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Changing the Paradigm for Informed Consent

August 4, 2016

Many large academic centers conduct hundreds of clinical trials and studies annually. Even smaller organizations conduct up to 50 studies and clinical trials per year. It is indeed an exciting time of discovery for the medical industry as new discoveries revolutionize healthcare delivery and disease treatment.


We also all see that personalized treatment and drugs for the treatment and cure of diseases such as cancer offer the promise of lifetime remission. However, to reach this amazing goal, many clinical trials and studies need to be conducted with the eventual goal of moving this type of treatment into the main stream.


Clinical Trials require that patients willing to participate in the trial, and that Review Boards (IRBs) are sure that the study is able to demonstrate that trial participants fully understand the trial, their participation, the risks of participation and are offered the opportunity to “reject” consent from participation.




Informing the patient about the trial cannot be a “sales presentation” but must present a fair and balanced set of information and instructions to the patient so they can indeed make an informed decision regarding their participation in the trial.


Despite significant advancements in information technology, most organizations do not have a standardized approach or methodology for informing a patient or gaining their consent for participation. In fact, the vast majority of trials collect participant consent on paper. Informing the participant is usually a face to face verbal discussion, and as a result there is no way to clearly ascertain if the participant truly understands what they are consenting too, or genuinely given the opportunity to decline or reject their participation.

If a patient does agree to participate, quite often they do not have access to any educational material regarding the trial, or an easy way to communicate with the team conducting the trial should they wish to terminate their consent or have other concerns.


In March 2015 the FDA released a document entitled “Use of Electronic Informed Consent in Clinical Investigations1”.  In this document, the FDA outlines draft guidance for organizations that wish to use Electronic Informed Consent (eIC) for Clinical Trials. This document provides “recommendations for clinical investigators, sponsors, and institutional 19 review boards (IRBs) on the use of electronic media and processes to obtain informed consent 20 for FDA-regulated clinical investigations of medical products, including human drug and 21 biological products, medical devices, and combinations thereof”


Among other items, the document places great emphasis on informing of patients / participants of the trial, documenting the patient/participants understanding of the trial and providing appropriate education about the study to the patient/participant.

Use of eIC across an organization also offers the opportunity for IRBs to standardize the entire eIC process. This offers better protection of patients as well as organizations conducting trials.

In recognition of the issues facing many organizations regarding informed consent, its appropriate documentation, patient/participant education, follow-up education and many other factors, Willowglade Technologies has developed an extension to the Personalized Patient Experience Platform that meets the recommendations of the FDA when it comes to eIC.




Patients/Participants are presented a video on a mobile device that is produced by the sponsoring organization – this video informs in a standard manner for all participants of a trial about the trial. It offers the opportunity to seek clarification from a healthcare professional when the video is complete and importantly it ascertains and documents if the patient/participant understands the study and the nature of their consent.


Willowglade eIC also allows the presentation of the actual consent form on a mobile device, the capture of electronic signatures as well as the ability to email or print the signed consent form. The patient/participant can also directly be emailed not only the signed consent form, but also links to the educational video they viewed prior to consent so they can refresh their understanding at any time, and of course share that educational material with their family and friends.


Importantly, the Willowglade eIC solution provides organizations with the opportunity to standardize their informed consent process across all of their studies, giving a level of comfort that all participants have an optimal opportunity to be educated, question and understand the study and what they are participating in.


To learn more about Willowglade eIC and about the many ways Willowglade Technologies is changing the electronic relationship between patients and providers, please feel free to visit our website or contact us at info@willowgladetechnologies.com


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











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