Consent

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Formative Research and Tool Development

Consent

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Attachment 1 Informed Consent


Informed Consent for GC Case Interview: Staff Interviews


If participant answers final question ‘YES,’ continue with interview.


Introduction: Hello, my name is _______, and I am an evaluator at the Centers for Disease Control and Prevention in Atlanta, Georgia. This health department participates in the STD Surveillance Network, also known as SSuN, which is an important project for the CDC’s work with STD surveillance. Currently, SSuN conducts random sample gonorrhea (GC) case interviews to obtain additional demographic and behavioral information that helps us better understand the epidemiology of STDs and inform STD prevention efforts. We are grateful for your health department’s ongoing contribution to this important initiative.


Purpose: We would like to get a better understanding of GC case interview practices in the SSuN health departments. We would like to discuss your department’s GC case interview protocols and practices because of your role at the health department. We believe you may be able to help us better understand the context and what might help explain the current GC case interview completion rates, particularly the related barriers to and facilitators for interviewing GC cases. This is not related to any performance evaluation of the program, department, you or anyone else.


If you agree to participate in the interview, I will ask you basic questions about your work on the SSuN project and about your processes for GC case interviewing. I will ask your opinion about GC case interviewing and the community context from which cases are sampled. The interview will take about 60 minutes to complete. I will be taking notes. I will use a recorder so that I have a more complete record of the interview and to help me ensure my notes are accurate.


Voluntary participation: Your participation is completely voluntary. Your supervisor will not know if you choose to participate or not. You may ask to turn the recorder off or you can tell me to stop the interview at any time if you do not want to continue. If there are questions you prefer not to answer, you do not have to answer them.


Benefits, risks, and confidentiality: There will be no money given to you for taking part in this interview. Participating in this interview will not help you directly, but it may help us to better understand variation in GC case interviewing completion rates across SSuN sites. Please share your true feelings about this issue. I will not record your name and anything you say to me during this interview will be confidential and will not be shared with other staff or supervisors. We will analyze and report the information from all of the interviews together. I will not use your name when discussing your responses with others. The information you give us will be stored securely and will only be available to members of my study team. The recording will be erased as soon as the interview notes are typed up. At the end of the interview you will be able to ask any questions that are of interest to you.


You may contact the investigators for this study, Brandy Maddox via telephone at: (404) 639-8511 or Emily Hays, at: (404) 718-7337 if you have any questions about the study or if you would like to withdraw your answers. If you have any questions about your rights as a participant in this assessment, please contact CDC/ATSDR’s Acting 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.




Informed Consent:

Do you have any questions? Yes No


Would you like to participate in this interview? Yes No



Participant ID: __________________________________


Participant Signature: _______________________________________


Investigator's statement


I, the undersigned, have defined and explained to the volunteer in a language he/she understands, the procedures of this study, its aims and the risks and benefits associated with his/her participation. I have informed the volunteer that confidentiality will be preserved, that he/she is free to withdraw from the interview at any time without affecting their employment status at the clinic. Following my definitions and explanations the volunteer agrees to participate in this interview.




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Date Name of investigator who gave information about the study



















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File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorHays, Emily (CDC/DDID/NCHHSTP/DSTDP)
File Modified0000-00-00
File Created2021-01-15

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