SSP Study
Consent to be a Research Subject: Staff and Community Stakeholders
Title
Syringe Service Programs’ (SSP) User Experiences with HIV/HCV/HBV Prevention, Testing and Linkage to Care and Treatment
The Centers for Disease Control and Prevention, with Research Support Services, Inc., IMPAQ International, LLC, and Emory University, is asking you to join a study to talk about your experiences with syringe service/exchange programs. This form tells you what you need to know before you decide if you want to be in the study. It is up to you if you want to be in this study or not. The results will help improve services for people who use syringe service programs.
Before making your decision:
Please carefully read this form, or have it read to you.
Please ask questions about anything that is not clear.
The purpose of this study is to look at HIV and viral hepatitis services at syringe service programs (SSPs). We will interview 60 clients, staff, and community stakeholders about programs that serve rural areas in North Carolina, West Virginia, and Kentucky. The study will help us understand the role SSPs play in offering HIV and viral hepatitis services to people who live in rural areas.
If you decide to be in the study, you will be asked to take part in a face-to-face interview. The interview will last about 1 hour. During the interview, we will ask you about your experiences and thoughts about the services offered by SSPs, about HIV and viral hepatitis services, and about the needs of people who inject drugs. The interview will be recorded, and the interviewer may take notes.
Benefits & Risks
There are no direct benefits to you for taking part in this study. You may enjoy knowing that what you say may be used to help others in the future.
There is no risk we know about if you take part in this study. Some of the questions might make you feel uncomfortable. You do not have to answer any questions that make you feel uneasy. If something comes up that you want to know more about or you think you need help with – like depression – we will provide a list of places that can help you.
The greatest risk to you is if your private information gets out. To prevent this from happening, we will assign you a study identification number. We will use this number, instead of your name on all study forms, except the Contact Form. The Contact Form links your name to your study identification number. This form is kept in a locked file cabinet when not used to schedule your interview or to remind you of your interview time. This form will be destroyed at the end of the study.
Token of Appreciation
You will receive $40 as a token of appreciation for participating in this study. There are no costs to you for participating in this study.
We will do everything we can to protect your privacy to the extent we are allowed by law. Your name will not be used on any study forms except the Contact Form and this Informed Consent Form, which will be kept secure and separate from your interview transcript and other study documents. All forms and audio recordings will be kept in a locked file cabinet in a secure place. When the interview is over, the audio recording will be transcribed. During transcription, we will remove any mention of your name, the names of other people, places or addresses, or anything that could identify you or those you discuss. At the end of the study, we will destroy the audio recording of your interview. The transcript of your interview will be kept on a secure computer in a password-protected file, and only authorized study staff will have access to your information. Your name and other facts that might point to you will not appear when we present this study or publish its results.
This study has been given a Certificate of Confidentiality. This means, anything you tell us will not be shared with anyone, even if a court orders us, unless you say it is okay to share the information. But under the law, we must report to the proper authorities if you tell us you are planning to cause serious harm to yourself or others.
If you have any questions about this study or if you feel you have been harmed, please call Dr. Paula Frew at 404-712-8546. If you have any questions about your rights as a participant in this study, please contact CDC/ATSDR’s Deputy Associate Director for Science at 1-800-584-8814. Leave a message with your name, phone number, and refer to CDC protocol # ____, and someone will call you back.
You have the right to leave the study at any time without penalty. Your participation is voluntary. It is totally up to you to be in this study. You can stop being in the study at any time. You may refuse to answer any questions that you do not wish to answer. Participating in this study will not affect your work with the SSP, as no information will be given to the program staff or supervisors about your screening or enrollment in our study. We may ask you to stop being in the study at any time if we decide that participation is not in your best interest. If we think that you are not following study instructions, or having trouble with the interview, we might ask you to stop participating in this study.
We will give you a copy of this consent form to keep.
Please, print your name and sign below if you agree to be in this study. By signing this consent form, you will not give up any of your legal rights. We will give you a copy of the signed consent, to keep.
Name of Subject
Signature of Subject Date Time
Signature of Person Conducting Informed Consent Discussion Date Time
Page 3 of 3 Version Date: 6/28/2018
IRB Form xxxx
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Laura Randall |
| File Modified | 0000-00-00 |
| File Created | 2021-01-13 |