Electronic Informed Consent

informed CONsent for clinical record and Sample use in research (iCONS)

iCONS aims to address the lack of a standard for capturing, reasoning, integrating and sharing consent permissions provided by subjects for reusing clinical data and samples for research. iCONS also meets the ethical imperative of educating patients on the consequences of consenting to share their data.

 

The goals of our research are:

  • Educate subjects so that they are truly informed before and after they consent to participate in research
  • Propose a standard to facilitate the capturing and reasoning on permissions given by the subjects through informed consent
  • Maximize researchers’ access, usage and sharing of resources that are already available in different bio-repositories and clinical data warehouse, while providing compliance with subjects’ permissions

 

To achieve our research goals, iCONS is composed of four components (Figure 1):

  • Electronic Informed Consent Management System – A web-based tool to educate the subject during and after consenting to participate in a study (Figure 2). This tool includes:
    • Multimedia to enhance understanding
    • Follow-up registry to inform the subject how the data are being used and in what research
  • Permission Ontology – Captures the subject’s consent in a machine-interpretable and implementation-independent format
  • Permission Repository – Saves the subject’s consent, which are expressed in the permission ontology
  • Resource Mediator – An ontology-based reasoning tool to check compliance with previously granted permissions for sharing clinical data and biorepositories

 

Figure 1: iCONS components interactions

 

Figure 2: Screen shot of the iDash Electronic Informed Consent Management tool for UCSD Moores Cancer Center biorepository study

 

Using the iCONS tool

How to make an electronic informed consent for use with the iCONS tool

This video shows how the finished limesurvey informed consent forms are used in the iCONS management tool. Once the informed consent documents are uploaded, they can be used for the consent process.