Consent changes and process

[marshalc]

From @ij-cope

@marshalc, having trouble finding what the bare minimum of data is that needs to be completed in the Transplantation form to allow a Follow-up form to be openend but am assuming these are the questions that need to be answered:

All should be answerable with the options available except signed_consent (django.db.models.NullBooleanField) – “RE13 informed consent given”

the options here are now YES or NO, where NO rightly excludes the case from the trial, as foreseen in the protocol. However, in the Netherlands the process to obtain consent has been rediscussed with the Ethical Committee and they have allowed consent to be requested after the transplant ( @aukjebrat, Aukje can you confirm). Therefore, there are instances where this question is PENDING at time of transplantation. If the TT in this case chooses NO they will miss essential data collection for the trial in case the recipient does give consent. Choosing YES would not be appropriate.

Would it be an option to add a third choice: UNKNOWN (as in pending, retrospective consent will be requested) that nevertheless allows collecting the data on the from and opening a follow-up form? In this case, could a banner be displayed on the initially opened follow-up form for the cases where RE13 is UNKOWN requesting retrospective consent to be obtained and confirmed? Or an additional variable added to the initial follow-up form reaffirming that consent was obtained?

In cases where retrospective consent is not obtained - and a minimum of recipient related data was collected during transplantation, those data should be cleared from the system - to discuss who will do this and how. - if we can go back to closed form in the admin mode where data changes can be done whilst the reason why the change was made is given that would be a traceable way to do this, no?

In cases where the patient withdraws consent during the trial there are 2 options:

• they withdraw consent to use any of their data / samples already collected and then those must be cleared from the system and the biobank - see above, to discuss who will do this and how
• they withdraw consent to collect any further data but are happy with data / samples collected so far to remain available for research purposes

When consent was initially given and is then withdrawn this should be documented - I do not think we currently have such a document in place. @AllyBradley do we have a template for such a document from one of the other COPE trials? Does SITU have templates?

[marshalc]

From @ij-cope

As discussed

protocol had foreseen consenting recipients at time of admittance to hospital therefore the field for informed consent was added to the transplantation form however, retrospective consent is now also allowed to discuss

how to deal with this in the database as non-consented recipients need to be excluded from analysis and any personal data collected from them would need to be removed I seem to remember there is already an issue in the repository relating to this but I cannot locate it.

To be discussed at F2F

[marshalc]

Protocol asks for consent on:

• Collection of data
• Collection of bio-samples

Also states that consent will be asked in advance of patient entering the trial.

Review of practice showed that many possible pairs were being missed out on because consent wasn't being asked early enough. Ethics board was then approached to discuss retrospective consent approval. No deadline has been set for when retrospective consent must be gathered, but the trial requires that happens prior to conclusion of trial.

Database currently respects the protocol process, and thus causes issues by stopping data collection too early.

[marshalc]

ACTION: Remove the automatic closing of T-Forms when consent is not given

wp4/compare/views.py - Ln422

            # Check for closing criteria
            if recipient_instance.signed_consent is False:
                no_consent_confirmed = True
                for element in recipient_form.changed_data:  # Was this changed this time, or previously?
                    if element == "signed_consent":
                        no_consent_confirmed = False

                if no_consent_confirmed:
                    organ.transplantation_form_completed = True
                    organ.save(created_by=current_person.user)
                    messages.success(
                        request,
                        'Case %s has been <strong>successfully saved and closed</strong>' % organ.trial_id
                    )
                    return redirect(reverse('wp4:compare:transplantation_list'))

                else:
                    messages.warning(
                        request,
                        "Recipient consent is required to proceed. This form will be <strong>closed upon " +
                        "the next save</strong> unless the signed consent is set to Yes"
                    )

[marshalc]

Determine a new sub-process for following up on recipients with no consent recorded.

The variation appears mostly in the Netherlands, so we need to determine when and how consent is being recorded in all locations.

Once we have that, we want to record the date of when consent was collected.

Question for @ij-cope and @AllyBradley to determine is a number of days post transplant where consent must be recorded by, otherwise this will be recorded as No Consent, and the data removal process starts.

[marshalc]

Create a new issue for Data Removal for No-Consent

[marshalc]

Create an issue to map out the Audit Process, which says when a collection has been audited and confirmed, and then have the record_locked.

record_locked + no-consent --> starts the Data Removal process.

@marshalc - find and record the number of days we have to update a record under DPA laws when notified.