UCL Session 12 - Ethics Slides 2020 PDF

Preparing research ethics applications – principles and practicalities Sonia Johnson UCL Division of Psychiatry MSc Clinical Mental Health Sciences / Mental Health Sciences Research Core research principles in mental health module...

Preparing research ethics applications – principles and practicalities Sonia Johnson UCL Division of Psychiatry MSc Clinical Mental Health Sciences / Mental Health Sciences Research Core research principles in mental health module Module leads: Sonia Johnson, Sarah Rowe Learning objectives To further familiarise students with principles of getting research ethics approval and preparing information sheets. For students to consider some questions and dilemmas in research ethics Practical exercise 1 Present your group’s views about: 1. The main issues that an ethics committee would discuss in the application that you have been sent to look at and the conclusions they might reach. 2. Whether, in your group’s view, the application should be approved. Major questions that NHS research ethics committees consider 1. Are staff qualified, experienced and adequately insured and resourced to carry out study? Have they conflicts of interest? 2. Is the research relevant and well designed, such that significant evidence is likely to emerge? 3. What benefits are likely to result for participants and for other current and future patients? 4. What hazards or discomfort may result, and what are researchers doing to minimise these? 5. Is patient information accessible and clear, and does it provide the information needed for an informed decision? 6. Is any pressure being exerted on potential participants? 7. Will confidentiality and anonymity be safeguarded adequately, including in recruitment arrangements? Practical exercise 2 Present your group’s views about the patient information sheet circulated last week and its good and not so good points. What are the key qualities of a good patient information sheet? Should come across as a polite invitation presenting a balanced view. Style: Plain English – short sentences, one main idea per sentence, avoid or explain technical terms, max 2 ‘hard words’ per sentence. But polite, not patronising! (Flesch reading ease tool?) Adapt to patient group – seek advice with children, people with intellectual disabilities etc. Can use more than one in same study. Engage people like the participants (e.g. services users) in developing and reviewing the sheet if you possibly can). Balance of brevity vs. sufficient information – will vary according to complexity of study e.g. a clinical trial information sheet cannot be very short. A simple summary at the start is helpful. Test out as much as possible, ideally with target audience What should a patient information sheet cover? Title of study, an initial paragraph inviting people to take part but making sure this is clearly voluntary. A summary paragraph. Details (as a minimum) of: – What the point of the research is. – What exactly will happen if the potential participant agrees. – Potential benefits to participants and others. – Potential hazards and how they will be minimised. – How confidentiality and anonymity will be safeguarded. Practical exercise : writing patient information You are about to embark on a pilot randomised controlled trial of a self- management app for young people who use Early Intervention Services for psychosis. The Android app will allow people to store their personal relapse signature (the signs and symptoms that indicate they may be relapsing). They can then use it to monitor whether they are showing early signs of relapse, and they can set up the app so that clinicians and/or family members are alerted if they record signs of relapse. You are going to conduct a small randomised trial of this app, with 20 people entering the group who have access to the app, 20 people the control. Outcomes, measured at baseline and 3 months, include psychotic symptom severity, social functioning and well-being. In small groups, prepare a first draft of one of the following (to be assigned): - A paragraph of invitation and an overall summary. - An explanation of what happens to participants. - An explanation of potential benefits and of harms and how they will be minimised. Some key questions on research ethics What is informed consent? How is capacity to make decisions assessed? Does having a mental illness cause people to lack capacity? Can people who lack capacity ever be included in research? How can children be included in research? Does all research need to go through NHS full ethical approval procedures? What happens after ethical approval? What is informed consent? Consent needs to be Given by a person with capacity – i.e. who understands the decision to be made and can weigh up its consequences realistically Voluntarily given, with no undue influence or pressure Given following provision of adequate information Given with an understanding withdrawal is possible. Patient information sheet a key component – supplemented by conversation, opportunities to ask questions. Consent is usually written but not essential (except in a trial of a medicinal product/medical device) How is capacity to make own decisions assessed? The Mental Capacity Act (2005) - statutory framework protecting people who may lack capacity. Lack of capacity involves: – Impairment or disturbance in functioning of brain (due to physical or mental illness, cognitive impairment, intoxication) AND - Consequent inability to understand and retain information relevant to decision, weigh it up and communicate decision. Principles: – Presumption of capacity unless proved otherwise – Capacity is relative and depends on understanding of and ability to reason about a particular decision – Need to give people necessary support to maximise capacity – Right to make eccentric decisions Does having a mental illness impair capacity to make decisions? Most depressed individuals, 70-80% of those with schizophrenia have capacity Negative symptoms, cognitive deficits, poor insight are most frequent causes of lack of capacity People often do not understand research they are agreeing to, even without current psychiatric impairment Both clinicians and researchers tend to miss lack of capacity Capacity improves with educational interventions Can people who lack capacity be included in research? Potentially yes if ethics committee agrees that: – No substantial risk of harm – Relates to patient’s condition and cannot be done in a valid way in a sample where all have capacity. – Very clear that benefits outweigh risks (level of acceptable risk depends on potential benefit to individual) Carers/ nominated representatives (e.g. someone from a relevant charity) act as consultees – would the person want to participate if had capacity? Withdraw if signs of resistance Advance directives – may allow people to express wish to participate if lose capacity (transiently or permanently) How can children be involved in research? 16-17 year olds: assumed they have capacity unless contrary evidence Under 16s: can give consent if evidence of good understanding and reasoning, but parents generally involved unless kids object (“double consent”). Under 16s without capacity: consent from parents but involve kids/get their assent as much as possible. Parents must consent for under 16s in Trials of Medicinal Products Clear explanations, lack of pressure especially important for kids Does all research need to go through full (NHS) ethical procedures? Not if: - No material ethical issues - system of proportionate review: light touch approach to research where no change in care or highly sensitive issues. However, rarely granted with mental health populations - Not recruiting NHS service users : Research involving the general population & NHS staff is appropriate for university ethics committee (similar principles but lighter touch). - Doesn’t meet criteria for research: Research generates new knowledge, tests hypotheses, addresses clear questions, may involve allocating patients to a particular treatment. Audit and service evaluation measure how services perform (against a specific standard for audit), involve no or very simple data collection (interview or questionnaire), do not involve randomisation/allocation to a treatment for purpose of the study. University ethics committees -Can approve research that: Is conducted by university staff or students with human participants Is not the remit of NHS ethics (research with patients & carers) or Social Care or Ministry of Defence committees -So general population, student and school samples, online surveys, NHS staff in UCL ethics committee remit, even if contentious -Can include people with a health condition if not recruited through NHS - NHS R and D processes may still apply with NHS staff - UCL staff and students – must have UCL ethics as well as local approval for research conducted outside UK UCL ethics: quicker less complex process than NHS, though somewhat more complex than in the past. Monthly deadlines, possibility of chair’s action with non-contentious studies What happens after approval is given? Reports must be provided as requested by the committee and by local R&D offices, or ethical permission can be withdrawn Major delays or changes in protocol must be reported (minor or substantial amendments) Adverse incidents such as deaths or acts of violence must be reported It is unethical not to make available to the public a report on the study results