NOTE This file contains links that will only work if it's downloaded as a PowerPoint presentation! This slide set analyses healthcare research review. I hope it will help Research Ethics Committee and IRB members. 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.

1. Judgments and
decisions in health
care research
review
four steps, eight questions

2. Introduction
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.

3. 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.

4. Step 1 Construction
Drawing a picture of the study
to find out what it’s all about.
Step 2 Deconstruction
Breaking 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

5. 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 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

6. PROJECT
“EGO”
CRITICAL
APPRAISAL
EXPEDIENCY
EVIDENCE
ETHICAL
THEORY
EXPERTISE
EXPERIENCE
COMMITTEE
DELIBERATION
DECISION
EMPATHY
EMOTION
How would an
ethical analysis
help?
What
What is
possible
published
evidence is
available?
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
What’s my before?
(“immediate”)
view?

7. 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”. 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 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”.
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.
*For more detail, go to this file and look at slide 47 onwards.

8. 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 they are a fair and valid
foundation for our judgements. (“If I’m revolted, others may be as well.”)
Perhaps a modern synthesis?
Blackburn’s “Staircase of
practical and emotional ascent”
Judgement
Preferences
Likes / dislikes
Tastes
Hostility
Disgust
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.

9. Empathy
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.
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
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?”

10. 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).
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.
Guidance guides, it doesn’t decide
These documents set boundaries but don’t usually make the judgement for us!
BUT
If decisions run contrary to guidance, clear reasons need to be presented.

11. Experience
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.
Will we be consistently WRONG
rather than RIGHT?
That depends on whether you’re
an optimist or pessimist!

12. 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.
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

13. 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
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.
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
But there is a continuing need to “research research ethics”.

14. 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 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.
“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

15. 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”?

16. Committee deliberation
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 parts
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 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.

17. Four steps
STEP 1: Constructing a picture of the research
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 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

18. Four steps
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
subjects
JAMA. 2000;283:2701-2711
What Makes Clinical Research Ethical?
* Integrated Research Application System (UK) www.myresearchproject.org.uk

19. Four steps
STEP 4: Working together
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.
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