Judgments and decisions in health

care research review

four steps, eight questions

This slide set analyses healthcare research review. I hope it will help Research Ethics Committee members when they start.

It breaks review down into 4 steps (Construction, De-construction, Judgement and Debate) and provides 8 questions we should ask when judging the acceptability of a research proposal.

I hope it may also help resolve disagreements when they arise and also help researchers when they design and present their research.

Introduction

The next slide depicts four steps into which we could break review (the left hand column), the question each addresses (middle column) and the skills we need (right hand column).

For further explanation put the mouse over any text box:-

You will then be taken to a different slide. To return to the diagram click on the slide.

Introduction

Step 1 Construction Drawing a picture of the study to find out what it’s all about.

Step 2 DeconstructionBreaking the study down into “research domains”

Step 3 Judgement

Step 4 Working in committee

What are the context and content of the study?

Can I break this study down into manageable

issues?

What gives rise to concern? Should it?

An individual view

Can we reach agreement?

Critical appraisal

Ordering and structuring

Moral imagination Moral analysis

Collaborative Working

Four steps of research review

Steps Questions Skills

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 diagram simply click on the slide.

A more detailed description can be found in:-

1 A model of Research Review Link

2 The full “REalistiC Decisions” presentation Link

Instructions

PROJECT

“EGO”

CRITICAL APPRAISAL

EXPEDIENCY

EVIDENCE

ETHICAL THEORY

EXPERIENCE

EXPERTISE

COMMITTEE DELIBERATION

DECISION

EMPATHY

EMOTION

How would an ethical analysis

help?

What published

evidence is available?

What is possible

and realistic?

How do I feel about this proposal? How might the

potential participant decide?

Eight questions in research review

What guidance is there from expertise in committee, peer review or external expert guidance?

What have I / we decided

before?What’s my (“immediate”)

view?

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”. However 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”*. What’s important when we work together is not necessarily this determination, rather the insight to help us find out where they come from.

“O wad some Pow'r the giftie gie usTo 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”.

It’s OK if everybody agrees but life becomes difficult for the chair if there is disagreement or debate. The REC manager will also have difficulty writing fair minutes.

Ego

*For more detail, go to this file and look at slide 47 onwards.

The debate about the place of the passions (emotions) in our moral decisions is longstanding. Some find emotions “uninviting allies” and others argue that they are a fair and valid foundation for our judgements. (“If I’m revolted, others may be as well.”)

Perhaps 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, all are entitled to their views. In committee, as with “Ego,” this approach may be a start but is unlikely to provide satisfactory consensus.

Emotions

Blackburn’s “Staircase of practical and emotional ascent”

Judgement Preferences

Likes / dislikes Tastes Hostility Disgust

Often quoted by REC members as their approach (and included in guidance), empathy would seem to offer fair foundations for judgement. As an ideal it would seem the best way to incorporate the views and feelings of others into our deliberations.

But empathy is contended. How far can we empathise with potential research participants about whom we know so little? Committee members need to accommodate the criticism that our capacity for empathy is limited and needs validation by other approaches.

Researchers can help by consulting patients and potential participants asking “Is the research question relevant to your needs? Is the burden of participation acceptable?”

Empathy

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

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

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).

But application of this guidance may not be straightforward. Documents have varying authority, are difficult to apply and are occasionally inconsistent and may not accommodate all the details or problems of a specific research project.

These documents set boundaries but don’t usually make the judgement for us!

Expertise

Guidance guides, it doesn’t decide

BUTIf decisions run contrary to guidance, clear reasons need to be presented.

It seems reasonable for applicants 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 consistency and, given the huge numbers of decisions expected of RECs and their members, this might provide an expedient approach.

However 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. For example the commercialisation of research, the use of large databases and genetic medicine give rise to new concerns.

Experience

Will we be consistently WRONG rather than RIGHT?

That depends on whether you’re an optimist or pessimist!

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

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. They are theories that help us explore or “interrogate” a study but don’t provide us with answers. Decisions and judgement are ours and rest on our deliberations on many research related issues.

As far as theory is concerned, 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.

Ethical theory

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

participant are examples. However, while evidence can be used to support decisions, facts

don’t lead directly to judgement and the place of evidence is contended as our current

evidence base is still limited and weak. We can accommodate both views.

But there is a continuing need to “research research ethics”.

Evidence

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

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 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.

Here we might also address the acceptability and comparison of the project with alternative research designs.

Expediency

“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

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”?

Critical appraisal

To reach consensus we must ensure we all have an accurate picture of the research, put forward our views, concerns and suggestions, listen to others, reach agreed decisions and remedies and then vest authority in those who will follow up.

The REC meeting can be divided in three parts1 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 researchers.)3 After the researcher has left the committee needs to reach agreed judgements, make decisions and suggest remedies. It also needs to consider the drafting of correspondence.

Committee deliberation

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).

STEP 1: Constructing a picture of the research

Four steps

Reading the project title, the Participant Information Sheet (PIS) or the summary

(A6(i) in IRAS*) can help.

* Integrated Research Application System (UK) www.myresearchproject.org.uk

STEP 2: Breaking the study into its research domains

Step I, “Construction” doesn’t permit judgement, it lacks sufficient detail to allow full analysis. For this we need to break the study into constituent “research domains”. Within each we can then make judgments and reach our decisions.

1 Based on IRAS*• Independent review• Social and scientific value • Suitability of applicant and support • Recruitment, access to information• Inclusion and exclusion . • Risk, harms and benefits• Consent and participant Information• Confidentiality• Payment to participants• Compensation, insurance• End of trial arrangements

2. After Emanuel et al (now the REC lead reviewer proforma)• Social or scientific value• Scientific validity• Fair subject selection• Favourable risk benefit ratio• Independent review• Informed consent• Respect for potential and enrolled

subjectsJAMA. 2000;283:2701-2711

What Makes Clinical Research Ethical?

* Integrated Research Application System (UK) www.myresearchproject.org.uk

Four steps

To reach a shared decision 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.

• Vest authority in those who will follow up issues.

STEP 4: Working together

Four steps

Task Skill

To read the studies Commitment

To understand the context of the research

Critical appraisal

To consider all involved Empathy and respect

To identify ethical problems in the research

Clarity of thought

To express opinions and judgments

Clarity 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 our own convictions and values

Insight