Ethics, Public Health and Population Studies

1
Ethics,Public Health and Population Studies

• Professor Charles R Gillis,
• Honorary Senior Research Fellow.
• University of Glasgow.
• Immediate past Chairman, Multi-centre Research
  Ethics Committee for Scotland.

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Definitions

• Ethics philosophy.
• Public health the science and art of preventing
  disease, prolonging life and promoting health
  through the organised efforts of society.
• Population studies The evidence for actions in
  public health.

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What is ethical review?

• Consideration of a research proposal by a group
  of individuals appointed by a health authority to
  ensure
• Non-maleficence
• Autonomy
• Beneficence
• Justice.

4
Why is ethical review necessary?

• To protect the public.
• Public respect and trust for medicine and science
  have declined.
• Examples of poor ethics in medical practice.
• Public opinion has become more strident fuelled
  by a media which does not put integrity first.

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Fundamentals

• Research is a privilege not a right.
• Ethical review is what is demanded by the UK
  Departments of Health to protect the public.
• Ethical review is more important than the
  research itself.
• Ethical review is not peer review.
• What is ethical may not be legal and vice versa.

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Who sits on the research ethics committee?

• Medicine
• Science
• Behavioural research?
• 1/3 Lay
• Independence - No conflicts of interest.
• Quorate.

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Are ethics committees competent?

• Competence in ethical review only comes from
  training, knowledge and experience.
• Each decision may only be that meetings
  interpretation of the governance.
• Consistency in decision making is an important
  aim.

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What is considered?

• Who is doing it, who is paying and how much?
• Can they make their proposals understood by the
  ethics committeepatients and public?
• Will a scientifically valid result be achieved?
• Have they assessed the long and short term risks?

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More ethical questions.

• Will the findings be published?
• What happens when the project is finished?
• What do the investigators think the ethical
  problems are?
• How are the disadvantaged treated?
• Are cultural differences dealt with?
• What happens when something goes wrong?
• What are the arrangements for compensation?

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Incapacity

• Incapable of
• Making a decision.
• Communicating a decision.
• Understanding a decision.
• Retaining memory of a decision.

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Adults with incapacity-protects the rights of
those who cannot consent. Except

• To obtain knowledge relating to the incapacity.
• No or minimal discomfort.
• Consent of nearest relative or guardian.
• Agreed by an approved (COREC) ethics committee.

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Ethics committees decide if the answers are
appropriate

• It is the responsibility of the principal
  researcher to ensure that the level of ethical
  review is appropriate for the study.

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Informed consent

• No deceptionNo coercion.
• Onora ONeill
• British Journal of Ethics 2002

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There are no simple research projects!

• Ethical review is required for any research
  project involving patients past or present,
  relatives or carers of patients and users of a
  public or private health service
• access to data, organs or other bodily material.

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Principle 1

• Data collected for one purpose cannot be used for
  another without ethical review.

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Principle 2

• There is no difference in ethical appraisal
  between interventions affecting individual
  patients and those affecting populations

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Approaches to practice and research in Public
Health

• Practice is often based on a review of the
  scientific literature i.e. research before
  strategies are implemented.
• These have rarely been subject to ethical review

18
Framework for review of public health (Roberts
and Reich 2002)

• Influencing adults to change their behaviour is
  an ethical issue.
• Efficacy, human rights, cultural respect, equity,
  individual choice are ambiguous ethical
  principles rarely analysed in Public Health.
• Utilitarianism Liberalism Communitarianism are
  relevant philosophical principles.
• Lancet 2002,359,1055-1059

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There is a public health code of ethics eg (JAPHA
2002) Principle 6

• Public health should provide communities with the
  information they have that is needed for
  decisions on policy, or programmes and should
  contain the communities consent for their
  implementation.

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The New European Code Against Cancer

• What is it?
• Opinion, scientific evidence, a political
  statement, a public health intervention?
• Who sponsored it?

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A public health intervention

• Evidence from research and recommendations
  prepared by experts but.
• Chosen by?
• Responsible to ?
• Has it taken account of new knowledge?
• Is risk dealt with in a manner appropriate and
  intelligible to EU populations?
• Public perception of cancer still seems different
  from other diseases.

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Should the New EAC Code be ethically reviewed?
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Ethical review promotes research

• Clarifies protocols,
• Suggests how to address a difficult problem
• If researchers cannot make themselves clear to
  the REC they are unfit to attempt to do so to
  the public.
• Ethical review is not peer review

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Screening Ethical Audit -UKCTOCS

• Compliant? - first reviewed 1999
• Are the risks explained?
• Is the documentation adequate?
• Can all participants consent?
• Do they have enough time to think about it?
• Can the principal researcher guarantee prompt and
  good quality care?
• What about anxiety?

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International studies - the example of IARC

• Primacy of national ethical review.
• Recognition of cultural differences and
  encouragement of high standards.
• Ensuring consistency and completeness of ethical
  review internationally.
• Responsibility for transparency.
• CIOMS.

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The critical attitude in medicine the need for a
new ethic.

• But I shall let the little I have learnt go
  forth into the day that someone better than me
  may prove and rebuke my error. At this I shall
  rejoice that I was yet a means whereby this truth
  has come to light. Albrecht Durer circa 1513