What does volunteering entail?

Patient participation in the ITN Registry is strictly on a volunteer basis.

Assessing your eligibility

If you are interested in participating, a registry investigator will contact you to further explain the study and answer any questions you may have. From this discussion, we will determine whether or not you meet the basic requirements for participation.

If you decide that you wish to participate, with your consent, the Registry will request a copy of your medical records that includes your transplant procedure information and post transplant medical care. A screening visit to one of the Registry medical centers is then required to reviewed your medical history and determine if it is indeed appropriate for you to participate in this study. If so, you will be asked to officially enroll in the study.

Study Evaluations

Patients enrolled in the study will be asked to visit their nearest Registry clinical site up to 6 times over the course of the following 3 years. These visits will take place approximately 6 months apart. You may choose to opt out of any specific clinical visits or tests at any time during the study.

At each clinical visit, the Registry physician will review your medical records with you. You will also be asked to provide blood and urine samples for routine laboratory testing and research purposes. In addition, upon your first visit after enrolment, you will be asked to provide a biopsy sample of your transplanted kidney to be used for microscopic analysis and other research tests (note that this is not necessarily required for participation in the study). Should the function of your transplanted kidney worsen, you may consent to having another biopsy taken.

Privacy and your medical records

Study records of patients enrolled in this study, including the medical records requested by the investigators, will be kept confidential and will be viewed only by personnel involved in the conduct of this study, for the purposes of conducting this study. Only a number or code will be used to identify enrolled patients - their name or other information that could identify them will not appear in any reports or publications arising from this research study.

All enrolled patients will have the right to see and copy the medical information collected from them in the course of the study for as long as that information is kept.

In addition, should any of laboratory tests show significant abnormalities, patients will informed of the results both verbally and in writing and may request that this information be shared with their primary physician.