Rapid development of technology in the medical industry is forcing life science companies and research institutions to review and modify internal procedures to adapt. Electronic informed consent (eConsent), though still highly debated, is a prominent example of a procedure in flux. According to the U.S. Food and Drug Administration (FDA), eConsent is the “use of electronic systems that may employ multiple electronical media to convey information related to the study and to obtain and document informed consent”.1 eConsent could, among other benefits, accelerate the patient consent process and allow for quicker dissemination of important clinical trial information to participants. However, some still regard the eConsent process as unreliable, question the current regulatory and ethical landscape around the technology, and fear that electronic documents are easier to forge or tamper.2
When asked about the introduction of electronic informed consent processes into the clinical trial landscape, Thorsten Ruppert, a Senior Manager at the Association of Research-Based Pharmaceutical Companies, stated many positive comments, explaining that it would be a “major improvement in the overall participant consenting process of clinical trials…eConsent can be relevant for every trial”. According to Ruppert, such technology will likely be demanded nearly everywhere very soon; therefore, it is vital to implement stricter protocol beforehand to prevent any incidents that could further increase the number of clinical investigation failures. Some countries, such as Switzerland, have already adopted eConsent in recent years; however, it is only allowed for certain clinical studies to act as a trial for the new program.2
Although there are many positives to adopting the eConsent program, sponsors should still consider any necessary integration between it and other previously existing consent programs. Due to the lengthy transition between the consent procedures, it is recommended that the company uses both programs to start to ensure seamless integration. This would also require training for new procedures that would need to be taken with eConsent. Additionally, the validity of the consent may not transfer between states and/or other ethics committees. 2
As adoption rates of electronic informed consent products and procedures increase within the life science industry, it is also recommended that companies and researchers discuss the transition with its ethics committee, or institutional/independent review board (IRB). Ensuring that the new consent procedure has been reviewed and approved prior to commencing a trial will ensure that studies can proceed as scheduled.2
If you need support transitioning towards an eConsent procedure or need your informed consent process and study protocol reviewed before your next clinical study, contact our experienced clinical research team today with your questions.
1 https://www.fda.gov/downloads/drugs/guidances/ucm436811.pdf
2 http://www.clinicalinformaticsnews.com/2019/01/23/what-is-holding-back-the-adoption-of-econsent.aspx