Quality of Informed Consent: Measuring Understanding Among Participants in Oncology Clinical Trials

Purpose/Objectives: To describe newly enrolled clinical trial subjects' knowledge and understanding of the oncology clinical trials in which they were participating.

Design: Descriptive, correlational.

Setting: The oncology center of a small community hospital in New England.

Sample: 8 patients who consented to enroll in oncology clinical trials.

Methods: The Quality of Informed Consent questionnaire was sent to 17 potential participants who recently had consented to participate in oncology clinical trials.

Main Research Variables: Knowledge of the basic elements of informed consent and participants' understanding of the clinical trials in which they were enrolled.

Findings: Scores on the Quality of Informed Consent questionnaire indicated that participants had a good overall understanding of the basic elements of informed consent as well as the clinical trials in which they were enrolled. However, half of the sample failed to understand that clinical trial treatment is not standard treatment and may involve additional risk when compared with standard treatment.

Conclusions: The results of this investigation provide valuable feedback regarding participants' understanding of the informed consent process. The Quality of Informed Consent questionnaire may be a useful tool for monitoring the quality of the informed consent process and contributing to patients' understanding of clinical trials and the research process.

Implications for Nursing: The Quality of Informed Consent questionnaire may provide valuable feedback regarding clinical trial participants' understanding of clinical trials and the research process. Individual responses to questions on the questionnaire may be used to aid personalized patient education and validation of the informed consent throughout trial enrollment. Future research efforts need to focus on the development of reliable tools to measure participants' understanding of informed consent and nursing interventions that improve the informed consent process as well as enhance patients' understanding of the research process.