Electronic consent

You might find something that was written by the RQA GCP Committee (& reviewed by the MHRA) useful. You can find it at [url]www.theRQA.com[/url] GCP Committee. The answer is from 2011 and so may be a little out of date.
QUESTION:- An investigator wants to use a smartphone system (e.g. EpiCollect on Android) to collect electronic consent. This consent could be in the form of a signing a screen or digitally capturing a fingerprint. Has anyone had any experience using this technology in this way, and what would be needed for it to be GCP-compliant?
Ref: PH03 Date: 23rd February 2011 (MHRA Approved)

RQA ANSWER:- The technology to collect e-signatures on an electronic consent form is relatively new, and to date, I have not found any organisation or individual investigator who is using it. I have also queried this with the Medicines and Healthcare products Regulatory Agency (MHRA) and the Good Clinical Practice (GCP) inspectorate have no experience of inspecting a study using such technology.

There are a number of key areas that would need to be addressed to be considered GCP compliant, as detailed below.

Firstly, there would need to be a way for the signature to be traced to the study information that the patient has received. That is, when a participant signs a standard consent
form, they are signing up to the clauses written on that form, which is linked to the version of the patient information sheet/consent form that they have been given (GCP 4.8.7 and
4.8.8). This trail would still need to exist in some form using the electronic signature method.

Another concern would be how to give a copy of the information sheet and signed consent form to the participant. GCP (4.8.11) states “prior to the participation in the trial, the subject or the subject’s legally acceptable representative should receive a copy of the signed and dated written consent form and any other written information provided to the subjects”. The signed consent form should also be filed locally so that the site has access to all information on the participant. This is particularly important should the participant be a patient at a medical centre, where it is expected that a copy of the consent is kept in the medical notes so there is a record of their participation in a study (GCP 8.3.12).

Validation of the system should be performed to ensure that it is fit for purpose. GCP does not go into much detail about electronic systems, aside from what is detailed in section 5.5.3. Essentially, you will need to ensure that the “system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistent intended performance (ie validation)”. This also applies to investigators in the study. A full audit trail needs to be incorporated to track any changes to the system and it should maintain an adequate security system to prevent unauthorised entry. There is also the question of longevity of the software. As all essential documents need to be archived for up to 15 years after the end of the study (for marketing authorisation holders as per Directive 2003/63/EC ), there is a need to maintain the software up to this point. A disaster recovery plan should also be considered in preparation for a system or software failure. You may want to investigate the FDA documents Electronic Source Documentation in Clinical
Investigations at: click here

Using either e-signatures or fingerprints does lead to the question of how will you ensure that that signature or fingerprint belongs to the participant in question? From experience, signing an electronic pad does not resemble my normal signature in the slightest. Keeping electronic versions of fingerprints may also lead to confidentiality issues, as
well, there will need to be a log of each fingerprint linked to each participant in the event of an audit/inspection where you will need to confirm which print was matched to each
participant.
There is much to consider in using this novel technology for the purpose of consent, and it is made more difficult as it seems few, if any, people are currently using it.
The difficulties in achieving a GCP-compliant system may explain why most studies continue to rely on paper signatures.