Electronic Informed Consent in Clinical Trials: Opportunity or Liability
[Posted on: Thursday, September 3, 2015]
In a news release today, it was announced that England approved its first electronic informed consent. There has been quite a lot of discussion regarding use of electronic or computer-based informed consent in clinical trials. The challenges of these I terms of added cost and time for creating one have not been fully addressed. FDA published a guidance document in March of this year on the topic detailing what it expects to see in computer-based informed consent. On the face value electronic informed consent (E-IC) seems quite promising as unlike paper informed consent forms (ICFs) which contain a “dry” description of a given trial, an E-IC can contains images, audio, video, and interactive tools allowing a better description of a given trial. Also, the E-IC can be hosted online (informed consent web-site) allowing trial subjects to review the E-IC on their home computers or smart phones prior to showing up at the clinical site, saving time. The trial personnel can monitor the subjects reading of the E-IC remotely and the tracking the understanding and acceptance of an E-IC can be more suitable to electronic case report forms (e-CRFs) common in clinical trial these days. There is ample support in the industry for use of E-IC both from non-profit groups, and pharma companies. However, an E-IC also raises concerns primarily around cost, time, authenticity and confidentiality of these consents. The FDA guidance clarified that E-IC does not change the basic requirements of an informed consent per GCP regulations. Most of the provisions of the traditional paper informed consent can be applied to electronic systems as well. But creating an E-IC is not as simple as writing a document for reading and sign-off. E-IC requires additional work in terms of organization of content, selection and use of additional elements to clarify issues related to the trial, and computer programming skills to design a computer-based system for patients. An E-IC is certainly an added expense and time. Other challenges are creating secure computer systems at diverse clinical sites. With the rise of electronic medical records, system security is becoming less of an issue. Technology is less expensive and widely available at least in the US and few Western countries. Even though technically quite feasible, practical applications of E-IC are limited due to the cost and time needed to implement one for a given trial. It may take time to see the benefit over added cost and time.
Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research