One barrier to recruitment of qualified research participants for clinical trials is the cumbersome, time-consuming consent process. Another is the lack of access to participants in remote locations.

Teleconsent, a novel solution developed by researchers at the Medical University of South Carolina (MUSC) in Charleston, addresses both of these difficulties.¹

“We developed teleconsent to address a major challenge, which was to recruit and consent research participants in a largely rural state,” says Brandon M. Welch, MS, PhD, assistant professor at MUSC’s Biomedical Informatics Center.

The researchers began exploring alternative ways to obtain consent that didn’t require travelling, either for the researcher or participant. They came up against similar difficulties with mail, fax, and electronic consents: There is no easy way to verify that the participant actually understood what he or she signed. It’s also difficult to verify the prospective candidate is the one completing the form.

“Having the ability to actually see the participant while they are completing the document is the key innovation over other solutions,” says Welch.

Not everyone has a computer with an internet connection, which is needed for a teleconsent call. This raises ethical concerns involving access. “We are currently addressing this issue by making teleconsent available on smartphones,” says Welch.

The group is working on a way for researchers to design and build their own electronic consent documents. “We’re also interested in integrating other features that support clinical research, such as survey forms, and devices for data collection and transfer,” says Welch.

Researchers still obtain consent in person in the vast majority of cases. They use teleconsent only when the participants can’t be accessed in person.

“Teleconsent is intended to complement, not replace, the traditional consent process,” notes Welch. Teleconsent makes it easier for researchers to recruit rural participants, who are typically underutilized in research.²

“I’ve heard researchers make the argument to our IRB that they are ethically bound to use teleconsent to be as inclusive as possible of those who are typically not represented in research studies,” notes Welch.

REFERENCES

1. Welch BM, Marshall E, Qanungo S, et al. Teleconsent: A novel approach to obtain informed consent for research. Contemporary Clinical Trials Communications 2016; 3:74-79.
2. Kim SH, Tanner A, Friedman DB, et al. Barriers to clinical trial participation: a comparison of rural and urban communities in South Carolina. J Community Health. 2014; 39(3):562-571.

SOURCE

• Brandon M. Welch, MS, PhD, Assistant Professor, Biomedical Informatics Center, Medical University of South Carolina, Charleston. Phone: (843) 792-5452. Email: welchbm@musc.edu.