Consent Scenarios:
Scenario 1 - Explicit Consent (Minimal
Adequate Information)
CTIMP RCT of Statins (GP Surgery)
Scenario:
Comparison of licenced statins to reduce low-density lipoprotein
(LDL) cholesterol - Individual Patient Randomisation
NHS Context:
Primary Care (General Practice)
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Key Factors:
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Possible
Consent
Option:
Constitutes Clinical Trial of Investigational Medicinal Products
(CTIMP)
All trial drugs are licenced and in routine use
No Blinding – All medicine ‘Patient information leaflets’ (PIL)
are available and provided to patients
There is insufficient evidence regarding comparative
effectiveness
Systematic reviews have been conducted and support that
there is genuine uncertainty (equipoise)
Only routine clinical data will be collected
Patient is not subjected to any risk greater than those related to
standard care
No interventions other than standard treatment
No additional intervention following randomisation
Explicit consent sought by GP/Other Health Care
Professional (HCP)
HCP reads standard text providing following information:
OPM Group
EXAMPLES OF SIMPLIFIED CONSENT
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It is the GP/HCP's opinion that the patient would benefit from a
treatment, known as a statin. However, there is uncertainty
amongst doctors regarding which licensed statin is best.
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We wish to find out which one works best by involving patients
in a research trial.
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The statin the patient would receive will not be decided by the
HCP; it will be decided randomly by a computer as part of the
clinical research trial.
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Both/All the drugs used in the trial are licensed, effective and
are used routinely.
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If you agree to take part in this research you do not need to do
anything more, all the data we need will be taken from your
medical records and shared with the researchers. We ask that
you agree for this to happen.
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You may withdraw from the research at any time by contacting
the GP Surgery/Researchers.
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If you do not agree to take part you will be prescribed statin [X]
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HCP gives patient Participant Information Sheet (PIS)
including information above and provides link to further online
information and contact details for researchers organising the
study.
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If patient agrees, on basis of verbal explanation/PIS,
consent documented in patient records by HCP
(GP/Practice Nurse/Pharmacist)
Or
If patient agrees, on basis of verbal explanation/PIS,
patient signs paper consent document.
Issues
Legal: The scenario above is a Clinical Trials of Investigational
Medicinal Products (CTIMP) and would need to satisfy legal
requirements under the Medicines for Human Use (Clinical Trials)
Regulations 2004 for:
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CLASSIFICATION:
Prior Interview and
2
OPM Group
EXAMPLES OF SIMPLIFIED CONSENT
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Written Consent
1. Would this option satisfy this requirement?
2. What is the minimum information required by the patient to
give meaningful consent?
3. What is the minimum information required to comply with the
law?
Scenario 2 – ‘Deemed’ Consent (Opt-Out)
CTIMP Cluster Trial (GP Surgery)
Scenario:
Comparison of licenced statins to reduce low-density lipoprotein
(LDL) cholesterol - Cluster Trial – Randomisation at GP Clinic
Level
NHS Context:
Primary Care (General Practice)
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Key Factors:
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No Blinding – All medicine ‘Patient information leaflets’ (PIL) are
available and provided to patients

There is insufficient evidence regarding comparative
effectiveness
Systematic reviews have been conducted and support that
there is genuine uncertainty (equipoise)
Only routine clinical data will be collected
Patient is not subjected to any risk greater than those related to
standard care
No interventions other than standard treatment
No additional intervention following randomisation
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CLASSIFICATION:
Constitutes Clinical Trial of Investigational Medicinal Products
(CTIMP)
All trial drugs are licenced and in routine use
3
OPM Group
EXAMPLES OF SIMPLIFIED CONSENT
Implicit/Deemed Consent (Opt-Out)
Possible
Consent
Option:
Issues
-
Poster on prominent display in GP surgery waiting room
explaining that trial of statins is taking place within the practice.
simplified information provided along with link to further
information (additional translated versions used where as
necessary)
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Poster includes explanation that all patients will be included in
the trial if they fit the inclusion criteria UNLESS they explicitly
inform the GP they do not wish to take part (Opt-Out).
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Information also provided on how to withdraw from the study
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HCP enrols patient if they fit the inclusion criteria but HCP
does not provide further information (either written or
verbal) regarding research component. HCP documents
patient enrolment into trial and all refusals and
withdrawals.
Legal:
Legal: The scenario above is a Clinical Trials of Investigational
Medicinal Products (CTIMP) and would need to satisfy legal
requirements under the Medicines for Human Use (Clinical Trials)
Regulations 2004 for:

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Prior Interview and
written consent
1. Would this option satisfy this requirement?
2. Would this option satisfy the requirements for “informed consent in
cluster trials” of the forthcoming EU Clinical Trials Regulation
provided the information provided the information required under
points (a), (b), (d) and (e) of Article 29(2) is given.
3. Does this satisfy cluster trials requirements in EU Regulation for
information to be “given” to the patient and would this constitute
the potential participant “being informed”?
4. Does it conflict with National Law?
CLASSIFICATION:
4
OPM Group
EXAMPLES OF SIMPLIFIED CONSENT
Ethical:
The Ottawa Statement on the Ethical Design and Conduct of Cluster
Randomized Trials (2012) states:
“An inappropriate reason to adopt a CRT [Cluster Randomised Trial] is
the mistaken belief that the need to seek informed consent can be
avoided by using cluster randomization.”
also
“If obtaining informed consent is feasible for some but not all study
interventions or data collection procedures, then researchers should
obtain separate informed consent, where possible, for each
procedure.”
5. Does this option adequately respect patient autonomy?
—
6. Does this option adequately protect the patients’/participants’
interests?
—
7. Does it constitute truly “informed” consent?
Scenario 3: No Consent
Non-CTIMP Cluster Trial (Hospital Ward)
Scenario:
Trial of Pressure Relieving Mattresses - Cluster Randomisation at
CLASSIFICATION:
5
OPM Group
EXAMPLES OF SIMPLIFIED CONSENT
Ward level
NHS Context:
Secondary Care
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Key Factors:
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Possible
Consent
Option:
Non-Drug Trial – compliance with common law only
Trial mattresses are both in routine use
There is insufficient evidence regarding comparative
effectiveness
Systematic reviews have been conducted and support that
there is genuine uncertainty (equipoise)
Only routine clinical data will be collected
Patient is not subjected to any risk greater than those related to
standard care
No additional intervention following randomisation
No interventions other than standard care
No Consent sought for the research as both mattresses represent
standard care and it would be impractical to move patient to a
different ward if the trial mattress is not what they would prefer
Do you agree that informed consent need only be sought for research
activities that differ from the standard of care that the patient would
otherwise receive?
Issues
In this case either mattress would constitute standard care and
thus consent need not be sought (with prior approval by Research
Ethics Committee)
1. Does this option adequately respect patient autonomy?
2. Does this option adequately protect the patients’/participants’
interests?
Document technical title (if appropriate)
CLASSIFICATION:
1 May 2014
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