Presentation on theme: "Ethics and Midwifery Research"— Presentation transcript:
1 Ethics and Midwifery Research Dr Catherine AngellBournemouth University
2 Aims To explain the origins of modern ethical thinking To describe the system of ethical governance in the UKTo introduce the main ethical research issuesTo 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 researchTo be aware of the ethical governance system in the UKTo explore some of the ethical dilemmas facing researchersTo 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 thinkingThe principles guiding humane, responsible and trustworthy researchPublically acceptable research behaviourThe system of ethical control of research
6 Why does research have ethical implications? An “unnatural intervention”…Research always affects the status quoEven 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 happenthere 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 issuesresearchers are in a powerful position to create changethere 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 1947Developed following research abuses in WW2Covers research on human subjectsVery clear directivesClause 5….
11 International controls on research Declaration of Helsinki 1964Amended 6 times, most recently in 2008Response 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) WMAWHO Geneva 2002Recommendations for international research involving human subjectsThese are not law but guidelines that considered as “customary International law”
12 Research Disasters…. Tenofovir trials on HIV transmission Hepatitis E vaccine trial in NepalNevirapine PMTCT trials in UgandaLetrozole trials in IndiaStreptokinase trials in IndiaFortified ORS trials in PeruRisperidone trials in IndiaNDGA trials in IndiaCariporide trial in ArgentinaVGV-1 trials in ChinaTGN 1412 trials in LondonRagaglitazar trials in India and other countriesTrovafloxacin trials in NigeriaCilansetron trials in IndiaZoniporide trials in IndiaMaxamine trial in RussiaTrials on foster care children in New YorkCilostazol trials in IndiaOrgan 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? Universities80% have Ethics CommitteesNational Research Ethics Service (NRES)Local Research Ethics Committees (LRECs)Committees of professional and lay membersMeet monthly to hear research proposals
15 LRECsALL research within the NHS or including participants gained via NHS sourcesAlso hear applications involving vulnerable groups – children, people with disabilities, the elderly, prisonersResearch papers should indicate the ethical process that was followedA positive LREC opinion is good practice and improves the trustworthiness of the research
16 Who says what about research ethics… Nursing and Midwifery Council NMCIncludes midwives undertaking researchGuidance around key issues in research ethics are covered by general code of professional conductInternational Confederation of MidwivesInternational Code of Ethics for Midwives, 1993Specifically notes the responsibility of midwives to engage in researchSince 2002 has recognised the need for code of international research ethics
17 Midwifery research Why do we need it? To benefit women and their childrenEvidence based practiceKeep pace with developments in related areas of practiceKeep pace with social changesUnique perspectiveEssential part of professional identity
18 So what are the ethical issues in midwifery research? ConsentCoercionConfidentialityParticipationRiskSponsorsDisseminating research
19 Consent Informed consent Consent or acquiescence? Providing informationEnsuring understandingCompetence to give consentChildrenYoung peoplePeople with additional needsDocumenting consentResearch 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 imbalancePressure to participateInferior quality of care or treatment
22 Confidentiality Anonymity Pseudonyms Publishing work Small samples Record keepingWhereWhoHow longLimits of confidentialityEvery 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”GovernanceOrganisational structures“The right tobe heard”Gaining access to participantsEnabling participationAdditional needsMinority groupsVulnerable people
25 The Bristol Third Stage Trial (Prendiville et al, 1988) RiskResearch always carries an element of riskAssessing and communicating riskCompetence and safetyCan you think of any examples of research where this might have been a concern?The Bristol Third Stage Trial (Prendiville et al, 1988)
26 RiskThe 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 PressTalking point….What do you think?
29 Disseminating research Ensuring correct interpretation and presentationTrustworthiness“Virtue ethics”Effect on future researchTalking PointWhat effect might some research have on future research studies?ConsiderHannah W.J., et al (2004) Term Breech Trial, BJOG, Oct 2004,111(10):
30 How does research ethics affect YOU? Reading research papersTalking to women about researchBeing a research participantConducting research for a studyDoing your own research