An Introduction to the
Ethics Review Procedure
Lindsay Unwin: Research & Innovation Services, UREC Secretary
Routes for ethics approval
1.University ethics review procedure
(administered in each academic department)
2.Alternative ethics review procedure (other
HEIs/organisations)
3.Administrative research ethics review
procedure
4.NHS ethics review procedure/Social Care
Research Ethics Committee (IRAS)
University Procedure
Remit:
• Research project (investigation
to gain knowledge & understanding)
• Involves human participants
or personal data
• Is led by this University
• Takes place within the UK
• Research involving NHS staff
or NHS premises
Alternative Procedure
Remit:
• Research conducted outside UK;
or
• Research led by another UK
university/research organisation
BUT:
• The other procedure must be
judged to be sufficiently robust by
the UREC; if in doubt, apply
University procedure
Administrative Procedure
• Research undertaken in administrative
departments
• Reviewed by central UREC
• Student Services has its own procedure
NHS Procedure
Remit:
• Patients & users of the NHS
(current or previous)
• Relatives or carers of NHS patients
• Access to data, organs, other bodily material of
past or present NHS patients
• Foetal material & IVF involving NHS patients
• Recently dead in NHS premises
NRES provide comprehensive
guidance on the types of research that
require NHS review
Social Care Research
Ethics Committee (SCREC)
• Apply via NRES (as per NHS procedure)
Remit:
• Staff-led social care research projects in which
some or all of the human participants are adults
who lack the capacity to consent for themselves;
• Department of Health-funded staff-led social
care research projects in which the human
participants are adults
University ethics review
procedure
How to apply ?
Staff:
• Find relevant ethics application (dept.
website/Ethics Administrator/online system)
• Fill in application
• Submit to Ethics Administrator
• Receive decision within 2 weeks
*Can also do generic applications (single
application for several similar student projects)
How to apply ?
Postgraduate research students:
• Find relevant ethics application (dept.
website/Ethics Administrator)
• Fill in application
• Submit to supervisor for sign-off
• Submit to Ethics Administrator
• Receive decision within 2 weeks
How to apply ?
Undergraduate/postgraduate-taught students:
• Supervisor should help identify relevant ethics
application
• Fill in application in consultation with supervisor
• Submit to supervisor
• Supervisor decides on risk level
• Low risk: supervisor reviews and gives decision
• High risk: supervisor submits to Ethics
Administrator for review by 2 people: receive
decision within 2 weeks
FOR ALL APPLICANTS:
MAY NEED TO REVISE AND RESUBMIT
SO ALLOW TIME FOR THIS PROCESS!
What happens once I’ve submitted my
application*?
• Ethics Administrator identifies reviewers:
- Staff/PGR projects – 3 (not including supervisor for PGRs)
- Potentially high risk UG/PGT projects – 2 (usually
supervisor +1)
(Potentially low risk UG/PGT projects – supervisor reviews)
• Reviewers provide comments and decision
• ‘Lead reviewer’ forms a consolidated response
• Ethics Administrator confirms decision to applicant
*SPECIFIC ARRANGEMENTS VARY BY DEPARTMENT
Review process for UG/PGT
Student
Low risk
Potentially high risk
Supervisor
Supervisor review
Student
Ethics administrator
Ethics administrator
2 reviewers (usu.
supervisor +1)
Ethics administrator
Lead reviewer
Student
Review process for PGR/staff
Researcher
Ethics administrator
3 reviewers (not inc.
supervisor)
Ethics administrator
Lead reviewer
Ethics administrator
Researcher
If PGR - supervisor
sign off
Outcomes of review procedure
• Approval = GO AHEAD!
• Approval with suggested amendments =
GO AHEAD BUT CONSIDER
SUGGESTIONS
• Approval with compulsory amendments =
MAKE CHANGES AND RE-SUBMIT
• Approval with suggested and compulsory
amendments = MAKE CHANGES AND
RE-SUBMIT + CONSIDER
SUGGESTIONS
Issues for applicants to consider
Have I provided
enough information
(in lay language)?
What risks does the
project pose & how
will they be
managed?
Does the project
require special
ethical consideration
e.g. vulnerable
people or sensitive
topics?
Is participant
information
appropriate for
audience (no
jargon,
abbreviations etc)?
How will I seek
informed
consent?
How will I
ensure
participant
safety and
well-being?
How will I
protect
participant’s
confidentiality/
anonymity?
Principles: Safety and Well-being
• Consideration must be given to potential for harm/distress
• Steps should be taken to minimise harm/distress (e.g.
informing participants of possibility; providing help/support
after participation)
• In some research (e.g. clinical trials), the researcher may
need to knowingly cause harm BUT possible harm should
be outweighed by the potential benefits
• Participants should be informed of procedures for
contacting researcher if problems arise
• Safety/well-being of researcher should also be considered
Principles: Informed consent
• Participants should be fully informed about
reasons/method and be able to ask questions/reflect –
INFORMATION SHEET?
• Participants should give free and voluntary consent, and
not be coerced
• Consent should ideally be in writing or witnessed oral
consent instead, although this may not always be
appropriate – CONSENT FORM?
• Must have right to refuse to participate or withdraw
• Need consent for data to be used for secondary
analysis;
• Special consideration should be given to projects where
informed consent will not be sought
Principles: Anonymity,
Confidentiality & Data Protection
• Must comply with Data Protection Act 1998
• Participants’ identities should not be disclosed without
prior consent; data should be anonymised where possible
• Access to data that could identify individuals should be
restricted to lead researcher(s) unless there is agreement
from the research participants
• Participants should be informed of:
1. Any risk that confidentiality may not be maintained (eg
disclosure of criminal activity);
2. Who will have access to data;
3. The purpose for which the data is to be used
Key points to take away
• Each research project should be considered
on a case by case basis but there are key principles;
• Ethics review is about heightening risk awareness –
not about preventing ‘potentially high risk’ research;
• Ethical review is about encouraging researchers to
think through potential ethical challenges;
• An ethically robust research project may still
encounter unexpected ethical challenges;
• Conducting research involving participants is
not an exact science-nor is the ethics review process
Put yourself in the participant’s shoes....
Further Guidance
www.sheffield.ac.uk/ethics
Lindsay Unwin/Peggy Haughton
(Research & Innovation
Services)
[email protected]
[email protected]
Download

Introduction to Research Ethics Presentation 2