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Protecting and promoting the interests of patients and the public in health research 1 Patients, the Public, and Research Information for patients and.

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Presentation on theme: "Protecting and promoting the interests of patients and the public in health research 1 Patients, the Public, and Research Information for patients and."— Presentation transcript:

1 Protecting and promoting the interests of patients and the public in health research 1 Patients, the Public, and Research Information for patients and members of the public who want to promote better research for better health care. Read moreRead more

2 a slide set to help those reviewing research make fair, shared and consistent decisions. This section of TTi has been created to help patients and members of the public who wish to promote better research for better health care. These include people helping to prioritise and design research to test treatments; those invited to participate in tests of treatments; and patient and public groups helping to improve tests of treatments and their impact in health care. In this section there is information for: i.People helping to decide what uncertainties should be addressed in research ii.People helping to design research to test treatments iii.People helping to review proposed researchPeople helping to review proposed research iv.Patients and others invited to take part in research v.People helping to prepare reports of research vi.People helping to distribute reports of research vii.People helping to ensure research results are considered in health care Back

3 Reviewing proposed research Questions we should consider i.Why do we have research review and what are its purposes?Why do we have research review and what are its purposes? ii.What are the difficulties for review?What are the difficulties for review? iii.What are our key initiatives in research review?What are our key initiatives in research review? iv.What is the role of our Research Ethics Committees?What is the role of our Research Ethics Committees? v.What is fair review?What is fair review? Back

4 Why do we have research review and what are its purposes? History (IC / HD) Balance between benefits and harms Public perspective (AH) Back

5 What are the difficulties for review? What are the challenges to fair review? HD Where are the disagreements? RaSS Back

6 What are our key initiatives in research review? HRA view and initiatives JW Back

7 What is the role of our Research Ethics Committees? Roles and responsibilities of RECs Personal views RB DL Back

8 What is fair review? What is a fair test of a treatment test? How do we test a treatment test? Back

9 A fair test of a treatment test 1. Is independent, balanced yet inclusive. 2. Is reasoned. 3. Is founded on an understanding of the project, its method and context. 4. Accommodates good research practice. 5. Accommodates guidance. 6. Accommodates evidence. 7. Is consistent. 8. Is proportionate and pragmatic. 9. Is itself open to review. independent, balanced yet inclusive.reasoned.understanding of the project, its method and contextgood research practice.guidance.evidenceconsistentproportionate and pragmaticopen to review. Back

10 Fair review accommodates good research practice. An introductory sketch of good research practice: questions to start with. What is the research question and is it of clinical or scientific relevance? Is the project building on what is known already? Can the method answer the research question? Are the research team suitably equipped to complete the study fairly? Has the research incorporated views of patients and participants? Are participants fairly recruited with justifiable inclusion and exclusion? Have participants been offered a fair choice? (Informed consent)? Have consequences (benefits/harms) been fairly evaluated and minimised? Is personal data handled appropriately (confidentiality)? Once the study is finished will participants receive appropriate care? Will the project be registered and results be in the public domain? Back to Fair Research Review

11 Fair review accommodates expertise and guidance (i/ii) Here we seek expertise inside or outside the REC to help us. (i) What expert (peer or scientific) review is available? Bad science is bad ethics and its clear from past research experience that appropriate scientific review could have made a significant contribution to participant safety. (ii) What expertise is available in committee? Evidence is that on many occasions, the REC satisfies itself of the studys science by considering the material presented and using expertise within the committee. Its when the science might be considered a deal breaker or internal expertise is lacking that members need to turn to external advice.

12 Fair review accommodates expertise and guidance (ii/ii) (iii) What other guidance have experts provided? Here we turn to expert opinion and professional guidance. International bodies such as the World Health Organisation, the World Medical Association and the Council of Europe have gathered scientific experts, philosophers, public and service users and we should be able to use their judgements. In the United Kingdom, the Medical Research Council, the Wellcome Foundation and the Nuffield Foundation have done likewise. However their application may not be straightforward. Articles or documents from these bodies have varying authority, hence uncertain ranking and are occasionally inconsistent. For some, provenance is not always robust. Also they may not match the specific purpose of an REC. Publications also may not be able to accommodate all the details of a specific research project. Their conclusions or recommendations may not therefore be appropriate. However if RECs go against guidance we ask them to explain why they did so. Back to Fair Research Review

13 Fair review accommodates evidence Here we use published evidence (e.g. interviews and surveys) about the acceptability (to the public or patients) of an aspect of the research proposal. If ethical research is that which society would accept, committee members need to reflect societys views. In the modern era, in parallel with the rise of evidence based medicine, some have described this as Evidence Based Research Ethics. This, as with the others, has its limitations. While such articles and reports can capture broad views across society and paint the background, appraising and assimilating the evidence presents problems. The research base is limited, of uncertain quality, and the results depend on methodology. The method is also time consuming. What is needed is a workable assessment of the hierarchy of the source of evidence that might allow us to weigh competing papers and methods that can assess their quality and validity. Back to Fair research review

14 Fair review is pragmatic Theres no such thing as a perfect research project! Any project will be limited by available resources. RECs have a role in promoting research and shouldn't place unrealistic burden on researchers. This, however, is NOT a licence for unethical research. These issues should be discussed with the research team. Back to Fair research review

15 Fair review of research should be independent, inclusive yet balanced. Back to Fair Research Review

16 Fair review of research should be reasoned. We must be prepared to justify our opinions, to explain how we have reached our position. Debate and ultimately consensus depends on this and later adjudication of an RECs decision requires exploration of reasons. Otherwise we sink to the pantomime argument Oh yes I will against Oh no you wont. If we are to understand research ethics and develop consistent and justifiable review we need to know not only what standards we would expect of ethical research but also where they come from. The key question that we always need to ask ourselves is: On what did I base my judgment, decision, view or opinion? The 8 Questions or 8 Es might help. Back to Fair Research Review

17 Fair review of research should be founded on an understanding of the project, method and context. Its important to recognise that factual errors are VERY likely to lead to ethical errors (and unnecessary argument) and the chair should ensure the committee shares the same (factual) view of the research project. This is one key purpose of the first part of REC deliberations, before the researcher attends. An understanding of the context will also help the REC understand any constraints the researcher may be working under. Back to Fair Research Review

18 Fair review of research is consistent That RECs should have consistent processes would seem difficult to contradict. This is the role of the Health Research Authority and REC officers. Consistent reasoning and decisions are a more difficult consideration. Certain parts of research review are matters of fact and we might reasonably expect consistency. Others are finer judgements and we might reasonably expect members to reach different conclusions. Some inconsistency may be justifiable. The burden however, if we meet inconsistency, is to justify it. Is it clear that the judgement is made on a sound factual basis. the different decision is ethically relevant - it morally matters. reasons have been clearly elucidated and discussed. Back to Fair Research Review

19 Fair review of research should itself be open to review Natural justice requires us to be accountable for our decisions. Members individual views should be open to examination (and challenge). The RECs views should be open for the researchers to comment and any final opinion should be open to appeal. Back to Fair Research Review

20 Process Understand your purpose(s) Help the chair and coordinator do their jobs Have a method Logic and Meaning Dont contradict yourself Agree and follow definitions within committee Values Be consistent Discourse Only say what you believe, dont game or bargain Allow all who have an interest to speak Allow all who have an interest to question Allow all who have an interest to express their views The REC debate: A deeper (philosophical) analysis Little (Journal of Medical Ethics ) lays out a theoretical structure for discourse following the philosopher Jurgen Habermas (Moral consciousness and communicative action. Cambridge Polity press). Quadrant 1 Working in committee What we ask you to do in committee

21 What we ask you NOT to do Attack people personally Keep to the idea rather than the person. Agree with everything The purpose of the meeting is to look at the application from different points of view. Be inconsistent/changing the subject without explanation It helps the chair and coordinator who have to write minutes if items are addressed and resolved in turn. Chat Impose your views on others Criticize (in a hostile manner) Best done in private, and comment on the idea not the person! Display anger Display superiority/domination Make a long-winded contribution Write down key points and stick to them. Youre more likely to be heard Back to key pointers for the new REC member

22 To read the studiesCommitment To try to understand the context of the research Critical appraisal and imagination, To consider all involvedEmpathy and respect To identify and work out any ethical problems in the research Clarity of thought To express opinions and judgmentsClarity of thought and expression To identify, understand, and accommodate others opinions Listening, respect and humility To accept and weigh up arguments to make a decision Respect and humility To accommodate disagreement but if necessary stand firm Humility and confidence To identify and question your own convictions and values Insight What we ask you to do What we ask of you

23 How do we test a treatment test? 1 The processes (will have to be suitable for international audience) 2 Link to proposed model HD Back


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