Measuring the process and quality of informed consent for clinical research: development and testing.

Purpose/objectives: To develop and assess the reliability and validity of an observational instrument, the Process and Quality of Informed Consent (P-QIC).

Design: A pilot study of the psychometrics of a tool designed to measure the quality and process of the informed consent encounter in clinical research. The study used professionally filmed, simulated consent encounters designed to vary in process and quality.

Setting: A major urban teaching hospital in the northeastern region of the United States.

Sample: 63 students enrolled in health-related programs participated in psychometric testing, 16 students participated in test-retest reliability, and 5 investigator-participant dyads were observed for the actual consent encounters.

Methods: For reliability and validity testing, students watched and rated videotaped simulations of four consent encounters intentionally varied in process and content and rated them with the proposed instrument. Test-retest reliability was established by raters watching the videotaped simulations twice. Inter-rater reliability was demonstrated by two simultaneous but independent raters observing an actual consent encounter.

Main Research Variables: The essential elements of information and communication for informed consent.

Findings: The initial testing of the P-QIC demonstrated reliable and valid psychometric properties in both the simulated standardized consent encounters and actual consent encounters in the hospital setting.

Conclusions: The P-QIC is an easy-to-use observational tool that provides a quick assessment of the areas of strength and areas that need improvement in a consent encounter. It can be used in the initial trainings of new investigators or consent administrators and in ongoing programs of improvement for informed consent.

Implications For Nursing: The development of a validated observational instrument will allow investigators to assess the consent process more accurately and evaluate strategies designed to improve it.