Enhancing Procedures for Informed Consent (epic) Study

Introduction

Informed consent is an important of research with human participants. Historically, deception was common practice. Through extensive litigation, the rights of human participants in research have grown. This study is evaluating a technology-mediated method of informed consent. The project is part of the Healing and Empowering Alaskan Lives Towards Healthy-Hearts (HEALTHH, IRB number: 598463-2) study; a video telemedicine intervention to improve heart health for Alaska Native (AN) People in rural Alaska. AN People have endured attempted cultural, physical, and social genocide. In addition, unethical research practices with AN People are well documented. Due to the problematic history of unethical research, historical trauma, and intrusion of a western worldview, it is a reasonable concern that AN People may be a vulnerable research population. This, coupled with additional concerns presented by telehealth delivery, highlights the need for researchers to ensure that truly informed consent is obtained from AN People.

Methods

A multimedia enhanced form of the consent process may provide a better understanding of the elements of the study and allow participants to be more thoroughly informed when choosing if they wish to take part in studies. This project created a 9-minute animated video version of the consent form to enhance the informed consent process. The information presented as a hypothetical patient joining the study and going through study activities. Half of the participants the standard paper-based consent while the other received the addition of the video. Immediately after, a brief survey and the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) were administered. The MacCAT-CR is an adaptable capacity assessment that measures understanding, appreciation, reasoning, and the ability to express a choice. It provides an overall score which can be used for comparisons.

Results

Preliminary data were gathered from N=17 AN People (8 men, 9 women) with an age range of 32 to 64 (M=52 SD=10.5). The MacCAT-CR scores for the intervention group (M = 27, SD = 4) were significantly higher (better) than the control group (M=18, SD=9); t(15) = 2.66, p = 0.018, demonstrating better comprehension and ability to express a choice.

Conclusions

Results indicate participants appear to better understand the study and may be able to give a more informed consent than with the standard process. Our video enhancement to the informed consent process is a useful prototype with large effects and applicability to a variety of health-related research projects.

Study funding: NHLBI Diversity Supplemnt Award to Grant #3R01HL117736