Article rédigé par la Société Pharmaspecific, spécialiste en recherche clinique

I wanted to thank Helen Marquet who helped me in writing this article.
The electronic way is increasingly used both in everyday life and in clinical research. Indeed, more and more exchanges are done electronically with the project team, investigators or even the Competent Authorities (Ethics Committee), ANSM. The study data are collected on electronic CRF and some hospitals have electronic medical records. So why not the informed consents? Is it possible to use electronic support to inform and obtain the informed consent of a patient? What are the advantages and limits of this method?

The informed consents in the United States

Yes, the informed consent of a patient is possible in the United States. The Food and Drug Administration (FDA) recently issued draft recommendations on the matter.

According to these recommendations, « electronic consent is the use of electronic systems and processes that could be in the form of multiple supports: text, graphics, audio, video, podcasts and interactive websites, biological recognition devices and card readers to transmit information concerning the study and to obtain informed consent.”

Obviously, the requirements for the content of the information delivered to the patient remain the same, in accordance with Good Clinical Practices: the information should be easily understandable for the patient, scientific terms and abbreviations must be explained at the first use.

However, the use of electronic and interactive systems gives leads to new requirements:

• The patient must be able to navigate easily through the system: go back, go further, stop and resume later.
• The patient must be able to use such a system; this excludes patients that doesn’t know or is not able to use a computer, having sight problems or motor difficulties… In this case, specific steps must be undertaken to ensure the information transmission and understanding to the patient. The FDA remains evasive about it. However, we can imagine the use of suitable devices for disabled person or simply choose oral information by the investigator.
• The patient must be able to ask any questions that arise to the investigator before signing the informed consent. The FDA recommends a face to face meeting with the investigator, or electronic combining messaging systems, phone calls, video conference or chat with the investigator to answer questions from the patient. Again, the security issue arises: data exchanged between the investigator and the patient must remain confidential.

The investigator has new methods to check that the patient have well understood the study, its potential risks and expected benefits: it is possible to add quizzes at the end of each section of the interactive electronic system.

The use of electronic support will then be allowed to transmit information to the patient, as long as this is understandable and appropriate, but also to collect the electronic signature of informed consent, if it complies with FDA regulation (Code of Federal Regulations title 21).

Under this Regulation, an electronic signature can be used when the said signature is reliable and equivalent to a handwritten paper signature. For this, the FDA recommends the use of systems such as encrypted electronic signatures, electronic signature pad, voice or fingerprint recognition signature (http://www.oscarservice.com/wp-content/uploads/2014/01/ePad-ink-w-hand_small .png).

• This type of system will collect the patient’s consent on site, but also remotely, in his absence. The system must therefore be able to clearly identify the patient to certify electronic signature in order to ensure that the person who signs is the right patient who will participate in clinical research.
• The system must record the electronic signature’s date of the informed consent.
• The patient must obtain an electronic form copy of the signed informed consent, that can be printed or sent by email or paper form.
• Access to interactive electronic system should be secured with restricted access. Obviously, patient confidentiality in the study should be assured: the patient’s identity, his participation in the study and the personal information entered into the system should not be disclosed.

The FDA therefore provides a framework for these electronic informed consents, but it is only a draft recommendation and not a regulation. However, since the recommendations publication, some CROs have implemented an electronic informed consent system in accordance with these recommendations.

The informed consent in Europe 

According to the European Directive 2001/20 / EC, informed consent is a decision, which must be written, dated and signed, to take part in a clinical trial, taken freely after being duly informed of the nature, scope, consequences and risks and have received appropriate documentation.

Up to now, no action appears to have been made regarding electronic informed consent.

And in emerging countries?

Particularly, some emerging countries are having a larger percentage of illiterate patients. According to GCPs, such patient requires the presence of an independent person from the investigator and promoter in order to read the information note to the patient.

To overcome this difficulty, India has authorized the collection of informed consent by video.  The whole study explanation process by the investigator, questions from the patient, and the confirmation that the patient has understood are filmed by a member of the investigator’s team (listed on the tasks delegation form)

While solving main issues, this process still raises questions about patient confidentiality:

• The patient is clearly identified in the video, because in addition to his name, appears his physical appearance.
•  If the patient refuses to be filmed, he cannot participate in the study. However, sick patients, do not necessarily want to be registered at that time. Moreover, following the implementation of this recommendation, 30-40% of patients who agreed to participate in the study in his normal physical state, refuse due to the collection of informed consent procedure.

To conclude

Electronic informed consent is a real improvement of its time. However, in this case, more than in the case of a paper form, every precaution must be taken to check the patient identity  and above all, guarantee his confidentiality. Electronic informed consents have non-negligible advantages:

• It allows a better understanding to the patient by the use of multiple supports: audio, video, interactive features and can actually facilitate study key data memorization by the patient.
• The patient’s understanding can be easily checked by the patient himself and perhaps by the investigator thanks, for example, to the presence of quizzes at the end of each part. The investigator can then provide additional explanations to the patient if he realizes that he did not understand or misunderstood.
• This reduces the informed consent result delays. Indeed, if the patient lives far from the site, he can easily get information about the study, discuss with the investigator and sign the informed consent remotely. The patient will have to move on site only for protocol visits.

This system can enable promoter immediate notification in case of a new patient inclusion on site.

In case of amendment to the protocol, patients can be notified promptly of changes in the study and can sign the informed consent from their home.

However, as shown in the case of India, precautions must be taken in the some consent:

• Some subjects may have difficulties with electronic tools (not familiar with computers, vision problems, reduced motor skills). Adapted or alternative solutions should be provided.
• If the patient does not meet the investigator face to face before signing the informed consent, the patient may have difficulty asking questions about the study. The investigator must contact him before he signs the informed consent in order to answer questions by telephone or videoconference. This implies that the patient must be reachable and has the necessary equipment in case of videoconference, for example.
• The patient’s personal data are more vulnerable than paper forms. Indeed, there are risks of piracy on the interactive device. Also, if the patient’s informed consent is saved on computer, mobile phone or tablet, they may be stolen, hacked or simply be found by another user of the device without the patient’s will. Furthermore, steps must be taken to prevent that the patient deletes the copy of his informed consent form by mistake.
• In case of electronic signatures, the patient’s identity must be checked. Indeed, provisions must be made to certify that the person signing is the patient who will participate in the clinical trial.

I hope this article provided you with relevant information on electronic consents. You can give your opinion on electronic informed consent in the comments.

Sophie Hammer

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