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.

Verbal Consent in Biomedical Research: Moving Toward a Future Standard Practice?
Review Article
Alycia Noe, Emilie Vaillancourt, Ma’n H Zawati
Frontiers in Genetics, 12 February 2025
Abstract
Properly obtaining informed consent is a core obligation for research conducted using human subjects. The traditional informed consent process involves written forms and obtaining signatures. This process remains the standard, but in various research settings, such as COVID-19 and rare disease research, verbal consent has increasingly become the norm. Although verbal consent is used in these settings, its use is still a subject of debate. This article reviews in what medical settings verbal consent is commonly seen today, various advantages and disadvantages of verbal consent, and its legislative and policy ecosystem. In doing so, this review article asserts that it is time for the debate over verbal consent to come to an end and for legislator and policymakers to acknowledge its use and to formalize the process. This will allow verbal consent to be regulated in a similar manner to written consent and will give clinician-researchers guidance on how to better implement verbal consent in their studies to addressing ongoing concerns with the consenting process as a whole.

Editor’s Note: We note that if verbal consent is employed there must also be a record of this transaction, either by way of recording or transcription, to allow for adequate documentation.

The Use of Electronic Consent (eConsent) Within the Ketamine for Long-Lasting Pain Relief After Surgery (KALPAS) Multicenter Trial
Lisa V Doan, Jeri Burr, Raven Perez, Hamleini Martinez, Randy Cuevas, Kevin Watt, Jing Wang
Journal of Pain Research, 4 January 2025
Abstract
Background
The informed consent process has traditionally taken place in person. The introduction of electronic consent (eConsent) has made remote consenting processes possible. Use of eConsent has increased since the COVID-19 pandemic. It has streamlined the process of consenting patients and has been shown to benefit the research study team and participants.
eConsent in the Ketamine Analgesia for Long-Lasting Pain Relief After Surgery (Kalpas) Study
The KALPAS study is a multicenter, double-blind, randomized controlled study investigating the effectiveness of ketamine in reducing chronic post-mastectomy pain in women undergoing mastectomy for oncologic indication. The study uses a two-part consent form consisting of a master consent with information applicable to all sites and site-specific information. All potential participants receive the full two-part consent form for review. When signing the eConsent, however, all potential participants are provided with a concise summary of the informed consent document, an approach not widely used by multicenter studies. eConsent has been noted to be beneficial to research staff when trying to gather informed consent from participants who live far away from the hospital, want to include their family and friends, and for researchers who can approach patients outside of their clinical appointments.
Conclusion
The ability to consent patients remotely has allowed for a flexible workflow within sites and a more patient-centric process that focuses on including loved ones in the discussion and scheduling time to speak to a principal investigator. Demand for eConsent will likely continue in the post-COVID era, and use of a concise summary can allow for a more efficient consenting process.

Impact of informed consent quality on illness uncertainty among patients with cancer in clinical trials: a cross-sectional study
Original Article
Sihan Kang, Jie Zhang, Dong Pang , Hong Yang, Xiaohong Liu, Renxiu Guo, Yuhan Lu
Asia-Pacific Journal of Oncology Nursing, 20 February 2025
Open Access
Abstract
Objective
This study aimed to examine the level of illness uncertainty and the quality of informed consent among patients with cancer participating in clinical trials and explore their interrelationship.
Methods
A cross-sectional study was conducted with 265 patients with cancer recruited from a tertiary hospital in Beijing, China, from April to November 2023. Participants completed a questionnaire encompassing demographic details, the Mishel Uncertainty in Illness Scale, and the Quality of Informed Consent Questionnaire. Descriptive statistics, correlation analyses, and multiple regression analyses were performed to assess the data.
Results
The mean illness uncertainty score was 40.63 ± 10.12, reflecting a moderately low level of uncertainty, with “Ambiguity” scoring the highest among its dimensions. The mean score for informed consent quality was 3.30 ± 1.20, indicating a moderate level of understanding, with notable gaps in elements such as alternatives and confidentiality. A significant negative correlation was found between the “Foreseeable risks or discomforts” element of informed consent and overall illness uncertainty (P < 0.05). Regression analysis revealed that factors such as clinical trial phase, primary caregiver relationship, and health insurance model significantly influenced illness uncertainty and its dimensions.
Conclusions
Enhancing the quality of informed consent can effectively reduce illness uncertainty among patients with cancer in clinical trials. Greater emphasis should be placed on clear communication of risks and discomforts and patient-centered interventions to mitigate psychological stress.

Personal Public Disclosure: A New Paradigm for Meeting Regulatory Requirements Under Exception From Informed Consent
Research Report
Catherine E. Ross, Monica E. Kleinman, Michael W. Donnino
Critical Care Medicine, 12 February 2025
Abstract
Objectives
To describe a novel approach to the requirement for public disclosure under regulations for Exception From Informed Consent (EFIC) in an inpatient clinical trial.
Design
Single-arm intervention study within a clinical trial.
Setting
Medical and medical/surgical PICUs at an academic children’s hospital.
Participants
Families of children and young adults younger than 26 years old receiving care in a PICU.
Interventions
As part of a multipronged approach to meeting requirements for public disclosure for EFIC, we developed and implemented a process termed “personal public disclosure,” in which a member of the study team notifies all potentially eligible patients/families in-person or by phone about the trial as soon as possible upon PICU admission. Patients/families may choose to opt out of future participation in the trial.
Measurements and Main Results
Over a 16-month period, 1577 potentially eligible patients/families were successfully contacted for personal public disclosure. Of these, 473 (30%) opted out of future participation in the trial. In the same period, 64 patients developed the emergent event of interest for the primary trial. Of these, only 9 (14%) were enrolled. Upon notification of enrollment, all 9 (100%) agreed to continue in the data collection phase of the study. Of the remaining 55 missed enrollments, 38 (69%) were due to the event occurring before personal public disclosure had been completed.
Conclusions
Personal public disclosure supports patient/family autonomy within an EFIC trial; however, this approach is limited by low cost-effectiveness, feasibility and appropriateness in many circumstances.

Towards better enrollment decision-making for perinatal clinical research: reconsidering recruitment and consent processes to support family values and preferences
Elliott Mark Weiss, Benjamin S Wilfond, Stephanie A. Kraft
Seminars in Perinatology, 25 January 2025
Abstract
Objective
Whether to participate in clinical research is a special type of decision for parents with infants in the neonatal intensive care unit (NICU). Parents often report negative experiences being approached for NICU research and researchers struggle to enroll a representative sample. We consider how enrollment decision-making might be better supported by integrating learnings from clinical decision-making.
Finding
Approaches to supporting decision-making about clinical research, though distinct from those for clinical decision-making, share many similarities. We consider ways researchers may incorporate advances in knowledge about clinical decision-making to: (a) improve documents used for regulatory purposes (e.g., consent forms), and (b) better support relationship building between researchers and parents considering research enrollment.
Conclusion
Researchers may benefit from considering approaches to enrollment decision-making that draw on clinical decision-making methods. Future work should assess the impact of such approaches on parental experiences of recruitment; enrollment and retention rates; and representative inclusion of NICU populations.

Navigating the consent river: questions to consider before waiving consent requirements in pragmatic cluster randomised trials
Cory E Goldstein, Monica Taljaard, Stephanie N Dixon, Charles Weijer
Journal of Medical Ethics, 18 December 2024
Open Access
Abstract
The robust design and conduct of pragmatic cluster randomised trials may be in tension with the ethical requirement to obtain written informed consent from prospective research participants. In our experience, researchers tend to focus on whether a waiver of consent is appropriate for their studies. However, pragmatic cluster randomised trials raise other important questions that have direct implications for determining when an alteration or waiver of consent is permissible. To assist those involved in the design, conduct and review of pragmatic cluster randomised trials, we outline four critical questions to consider: (1) What is the nature of the intervention being evaluated? (2) Is the choice to use cluster randomisation justified? (3) Can the risk of recruitment bias be addressed? and (4) Is an alteration or waiver of consent appropriately justified? We recommend that researchers and research ethics committees conduct a stepwise analysis of a planned cluster randomised trial using these questions. To illustrate the application of this stepwise analysis, we use three pragmatic cluster randomised trials in the haemodialysis setting as case studies.