCure Kidney Network may also share de-identified data with other related databases, such as the National Patient-Centered Clinical Research Network (PCORnet). Combining the NephCure Kidney Network’s de-identified data with similar data from other registries or databases may help us expand our knowledge about Nephrotic Syndrome and could lead to new research studies, clinical trials, and new treatments. If information from the Registry is published or presented at scientific meetings, your name and other personal information will never be used.
You understand and agree that NephCure Kidney Network Registry study staff may disclose information provided by you if in its good faith belief such disclosure is required by applicable law. The Food and Drug Administration and Chesapeake IRB may have access to the registry study data.
Discussion of New Findings with You
We do not provide participants in the Registry with specific health or medical information related to their care or that of other participants. However, individual participants can
see the combined results of all answers collected by all participants (de-identified data only). If you take part in a specific research study as a result of being in
the NephCure Kidney Network Patient Registry, the scientists may share results with you. If scientists learn anything interesting about Nephrotic Syndrome using
data from the NephCure Kidney Network, we will post these results on the Registry website (www.nephcurekidneynetwork.org
Rights of Withdrawal
If you decide to participate in the Registry, you can decide to stop at any time. There is no penalty or loss of benefits to you. Simply contact the NephCure Kidney Network
Patient Registry Manager at firstname.lastname@example.org
and your data will be removed immediately. However, de-identified data cannot be retrieved from researchers that have already accessed it prior to your request for removal. Registry study staff may withdraw you from the Registry if circumstances arise that warrant doing so, even if you would like to continue. For example, inactive accounts may be withdrawn from the Registry if account users are repeatedly contacted without a response. We will tell you about new information or changes in the Registry that may affect your willingness to continue participation.
There are no costs to join the NephCure Kidney Network Patient Registry. You will not get any money for taking part in the Registry.
Problems or Questions
If you have any problems or questions about the NephCure Kidney Network Patient Registry or about your rights as a Registry member, contact the NephCure
Kidney Network Registry Manager by email ( Registry@nephcure.org
) or by calling 610-540-0186 x 19.
If you have any questions or complaints about your rights as a participant, you may contact: Chesapeake Institutional Review Board (IRB) at 877-992-4724 (toll free), by email at
, or by mail at Study Subject Adviser, Chesapeake IRB, 6940 Columbia Gateway Drive, Suite 110, Columbia, MD 21046. Please reference the following number when contacting the Study Subject Adviser: Pro00008061. An IRB is a group of people which review studies to protect the rights and safety of study participants.