Consent processes are critical for clinical care and research and may benefit from incorporating digital strategies. We compared an electronic informed consent (eIC) option to paper consent across four outcomes: (1) technology burden, (2) protocol comprehension, (3) participant agency (ability to self-advocate), and (4) completion of required document fields.

We assessed participant experience with eIC processes compared with traditional paper-based consenting using surveys and compared completeness of required fields, over 3 years (2019-2021). Participants who consented to a clinical trial at a large academic cancer center via paper or eIC were invited to either pre-COVID-19 pandemic survey 1 (technology burden) or intrapandemic survey 2 (comprehension and agency). Consent document completeness was assessed via electronic health records.

On survey 1, 83% of participants (n = 777) indicated eIC was easy or very easy to use; discomfort with technology overall was not correlated with discomfort using eIC. For survey 2, eIC (n = 262) and paper consenters (n = 193) had similar comprehension scores. All participants responded favorably to at least five of six agency statements; however, eIC generated a higher proportion of positive free-text comments (P < .05), with themes such as thoroughness of the discussion and consenter professionalism. eIC use yielded no completeness errors across 235 consents versus 6.4% for paper (P < .001).

Our findings suggest that eIC when compared with paper (1) did not increase technology burden, (2) supported comparable comprehension, (3) upheld key elements of participant agency, and (4) increased completion of mandatory consent fields. The results support a broader call for organizations to offer eIC for clinical research discussions to enhance the overall participant experience and increase the completeness of the consent process.

Presented in part at the 2022 ASCO Annual Meeting, Chicago, IL, June 3-7, 2022 and the 2020 ASCO Annual Meeting, virtual, May 29-31, 2020.

This research was funded in part through the NIH/NCI Cancer Center Support Grant P30 CA008748.

Conception and design: Michael T. Buckley, Molly R. O'Shea, Collette Houston, Stephanie L. Terzulli, Joseph M. Lengfellner

Administrative support: Michael T. Buckley, Collette Houston, Joseph M. Lengfellner

Collection and assembly of data: Michael T. Buckley, Sangeeta Kundu, Suken Shah

Data analysis and interpretation: Michael T. Buckley, Molly R. O'Shea, Allison Lipitz-Snyderman, Gilad Kuperman, Suken Shah, Alexia Iasonos, Paul Sabbatini

Manuscript writing: All authors

Final approval of manuscript: All authors

Accountable for all aspects of the work: All authors

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With Traditional Paper-Based Methods

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/op/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Alexia Iasonos

Stock and Other Ownership Interests: Bristol Myers Squibb/Sanofi

Consulting or Advisory Role: Intelligencia, Mirati Therapeutics

Paul Sabbatini

Honoraria: UpToDate

Research Funding: Bristol Myers Squibb (Inst), Ludwig Institute for Cancer Research (Inst)

No other potential conflicts of interest were reported.