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
Life threatening illnesses Children Prisoners Compulsorily detained under Mental Health Act 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

Research without direct consent

A REC can approve:

High risk interventions
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
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:

CTIMPs 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
Dr Niki Bannister

November 2011

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?

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 doesnt need to see:

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: dont 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 todays talk) The Participant Information Sheet (PIS) read the NRES guidance and make sure you follow it
November 2011 Dr Niki Bannister

The Protocol:
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 participants 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 participants 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
Web address valid 27 Nov 2011 Dr Niki Bannister November 2011

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

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?
Dr Niki Bannister

November 2011

Methodological Pitfalls
Is the research question valid? Does the method address the question? Case selection bias Historical controls Failures of blinding Questionnaire validity randomisation
Dr Niki Bannister

November 2011

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 doesnt 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

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
Dr Niki Bannister

November 2011

Final Message
Point yourself at the NRES website at an early stage Attend the REC meeting with your supervisor
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