Page 410 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Rec-104 SOP Title: e-Consenting
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PURPOSE
The purpose of this standard operating procedure (SOP) is to define the procedures for accessing and usage of Adobe Sign also known as ECHO in the e-consenting process for research study participation.
INTRODUCTION
This is in line with our institution(s) strategic priorities of quality and efficiency, research administration (RA) has integrated a centralized electronic and physical process that incorporates clinical research essential materials. At a minimum, these procedures will include the process for obtaining access to Adobe Sign, modifying existing research studies to include verbiage of e-consenting, the e-consenting process as directed by the UTSW Institutional Review Board, and finally proper usage of Adobe Sign when completing an e-consent.
SCOPE
This SOP is relevant to all research coordinators, associates, team leads in Medical/Surgical/Heart Centers, physicians, and any other person(s) listed on the authority log that is delegated the responsibility of obtaining consent/assent for research participation.
RESPONSIBILITIES
All those who conduct research at Children’s Health are ultimately responsible for principal investigator delegated tasks in partial fulfilment of good clinical practice and relevant governing regulations and policies. As it relates more specifically to Adobe Sign and the e-consenting processes, coordinators are responsible for obtaining appropriate approval through Research Administration, Institutional Review Board approval of allowing e-consenting, and finally the proper usage of Adobe Sign, following all institutional and national guidance.
Requirements:
a. The Adobe Sign SOP will be in the Research Administration (RA) e-book.
b. At a minimum this will include the process for obtaining access to Adobe Sign,
modifying existing research studies to include verbiage of Adobe Sign and e- consenting, the e-consenting process as directed by the UTSW Institutional Review Board, and finally proper usage of Adobe Sign when completing an e- consent.
SPECIFIC PROCEDURE
Obtaining Access to Adobe Sign Access
The Research Coordinator or Research Associate should first determine if e- Consenting will fit your patient population. Does your population have the following?
a. Computer or phone with internet access b. Accessible email address.
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