Abstract
Background and Aims: The main purpose of this NIDDK-funded group-randomized trial is to evaluate the effect of teaching resident physicians fundamental principles of diabetes management using an interactive computer simulation program called SimCare. A minimum of 20 primary care residency programs with up to 700 residents total will be randomly assigned to either (a) an early SimCare Diabetes learning program group or (b) a delayed SimCare Diabetes learning program group. This presentation will provide an explanation of and justification for using an online informed consent process to facilitate informed consent for a national trial of this scale.
Methods: Resident physicians interested in participating in this study will be asked to read an online informed consent form that fully details the study procedures, potential risks and benefits to participating, the study’s voluntary nature, and issues surrounding confidentiality. As they move through each page of the online consent form, they will be required to confirm their understanding of the page’s content by clicking an “I understand” check box before they can proceed. Reviewing the online consent and enrolling in this study confers their informed consent.
Results: The online informed consent process for this study has been developed and IRB-approved. To enroll, a resident will create a user name and password and provide contact information to be used to communicate with them during the study. A link to the principal study staffs’ contact information will also be clearly posted on each page so that if a resident has a question or concern, they can contact the study staff prior to completing the form. At the end of the form, a resident has the choice to agree to participate and enroll in the study and print a copy of the consent, ask questions to the study staff prior to consenting, or decide not to participate.
Conclusions: It is difficult to coordinate informed consent for a national trial, but an online informed consenting process such as this provides an efficient avenue that meets internal review board standards.
- Received May 27, 2010.
- Accepted May 27, 2010.
