Ethics and Midwifery Research Dr Catherine Angell Bournemouth University

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

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

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?

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

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

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…

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

So what controls are there on research involving humans?

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

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”

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

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 1988-1996. 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.

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

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

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

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

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

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

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?

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

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

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?

“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

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)

Risk The right to take risks “Desperate measures” Altruism

Sponsors Vested interests Ethical sponsorship? Control of research publishing

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 : 1647-1656 Cambridge University Press Talking point…. What do you think?

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):1065-74.

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

Thank you cangell@bournmouth.ac.uk