Introduction to Research Ethics - UCL PDF

Introduction to research ethics – online preliminary talk Sonia Johnson UCL Division of Psychiatry MSc Clinical Mental Health Sciences / Mental Health Sciences Research Core research principles in mental health module Module leads: Sarah Rowe, Sonia Johnson Learn...

Introduction to research ethics – online preliminary talk Sonia Johnson UCL Division of Psychiatry MSc Clinical Mental Health Sciences / Mental Health Sciences Research Core research principles in mental health module Module leads: Sarah Rowe, Sonia Johnson Learning outcomes For students to understand why ethical regulation of research is needed For students to be familiar with important criteria for ethical approval For students to have a basic familiarity with systems for applying for ethical approval via university and NHS routes For students to be aware of and able to begin to apply the principles of good design of patient information sheets. The disreputable side of medical research Hitler’s personal physician on trial at Nuremberg  Medical ethics in the 20th century Breakdowns of ethical conduct by health researchers. – medical experiments in the concentration camps – Tuskegee (Alabama) study of the course of untreated syphilis, conducted 1932-72 – Willowbrook School experiment (NYC): children with learning disability deliberately infected with hepatitis – 1956-1970. – Many developed countries including UK – history of sometimes dangerous experiments on people with intellectual disabilities, prisoners in early –mid 20th century 1948: Nuremberg Code following Nazi war crimes tribunals, setting basic standards for medical research. 1964: Declaration of Helsinki The Declaration of Helsinki First statement World Medical Association - 1964 Most recent revision -2013 Considerations related to the well-being of the individual participant must take precedence over the interests of science and society Acknowledged risks need to be balanced against benefits (individual and community) Participants must be informed volunteers Control as well as experimental groups must receive optimal quality care according to current evidence Participants who lack capacity - include only if essential, consent from a legally recognised representative Research must of good quality and likely to yield useful evidence, and must be disseminated  Some key principles of ethical research Autonomy: Make own decisions – Informed consent Justice: Fairness – First do no harm – commission or omission – Risk and benefits: to be balanced Confidentiality GDPR Attention to vulnerable groups (children, people who lack capacity, prisoners etc)  Autonomy Each person should be given the respect, time, and opportunity needed to make their own decisions. Prospective participants must be given all the information they will need to decide to enter a study or not to participate. There should not be pressure to participate (including incentives so large as to be coercive). Withdrawal should be easy and without penalty Informed consent only possible when someone has capacity to make the decision (including sufficient information on which to base it) 7  Justice: balancing risks and benefits Risks Benefits Physical Harms Individual benefit from a new treatment Psychological Harms Benefit to others like the Invasion of privacy research participant Some evidence that Breach of confidentiality research participants have better outcomes in general. Social and economic harms Not receiving optimal care  Confidentiality Safeguarding confidentiality of paper and electronic data is a key priority, issues include: – Where paper and electronic data is stored. – Whether any of it is identifiable. – Whether reports on data allow people to be identified. – How long data is kept – Who has access to it. GDPR (General Data Protection Regulation) – European framework that since 2016/7 sets out requirements for keeping data on living individuals 9 Development of frameworks for NHS ethical approval in the UK Surely it is often quite impossible to tell ill-educated and sick persons the pros and cons of a new and unknown treatment versus the orthodox and known?” Austin Bradford Hill, 1964 - Until 1960s – paternalism, professional ethics, some interest from MRC. - Late 1960s: ethics committees in most hospitals. - 1991: the Department of Health’s “Red Book”; first national code to regulate very diverse ways of working. - 1997: multicentre research ethics committees - 2003: Standard application procedures - 2004: European Directive on Clinical Trials - 2007- National Research Ethics Service: national coordination of committees with research considered initially by any qualified committee. - 2011 – Human Research Authority (www.hra.nhs.uk) - International picture: availability of ethics commitees varies greatly. Where none – WHO has a role & universities are obliged to ensure staff have approval. NHS ethics approval process Governs research involving patients and carers in the NHS Now centralised and governed by national standard operating procedures Any committee can approve any application, though some more specialised committees Mixture of lay people, researchers and clinicians (some mixed backgrounds) Ethics applications need not only approval from committee but also: – sponsorship from a university or Trust that will support and insure them – data protection approvals – checks for individual researchers – local site confirmation that all appropriate governance arrangements are in place (known as R& D approval) Can take many months – even as much as a year University ethics committees Many set up in early 2000s after drive to ensure all research with human participants regulated Regulate: – Research in general population/education/most settings outside NHS and social care – Research within university/?across multiple universities – Research with NHS staff (but Trust-level approval may still be needed) – Research abroad by university staff/students Very little standardisation of procedures – evidence suggests operation and outcomes highly variable Process generally taking a few weeks Opportunity not given to attend, but can submit repeatedly Departmental sign off before university committee Low risk studies may get chair’s action  What do research ethics committees look for? Scientific merit (assessed by separate peer review) and potential benefit for patients or people like them Realistic evaluation of risk, balancing them against clear benefits Whether project is feasible and researchers and supervisors adequately qualified. Clear consent procedures (usually written) A good information sheet Procedures for confidentiality, GDPR compliance Conflicts of interest – what conflicts does researcher have, are they explicit and may they be damaging? Specific EU guidance on trials of medicinal products – nightmare. NB – ethics committees appreciate help. If issue is tricky, refer them to appropriate guidance that you have found! Participant information sheets & consent forms The most scrutinised part of the application. Get input from service users, general public. Explanation in simple language (“Plain English” style, including: – Purpose of study – What will actually happen to the participant – Benefits and potential risks – Confidentiality and what will actually happen to the data. – No pressure (care not affected) – The right to withdraw.