Informed Consent

This page describes processes for informed consent.

Table of contents

  1. Informed Consent Telephone Discussion
    1. Discussion about taking part
    2. Discussion about device configuration
  2. Receiving a Completed Consent Form

Discussion about taking part

This is taken from Section 11.2 (Study Procedures > Informed Consent) of the Protocol. Responses are recorded in the Qualtrics ‘Informed Consent Call’ survey.

Potential participants who are interested in participating will call the study team (as indicated in the invitation letter). During the call, a study team member will:

  • Introduce themself (name and affliation)
  • Check that the potential participant is interested in taking part.
  • Ask for the potential participant’s name and contact number (which will be destroyed if the participant does not want to take part).
  • Determine whether the potential participant is eligible for the study. The criteria to check at this stage are:
    • Inclusion: Lives in private accommodation
    • Exclusion: Regularly sleeps on front
    • Exclusion: Has a chest wound
    • Exclusion: Previous reaction to, or known allergy to ECG electrodes or silicone
  • Check whether the potential participant is currently taking part in any other research studies (and if so, check for any potential safety concerns).
  • Outline the study with reference to the PIS, and answer any questions:
    • We want to find out whether new wearable devices such as smartwatches could be used to identify atrial fibrillation, an irregular heart rhythm.
    • We’re asking participants to wear three devices at the same time for seven days: two wrist-worn devices, similar to watches; and a patch which sticks to the chest. We’re also asking participants to complete a questionnaire on how they found wearing the devices.
    • Step 1: We’ll send you the devices, instructions, and a questionnaire.
    • Step 2: Once you receive the devices we’ll have a call to explain how to wear and use the devices.
    • Step 3: We’ll ask you to wear the devices for seven days, going about your daily life as normal. We’ll call you during these seven days to check for any problems. If you decide you no longer want to wear a device then you can remove it, and that will be helpful for us as we want to understand people’s views on wearing the devices.
    • Step 4: At the end of the seven days we’ll ask you to complete the questionnaire, and then send the devices back to us using prepaid postage.
  • State that since these devices are still in development, we don’t yet know whether they can provide reliable results, so we won’t be reporting results back to participants or GPs.
  • State that participants are free to withdraw from the study at any time, with no obligation to give a reason for withdrawal.
  • Ask whether the potential participant has decided whether they would like to take part:
    • If they do not want to take part: they will be asked whether they would indicate their reasons for declining the invitation (although there will be no obligation to do so).
    • If they are undecided: they will be asked if the study team could call them to discuss the study after they have had at least a further 24 hours (or longer if they wish) to think about the invitation.
    • If they would like to take part: they will be asked if they have had long enough to decide, and if so, they will be asked to provide consent by returning the consent form using the prepaid envelope.

Record in the database: date and time of discussion, the participant’s decision, and (if not taking part) any reason(s) given.

Discussion about device configuration

Ask the participant whether or not they would be prepared to keep a mobile phone on charge during the study, and also whether they would be prepared to charge the devices. Depending on the answer:

  • If they are prepared to use a mobile phone and charger:
    • Wrist PPG: PulseOn OHR in continuous mode, with charger and phone
    • Wrist ECG: Withings Move ECG (or alternative wrist ECG device), with phone
  • If not:
    • Wrist PPG: PulseOn OHR in sampling mode
    • Wrist ECG: Withings Move ECG (or alternative wrist ECG device)

Record in the database: the device configuration to be used.

  • Inform GP Practice of the participant’s participation.
  • Update database.

Copyright © 2021 Peter Charlton.