Controlled Human Inhalation-Exposure Studies at EPA (2017) / Chapter Skim
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7 Communication about Informed Consent in Controlled Human Inhalation Exposure Studies
7 Communication about Informed Consent in Controlled Human Inhalation Exposure Studies
Pages 87-94
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From page 87... ...
This chapter expands upon Chapter 6, and focuses specifically on the communication of risk to study participants through the informed-consent process. It also provides recommendations regarding the content of consent documents and the assessment of participants' understanding of informed consent.
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From page 88... ...
The following sections describing risks and benefits are critical to this chapter's focus on communication, given the importance of clear communication of potential risks and benefits during the disclosure process element of informed consent for the CHIE studies. Risks Risk characterizations are an especially important part of disclosure to potential participants.
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From page 89... ...
Even though societal benefits provide the overriding ethical justification for EPA studies, potential volunteers typically see benefits accruing to them personally as relevant to their decision to participate. Personal Benefits Medical benefits to research participants: Multiple studies have shown that research participants, especially those who are ill, typically overestimate the potential for direct medical benefits for themselves from participation.
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From page 90... ...
for whom monetary rewards could alter their judgments about risks. RESEARCHER COMMUNICATION AND PARTICIPANT UNDERSTANDING OF INFORMED CONSENT Risk Perception and Risk Communication Risk perception is a subjective assessment by a person based on his or her beliefs regarding the probability of a potential hazardous event or activity and how it will affect him or her.
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From page 91... ...
. A review of 44 intervention studies using strategies for improving comprehension of informed consent demonstrated that interventions providing additional written information (such as information specific to a procedure or brief information booklet in addition to the written consent form)
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From page 92... ...
Additional tools and approaches for ensuring participants' understanding of research protocols that could improve EPA's checklist method are described here. Ensuring participants have answers to key questions: The Institute of Medicine workshop and report on informed consent and health literacy included presentation of a curriculum for community members making decisions regarding research participation (IOM, 2015)
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From page 93... ...
. Using teach-to-goal methodology in the review of the research consent process has demonstrated significant improvements in comprehension by individuals from diverse backgrounds and with lower literacy levels (Kripalani et al., 2008; Sudore et al., 2006)
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From page 94... ...
To improve the way it ensures participants' understanding of research protocols, EPA should modify the current informed-consent checklist to involve a more in-depth assessment of participant comprehension of risks of participation and societal benefits accrued by these studies. The agency should use tools and approaches described in this chapter, including the following: Asking participants specific questions about the study to ensure understanding of consent form, Using teach-back methods with participants during the consent process, and Continuing to provide participants with the opportunity to ask questions.
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