Transcript Training Presentation (PowerPoint)

Training for Ethics Administrators
Aims:
 To clarify the role of Ethics Administrator
 To clarify boundaries between procedures
 To consider the University Ethics Procedure
 Record Keeping (maintaining audit trail)
 Departmental Ethics Webpage
 Grey areas & FAQs
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Job Description?
Core Responsibilities:
 Processing University research ethics
applications from submission to feedback
(including ‘generic’, ‘contentious’, ESRC£ …)
 First point of contact re. route into the
University ethics review procedure
 Retaining audit trail for research projects
that have been ethically reviewed (retention
and archiving)
 The Annual Report
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Procedural boundaries:
University?, NHS?, Alternative?
(99% of time its one or other –
i.e. not both)
University Procedure
Remit:
Research project (investigation
to gain knowledge & understanding)
Led by this University
Involves human participants,
personal data or human tissue
Does NOT involve the NHS
‘Takes place within the UK’
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
NHS Procedure
Remit:
Patients & users of the NHS
(recruited due to past/present NHS treatment)
Relatives or carers of patients & users of NHS
Access to data, organs, other bodily material of
past or present NHS patients
Fetal material & IVF involving NHS patients
Recently dead in NHS premises
Use of/potential access to premises
Staff (recruited due to professional role)
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Alternative Procedure
Remit:
Research takes place in another country?
then ‘robust’ procedure in country(ies) applies
and the procedure may be compulsory
(robust? – i.e. compared against University procedure sufficiently robust mechanism to help protect dignity, rights,
safety & well-being of human participants in research
Research is led by another organisation?
then ‘robust’ procedure in organisation applies
Vulnerable approach – can’t audit
must entirely trust applicant
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Alternative Procedure
Advice to give:
1. read Alternative procedure guidance at:
www.shef.ac.uk/researchoffice/gov_ethics_grp/ethics/er/ers.html2.
2. email Richard Hudson:
[email protected]
(provide:
i) A copy (preferably electronic) of the
institution’s research ethics application form
ii) Information on the ethics reviewers
- via a website (if available)
3. If procedure is robust then apply via that but
send ethics decision letter to Administrator
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Boundary Grey Areas
1. Student project about NHS IT policy?
Project involves NHS & human participants but is
not classed by NHS as research (e.g. is ‘audit’ or
‘service evaluation’) then University procedure
applies:
www.rdforum.nhs.uk/docs/categorising_projects_guidance.doc
2. Asking ex-students to complete questionnaire
about experience of curriculum?
If part of normal course evaluation then ethics
review not required.
If it’s a more general study about effectiveness of
teaching then ethics review is required.
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Boundary Grey Areas
3. Project involves both people who have been
recruited via the NHS & people who have not
Ethics review is only required via NHS if the
approach used to recruit & inform the prospective
participants (e.g. patients & volunteers) is broadly
similar
4. Project takes place in more than one country
Ethics review is required via the appropriate
procedure in place within each participating country
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
University ethics review
procedure (UERProcedure)
UERProcedure - Evolution
2004: UREC identifies governing
principles & consults departments
2007/8: Marked scaling up
of awareness raising
activities
2006: 2nd initiative to
streamline process: lowhigh risk UG & PGT
projects
2005: Launch of procedure
Staged roll out of accreditation
2005: Awareness raising
& training events
2005: 1st initiative to streamline
process: ‘Generic’ projects
2006: UREC starts to monitor
process – annual reports, visits
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Minimum expectations
Decisionmaking 3.
Independent
Transparent
Quick turn
around times
2.
(not prescribed)
Efficient Risk based
1.Competent
Consistently protects
dignity, rights, safety,
well-being of human
participants
No conflicts of interest
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
UERProcedure – Flexibility
1. In terms of number of ethics reviewers:
3 ethics reviewers for staff-led & PGR (none of
whom have conflict of interest with application)
2 ethics reviewers for potentially high risk distinct
supervised-UG & PGT research (one is Supervisor)
1 ethics reviewer (Supervisor) for potentially low risk
distinct supervised-UG & PGT research
Ethics Review Panel (i.e. more than 3 reviewers)
reviews ‘generic’ projects (i.e. sufficiently similar
supervised-UG &/or PGT projects)
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
UERProcedure – Flexibility
2. In terms of where reviewers are from:
ESRC-funded research – 1 of 3 ethics
reviewers must be from different academic
department
Can
staff
from other
depts.
the norm
3. Ininclude
terms of
whether
to apply
theas
low-high
risk
approach to UG/PGT distinct research
4. In terms of the University form (dept. can
adapt the form’s layout & add questions)
5. In terms of how to conduct reviews (e.g.
electronic, face to face, invite applicants)
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
UERProcedure Key Stages
Action/Decision:
Taken by:
1. Need ethics approval?
Applicant
2. Need it via University?
Applicant
3. Complete documents
Applicant
4. Check documents
Administrator
5. Identify reviewers
Administrator
6. Review documents
Reviewers
7. Make decision
‘Lead’ Reviewer
8. Inform applicant
Administrator
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
UERProcedure Stage 4
• Check project does not involve the NHS
• Undertake checks:
i.e. all required documents are enclosed
(as specified in the ‘cover sheet’)
i.e. all questions have been answered
• Need signed Declaration (Part B of
standard form or Annex 1 or 2 of UG/PGT
form)
• Date & version number the footers
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
UERProcedure Stage 5
• Pick ‘3’: (staff-led / postgrad. researcher)
• Pick ‘2’: (UG or PGT-level research)
• ***Exceptions***
i.e. Generic Applications
i.e. Contentious Applications/Appeals then
Ethics Review Panel must review
• Rotate the ethics reviewers
• Send all documents + ‘Comments Form’
(give reviewers at least 7 working days)
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
UERProcedure Stages 7 & 8
• Identify ‘lead’ when comments are returned
i.e. apply rotation system or ask person with
most comments to be lead
(give 3 working days)
• Check comments are ‘valid’ (‘reasonable’)
• ‘Lead’ should explain decision clearly in
writing (including any conditions)
• Provide reviewers’ comments to ‘lead’
(can collate them)
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
UERProcedure requires
Transparent Communication
• Inform applicant when s/he will hear the
decision (keep informed if delays occur)
• Send ‘reminder’ emails if necessary
• Inform other ethics reviewers of ‘lead’
• Inform all ethics reviewers of decision
(include positive feedback?)
• Inform applicant of decision – quick email
and/or signed, written confirmation
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
UERProcedure
for Staff & PGR Students
Potential Decisions:
- approved
- approved with suggestions
- approved subject to requirements
- approved with suggestions and
subject to requirements
- not approved (applicant may appeal)
- no decision: application is contentious
UREC
Ethics
Review
Outcome
Departmental
Ethics Review Panel
Route for Appeals &
Contentious Applications
Minimum of 3
Independent ethics reviewers
Ethics Administrator
Applicant completes the University’s
research ethics application form
(& other documents if appropriate)
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
UERProcedure: Exception
Generic Research Projects:
www.shef.ac.uk/researchoffice/gov_ethics_g
rp/ethics/er/ers.html
Question
Aims &
Objectives
Nature of
participation
Topic
Generic Research
Content of
info. sheet
…
Method to
inform
participants
Type of
Participant
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Methodology
UERProcedure: Exception
Generic Research Projects
• Two ‘Types’ - students:
- are involved in one large project
- undertake slightly different but ‘’sufficiently
similar’’ projects
• Course module leader/Research Director
is accountable for all projects covered by
the application and should complete it
• Ethics Review Panel may approve up to
3 years
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
UERProcedure
Generic Research Projects
Ethics
Review
Outcome
Departmental
Ethics Review Panel
Ethics Administrator
Supervisor / Course Module Leader / Research Director
completes the University’s research ethics application form
(& other documents if appropriate)
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
UERProcedure
for Distinct UG/PGT research
•
Supervisors categorises research project
as potentially low or high risk
Supervisor classifies project as:
Potentially LOW Risk or as Potentially HIGH Risk
LOW Risk:
Potentially HIGH Risk:
No ‘particularly vulnerable’
people involved
Does not ‘focus’ on highly
sensitive topics
Particularly vulnerable
participants; and/or
Focuses on highly
sensitive topics
www.shef.ac.uk/researchoffice/gov_ethics_g
rp/ethics/er/ers.html
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
UERProcedure
for Distinct UG/PGT research
•
Administrator processes ‘potentially high
risk’ applications as per normal process
(Supervisor has signed Annex 2)
•
‘Potentially low risk’ applications:
Administrator receives electronic copy of
approved application (i.e. all documents)
plus record of ethics decision
Administrator has the right to consult
Chair of Ethics Review Panel if s/he has
concerns about the risk categorisation
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
UERProcedure
for Distinct UG/PGT research
Ethics
Review
Outcome
LOW RISK applications:
Minimum of 1 ethics reviewer
(this can be the Supervisor)
Supervisor
Potentially HIGH RISK applications:
Minimum of 2 independent
ethics reviewer
Ethics Administrator
Applicant completes the University’s
STUDENT research ethics application form
(& other documents if appropriate)
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Record keeping –
maintaining the audit trail
Record Keeping
Rationale:
* University Research Ethics Committee has
to monitor the ethics review arrangements within
academic departments, which includes reviewing
ethics decisions, on an annual basis
* Protects the department
* Complete, linear audit trail needed that is clear
to people unfamiliar with the research
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Record Keeping - Retention
•
Projects processed via Alternative route
retain record of final ethics decision
•
Keep the following records for projects
processed via University procedure:
* copy of all the documents that were
initially submitted for ethics review;
* signed, dated Declaration;
* record of who lead reviewer was;
* record of initial ethics decision;
* signed, dated final ethics decision;
* final approved documents.
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Record Keeping - Retention
•
Retain for up to 3 years following
completion of research for STAFF & PGRs
•
Retain for up to 1 year following
completion of research for UGs & PGTs
Record Keeping – Storage & Archiving
•
Store electronically wherever possible –
store on CDs/scan hard copies to PC to
CD
•
Archive in an environment that enables
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Grey Areas
Grey Areas?
•
University-NHS-Alternative boundaries
•
‘RISK’ with respect to distinct UG & PGT
research projects
•
Generic research
•
ESRC-funded research
•
Freedom - e.g. to change standard form
•
Administrator & Principal Ethics Contact
(roles need to be complementary)
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Departmental
Ethics Webpage
Departmental Ethics Webpage
•
Link to central research ethics website
•
Explain the departmental procedure
•
Identify all departmental staff involved
(i.e. Administrator, Principal Ethics
Contact, Ethics Reviewers)
Examples of effective webpages:
APS: www.shef.ac.uk/aps/ethics
Law: www.shef.ac.uk/law/researchactivity/ethics.html
Music: www.shef.ac.uk/music/research/ethics
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Relevant FAQs
Relevant FAQs
Will a researcher need to reapply for ethics
approval if the potential degree of risk to the
human participant(s) changes during the
-research
…
project’s lifetime?
YES (consult Chair of Ethics Review Panel
if unsure)
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Relevant FAQs
Will a researcher need to reapply for ethics
approval if s/he decides to use additional
methods of contacting participants?
- Depends – do the following:
1. * Administrator should be given document.
(e.g. poster)
2. * Send document to lead ethics reviewer.
3. * Provide amended ethics approval letter
to applicant.
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Relevant FAQs
Does research by distance-learning
students, or by students based outside the
UK but who are registered with this
University, require ethics approval via the
University ethics review procedure?
YES
Does University ethics review procedure
apply to course/curriculum evaluations?
YES – if evaluation constitutes research &
does not involve NHS – e.g. evaluation of
innovative teaching techniques
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Relevant FAQs
My project will only involve anonymised or
aggregated data which was, when collected,
subject to relevant ethics approval. Does my
-project
…
need to be ethically reviewed again?
NO IF DATA IS TRULY ANONYMOUS –
i.e. researcher cannot possibly identify the
participants to whom the data relates (e.g.
data collected by Office of Nat. Statistics)
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Relevant FAQs
My research project will only involve access
to data stored on publicly available
databases (i.e. data in the public domain).
Is ethics approval needed?
NO (so long as the people to whom the data
relates gave permission for data to be
included in the databases and on provision
that it is impossible to identify them)
I wish to access data from the internet.
Is ethics approval required?
Depends: If website(s) is in public domain
then no
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Relevant FAQs
Do I need ethics approval in order to obtain
tissue from the National Blood Service?
- Yes (but from NHS research ethics
committee)
For further guidance on human tissue
consult the guidance factsheet at:
www.shef.ac.uk/content/1/c6/07/21/15/Tissue.doc
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
www.shef.ac.uk/researchoffice/
gov_ethics_grp/ethics/system.html
17/07/2016 © The University of Sheffield / Department of Marketing and Communications
Further Guidance
Richard Hudson (Secretary to the UREC)
[email protected], ext.21448
17/07/2016 © The University of Sheffield / Department of Marketing and Communications