Research Ethics Dónal O’Mathúna, PhD Senior Lecturer in Ethics, Decision-Making & Evidence

History Nuremberg Code (1947) Declaration of Helsinki (1964 – 2002) Belmont Report (1979) Council for International Organizations of Medical Sciences (1982 – 2002) Guidelines and Recommendations for European Ethics Committees (1997) EU Clinical Trials Directive 2001/20/EC (2001)

1.Research Question 1. Research should be valuable 2. Could the results lead to benefits or useful information? 3. Is the research necessary? 4. Has the question already been adequately answered? Responsible use of resources Shows respect to all involved

Importance of adequate literature review. Importance of input from others with more expertize or experience. Role of supervisor.

2. Scientific validity Is the study design appropriate? Is it feasible? Does the study have sufficient power? “Invalid research is unethical because it is a waste of resources as well: of the investigator, the funding agency, and anyone who attends to the research.” Vanderpool, Ethics of Research Involving Human Subjects (1996)

3. Scientific attitudes AccuracyCarefulnessThoroughnessUnbiased Fraud is not ethical!!

4. Subject recruitment This ought to be fair/just. Certain communities or groups should be chosen because of the study goals, not because of vulnerability or privilege. Those who bear the risks should have a good chance of benefiting from the fruit. ‘Convenience’ may not be a good enough reason.

Contact information must be properly obtained. Data Protection Act must be adhered to. Guiding principle: personal information can only be released if directly related to why the data was collected. Local policies must be adhered to.

5. Researcher’s conflicting roles The roles of researcher and carer/therapist can be muddied. The potential subject should be clearly informed that your primary role in this project is that of researcher. False expectations may be created. These should be listed and addressed. Beware of personal biases.

6. Informed consent A. Competence B. Information – plain language statement C. Understanding D. Lack of Coercion E. Authorisation

Respect for people as opposed to treating them as objects to help researchers reach their objectives. Respect for people’s autonomy – it is their decision whether or not to involve themselves in the research.

7. Risk-benefit ratio Risks and benefits are inherently uncertain. Potential risks must be minimised. Potential benefits must not be exaggerated. Risk-benefit evaluation must be proportionate. Must be clear that the benefits may apply more to society than the individual subject. There might not be any personal benefits.

8. Confidentiality Handling of all data Anonymous Storage – tapes, videos, computers Might they be contacted in the future?

9. Financial issues Sources of funding Inducements generally looked on with suspicion

10. Leaving the field “The more sensitive and compassionate the researcher is the more the issues of ending and parting will need to be addressed.” De Raeve (1996) Nursing research: an ethical and legal appraisal

Research Ethics Committees DCU policy: all student research projects must receive ethical approval from a university or health services/external ethics committee. School of Nursing policy: all student research projects must be reviewed by supervisors and then the School Ethics Advisory Committee before being submitted to another ethics committee (DCU, health services, etc.)

School of Nursing Ethics Advisory Committee accepts whatever application form you will eventually be using (DCU or external). Committee meets 2 nd Monday of the month (usually). Proposals submitted by 5 pm on the last business day of the previous month. Submissions to the Chair of the School of Nursing EAC, Veronica Lambert Signed hard copy and electronic copy must be submitted.

DCU Research Ethics Committee forms: Meetings: 2009: Sept 25, Nov : Feb, April, June Proposals submitted 2 weeks beforehand to Fiona Brennan, OVPR, and NOTE: expedited review is available for appropriate low-risk projects.

Research Ethics Committees Find the guidelines for the University, hospital, health service executive, etc. Get the deadlines. Is expedited review available for low-risk research? Submission of signed hard copies and/or electronic copies? NOTE: supervisors need time to review and you need time to incorporate their suggestions.

Questions? Dónal O’Mathúna, PhD