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Handling disagreements

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What to do

• Ensure you have an accurate picture of the project. Factual

errors are very likely to lead to ethical errors (and argument).

• Clarify the positions and differences.

• If the disagreement will make no difference to your ethical

opinion, think carefully whether you want to argue your case!

• Go beyond differences and seek people’s “reasons” for

these different positions. They’re easier to influence.

• Anticipate different views. What will their arguments be?

Develop counter- arguments but try to see the project from

other points of view.

• Be prepared to consider compromise, or if you’re in a

minority, accept the committee’s view. The chair will register

yours.

• Use the disagreement to learn.

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What NOT to do

• Argue when it doesn't matter.

• Attack people personally. Keep to the idea rather than the

person.

• Impose your views on others. Use “I” not “We”

• Criticize (in a hostile manner).

• Get angry .

• Display superiority

• Throw your “expertise” around.

• Try to dominate

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Some cases

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Efficacy of Emesatide on Cisplatin induced nausea and

vomiting in patients undergoing chemotherapy for lung

cancer

The study will compare a new drug Emesatide with placebo in

28 patients with cancer due to receive cis-platin treatment (this

treatment is VERY likely to make them vomit). Patients will be

randomly allocated 1 to 1 to receive either standard treatment

plus placebo or standard treatment plus Emesatide. Rescue

treatment will be provided for either group if treatment fails.

Robin, a committee member opens the discussion: “I think

placebo is completely unacceptable, I can’t approve this study! I

hope you’ll all agree.”

Noel: “Well I’m happy with this placebo arm. You always

criticise placebo Robin”

wERBvRbEight questions to help resolve dispute

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DECISION

ETHICAL

THEORY: how

would such

analysis help?

EVIDENCE: what

evidence is available?

EXPEDIENCY:

What is possible

and realistic?

EMPATHY: how do I

accommodate views of

all interested parties?

EXPERTISE: what

guidance is there

from expertise in or

outside the

committee?

EXPERIENCE: what

have I / we decided

before?

An “EARLY”

POSITION

ISSUE EMOTION: how do I

feel about this?

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ISSUE

When might I use this approach?• Expected

agreement• No or little moral

quandary(low moral intensity)• Low risk• Familiarity with

the area (pattern recognition)

When might this approach be problematic?• New methods• Controversy• Seemingly high

risk• Unfamiliarity

DECISION

What’s my

(“immediate”)

view on

placebo?

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Emotion

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Empathy

Here other views (public, patients’ or participants’

views) are our standard. As an ideal accommodating

these would seem the best way to represent others in

our review.

What would those who might join the project think

about taking a placebo?

Has the research team consulted potential

participants? If so, what were the results?

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Expertise

Justifying placebo• Is there a licensed or established treatment?

• Is there uncertainty or “equipoise”?

• Are there clear scientific reasons for using a placebo?

• Could a trial without placebo answer the question?

• Would risks of placebo be greater than “minimal risk”?

• Will placebo adverse consequences be minor and

reversible?

• Will adverse events be managed properly for all?

• Does the information explain clearly the possibility of

placebo?

Emanuel EJ, Miller FG 2001 The ethics of placebo-controlled

trials--a middle ground. N Engl J Med. 2001 Sep 20;345(12):915

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Experience

What previous decisions have we made?

What

have we

decided

before?

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Evidence

What published evidence is available about the

acceptability of placebo?

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Ethical theories

1. Consequentialism

2. Principle based ethics

• Beneficence

• Non-maleficence

• Respecting Autonomy

• Justice

3. Virtue theory

What do they say about placebo?

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Expediency

What is possible and realistic?

The 1996 (heated) debate on placebo…..

wERBvRbComments?

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Regent Pharma phase I unit proposes to pay 10 participants

£1500 each to take part in their phase I study:-

“ Pharmacokinetics of HTD125118 in healthy volunteers”

This involves a four day stay in their unit, starting with a medical

assessment and gastroscopy, drug administration (orally), an

intravenous line for 24 hours with 4 hourly blood sampling and

then 48 hours observation with blood pressure, pulse and

temperature monitoring. A final blood sample is taken before

discharge. The participant information sheet states

“We propose to pay each participant £1500 on completion of

this trial. This will be in addition to costs such as travelling to

our unit”

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Regent Pharma phase I unit proposes to pay 10 participants

£1500 each to take part in their phase I study:-

“ Pharmacokinetics of HTD125118 in healthy volunteers”

David: “This is clear undue influence. Who knows what the

risks are? This is going to be temptation to people who might

think of joining. I’m always cautious about this exploitation in

phase 1 research.”

Judith: “I wouldn’t agree. You always worry about this, David. I

see this as fair payment for taking part.”

Andrew, the chair : “OK well we, as a committee, have to

decide whether this is fair or adequate payment for this study.

How should we go about this? Can I turn to the rest of the

committee to help me?”

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Is consent needed?

Development of diabetic complications are closely linked to

blood sugar levels but these can’t be the whole answer. A

molecule, Glycolipid X looks like a promising marker.

In Hogsback Hospital blood samples have been collected over

the last 15 years which can be used to measure Glycolipid X.

Past HbA1c levels are available from the computerised patient

database established by the clinic 15 years ago and the

patients’ current clinical condition including the development of

complications can also be extracted from the clinic DM

database. The research doesn’t include obtaining consent.

Paul “OK..cool”

Hugh “Of course you can’t do this…you must seek consent.”

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A trial of Amoxycillin and Augmentin in pneumonia

You’re chairing a REC meeting. At the last meeting you gave conditional

opinion to a study presented by Professor Rolance, professor of general

practice at Leicester University. He wishes to establish a study comparing

these standard, licensed, antibiotics in “community acquired pneumonia”.

The committee was happy with all aspects but were concerned that there

was no facility for translation of the patient information sheet. He attends

and argues (and provides references) that ethnic variation is not expected,

the incidence of disease in both communities is the same and therefore

results could be applied to any community and by restricting the study to

those comfortable with English, he would avoid any possibility of

“uninformed” consent or misunderstandings.

Sheila (once the good Professor has left) “What planet is the Professor

on? Leicester…there are huge ethnic groups”

Murmurs of agreement around the table.

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Research involving young people and children

You’re chairing an REC meeting considering a comparative

study of licensed hydrocortisone cream against licensed

hydrocortisone ointment in children with eczema.

Jim: “You can’t do this trial on children. The work should be

done in adults first.”

Joan: “Yes you can. It’s clear from the application and

accompanying scientific review that we don’t know which is

better. Kids need research.”

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Research in emergencies

You’re chairing an REC meeting!

Peter “This is an emergency so we should allow the researcher

to recruit without consent or consultation.”

Andrew “What! Research without any permission at all, no way!

No one is going to accept that.”

Howard, a committee member and A and E consultant “But

then how am I going to undertake research to improve my

care?”

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Health related findings

You’re chairing an REC meeting, considering a study of

functional Magnetic Resonance Imaging (fMRI) of the brain in

patients with anorexia nervosa. These scans may show up

“health related, incidental findings”.

Roger: “I firmly believe that research participants should be

able to refuse receiving any information about any health

related findings that might turn up during or after the trial. They

have a right not to know.”

Jonathan: “No, I’m sorry I really can’t agree. That might put the

doctors in a difficult position. What if they found something

serious but treatable?”