Informed Consent

Attachment B: Focus Group Informed Consent Form

PARTICIPANT INFORMATION SHEET & INFORMED CONSENT FORM

This informed consent form is for participants recruited from the general U.S. population who we are inviting to participate in a project regarding public health communication focused on antimicrobial resistance (antibiotic- and antifungal-resistance).

Principal Investigator: Carolyn Kopf

Organization: C.E.K. & Partners

Contributors: Penny McMillan-Hughes, MPH & Emmase Adams, PhD 

Organization: CATMEDIA

Sponsor: Centers for Disease Control and Prevention, Antimicrobial Resistance Coordination & Strategy Unit

This document has two parts:

• Participant Information Sheet (to share information about the study with you)

• Informed Consent Form (for electronic signatures if you choose to participate)

You will be given a copy of the full Informed Consent Form.

Part I: Participant Information Sheet

Introduction

My name is ___________, and I am a recruiter from [insert panel provider name] contacting you about a study on antimicrobial resistance and how to effectively communicate health messages involving this important public health topic. I am working on behalf of C.E.K. & Partners, a marketing and research firm located in Atlanta, GA. This study is being conducted by CATMEDIA, a Program Management and Creative Services firm in Tucker, GA, on behalf of Centers for Disease Control and Prevention (CDC). You are invited to participate in this study regarding general knowledge and health communication messages for antimicrobial resistance.

Participation is completely voluntary, and you will be given time to decide whether to participate or not.

If you are unable to read and understand text presented digitally on a device screen –

whether it is a tablet, laptop, or smart phone, or desktop computer – you will be required to have an assistant join you during the discussion session to help you read the content of the materials presented.

Purpose of the Project

We are seeking to learn about your experiences, understanding and feedback on potential health communications regarding antimicrobial resistance related to infections/diseases.

Type of Intervention

This project will be comprised of two different approaches (focus groups or one-on-one interviews). These approaches will use a virtual meeting tool with both audio and video capabilities enabled by you as the participant.

We are only asking for your participation in [select one]:

• Virtual focus groups that will take up to one hour

• Virtual one-on-one interview that will take up to 30 minutes

Participant Selection

You have been chosen randomly to participate in this project based on your age category.

Voluntary Participation

Your participation in this study is completely voluntary. You can change your mind and decide not to participate at any time, even after you have provided your consent to participate and/or have started your interview.

Procedures

We are asking you to help us learn more about your understanding of antimicrobial resistance and respond to public health communications about it. This project will consist of your participation in a virtual session using a video teleconferencing platform.

If you choose to accept our invitation to participate in this project, you will be asked to perform a 15-minute technology check one-two days prior to your scheduled interview. During this meeting we will ask you to use the same device you would for your session. We will ask a few questions to simply ensure you’re set up and able to easily access and use Zoom. On the day of your scheduled research session, at your designated time, after check-in and introductions, the focus group will last approximately 60 minutes, or the in-depth interview will last 30 minutes.

• In the interview, a moderator from the C.E.K. & Partners’ team will ask you a series of questions based on your experiences and understanding as it relates to antimicrobial resistance. We will also ask you to review public health communication materials and messages. You will then be guided through a set of questions asking you to give your opinion and feedback on those materials and messages. After a brief check-out, the interview will be complete.

This interview may involve sensitive subject matter. It is important that you have a computer, tablet, or personal smart mobile device that you can access via a private and quiet space during the entirety of the interview, as well as a strong and reliable internet connection. If you do not wish to answer any of the questions during the discussion, you may simply ask the interviewer to move on to the next question. The information recorded is confidential, and no one else except C.E.K. & Partners and the CATMEDIA project teams will have access to the information documented during your interview. The entire interview will be video and audio-recorded, but no one will be identified by name on the recording. After transcription, the research team at CATMEDIA will remove any possible identifying information, such as your name, that could link you to this study from the files. We will then review and analyze your responses and present our summary findings to CDC.

Risks

We anticipate no risk to you. However, considering the potentially sensitive nature of the study, you may feel uncomfortable discussing some of the subject matter. You do not have to answer any question or take part in the discussion/interview if you do not wish to do so. You also do not have to provide a reason for not responding to any question, or for refusing to take part or to continue in the discussion/interview. This project has been reviewed by an institutional review board (IRB), which is a committee that reviews research studies to help ensure that the rights and welfare of research participants are protected. This also includes making sure that this project is conducted in an ethical manner.

Confidentiality

Our project team will maintain the confidentiality of data with respect to both information about you and the information you share. Although C.E.K. & Partners and CATMEDIA will take every precaution to protect your identity, we must acknowledge the existence of cybercrime and the potential for a data breach. If a data breach were to occur, you would be notified in writing and all possible attempts would be made to recover the data and ensure your confidentiality.

Sharing the Results

The knowledge that we gain from this study will be presented to CDC to inform development of public health communication materials to increase awareness and understanding of antimicrobial resistance, as well as to reduce the number of new cases of antimicrobial-resistant infections.

Who to Contact

If you have any questions or concerns now or in the future, you may contact Carolyn Kopf at 404.345.6447 or [email protected].

Form Approved

OMB Control No.: 0920-1154

Expiration date: 03/31/2026

INFORMED CONSENT FORM (Focus Group)

Part II: Informed Consent Form

I have been invited to participate in a project about antimicrobial resistance and related public health communication materials. I acknowledge that a video/audio-recording of my interview is required to participate.

I have read, or someone has read to me, the foregoing information. I have had the opportunity to ask questions about it. Any questions regarding any part of the project have been answered to my satisfaction. I consent voluntarily to be a participant in this project.

PLEASE CHECK ONE OF THE BOXES AND TYPE YOUR NAME AND DATE BELOW.

Yes, I agree to participate in this project. By checking this box, I acknowledge that my typed named below will serve as my electronic signature. By typing my name and entering the date, I am electronically signing this consent form. I may also print out this form and sign on the signature line, scan, and email the document to [insert here].

To thank you for your time, you will be provided with $125.00 as a token of appreciation for your time and participation in the form of a prepaid gift card.

No, I do not agree to participate in this project.

Print Name (electronic signature) of Participant___________________________

Date ___________________________

Day/month/year

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Public reporting burden of this collection of information is estimated to average 60 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.  An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB Control Number.  Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30333; ATTN: PRA 0920-1154

Statement by the project lead/person taking consent

I confirm that the participant was given an opportunity to ask questions about the project, and all the questions asked by the participant have been answered correctly and to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.

A copy of this Informed Consent Form has been provided to the participant.

Print Name (electronic signature) of person taking the consent________________________

Date ___________________________

Day/month/year