How to Get Your Project Past the NRES/NHS Research Ethics Committee

How to Get Your Project Past
the NRES/NHS Research
Ethics Committee
Dr Niki Bannister
Vice-chair Essex REC
(Flags: CTIMP, MCA, Prison)
November 2011
Dr Niki Bannister
What is a REC?
• A bunch of jobsworth busybodies putting
unrealistic barriers in the way of would-be
researchers?
• An unpaid team of trained people from
inside and outside the NHS and academia,
who are charged with ensuring healthcare
research is legal, decent, honest, and
truthful for the participants, and the wider
community?
November 2011
Dr Niki Bannister
A NRES REC can approve:
• Research on Human Tissue
– collected as a new sample
– on surplus from NHS procedures
– from archives
• Trying out new ‘treatments’
– drugs without a licence (CTIMP)
– devices not yet tested for effectiveness
– unapproved procedures
– in emergencies, including Public Health
November 2011
Dr Niki Bannister
A NRES REC can approve:
• Collection of additional new data
– directly from patients/relatives/carers
– from healthcare staff
– recordings and images
• Access to ‘sensitive’ data
– from medical records
– from NHS databases
– linking to other records (state-held, or
independent)
November 2011
Dr Niki Bannister
A REC can approve:
• Research on vulnerable groups
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Life threatening illnesses
Children
Prisoners
Compulsorily detained under Mental Health Act
• Research without direct consent
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Research on the very young
Mental incapacity due to mental illness
Incapacity due to physical illness
Incapacity due to medical intervention
• Anaesthesia, sedation, ITU/|HDU
November 2011
Dr Niki Bannister
A REC can approve:
• High risk interventions
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Ionising radiation
new drugs with high toxicity
High risk innovative surgery
New medical devices
New ways of working
Questionnaires
Risks to the researcher
• Working in the community
• Infected material
November 2011
Dr Niki Bannister
A NRES REC can approve:
• Workplace research on staff
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Low-risk research does not need REC approval
the workplace environment
training and performance
attitudes, interactions and feelings
• ‘Clandestine’ activity
– ‘blind’ studies
– concealment of a true aim, or of the research activity,
if essential to avoid bias
November 2011
Dr Niki Bannister
The Following Always Require
Review at a Full REC Meeting:
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CTIMP’s
Medical devices prior to CE marking
Adults lacking capacity MCA 2005
Invasive basic science on healthy volunteers
Ionising radiation additional to routine clinical
Research tissue banks and databases
Prison research
Studies funded by the US Department for Health
and Human Sciences
November 2011
Dr Niki Bannister
Proportionate Review
• Studies which present minimal risk or
burden for participants
• To be reviewed by a sub-committee
• Within 14 days of receipt of a valid
application.
• Not yet rolled out uniformly to all RECs
• Http://www.nres.npsa.nhs.uk/applications/
proportionate-review/
link confirmed valid 27-11-2011
November 2011
Dr Niki Bannister
Proportionate Review
• Research using data or tissue that is
anonymous TO THE RESEARCHER
• Research using existing tissue samples
already taken with consent for research
• Research using “extra tissue” (e.g. further
blood taken at time of routine sampling or
tissue taken at “clinically directed” operation)
November 2011
Dr Niki Bannister
Proportionate Review
• Questionnaire research that does NOT include
highly sensitive areas or where accidental disclosure
would NOT have serious consequences
• Research interview / focus group that does NOT
include highly sensitive areas or where accidental
disclosure would NOT have serious consequences
• Research surveying the safety or efficacy of
established non drug treatments, involving limited
intervention and NO change to the patients’
treatment
November 2011
Dr Niki Bannister
Is it Ethical?
• Scientific validity (more on this later)
• Is any potential harm justifiable, and is
safety duly considered?
• Is is voluntary, without affecting ‘normal’
care, and without undue persuasion?
• Is it properly explained to participants?
• Will data, samples, images etc be
protected?
November 2011
Dr Niki Bannister
What are you trying to find out?
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Is it Research?
Is it Audit?
Is it Service Evaluation?
Is it Public Heath Surveillance or practice?
Case study or satisfaction survey?
Equipment or systems testing?
• http://www.nres.npsa.nhs.uk/applications/isyour-project-research/
Web address valid 27 Nov 2011
November 2011
Dr Niki Bannister
Is Your Project Research?
• Looking for new knowledge about a
condition, treatment, diagnostic method,
the personal experience or relationship.
• a change of care
• extra: interventions, biological samples or
data collection from routine care, or new
use of routine samples and/or data
• May involve a questionnaire
• May have staff as participants
November 2011
Dr Niki Bannister
The REC doesn’t need to see:
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Audit
Service evaluation
Research on anonymised data (new rules)
Research on material with previous
consent if held appropriately
• Public Health Surveillance/practice
– Beyond scope of this talk
– Identification of cause and treatment of
disease outbreak
November 2011
Dr Niki Bannister
Is It Service Evaluation?
• What level of service do we achieve?
– No standard for comparison
– No change in care is involved
– Not looking for new knowledge about the
condition or treatment
– E.G. How long are our referrals made to wait?
• Might involve a simple interview or
questionnaire
– May have ethical issues, but not for the REC
November 2011
Dr Niki Bannister
Audit:
• Are we doing it like we should?
• There is a standard that should be met:
– No change in care is involved from usual
– Not looking for new knowledge about the
condition, treatment, staff or patient attitudes
– Might involve a simple interview or
questionnaire to gather relevant data
– May have ethical issues, but not for the REC
– e.g. do we meet the 2-week wait target for
suspected cancer referrals
November 2011
Dr Niki Bannister
Previously Collected, Nonidentifiable Information
• Research limited to secondary use of information
previously collected in the course of normal care is
generally excluded from REC review,
• Provided that the patients or service usrs are not
identifiable to the research team.
• A care team using information previously collected in the
course of care for their own patients or clients,
• Provided that data is (pseud)anonymised .
• Alternative sources of ethical review may be available
e.g. from a university REC.
November 2011
Dr Niki Bannister
Previously Collected, Nonidentifiable Tissue Samples
• previously collected, non-identifiable
material consisting of or including cells in
accordance with the terms of donor
consent is generally excluded from REC
review.
• But terms and conditions apply
November 2011
Dr Niki Bannister
REC review if:
• Consent for research has not been given, or the
research is not within the terms of the consent
• The samples will be held on premises in
England, Wales or Northern Ireland without a
licence from the Human Tissue Authority to store
relevant material for scheduled purposes
• The research also involves removal, storage or
use of new samples from the living or the
deceased
• The research also involves use of identifiable
information held with the samples.
November 2011
Dr Niki Bannister
Public Health
• Public Health Surveillance/practice
– Identification of cause and treatment of
disease outbreak
– collecting personal data and samples with the
intent to manage an incident.
– analysis of existing data or administration of
interview or questionnaire to those exposed.
November 2011
Dr Niki Bannister
Is your objective educational ?
• Consider Audit or Service Evaluation
• Biological samples and the Human Tissue
Act: don’t store for future use.
• Avoid personal data: use surplus material
or data, anonymised by the care team
• Research on health care staff: go outside
your own workplace if you can
• Questionnaires are not risk free.
November 2011
Dr Niki Bannister
The Integrated Research
Application System (IRAS):
• A single system for research in the UK
• Enables you to enter the information about your
project once
• Uses filters to ensure that the data collected and
collated is appropriate to the type of study, and
the permissions and approvals require
• Helps meet regulatory and governance
requirements
• https://www.myresearchproject.org.uk/
November 2011
Dr Niki Bannister
At an early stage sort out:
• A protocol (a set of instructions for
someone else who knows nothing about
the field)
• The forms: IRAS (beyond the scope of
today’s talk)
• The Participant Information Sheet (PIS)
read the NRES guidance and make sure
you follow it
November 2011
Dr Niki Bannister
The Protocol:
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Why are you doing it (background)
What you are trying to find out
What you plan to do
Show your method is ‘good science’
Identify foreseeable risks
How will unforeseeable risks be detected
Is all the legal stuff in order: indemnity, data,
disclosure
• Publication policy
• Informed consent (PIS)
November 2011
Dr Niki Bannister
Consult Service Users:
• A participant’s perspective on the
research.
• Highlight (and resolve in advance) issues
related to the burden of the research:
– When and how appointments are given out,
– Access to venues, time of day, bus routes,
expenses, child care, privacy,
– Feedback of research outcome (or maybe
participant’s own data verification).
November 2011
Dr Niki Bannister
Local Support Groups
• Usually pleased to be consulted,
especially if part of a national organization
such as for cystic fibrosis, motor neurone
disease, age concern etc.
• Do not be worried about ‘bothering’
people: they may be highly motivated.
• A problem might be managing their
expectations
November 2011
Dr Niki Bannister
Taking the PIS
• Participant Information Sheet:
– does it fully inform about what they are letting
themselves in for, and why?
– does it reflect the protocol
• Aims
• Methods
• Risks
• Etc etc etc
• http://www.nres.npsa.nhs.uk/applications/guidance/cons
ent-guidance-and-forms/?1311929_entryid62=67013
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Web address valid 27 Nov 2011
November 2011
Dr Niki Bannister
The invitation to participate
• In general the researcher should only
know the identity of those giving consent
– Is the researcher already on the ‘care team’
– How will ‘recruits’ be found, and by whom
– Who issues the invitation, and how
– How is the participant notified to the
researcher once consent given?
– Will non-responders be reminded?
November 2011
Dr Niki Bannister
Personal data (PID)
• PID allows a participant to be identified to an
outsider
– Name, address, postcode, dob, images, etc
• Anonymised study data is not PID
– Unless identification is possible from other data
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Do you need to know or store PID?
Use a study number instead.
Do you need to keep a link to the PID?
How is the link stored, by whom, for how long?
November 2011
Dr Niki Bannister
Methodological Pitfalls
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Is the research question valid?
Does the method address the question?
Case selection bias
Historical controls
Failures of blinding
Questionnaire validity
randomisation
November 2011
Dr Niki Bannister
Scientific validity
• A REC need not reconsider the quality of the
science, as this is the responsibility of the
sponsor and will have been subject to review
by one or more experts in the field (known as
‘peer review’).
• The REC will be satisfied with credible
assurances that the research has an identified
sponsor and that it takes account of
appropriate scientific peer review.
November 2011
Dr Niki Bannister
REC Attendance by Supervisor
Ethical review of student research
Guidance for students, supervisors and Research
Ethics Committees (NRES)
• In the case of any study undertaken mainly
for educational purposes, it is highly
desirable that both the supervisor and the
student should attend the REC meeting
wherever possible, whether or not the
student is the named CI on the application.
November 2011
Dr Niki Bannister
Common Qualitative Pitfalls
• The aim of the study is not clear
• The research method doesn’t match the aim
• Interviews and questionnaires:
– What if a participant gets upset?
– What if a participant discloses ‘at risk’, criminal or
unprofessional activity?
– Permission to approach relatives and carers
– audio or video recording, and transcription
– Use of direct quotes
– Home visits: Lone worker policy
– Workplace research: in work time?
November 2011
Dr Niki Bannister
Common Quantitative pitfalls
• Does your method match your aim?
– Defined endpoint?
• Randomisation
– Sealed envelopes?
– Block randomisation?
• Power calculation
– Numbers for statistical significance depend on size of
expected difference
– start with the numbers of cases you expect to handle
and work backwards to the effect size: is it realistic?
– Is it really a pilot study?
November 2011
Dr Niki Bannister
’The Usual’ Recurring Common
Ethical Issues
• Does the title, or short title, reflect the study aims
and make sense to a layperson?
• Identification and recruitment of participants:
how is the invitation made?
• Procedure- and medicine-related safety,
including possible distress for questionnaires
and interviews/focus groups, and pregnancy for
medicines: possible termination?
• Researcher safety in home visits etc.
November 2011
Dr Niki Bannister
Common Ethical Issues
• workplace and employment protection for
studies on health care or other workers
• recording and transcription, and use of
quotes (permission required)
• could any ‘at-risk’ activity be revealed?
• data protection and storage, compliance
with DPA and Caldicott
• if biological materials from participants are
involved, HTA compliance on material,
including storage, transfer and disposal
November 2011
Dr Niki Bannister
Common Ethical Issues
• scientific review of the submitted protocol
by an appropriate disinterested body or
person to confirm each study question is
relevant, and that the methods will answer
them (PhD level)
• indemnity for protocol and study risks.
• dissemination of results, will results be
valid if used to modify a service?
November 2011
Dr Niki Bannister
PIS Common Ethical Issues
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title and headed paper
readability by target group,
is the protocol reflected appropriately,
is the burden on the participants set out;
are non-study alternatives set out
is randomisation explained for RCTs
NRES compliance, for content
November 2011
Dr Niki Bannister
Final Message
• Point yourself at the NRES website at an early
stage
• Attend the REC meeting with your supervisor
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Not compulsory, but much appreciated by the REC
The student should do the talking
Be ready to defend the scientific review
Be ready to answer questions about indemnity
November 2011
Dr Niki Bannister
Conclusions
• Bypass the REC with Audit or Service
Evaluation if you can
• Tell participants everything a caring
intelligent relative would want to know
• Make the PIS readable by an 11 year old
• Read and follow the NRES Guidance
when you fill in the forms
• Ask for help and advice (NRES or REC
chair)
November 2011
Dr Niki Bannister
Thanks to:
• Members and chair of Essex NRES REC
• Too many researchers and their
supervisors to list
• The NRES website
– http://www.nres.npsa.nhs.uk
November 2011
Dr Niki Bannister