Electronic Informed Consent: Empowering Researchers and Participants

News / TRIbune Newsletter

What is e-consent?

E-consent may take place using a shared interface via a website, app, or other specific platform with audio-visual and interactive features. The process, however, is more than just getting a research participant’s electronic signature or checking on an “Agree” or “Yes” box on a mobile device. The digital process for informed consent, as with using a paper consent form, must disclose information about the study so the participant can make a voluntary, informed decision with a full understanding of the risks and benefits involved and can reverse their decision if they want. The process also must be documented.

The key is what digital method or methods are used to implement the e-consent process securely and meet regulatory and research protocol requirements, such as approval of the consenting process by ethics committees, identity verification, and FDA inspections. Varied e-consenting approaches may be used simultaneously, allowing researchers flexibility in customizing methods to meet their project’s needs or specific participants’ needs or preferences.¹ For example, remote e-consent may include video chat discussion, self-paced navigation of the e-platform, electronic signature, and electronic archiving and storage. Alternately, e-consent may combine traditional face-to-face in-person discussion with a knowledgeable research team member to help navigate the e-platform and answer questions in real time before e-consenting electronically.

The U.S. Food and Drug Administration (FDA),² the Health Research Authority (HRA), and the Medicines and Healthcare products Regulatory Agency (MHRA)³ recognize e-consent as a credible alternative to conventional face-to-face consenting processes. Last year, with the COVID-19 outbreak, the FDA released additional guidance³ recommending e-consent⁴ instead of traditional paper consent. The FDA is even providing access to a free e-consent platform available via the Apple App and Google Play stores, given COVID-19 safety concerns.⁵ Various commercial software programs for e-consent also are available, along with homegrown systems.

Moving from paper to e-consent

Advantages

For remotely conducted research, e-consent provides a feasible, robust alternative to in-person consenting approaches, including the following benefits:

Enhance infection prevention and control. With consent taking place over an electronic or digital platform, research staff can decrease infectious or infection exposure and use of personal protective equipment (PPE). Participants can use their own internet-connected devices to talk with staff about the research and access the Informed Consent Form (ICF). For participants who do not have an internet-connected device, research staff may consider temporarily providing a device that can be disinfected when returned.

Expand research opportunities in new locations. For research staff centrally located in a care system with different hospital or clinic locations, possibly throughout the country, e-consent enables broader reach for research participant recruitment. E-consent helps research staff capture more participants and may improve participant diversity and inclusion by enabling under-represented populations, such as in rural areas or among non-white communities, an opportunity to participate. At the University of Minnesota, researchers at the academic health center built their own e-consent platform to use at more than 10 locations within their broader hospital system as well as at 10 locations outside of Minnesota.⁶ Researchers screened for potentially eligible patients remotely and then contacted clinical staff at each site to assist with qualified participants.

Improve research workflows and compliance. Research reviews¹ show that e-consent can help reduce several issues, including the burden of collecting signed hardcopy consent forms, participants just checking “Agree” when reading long paper documents, and errors associated with archiving paper ICFs. With verified time-stamped signatures (monitors can know when a participant has electronically signed consent) and hard stops to prevent missing fields, e-platforms for consent may also facilitate using the most updated version of an ICF, as well as conducting quality control checks, audits, and data searches. Experts⁶ also note e-consent enables participants to review consent information and documents without research staff present, which may mitigate any potential feelings of coercion from doing an in-person consent and feeling compelled to sign a form.

Increase participant (or Legally Authorized Representative [LAR]) understanding. Using a digital interactive interface can enhance how information is presented to help ensure potential participants give their informed consent.⁷ For example, some e-platforms allow participants to alter the size of the text, improving readability if visually impaired. Audio allows for playback and hyperlinks provide explanations of keywords. Other features may include audio-visual enhancements, such as images, diagrams, call-out boxes, and reports, to highlight important information and improve participants’ engagement with the consenting information; short quizzes to assess comprehension; and video to standardize the process and give the same information to all participants.

Challenges to increased use of e-consent

Although e-consent offers positive aspects to improving the informed consent process, various important pitfalls also must be considered, including the following:

Equitable access and e-literacy. Widespread socioeconomic implementation of e-consent may not be feasible for people with limited technology and internet access.⁶ As with paper consent, visual impairment may be a concern if the e-platform is not adjustable (for example, to increase type size, either within the e-platform or via the device used to access the e-platform). If the e-platform includes audio, an auditory deficit also may be a concern. Additionally, the e-platform may require entering digital personal information, such as an email address or login key, to access the e-consent system. Participants also may not be technologically literate or have limited interest or ability to learn or navigate complex technical systems.

Site monitoring of e-consents. If the e-consent does not include an electronic method for notifying the Clinical Research Associate (CRA) when a participant has signed the e-consent, whether done on site or remotely, establishing a process for monitoring will be needed.

Capacity to consent. In general, assessing a participant’s capacity to consent can be difficult, and if the individual is critically ill, even more so. The University of Minnesota found that using a competence assessment tool, administered by phone or video chat was successful, but further research validating this approach is needed.⁶ Trials with critically ill patients often permit a LAR to provide consent, which can be conducted with e-consent or paper consent.

Electronic document fatigue. As with fatigue in reading and understanding long paper consents, using an electronic process for the research consent process may pose a similar concern, if participants are required to fill out different types of forms or review lots of materials (videos, etc.) electronically regarding their care. Research¹ indicates some participants may simply prefer paper consent.

Interactive format. While research reviews⁷ indicate that research participants express the usefulness of graphics and audio, participants also voice caution that background music and sound effects, if used in the e-platform, could be an added distraction, and that 5-minute videos are too long.

Confirming identity. Ethics committees may express uncertainty about the ability to confirm research participants’ identity remotely.⁷

Secure platform. Research participants may have concerns about the security of the e-platform, including privacy breaches, data misuse, and anonymity relating to e-consent.^7,8 As one expert points out, if a study uses a website app or device, researchers need to pay attention to the website or device Privacy Policies (PP) and Terms of Service (ToS), which may undermine the terms of the e-consent with exculpatory language (e.g., manufacturer not responsible for security).⁹

Retrospective studies. With retrospective studies, guaranteeing anonymity to participants about future use of data and biologic samples when they initially sign consent may be difficult.¹⁰ With growing ability to easily transfer data using digital technologies, data collected for one purpose later used for another or combined with datasets made identifiable may pose a risk to assured anonymity.

Responsible implementation of e-consent

With digital health processes in general increasingly becoming the norm, and patients and research participants wanting greater control of how their data or biologic samples are or may be used, e-consent offers the possibility of using a personalized approach in clinical trials. E-consent research indicates study participants usually are positive about their e-consent experience, reporting that e-consent was more interesting and easier to navigate than the paper alternative, more convenient to read sections at a time at their own pace, and they could use the e-consent system to get information about the study.¹

Special attention, however, needs to be paid to addressing inequities in implementing e-consent. Research staff must plan for the challenges inherent in ensuring potential participants have equitable opportunity to participate in the research. When a study team cannot meet in person with a potential research participant or their LAR to conduct an informed consent discussion, get their signed voluntary consent, and archive documentation, e-consent can provide for an efficient consenting process. Yet investigators must determine specifically how to implement an e-consent process for each study and its specific participants. E-consent platforms must also always adhere to security and management regulations, as well as national and local research ethics guidelines for the specific study. In addition, e-platforms should leave room for customization for the specific study and participants. Research reviewers of the e-consent process recommend that paper-based ICFs are available as an alternative to accommodate a participant’s preference.

It is also important to consider practicalities, such as impact on workflows and financial implications, before implementing e-consent processes. While the FDA app available during the COVID-19 public health emergency to support continuation of clinical trials is free, other e-consent platforms vary in cost. Customization of a platform to meet a clinical trial’s specific needs may affect cost as well. Some platforms require online license agreements, even if these platforms are available at no charge to nonprofit organizations, such as Research Electronic Data Capture (REDCap), a customizable web-based platform application with several language translations (e.g., Chinese, French, German, Portuguese) that Vanderbilt University developed.¹¹ Various commercial companies that offer a range of e-consent options, such as Medidata Rave eConsent, DrugDev, ICON’s FIRECREST, SIGNANT Health, Medrio eConsent, Medable, ClinConsent, ClinOne Florence, Clinical Ink, SCI Solutions, Bio-optronics, Castor, Kayentis, Interlace Health, Crucial Data Solutions, Cloudbyz, and Datacubed Health, may also provide discounted access during the COVID-19 pandemic.¹²

Access to the e-consent platform is just one of a range of features. For example, REDCap lets participants retrieve documents through a 1-click hyperlink sent by text or email, so they do not need to create a username or password.² Other differences between platforms may include the type of assessment of understanding (e.g., quiz to measure content knowledge vs. time to reflect on new knowledge) or the type of self-paced navigation, such as linear (only forward or backward) vs. non-linear.⁹ With many options available, thinking about their impact and whether beneficial to the specific needs of a particular study is critical.

Opportunities exist for researchers and commercial software vendors to collaboratively develop e-consent approaches that meet specific research programs’ needs and address the challenges inherent in the e-consent process while also fulfilling the ethical obligation for informing potential participants. TRI’s Human Subject Protection, Multimedia, and IT teams offer the optimum combination of expertise to support e-consent. As new electronic and digital tools, platforms, and processes are developed, TRI is well-positioned to improve e-consent experiences and expectations for participants and clinical research teams.

About the Author

Ruth Taswell, MA, CSER, has over 3 decades of experience developing evidence-based, award-winning customized resources for researchers, clinicians, and patients.

Footnotes

Skelton, E., Drey, N., Rutherfor, M., Ayers, S. and Malamateniou, C. (2020). Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting. International Journal of Medical Informatics, 143, 104271. doi:10.1016/j.ijmedinf.2020.104271

U.S. Food and Drug Administration. (2016, December). Use of electronic informed consent: questions and answers.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-informed-consent-clinical-investigations-questions-and-answers

Health Research Authority. (2018, September). HRA and MHRA publish joint statement on seeking and documenting consent using electronic methods (eConsent).
https://www.hra.nhs.uk/about-us/news-updates/hra-and-mhra-publish-joint-statement-seeking-and-documenting-consent-using-electronic-methods-econsent/

U.S. Food and Drug Administration. (2020, March; updated 2020, December). Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards. https://www.fda.gov/media/136238/download

U.S. Food and Drug Administration. (2020, May). COVID MyStudies Application (App). https://www.fda.gov/drugs/science-and-research-drugs/covid-mystudies-application-app

Jaton, ER., Stang, J., Biros, M., Staugaitis, A., Scherber, J., Merkle, F., Mohr, N.M., Streib, C., Klein, L., Puskarich, M.A. (2020). The use of electronic consent for COVID-19 clinical trials: Lessons for emergency care research during a pandemic and beyond. Academic Emergency Medicine, 27(11), 1183–1186. doi.org/10.1111/acem.14141

De Sutter, E., Zace, D. Boccai, S., Di Pietro, M.L., Geerts, D., Borry, P., Huys, I. (2020). Implementation of electronic informed consent in biomedical research and stakeholders’ perspectives: Systematic review. Journal of Medical Internet Research, 22(10), e19129. Doi: 10.2169/19129

Chen, C., Lee, P., Pain, K.J., Delgado, D., Cole, C.L., Campion, Jr., T.R. (2020). Replacing paper informed consent with electronic informed consent for research in academic medical centers: A scoping review. AMIA Joint Summits on Translational Science Proceedings, 2020, 80–88.

Doerr, M. (2020). Use of e-consent in human subjects research [Webinar]. Sage Bionetworks Lunch and Learn Series. https://sagebionetworks.org/tools_resources/ohrp-econsent-webinar/

Teare, H.J.A., Prictor, M. Kaye, J. (2020). Reflections on dynamic consent in biomedical research: the story so far. European Journal of Human Genetics, doi.org/10.1038/s41431-020-00771-z
https://www.nejm.org/doi/full/10.1056/NEJMoa2007764

REDCap. (2021, February 22). Projectredcap.org

Katsarova, N. (2020, April 7). List of eConsent solutions for clinical trials. TrialHub, https://trialhub.findmecure.com/blog/articles/econsent-solutions/