Sepsis Consent

Attachment 23_ Informed Consent IDI-FG Sepsis.docx

CDC/ATSDR Formative Research and Tool Development

Sepsis Consent

OMB: 0920-1154

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Sepsis Campaign – Verbal Consent Script

Consumer Focus Groups and Healthcare Professional Interviews


ICF is conducting digital [interviews, focus groups] with [healthcare professionals, consumers] on behalf of the Centers for Disease Control and Prevention (CDC) to learn about sepsis, infections that lead to sepsis, and response to sepsis campaign messages. [Interview, focus group] findings will inform the development of a CDC antibiotic use communication campaign for [HCPs, consumers]. We expect this [interview, focus group] to take about [60 minutes, 90 minutes].

You are the expert on your experience, and your thoughts and opinions are greatly valued and appreciated. We want to learn from you so I encourage you to speak openly and honestly about your experience. There are no right or wrong answers. Should you agree to participate in the discussion, here are some points you should know:

  • Rights Regarding Participation: This discussion is completely voluntary. You may choose to leave the [interview, focus group] and/or not answer a question at any time for any reason.

  • Privacy: We will take every precaution to protect your identity and ensure your privacy unless otherwise determined by law. We will keep your name and answers to these questions private. Your contact information will be kept separate from any [interview, focus group] responses and your name will never be linked to any responses. We also will never use your name in any reports.

  • Benefits: Your participation in the [interview, focus group] will not result in any direct benefits to you. However, your input will help to develop a communication campaign for antibiotic use.

  • Risks: The [interview, focus group] poses minimal, if any, risks to you. None of the questions are of a sensitive nature, so none of them should make you uneasy.

  • Incentive: In appreciation of your time, the recruiter will send you a gift of [$35 (consumer), $75 (NP/PA; Emergency Department Triage Nurse; General Medical Ward Staff, Nursing Home Staff, and Home Healthcare Provider), $125 (physician)] for participating in today’s [interview, focus group].

  • Audiotaping: The discussion will be audio-recorded. Again, no quotes or comments you make would be linked with your name in any way. We will take notes throughout our [interview, focus group] today to help us keep track of your responses. These notes will be destroyed upon conclusion of the project. We will keep all information, notes, and audiotapes locked in a file cabinet or a secure computer file. Only study staff will be able to access the information. Please let the moderator know if you do not want the [interview, focus group] recorded and we will take notes only. Do we have your permission to record the [interview, focus group]?

  • Observers: Individuals from CDC will be observing this [interview, focus group] silently. They will not participate in the discussion. All observers have signed confidentiality forms stating that they will not discuss the specifics of the [interview, focus group].

  • Questions: We will answer any questions you have about this [interview, focus group] discussion before you take part. You will receive [$35, $75, $125] for your participation in this [interview, focus group].

  • Contact Information: If you have any questions about this discussion or the communication campaign, please contact the Research Director, Ashani Johnson-Turbes, PhD, at 404-321-3211.

Do you consent to participate in the [interview, focus group]? Yes No

Do you agree to be audiotaped? Yes No

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