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.

2. 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.

3. 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.

5. 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.

6. Who sits on the research ethics committee? Medicine Science Behavioural research? 1/3 Lay Independence - No conflicts of interest. Quorate.

7. Are ethics committees competent? Competence in ethical review only comes from training, knowledge and experience. Each decision may only be that meeting�s interpretation of the governance. Consistency in decision making is an important aim.

8. What is considered? Who is doing it, who is paying and how much? Can they make their proposals understood by the ethics committee�patients and public? Will a scientifically valid result be achieved? Have they assessed the long and short term risks?

9. 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?

10. Incapacity Incapable of; Making a decision. Communicating a decision. Understanding a decision. Retaining memory of a decision.

11. 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.

12. 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.

13. Informed consent `No deception�No coercion.` Onora O`Neill British Journal of Ethics; 2002

14. 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.

15. Principle 1 Data collected for one purpose cannot be used for another without ethical review.

16. Principle 2 There is no difference in ethical appraisal between interventions affecting individual patients and those affecting populations

17. 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

19. 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.

20. The New European Code Against Cancer What is it? Opinion, scientific evidence, a political statement, a public health intervention? Who sponsored it?

21. 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.

22. Should the New EAC Code be ethically reviewed?

23. 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

24. 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?

25. 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.

26. 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