title: Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents.
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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Duke University, Durham, NC, USA.
authors.forename: Iain C
authors.initials: IC
authors.lastname: Sanderson
authors.forename: Jihad S
authors.initials: JS
authors.lastname: Obeid
authors.forename: Kapil Chalil
authors.initials: KC
authors.lastname: Madathil
authors.forename: Katherine
authors.initials: K
authors.lastname: Gerken
authors.forename: Katrina
authors.initials: K
authors.lastname: Fryar
authors.forename: Daniel
authors.initials: D
authors.lastname: Rugg
authors.forename: Colin E
authors.initials: CE
authors.lastname: Alstad
authors.forename: Randall
authors.initials: R
authors.lastname: Alexander
authors.forename: Kathleen T
authors.initials: KT
authors.lastname: Brady
authors.forename: Anand K
authors.initials: AK
authors.lastname: Gramopadhye
authors.forename: Jay
authors.initials: J
authors.lastname: Moskowitz
mesh_terms: D002986:Clinical Trials as Topic; D004282:Documentation / Q000379:methods; D006801:Humans; D019451:Information Management / Q000458:organization & administration*; D007258:Informed Consent; D018579:Patient Selection; D010865:Pilot Projects; D012984:Software; D013022:South Carolina; D014584:User-Computer Interface