Sandra SAM Sather

There are many benefits for sites adopting electronic informed consent (eConsent) and it is vital that site study teams are not bystanders in the move towards its use. Being engaged and proactive when it comes to study start-up, training, source data controls, audit readiness, and communication will allow sites to gain a competitive advantage and make significant steps in improving compliance.

	With both regulators and industry groups advocating the impressive benefits of eConsent, it is no surprise that 66% of top 50 Pharma companies are engaged or planning an eConsent initiative in the near future, with 10 of the top 10 already having an eConsent strategy in place.

 In a recent site-specific survey, CRF Health gathered feedback from 105 respondents in roles including study coordinator, CRA, investigator, and researcher and found that eConsent is gaining greater acceptance and adoption by sites. 85% of respondents believe eConsent would be useful in their role and 61% of respondents believe eConsent will allow them to consent more participants into a trial.

	Securing informed consent from clinical trial participants involves more than a signature-researchers need to ensure participants truly understand what they’re signing. A critical first step, consent has a major impact on regulatory compliance, enrollment rates, and expenses across the life of a study. Comprehensive consent reporting enables site, sponsor, and ethics committee study teams to monitor the consent status at a study, site, and participant level, allowing better tracking and analysis of compliance.

	eConsent is one of the technological innovations introduced to clinical trials that has recently gained traction in adoption; it offers the potential to address some of the challenges associated with patient recruitment and retention

. In today’s progressively demanding climate, study sites are becoming wise to the advantages that the switch to eConsent can bring. Failing to obtain proper consent can have a negative impact on regulatory compliance, data integrity, human subject protection, and expenses across a study’s lifecycle. Therefore, improving the way in which the consent process is presented and decreasing the risk of inadequate consent is critical to a clinical trial’s success.

	Like the introduction of any technology in clinical trials, adoption of eConsent is slow and there is still considerable work to be done in preparing study sites for the move. However, the benefits are helping re-shape interaction with patients, bringing more convenient workflows for higher patient satisfaction. The use of eConsent can significantly impact a study for both participants and study organizers, as demonstrated by some of the benefits outlined below:

					The participants can start the consenting process at home and in some cases not have to go to a research site, if feasible for the particular study.

					The participant can start the consent and take a break as needed, and start where they left off. Participants may feel less pressure to sign straight away-they have time to review without feeling anxious and can involve family and friends in their decision.

					The presentation of the consent information with multi-media offers more features to offer links to additional resources for supporting an informed decision. 

					Paper consent documents are not interactive and challenging to reference information later than user digital technologies. eConsent sessions document when and what type of questions they have, better supporting the site to assist the participant in getting questions answered.

Benefits of eConsent for Sponsors/CROs/Investigators/IRBs

					Intuitive/interactive eConsent promotes participant compliance and retention through better comprehension.

					Enhanced convenience and understanding of what they’re signing impacts enrollment rates.

					By verifying that participants comprehend consent information, eConsent supports better information review with tiered information delivery, interactive assessments, rich media, and support for interactive communication with study staff.

					System documentation of the consent process that is supported by eConsent, e.g., version control, activity audit trail.

					Over time as content is repurposed, eConsent saves time by expediting consent development, approval, and deployment.  

					Ensuring patients receive standardized, up-to-date, and accurate information often results in more engaged patients.

Enhanced convenienceâand collaboration

					User-friendly online eConsent makes it easy for sponsors, sites, and IRBs/IECs to work together efficiently.

					The ability to consent participants remotely enables a wider participant base to be reached.

					eConsent delivers significant long-term cost savings over the life of a trial. By improving recruitment, reducing on-site consent monitoring activities, and mitigating the risk of regulatory and litigation-related expenses, eConsent limits costs while protecting the integrity of a clinical trial from the start.

	The paper-based supported informed consent process is widely-acknowledged as being among one of the most cited regulatory deficiencies, resulting in data integrity issues, spoiled reputation, delays, litigation, and even contributes to trial failure. Regulators have recognized this and are driving changes that include electronic informed consent methods. In line with this, the U.S. Food and Drug Administration (FDA) released a final guidance document in December 2016, Use of Electronic Informed Consent in Clinical Investigations, Questions and Answers. In this guidance, the FDA notes the research community’s increasing interest in electronic media to support consent is because of eConsent’s ability to:

	· Supplement or replace paper-based consent processes

	· Present the informed consent document information in an electronic media

	· Evaluate the participant’s comprehension of the information presented

	· Document the consent of the participant or their legally authorized representative (LAR)

	· Facilitate the participant’s ability to retain and comprehend the information

	· Allow for speedy participant notification of any pertinent new information that may affect their willingness to continue the study

	· Promote timely entry of any electronic consent data into the site and sponsor study databases

	· Allow for timely collection of the participant’s informed consent data from remote locations

	Despite the advantages, there is concern about the increased burden that the introduction of eConsent will place on study sites, despite its potential to revolutionize compliance and improve patients’ understanding of complex study information. Therefore, sites preparing to integrate eConsent technologies should take into consideration the following key points:

	This is a regulatory prerequisite most often directed by sites, so they need to ensure they protect patient private information and ensure the system they use satisfies the privacy laws in their region. Sites will also want to know how an eConsent system protects patients’ private health information.

	Sites should evaluate how using eConsent would be supported in the current way they conduct and document informed consent, how they schedule patients and how they perform the informed consent process. The introduction of eConsent technology will have a major impact on many site processes including workflows. Sites will need to understand how eConsent will impact how they currently undertake study start-up related to informed consent and working with ethics committees. Once these procedures are identified, sites can make well-defined decisions about how eConsent can be best integrated into existing workflows.

	Each site needs to be provided documentation of what information an eConsent solution automates versus what the site will still need to document manually. The site should establish a plan for how this will be managed in general and with each study since the protocol and the eConsent solution impacts the site consent process activities and documentation. Many eConsent technologies document consent process information that conventionally would have been recorded on paper, such as whether the patient had any questions and if these had been adequately answered. In addition, some eConsent systems enable sites to store source document notes, while others do not offer this functionality.

	Discussions around training need to originate early to avoid any delays in use or unexpected issues. Sites will need to plan what training requirements are necessary prior to using the system, how will the training be completed and documented, and how are they supported when using the system when questions come up with new users. It might initially be that the sponsor or eConsent vendor will provide the training for site personnel.

	Sites should have continuous access to their patient data entered into the system and the eConsent session journal of the participants’ consent activities. Consideration should be given as to how sites can provide direct access to the eConsent system if requested by the regulatory authorities during inspection. As mentioned, informed consent is among the most cited regulatory deficiencies and eConsent can support mitigation of these risks with digital timestamps, version control, real-time remote monitoring, and ongoing consent tracking, providing a clear audit trail. Participants can submit their signatures digitally or print and sign a paper version, making it easy to comply with local regulations.

	Informed consent is more than just a signature on a form, it is a process of information exchange that may include, in addition to reading and signing the informed consent document, subject recruitment materials, verbal instructions, question/answer sessions, and measures of subject understanding.

 A recent survey was undertaken in order to benchmark current eConsent use, gauge experiences and expectations, better understand adoption hurdles and challenges, and anticipate how eConsent use will grow in the future.

	The State of eConsent Industry Survey gathered opinions from 146 respondents from 100 biotech, pharmaceutical, CRO, and IRB organizations. The survey demonstrated that enhancing participant understanding and improving satisfaction are driving eConsent interest. Many organizations want to improve their informed consent processes and 90% of respondents agree that increasing the participant’s understanding of consent is a key business driver. The second highest factor at 88% is improving patient satisfaction.

	When asked to rank the benefits of eConsent, increasing compliance of study procedures/protocol was the #1 feature overall, followed by increasing the number of study participants, reducing study drop-outs, and minimizing time spent by site staÂ­ff explaining the study to participants. According to survey results, perceived high cost and uncertain ROI are preventing many organizations from becoming early adopters of eConsent (see Figure 1.) Time, privacy concerns, and user tech-savviness were less of a concern. Organizations want more evidence and education to prove the true value of eConsent.

	Figure 1: Barriers to implementing eConsent

	A key takeaway message was that eConsent adoption is on the rise. Momentum is building as sponsors shift from paper-based informed consent processes to eConsent. 33% of respondents are either using eConsent now or planning to in the near future. In the CRF Health site specific survey, 85% of respondents believe eConsent sounds useful in their role.

	The investigator’s recruitment and retention of an adequate study population remains a major determinant of the success of a clinical trial. Low rates of recruitment and retention result in longer study durations and delayed completion, not to mention higher costs. Over 40% of studies face challenges in meeting predefined enrollment goals, leaving sponsors and sites struggling to conduct trials effectively. Furthermore, 85% of clinical trials fail to retain enough patients, with the average dropout rate being as high as 30%.

	The introduction of eConsent represents a major advancement in clinical research programs, bringing improved presentation and flow of information for enhanced patient support, comprehension, and experiences. With better informed participants and the ability to keep subjects more easily updated, study teams should yield better quality data throughout the course of the trial and can establish themselves as innovators in improving the consent processes.

, Regulatory & Quality, TrialConsent®, CRF Health

	1. WIRB Copernicus Group: Electronic Informed Consent A New Industry Standard

http://resources.crfhealth.com/ebooks/state-of-econsent-2017-report

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm436811.pdf

https://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm

https://www.clinicalleader.com/doc/considerations-for-improving-patient-0001

Articles

There are many benefits for sites adopting electronic informed consent and it is vital that site study teams are not bystanders in the move towards its use.

Sandra SAM Sather

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Key Considerations for the Adoption of eConsent for Sites