The purpose of informed consent is to ensure people are fully aware of what they would be signing up for by volunteering in a clinical trial. The consent of a patient is memorialized in an informed consent form/agreement (ICF) and retained as part of the trial’s records. Historically, informed consent has been performed via a face-to-face meeting with a clinician during which the participant is asked to read and sign a dense, lengthy legal document.
eConsent (electronic informed consent, also abbreviated eIC or eICF) refers to using modern digital technology to help with consent-related processes in a clinical trial. eICF can be carried out in-clinic, or remotely, or sometimes a mixture of the two.
There are many excellent reasons why researchers are choosing electronic informed consent for clinical trials (eICF). Here are five:
One: Improved effectiveness.
The purpose of informed consent is to educate the participant. Digital tools offer a more immersive and effective way to meet this goal compared to paper. For example, eICF can allow clinical trials to introduce concepts via video as well as to incorporate questions that can help verify a participant’s understanding. Equally important, participants can drill down to successive layers of detail.
As a longtime leader in clinical trials shared in Clinical Leader:
“…electronic informed consents can improve understanding if they are well designed and their whole multilayer potential is used, including hyperlinks to terms often posted by patient organizations and advocates on patient associations’ websites, videos, articles and other resources, quizzes, etc.”
Two: Easier record-keeping.
Once an eIC is electronically signed, it’s automatically saved into the permanent record for the clinical trial. Study protocols often change, and these changes may require re-consenting participants. eConsent in clinical trials makes re-consenting much easier.
Three: More efficient workflows.
eIC systems can help ensure participants are consented on the appropriate protocol version at any time. When used in conjunction with an electronic data capture system, one can programmatically ensure patients are participating only in activities for which they have consented. eIC also simplifies work for study monitors, who no longer need to manually verify consent status against a paper document housed at a study site.
Remote administration of consent offers increased convenience for both participants and the study team. Especially when used as part of a broader decentralized clinical trial approach, eConsent in clinical trials enables sponsors to recruit patients with fewer geographic constraints. While remote consent may not always align with the nature and goals of a given clinical trial, many of these five benefits still apply when eConsent is used in-person.
Five: Patient preference.
A three-year study published by the American Society of Clinical Oncology found patients are more likely to complete electronic informed consent forms than the paper version and the participants who used electronic forms had “increased completion of mandatory consent fields.” A survey of participants showed an overwhelming number (83 percent) said “eIC was easy or very easy to use.”
At OpenClinica, our clients have experienced easy implementation of eConsent capabilities, better engaged participants and streamlined record keeping and compliance in any trial setting. Click here for more information about digital eConsent management in clinical trials.
While informing the patient about the purpose and methods of the research, the risks involved, and how their data will be used may seem like the obvious, ethical thing to do, research wasn’t always carried out this way. In fact, the practice of obtaining a clinical trial participant’s informed consent only became a requirement in the latter half of the 20th century. Today, in the United States, informed consent is codified in law in under 45 CFR 46 and 21 CFR 50.