1. DR TAMSIN NEWLOVE-DELGADO MRCPSYCH MFPH NIHR DOCTORAL RESEARCH FELLOW UNIVERSITY OF EXETER MEDICAL SCHOOL Research questions, governance, ethics and funding

2. PLAN OF THE DAY o 10-11.30 ish o Framing a research question - reminder o Research governance o Research ethics o Research funding o 11.30-11.45 - Break o 11.45-12.30 – Journal club o 13:00-15:00 – Study designs: case control, cohort and qualitative

3. MRCPsych exam – Paper 3 Critical Review Approx one third of the exam Research methods Statistics Evidence based practice Critical appraisal

4. Exam syllabus links to today 1. Translation of clinical uncertainty into an answerable question 3.1.10Knows the benefits and weaknesses of different quantitative study designs to address different clinical questions:  Cohort studies  Case control 3.4 Qualitative methods: methodologies, sampling, data collection, quality, analysis etc

5. WHAT MAKES A GOOD RESEARCH QUESTION? 1. Framing the question

6. FINER criteria Feasible Subjects Expertise Cost InterestingNovel Confirms Refutes Extends EthicalRelevant Knowledge Clinical Future research Policy

7. PICOT Patient Intervention Comparison Outcome Time

8. 2. Research Governance

9. Tuskegee syphilis experiment 1932-1972

10. Other examples

11. What is research governance? Principles, processes and standards Improve research and safeguard public by:  Enhancing ethical awareness and scientific quality  Promoting good practice  Reducing adverse incidents and ensuring lessons are learned  Forestalling poor performance and misconduct

12. DH research Governance Framework Ethics Science Health and Safety Information Finance Quality

13. Influential legislation Research Governance Framework for Health and Social Care 2001 Medicines for Human Use (Clinical Trials) Regulations 2004 Human Tissue Act 2004 Mental Capacity Act 2005

14. Who is responsible? Research governance is the responsibility of everyone involved in research Think about it:  When asked to take part in a project  When writing own proposal – consider time and resources needed  If a project is using NHS patients, staff, resources or premises, NHS Research and Development (R and D) approval required – even for non-clinical research

15. 3. Research ethics

16. Importance To protect patients To protect researchers Usually a mandatory requirement of the institution, and the funder A pre-requisite of publication

17. Key ethical principles AutonomyJusticeBeneficence Non- maleficence Declaration of Helsinki:

18. Key ethical principles Could also be expressed as:  Knowledge  Necessity :  Benefit  Consent

19. The three Cs of research ethics Informed consent ConfidentialityConduct

20. Informed consent UK case law on consent:  Consent should be given by someone with the mental ability to do so  Sufficient information should be given to the participant  Consent must be freely given

21. Informed consent Preconditions: Voluntariness Competence Information elements: Disclosure Understanding Authorisation Informed Consent

22. Competency Understand and retain information Use and weigh up Communicate decision

23. Voluntariness Consider the factors which might affect voluntariness Ideally should be an independent researcher Emphasise that can withdraw at any time Cooling off period

24. Information - disclosure Example of a BAD participant information sheet (adapted from my GOOD PhD one!) Take 5 minutes to read through and spot what’s missing or wrong

25. Information: Disclosure Aims and methods Funding source and conflicts of interest Benefits – ‘reasonably expected’  Are there likely to be any benefits to the participants?  If not, this should be made clear  Randomisation Risks and inconveniences – ‘foreseeable’ Duration of involvement What happens to data/samples Withdrawing from the trial

26. Some examples Ethical pitfall examples.......... What might be the problem with these research scenarios? If you were on the Ethics Committee, would you:  Accept outright  Reject outright  Request amendment – what/and what more might you want to know?

27. SCENARIO 1 An epidemiological cross sectional study is inviting men and women aged 65-84 for a cognitive assessment and MRI to measure their burden of cognitive impairments. All participants will be scanned, and all will receive feedback on any abnormalities found in their scan. Issue here around feeding back... Is it unethical to inform patients about abnormalities that are likely to be of no clinical significance and/or for which no further investigations or treatment exist?

28. SCENARIO 2 A pilot non-controlled trial of art and music reminiscence programme for people with advanced dementia. The researchers plan to assess the capacity of each participant individually and then consult the relatives of those who don’t have capacity to consent. Does this research have the potential to directly benefit the patients? Can it be done in other groups instead? Are the risks disproportionate?

29. SCENARIO 3 A basic science cohort study involving collecting blood samples once every three months for 5 years to monitor the concentrations of a biomarker in patients in a medium secure psychiatric unit. The current plan is for the consultant forensic psychiatrist to recruit patients to the trial. Consent to samples and storage of samples (Human Tissue Act) Voluntariness Will it be made clear that there’s no direct benefit to the patients?

30. Psychiatric research ethics ‘Although certain individuals with psychiatric disorders may at times lack the capacity to consent, the vast majority of people with a mental illness have the right to decide for themselves whether or not they wish to take part in a study’ The Royal College of Psychiatrists statement on research ethics

31. Psychiatric research ethics There are specific groups of individuals in psychiatric or other research who require additional safeguards :  Children  People with learning disabilities  People detained under the Mental Health Act  People with reduced or lost capacity due to dementia  And others……………….

32. The mental capacity act and research Aim is to balance the importance of properly conducted research with the need to protect the interests and respect the current or previously expressed wishes of those involved. Covers ‘intrusive research’ – covers data collection as well as collection of samples

33. Including participants who lack capacity: 2 questions Is the research related to the impairing condition that causes the lack of capacity – or to treatment of the condition? Could the research be carried out as effectively with people who do have the capacity to consent?

34. Including participants who lack capacity: 2 questions Research is related to the impairing condition or its management Research could not be undertaken as effectively with people who do have capacity to consent Seek approval from ‘appropriate body’

35. Study must meet one of these requirements: OR It is likely to be of benefit to the person – either directly or indirectly; and that the benefit is in proportion to any risks/burden The research will serve to increase knowledge of cause, treatment or care of people with the same/similar condition – AND that the risks will be negligible with no significant interference with privacy or freedom

36. Consultees for those lacking capacity The researcher should take ‘reasonable steps’ to identify a ‘personal consultee’ This is a close contact who is not acting in a paid capacity If no personal consultee is available, the researcher should nominate a ‘nominated consultee’ Can be a professional but must have no connection with the research study

37. Exclusions from mca in research Generally speaking……….. Under 16s Clinical Trials covered under Clinical Trials Regulations Research involving only anonymised data Some human tissue research Special permissions……..

38. Practicalities of ethical approval Is it research or not? Can check with NHS R and D

40. Practicalities of ethical approval If not managed as research, don’t need NHS R and D or REC approval, but may need other local/institutional approval processes If project is research and involves participants or data from the NHS, it will require NHS Ethics approval Guidance is available from the National Research Ethics Service: http://www.nres.nhs.ukhttp://www.nres.nhs.uk Applications are through the Integrated Research Applications Systems (IRAS): https://www.myresearchproject.org.uk/ https://www.myresearchproject.org.uk/

41. Mhra: medicine and healthcare regulatory agency Deals with clinical trials Covers:  New drugs  Old drugs being tested for a new use  Old drugs reformulated/packaged differently  Possibly more! These will require authorisation from MHRA

42. 4. Research funding What proportion of the medical research budget is spent on mental health research? Guesses?

43. Spending on health specific categories by year compared with health burden.3 DALY=disability adjusted life year. Kingdon D, and Wykes T BMJ 2013;346:bmj.f402 ©2013 by British Medical Journal Publishing Group

44. Funders of mental health research Government: NIHR and MRC Industry/Commerce Large charities e.g. Wellcome Trust Professional bodies Royal Colleges BMA Smaller charitable foundations e.g. Mental Health Research UK Europe and international

45. Mechanisms of funding National commissioned calls Grants and researcher-led proposals  NIHR Programme Grants for Applied Research Fellowships for research and research training from big funders

46. Mental health research networks locally NIHR Mental Health Clinical Research Network – West Hub NIHR Peninsula Comprehensive Local Research Network (CLRN) NIHR Research Design Service University of Exeter – Mental Health Research Group, Child Health Research Group

47. Thank you Questions?