Case Study Interview Consent Title of Project: CVRT Integration Model
Principal Investigator: Lisa Allee! !
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Background
This study will interview former patients of VIAP (Violence Intervention Advocacy Program) and CVRT (Community Violence Response Team) about their experience with the programs. Community advocates and mental health professionals at Boston Medical Center collaborate to make it easy for patients to make the most of these two programs.
We want to better understand patients’ experience with the newer mental health program, CVRT. We also want to evaluate patients’ experience of the collaboration between the two programs. In this study we will conduct individual interviews with patients who worked with VIAP and CVRT counselors for two months or longer. We want to get feedback on what it is like for patients to work with these programs. We will use the results of this study to improve our programs for future patients and also to help other programs improve their services to help people who have experienced interpersonal violence.
Purpose
The purpose of this study is to interview former patients of the VIAP and CVRT programs to find trends in what patients think are the strengths of our model, and any areas we might be able to improve for future patients. We also hope that a formal description and analysis of our model can help other trauma centers adapt similar programs to serve their patient populations.
What Happens In This Research Study
You will be one of approximately 4 subjects to be asked to participate in this study. The research will take place at the following location(s): Boston Medical Center. After you review the information in this document, and if you agree to participate in the
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RESEARCH CONSENT FORM
Case Study Interview Consent Title of Project: CVRT Integration Model
Principal Investigator: Lisa Allee! !
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research study, we will conduct an interview with you.
The interviewer will first describe the study to you. You should ask any questions you have to make sure you understand the study and so that you can decide whether or not you want to participate. If you decide to participate, we will start the anonymous recorded interview after we finish the consent process.
The interview will last 45 to 90 minutes. At the end of the interview, you will receive a $25 gift card to Target.
If talking about your injuries and recovery process is upsetting for you, we have a social worker on call who will talk to you. If you are having an emotional response to the interview, the interviewer may ask the social worker to come in to help you. You may ask to speak with the social worker after the interview, or may call CVRT to talk to a counselor in the days following the interview.
The interviewer will transcribe the audio recording of the interview after it concludes. She will change any names used to protect your privacy. Another investigator will check the written transcription for accuracy, and then your voice recording will be deleted. The study investigators will assess all of the interview transcriptions to look for trends in patients’ experience of CVRT and VIAP. The investigators will write up the results of their analysis, and may change violence intervention programming based on what they find from the interview data.
Risks and Discomforts
It is possible that you may experience an emotional reaction to discussing your injury and recovery. These feelings might be uncomfortable for you. The only inconvenience due to your participation in this study is taking the time to travel to and participate in the interview. If you do feel uncomfortable, you may stop your participation in this study at any point. You may ask to speak with a social worker at any time.
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RESEARCH CONSENT FORM
Case Study Interview Consent Title of Project: CVRT Integration Model
Principal Investigator: Lisa Allee! !
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participation in this study, the investigators are required to report this information. Everything you say that is unrelated to harming someone would remain confidential. If this happens, the research assistant will report the incident to the lead study investigator and notify the social worker on call. The social worker will speak with you, and may bring you to the Emergency Department for evaluation, for your own safety. Any statements of intention to harm someone else will be reported to the police as required by law.
There may be unknown risks/discomforts involved. Study staff will update you in a timely way on any new information that may affect your health, welfare, or decision to stay in this study.
Potential Benefits
You will receive no direct health benefit from your participation in this study. It is possible that you may feel better by discussing your recovery and experience with our violence intervention programs. You are free to tell your story in any way that you would like. Your participation will help the investigators better understand the current model for violence intervention programs at Boston Medical Center.
Alternatives
Your alternative is not to participate in the study.
Subject Costs and Payments
There are no costs to you for participating in this research study. You will be compensated with a $25 gift card to participate in this research study.
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RESEARCH CONSENT FORM
Case Study Interview Consent Title of Project: CVRT Integration Model
Principal Investigator: Lisa Allee! !
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Confidentiality
Information from this study and from your medical record may be reviewed and photocopied by the Food and Drug Administration (FDA) and/or state and federal regulatory agencies such as the Office of Human Research Protection as applicable, and the Institutional Review Board of Boston University Medical Center. Information from this study may be used for research purposes and may be published; however, your name will not be used in any publications.
Your identity will be protected at all times. We will use first names only during the interview. After the interview, study investigators will transcribe the voice recording into words, and then the voice recording will be destroyed. The interview transcriptions and any other study documents will have your subject number as identification, but they will not have your full name or any medical information on them. Only the members of CVRT who do preliminary subject screening will know who is being included in this study. These members already had access to this information as part of their jobs as counselors for CVRT. The interviewer will not know anything about you or your medical record before the interview. Names will be changed in any publications. We will keep transcriptions of the interviews for 5 years after the end of the study.
Subject's Rights
By consenting to participate in this study you do not waive any of your legal rights. Giving consent means that you have heard or read the information about this study and that you agree to participate. You will be given a copy of this form to keep. If at any time you withdraw from this study you will not suffer any penalty or lose any benefits to which you are entitled.
You may obtain further information about your rights as a research subject by calling the Office of the Institutional Review Board of Boston University Medical Center at 617-638-7207. If this study is being done outside the United States, you can ask the investigator for contact information for the local Ethics Board.
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RESEARCH CONSENT FORM
Case Study Interview Consent Title of Project: CVRT Integration Model
Principal Investigator: Lisa Allee! !
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The investigator or a member of the research team will try to answer all of your questions. If you have questions or concerns at any time, or if you need to report an injury while participating in this research, contact Lisa Alleeat 617-414-8007 during the day. After hours, call 911 or report to the nearest Emergency Department with serious or life-threatening injuries.
Right to Refuse or Withdraw
Taking part in this study is voluntary. You have the right to refuse to take part in this study. If you decide to be in the study and then change your mind, you can withdraw from the research. Your participation is completely up to you. Your decision will not affect your being able to get health care at this institution or payment for your health care. It will not affect your enrollment in any health plan or benefits you can get. If you choose to take part, you have the right to stop at any time. If there are any new findings during the study that may affect whether you want to continue to take part, you will be told about them as soon as possible.
The investigator may decide to discontinue your participation without your permission because he/she may decide that staying in the study will be bad for you, or the sponsor may stop the study.
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RESEARCH CONSENT FORM
Case Study Interview Consent Title of Project: CVRT Integration Model
Principal Investigator: Lisa Allee! !
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Signing this consent form indicates that you have read this consent form (or have had it read to you), that your questions have been answered to your satisfaction, and that you voluntarily agree to participate in this research study. You will receive a copy of this signed consent form.
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Subject (Signature and Printed Name) Date
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