Cancer Patient Perspectives on Clinical Trial Discussion and Informed Consent Through Telemedicine
Original Reports
Yasin Khadem Charvadeh, Sahil D. Doshi, Kenneth Seier, Erin M. Bange, Bobby Daly, Allison Lipitz-Snyderman, Fernanda C.G. Polubriaginof, Michael Buckley, Gilad Kuperman, Peter D. Stetson, Deb Schrag, Michael J. Morris, Katherine S. Panageas
JSO Oncology Practice, 18 March 2025
Abstract
Purpose
Clinical trials are integral for patients with cancer but remain inaccessible to many because of barriers including geographic and transportation challenges. This study aimed to evaluate cancer patients’ preferences for telemedicine versus in-person visits for clinical trial discussions and informed consent (IC).
Methods
An electronic survey was administered to first-time telemedicine users at Memorial Sloan Kettering Cancer Center from 2021 to 2023. The survey assessed patients’ preferences for telemedicine versus in-person visits for the IC process and their comfort with discussing clinical trials virtually. The primary outcome was the proportion of patients who indicated that they preferred a telemedicine visit for the IC process. Patient comfort and preference for discussing clinical trials through telemedicine versus an in-person visit was also explored. Structured responses provided quantitative data over the 2021-2023 observation period and demographic variations. To gain a more detailed understanding, unstructured free-text responses describing clinical trial discussions were also analyzed through language modeling.
Results
Overall, 57% of patients (540/955) preferred telemedicine, 26% (249/955) had no preference, and 17% (166/955) preferred in-person visits for the IC process. The preference for telemedicine remained consistent across the 2021-2023 observation period. Most patients reported no difference between a telemedicine versus in-person visit for clinical trial discussion, including asking questions, sharing concerns, declining participation, and asking for more time to make a decision. Language modeling analysis revealed areas for improvement.
Conclusion
A majority of patients at a comprehensive cancer center who participated in clinical trial discussions through telemedicine reported a preference for telemedicine to complete the IC process. Telemedicine thus represents a valuable tool for reducing barriers to clinical trial participation, particularly in reducing travel and time barriers.

Effectiveness of Telehealth Versus In-Person Informed Consent: Randomized Study of Comprehension and Decision-Making
Saif Khairat, Paige Ottmar, Prabal Chourasia, Jihad Obeid
Journal of Medical Internet Research, 5 March 2025
Abstract
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.

Landscape of informed consent practices and challenges in point-of-care clinical trials
Policy Analysis
Caleigh Propes, Trevan Locke, Rachele Hendricks-Sturrup
Learning Health Systems, 3 March 2025
Open Access
Abstract
Point-of-care trials, an approach to trial design that assesses medical product effectiveness while fully integrating research and care, represent a promising opportunity to generate practically relevant evidence efficiently for priority disease areas. However, this approach presents unique considerations for appropriate and ethical informed consent. As point-of-care trials evolve, it will be important to examine informed consent through the lens of their supporting technology, of the clinicians who are responsible for administering it, and of their broader regulatory environment. Steps should be taken to establish ethical standards for point-of-care trials that reflect and serve the best interests of patients while reducing administrative burden and complexity. Our commentary describes, overall and through the use of real-world examples, how this work is vital to ensuring a modern clinical trial enterprise that is patient-centered and equips patients to make fully informed decisions about their health care.

Patients’ Information Needs for Informed Consent to Participate in First-in-Human Pig Kidney Xenotransplant Clinical Trials: A Mixed Methods Study
Original Article
Elisa J. Gordon, Michael K. Gusmano, Jessica Gacki-Smith, Hannah L. Brooks, Margaret M. Matthews, Dahlya Manning, Joseph Leventhal, Karen J. Maschke
Xenotransplantation, 24 February 2025
Open Access
Abstract
Background
Transplant programs preparing to initiate first-in-human pig kidney xenotransplant clinical trials must be especially careful when obtaining participants’ informed consent. Little is known about the kind of information patients want for making an informed decision about trial participation.
Methods
We conducted semi-structured telephone interviews with waitlisted kidney transplant patients about information needs regarding participating in a first-in-human pig kidney xenotransplant trial, which guided development of a prototype consent form. Subsequent usability testing interviews sought patient feedback on the consent form. We analyzed qualitative data by thematic analysis and quantitative data by descriptive statistics.
Results
Twenty-eight patients participated in semi-structured interviews; 16 patients participated in usability testing interviews. Most interview participants were male (68%, 56%), White (54%, 56%), or Black (36%, 31%), respectively. Interview participants identified five types of information needs: (1) the potential for infection contraction and transmission; (2) risks, benefits, and impact of xenotransplant trials; (3) xenotransplant clinical trial and recipient experience; (4) clinical trial logistics; and (5) the pig and its kidney. Usability testing participants suggested adding details to the prototype. Participants’ preparedness to make a decision about participating in a xenotransplant trial increased after reviewing the prototype (12.5% vs. 31.3%, n.s.).
Conclusion
We identified multiple unique types of information patients desired to make informed decisions about pig kidney xenotransplant trial participation. Transplant programs initiating xenotransplant trials should be prepared to address patients’ information needs to optimize informed decision-making for trial participation. The prototype consent form may support a patient-centered approach to informed consent.

Application of Digital Engagement Tools for Exception from Informed Consent Community Consultation and Public Disclosure in the Pediatric Prehospital Airway Resuscitation Trial
Henry E. Wang, Shannon W. Stephens, Kammy Jacobsen, Brittany Brown, Cara Elsholz, Jennifer A. Frey, John M. VanBuren, Marianne Gausche-Hill, Manish I. Shah, Nichole Bosson, Julie C. Leonard, Nancy Glober, Caleb Ward, Daniel K. Nishijima, Kathleen Adelgais, Katherine E. Remick, Joshua B. Gaither, M. Riccardo Colella, Douglas Swanson, Sara F. Goldkind, Alexander Keister, Matthew Hansen
Resuscitation Plus, 28 February 2025
Abstract
Background
Emergency care trials may require compliance with federal Exception from Informed Consent (EFIC) regulations, including community consultation (CC) and public disclosure (PD). The reach of traditional CC and PD modalities is limited. We describe the application of novel digital engagement tools to enrich CC and PD in a pediatric emergency care trial.
Methods
In support of EFIC CC and PD efforts for the Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART), a multicenter trial of paramedic airway management in critically ill children, we deployed two digital engagement tools: 1) social media advertisements, and 2) marketing research panels. We disseminated social media advertisements (Facebook and Instagram) describing the study to targeted users in 10 communities. We determined social media advertisement impressions and engagements (shares, reactions, saves, comments, likes and clicks). We also disseminated community surveys using a marketing research panel (Qualtrics Marketing Research Services), determining the number of completed surveys, time to achieve 200 surveys, demographics of survey respondents and percentage with supportive responses.
Results
There were 23.3 million social media advertisement impressions (range 1.8-2.7 million per community) reaching 3.4 million unique users (range 239,494-439,360 per community) and resulting in 13,873 engagements (range 828-1,656 per community). Distribution of the community survey through the marketing research panel resulted in 6,771 completed surveys (range 531-914 per community). Across communities, time to 200 completed surveys ranged from 5-28 days. Survey respondents were 61.9% female, 27.0% minority race and 40.8% household income <$50,000. Most survey respondents (90.7%) supported the trial.
Conclusions
Digital engagement tools efficiently reached a large and diverse population and yielded key community feedback to inform research trial deployment. Digital engagement tools offer valuable techniques to enrich EFIC CC and PD efforts.