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Research Participant Informed Consent and Privacy Authorization Form

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Research Participant Informed Consent and Privacy Authorization Form Do not use this form for consenting research Date: 10/08/2018 participants unless the Johns Hopkins Medicine Principal Investigator: Rebecca Landa, Ph.D., CCC-SLP Logo appears here. Application No.: NA_00066880 Approved October 8, 2018 If you are using Epic for this study, fax a copy of the signed consent form to 410-367-7382. Patient I.D. Plate RESEARCH PARTICIPANT INFORMED CONSENT AND PRIVACY AUTHORIZATION FORM Protocol Title: Validation of a Social, Communication, Interaction, and Play Screener Application No.: NA_00066880 Principal Investigator: Rebecca Landa, Ph.D., CCC-SLP 3901 Greenspring Ave. Baltimore, MD 21211 443-923-7680 443-923-7560 (fax) 1. What you should know about this study: You are being asked to join a research study. This consent form explains the research study and your part in it. Please read it carefully and take as much time as you need. Ask your study doctor or the study team to explain any words or information that you do not understand. You are a volunteer. If you join the study, you can change your mind later. There will be no penalty or loss of benefits if you decide to quit the study. During the study, we will tell you if we learn any new information that might affect whether you wish to continue to participate. When Johns Hopkins is used in this consent form, it includes The Johns Hopkins University, The Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Howard County General Hospital, Johns Hopkins Community Physicians, Suburban Hospital, Sibley Memorial Hospital and All Children’s Hospital. If children and adults can join this study, the word “you” in this consent form will refer to both you and your child. 2. Why is this research being done? This research is being done to test out a new way to identify children with social and/or communication delays, or autism spectrum disorder (hereafter “social-communication delays”). Right now, there are no existing video-guided surveys that are able to predict if children will be diagnosed with a social- communication delay. We are hoping to test a new video-guided survey, called the Social, Communication, Interaction, and Play Screener (SCIPS) to find out if it is able to identify children with social-communication delays. If it is able to correctly identify children as having a social-communication delay, then we hope to make it available for use around the country. Parents of children with and without developmental concerns about their children may join. Page 1 of 5 Combined Informed Consent/Authorization June 2015 Version 15 Do not use this form for consenting research Date: 10/08/2018 participants unless the Johns Hopkins Medicine Principal Investigator: Rebecca Landa, Ph.D., CCC-SLP Logo appears here. Application No.: NA_00066880 Approved October 8, 2018 How many people will be in this study? We hope to enroll around 500 families in this study. 3. What will happen if you join this study? If you agree to be in this study, we will ask you to do the following things: Complete a series of questions about you and your child (i.e. age, race, gender, etc.) followed by questions about any concerns you may have about your child’s development and any history of treatment. These questions will take about 10 minutes to complete. Within 1-2 business days of completing these questions, you will receive a link to a secure website. You will be asked to complete three online developmental screening tools (including the SCIPS). o When completing the SCIPS, you will be asked to watch videos of children with and without social-communication delays, and answer questions about your child’s behavior based on what you see in the videos. o To examine the success of the SCIPS in correctly telling whether a child does or does not have a social-communication delay, we will be comparing the results of the SCIPS to results of two other screeners currently used by clinicians. o All three developmental screeners will take approximately one hour to complete in total. After you complete the online developmental screeners, you will be invited to complete the SCIPS again, one to eight weeks after first completing the first SCIPS, AND receive a follow-up, play- based developmental assessment. o This assessment can be scheduled at Kennedy Krieger Institute, Baltimore Infants and Toddlers Program (BITP), or your child care center. o This assessment will take about 2 hours, including breaks and snacks for your child. o Following completion of this assessment you will receive a report of your child’s development. o If you give permission, we can share and receive information about your child’s screening and assessment results with your child’s provider(s) (e.g., Baltimore Infants and Toddlers Program, pediatrician, etc.). o The assessment will be videotaped so that assessments can be scored at a later time. How long will you be in the study? The online survey portion of the study will last as long as it takes you to complete: (a) the questions about you and your child, (b) the SCIPS, and (c) the comparison screeners (about 1 hour). The second SCIPS, which must be done within 1-8 weeks of completing the first SCIPS, should take approximately 30 minutes to complete. The developmental assessment, which must be done within 1-8 weeks of completing the first SCIPS, will last about 2 hours. 4. What are the risks or discomforts of the study? There are minimal risks or discomforts for this study. Placing your information into a research database is a potential security and privacy risk. All data are stored at Kennedy Krieger Institute in a protected database and we will take every step to minimize risks. There are no known health risks associated with participation. However, there may be some other risks such as: fatigue during the study, discomfort answering personal questions or being videotaped, and time commitment (which may result in missing other commitments). There are no costs for participation. You do not have to answer any questions that you are not comfortable with. You are free to ask questions at any time during the study. Page 2 of 5 Combined Informed Consent/Authorization June 2015 Version 15 Do not use this form for consenting research Date: 10/08/2018 participants unless the Johns Hopkins Medicine Principal Investigator: Rebecca Landa, Ph.D., CCC-SLP Logo appears here. Application No.: NA_00066880 Approved October 8, 2018 5. Are there benefits to being in the study? There are no individual health benefits for participating. This study will provide information about the feasibility of using this screener in real world settings. If you take part in this study, you may help others in the future. 6. What are your options if you do not want to be in the study? You do not have to join this study. If you do not join, your care at Kennedy Krieger Institute and Johns Hopkins will not be affected. 7. Will it cost you anything to be in this study? No. However, you will be responsible for the costs of transportation (to and from the Center, BITP, your child care center, etc.) for the developmental assessment. Parking is free. 8. Will you be paid if you join this study? You will not be compensate monetarily for your participation in this study. 9. Can you leave the study early? You can agree to be in the study now and change your mind later. If you wish to stop, please tell us right away. Leaving this study early will not stop you from getting regular medical care. If you leave the study early, Kennedy Krieger Institute and Johns Hopkins may use or give out your health information that has already been collected if the information is needed for this study or any follow-up activities. 10. How will your privacy be protected? We have rules to protect information about you. Federal and state laws and the federal medical Privacy Rule also protect your privacy. By signing this form you provide your permission, called your “authorization,” for the use and disclosure of information protected by the Privacy Rule. The research team working on the study will collect information about you. This includes things learned from the procedures described in this consent form. The research team will know your identity and that you are in the research study. Other people at Johns Hopkins, particularly your doctors, may also see or give out your information. We make this information available to your doctors for your safety. People outside of Johns Hopkins may need to see or receive your information for this study. Examples include government agencies (such as the Food and Drug Administration), safety monitors, other sites in the study and companies that sponsor the study. If you are in a cancer study that receives federal funding, the National Cancer Institute (NCI) now requires that we report identifiable information (such as, zip code) about your participation. You may contact the NCI if you have questions about how this information is used. We cannot do this study without your authorization to use and give out your information. You do not have to give us this authorization. If you do not, then you may not join this study. We will use and disclose your information only as described in this form and in our Notice of Privacy Practices; however, people outside Johns Hopkins who receive your information may not be covered by this promise or by the federal Privacy Rule. We try to make sure that everyone who needs to see your Page 3 of 5 Combined Informed Consent/Authorization June 2015 Version 15 Do not use this form for consenting research Date: 10/08/2018 participants unless the Johns Hopkins Medicine Principal Investigator: Rebecca Landa, Ph.D., CCC-SLP Logo appears here.
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