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. 2013 Aug;10(4):604-11.
doi: 10.1177/1740774513491338.

Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents

Iain C Sanderson  1 , Jihad S Obeid, Kapil Chalil Madathil, Katherine Gerken, Katrina Fryar, Daniel Rugg, Colin E Alstad, Randall Alexander, Kathleen T Brady, Anand K Gramopadhye, Jay Moskowitz
Affiliations

Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents

Iain C Sanderson et al. Clin Trials. 2013 Aug.

Abstract

Background: One mechanism to increase participation in research is to solicit potential research participants' general willingness to be recruited into clinical trials. Such research permissions and consents typically are collected on paper upon patient registration. We describe a novel method of capturing this information electronically.

Purpose: The objective is to enable the collection of research permissions and informed consent data electronically to permit tracking of potential research participants' interest in current and future research involvement and to provide a foundation for facilitating the research workflow.

Methods: The project involved systematic analysis focused on key areas, including existing business practices, registration processes, and permission collection workflows, and ascertaining best practices for presenting consent information to users via tablet technology and capturing permissions data. Analysis was followed by an iterative software development cycle with feedback from subject matter experts and users.

Results: An initial version of the software was piloted at one institution in South Carolina for a period of 1 year, during which consents and permission were collected during 2524 registrations of patients. The captured research permission data were transmitted to a clinical data warehouse. The software was later released as an open-source package that can be adopted for use by other institutions.

Limitations: There are significant ethical, legal, and informatics challenges that must be addressed at an institution to deploy such a system. We have not yet assessed the long-term impact of the system on recruitment of patients to clinical trials.

Conclusions: We propose that by improving the ability to track willing potential research participants, we can improve recruitment into clinical trials and, in the process, improve patient education by introducing multimedia to informed consent documents.

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Conflict of interest statement

Conflict of interest

None declared.

Figures

Figure 1
Figure 1
Typical RPMS workflow. (a) The process starts with the patient registration. Patient demographic data are transmitted via HL7 messages to a central data store and matched against the EMPI. (b) Patient information is displayed on an iPad, and the patient is presented with consent options. (c) The consent data are transmitted to the CDW. (d) A PostScript version of the consent form is generated and stored in the electronic patient folder and may be (e) printed and given to the patient. (f) The consent data are expressed through a research query interface along with clinical data for browsing by researchers. RPMS: Research Permissions Management System; EMPI: Enterprise Master Patient Index; CDW: Clinical Data Warehouse; HL7: Health Level 7; EMR: electronic medical record.
Figure 2
Figure 2
A screenshot of a typical research permission, which allows the user to check a box, in this case for opting out of being contacted for research.
See this image and copyright information in PMC

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