Iona Heath, London GP and member of the BMJ Ethics
Committee
JK Galbraith wrote in The Good Society: the Humane Agenda
(1996) "A comfortable and disciplined culture resting often on past success
takes the place of innovation and change."
Research ethics committees have made a huge contribution to academic work, but
there are issues around the ossification of process, how innovation and change
can be accommodated, and about the perverse incentives that any bureaucratic
system imposes on everyone who interacts with it.
In a recent paper in the
BMJ
(2005; 330: 468-73),
Derek Wade contended that both research and audit start with a question, and
expect the answer to that question to change or influence clinical practice.
They require formal data collection of patients, and depend on using an
appropriate method of design to reach sound conclusions.
Research requires ethical committee approval; audit does not. This implies
that there is clear water between the two and that it is very easy to
distinguish one from the other.
But, increasingly, research is being presented as audit to
avoid the need for ethics committee approval. And some audits clearly have
ethical implications, so why should they be immune from ethical scrutiny?
Essential components of every clinical encounter
According to Derek Wade, every clinical encounter has three
components:
- The epistemic: the situation is analysed and potential actions identified
- The pragmatic: you work out what potential actions are possible
- The ethical: this identifies which of the many potential actions are
morally acceptable or preferred, in other words which are most compatible with
the values of society, the patient, and the clinical team
It's where those values come into conflict that provokes ethical debate
and ethical scrutiny.
All clinical practice should be undertaken ethically, and that
includes both research and audit. The task for society is to work out where
formal ethical scrutiny should be focused where it is most needed. Derek's contention is
not served by saying that only research merits formal ethical approval and
everything else is exempt.
Levels of scrutiny
Every investigation should be scrutinised to some extent in
respect of the degree of change in local clinical practice associated with the
study, particularly the:
- additional burden imposed on the patient and others by the study
- additional risk imposed on the patient directly from the procedure or indirectly
from any additional data - likelihood of direct patient benefit
- likelihood of the benefit to society, either directly from
the knowledge obtained or indirectly from teaching research, stimulating
better studies, contributing data to (later) meta-analysis
Current UK and international practice needs urgently to encourage some focused
review of the degree of ethical problem implied within the study.
Proportionality is key. If the burdens and risks are very small, they should not
be treated in the same way as an audit where these are much larger.
Proportionality should also apply to consent.
Proportionality is one of the platforms of the whole Data Protection Act. But it
does not seem to affect our handling of ethical problems in research.
JK Galbraith wrote: "There is no escape into ideology from
thought; all depends on the specific case within the larger context."
There is obviously a major continuing role for formal ethical scrutiny.
But the researchers also have a responsibility to think about
the ethical implications of what they are doing, beyond just filling out the
form. And the same applies to editors. It's not just a matter of ticking the boxes.
A commentary in the BMJ from Shirley Nurock, the London
Regional Coordinator for the Alzheimer's Society Quality Research in Dementia
Consumer Network and a carer of her husband, pointed out the difference in the
estimation of acceptable risk between ethics committees and patients. (BMJ
2005; 330: 471-2)
She argued that committees may overestimate risk and underestimate patient
altruism in wishing to make a contribution and find some good in the desperation
of their own situation. And she also suggested that all the focus is on the
ethics of research when there is no evidence of anyone having any ethical
concerns about the low standards of care in care homes, for example. Society is
focusing ethical issues on politically safe areas rather than unsafe ones.
We have too many guidelines. Every GP registrar now has to do a project on some
form of audit for their summative assessment. What sort of ethical scrutiny do
we need for that? And what about patient satisfaction surveys? Where
do you draw the line? We have hierarchies with arbitrary boundaries: there's ethical scrutiny for research, less for audit, even less for
medical practice, and none for standards of social care.
Are we using ethics as a problem solving tool or just looking for a simple list
of answers? Another commentary from John McMillan and Mark Sheehan
suggests that ethical review might itself be accused of encouraging a
bureaucratic approach to ethics. It might not be the best way to ensure that
people are moral, especially given that Derek Wade suggests that ethics is
concerned with the moral character of individuals as shown by their actions.
JK Galbraith states in his 1996 book, The Good Society: the Humane
Agenda: "In the modern economic and political system ideological
identification represents an escape from unwelcome thought—the substitution of
broad and banal formula for specific decision in the particular case."
Ethics must be about resisting the escape from unwelcome thought.
Comments
Definitions
- Audit looks to see whether clinicians and practitioners have applied what
research has found. For example, a patient needs to be operated on within 24
hours of fracturing the neck of the femur: an audit would want to know if that
clinician had done it. But a research question might ask: does it make any
difference if the patient is operated on within 24 hours? - They both use research methodologies to acquire their information. Audit is
about standards of practice and whether these are being applied; research
is about creating new knowledge and understanding. - Put another way: audit is about the application of existing
knowledge; research is about the creation of new knowledge. - Audit is not always about standards, but often about finding out what's
happening. In practice, the definition of audit is much broader than the rather
pure unrealistic definition that is frequently used. - An example was cited in which patients were sent a survey to complete that had
not been subject to any kind of scrutiny before despatch, because it was for the
purposes of audit. It caused a great deal of distress to recipients. - In Australia, the term quality assurance is used. This includes 10 different
processes, such as process mapping. Even health service research can be applied
in a quality assurance manner. - There are some tricky issues for audit, including when one group of people
collect data, and use it to comment on the standards of care of another group.
When the data are shared, who owns the data, and where do they go? - Ethics committees and COPE provide a consensus on which standards to apply. The
editors' code provides an industry standard of what is reasonable
behaviour to expect. - We all do have to apply standards and we all do have to apply a code of practice
to individual circumstances, but the consensus judgements are a valuable basis
to work from.
A separate code of practice for audit?
- Some research has very few ethical implications, so there is no need for a
blanket rule. But it's not just a question of having a different code for
audit, because some audit has huge ethical implications and should be subject to
some form of scrutiny. The accretion of too many codes threatens to paralyse. - Ethics committees are there to make those very decisions, which invalidates the
application of a blanket rule or ideology. But the proliferation of codes of
practice speaks to the increasing prevalence of litigation and that is what is
eroding individual responsibility. - That doesn't make it the right thing to do; it's defensive
practice. - In the UK and continental Europe, we are going down the same route as the US in
terms of litigation.
What should be left out of ethical scrutiny?
- The definition of clinical science is much broader than it was 20 or 30 years
ago, and much of what we do now is about patients and how to treat them. It has
to be scrutinised by an ethical body. This includes audits and anything else
used to measure something that is important for patients. If we include this,
should we then extend it to animal research? Are protocols for patients really
applicable in those circumstances? - It's impractical to broaden it out like this. The ethics of causing harm to
patients are at the sharp end, and it's people who will sue. - How do you define harm to the patients? Banked samples may cause harm, for
example. - If animal experimentation is falsified it can have knock on effects for
patients, and equally, the person who commits fraud in animal experiments could
do the same in human experiments. - Meta analysis might be regarded as audit by some of these definitions. There's a
triage system, which prevents some of the audit questions coming to ethics
committees. And that's part of the problem. - Research ethics committees are set up to look at research ethics, so when they
receive a proposal that is audit, they decide whether it's audit or
research. People in the research arena believe that the ethics of audit should
be looked at, but there is no mechanism for that. What about quality
assurance? Do clinical ethics committees, which quite a few trusts have, or
university ethics committees provide it? - The enormously long form, which goes to ethics committees, does not highlight
these issues. Perhaps the answer is to specialise, so that particular ethics
committees look at particular questions, irrespective of whether it's research
or audit. The distinction would then be made on the issues, not whether it's defined as research or audit.
What's the responsibility of the editor?
- How far should editors be responsible for ensuring that ethical approval has
been granted? - In the summative assessment work, there's now an expectation that the
authors of GP registrar audits will discuss the ethical implications against
those sorts of headings. Authors must therefore prove that they have considered
the ethical implications, even if they have not filled out a form. That ought to
be much more common practice. That would also increase the ethical literacy of
the research community if there were an expectation to do that rather than just
fill out the form. - Derek Wade has now produced a checklist based on his article, so editors can
look beyond formal ethical approval to make sure that they have thought it
through as well. - There are issues in respect of submissions from international authors, where
ethical standards may be different.
Should unethical research ever be published?
- Suppose a research paper submitted was clearly unethical,
such that the editor felt that s/he would have to report the individual to the appropriate
body and not publish the paper, yet the answer provided by that piece of
research was fundamentally important? - It might be an unethical experiment, but it came up with a cure for AIDS? Should
it still be published, because not to do so would have enormous implications? - It's a balance of two incompatible positions. But a line has to be drawn
in the sand. These are criminally collected data, and presumably there would be
ways of repeating the research in an ethical way. - There may be ways of repeating it, but the knowledge may not be there. Someone
might have effectively killed a dozen people for the research, but has the
potential to save millions of lives throughout Africa? - What if someone has done something experimental in surgical practice, as a
result of which there is a subtle shift in practice. What about the ethical
oversight of that? - How can we avoid paralysis of innovation? Can we still learn, change, and
innovate while at the same time protecting people from abuse and harm?
Both are equally important, and need to be held in the balance.
Cultural differences in the definition of ethical research
- How can we apply our ethical moral framework to most submissions from
overseas? Whose standards should we apply? - Our journal asks for evidence of ethics approval in the relevant country. One
author in an Asian country queried the importance on the grounds that the
research involved "just samples from patients." There are huge
cultural difference between Europe and North America and the rest of the world. - What is the proof of ethics committee approval? They don't come with watermarks.
It's tough for small journals with few resources. - We have recently started to ask people for the reference number. We don't
check it, but authors put themselves in a very awkward position if they make
that up. The ethical committees are working from the Helsinki Declaration, which
is a WHO document. - Different people take different views on this. A senior lecturer at a British
university was reported to the GMC for falsifying ethics committee approval
forms, but the GMC only reprimanded him. - We ask authors to state in the paper that they have ethical approval, but we
don't ask for evidence. - It's a system based on trust. Small journals can't go around
enforcing every part of the instructions for authors. In the same way as
journals have competing interests sections, perhaps we could include an ethics
approval section, stipulating the committee, the serial number, etc.