Effectiveness of Telehealth Versus In-Person Informed Consent: Randomized Study of Comprehension and Decision-Making.

Background: Obtaining informed consent (IC) is vital for ethically and effectively recruiting participants in research projects. However, traditional in-person IC approaches encounter notable obstacles, such as geographic barriers, transportation expenses, and literacy challenges, which can lead to delays in enrollment and increased costs. Telehealth, especially teleconsent, offers a potential way to overcome these obstacles by facilitating the IC process in a digital setting. Nonetheless, there are concerns about whether teleconsent can achieve levels of understanding and involvement that are equivalent to those of in-person IC meetings.

Objective: This study aims to evaluate comprehension and decision-making in participants undergoing teleconsent versus traditional in-person IC. We used validated assessments to determine whether teleconsent is a viable alternative that maintains participants' understanding and decision-making abilities.

Methods: A randomized comparative study design was used, recruiting potential participants for a parent study assessing patient experiences with patient portals. Participants were randomly assigned to 2 groups: teleconsent and in-person consent. The teleconsent group used Doxy.me software, allowing real-time interaction between researchers and participants while reviewing and electronically signing the IC documents. Recruitment involved using an institutional web-based platform to identify interested individuals, who were then contacted to assess eligibility and gather demographic information. The Decision-Making Control Instrument (DMCI) survey was used to assess the perceived voluntariness, trust, and decision self-efficacy. The Quality of Informed Consent (QuIC) was used to measure the comprehension level of the consent form. The validated Short Assessment of Health Literacy-English tool was used to measure participants' health literacy levels.

Results: A total of 64 participants were enrolled in the study, with 32 in the teleconsent group and 32 in the in-person group. Of 64 participants, 32 (50%) were in the teleconsent group, 54 (84.4%) were females, 44 (68.7%) were aged 18-34 years, 50 (78.1%) were White, and 31 (48.4%) had a bachelor degree. The mean SAHL-E scores were different between the teleconsent and in-person groups (16.72, SD 1.88 vs 17.38, SD 0.95; P=.03). No significant differences were found between the average scores at baseline and follow-up for QuIC part A (P=.29), QuIC part B (P=.25), and DMCI (P=.38) within the teleconsent and in-person groups. Additionally, there were no significant differences in QuIC or DMCI between subgroups based on age, sex, and ethnicity.

Conclusions: This study assessed the effectiveness of IC processes through telehealth compared to traditional in-person visits. Findings indicate that telehealth offers similar participant understanding and engagement while overcoming geographic and accessibility barriers. As health care adopts digital solutions, these results highlight telehealth's potential to improve recruitment and retention in clinical research, suggesting that policy makers should integrate telehealth practices into regulations for better access and health outcomes.