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A Familiarization Protocol Facilitates the Participation of Children with ASD in Electrophysiological Research
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Facilitating the Informed Consent Process Using Teleconsent: Protocol for a Feasibility and Efficacy Study.

Saif Khairat1, Paige Ottmar1, Betsy Sleath1

  • 1University of North Carolina- Chapel Hill, Chapel Hill, NC, United States.

JMIR Research Protocols
|October 19, 2018
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Summary

Teleconsent, a telemedicine approach, enhances clinical trial informed consent. This method facilitates remote participant interaction and signature collection, improving the process for diverse populations.

Keywords:
clinical trialsinformed consentmobile phonetelemedicine

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Area of Science:

  • Clinical Research
  • Health Informatics
  • Telemedicine

Background:

  • Informed consent is a significant challenge in clinical trial recruitment, particularly for minority and rural populations.
  • Recruitment barriers include budget constraints, insufficient trained personnel, and difficulties reaching specific demographics.

Purpose of the Study:

  • To evaluate the use of telemedicine for improving the informed consent process in clinical research.
  • To assess the feasibility and effectiveness of a teleconsent intervention in both urban and rural settings.

Main Methods:

  • The study was conducted concurrently at two institutions: Medical University of South Carolina and University of North Carolina at Chapel Hill.
  • This comparative approach allows for analysis within and across institutions.

Main Results:

  • Phase 1 enrollment occurred from March to May 2018.
  • Data transcription and analysis were scheduled from June to September 2018.

Conclusions:

  • Teleconsent, a novel telemedicine modality, enables live interactions between research coordinators and participants.
  • The system allows for synchronous presentation of consent forms and electronic signature capture via doxy.me.
  • Teleconsent shows potential to improve the informed consent process for clinical trial participants.