Data for Clinical Research ongoing development aided by Electronic Informed Consenting

by | Jan 5, 2023

According to a study published in JCO Oncology Practice, electronic informed consenting (eIC) for clinical research using EHR patient portals could assist increase the completeness of needed fields compared to paper-based consenting surveys. Researchers examined the three-year completion rates of needed fields and evaluated participant experience using electronic consenting (eIC) against traditional paper-based consenting from 2019 to 2021 The study’s authors distributed surveys one (technology burden) and two (survey two) to individuals who provided written or electronic informed consent for a clinical trial at a significant academic cancer center comprehension and agency. Participants chose for themselves how they would give their approval for their main protocol. Participants in both surveys received electronic surveys through their patient portals from the researchers. 83 percent of respondents to survey one said using eIC was easy or very easy; difficulty with technology in general did not appear to be connected with eIC discomfort.

For survey two, comprehension ratings for eIC and paper consenters were comparable. However, eIC produced a higher percentage of favorable free-text responses, with themes including the depth of the discussion and the expertise of the consenter. In contrast to 6.4 percent for paper, using the eIC resulted in no completeness problems across 235 consents. Comparable survey cohorts existed for all racial and ethnic groups. The researchers commented the following: “Scores suggest a high degree of participant satisfaction and maintenance of a positive consent experience overall, regardless of consent medium or protocol,” the researchers noted. “Scores suggest that even in cases when one or more agency-associated criteria were not met (eg, participant was not offered the choice of consent method), participants did not feel their overall experience was undermined.” Giving participants enough time to make a decision, providing sufficient information about complicated or in-depth study components, and offering participants a choice of consent medium are all areas for improvement, according to the researchers. The absence of a time constraint for survey completion by the researchers raised the possibility that recollection bias may have affected participants’ responses, which could have limited the study’s possible findings.

“Survey burden was likely a driver for our observed response rates, with higher survey burden resulting in more dropouts and/or nonresponse,…Survey one had lower survey burden with five opinion questions (27 percent response), whereas survey two had higher survey burden with a 10-question comprehension and agency assessment (19 percent response)…Other limitations are that this study was conducted at a single center, and only two protocols were chosen to assess consent comprehension and agency,” they added. “Further investigation into participant self-advocacy, knowledge as a currency of power, and the locus of decision making as elements of the consent discussion is warranted.”

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