Designing e-consent protocols for pragmatic clinical trials: case studies from a UKCRC clinical trials unit
Matt Hammond, Polly Ashford, Juliet High, Lucy Clark, Gregory Howard, Megan Jones, Susan Stirling, Claire West
BMC Trials, 22 May 2024
Abstract
Background
Interest in and use of electronic consent (e-consent) in the conduct of academic clinical trials has increased since the COVID-19 pandemic. E-consent offers advantages including increased efficiency and accessibility, and reduced burden on site staff, which can be appealing to academic trialists anticipating challenges in recruitment to complex trial designs or with limited funding. However, there are many options to consider when using e-consent in a study protocol. This paper presents five case studies from Norwich Clinical Trials Unit, demonstrating how e-consent models can be effectively tailored to the needs of different trials. These examples illustrate the options around and benefits of e-consent, the acceptability of e-consent by participants, and the design considerations that were made during the development of the trial protocols.
Case Studies
Five randomised trials are presented, selected from a range of different trial designs, disease areas, interventions, and patient populations. E-consent was either offered as an alternative to paper consent, according to participant preference, or as the sole method of consent. E-consent was generally used to facilitate remote consent in decentralised trials but was also chosen to increase efficiency and reduce burden in an emergency department setting. The technical implementation of e-consent and detailed participant procedures were tailored to the needs of the trial settings and patient populations. For example, accompanying participant information sheets were provided in paper or electronic form, and electronic signatures could be typed or drawn. Administrative data on uptake of e-consent is presented where available.
Conclusion
This paper demonstrates that the operational and technical aspects of implementing e-consent in clinical trials can be influenced by the trial design, the needs and characteristics of the trial population, financial/efficiency considerations, and level of risk. E-consent is not a one-size-fits-all tool for trials, and its use should be carefully considered during the development of the trial protocol, in conjunction with patient and public involvement contributors, site staff and other trial stakeholders.

Development and validation of a stakeholder-driven, self-contained electronic informed consent platform for trio-based genomic research studies
Bethany Y Norton, James Liu, Sara A Lewis, Helen Magee, Tyler N Kruer, Rachael Dinh, Somayeh Bakhtiari, Sandra H. Nordlie, Sheetal Shetty, Jennifer Heim, Yumi Nishiyama, Jorge Arango, Darcy Johnson, Lee Seabrooke, Mitchell Shub, Robert Rosenberg, Michele Shusterman, Stephen Wisniewski, Blair Cooper, Erin Rothwell, Michael C Fahey, M. Wade Shrader, Nancy Lennon, Joyce Oleszek, Wendy Pierce, Hannah Fleming, Mohan Belthur, Jennifer Tinto, Garey Noritz, Laurie Glader, Kelsey Steffan, William Walker, Deborah Grenard, Bhooma Aravamuthan, Kristie Bjornson, Malin Joseph, Paul Gross, Michael C Kruer, the Cerebral Palsy Research Network
medRxiv, 3 May 2024
Abstract
    Increasingly long and complex informed consents have yielded studies demonstrating comparatively low participant comprehension and satisfaction with traditional face-to-face approaches. In parallel, interest in electronic consents for clinical and research genomics has steadily increased, yet limited data are available for trio-based genomic discovery studies. We describe the design, development, implementation, and validation of an electronic iConsent application for trio-based genomic research deployed to support genomic studies of cerebral palsy. iConsent development incorporated stakeholder perspectives including researchers, patient advocates, institutional review board members, and genomic data-sharing considerations. The iConsent platform integrated principles derived from prior electronic consenting research and elements of multimedia learning theory. Participant comprehension was assessed in an interactive teachback format. The iConsent application achieved nine of ten proposed desiderata for effective patient-focused electronic consenting for genomic research.

Overall, participants demonstrated high comprehension and retention of key human subjects’ considerations. Enrollees reported high levels of satisfaction with the iConsent, and we found that participant comprehension, iConsent clarity, privacy protections, and study goal explanations were associated with overall satisfaction. Although opportunities exist to optimize iConsent, we show that such an approach is feasible, can satisfy multiple stakeholder requirements, and can realize high participant satisfaction and comprehension while increasing study reach.

Piloting electronic informed consenting in a pneumococcal human infection study in Blantyre, Malawi
Research Article
Clara Ngoliwa, Chikondi Chakwiya, Joel Gondwe, Edna Nsomba, Vitumbiko Nkhoma, Modesta Reuben, Linda Chantunga, Pemphero Liwonde, Edward Mangani, Evaristar Kudowa, Lumbani Makhaza, Neema Toto, Tiferanji Sochera, Tarsizio Chikaonda, Ben Morton, Marc Y.R. Henrion, Dingase Dula, Stephen B. Gordon, Anthony E. Chirwa
Wellcome Open Research, 29 April 2024
Open Access
Abstract
Background
Electronic consent can potentially improve accuracy, workflow, and overall patient experience in clinical research but
has not been used in Malawi, owing to uncertainty about data security and technical support.
Objectives
We explored the feasibility of using electronic consent (e-consent) in an ongoing human infection study in Blantyre Malawi. We dual-consented participants by both electronic and paper methods to assess the feasibility of electronic consent, and then compared benefits and challenges of the two methods.
Methods
The approved paper consent forms were digitized using Open Data Kit (ODK). Following participant information giving by the research staff, healthy literate adult participants with no audio-visual impairments completed a self-administered e-consent and provided an electronic signature. Signed e-consent forms were uploaded to a secure study server. While the participants were in clinic, the signed electronic consent form was printed as a copy for the participant. The feasibility, advantages and disadvantages including data safety consideration for e-consenting were evaluated by exploring issues surrounding use of e-consenting versus paper-based consenting. Consent forms were analysed by research staff for errors such as overwriting and legibility.
Results
We piloted 109 participants to e-consenting. It was found to be user friendly, had 0% (n 0/109) errors compared to 43.1% (n 47/109) in paper based methods along with enhanced data safety. The challenges included difficult digitization of ethics stamped documents, volunteer unfamiliarity with tablet user interface and its requirement for a working internet and printer.
Conclusion
E-consenting was feasible but required additional resource investment. Benefits included error minimization and data security.