Short Title: Alternate Consent Process Testing an Alternate Informed Consent Process

1 Background: One of the main problems in conducting clinical trials is a low participation rate 2 due to potential participants’ misunderstanding of the rationale for the clinical trial or 3 perceptions of loss of control over treatment decisions. 4 Objectives: The purpose of this study was to test an alternate informed consent process in 5 cardiac rehabilitation participants that involved the use of a multimedia flip chart to describe a 6 future randomized clinical trial and then asked, hypothetically, if they would participate in the 7 future trial. 8 Method: An attractive and inviting visual presentation of the study was created in the form of a 9 23-page flip chart that included 24 color photographs displaying information about the purpose 10 of the study, similarities and differences between the two treatment groups, and the data 11 collection process. We tested the flip chart in 35 cardiac rehabilitation participants. Subjects 12 were asked if they would participate in this future study on two occasions: immediately after the 13 description of the flip chart and 24 hours later, after reading through the informed consent 14 document. Subjects were also asked their perceptions of the flip chart and consent process. 15 Results: Of the 35 subjects surveyed, 19 (54%) indicated that they would participate in the 16 future study. No subject changed his/her decision 24 hours later after reading the full consent 17 form. The participation rate improved 145% over an earlier feasibility study where the 18 recruitment rate was 22%. Participants overwhelmingly stated that the flip chart was helpful and 19 informative and that the photographs were effective in communicating the purpose of the study. 20 Discussion: Participation rates could be enhanced in future clinical trials by using a visual 21 presentation to explain and describe the study as part of the informed consent process. More 22 research is needed to test alternate methods of obtaining informed consent. 23 * Manuscript (Including Abstract, References and Figure Legends)