邢唷��>� `b��_��欹�a� ��0Lbjbj[[ 4d9bE\9bE\濩��D D ��8$,<��B"rhh(��!�!�!�!�!�!�!$�#�j&V�!��!��!///��!/��!//V� @� ��泄(毑��+v� �!"0B"� �&��&� � "�&�!��/��!�!/��B"��&��D >�: University of North Carolina at Chapel HillParental Permission for a Minor Child to Participate in a Research Study � Consent Form Version Date: 2/21/2016IRB Study # 07-0352Title of Study: Successful Transition to Adulthood with Therapeutics (STARx)Principal Investigator: Maria FerrisPrincipal Investigator Department: Unc Kidney CenterPrincipal Investigator Phone number: (919) 966-2561Principal Investigator Email Address: maria_ferris@med.unc.eduFunding Source and/or Sponsor: Renal Research Institute_________________________________________________________________ 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 how爌atients 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 if爏/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?As of this year, there are approximately 850 participants enrolled in this study. This year we anticipate enrolling around 100 new participants. As our study is longitudinal, enrollment is ongoing indefinitely. � How long will your child抯 part in this study last? This is an ongoing study that will last until you withdraw consent. Your child抯 medical information will continue to be utilized in this study even if deceased, unless you withdraw consent beforehand. The next section爌rovides an estimate of爃ow 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 child抯 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. You will NOT be asked to complete燼ll 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.牋 REALM (Rapid Estimate of Adult/Adolescent Literacy in Medicine): You and your child may be asked to read a list of燾ommon medical words and lay terms for body parts and illnesses aloud. This will help your child's medical team know how to better燾ommunicate with and teach爕ou and your child燼bout爐heir condition and medications. It will take no more than 2-3 minutes to complete and you/your child爓ill only be asked to do this once. Parent survey on Transition: We爉ay ask爕ou (the爌arent/caregiver)爐o give us爄nformation about your child's health, social, and educational history. This survey may take�10mins to complete, but爕ou will only be asked to complete it once. Measures of Health-Related Quality of Life (HRQL):燳ou and your child爉ay be asked to fill out a one page survey with questions about爃is/her physical, emotional, and social well being. This survey will take you/your child爊o more than 5mins to complete. You and your child may be asked to answer these questions again every 12 months. The TRxANSITION Scale�(patient and parent version): You and your child may be asked to answer�32 questions related to your child's爃ealth condition knowledge and disease management skills to find out what you/they know and don抰 know. A researcher will ask爐he questions out loud. It爐akes an average of 7 minutes to燼nswer all of the questions. You and your child may be asked to answer these questions again 6 months after the first time you answered them and again every 12 months. Mood Face Scale: You and your child爉ay be asked to look at爌ictures of 9 faces and pick the one that represents how you and your child爁eel deep down inside. This takes less than 1min to complete. You and your child爉ay be asked to do this at every visit. Medical Passport:燳our child's picture may be taken to create燼 brief, portable health record爐hat is爐he size of credit card and contains a summary of your personal health information.燭his card will include the following爄nformation: name, DOB, insurance provider, emergency contact number for hospital, diagnosis(es), allergies, health provider contact numbers, personal emergency contact numbers provided by patient, and medication name, dosage, and purpose.燳our child爓ill be given as many copies of this card as you would like. STARx Transition Readiness Survey: You and your child may be asked to answer 18 questions about how much you feel your child爇nows about爐heir health and taking care of themself, in addition to how ready爏/he feels爐hey are to switch to an adult doctor. Or, if your child is already seeing an adult doctor, how easy or hard it was for爐hem to take medical advice from a new doctor. It takes no more than 8mins to燼nswer all爋f the questions燼nd it is completed on your own. You and your child爉ay be asked to answer this survey again 6 months after you complete it the first time and then every 12 months after that. The Family Relationship Index: Your child爉ay be asked to answer 27爍uestions about how well your family gets along, communicates, and supports each other.燳our child爓ould answer these questions on爐heir own and it爓ould take no more than 7mins to complete. Your child爓ould only have to answer these questions one time. � CES-D : Your child爉ay be asked to answer 11 questions about how爐hey are feeling. This questionnaire will help to identify symptoms of depression. It will take your child爊o more than 5mins to complete and your child爉ay be asked to do this more than once. Medical Passport Usage Survey: If your child爎eceives a medical passport,爏/he may be asked to answer questions about where爐hey use it, why爐hey use it, and what爐hey think about it. It will take no more than 8mins for your child爐o answer these questions and爐hey will only have to do it once. Patient/Parent Satisfaction Survey: You and your child爉ay be asked to answer燼 brief set of questions about the quality of services you receive from medical staff here. This survey will take no more than 8mins to complete and you may be asked to complete it every 12 months. Morisky 8 item Medication Adherence Scale: Your child爉ay be asked to answer 4 questions about their medication taking behavior. This will take no more than 2mins and爏/he will only be asked to answer them once. Social Support Questionnaire SSQSR (Short Form-Revised): Your child爉ay be asked to answer questions about how supported爏/he feels by their peers and family. This questionnaire is completed one time and takes no more than 5mins. Kidney Transplant Knowledge Questionnaire: If your child has爎eceived a kidney transplant,爏/he may be asked to answer 10 questions about issues and events related to爐heir爐ransplant. This questionnaire is completed one time and takes no more than 5mins. The Newest Vital Sign: Your child may be asked to answer 6 questions about a food label. S/he will be given a food label to look at while they respond to the questions. This should take no longer than 5mins to complete. Your child may be asked to do this more than once. Prescription Drug Label: Your child may be asked to find 5 pieces of information on a prescription label. This will take no longer than 3 mins. Your child may be asked to do this more than once. Parental Authority Questionnaire: Your child may be asked 30 questions about parenting methods at home. This will take no longer than 10 mins. Your child will only asked to complete this survey once. PROMIS Depression Scale: Your child may be asked to answer 8 questions about how sad or depressed he or she have felt in the past 7 days. This should take no longer than 3 mins and your child will only be asked to answer these questions once. PROMIS Peer Relationships: Your child may be asked to answer 15 questions about his/her friendships and relationships with people their age. This should take no longer that 7 mins and your child will only be asked to answer these questions once. Parental Monitoring Items: Your child may be asked to answer 6 questions about how much you are involved in their daily life. This should take no longer than 5 mins and your child will only be asked to answer these questions once. These questionnaires may help researchers learn more about what can be helpful to爕oung people燼s they prepare to change from a pediatric health system to an adult-centered health system.燗nswering these questionnaires is completely voluntary and you/your child爉ay燾hoose not to燾omplete any questionnaire or answer any questions燼t any time.燳our child爓ill be seen only during regularly scheduled clinic appointments.燦o 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 of爋btaining 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. If you and/or your child are eligible to complete certain scales, you may both receive compensation in the form of a gift card up to $15.00 each. 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 potential risk that confidential medical information about your child may become available to others if s/he loses their medical identification card. 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 child抯 participation in the study. How will your child抯 privacy be protected?Any personally identifiable information (i.e.,爊ame, date of birth, address, etc) we collect from you and your child will be stored in a password protected database that only the researchers爊amed 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 all燿ata/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 will爃ave this ID instead of you/your child抯爊ame.牋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, 黑料网-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/or 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 child抯 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� Additionally, we hope to review your child抯 and other patients� healthcare costs by analyzing records of health care utilization and charges to the system. This will be completed through collaboration with NC TraCS Institute. What if you or your child wants to stop before your child抯 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 child抯 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?Neither you nor your child will receive anything for being in this study.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 (name of Drug Company, the National Institutes of Health, etc.).� 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 child抯 rights as a research participant?All research on human volunteers is reviewed by a committee that works to protect your child抯 rights and welfare. If there are questions or concerns about your child抯 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.� � Parent抯 Agreement: I have read the information provided above. I have asked all the questions I have at this time. 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