Ethics committee workshop:developing good practice

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Ethics committee workshopdeveloping good practice

• Dr Ann Crosland
• Principal Lecturer
• Primary Care Development Centre

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Ethics Northumbria University policy statement

• A mark of outstanding quality is a commitment
  to ethical standards in academic life. Broadly
  defined this means a systematic regard for the
  rights and interests of others.

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Ethics Principles

• Beneficence and non-maleficence
• Respect for the rights of others
• Justice
• Balance between different values

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Framework for considering ethics

• Each member of staff (and students where
  appropriate) is responsible for abiding by the
  university policy
• Each School is responsible for ensuring good
  practice
• University responsible for providing an
  institutional oversight

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Role of University Ethics Committee

• Provide written guidance on ethical issues
• Take an overview of Ethics Policy implementation
• Recommend policy changes
• Advise on issues referred to it by the Deans
• Receive relevant papers from external bodies for
  consideration

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School role

• Ensure good practice and a climate of ongoing
  reflection
• Support academic staff and students
• To ensure scrutiny of all research and
  consultancy at critical points
• Ensure meetings take place as required (at least
  three times per year)
• Be aware of legislation and its requirements
• Maintain a record of all research and consultancy
  projects which include ethical issues

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Implementing the Northumbria University ethics
policy

• Considerations for members of ethics
  sub-committees

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Developing good practice

• Raising awareness of policies, procedures and
  responsibilities
• Ensuring co-operation
• Providing transparency in the process of
  implementation
• Providing positive feedback
• Ensuring consistency and fairness
• Providing support for committee members

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Supporting staff and students

• Raising awareness of individual and
  organisational responsibilities
• Providing guidance and training
• Ensuring clarity in information
• Maximising opportunities for learning
• Providing support for staff and students who are
  required to undertake external ethical/peer
  review

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Scrutiny

• How to ensure that all appropriate work is
  submitted for scrutiny?
• Providing guidance on information to be
  scrutinised
• Deciding who will scrutinise
• What to look for when scrutinising
• Ensuring workload is realistic and achievable
• Recording the outcome

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Legislation and its requirements

• Deciding which legislation is relevant
• Data protection Act 1998
• Public Interest Disclosure Act 1999
• Human Rights Act
• EU Clinical Trials Directive
• Keeping up to date
• Obtaining specialist advice
• Implementing other relevant policies/ frameworks

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Maintaining records

• What should be recorded and where
• Who should have access
• Auditing the process
• Compliance with data protection

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The scrutiny process

• Assessing the benefits of the project
• Identifying if there is potential to do harm
• Assessing the quality of the project
• Considering how researchers will gain access and
  informed consent from participants
• Considering proposals for data handling and
  storage
• Identifying and dealing with conflicts of
  interest

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Scrutiny process continued

• Ensuring fairness and equity
• Making and feeding back recommendations
• Ensuring recommendations are acted upon
• Dealing with problems/ non adherence
• Reviewing the process

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Informed consent

• Why informed consent?
• When to obtain informed consent
• Consent and assent
• The process of obtaining consent
• The University policy