Research review: four steps and eight questions

1. Research review:four steps and eight questions A schematic picture of research review

2. Four steps of research review Steps Questions Skills Step 1 Construction “Understanding the study” Step 2 Deconstruction “Breaking the study down into research domains” Step 3 Judgement Step 4 Working in committee What does the study entail? What gives rise to concern? Should it? An individual view Can we reach consensus? Critical appraisal Order! Moral imagination Moral analysis Collaborative Working

3. Instructions The next slide depicts how we might found our judgements in research review. Start at the top left. Put the mouse over any text box for further explanation. You will be taken to a different slide. To return to the cartwheel simply click on the slide. A more detailed description can be found in:- 1 A model of Research Review 2 The full “REalistiCDecsisions” presentation

4. Eight questions in research review PROJECT How do I feel about this proposal? How might the potential participant decide? EMOTION CRITICAL APPRAISAL EMPATHY What guidance is there from expertise in committee, peer review or external expert guidance? What is possible and realistic? EXPERTISE EXPEDIENCY “EGO” What have I / we decided before? What’s my (“immediate”) view? EXPERIENCE What published evidence is available? EVIDENCE COMMITTEE DELIBERATION ETHICAL THEORY How would an ethical analysis help? DECISION

5. Ego • We start our deliberations, quite reasonably, with our own views, often closely related to our personal experience. It’s expedient and can lead to rapid decisions. But the foundations of our thinking may be “undeclared”. Even if they are indeed immediate they must rest on something - conscience, conviction, intuition, feelings, moral sense, law or maxim, “Thinking fast, not slow” “Thin slicing”, “Recognition-primed decision”, or other “Es”. Unexamined review can also hide “motivated reasoning” or “gaming”. • Without further elucidation, debate and shared decisions are impossible and life becomes difficult for the chair and REC manager! There can be no true debate or consensus and writing minutes of any meeting run in this way is extremely problematic. • There are many ways to depict how we make judgments but what’s important when we work together is not the description rather the insight to help us find out where they come from. • “O wad some Pow'r the giftiegie us To see oursels as ithers see us! It wad frae mony a blunder free us, An' foolish notion: What airs in dress an' gait wad lea'e us, An' ev'n devotion!” • Robbie Burns “To a louse”.

6. Emotions The debate about the place of the passions (emotions) in our moral decisions is longstanding. Some find emotions “uninviting allies” and others argue that such emotions are a fair and valid foundation for our judgements. (“If I’m revolted, others may be as well.”) A modern synthesis? What’s important when we review research is that we have the insight to recognise when these emotions are the foundations for our decisions. In committee, as with “Ego,” this approach may be a start but is unlikely to provide satisfactory consensus. Judgement Preferences Likes / dislikes Tastes Hostility Disgust Blackburn’s “Staircase of practical and emotional ascent” Index

7. Empathy Often quoted by REC members as their approach, empathy would theoretically seem to offer fair foundations for judgement. As an ideal, this approach would seem the best way to incorporate the views and feelings of others into our deliberations. Consequently REC members often describe this as their approach but empathy is contended, RECs need to accommodate the criticism that our capacity for empathy is limited and needs validation by other approaches. How far can we empathise with potential research participants about whom we know so little? Researchers can help by consulting patients and potential participants asking “Is the research question relevant to your needs? Is the burden of participation acceptable?” RECs evaluate … a research proposal from two main standpoints: • the ethical implications… • from the standpoint of the prospective research participants Council of Europe Bioethics steering committee 2.65 Among the members some individuals ….should be able to look at the application from the participants’ point of view…” Royal College of Physicians

8. Expertise Here we turn to expertise both in and beyond the REC to help us make our decisions (REC expert members, managers and chairs, peer review, government and regulatory bodies, patient groups, “August” and academic and professional bodies). However application and use of guidance may not be straightforward. Documents have varying authority, are difficult to apply and are occasionally inconsistent. They don’t usually make the judgement for us Guidance may not accommodate all the details or problems of a specific research project. Guidance guides, it doesn’t decide BUT If decisions run contrary to guidance, clear reasons need to be presented.

9. Experience • Applicants to RECs might fairly expect to be treated equally . There should be consistency of process and consistency of consideration. • Descriptions of past debate, recollections of moral positions previously adopted and recall of evidence and previous decisions can speed review and provide consistency. This may not be explicit conduct in RECs but probably does shape individual opinions and REC decisions. • Following these will obviously provide consistencyand, given the huge numbers of decisions expected of RECs and their members, this might provide an expedient approach. • A casuistic argument is that differences between studies mean that each has to be judged on its own merits and problems presented by research change. The commercialisation of research, the use of large databases and genetic medicine give rise to new concerns. • Will we be consistently WRONG rather than RIGHT? • That depends on whether you’re an optimist or pessimist!

10. Ethical theory Ethical theory contributes to review in many ways (helping us when uncertain, defining “moral maxims”, designing or reviewing research using new or contentious methods). It can take the sting out of committees in dispute and help us explore the reasons for our opinions. But no ethical theory makes the decision for us. Ethical theories help us explore or “interrogate” a study but don’t provide us with answers. Our decisions and judgement are ours and rest on our values. The utilitarian must place his or her own judgement on possible benefits and harms and then weigh them up. The deontologist must balance the demands of duties (to a party involved) under consideration. To add complexity, these different ethical models may conflict. If we use more than one, we have to weigh up the conclusions from each. The judgement must be ours “we can no more learn to act rightly by appealing to ethical theory.. Than we can play golf by appealing to mathematical theory of the flight of the golf ball” Dworkin

11. Evidence There are many ways in which evidence might inform our debate. Establishing public and patient opinion, evaluating the consequences of research and how best to inform potential participantare examples. However the place of evidence is contended but accommodation does seem possible although our current evidence base is still limited and weak. However, while evidence can be used to support decisions, facts don’t lead directly to judgement. There is a continuing need to “research research ethics”. Norms and facts should not be seen as rivals for a sovereign position in ethical reasoning…norms and facts should be seen as interdependent … value judgements play a role (in appraising evidence) Strech 2010

12. Expediency • We must test and develop treatments, both of which can only be effected through research. However this requires resources and to control health care costs, research must be relevant, efficient and expedient. Consequently researchers inevitably work under constraints that RECs must accommodate these in their review. • As Research Ethics Committees have a role in promoting research, they should be cautious that they don't place further burdens in the shape of unrealistic demands on researchers. • However, while we need research, this call for expediency can’t be a licence for unethical projects. “2.1 Research Ethics Committees have a duty to encourage and facilitate important ethical research …RECS should avoid making disproportionate demands….. 5.58 RECs should encourage pragmatic solutions…the ideal may be impractical” Royal College of Physicians 2007 guidelines

13. Critical appraisal • When we start, we need an overview of the study. We need to “find out what it‘s all about”, “determine the facts of the matter”. It’s important to recognise that factual errors are VERY likely to lead to ethical errors (and even argument). Reading the title, the Participant Information Sheet (PIS) or the IRAS summary (A6(i)) can help. • This process of “construction” also has a further purpose. It helps identify key ethical issues that will help review. As an example, what are the likely ethical issues in • “A randomised, placebo controlled trial of pufficillin in children with Cystic Fibrosis assessing response by lung function”?

14. Committee deliberation • To reach consensus we must resolve uncertainties so we all have an accurate picture of the research, put forward our views concerns and suggestions, listen to those of others, reach agreed judgments, decisions and remedies and then vest authority in those who will follow • The REC meeting can be divided in three • 1 Before the researcher attends, the REC needs to • resolve factual uncertainties, • hear concerns and possible suggestions • identify early consensus and differences • identify issues to discuss with the researcher: • 2 Discussion with the researcher to resolve remaining uncertainties, to listen to the researchers’ summary of the ethical dimensions of the research, to put forward committee concerns and listen to responses. (There is an undoubted subtext to review – assessment of the probity and character of the researcher.) • 3 After the researcher has left the committee needs to reach agreed judgements, decisions and remedies and consider the drafting of correspondence and to vest authority in those who will follow up issues