Consent Management - SAM

Principal Investigator (phone) John Pestian, PhD (513-636-0469) / Study Coordinator, Lesley Rohlfs, MS, (513-636-0469)

INTRODUCTION

We are asking your permission for your child to participate in a research study sponsored by Cincinnati Children’s Hospital Medical Center (CCHMC). Only you can choose if your child will be in this study. We want to see if a smartphone app called SAM can identify suicidal language in school aged children. You can see a video of SAM at pestianlab.cchmc.org. If SAM works, it can help find suicidal students sooner. Your child may be in the study if they come to a school counselor or therapist (care provider) for any reason. If it’s okay with you, SAM may be used when your child is visiting the school healthcare provider. If you do not want your child to participate do not sign or return this consent. Nothing will be different in your child’s care or education. There is no cost or payment for your child’s participation in this study.

WHO IS IN CHARGE OF THE RESEARCH?

Dr. John Pestian is the researcher at CCHMC in charge of this study. He has conducted nearly 10 years of research on this topic. Lesley Rohlfs, MS is the study coordinator.

WHAT WILL HAPPEN DURING THE STUDY?

SAM will listen to your child’s conversation to show if their language is similar to suicidal language previously collected. Sometimes, the student will meet with the care provider who uses the SAM. If the words match the interviews from suicidal individuals in earlier studies, the care provider may be alerted to make a referral to you and CCHMC. If a referral is made to CCHMC’s emergency department, we may obtain CCHMC medical records as part of our research. Your child can be in the study multiple times. If your child visits a care provider more than once during the study, your child will be asked at each visit if it is okay to record the conversation. Your child can change his or her mind at any time.

WHAT ARE THE GOOD OR BAD THINGS THAT CAN HAPPEN?

Data from this study will help with earlier identification of suicidal behavior. We don’t know of any bad things.

HOW WILL INFORMATION ABOUT YOUR CHILD BE KEPT PRIVATE?

Your child’s name will never be used on study material. Instead a study number will be assigned to your child. This number will be used to label all data. Any Information gathered will be stored on a secure computer. Data used for analysis, will be sent to CCHMC through a secure encrypted internet connection.

WHAT IF WE LEARN NEW INFORMATION DURING THE RESEARCH?

The care provider or study investigator will tell you if they find out about new information that may impact your child’s health, safety or your willingness for your child to stay in this study.

WHAT HAPPENS IF YOUR CHILD IS INJURED FROM BEING IN THIS STUDY?

If the injury is serious, take your child to CCHMC emergency department or any other emergency department. Give a copy of this consent to the hospital personnel. Decision about compensation for the medical treatment of physical injuries that happened during research are made individually. Otherwise, contact Dr. John Pestian at 513-636-0469 –or- john.pestian@cchmc.org

WHO DO YOU CALL IF YOU HAVE QUESTIONS OR PROBLEMS?

If you would like to talk to someone that is not part of the research staff or if you have general questions about your research study rights or questions, concerns, or complaints about the research, you can call the CCHMC Institutional Review Board at 513-636-8039

AUTHORIZATION FOR USE/DISCLOSURE OF HEALTH INFORMATION FOR RESEARCH

To be in this research study you must also give your permission to use and share your child’s “protected health information” (called PHI for short).

What protected health information will be used and shared during this study?

CCHMC will need to use and share your child’s PHI as part of this study. This PHI will come from, but not limited to, your child’s CCHMC medical records, and if they exist, mental health records and research records.

WHO WILL SHARE, RECEIVE AND/OR USE YOUR CHILD’S PROTECTED HEALTH INFORMATION IN THIS STUDY?

Study staff at CCHMC, personnel who provide services to your child as part of this study, other individuals and organizations that need to use your child’s PHI in connection with the research, including people at the sponsor and organizations that the sponsor may use to oversee or conduct the study.

CAN YOU CHANGE YOUR MIND?

You may choose to withdraw your permission and data use at any time. If you wish to withdraw you need to notify the study doctor, listed on the first page of this document, in writing. Your request will be effective immediately and no new PHI about your child will be used or shared. The only exceptions are (1) any use or sharing of PHI that has already occurred or was in process prior to you withdrawing your permission and (2) any use or sharing that is needed to maintain the integrity of the research.

Will this permission expire?

Your permission will expire at the end of the study. If the study involves the creation or maintenance of a research database repository, this authorization will not expire.

Will your child’s other medical care be impacted?

By consenting you agree for your child to participate in this research study and give permission to CCHMC to use and share your child’s PHI for the purpose of this research study. If you refuse to consent, your child will not be able to participate in the study. However, your child’s rights concerning treatment not related to this study, payment for services, enrollment in a health plan or eligibility of benefits will not be affected.

SIGNATURES

By signing you are consenting for your child to participate in this research study and give permission to CCHMC to use and share your child’s PHI for the purpose of this research study. If you agree to have your child participate please print your child’s name on the line provided below, both you and your child sign and date.