Kalani Raphael, MD Page 1 of 14 Consent and Authorization Document BACKGROUND You are being asked to participate in this research study because you have chronic kidney disease, also called CKD, a condition in which your kidneys do not filter waste substances from the blood as well as healthy kidneys do. Before you decide, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with friends and relatives if you wish. Ask the research doctor or staff if there is anything that is not clear or if you would like more information. Take time to decide whether or not to volunteer to take part in this research study. Treatment with sodium bicarbonate, also known as baking soda, may help prevent kidney failure in people who have CKD. However, the evidence is not certain and the best dose of sodium bicarbonate to prescribe to people with CKD is unknown. Kalani Raphael, MD and Alfred Cheung, MD are conducting a research study sponsored by the National Institutes of Health to determine which of two doses of oral sodium bicarbonate will be best, in terms of safety and tolerability, for people with CKD. The results of this study will help us decide what dose of sodium bicarbonate to prescribe to people with CKD in a future large-scale clinical trial. STUDY PROCEDURES If you consent to participate, your participation in this study will last approximately 10 months and include approximately 10 in person study visits. Additional study visits may be required. There are four periods of the study: 1. Screening Period, 2. Baseline Period, 3. On-Treatment Period, and 4. Off-Treatment Period. Things you will be asked to do are to: Attend study visits where we will perform a brief physical exam, obtain blood and urine samples, give you the study medication and urine collection supplies, and assess for potential side effects of the study medication; Take the study medications as directed; Collect 24-hour urine samples; and Bring in the study medication pill bottles to your study visits.
Kalani Raphael, MD Page 2 of 14 It is also important to know that during the study, the investigators may need to change doses of some of your non-study medications, stop some of your non-study medications, or start new non-study medications. The reasons are to reduce the chance of having potential side effects or to treat potential side effects of sodium bicarbonate during the study. These potential side effects include: 1. High blood pressure, 2. Low blood potassium, 3. High blood bicarbonate, 4. Fluid retention, and 5. Upset stomach. Therefore, they may adjust, stop, or start anti-hypertensive medications, potassium supplements, diuretics, or medications that help with upset stomach during the study. Other medication changes may be made depending on the situation. If adjusting these medications does not relieve the side effects, we may reduce the dose of the study medication or stop the study medication. Screening Visit The purpose of the Screening Visit is to determine whether you can participate in the study. During the screening visit, you will meet with a member of the research team who will explain the study to you in detail. You will be asked to read this consent form carefully. If you would like to participate, we will ask you to sign the consent form. You will receive a signed copy of the consent form to keep for your records. After you sign the consent form, we may require blood and urine tests and measurements of height, weight, and blood pressure to see if you qualify to participate in this study. A member of the research team will review the results of these tests and procedures. If you don t qualify, we will tell you why. If you qualify for the study, you will proceed into the Baseline Period. The following procedures will be done at the Screening visit: We will measure your blood pressure, heart rate, swelling in your lower legs, height and weight. We will ask you questions about your medical history and current medications. About 2 teaspoons of blood may be drawn to determine if you can participate. These blood tests will measure your serum electrolytes, BUN/Creatinine (measures of kidney function), bicarbonate, glucose, and albumin. You may be asked to provide a urine sample to determine if you can participate. This sample will be used to measure albumin/creatinine (a measure of kidney damage). A pregnancy test may be required. Baseline Period (Baseline visits 0 and 1) The Baseline Period consists of two visits approximately two weeks apart. Additional Baseline visits may be necessary depending on results of your blood pressure and blood tests.
Kalani Raphael, MD Page 3 of 14 Baseline Visit 0 will take approximately 1 hour to complete. At this visit, we will: Measure your blood pressure, heart rate, swelling in your lower legs, and weight; Ask you questions about your current medications; Draw about 2 teaspoons of blood to measure your serum electrolytes, BUN/Creatinine (measures of kidney function), bicarbonate, glucose, phosphorus and albumin; You will provide a urine sample. From this sample, we will measure albumin/creatinine (measures kidney function). Give you a questionnaire to fill out about any gastrointestinal (stomach) symptoms you may have, about your ability to take the study drugs, and to assess for any potential side effects of the study drugs. Provide you the study medications; Instruct you to take two of the study pills in the morning and two pills in the evening each day until the next study visit; Instruct you to bring the study pill bottle with you to your next study visit; Give you urine collection supplies and instructions on how to collect a 24-hour urine sample; and Give you a handout with suggestions to follow a low sodium diet. You will return for a second visit (Baseline 1) approximately two weeks later. You will need to bring in to this visit: The pill bottle that we gave to you at Baseline 0 with the remaining study pills so we can count how many pills you have taken, and The 24-hour urine collection. (The 24-hour urine collection should begin on the day prior to the B1 visit.) This sample will be used to measure 24-hour urine electrolytes, ammonium, ph, creatinine, and urea nitrogen. The Baseline 1 visit will take approximately 1 hour to complete. At this visit, we will: Measure your blood pressure, heart rate, swelling in your lower legs, and weight; Ask you questions about your current medications; Draw about 2 teaspoons of blood to measure your serum electrolytes, BUN/Creatinine (measures of kidney function), bicarbonate, glucose, and albumin; and If you agree, we will draw blood samples (30 mls, 2 tablespoons) and save urine samples to store for future studies (refer to the Optional Study Element section at the end of this consent form); and. Give you a questionnaire to fill out about any gastrointestinal (stomach) symptoms you may have, about your ability to take the study drugs, and to assess for any potential side effects of the study drugs. You will proceed to the next period of the study, called the On-Treatment Period, if: 1. You took at least 80% of the pills you should have taken between the Baseline 0 and Baseline 1 visits, 2. Your blood pressure is less than 150/90 mm Hg,
Kalani Raphael, MD Page 4 of 14 3. Your blood potassium levels are between 3.5 and 5.5 meq/l, and 4. Your blood bicarbonate levels are between 20 and 28 meq/l. If you took at least 80% of the pills that you should have, but your blood pressure, blood potassium levels, or blood bicarbonate levels are not in the required ranges, it will still be possible for you to move to the next period of the study if we can bring each into range with dietary and/or medication changes. However, this will require additional Baseline visits. If we cannot bring these into range within three months after the day you signed the consent form, then you will not be able to move forward to the next period of the study. An additional Baseline visit will also be required if the 24-hour urine collection was not done correctly. If additional Baseline visits are required, some or all of the following procedures may be done: We will measure your blood pressure, heart rate, swelling in your lower legs, and weight. We will ask you questions about your current medications. About 2 teaspoons of blood will be drawn. We will measure your serum electrolytes, BUN/Creatinine (measures of kidney function), bicarbonate, glucose, albumin, and phosphorus. The 24-hour urine collection. (The 24-hour urine collection should begin on the day prior to the scheduled visit.) This sample will be used to measure 24-hour urine electrolytes, ammonium, ph, creatinine, and urea nitrogen. At the end of the Baseline Period, we will review your results and determine if you are able to be randomized and move on to the next period of the study, called the On-Treatment Period. If you don t qualify, we will tell you why. Randomization to Study Groups This is a randomized, double-blinded study, which means that neither you nor the study doctor nor the study staff will know which treatment you are receiving. However, in an emergency, study doctors can get this information. In a randomized trial people are put in one group or the other by chance (similar to flipping a coin). This means that a computer will decide by chance which group a person is in, not the doctors running the trial. If you are eligible for the On-Treatment Period, you will be randomly assigned to 1 of 4 groups once all of the baseline study requirements have been met. 1. The first group will take lower-dose oral sodium bicarbonate, which will be 2-4 pills a day depending on your body weight. You have a 27% chance of being in this group. 2. The second group will take higher-dose oral sodium bicarbonate, which will be 3-6 pills a day depending on your body weight. You have a 46% chance of being in this group. 3. The third group will take lower-dose oral placebo, which will be 2-4 pills a day based on your body weight. You have a 13.5% chance of being in this group. 4. The fourth group will take higher-dose oral placebo, which will be 3-6 pills a day based on your body weight. You have a 13.5% chance of being in this group.
Kalani Raphael, MD Page 5 of 14 A placebo is a pill that looks like the pill that contains the study drug but is not. Placebos contain no drugs or active ingredients. People in research studies are often given placebos so that the effects of a drug can be compared against no drug. Use of placebos also prevents the research participant and the doctor from knowing during the study whether or not the participant is getting the drug. Since people with normal bicarbonate levels in the blood are not usually treated with medicines like sodium bicarbonate, there is no disadvantage to you if you are assigned to the placebo treatment Taking the Study Drugs during the On-Treatment Period We will give you a supply of study drugs to take home with you. You will be taking either sodium bicarbonate or placebo. The number of pills you take is based on whether you were assigned to the lower-dose or higher-dose group and your body weight. If you are assigned to the lower-dose group you will take approximately 2-4 pills a day. You will take the same dose for the entire On-Treatment Period (Week 0 to Week 28), unless we tell you otherwise. If you are assigned to the higher-dose group you will take approximately 2-4 pills a day for the first four weeks (Week 0 to Week 4), then you will take approximately 3-6 pills a day for the rest of the On- Treatment Period (Week 4 to Week 28), unless we tell you otherwise. Half of the pills should be taken in the morning and the other half at night. If the number of pills is an odd number, then you will take the greater number of pills in the morning. It is important for you to follow our instructions about how to take the study drugs. You will be asked to bring any unused study drugs and your empty pill bottles with you to every study visit. Doses or frequencies of your study medications may need to be adjusted during the study and members of the study team will give you detailed instructions on any changes. On-Treatment Period (Follow up Visits: Week 0 to Week 28) There will be at least 6 in person visits during the On-Treatment Period. These will be at Weeks 0, 4, 8, 12, 20, and 28. There will also be two visits conducted by telephone at Weeks 16 and 24. During the Week 0 visit, the following procedures will be done: You will be randomized into 1 of 4 groups (see Randomization to Study Groups section above). We will measure your blood pressure, heart rate, swelling in your lower legs, and weight. We will ask you questions about your current medications. About 2 teaspoons of blood will be drawn. We will measure your serum electrolytes, BUN/Creatinine (measures of kidney function), bicarbonate, glucose, and albumin.
Kalani Raphael, MD Page 6 of 14 Study medications and instructions about how many pills to take will be given. We will ask you to bring the study pill bottle with you to your next study visit. You will provide a urine sample. From this sample, we will measure albumin/creatinine (measures kidney function). If you agree, we will draw blood samples (30 mls, 2 tablespoons) and save urine samples to store for future studies (refer to the Optional Study Element section at the end of this consent form). During the Weeks 4, 8, and 20 visits, the following procedures will be done: We will measure your blood pressure, heart rate, swelling in your lower legs, and weight. We will ask you questions about your current medications. About 2 teaspoons of blood will be drawn. We will measure your serum electrolytes, BUN/Creatinine (measures of kidney function), bicarbonate, glucose, and albumin. Study medications and instructions will be given. We will ask you to bring the study pill bottle with you to your next study visit. A member of the study team will count how many pills you have taken since your last study visit. We will give you a questionnaire to fill out about any gastrointestinal (stomach) symptoms you may have, about your ability to take the study drugs, and to assess for any potential side effects of the study drugs. During the Weeks 12 and 28 visits, the following procedures will be done: We will measure your blood pressure, heart rate, swelling in your lower legs, and weight. We will ask you questions about your current medications. About 1 tablespoon of blood will be drawn. We will measure your serum electrolytes, BUN/Creatinine (measures of kidney function), bicarbonate, glucose, albumin, and phosphorus. Study medications and instructions will be given (week 12 only). We will ask you to bring the study pill bottle with you to your next study visit. A member of the study team will count how many pills you have taken since your last study visit. We will give you a questionnaire to fill out about any gastrointestinal (stomach) symptoms you may have, about your ability to take the study drugs, and to assess for any potential side effects of the study drugs. You will provide a urine sample. From this sample, we will measure albumin/creatinine (measures kidney function). The 24-hour urine collection. (The 24-hour urine collection should begin on the day prior to the study visit.) This sample will be used to measure 24-hour urine electrolytes, ammonium, ph, creatinine, and urea nitrogen. If you agree, we will draw blood samples (30 mls, 2 tablespoons) and save urine samples to store for future studies (refer to the Optional Study Element section at the end of this consent form). Telephone calls
Kalani Raphael, MD Page 7 of 14 On weeks 16 and 24 a member of the study team will call you and ask how you are doing. The study coordinator will check on your pill supply, blood pressure measurements at home, weight, medication changes, and hospitalizations or emergency room visits. These phone calls will take about 10 to 15 minutes each. In addition to the scheduled follow up visits and unscheduled visits, a member of the study team may contact you by phone between your visits to ask how you are feeling or if the study medication is causing any side effects. You may also be asked if you are having any trouble taking any of your study medications, and if you have been started on any new medications since the last visit. The purpose of the telephone calls is to assess for potential safety concerns, and information obtained during the telephone calls may lead to an unscheduled visit so that we can evaluate potential safety concerns in person. Off-Treatment Period After you complete the 28 weeks On-Treatment Period, you will stop taking the study drug. You will return for a final visit at week 32 to see if any potential side effects of the study medication have worn off. During the week 32 visit, the following procedures will be done: We will measure your blood pressure, heart rate, swelling in your lower legs, and weight. We will ask you questions about your current medications. About 2 teaspoons of blood will be drawn. We will measure your serum electrolytes, BUN/Creatinine (measures of kidney function), bicarbonate, glucose, and albumin. We will give you a questionnaire to fill out about any gastrointestinal (stomach) symptoms you may have, about your ability to take the study drugs, and to assess for any potential side effects of the study drugs. Unscheduled visits In addition to the follow up visits described above, you may be asked to come back for additional unscheduled visits during which the following procedures may done: Measure your blood pressure, pulse, weight, and swelling. If the study physician thinks you need additional blood testing, we will draw a blood sample. Ask you questions about gastrointestinal symptoms that you may have, about your ability to take the study drugs, and about any side effects from the study drugs. The doses or frequency of your study medications may be adjusted. Change the dose of your non-study medications, stop non-study medications, or start new nonstudy medications. After You Complete the Study After you complete the study, we will refer you back to your own doctor for your ongoing medical care. All procedures conducted for this study are for research purposes only, though adjustment of blood pressure medications to keep blood pressure <140/90 mm Hg is the standard of care.
Kalani Raphael, MD Page 8 of 14 RISKS The risks of the study procedures include: Brief pain and bruising due to the blood draws. The collection of all urine for 24 hours of urine may be cumbersome. Participating in this research may involve providing details that you consider confidential or private. Some of the questions may make you upset or uncomfortable. You have the right to refuse to answer any of the questions. Other potential risks of this study include: You may have side effects from the specific study medications, as described below. Sodium Bicarbonate Potential risks of sodium bicarbonate are weight gain, fluid retention, increased blood pressure, poor taste of the medicine, abdominal (stomach) bloating, low blood potassium levels, and high blood bicarbonate levels. But these side effects may not occur. Some of these potential side effects (fluid retention, weight gain, and increased blood pressure) are due to the sodium component of the study drug. Please note that significant increases in fluid retention, weight gain, and blood pressure have not been observed in prior studies. Nonetheless, to help reduce these possibilities, we will provide you with a handout from the National Kidney Foundation about lowering sodium in your diet. If you have fluid retention that is troublesome or is causing your blood pressure to increase, we may give you diuretics (water pill) or increase the dose of your diuretics. We may also make changes to your other medications to help keep your blood pressure less than 140/90 during the study. If you have abdominal discomfort, we can prescribe medications that might help relieve this. Your blood potassium and bicarbonate levels will be checked with each blood draw. If the blood potassium level is low we will treat that either with potassium supplements or by encouraging dietary modifications to increase potassium in the diet. If the blood bicarbonate levels are too high, we will reduce the dose and/or ask you to stop taking the assigned treatment. Additional blood tests may be required to follow-up on these blood levels and help us decide when to restart treatment if it is stopped. Placebo Your blood bicarbonate levels may fall as a result of having CKD. This is more likely to occur in people who receive placebo. If this happens, we may prescribe sodium bicarbonate for you to take. You would
Kalani Raphael, MD Page 9 of 14 continue to take the assigned study medication, since we wouldn't know whether you were taking sodium bicarbonate or placebo. Confidentiality There is also a risk that your confidentiality will be breached. Every effort will be made to maintain your confidentiality. Unknown Risks There may be other side effects, in addition to those described here, which are not known at this time. We will give you any new information that we learn during the course of the study. This new information might affect your willingness to be in or stay in the study. If you notice any side effects during the study, you should tell us right away. REPRODUCTIVE RISKS There are no known risks of sodium bicarbonate during pregnancy to mother or child. If you become pregnant while taking part in the study, you must immediately tell your research doctor. Options will be discussed with you at that time. Whether or not you remain on study treatment, we will follow the outcome of your pregnancy and we will continue to follow you according to the study plan. UNFORESEEABLE RISKS Because this is an investigational study there may be some unknown risks that are currently unforeseeable. You will be informed if the researchers learn of any change in the amount of risk to you. BENEFITS Since this is a short-term study, we cannot promise that the sodium bicarbonate will be helpful in the long-term if you receive it. However, the information we get from this study may help us treat future patients. ALTERNATIVE PROCEDURES You may choose not to participate in this study. If you have normal acid levels in your blood, it is not necessary that you receive the treatment that is part of this research study. If your blood acid levels are in the lower end of the normal range, then your doctor might want to start you on sodium bicarbonate. We will test your blood acid level during the screening period. If you fall in this low-normal range, we will let you know so that you can discuss with your physician if you should take part in this study. PERSON TO CONTACT If you have questions, complaints, or concerns about this study, you can contact Dr. Raphael at (801) 582-1565 ext. 1794. If you think you may have been injured from being in this study, please call Dr. Raphael at (801) 582-1565 ext. 1794. He can be reached at this number Monday through Friday from
Kalani Raphael, MD Page 10 of 14 9am to 5pm. After hours, you can also call the University of Utah Hospital operator at (801) 581-2121 and ask to speak to the kidney doctor on call. Institutional Review Board: Contact the Institutional Review Board (IRB) if you have questions regarding your rights as a research participant. Also, contact the IRB if you have questions, complaints or concerns which you do not feel you can discuss with the investigator. The University of Utah IRB may be reached by phone at (801) 581-3655 or by e-mail at irb@hsc.utah.edu. Research Participant Advocate: You may also contact the Research Participant Advocate (RPA) by phone at (801) 581-3803 or by email at participant.advocate@hsc.utah.edu. RESEARCH-RELATED INJURY If you are injured from being in this study, medical care is available to you at the University of Utah, as it is to all sick or injured people. The University of Utah has not set aside any money to pay the costs for such care. The University will work with you to address costs from injuries. Costs would be charged to you or your insurance company (if you have insurance), to the study sponsor or other third party (if applicable), to the extent those parties are responsible for paying for medical care you receive. Since this is a research study, some health insurance plans may not pay for the costs. By signing this consent form you are not giving up your right to pursue legal action against any parties involved with this research. The University of Utah is a part of the government. If you are injured in this study, and want to sue the University or the doctors, nurses, students, or other people who work for the University, special laws may apply. The Governmental Immunity Act of Utah is a law that controls when a person needs to bring a claim against the government, and limits the amount of money a person may recover. See sections 63G -7-101 to -904 of the Utah Code. VOLUNTARY PARTICIPATION It is up to you to decide whether or not to take part in this study. If you decide to take part you are still free to withdraw at any time and without giving a reason. Refusal to participate or the decision to withdraw from this study will involve no penalty or loss of benefits to which you are otherwise entitled. If you don t take part, you can still receive all standard care that is available to you. This will not affect the relationship you have with your doctor or other staff, nor decrease the standard of care that you receive as a patient. RIGHT OF INVESTIGATOR TO WITHDRAW The investigator can withdraw you without your approval for the following reasons: If it appears to be medically harmful to you; If you fail to follow directions for participating in the study; If it is discovered that you do not meet the study requirements; If the study is canceled; or For administrative reasons, including competitive enrollment - the target number of subjects has entered the treatment phase.
Kalani Raphael, MD Page 11 of 14 COSTS AND COMPENSATION TO PARTICIPANTS There will be no costs to you or your insurance for any procedures or testing done only as part of this research study. If you receive a bill for services that you think could be related to your participation in this study, you should contact the study team. If we adjust doses of non-study medications or start new non-study medications during the study, we will not be able to compensate you for any additional costs related to these changes. You will receive $25 for completing the Screening Visit. You will receive $100 for completing the entire Baseline Period. (You will receive $50 if you complete at least one Baseline visit but do not complete the entire Baseline Period). You will receive $40 for each completed in-person study visit, $20 for each successful 24-hour urine collection at Weeks 12 and 28, and $10 for each phone call (Weeks 16 and 24). If you complete all scheduled study visits, 24-hour urine collections and phone calls, you will receive a total of $465. If the investigator believes that an additional visit is necessary to evaluate and/or manage a side effect, then you will receive an extra $20 for each additional visit. You will be paid by check after the Screening Visit, after the Baseline Period, and after the Off-Treatment Period. Checks will be distributed at the following study visit (the final check will be mailed). Since you will be paid for participating in this study, it is necessary for us to collect your Social Security Number. You will provide this information on a Federal W-9 Form that is filed with our accounts payable department. No other information (e.g. the name of this study) will be provided to that office. The amount you receive for taking part in this study will be turned into the Internal Revenue Service (IRS) as taxable income. You can choose not to provide us with your Social Security Number for this form and still participate in this study; however we will not be able to pay you as outlined in this consent form. NEW INFORMATION Any new findings developed during the course of this research that may affect your willingness to continue in this study will be shared with you. NUMBER OF PARTICIPANTS The study investigators hope to enroll 27 subjects at the University of Utah and SLC VA and 192 nationwide. The study sites are Salt Lake City VA, University of Utah, Northwestern University, George Washington University, University of California San Diego, Denver Nephrology, and Baylor Scott and White. AUTHORIZATION FOR USE OF YOUR PROTECTED HEALTH INFORMATION Signing this document means you allow us, the researchers in this study, and others working with us to use some information about your health for this research study. This is the information we will use and include in our research records: - Demographic and identifying information like your name, address, and phone number
Kalani Raphael, MD Page 12 of 14 - Social Security Number (in order to issue a check for your study participation). You may participate without providing your social security number, however we will be unable to pay you. - Date of birth - Medical history - Current and past medications or therapies - Information from physical examinations, such as blood pressure reading, heart rate, breathing rate, and temperature - Lab tests - All other tests and procedures that will be performed in the study How we will protect and share your information: We will do everything we can to keep your information private but we cannot guarantee this. Study information will be kept in a secured manner and electronic records will be password protected. Study information may be stored with other information in your medical record. Other doctors, nurses, and third parties (like insurance companies) may be able to see this information as part of the regular treatment, payment, and health care operations of the hospital. We may also need to disclose information if required by law. A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time. In order to conduct this study and make sure it is conducted as described in this form, the research records may be used and reviewed by others who are working with us on this research: o Members of the research team at the University of Utah Health Sciences Center; o The University of Utah Institutional Review Board (IRB), who reviews research involving people to make sure the study protects your rights; o Other local hospital(s) that we are working with: VA Salt Lake City Health Care System o Other academic research centers we are working with: Northwestern University, NorthShore University Health System, George Washington University, University of California San Diego, Denver Nephrology, and University of Colorado (Denver). These are all study sites for this multi-center study. o The study sponsor: National Institutes of Health (NIH) o A research coordinating office: Cleveland Clinic Foundation Data Coordinating Center o Government agencies and public health authorities, such as the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS). After completion of the trial, a copy of the de-identified data will be retained for future research. This dataset will be a limited dataset that will contain relevant dates of study participation and your date of birth, but no direct personal identifiers. This dataset may be shared with research associates at other institutions, pending approval by their institutional review board.
Kalani Raphael, MD Page 13 of 14 If we share your information with groups outside of the University of Utah Health Sciences Center, we will not share your name or any information that directly identifies you. We will label your information with a code number, so they will not know your identity. If you do not want us to use information about your health, you should not be part of this research. If you choose not to participate, you can still receive health care services at the University of Utah Health Sciences Center. What if I decide to Not Participate after I sign the Consent and Authorization Form? You can tell us anytime that you do not want to be in this study and do not want us to use your health information. You can also tell us in writing. If you change your mind, we will not be able to collect new information about you, and you will be withdrawn from the research study. However, we can continue to use information we have already started to use in our research, as needed to maintain the integrity of the research. This authorization does not have an expiration date. OPTIONAL STUDY ELEMENT: Tissue Bank As part of this study, we would like to send some of your blood and urine specimens to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository, a research resource supported by the National Institutes of Health. The Repository collects, stores, and distributes biological samples and associated data from people with many kinds of disorders, from unaffected family members, and from other healthy people. The purpose of this collection is to make samples available for use in research for the study of chronic kidney disease after the current study is completed. Sending samples to the Repository may give scientists valuable research material that can help them to develop new diagnostic tests, new treatments, and new ways to prevent diseases. These specimens will also be labeled by a unique code and without your personal health identifiers. Therefore, the Repository will not be able to give out your name, or other information that identifies you to the scientists who receive the samples. Also, because your sample cannot be linked back to you, we will not share the results from future studies with you or your doctors. This study does not plan to collect your DNA or to do any studies with DNA. Your samples will be used only for research and will not be sold. Tissue or blood samples obtained from you in this research may help in the development of a commercial product by the NIH or its research partners. There are no plans to provide financial compensation to you should this occur.
Kalani Raphael, MD Page 14 of 14 Requests for samples: An appropriate external panel will review all requests to use Repository samples. That panel will include a bioethicist and other individuals with expertise in one or more areas including: clinical research, epidemiology, physiology, and statistical analysis. If you agree to have your sample(s) stored in the Repository, you can change your mind up until the end of the study at that time, the list that links names and study ID numbers will be destroyed. When study researchers receive written instructions from you, they will destroy your sample(s). After the study ends, you will not be able to withdraw your sample(s) because the Repository will not know which one is yours. The sample(s) will stay in the Repository indefinitely. You do not have to participate in the tissue bank to be in the main part of this study. No matter what you decide to do, your decision will not affect your medical care. You can tell us your choice by initialing one of the choices below: I consent to banking of my blood and urine specimens for future research. I do not consent to banking of my blood and urine specimens for future research. CONSENT I confirm that I have read this consent and authorization document and have had the opportunity to ask questions. I will be given a signed copy of the consent and authorization form to keep. I agree to take part in this research study and authorize you to use and disclose health information about me for this study, as you have explained in this document. Participant s Name Participant s Signature Date Name of Person Obtaining Authorization and Consent Signature of Person Obtaining Authorization and Consent Date