Ethics of Informed Consent
Multiple studies have reported that biobank consents are often confusing or misunderstood among participants. Participants misperceive the scope of biobank research, potential risks and benefits of participation, biospecimen ownership, confidentiality and the return of results (Allen & McNamara 2011; Barr 2006; Lemke et al. 2010; Maradiaga & Maulsby 2011; McCarty et al. 2007; Ormond et al. 2009; Toccaceli et al. 2009). These findings are largely specific to well-educated, higher income Caucasians. Other individuals, including underrepresented minorities, may have even greater difficulty understanding biobank consents. African Americans, Hispanics and individuals with limited English proficiency in particular have displayed clear vulnerabilities in understanding consent for genomic and clinical research (Kaphingst et al. 2012; Miller et al. 2005; Simon et al. 2006). Various factors contribute to problems in informed consent (DuBois et al. 2012). Participant confusion or misunderstanding undermines the high value placed on accurate deliberation of the facts about the research (Beauchamp & Childress 1979; Berg et al. 2002) and risks participant mistrust and dissatisfaction in the consent process, the research and the research enterprise. Such negative outcomes have contributed to unfortunate consequences (e.g., Allen et al. 2010; Havasupai Tribe v. Arizona Board of Regents 2008; Harmon 2010; Beleno v. Tex. Dept. of State Health Servs. 2009).
Informed Consent as a Learning Paradigm
In addition to its legal and ethical dimensions, the informed consent process can be considered a learning paradigm (Krathwohl 2002), in which participants are presented with information about the research study and use that information to decide about participating. Research on improving understanding has often focused on making changes to the content, length and readability of the consent document (e.g. Beskow et al. 2010; Dresden & Levitt 2001; Epstein & Lasagna 1969; Wittenberg & Dickler 2007), or on the decision making process to enhance reasoning (Kass et al., Mintz er al., and Merz & Sankar in Agre et al. 2003; Benson et al. 1988). These approaches have yielded some success (see Nishimura et al. 2013). Our approach leaves the content of the informed consent document unaltered; instead, it focuses on improving the delivery of content through interactivity and multimedia. Thus, it adds to other approaches that researchers have available to improve informed consent.
Multimedia is a combination of visual and auditory information such as pictures, animations, recorded words, live words, sounds, and video (Mayer 2009; Sims 1997). According to dual coding theory (Paivio 1990), people process information through two simultaneous pathways, verbal (words and symbols) and spatial (pictures and movement). By strategically presenting information through both pathways, information is learned more efficiently and learning is enhanced (Clark & Mayer 2008; Mayer 2002, 2009; Mayer & Moreno 1998; Mousavi et al. 1995; Sadoski & Paivio 2001). Multimedia also enhances learning by maintaining cognitive load at an optimum level, when designed on principles of Cognitive Load Theory (CLT) (Schnotz & Kirschner 2007; Sweller et al. 1998; van Merrienboer & Sweller 2005). Optimal learning engages but does not overwhelm the learner. Thus, by designing both content and presentation of instruction to optimize load, multimedia instruction facilitates the control of content and presentation of information (Chandler & Sweller 1991; Mayer & Moreno 2003; Paas & van Merrienboer 1994; Sweller et al. 1998). To manage cognitive load, investigators must focus on instructional design. By improving the way in which information is presented, participant learning is expected to improve.
Many studies have attempted to leverage multimedia but have neglected the role of interactivity. By interactivity, we mean interactive content - the degree to which an individual is asked to use or respond to information and provided with feedback on those responses (Kiousis 2002; Koolstra & Bos 2009; Yacci 2000). Such interactivity requires active involvement by the learner, in contrast to passive reception of information such as watching a video. According to information processing and interactivity theories such as constructivism (Yacci 2000), this active involvement enhances learning by engaging learners to process information, selecting, organizing and integrating relevant information into memory (Mayer 2002). Interactivity also enhances engagement by providing a sense of social presence (Yacci 2000), perception of reduced effort (Downes & McMillan 2000), gaining and maintaining learner attention (Lustria 2007), and correcting misperceptions (Palmer et al. 2008). Even the expectation of receiving feedback has been shown to improve learning (Vollmeyer & Rheinberg 2005).