Ethics & GovernanceAn Overview

Dr Peter HedgesHead of University Research Office

University of Cambridge

Overview

• 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

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).

What is (are) ethics?

http://en.wikipedia.org/wiki/Ethics

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.

Or….

Hedges, P.A (2009) – a wholly personal view!

'Locked-in syndrome' man to have right-to-die case heardA 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 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

When suicide was illegal

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

• 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.

Some History

1964 The Helsinki Declaration–A code of practice for physicians

involved in medical research– Issued by the World Medical Association

More History…

Alder Hey organs scandal - the story so far

Read more: http://news.bbc.co.uk/1/hi/1136723.stm

Not all “ancient” history…

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 first question specified “ethical concerns”, not “ethical approval”.

Research that does not require ethical approval can have significant ethical

concerns.

What might these be?

The trick in the question..

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?

Some Ethical Concerns…

What are the four specific research activities that, if followed, require

formal ethical approval?

Another question…

• Any research involving human subjects• Any research using human tissue• Any research using personal data• Any research using animals

The Four Activities are…

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 FrameworkClinical Trials• The Medicines for Human Use (Clinical Trials) Regulations 2004Specific 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….

• 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 DisputeA 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?