Essential - NIHR Clinical Research Network

Identifying and recruiting participants
Eligibility & informed consent
Introduction to GCP v3.0
Signpost
Learning outcomes
● Understand what the recruitment process is and its importance,
including patient identification, assessing eligibility and the informed
consent process
● Demonstrate the ability to identify potential participants using
protocol inclusion and exclusion criteria (eligibility assessment)
● Understand the importance of informed consent and demonstrate
understanding of the process of receiving valid informed consent
Signpost
The Clinical Research Delivery Pathway
Research
ideas
Study
development
& planning
Study
Set-up
Study
recruitment
& follow up
• Identifying
and
recruiting
participants
Signpost
Study
close
What is recruitment ?
Recruitment is the process by which:
● eligible patients are identified
●
and approached to determine if they are willing to consent to
participate in a study.
Essential
Explain slide
Why is recruitment important?
● Provides patients with the opportunity to become involved in
studies which may be of benefit to them
● Appropriate recruitment ensures
o patient safety in that only eligible patients are included in the
study
o high quality data will be collected, focused upon answering the
study question
● National and local targets are set to ensure studies deliver to time
and target as delays in recruitment increase the length of time it
takes to make successful treatments widely available
Essential
Explain slide
Identifying potential participants
● Each protocol details the inclusion and exclusion criteria for potential
participants
o Inclusion: criteria which must to be present in order to
address the research question
o Exclusion: further criteria which may mean the study is not
safe for the potential participant, or that their involvement
would undermine the scientific basis of the study.
Essential
Explain slide
Highlight through the use of simple example(s):
●
●
●
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Blood pressure less than 90 mmHg
Blood glucose less than 8 mmol/l
20 history of cigarette smoking
Patients with a diagnosis of Heart Failure
Patients with a history of chronic respiratory disease
Exclusion criteria often include:
●
Patients taking a specific medication
●
Patients unable to adhere to study treatment schedule
●
Patients unable to give informed consent (If this example is used, be
prepared to discuss capacity issues at this point).
Assessment of eligibility
Patient
population
Meet inclusion &
exclusion criteria
● Potential participants are
identified:
o along the patient care
pathway
o in databases of existing
patients
● Determine whether each
patient meets the inclusion
criteria and none of the
exclusion criteria
● Sometimes known as
screening
Essential
Examples Essential
Use an example study to bring the concept of eligibility, and the impact it has on your
number of potentially eligible patients, to life.
Medical assessment of eligibility
● Undertaken by a medically
qualified person
Patient
population
Meet inclusion &
exclusion criteria
● Consider detailed past
history, co-morbidities and
other pre-existing conditions
● Determine whether it is
medically appropriate for
the potential participant to be
prescribed the IMP.
Medically
appropriate
Essential
Examples Essential
Use an example to bring the concept of medical appropriateness in CTIMPs, and the
impact it has on your number of potentially eligible patients, to life.
Group Activity
● Read through the inclusion
and exclusion criteria summary
sheet and the patient histories
● Comparing the patient
histories with the inclusion and
exclusion criteria
● Determine whether each
patient would be eligible to
participate?
Essential
Time: 10 minutes
Equipment: Exercise materials (IntroGCPv3_3_B_Eligibility Exercise Sheet
A_FINAL and IntroGCPv3_3_B_Eligibility Exercise Sheet B_FINAL) for use in small
groups.
Activity:
1.
Ask participants to read through Sheets A (inclusion/exclusion criteria) and B
(patient histories) to determine whether they feel each patient is eligible for
the study
2.
Receive feedback and discuss the reasons why each patient is or is not
eligible.
Patient A:
Not eligible due to being an ex-smoker
Patient B:
Not currently eligible, but potentially eligible dependent upon
hypertension being controlled by next clinic visit
Patient C:
Eligible as meets all inclusion and none of exclusion criteria
Patient D:
Not eligible as 86 years old and awaiting planned cardiac surgery
What is informed consent ?
“A process by which a subject voluntarily confirms his or her
willingness to participate in a particular trial, after having been
informed of all aspects of the trial that are relevant to the subject’s
decision to participate. Informed consent is documented by means of a
written signed and dated Informed Consent Form.”
ICH GCP, 1.28
Essential
Explain slide
When should informed consent be
received ?
● Prior to ANY trial related procedure taking place
● This includes Quality of Life Questionnaires or screening bloods.
Essential
Examples Essential
Informed Consent
Put yourself in the participants shoes…
Essential
Play both clips, from healthtalkonline.org
IntroGCPv3_3_C_Informed consent clip 1.wmv (negative experience)
IntroGCPv3_3_C_Informed consent clip 2.wmv (positive experience)
The only difference between the two experiences is the approach of the
research team. It is within the participants power to impact on this directly.
The Consent Process:
Introducing & explaining the study
●
Briefly introduce the idea of study participation
●
Further detailed explanation using approved verbal and written
information (Patient Information Sheet)
●
Specific points to cover - See p.13 of the Pocket Guide
●
Involve family members (where appropriate)
●
Opportunity to ask/answer questions
●
Time to think …
Essential
Explain slide
The Consent Process:
Receiving informed consent
● Informed consent can be received by anyone who has been
appropriately delegated this duty, as stated in the protocol
○ Check the potential participant understands the study
information, what is involved and what they will be asked to
do / provide
○ Assure yourself they are making an informed decision,
understanding fully what is involved and the implications of
their decision
○ Gain agreement to proceed from the participant, both verbally
and in writing, using the current, approved Informed Consent
Form.
Essential
Explain slide
Everyone involved with the
consent process should be:
● Familiar with the study protocol
● Knowledgeable of available
treatment options
● Aware of the need to receive
informed consent
● Having the time for full
discussion with the participant
● Sensitive to the participant’s
particular circumstances.
Essential
Explain slide
For information, should questions about nurses (or other personnel) receiving
consent in CTIMPs arise.
“The UK regulations allow for the interview with a potential subject (or other
person giving consent) to be undertaken by any member of the investigational
team at the site. The application submitted to the main REC must set out the
general policy for the trial in terms of what types of personnel will be involved
(for example, the principal investigator, medical sub-investigators and/or
research nurses) and the procedures that will be followed. All personnel
involved in the consent process must have had appropriate training for this
role.” MHRA (2012) Good Clinical Practice Guide, p.99 (also known as Grey
Guide)
Note: local policies may not allow for this, and individuals should check
SOPs/with R&D regarding receiving consent for CTIMPs.
Putting participants first
● May have recently received
bad news
● English may not be their first
language
● Each patient’s need for
information and understanding
will be different
● Explaining randomisation and
blinding with trust and
confidence
● More informed population access to information on the
internet
● May not be eligible if wish to
choose a particular treatment
Essential
Examples Essential
Highlight one or two points with examples from your own experience.
Declining to participate
● The requirement for voluntary consent recognises that eligible
participants may, for a variety of reasons, not wish to be a part of
the study
● A patient declining to participate in the study could be a positive
outcome and an indication that the process has been effective
Essential
Explain slide
Declining to participate (continued)
● If you notice patterns emerging there could be a problem:
○ with the study
○ with the way the study is being explained
to potential participants.
Essential
Explain slide
Group Activity
Discuss the following scenarios...
How would you proceed?
Essential
Time: 10 minutes
Equipment: Following 6 slides
Activity:
1.
2.
3.
Describe the scenario presented on each of the following 6 slides
Invite answers from the participants
Discuss the appropriate actions with the group.
Scenario 1
● A potential study participant is waiting in the emergency
department to be seen by the nurse practitioner
● There is currently a 20 minute wait time
● The study involves the administration of a quality of life
questionnaire, which takes about 20 minutes to complete
● The research nurse asks the potential participant to complete the
questionnaire whilst they are waiting for the doctor to give their
consent.
Is this acceptable?
Why?
Essential
Not acceptable. No research activities can be conducted prior to receiving consent.
Scenario 2
● A number of patients are failing screening due to a blood result
which must be within certain parameters for the patient to be
eligible
● The screening visit takes about one hour to complete and the
consent form is seven pages long
● To save both time and effort, the doctor decides to take the extra
blood sample along with routine bloods to check eligibility, before
approaching the patient.
Is this acceptable?
Why?
Essential
Not acceptable. No research activities can be conducted prior to receiving consent.
May consider discussing issues affecting screening with the sponsor.
Scenario 3
● You approach a potentially eligible patient to receive informed
consent
● Before you have explained any of the study details to the patient
they immediately agree to participate.
What would you do?
Why?
Essential
Not appropriate to proceed. The patient is not making an informed decision. High
likelihood of non-compliance/withdrawal from the study.
Scenario 4
● A diabetic patient patient attends clinic ‘fasted’ for a screening visit
● The doctor who has agreed to receive consent has been called
away and cannot attend the clinic
● The patient is on insulin and has travelled a significant distance to
attend.
How would you proceed?
Why?
Essential
Check if someone else who has been delegated the responsibility to receive consent
is available to see the patient. If not, feed the patient and try to make another
appointment.
Scenario 5
● You are performing a bone marrow biopsy and take an extra
sample, just in case the patient is eligible to participate in another
study
Do you need informed consent?
How might you approach this?
Essential
Yes. No research activities can be conducted prior to receiving consent, and consent
has only been received for the first study. Additional procedure could be avoided by
asking for consent to take additional samples to screen for future studies when
seeking the initial consent. Check in line with local policies / study procedures.
Scenario 6
● You have just spent 45 minutes explaining a respiratory study to a
potentially eligible patient
● They are not sure and ask ‘What you would do?’
How would you proceed?
Why?
Essential
Not appropriate to tell the patient what to decide. Additional support and time could
be given, but it may be more appropriate not to proceed if the patient is unable to
decide for themselves what to do.
Documenting the consent process:
the consent form
● Participant initials each point
● Participant writes their name,
the date and signs the form
● Person receiving consent signs
and dates the form at the same
time
● Original in site file, copy to
participant, copy in patient
records
o check the protocol for
number of copies required
o consider electronic patient
records
Essential
Explain slide
Bullet 2 still a common finding at inspection - participants must write their own name
and the date in addition to signing the form.
Documenting the consent process:
patient notes
● Document recruitment process including assessment of eligibility
● Document introduction, explanation of study and information
provided and discussed (including versions)
● Document specific points covered as part of the discussion,
including opportunity to ask questions, further information and
anyone else present
● Document informed nature of decision making process, including
what is involved and potential implications
● Re-confirm and document willingness to continue in the study at
every visit.
Essential
Explain slide
Documenting the consent process:
patient notes (continued)
Essential
Explain slide
Demonstrates adherence to GCP
●
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legible
chronological
attributable
clear which study the record is concerning
process is clearly described
inclusion and exclusion criteria are assessed
clear who introduced the study to the potential participant
version and date of patient information sheet is clear
time to consider and discussion with family members is documented.
Documenting the consent process:
patient notes (continued)
Essential
Explain slide
Captures participant’s understanding as well as process followed:
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●
●
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specifics of the process
opportunity to ask questions and what further information was provided
freedom to withdraw explained
routine care described and how the trial differs
potential side effects
informed consent received and consent form used.
Documenting the recruitment
process
Maintain a screening log to demonstrate:
● Timeline of introduction, approach, discussion and consent process
● Number of people assessed for eligibility
● Number of people approached to join the study
● Number of declined offers (and reasons if given)
● Number of people recruited into the study
● Demonstrates:
o Potential issues with the protocol where a large number of
participants are declining
o The achievement of targets.
Essential
Explain slide
Research with vulnerable groups
● It is important to understand the processes for CTIMPs and nonCTIMPs when conducting research with vulnerable groups.
● NIHR CRN e-learning modules are available which explore informed
consent, and the equivalent process when conducting research
o in a paediatric setting
o with adults lacking capacity.
Useful Explain slide
Summary
● The recruitment process is fundamental in ensuring only
appropriate participants are given the opportunity to participate
● The process begins by identifying potentially eligible patients, then
screening those patients against protocol defined inclusion and
exclusion criteria
● The recruitment process culminates in receiving informed consent,
which must be documented by means of a signed consent form and
a detailed record in the patient notes.
Signpost