Ethical Approaches if Researchers Use Telehealth to Obtain Informed Consent
May 1, 2025
By Stacey Kusterbeck
When someone is considering whether to participate in a clinical trial, anything researchers can do to streamline the process can boost recruitment and retention. “Geographic barriers, transportation costs, and literacy issues can delay participant enrollment and increase costs,” says Saif Khairat, PhD, MPH, a research fellow at Sheps Center for Health Services Research at University of North Carolina at Chapel Hill.
Using telehealth as part of the informed consent process could streamline the procedure, but it also presents some ethical concerns. Khairat and colleagues conducted a study to explore if teleconsent could provide a viable alternative to traditional in-person informed consent, while maintaining participants’ understanding of the study protocol and decision-making abilities.1
Participants were assigned to either a teleconsent group or in-person consent group, each with 32 participants. The teleconsent group reviewed and electronically signed the informed consent documents but also had access to real-time interaction with researchers. Both teleconsent and in-person methods resulted in comparable levels of comprehension and voluntariness. “This suggests that telehealth can effectively overcome barriers to participation. These findings challenge the assumption that remote consent processes could hinder understanding compared to face-to-face interactions,” says Khairat.
Khairat says these are important considerations for researchers who want to use telehealth for informed consent processes:
- Researchers must consider the technological capabilities of participants. Not everyone has access to the necessary devices or internet connectivity for teleconsent. To address this, the researchers developed a Digital Health Index to assist investigators in measuring the readiness of U.S. communities to use digital tools. “Lack of access to technology or digital literacy can hinder telehealth’s effectiveness in informed consent processes,” explains Khairat. Researchers should assess the digital readiness of participants using tools such as the Digital Health Index to determine if teleconsent or in-person consent is more suitable for prospective study participants. “This enables researchers to tailor their recruitment effort to the preparedness of interested participants,” says Khairat.
- Researchers should ensure that the telehealth platform supports key informed consent requirements (such as screen sharing and obtaining a live signature). “The goal is to mimic the in-person experience, plus add additional identity validation measures,” says Khairat.
- Researchers should be aware that regulatory hurdles could limit the adoption of telehealth for informed consent. Regulations may require researchers to ensure that the person who participates in the teleconsent session actually is the same person who signs the consent form. “Therefore, during the signature part of the teleconsent session, a picture of the participant is taken and stored along with their digital signature,” says Khairat.
Khairat says that Institutional Review Boards should focus on these concerns when reviewing study protocols including telehealth for informed consent:
- the ability of the interested participant to comprehend the study protocol;
- the secure storage of the signed consent forms;
- ensuring that the use of teleconsent does not create barriers to people who are digitally disadvantaged.
“Telehealth has the potential to enhance recruitment and retention in clinical research by overcoming geographic and accessibility barriers, making it easier for participants to engage with clinical studies,” concludes Khairat.
Reference
1. Khairat S, Ottmar P, Chourasia P, Obeid J. Effectiveness of telehealth versus in-person informed consent: Randomized study of comprehension and decision-making. J Med Internet Res. 2025;27:e63473.
When someone is considering whether to participate in a clinical trial, anything researchers can do to streamline the process can boost recruitment and retention. Using telehealth as part of the informed consent process could streamline the procedure, but it also presents some ethical concerns
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