IRB Review

10/6/2017

IRB expedited review: Sepsis educational awareness message/materials assessment (162961)

The IRB conducted an expedited review of this task.

Project Description

The purpose of this research is to understand how CDC’s sepsis educational effort messages/materials are perceived by target audiences, and if educational effort messages/materials are thought to have the desired effect on expected outcomes. This study will explore if/how the Get Ahead of Sepsis (GAOS) educational effort contributes to CDC-specified target audiences’ (healthcare professionals and consumers age 18 or older) awareness, knowledge, perceived susceptibility to sepsis, perceived severity of sepsis, self-efficacy, response efficacy, and behavioral intentions.

The study uses a QED one-group retrospective – retrospective post then pre – design. This will be administered through a single survey. Respondents will be asked about exposure to messages and exposed respondents will be asked additional questions; all respondents will be asked additional questions after viewing the messages.

Participants will be selected through a recruiting firm, possibly supplemented by additional respondents identified by partner organizations and online advertising. The total target sample size is about 1800 each in the exposed and not exposed categories. Participants will be screened by the recruiting firm and given an incentive in the form of points. The study also is under review by OMB.

The survey focuses on measuring exposure to the educational effort and respondents’ perceived effectiveness of messages/materials, changes in knowledge, beliefs about susceptibility to sepsis, beliefs about the severity of sepsis, self-efficacy, response efficacy and behavioral intentions related to GAOS exposure. This survey does not gather any PII or sensitive information.

Questions/Issues

Since no PII is collected, this does not require IRB review. It is determined to be exempt under 45 CFR 46.101(b)(2).

One question, though not really an IRB question – why do you ask birth and current gender identity? Does not seem to be obviously related to sepsis or response to educational materials about sepsis. Other demographic questions (age, race) make sense.

Note to the Project Director: Please use tracked changes when making revisions, or some other form that makes your revisions easily identified. Please let us know if you think any suggested changes to the study procedures would adversely affect the study. The IRB needs to take such concerns into consideration before making final decisions.

Waiver of written consent?

☐Waiver approved

IRB Review conducted by Janet Griffith