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Table 2 Examples of different ways of taking consent used in COVID-19 trials

From: Monitoring advances including consent: learning from COVID-19 trials and other trials running in UKCRC registered clinical trials units during the pandemic

Type of consent Comment Pros Cons
How consent is taken
 eConsent face-to-face There is validated software, often linked to data management capture tools, available that can be downloaded onto a tablet for patients to provide electronic consent. Generic electronic signature products can also be used. Informed consent can be enhanced with various features, e.g. video information, call out boxes, pictures and consent flags (dependent on the software solution).
A central record can be maintained by those who require it, e.g. sponsor or CTU.
Sites have access to electronic record of the informed consent form (ICF).
Sites can clean electronic devices between use.
Solves the problem of moving paper within infectious areas (red zones).
The approach is supported by the MHRA and HRA [8].
Some evidence that eConsent improves recruitment [9].
The software has cost implications for sponsors.
The availability of electronic devices in hospitals is limited or incurs a cost for sites or sponsor to purchase. Storage and charging need to be arranged.
The local team may not be familiar with the software.
Those monitoring will also need to be trained on this method/software.
 eConsent conducted by video call Interested participants are directed to a trial website, which outlines the study and provides the PIS. The interested participant goes through simple screening questions and those that pass are asked to provide contact details. The CTU receives the details and liaises with a clinician to call the patient. If eligible, a video call is set up with the clinician, where the PIS is discussed in full, eligibility is taken and consent is provided by the patient and clinician. On verification of consent, an email is sent to the participant which holds a link to their consent form. The clinician and CTU can access the consent form via the secure website. Trial consent can be taken anywhere and the patient does not need to be co-located with the clinician.
Site staff burden is reduced as the trial has a central group of clinicians to liaise with patients and take consent.
Patients are not required to leave their homes during a pandemic so virus transmission risk reduced.
Copies of the consent form are provided by email link to patients, as a record of patient consent.
Evidence of consent is available to sponsor/CTU by electronic means via a secure website.
Patients may not be familiar or comfortable with sending contact details via the trial website.
Patients may not be familiar with video calls. Where patients do not have access to the required technology, back up measures should be considered so that they are not excluded from the research for this reason.
Additional training requirements to conventional consent.
Physical examinations are not possible.
High-risk trials are likely to be unsuitable, due to the virtual nature of the trial, or additional steps to confirm eligibility via patient records need to be implemented.
Need a process in place to verify the participant is who they say they are—photo ID for example
 Photo of written consent Patients are provided with paper copies of the written informed consent documents on the ward. Patients/investigators sign and date consent and a photo or scan is taken of signed documents. There are minimal cost implications, unless hospital equipment needs to be purchased.
Provision of consent is in line with the usual process which local team are familiar with.
Solves the problem of moving paper within infectious areas as the paper version can be processed or destroyed (and documented) in accordance with local policies.
Data protection considerations must be considered. For example:
• Sites need to be compliant with their data protection policies/GDPR/SOPs, which does include photography.
• Emailing identifiable images to the central office may need advance consideration of data protection issues, secure transfer and site training.
Sites need access to devices to be able to take photographs.
Risk that signatures are not legible/visible in photos/scans, there is a risk that the photo is lost or deleted in error resulting in a loss of evidence of consent.
Who takes the consent
 Witness [10] A witness could be present at the time the patient gives oral consent. The witness then provides written proof of the witnessing of oral consent in a non-infected area. There are no cost implications, a paper copy of the written informed consent document is maintained and available for monitoring purposes. Reliant on the availability of a witness at the time of consent.
 Personal legal representative (PerLR) The use of personal legal representatives is a well-established method of consent for use in certain situations. Some COVID-19 trials have made use of this due to patients requiring mechanical ventilation.
A relative or close friend is approached, either in person or via telephone, provided with the relevant information sheets and asked if they feel the participant would consent to being included in the research. If they feel the participant would be happy to take part, then a personal legal representative consent form is completed. In the context of COVID-19, these conversations should take place outside the infection area (red zone).
If the participant regains capacity to consent at a later date, they are provided with the relevant information sheets and are asked to complete the consent forms indicating that they are happy for data to be used/to continue in the trial.
No cost implications. Paper copies of written informed consent are available for monitoring purposes.
Preferential even when the relative or close friend was on the phone and the clinician documents their consent and the clinician signs the consent form.a
May be restricted to use only with patients who lack the capacity to consent due to the severity of their illness.
Family may be unsure of what the participant’s wishes would be and may be reluctant to provide consent on their behalf.
 Professional legal representative (ProfLR) For patients who are critically ill and are unable to provide consent and there is either no-one suitable by virtue of their relationship to the patient or a suitable person does not wish to or is unavailable to act as the legal representative, a professional legal representative (ProfLR) may be approached. This is a medical professional caring for the patient who is unconnected to the trial. If they have no medical or ethical objections to the participant taking part, then a ProfLR consent form is completed. Again, in the context of COVID-19 research, all paperwork should be completed and stored outside the infection area (red zone).
If the patient regains capacity to consent, they will be asked to complete consent to continue as detailed above.
No cost implications. Paper copies of written informed consent are available for monitoring purposes. Restricted to use only with patients who lack the capacity to consent due to the severity of their illness.
  1. aIn Scotland, the ‘guardian or welfare attorney’ is the first preference, prior to the nearest relative
  2. Legend: ‘electronic methods for seeking informed consent’ and ‘eConsent’ refer to the use of any electronic media to convey information and to see and/or document consent via an electronic device