This research focuses on the applied development of an effective informed consent form and process for donation of blood to a DNA Bank solely for research purposes. This is part of a continuing effort to develop a comprehensive consent form to DNA Banking. This form will be used for securing a hypothetical consent from patients in the General Clinical Research Center at the Hospital of the University of Pennsylvania. A short series of vignettes is used to prompt cognitive processing of the information in the consent form. Use of the information in this way is hypothesized to increase understanding and recall of the information. We will test the vig in clinical uses as an informed consent intervention, randomly assigning subjects who agree to be in our study to receive either just the consent form or the form and the vignettes. The responses to the vignettes will be examined by the research assistant in the informed consent meeting. This will provide a basic assessment of understanding by donors and the basis for a discussion to clarify any inconsistent responses. After completing the informed consent discussion, we will ask individuals to participate in a brief survey about the consent process. We will give those who assent a questionnaire that tests understanding. The questionnaire will also examine perceptions of risks and benefits and other preferences of those who are asked to donate a blood sample from which their DNA will be banked for research purposes. Donor choices documented on these consent documents will inform researchers about information needs and desires and how to facilitate meaningful choices of those asked to donate blood or other tissues for banking and research purposes. Based upon the results of these analyses, we may modify the content and format of the consent form and vignettes or the process of securing consent from prospective donors.
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