Understanding Barriers and Facilitators for Ethnic Minority Groups to Audio Recording Recruitment Discussions in Clinical Trials: A Participatory Approach to Improving Informed Consent and Participation
Saba Faisal, Giles Birchley, Julia Wade, Athene Lane, Frida Malik, Tom Yardley, Shoba Dawson
Health Expectations, April 2025
Abstract
Introduction
Fully informed consent is essential for ethical trial conduct, yet gaps in participant comprehension and recall can occur, particularly among underserved groups, for example, ethnic minorities. This Patient and Public Involvement and Engagement (PPIE) project explored the engagement of ethnic minority communities in trial recruitment discussions, particularly their views about audio recording discussions with healthcare professionals.
Methods
This PPIE project engaged ethnic minority communities in Bristol [UK], collaborating with community partners to facilitate access to then foster dialogue among Somali, South Asian and Chinese groups. Separate workshops for men and women from these ethnic groups were held to introduce community members to clinical trial processes. Discussions, both audio recorded and not, simulated real recruitment scenarios. To ensure cultural relevance and accessibility, discussions were partly facilitated by our PPIE community partners in native languages.
Results
The insights gained during workshops were organised into key themes. Gaps in understanding regarding clinical trial participation were highlighted. A key finding was that trust played an important role and was facilitated by engaging community leaders and ensuring cultural and linguistic sensitivity during discussions. To address gaps in knowledge about trials and streamline the educational process, we developed storyboards and multilingual video resources. These explained the importance of clinical trials generally and the importance of recruiting diverse patient populations in particular. The materials were co-created with community partners and refined through iterative feedback to ensure accuracy and cultural appropriateness. The challenge of language barriers necessitated skilled interpreters, especially when discussions were audio recorded, to optimise understanding among people from diverse ethnic backgrounds. The video, available in English, Urdu, Mandarin, Cantonese and Bangla, facilitates understanding of trial purposes and processes, with the aim of widening trial participation in these groups.
Conclusion
Our PPIE activities highlighted gaps in understanding, the critical role of trust and the challenge of language barriers. The co-created resources have been made available for those wanting to address and overcome some of these issues. The initial feedback from the clinical trials community on the video resources has been promising, underscoring their potential to impact future recruitment efforts and PPIE activities.
Patient or public contribution
To foster a co-creation process, this project included the active involvement of our PPIE collaborators and co-applicants ‘Khaas’ for funding. They also helped us reach contributors from the South Asian community (mainly of Pakistani and Bangladeshi origin) and arrange workshops. Our two PPIE contributors from Somali Resource Centre and Barton Hill Activity Club helped us reach the Somali community at the Wellspring Settlement. Similarly, the Chinese Community Wellbeing Society helped us reach people from the Chinese community. These PPIE partners also helped us run the workshop by providing live translation of discussion. They also helped translate video scripts and do voiceovers in videos. Also, PPIE contributors Tom Yardley and Amanda Roberts helped with the script development.

Stakeholder Views on Novel Consent Forms for an Acute Stroke Trial
Candace D Speight, Opeolu M Adeoye, S Iris Davis, Michael J Linke, Andrea R Mitchell, Neal W Dickert
Ethics & Human Research, March-April 2025; 47(2) pp 16-25
Abstract
Lengthy consent forms are poorly suited for clinical trials in emergency contexts; however, innovations in consent processes are challenging to implement. A previously developed, context-sensitive consent form and information sheet were approved by a single institutional review board (sIRB) of record for use in a multisite stroke treatment clinical trial. This study sought views on using these materials by research teams and representatives from local institutional review boards (IRBs) and human research protection programs (HRPPs). Semistructured interviews were conducted with 22 local IRB/HRPP respondents and study team members from various study sites. Study teams appreciated the abbreviated length of the consent form and how the information tailored to help patients’ decisions was included while supplementary information was placed in an information sheet. They also described positive impacts on their interactions and processes; IRB/HRPP respondents valued the simplicity of the language, formatting, and attention to what was in the consent form versus what was on the information sheet. They supported the efforts and questioned whether local IRBs would have given approval. Some respondents were unsure of how to best use the information sheet. The consent forms were found to be patient-centered and implementable by study teams. Further experience is needed to identify optimal ways of incorporating supplemental written information. Since many of the IRB/HRPP respondents were uncertain whether their local IRBs would have approved the consent materials that were approved by the sIRB, these findings reinforce the potential for sIRB processes to facilitate the implementation of innovative approaches to consent.

Readability and complexity of written information presented to hospitalised patients for trial consent during the COVID-19 pandemic in the UK: a retrospective document analysis
Ewan Gourlay, Tim Felton, Mona Bafadhel, Christopher E Brightling, Jane C Davies, Rachael A Evans, Ling Pei Ho, Stefan J Marciniak, Nick A Maskell, Joanna Porter, Elizabeth Sapey, Salman Siddiqui, Samantha Walker, Tom Wilkinson, Alex Robert Horsley
BMJ Open, 21 March 2025; 15(3)
Abstract
Objectives
Patient information sheets (PISs) and informed consent forms (ICFs) are essential tools to communicate and document informed consent for clinical trial participation. These documents need to be easily understandable, especially when used to take informed consent from acutely unwell patients. Health literacy guidance recommends written information should be at a level between reading ages 9-11. We aimed to assess the readability and complexity of PISs/ICFs used for clinical trials of acute therapies during the COVID-19 pandemic.
Design
Retrospective document analysis.
Setting
PISs/ICFs used in trials involving pharmaceutical interventions recruiting hospitalised patients with COVID-19 during the first year of the pandemic were sourced from hospitals across the UK.
Primary and secondary outcome measures
PISs/ICFs were assessed for length, approximate reading time and subsection content. Readability and language complexity were assessed using Flesch-Kincaid Grade Level (FKGL) (range 1-18; higher is more complex), Gunning-Fog (GFOG) (range 1-20; higher is more complex) and Flesch Reading Ease Score (FRES) (range 0-100; below 60 is ‘difficult’ for comprehension).
Results
13 documents were analysed with a median length of 5139 words (range 1559-7026), equating to a median reading time of 21.4 min (range 6.5-29.3 min) at 240 words per minute. Median FKGL was 9.8 (9.1-10.8), GFOG 11.8 (10.4-13) and FRES was 54.6 (47.0-58.3). All documents were classified as ‘difficult’ for comprehension and had a reading age of 14 years old or higher.
Conclusions
All PISs/ICFs analysed contained literary complexity beyond both recommendations and the reading level of many in the UK population. Researchers should seek to improve communications to improve trial volunteer comprehension and recruitment.

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.