1. Ethics and Midwifery Research
Dr Catherine Angell
Bournemouth University

2. Aims To explain the origins of modern ethical thinking
To describe the system of ethical governance in the UK
To introduce the main ethical research issues
To provoke discussion around ethical dilemmas

3. Objectives To recognise the main codes guiding ethical research
To be able to discuss the main ethical issues associated with midwifery research
To be aware of the ethical governance system in the UK
To explore some of the ethical dilemmas facing researchers
To understand the ethical responsibilities of the midwife in relation to research

4. What are ethics? What do you think?
Derived from the Greek word ethos meaning “character”
“the study of value concepts, such as good and bad, right and wrong” (Campbell, 1984)
“a set of moral principles”
(Oxford English Dictionary, 2008)
But how can we relate such broad principles to research?

5. What are research ethics?
Mmmmm….difficult to pin down isn’t it….
A code of research practice based on Modern Western ethical thinking
The principles guiding humane, responsible and trustworthy research
Publically acceptable research behaviour
The system of ethical control of research

6. Why does research have ethical implications?
An “unnatural intervention”…
Research always affects the status quo
Even observation changes a situation…
...Schrodinger’s cat

7. Why does research have ethical implications?
Experimental….
the whole point is that we don’t know what’s going to happen
there may be side effects…

8. Why does research have ethical implications?
Significant consequences…
research should have “a purpose”
research may be around important and sensitive issues
researchers are in a powerful position to create change
there may be huge consequences for individuals and society

9. So what controls are there on research involving humans?

10. International controls on research
Nuremburg Code 1947
Developed following research abuses in WW2
Covers research on human subjects
Very clear directives
Clause 5….

11. International controls on research
Declaration of Helsinki 1964
Amended 6 times, most recently in 2008
Response to research abuses since 1947
“The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data”
Para. 1 of the October 2000 version of the Declaration (Helsinki VI) WMA
WHO Geneva 2002
Recommendations for international research involving human subjects
These are not law but guidelines that considered as “customary International law”

12. Research Disasters…. Tenofovir trials on HIV transmission
Hepatitis E vaccine trial in Nepal
Nevirapine PMTCT trials in Uganda
Letrozole trials in India
Streptokinase trials in India
Fortified ORS trials in Peru
Risperidone trials in IndiaNDGA trials in India
Cariporide trial in Argentina
VGV-1 trials in China
TGN 1412 trials in London
Ragaglitazar trials in India and other countries
Trovafloxacin trials in Nigeria
Cilansetron trials in India
Zoniporide trials in India
Maxamine trial in Russia
Trials on foster care children in New York
Cilostazol trials in India
Organ removal without consent at Alder Hey in the UK

13. Monday, 29 January, 2001, 08:49 GMT Organ scandal background
Organs were retained at the hospital without consent The scandal at Alder Hey Children's hospital centres on the retention of hearts and organs from hundreds of children. The organs were stripped without permission from babies who died at the hospital between Hospital staff also kept and stored 400 foetuses collected from hospital around the north west of England. The findings of an inquiry into the affair have been described by Health Secretary Alan Milburn as "grotesque" and helplines have been set up to deal with calls from distressed parents. The first organ scandal broke in Bristol in 1998 when it became clear that staff at the hospital had been keeping hearts following surgery at the hospital. The scandal at Alder Hey emerged almost accidentally when heart specialist Professor Robert Anderson revealed at a separate official inquiry into heart surgery at Bristol that a store of children's hearts was kept at Alder Hey.

14. So who decides what research is okay?
Universities
80% have Ethics Committees
National Research Ethics Service (NRES)
Local Research Ethics Committees (LRECs)
Committees of professional and lay members
Meet monthly to hear research proposals

15. LRECs
ALL research within the NHS or including participants gained via NHS sources
Also hear applications involving vulnerable groups – children, people with disabilities, the elderly, prisoners
Research papers should indicate the ethical process that was followed
A positive LREC opinion is good practice and improves the trustworthiness of the research

16. Who says what about research ethics…
Nursing and Midwifery Council NMC
Includes midwives undertaking research
Guidance around key issues in research ethics are covered by general code of professional conduct
International Confederation of Midwives
International Code of Ethics for Midwives, 1993
Specifically notes the responsibility of midwives to engage in research
Since 2002 has recognised the need for code of international research ethics

17. Midwifery research Why do we need it?
To benefit women and their children
Evidence based practice
Keep pace with developments in related areas of practice
Keep pace with social changes
Unique perspective
Essential part of professional identity

18. So what are the ethical issues in midwifery research?
Consent
Coercion
Confidentiality
Participation
Risk
Sponsors
Disseminating research

19. Consent Informed consent Consent or acquiescence?
Providing information
Ensuring understanding
Competence to give consent
Children
Young people
People with additional needs
Documenting consent
Research without consent

20. Consent Talking Point….
Some research involves a retrospective study of medical records.
In many cases no consent is obtained from those people whose notes are reviewed.
Is this ethical?
What are the arguments for and against this type of research?

21. Coercion What does this mean? What are the issues arising from this?
Power imbalance
Pressure to participate
Inferior quality of care or treatment

22. Confidentiality Anonymity Pseudonyms Publishing work Small samples
Record keeping
Where
Who
How long
Limits of confidentiality
Every Child Matters
“All those who come into contact with children and families in their everyday work… have a duty to safeguard and promote the welfare of children”
Every Child Matters 2006

23. Confidentiality Talking point…
When visiting a home for a research interview you become very disturbed about the wellbeing of the woman’s 2 year old child…
What are the ethical dilemmas?

24. “Protecting the vulnerable”
Participation
“Protecting the vulnerable”
Governance
Organisational structures
“The right to
be heard”
Gaining access to participants
Enabling participation
Additional needs
Minority groups
Vulnerable people

25. The Bristol Third Stage Trial (Prendiville et al, 1988)
Risk
Research always carries an element of risk
Assessing and communicating risk
Competence and safety
Can you think of any examples of research where this might have been a concern?
The Bristol Third Stage Trial (Prendiville et al, 1988)

26. Risk
The right to take risks
“Desperate measures”
Altruism

27. Sponsors Vested interests Ethical sponsorship?
Control of research publishing

28. Sponsorship Talking point…. What do you think?
"Favourable outcomes were significantly more common in studies sponsored by the drug manufacturer (78%) than in studies without industry sponsorship (48%) or sponsored by a competitor (28%). These relationships remained after controlling for the effects of journal, year, drug studied, diagnosis, sample size, and selected study design variables”
KELLY, R.E. et al., Relationship between drug company funding and outcomes of clinical psychiatric research Psychological Medicine (2006), 36 : Cambridge University Press
Talking point….
What do you think?

29. Disseminating research
Ensuring correct interpretation and presentation
Trustworthiness
“Virtue ethics”
Effect on future research
Talking Point
What effect might some research have on future research studies?
Consider
Hannah W.J., et al (2004) Term Breech Trial, BJOG, Oct 2004,111(10):

30. How does research ethics affect YOU?
Reading research papers
Talking to women about research
Being a research participant
Conducting research for a study
Doing your own research

31. Thank you cangell@bournmouth.ac.uk