Patient perspectives on the process of informed consent for DNA testing

Abstract

The informed consent process (ICP) has long been recognized to be an important component of clinical practice and, more recently, of research as well. Yet limited information is available regarding the impact of ICP on patients and their families. We set out to evaluate patient perceptions of ICP which includes a newly devised DNA testing/banking consent form. In addition to addressing the issues currently recognized to be critical to informed consent, this form allowed individuals to choose between the options of closed consent (sample destroyed after requested testing completed) versus open consent (sample banked for use in ongoing research). Participants completed self-administered questionnaires pre and post ICP. Results are available from 50 completed questionnaires to date. 76% of participants chose open consent and 24% chose closed consent. 72% indicated an interest in a detailed discussion in the pre-counselling questionnaire and 76% responded that ICP was helpful in the post-counselling questionnaire, although 83% indicated that they had decided to proceed with testing prior to ICP. Of note, 68% agreed with the statement “consent forms are mostly to provide legal protection for health care professional”. Anxiety levels ascertained by visual analog scale revealed no significant change in anxiety levels pre and post ICP in half of the respondents. The remaining respondents reported increased or decreased anxiety levels with approximately even distribution. Preliminary findings indicate a positive attitude towards ICP and provide justification for its implementation in clinical practice. More detailed data analysis, from a larger sample size, will be presented and this information will be utilized to develop guidelines to improve ICP to better meet patient needs.