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PATSy's project Directors sought advice from 2 Health Trusts'
ethics committees (York Health Trust in England and the Edinburgh and
Lothian ethics Health Board in Scotland) regarding the issue of
participant consent. Table 1 summarises the conditions under which
consent is or is not required. An explanation of the guiding
principles is tabulated below.
Summary of conditions when participant consent is required
| Participant | Mental State | Show Video | Show video with face covered by mosaic effect | Show anonymised data | Special condition |
|---|
| Adult |
Normal | Consent required | Consent not required | Consent not required | |
| Deteriorating | Disallowed | Consent not required | Consent not required | |
| Child |
Normal | Parent consent required | Consent not required | Consent not required | Renewed consent sought at 16 years |
| Deteriorating | Disallowed | Consent not required | Consent not required | |
| Deceased |
| Disallowed | Consent not required | Consent not required | |
NB: Considerations of courtesy to particpants apply even if consent
is not required under the Health Trusts' conditions
Loss of anonymity
Consent must be sought when the
participant is not anonymous e.g. when a video or photograph of the
participant is shown.
Consent is not necessary if the data contributed is anonymous
eg. as one does in a journal paper In these situations, however it is
courteous to ask the participant if he or she is happy with how the
data is to be disseminated.
Who may give consent
Consent may only be secured from
participants whose mental state allows them to both give and withdraw
consent. Careful consideration is required when considering people
with a learning disability, dementia and progressive disorders that
lead to mental incapacity.
Children
For children under 16 years, parents or legal
guardians may sign the Consent form on behalf of the child. Oral
consent should be sought from the child whenever possible. Renewed
written consent is sought (via the GP) when the child reaches 16 years
of age.
Deceased patients
Deceased patients' video clips may not be shown. Spouses may not give
consent.
People with comprehension problems
It is very important
that the participant understand why she or he is giving consent. A
very useful approach is to show PATSy (in Guest mode) to the
participant and his or her family. Support the explanation with an
oral account of what is happening. We cannot recommend the use of
highly simplified consent forms (e.g. aphasia-friendly consent forms)
with confidence because it is difficult to assess how useful these
communicate the nature of a system such as PATSy. If doubt remains
regarding how well the person understands the nature of the request, then
you may wish to reconsider what you represent on PATSy for
this individual.
Who may secure consent from participants
The researcher, or practitioner, or a third party.
PATSy's Directors may not approach participants for consent.
Helping participants keep track of PATSy
To enable participants to exercise their right to withdraw their data,
it is necessary for the PATSy Directors to have the participant's
doctor's address. Participant's may, via their GP, elect to withdraw
their data. A copy of the consent form and any changes of addresses
may be communicated by the participant and the Director's through the
participant's medical record. Participant's may waive this
requirement.
Procedure for Seeking Consent
It is important to follow these procedures in this order.
- DOCUMENTS
- Download PATSy's ethics approved Information sheet (Word document).
- Provide the participant with PATSy's "Information sheet" to take home to share with his or her family.
- Download PATSy's ethics approved Consent Form (Word Document).
(Please do not modify the text in these forms except to insert local details. Check your modifications with Directors).
- REQUEST
- Make your request and describe PATSy to the participant and a family member if possible.
- Use oral explanation and or demonstration using Guest mode of access.
- Produce the Information sheet and the Consent Form for the participant to take them home
- Explain that the participant may request a copy of the video to be shown and may also see his or her own data on PATSy when it is completed. Notify Directors if these are requested.
- Allow at least 1 week 'cooling off' period
- Signed Consent From returned
- Sign the Consent form yourself
- Send the signed form to the Directors
- Directors will sign and send copies to you for you and the participant. A copy with a cover letter will be sent to the participant's GP for keeping in the medical record.
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