Making an Application to an NHS REC 25 th November 2013 Professor Margaret Rees Chair of Oxfordshire Research Ethics Committee B 20062013 Member Open University REC 2013 present Secretary of the Committee of Publication Ethics COPE ID: 636006
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Slide1
AfRE /ARECIN PARTNERSHIP WITH HRA AND Manchester University
Making an Application to an NHS REC
25
th
November 2013Slide2
Professor Margaret Rees
Chair of Oxfordshire Research Ethics Committee B 2006-2013Member Open University REC 2013- presentSecretary of the Committee of Publication Ethics (COPE)
Editor in Chief of
Maturitas
Chair Elect of
AfRESlide3
What does an NHS REC look for?Is there a checklist?
Do all RECs view things the same way?
Why an application might be rejected?
How to avoid common mistakes.Slide4
What is an ethics committeeExpert membersLay membersNumber maximum 18
Quorum 7Aim is to protect participantsMembers need to do regular training
and are auditedSlide5
PreliminariesReputational Issues: Work as closely as possible with Supervisor prior to sign-off
University Review, R and D review, external peer review?
Attendance at REC meetings – Student / Supervisor
The MeetingSlide6
Do all RECs view things the same way?A checklist:
Key Ethical issuesRelevance of the research and research design
Suitability
of applicant and supporting
staff
Quality
of
Facilities
Evaluation
of anticipated benefits and
risks
Care
and protection of research
participan
tSlide7
A checklist:Hazards, discomforts and distress of participants
Consent of research participant (Including justification for research on persons lacking mental capacity)Participant
Information
Sheet/ Consent form:
Adequacy and
completeness
Recruitment arrangements
Confidentiality
: Privacy and Protection of
Data
Indemnity
and CompensationSlide8
Key Ethical issuesConsent
ConfidentialityData Protection
Vulnerable Groups
RiskSlide9
RiskSide effects of the intervention
eg drugs/surgeryHow many people have received the drug so far
Radiation:
cancer induction no threshold dose of radiation but larger doses increase risk/ damage to a system
eg
skin burn where there is a threshold dose
40-year-old male who underwent coronary angiography, coronary angioplasty and a second angiography procedure due to complications, followed by a coronary artery by-pass graft.Slide10
Relevance of the Research and Research designImportance of justification – not over justification/ over sell
Clarity of the science – Lay membersSlide11
AdvertisingConcerns were raised with regard to the wording of the advertisement, as ‘.........................’ was felt to send a subliminal message and may suggest unreasonable expectations to participants.Slide12
Suitability of applicant and supporting staffStudent / Supervisor
Risk – Supportive Environment?
Quality of Facilities ( R and D)Slide13
Evaluation of anticipated benefits and risksKey element in Risk Assessment
Management of Risk
LimitsSlide14
Care and Protection of Research ParticipantDuty of Care
Supportive Environment – Relevant PermissionsClarity and Sufficient detail – Participant Information
Sheet/ Consent form
Look at current guidance
Hazards, Discomforts and Distress of ParticipantsSlide15
Consent of Research Participant (Including justification for research on persons lacking mental capacity)
Consent Form – Relevance / Clarity / Appropriate linkage
with PIS
Conformity with Mental Capacity Act 2005
A Continuing obligation?Slide16
Mental capacity The research is connected with an impairing condition which can affect capacity.The research cannot be carried out as effectively if it was confined to participants able to give consent as they would not have the relevant clinical condition.
The research has the potential to benefit participants lacking capacity without imposing a disproportionate burden on them.
Reasonable arrangements were in place for identifying personal
consultees
, and for appointing nominated
consultees
independent of the project where no person can be identified to act as a personal
consultee
.
Information is adequate to enable
consultees
to give informed advice about the participation of persons lacking capacity.
Reasonable arrangements are in place for withdrawal from the projectSlide17
Participant Information Sheet:Clarity
AdequacyC
ompletenessSlide18
Recruitment ArrangementsFeasibility
Permission
RiskSlide19
Confidentiality: Privacy and Protection of DataData Protection
Public Interest ExceptionsSlide20
Why an application might be rejected?Committee Options
Incomplete paperworkKey Ethical Themes:
Omitted
Incomplete
Misunderstood / Ignored
Unsatisfactory responses – commonly through no attendance
Poor written presentation – particularly the PIS / Consent Form
Flawed methodology – A Research Ethics issue?Slide21
PublicationFabrication and falsificationLack of ethical approval
Authorship Conflict of interestPlagiarismDuplicate/ salami slice submissionSlide22
ConclusionsHRA / IRAS –
Continuous developmentA Learning Training
Opportunity
Not an impediment to
Research
Ethical approval essential
for publication