Ethics & Governance
An Overview
Dr Peter Hedges
Head of University Research
Office
University of Cambridge
Overview
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Some Basics – what is/are ethics?
Definitions & practice
What is Governance?
How do we manage ethics and governance?
• Group Exercise – potential issues for research
at Warwick
What is (are) ethics?
Ethics is a branch of philosophy which seeks to address
questions about morality, such as what the fundamental
semantic, ontological, and epistemic nature of ethics or
morality is (meta-ethics), how moral values should be
determined (normative ethics), how a moral outcome can
be achieved in specific situations (applied ethics), how
moral capacity or moral agency develops and what its
nature is (moral psychology), and what moral values
people actually abide by (descriptive ethics).
http://en.wikipedia.org/wiki/Ethics
Or….
Ethics means many things to many people. It is essentially
subjective. There are socially accepted ethical norms that
change (sometimes radically) over time. What you or I may
think is ethically acceptable may be deeply offensive to
another, or vice versa. It is essential that every active
researcher is aware that ethics in research is a live an
important issue, and it is the responsibility of everyone to
adopt good practice with regards ethics in research.
Hedges, P.A (2009) – a wholly personal view!
'Locked-in syndrome' man to have right-to-die case heard
A paralysed man who wants a doctor to be able to lawfully end his life can
proceed with his "right-to-die" case, a High Court judge has ruled.
Tony Nicklinson, 58, from Melksham, Wiltshire, has "locked-in syndrome"
following a stroke in 2005 and is unable to carry out his own suicide.
He is seeking legal protection for any doctor who helps him end his life.
The Ministry of Justice argues making such a ruling would authorise murder
and change the law governing it.
BBC News Web Site 13 March 2012
When suicide was illegal
When police found Lionel Henry Churchill with a bullet wound in his forehead
next to the partly-decomposed body of his wife it is hard to imagine the
emotional turmoil he must have been in.
He had tried but failed to take his own life in the bed of their Cheltenham
home. Doctors said the 59-year-old needed medical treatment at a mental
hospital, but magistrates disagreed. In July 1958 he was sent to prison for six
months after pleading guilty to attempted suicide.
Reported BBC News Web Site 3 August 2011
Unitarian chapel in Manchester celebrates first civil
partnership licence
The Cross Street Unitarian Chapel in Manchester has announced it received a
licence from Manchester City Council to hold civil partnerships on its premises,
believed to be the first of its kind.
The General Register Office believes the chapel is the first religious building in
England and Wales to be approved for civil partnership ceremonies.
The chapel said they would be the first to allow gay and lesbian couples to hold
a religious ceremony on religious premises, with the civil ceremony taking
place before or afterwards.
Pink News 12 March 2012
Gay marriage is the front line in a bloody culture war
Make no mistake: the row over proposals to make gay marriage law is the frontline in
a bloody culture war. On the one side, you have a strident and self-confident liberal
lobby supported, ironically, by the confused Conservatives. Opposing them is the
great silent majority supported by real conservatives, such as certain members of the
Christian clergy.
I say that David Cameron’s Conservatives are ‘confused’, because the whole point of
conservatism is to conserve. Conventionally, conservatives understood that society
is, as the great Edmund Burke wrote, ‘a partnership not only between those who are
living, but between those who are living, those who are dead, and those who are to
be born’. Ours is but a temporary trusteeship of the social, moral and political
capital, which has been transmitted to us by the dead for safe keeping.
Mark Dooley Daily Mail 13 March 2012
Russia: Block St Petersburg’s Homophobic Law
On March 7, 2012, the governor of St. Petersburg, Georgiy Poltavchenko,
signed the draconian homophobic law banning so-called “propaganda of
sodomy, lesbianism, bisexualism and transgenderism, and pedophilia to
minors.” The law goes into force 10 days after its official publication.
Governor Poltavchenko’s failure to use his right of veto to stop this deplorable
legislative initiative is profoundly disappointing, Human Rights Watch said.
Human Rights Watch, March 12 2012
Some History
• 1947 Nuremberg code, following ‘experiments’
on prisoners in concentration camps
Usually considered to be the starting point for
medical research ethics. Is a clear articulation
of the need for informed consent.
More History…
1964 The Helsinki Declaration
– A code of practice for physicians
involved in medical research
– Issued by the World Medical Association
Not all “ancient” history…
Alder Hey organs scandal - the story so far
Read more:
http://news.bbc.co.uk/1/hi/1136723.stm
Two Questions for you…
What subjects/themes of research do
you think can be actively pursued
without any ethical concerns.
What subjects/themes of research
which you think cannot be pursued
without ethical approval
The trick in the question..
The first question specified “ethical
concerns”, not “ethical approval”.
Research that does not require ethical
approval can have significant ethical
concerns.
What might these be?
Some Ethical Concerns…
Is the research appropriate?
Is the research sound?
Is the research morally/ethically acceptable?
Will the research threaten the reputation of
the researcher, Department, or the
University?
Will the research risk legal or financial
penalty?
Another question…
What are the four specific research
activities that, if followed, require
formal ethical approval?
The Four Activities are…
• Any research involving human subjects
• Any research using human tissue
• Any research using personal data
• Any research using animals
Some Definitions
• Research ethics
– Rules or standards for the conduct of research
• Research governance
– Rules or standards for the management, conduct
and monitoring of research
• Good Research Practice (GCP, GLP, GMP)
– The ‘right way’ to conduct research
– Rules or standards for the conduct of research
Ethics – the Legal Framework
Clinical Trials
• The Medicines for Human Use (Clinical Trials) Regulations 2004
Specific legislation regarding Human subjects:
• Data Protection Act
• Human Tissue Act (April 2006)
• Mental Capacity Act (2007)
• Other regulatory requirements (CRB, HEFA)
Other:
• Animals (Scientific Procedures) Act
– Home Office License
Ethical Approval Routes
• Patients (NHS/vulnerable groups/prison)
– requires approval from external Ethics Committee
(National Research Ethics Service)
• Other humans (e.g. social science research)
– usually requires ethical approval e.g. University
REC or School – NRES now has SS committee
• Animals (usually H&S committee)
– Home Office licence required
Ethical issues: human participants
• The research subject’s welfare
• Vulnerable groups
• Equitable distribution of benefits and
burdens
• Informed consent (opt out / deception /
DPA)
• Confidentiality and privacy
The Goal of Good Governance
To protect the interests of the
participants in research and to
ensure the quality and
reproducibility of research results.
Research Governance
• Sets standards for Good Practice in
Research including:
• Management and monitoring of
research
• Mechanisms to investigate Research
Misconduct: complaints, appeals,
sanctions
Good research practice involves…
• Behaving with integrity
• Ensuring ethical approval of research involving
human participants (and animals)
• Compliance with other governance principles
e.g. financial probity (insurance), peer review,
risk assessment, safety (HR/CRB)
• Monitoring of research
• Management of IP and conflicts of interest
Governance systems are needed to….
• Protect participants;
• Protect the reputation of the researcher,
the institution and research itself;
• Protect public interest;
• Confirm to legal and regulatory
framework;
• Satisfy funders’ requirements.
The Two Key Challenges….
• Developing practices that enable us to
‘ethically find things out’
• Developing administrative, regulative
and audit processes that support
(rather than hinder) practices that
allow us to ‘ethically find things out’
And The Trick is…!
To have processes that are sufficiently
rigorous to ensure ethical compliance
and sufficiently simple/painless that
researchers won’t work around them!
And we do this by…
• Establishing & Managing Research Ethics
Committees
– NHS RECs
– Universities RECs
– Potential external RECs (e.g. overseas)
• Putting in place appropriate policies,
practices and training – e.g. like this!
Typical REC Responsibilities…
• Consider ethical implications of all research
involving human participants carried out at the
University
• To receive proposals and to allow, refer back or
disallow such proposals, specifying any
conditions
• Make available application forms, guidelines and
background documentation
• Advise on effective preparation of applications
• Training
For each proposal/project…
• The proposed study is scientifically valid and
justifiable in terms of its possible benefits
compared with any inconvenience or harm
• Adequate steps have been taken so that physical
or psychological harm does not occur
• That confidentiality of all personal and medical
information is ensured and privacy maintained
• Consent is valid (informed) and given without any
form of duress
Other considerations….
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Indemnity insurance
Case-specific issues (e.g. minors)
Ensuring protection of researchers (risk)
NHS patients/data/organs/tissue – IRAS and R&D
approvals
Training: faculty and research students
Ensuring effective peer review
Monitoring arrangements
Conflicts of Interest
Research Misconduct
• Fabrication, falsification, plagiarism or deception
in proposing, carrying out or reporting results of
research
• Deliberate, dangerous or negligent deviations
from accepted practices in carrying out research
• Misrepresentation of activity to REC/funders,
disregarding University regulations or REC
advice/rulings
• Failure to follow procedures/protocols
• Whistle blowing?
Discussion of
Potential
Issues
Can work start?
RSS receives a telephone call from the Principal
Investigator of a recently announced NIHR-funded
clinical trial insisting that they be issued with an
early code to start their project immediately as they
wish to retain support for a postdoctoral research
assistant whose contract finishes next week. What
should we say to them?
Potential Misconduct
RSS receives an e-mail from an anonymous
googlemail account reporting that a PhD student in
the Medical School has fabricated data in a recent
article published in Chemical Communications. The
e-mail states that the student is due to received
their MD degree in the Science Faculty ceremony
next week. What should we do next?
Research Funding issues
RSS receives a request for retrospective approval from
Professor Steel in the School of Engineering for a
project titled “Extreme metallurgical deformation of
structural materials in highly dynamic and hostile
environments”. The subcontract recovers full FEC with
the IP assigned to the main contractor, Shanghai Steel
Corporation, with funding from MODAFL. What
should RSS do?
Research Funding issues
RSS receives a request for retrospective approval from
Professor Steel in the School of Engineering for a
project titled “Extreme metallurgical deformation of
structural materials in highly dynamic and hostile
environments”. The subcontract recovers full FEC with
the IP assigned to the main contractor, Shanghai Steel
Corporation, with funding from MODAFL. What
should RSS do?
OK to publish?
RSS receives an inquiry from a PhD student who has
been participating in site visits to companies with her
supervisor under a number of consultancy agreements.
The work has led to some additional and important
conclusions to her PhD thesis that was examined last
week, and she now wishes to submit this for
publication. She has been advised that she check with
the Research Office before sending her manuscript to
the publisher – what should RSS advise her?
Study Complaint
The Director of RSS receives an angry complaint from
the daughter of a resident of a local care home
concerning the behaviour of a “member of the
University’s staff” during their recent visit to the
Home. Their parent, who suffers from dementia, has
complained that `they were asked “far too many, and
very personal questions” about their health. What
should he do next?
Ethics Committee Enquiry
The Registrar receives a request from a local resident
asking for details of all of Warwick’s current research
projects supported by Cancer Research UK, the British
Heart Foundation and the Wellcome Trust. He also asks
whether he can apply to serve as a lay member of your
local “ethics oversight committee”. What advice should
RSS offer to the Registrar
Authorship Dispute
A postdoctoral research assistant requests an appointment
with the Head of Research Governance to discuss a recent
application to the EPSRC. He states that he was expecting to
be included as a Named Investigator on a major grant
application but was informed by the Principal Investigator
that the application had failed the internal peer review
process. He is concerned that the PI has now submitted
significant elements of the application without his approval
as part of a different EPSRC proposal that has an existing PhD
student as the named PDRA. What advice should be offered
to the PDRA and what actions should be taken?
External Participants
A research group in the Theatre Studies wish to
submit an application to AHRC on “Innovative
Approaches to the Use of Speech and Drama in the
Widening Participation of Young Adults with
Learning Difficulties in Public Performance”. They
are seeking to engage with local Schools and a
charity drama group as co-funded participants in
the work. What advice should RSS give to them?