The funded R21 project is developing and testing the feasibility of implementing and measuring two novel and simple means of improving informed consent in the context of five ongoing Johns Hopkins (JHMI) clinical trials. Previous studies designed to improve informed consent have focused significantly on consent forms, and have generally tested interventions in simulated rather than actual trial settings. That is, most interventional informed consent research has asked healthy study subjects to imagine entering a trial and then compared the effectiveness of different consent approaches among subjects who are simulating trial enrollment.
Our funded R21 is developing two modified, simplified approaches to informed consent, and testing them within five ongoing actual clinical trials. Specifically, the R21has three aims:
1) to develop both simple and easily replicated a) modifications to informed consent forms, and b) modifications to informed consent procedures designed to improve subjects’ understanding of clinical research;
2) to develop a Consent Understanding Evaluation (CUE) survey tool to assess how well subjects understand clinical trials into which they are recruited under standard vs. enhanced consent conditions;
3) to conduct a pilot randomized trial of standard vs. modified consent approaches in five ongoing JHMI clinical trials. This trial is designed to determine feasibility of all methods, forms, assessments, and collaborative relationships in preparation for the submission of an R01 proposal for a large, multicenter randomized trial comparing patient-subjects’ understanding and satisfaction of standard vs. simplified approaches for informed consent.