Research Nurses' Attitudes and Practices Regarding Communication of Risks and Benefits During the Research Informed Consent Proces

Many studies show that research participants frequently do not fully comprehend information regarding risks and benefits (R&B) associated with clinical trials even though this is a fundamental component of the research informed consent (IC) process, required by ethical and regulatory guidelines. Research nurses often take an active role in obtaining IC while explaining study details and verifying potential participants' understanding. Although there are published recommended strategies to enhance the IC communication process, particularly for R&B communication, there is a paucity of research focused on research nurses' perspectives about the process. This study addresses this gap in the literature and provides comprehensive empirical data on research nurses' attitudes and practices related to R&B communication in the informed consent process. Using a two-phase exploratory mixed methodology design, an online survey tool was developed and administered to a national sample of 107 research nurses having experience in obtaining IC for clinical trials. Variations in the research nurses' attitudes, preparedness, and practices related to R&B communication were identified. Recommendations directed at strengthening the IC process are suggested.