Informed Consent Remains a Process, Not a Checkbox
The use of electronic consent (e-consent) at Weill Cornell Medical College has expanded rapidly with the sudden demands of COVID-19 research. Researchers have been experimenting with various forms of e-consent for several years.
The health system built a home-grown solution (based on the NIH-sponsored REDCap system),1 which was more successful — at a lower cost, according to Curtis L. Cole, MD, chief information officer.
While working to find the single best way to implement e-consent, researchers conducted a systematic literature review. They examined 69 studies, hoping to learn from the experience of other health systems. The investigators found there was no unified approach for e-consent implementation.2 “I personally was surprised by how little was written, and the relatively low quantity of strong studies,” says Cole, one of the study’s authors.
The lack of consensus on how to switch to e-consent makes it more difficult to realize its potential benefits. Not everyone has the time or patience to explain the same thing at varying educational levels, in different languages, and confirm comprehension. “While humans still outperform computers in many ways, we are not great at consistency, and we all have biases,” says Cole, adding the ethical obligation is to maximize the benefits of e-consent while minimizing its harms.
E-consent can make the informed consent process better than the current paper-based format, according to another systematic review.3 “Different organizations are showing increasing interest in electronic tools to supplement or replace traditional, paper-based informed consent forms. However, implementation in biomedical research is slow,” says Evelien De Sutter, PhD, the study’s lead author and a researcher at KU Leuven in Belgium.
De Sutter and colleagues identified several concerns with e-consent, including confusion about the ethical review process. There also were varying views regarding the use of e-signatures, and what to do if participants lack digital literacy. “It is important to offer [participants] the choice between electronic informed consent and a paper-based informed consent form. It cannot be tolerated that participants are excluded from a research study,” De Sutter says.
Problems arise if e-consent turns informed consent into a “check the box” mentality, according to Julie M. Aultman, PhD, director of the medical ethics and humanities program and chair of the institutional review board at Northeast Ohio Medical University in Rootstown.
Researchers should be inviting questions and, along the way, determining people’s decision-making capacity. The level of risk involved in the study also should be weighed. An anonymous, minimal-risk survey that involves investigators gathering information on healthcare providers might be appropriate for e-consent.
For a study with known risks that are outside the scope of everyday practice or living, the consent process is more complex. That probably calls for a combination of e-consent and in-person communication. Research subjects might use e-consent during ongoing studies after an initial face-to-face paper consent is completed. Some studies include various stages or activities over months or years, such as a medical intervention followed by a focus group.
“E-consent can be useful to remind subjects of the multiple research activities they might be involved in over time, and of the continuous opportunity to ask questions and disclose concerns,” Aultman offers.
At any point of a study, a subject has the right to withdraw. “The process of consent is an important reminder of such rights,” Aultman says.
The drawback of e-consent is that if researchers cannot see the person, it is more difficult to gauge how well all this information is understood. Virtual meetings, pre-study surveys to assess capacity to consent, and follow-up phone calls are some options to ensure an ethical informed consent process.
Finally, consider whether people own the right equipment and can participate. “To deny opportunities due to inability to utilize e-consent is an injustice,” Aultman adds.
- Chen C, Turner SP, Sholle ET, et al. Evaluation of a REDCap-based workflow for supporting federal guidance for electronic informed consent. AMIA Jt Summits Transl Sci Proc 2019;2019:163-172.
- Chen C, Lee PI, Pain KJ, et al. Replacing paper informed consent with electronic informed consent for research in academic medical centers: A scoping review. AMIA Jt Summits Transl Sci Proc 2020; 2020:80-88.
- De Sutter E, Zaçe D, Boccia S, et al. Implementation of electronic informed consent in biomedical research and stakeholders’ perspectives: Systematic review. J Med Internet Res 2020;22:e19129.
E-consent can make informed consent easier, but researchers must avoid turning the process into a mindless task.
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