We organized a webinar on 23/11 entitled “eConsent in clinical research: how to guarantee it”. We welcomed Michel Arnoult, a consultant and expert in regulatory requirements in the field of clinical research, to discuss the legal framework for electronic patient consent.

Many issues have been raised directly. Here is a summary with the answers provided by our experts.

  • Is the eConsent system possible for pediatric studies? What about a tutor’s signature? Protocol must have foreseen this case. The PPC and/or an Ethics Committee must agree.
  • It seems to me that from the moment you transfer data to a French or European subsidiary of an American company, that was equivalent to transferring the data to the United States. How to protect the data in this case? The paper consent remains with the investigator under his responsibility. It is therefore necessary to ensure the location of eConsent storage by contract (HDS in the EU for example) during the legal period. eConsent must not at any time be controlled by the promoter and must not circulate between the promoter’s subsidiaries.
  • So we agree that in France, eConsent is not accepted for the moment? At least not with a remote patient? Can we be MR compliant with an e-consent? Legally, there is no obstacle. Practical arrangements for harmonization are pending. Indeed for the remote patient this seems discouraged.
  • As long as the patient has done a face-to-face with the investigator, is e-consent more easily accepted by the authorities (fewer questions about the patient’s reality)? Probably yes, if all this is well described in the protocol and submitted to the CPP (and/or Ethics Committee).
  • Does it pose a problem with the CNIL that you collect the patient’s phone number? The controller must justify the need to collect the telephone number. Only the investigator or eConsent provider should be able to know this information, which should not be accessible to the sponsor.
  • Once the patient is reading eConsent, can they digitally add their own notes? If so, does eConsent remain legislative? Peut-il être considéré comme un véritable consentement? In short, can we have an interactive eConsent? eConsent should be able to improve the exchange with the investigator to allow the patient to be better informed. In traditional mode, oral exchanges between the patient and the investigator are not recorded. My feeling is that the eConsent must remain in the form submitted to the authorities (PPC…)
  • Has the CNIL been consulted on the topic of e-consent? Has it made any recommendations, particularly with regard to third-party access to a patient’s personal data? The controller must justify the need to collect the telephone number (purpose). Only the investigator or eConsent provider should be able to know this information, which should not be accessible to the sponsor. CNIL MR-001
  • Archiving of paper consents is 15 years in a secure location. With e-consent, what is the process? Do we have to report the collection software to the PPC, CNIL? The paper consent remains with the investigator under his responsibility. It is therefore necessary to ensure the location and access to eConsent storage by contract (HDS for example) during the legal period. Yes, the method of obtaining consent, and therefore the computerized solution, must be presented to the PPC.
  • Can you explain what happens when the patient asks to speak to an expert? This process depends on the organization of the study, the e-consent process being itself very different from one study to another. When the patient chooses this option, a notification is sent.
  • After the investigator signs the consent, does the patient have a deadline to sign the consent? The cooling-off period for signing the consent agreementis fully configurable.
  • What about countries that do not accept eConsent and impose paper, how do you handle this with Arone ePRO? Arone ePRO can work without consent, depending on the study setting. A form may be dedicated to collecting information proving that consent has been given.
  • In the case of withdrawal of consent and request for erasure of data, can you delete everything easily in this system? A patient can be deleted if requested.
  • e-consents yes, there are still authorities who want the centers to keep a paper version. Does your solution offer the possibility of printing? Yes
  • How can we guarantee that doctors will not be liable in the event of a provider’s failure? Can this type of failure be covered in the test insurance? According to the demo, data (age, height, weight, phone) are collected before the consent process.
  • How to ensure that the patient has authorized this collection according to the GDPR? The workflow can be created differently: starting with the collection of consent by the patient.
  • If the email is transferred to another person, can the person respond and sign for the patient? No, it’s not possible. We need permanent access to voicemail. The signature codes are constantly renewed and are valid only for a configurable time (by default 2mn).
  • Is it possible that the investigator signs after the patient? The workflow can be created differently: starting with the collection of consent by the patient.
  • Is it possible to add videos? Yes all types of media supported on the Internet
  • For the electronic signature, the phone number is collected before? Yes, if the signature is to be done by SMS
  • How do you protect the direct identity of patients? The data used to identify the patient can only be accessed by the persons to whom the corresponding authorizations are explicitly given. The data is hosted on an HDS platform with all the guarantees of security.
  • As a rule, “the storage site” must be mentioned in the eConsent with patient acceptance, if the patient refuses? What is Plan B if the “system” does not work/access eConsent? The content of the e-consent is fully customizable. The e-consent system is integrated with Arone EDC which is hosted on an HDS system, monitored and with a high availability corresponding to the SLA of the Azure platform.
  • If the patient clicks on “need an expert”, the process is suspended or the patient can complete the rest? This depends on how the eConsent process is designed and configured. The workflow is fully configurable.
  • If the patient wishes to withdraw consent during the course of the study, how can they proceed and how are the coordinating centers or promoters informed? Are they informed in real time? They can withdraw their consent by logging back in with the url provided to access the application. Simply click on the remove button that is still visible. Yes the notification is sent immediately.

More information about our Arone ePRO solution?

Visit the page dedicated

Asf for a demo