KRI Registry: a participant registry for future studies |
Investigators' Statement:
We are asking you to be in a research registry. The purpose of this consent form is to give you the information you will need to help you decide whether to be in the Kidney Research Institute (KRI) Registry. Please read this form carefully. You may ask questions about what we will ask you to do, the risks, the benefits, your rights as a volunteer, or anything else about the Registry or this form that is not clear. When we have answered all of your questions, you can decide if you want to be in the KRI Registry or not. This process is called "informed consent." We will give you a copy of this form for your records.
Purpose of the Registry
We want to conduct research on kidney problems, dialysis, and related conditions now and in the future. A registry of patients with these conditions, as well as healthy individuals, makes research possible. We want to contact eligible people to take part in future studies.
Registry Procedures
If you choose to be in the Registry, we would like to record your name and contact information.
Survey: We will ask you some questions, such as age, gender, race, and health questions. It will take about 15 minutes to complete.
In the future, we will periodically access your medical record to confirm your current contact information. We will also record information to find out what studies you may qualify for. We will record: age, gender, race, diagnosis, medical and surgical history, complications, medications, blood pressure, and lab results.
We may contact you in the future by phone or mail if we think that you may be a good fit for a research study. We will then tell you about the new study. You do not have to take part in it if you don't want to.
Phone call: If we do call you about a new study, then we will ask you more questions to find out how good a fit you are for that study. The questions we ask will depend on the study. The questions will be related to your recent health status and health care.
Screening visit: We will invite you to come to a screening visit for that study, if it looks like you may qualify. You will decide whether or not you want to come to the screening visit.
After the screening visit, we will let you know for sure if you are eligible for the new study or not.
Risks, Stress, or Discomfort
There are no physical risks from taking part in the registry. Some people feel that providing information is an invasion of privacy. We have addressed concerns about your privacy in the following section of the OTHER INFORMATION section of this consent form. Some people do not want to be contacted about research studies.
Alternatives to Taking Part in this Registry
Taking part in this registry is voluntary. You can stop at any time. If you choose not to take part in this registry, we will not record information from your medical record for this registry.
Benefits of the Registry
The only benefit from taking part in this registry is that you may learn about opportunities to take part in studies related to the kidneys. We hope that future studies will teach us more about people with kidney disease and related conditions, and how to improve their care.
Other Information
Taking part in this Registry is voluntary. You can stop at any time. Even if you decide now to take part, you can change your mind later. You can withdraw from the registry by requesting to do so in writing, by sending a letter to: Jonathan Himmelfarb, MD, 325 9th Avenue, Box 359606, Seattle, WA 98104.
Researchers will keep the Registry information confidential and secure. We will assign a Registry code to your information. Your name and contact information will be kept in a separate location. The Registry team will have a link between the coded information and your name. We will keep the link indefinitely.
Government, University, or NW Kidney Center staff sometimes review studies such as this one to make sure they are being done safely and legally. If a review of this registry takes place, your records may be examined. The reviewers will protect your privacy. The registry records will not be used to put you at legal risk of harm.
You will not have to pay anything to be a part of this registry, and you will not be paid to take part in the registry.
If you have questions about this research or about this registry, please contact us at 206-616-8574 or email us at registry@kri.washington.edu. If you have questions about your rights as a subject, please contact the University of Washington Human Subjects Division at (206) 543-0098.
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