Informed consent to genetic research: Student participation and perception of risk

Abstract

I would like to express my deepest thanks to my patient and forgiving wife who tolerated my many late nights spent in the glow of a computer screen, who listening to my rants, complaints, and excited revelations, and who allowed me to fill a room with research articles, statistical output, and manuscript drafts. I make here public declaration to come to bed at a reasonable hour (most nights), reduce my graduate student ramblings, and clear the clutter from the back room. Without you, I would have surely worked myself too long and hard, and with no personal enjoyment. Thank you, Lacy. Thank you to my parents. You said you liked to edit papers; however, I know you must just say that as a father, because this document is entirely too long to want to read it more than once. Thank you both for your words of wisdom and support when work was slow and arduous; I am truly thankful for such wonderful parents. I would also like to offer my thanks to the faculty members who provided guidance through this project. Thank you to my committee members Drs. David Vogel and Mack Shelley for your consultations and feedback. Also, thank you to Dr. Patrick Armstrong for providing me with access to several measures and early guidance regarding design. Additionally, thank you to Dr. Douglas Bonett for your statistical consultations. I believe it is also important to thank the library staff for scanning or acquiring many articles and texts from far away places, your work is much appreciated. Finally, a great thanks to Dr. Norman Scott, my mentor, major professor, and friend. Your encouragement and guidance was critical to making this a successful project. I would not have dared to take on a deception study without your keen acumen of ethics. Thank you for your expert advice and editing skills. I look forward to our continued work in this area.

Toward Comprehension: Improving Informed Consent in Behavioral Genetic Research

“…More recent work by Ascheman (2009) aimed to investigate how participants viewed potential risks to loss of genetic privacy by suggesting that their genetic data might be shared with a variety of groups in addition to the investigators in a specific study. In this study the experimenter used research informed consent documents as a manipulation, with varying levels of risk to loss of privacy and disclosure of genetic information, with use of cued recall comprehension checks to ensure the validity of the study.…”

“…Following up on Ascheman's (2009) work, Batchelder (2012 posed similar questions related to behavioral genetic research with variations in risk to loss of genetic privacy and various levels of monetary compensation for participants. However, in the latter study modification from use of standard informed consent forms was the central manipulation.…”

“…Further, this study is framed around behavioral genetic research to further the understanding of what methods are most effective for communicating information relevant to the informed consent process in this emerging and ethically challenging domain of behavioral genetic research. As an additional feature, this study examines comprehension of informed consent documents for behavioral genetic research immediately following the presentation of the information using cued recall measurements from previous literature (Ascheman, 2009;Pedersen et al, 2011;Batchelder 2012) as well as cued recall and recognition measurements one week after initial presentation. This approach provides additional insight regarding how well information regarding elements of informed consent is retained for behavioral genetic studies after a significant delay, which is particularly relevant as digitized genetic information may be stored and potentially used in future analyses as new technologies and methodologies emerge.…”

“…Experimental examination of comprehension in informed consent has seen far less research in the past twenty years than in the twenty that preceded it, but more recent work has demonstrated that comprehension is still an elusive, and increasingly critical, element of the informed consent process (Ascheman, 2009;Pedersen et al, 2011;Batchelder, 2012). More recent work on the informed consent process and the potential pitfalls of low levels of comprehension and document readability have focused in more specific areas, such as informed consent in psychotherapy (Handelsman & Martin, 1992;Wagner, 1998;Walfish & Ducey, 2007) and more recently how the informed consent process plays into the emerging field of integrated primary care (Hudgins et al, 2013).…”

“…However, little research has been conducted to better understand how to most effectively communicate to potential participants in behavioral genetic research their rights and potential risks, and to assess the comprehension of such information has been demonstrated to be quite poor. Extensive research on participant understanding of research protocols' informed consent documents have indicated very low rates of comprehension (Hassar & Weintraub, 1976;Kniffen, 1979;Cassileth et al, 1980;Duffy & Kabance, 1982;Riecken & Ravich, 1982;Taub & Baker, 1984;Ascheman 2009;Pederson et al, 2011).…”