Effect of ethnicity, gender and drug use history on achieving high rates of affirmative informed consent for genetics research: impact of sharing with a national repository

Abstract

Aim Genetic research representative of the population is crucial to understanding the underlying causes of many diseases. In a prospective evaluation of informed consent we assessed the willingness of individuals of different ethnicities, gender and drug dependence history to participate in genetic studies in which their genetic sample could be shared with a repository at the National Institutes of Health. Methods Potential subjects were recruited from the general population through the use of flyers and referrals from previous participants and clinicians with knowledge of our study. They could consent to 11 separate choices so that they could specify how and with whom their genetic sample could be shared. Rates of affirmative consent were then analysed by gender, ethnicity and drug dependence history. Results Of 1416 volunteers enrolled, 99.7% gave affirmative informed consent for studies of addiction conducted in our laboratory. No significant difference was found for participation in genetic studies conducted in our laboratory by gender, ethnicity or drug dependence history. Over all 11 questions, individuals with a history of drug use were more likely to agree to consent to participate in our study than were healthy volunteers. Conclusion A high percentage of each category of gender, ethnicity and drug history, gave affirmative consent at all levels. The level of detail in and the amount of time spent reviewing the informed consent, and a relationship of trust with the clinical investigator may contribute to this outcome.

Personality, Sex of Participant, and Face-to-Face Interaction Affect Reading of Informed Consent Forms

“…The fi nding that this diff erence was pronounced in the laboratory phase is similar to the Bento, et al (2008 ) fi nding that women preferred a face-to-face setting where they could potentially receive information verbally, if desired. The fi ndings of this study do diff er from a previous work that found no sex diff erences in giving positive consent to a genetics study ( Ray, Jackson, Ducat, Ho, Hamon, & Kreek, 2011 ).…”

Beyond Readability: Tailoring Informed Consent Communications for Digital Health Research (Preprint)

“…Our findings demonstrate that demographic background, susceptibility to possible risks, and study interest all play into a participants' need for more and less detail about a study. Similar findings have been reported in previous studies, which found that ethnicity, level of education, age, and gender were factors impacting participants' comprehension of informed consent information for genetics research, while factors like substance dependency were significantly more likely to increase the level of consent participants accepted 5,15,16 . By taking a two-step approach to consent material development, digital health researchers can potentially identify these considerations and incorporate them to refine the study materials:  Step 1.…”

Estimating ancestral proportions in a multi-ethnic US sample: implications for studies of admixed populations

“…Ambiguous responses were assigned by the authors based on geographical regions. All subjects signed an informed consent for genetic studies with a 99.7% consent rate [ 17 ]. The institutional review boards of The Rockefeller University, VA NY, and Cornell University approved the study.…”