ࡱ> UWT 9bjbjWW 4P55000000DDD8|$<DF f(  +$!^$T03  3300 SSS3|00S3SSV@}8G.  0F  $v$"$0Ap33S33333S333F 3333$333333333 : University of North Carolina at Chapel Hill Parental Permission for a Minor Child to Participate in a Research Study ________________________________________________________________________ IRB Study #14-0539 IRB Version Date: March 7, 2014 Title of Study: CKD Parent-Youth Project Persons in charge of study: Ali Annaim, BS Where they work at -Chapel Hill. -Chapel Hill Phone number: 919-966-2561 Email Address: ali_annaim@med.unc.edu Other people who work on the study: Sarah Cohen, Kristi Bickford Source of funding for the study: Renal Research Institute Study Contact: Kristi Bickford Study Contact telephone number: 919-966-2561 Study Contact email: HYPERLINK "mailto:kristi_bickford@med.unc.edu" kristi_bickford@med.unc.edu _________________________________________________________________ What are some general things you and you child should know about research studies? You are being asked to allow your child to take part in a research study. To join the study is voluntary. You may refuse to give permission, or you may withdraw your permission for your child to be in the study, for any reason, without penalty. Even if you give your permission, your child can decide not to be in the study or to leave the study early. Research studies are designed to obtain new knowledge. This new information may help people in the future. Your child may not receive any direct benefit from being in the research study. There also may be risks to being in research studies. Details about this study are discussed below. It is important that you and your child understand this information so that you and your child can make an informed choice about being in this research study. You will be given a copy of this consent form. You and your child should ask the researchers named above, or staff members who may assist them, any questions you have about this study at any time. What is the purpose of this study? The purpose of this study is to learn more about howpatients who have been diagnosed with a chronic health condition as a child grow into adulthood, from their own point of view and the point of view of their parents and caregivers. Your child is being asked to be in the study because s/he has a chronic health condition that was diagnosed in childhood. Information about your child and other patients will be combined to help us improve what we teach transition-age patients and their families about chronic health conditions and about growing into healthier adults. Are there any reasons your child should not be in this study? Your child should not be in this study ifs/he does not feel comfortable talking about various aspects of their health (i.e., physical, mental, sexual, etc). How many people will take part in this study? There will be approximately 200 people in this research study. 100 parents and 100 children will be included in this study. How long will your childs part in this study last? This is an ongoing study that will consist of this interaction. The entire set of questions should take an hour to complete. Your childs medical information will continue to be utilized in this study even if deceased, unless you withdraw consent beforehand. The next sectionprovides an estimate ofhow long each tool/questionnaire your child may be asked to complete will take. You and your child can spend as much time or as little time with the researcher(s) as you desire. Your childs participation is completely voluntary and at your discretion. What will happen if your child takes part in the study? If you choose to allow your child to participate in this study, you and your child may be asked to complete some or all of the following questionnaires during the course of his/her study enrollment. Your child will be asked to completeall of them during one visit. Most of the questionnaires are online, so they can be emailed to you/your child for completion at home if you prefer. REALM (Rapid Estimate of Adult/Adolescent Literacy in Medicine): You may be asked to read a list ofcommon medical words and lay terms for body parts and illnesses aloud. This will help your medical team know how to bettercommunicate with and teachyou about your condition and medications. It will take no more than 2-3 minutes to complete and you will only be asked to do this once. The TRxANSITION Scale(patient and parent version): You may be asked to answer32 questions related to your health condition knowledge and disease management skills to find out what you know and dont know. A researcher will ask you the questions out loud. Ittakes an average of 7 minutes toanswer all of the questions. Parental Authority Questionnaire-Revised: You will asked 30 questions that will assess your parenting style. A researcher will ask you the questions out loud. Ittakes an average of 7 minutes toanswer all of the questions. Learning Preference: You will be asked 5 questions to learn how you gather information about your childs condition. This will take approximately 5 minutes to complete. Focused Interview: You will be asked a series of questions to understand how your parents use the internet and or games in general. This series of questions will take an average of 15-30 minutes. These questionnaires may help researchers learn more about what can be helpful toyoung peopleas they prepare to change from a pediatric health system to an adult-centered health system.Answering these questionnaires is completely voluntary and you/your childmaychoose not tocomplete any questionnaire or answer any questionsat any time.Your childwill be seen only during regularly scheduled clinic appointments.No additional visits/appointments will be required or necessary for participation in this study. What are the possible benefits from being in this study? Research is designed to benefit society by gaining new knowledge. The benefits to your child from being in this study may be the possibility ofobtaining a portable method (i.e., medical identification card) to communicate their health information with others wherever they are. Your child also may benefit from extra education about their health condition, medicines, and how to take care of themselves. This will be provided by the Transition Coordinator, doctors, nurses, etc. You and your child will have access to one-on-one time with the Transition Coordinator or research assistant during clinic visits and resource information as needed. We do not know of any other direct benefits that you or your child will get from being in this study, but being in the study may help others with the same disease to benefit in the future. What are the possible risks or discomforts involved from being in this study? There is the little risk that confidential medical information about you may become available to others because of the precautions we take. Additionally, the following situations may cause minimal discomfort in participants: when asked to discuss their chronic health condition, discussion of referral to other providers (i.e., mental health, adolescent specialist, etc), discussion of weight and/or healthy eating habits so we can understand to level of self-management. Additionally, the following situations may cause minimal discomfort in participants: when asked to discuss their chronic health condition, discussion of referral to other providers (i.e., mental health, adolescent specialist, etc), discussion of weight and/or healthy eating habits, and possible discussion of sexual activity, and drug/alcohol use, as warranted by patients clinical condition. To minimize discomfort, these issues will be discussed with your child in private. Their answers will be kept confidential unless potential danger or harm is disclosed. There may be uncommon or previously unknown risks. You should report any problems to the researcher. What if we learn about new findings or information during the study? You and your child will be given any new information gained during the course of the study that might affect your willingness to continue your childs participation in the study. How will your childs privacy be protected? Any personally identifiable information (i.e.,name, date of birth, address, etc) we collect from you and your child will be stored in a password protected database that only the researchersnamed in this study will be permitted access to. Data and information may be shared with other researchers and/or health care providers working with them, but alldata/info will be coded with a unique study ID. Any questionnaire you and/ or your child completes or that is administered to you and/or your child willhave this ID instead of you/your childsname. The researchers on this study have had training in protecting the privacy and rights of patients. Participants will not be identified in any report or publication about this study. Although every effort will be made to keep research records private, there may be times when federal or state law requires the disclosure of such records, including personal information. This is very unlikely, but if disclosure is ever required, -Chapel Hill will take steps allowable by law to protect the privacy of personal information. In some cases, your information in this research study could be reviewed by representatives of the University, research sponsors, or government agencies (for example, the FDA) for purposes such as quality control or safety. At some point in time, the researcher(s) may ask you if they can digitally record an interview with you and your child. This digital recording will not contain any personally identifiable information (i.e., name, date of birth, address, etc), only you and/or your childs voice. The recording will only be used to obtain qualitative data. You have the choice of allowing the researcher(s) to record you/your child or not. Please indicate your decision below. Check the line that best matches your choice: _____ OK to record me during the study _____ Not OK to record me during the study What if you or your child wants to stop before your childs part in the study is complete? You can withdraw your child from this study at any time, without penalty. The investigators also have the right to stop your childs participation at any time. This could be because your child has had an unexpected reaction, or has failed to follow instructions, or because the entire study has been stopped. Will your child receive anything for being in this study? You will be reimbursed with gift card for $20. Will it cost you anything for your child to be in this study? It will not cost anything to be in this study. Who is sponsoring this study? This research is funded by the Renal Research Institute. This means that the research team is being paid by the sponsor for doing the study. The researchers do not, however, have a direct financial interest with the sponsor or in the final results of the study. What if you or your child has questions about this study? You and your child have the right to ask, and have answered, any questions you may have about this research. If there are questions about the study (including payments), complaints, concerns, or if a research-related injury occurs, contact the researchers listed on the first page of this form. What if there are questions about your childs rights as a research participant? All research on human volunteers is reviewed by a committee that works to protect your childs rights and welfare. If there are questions or concerns about your childs rights as a research subject, or if you would like to obtain information or offer input, you may contact the Institutional Review Board at 919-966-3113 or by email to IRB_subjects@unc.edu.  Parents Agreement: I have read the information provided above. I have asked all the questions I have at this time. 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