I think Kev Hopayian gives a useful example of what actually happens in
practice. The problem occurs in two different directions. Some projects here
are submitted to Ethics Committees, but are not reviewed because they are
(sometimes incorrectly) classified as audit. On the other hand, there are
audit projects that have ethical implications. I think the ethical
implications need to be reviewed regardless of the stated design. This is a
very unpractical attitude, I know, when considered in light of the amount of
work that Ethics Committees already have to do!
Janet Harris
Academic Director, Health Sciences
University of Oxford
Centre for Professional Development
16/17 St Ebbes Street
Oxford ENGLAND
OX1 1PT
01865 286944/286942
> -----Original Message-----
> From: Djulbegovic, Benjamin [mailto:[log in to unmask]]
> Sent: 25 June 2002 15:39
> To: 'Harris, Janet'; [log in to unmask]
> Subject: RE: audits as evidence
>
>
> Sure, any project can have the ethical dimension. However, if
> the project is
> considered to be a "low risk" to "human subjects" (somehow it is so
> difficult to get this term "subjects" out of the ethical
> lexicon) (that is,
> anticipated risks do not exceed those risks of everyday human
> activities,
> and this would include protection of the patients'
> confidentiality), then
> separate IRB approval is usually not necessary. For the most part, the
> audits can meet this criterion. (Of course, purists may still
> want to apply
> Kantian ethical criterion and argue that even under these
> circumstances the
> people are being used as means for the purpose not originally
> anticipated).
> What do you think?
> ben
>
> -----Original Message-----
> From: Harris, Janet
> [mailto:[log in to unmask]]
> Sent: Monday, June 24, 2002 10:58 AM
> To: [log in to unmask]
> Subject: Re: audits as evidence
>
>
> Thanks to everyone for answering my questions.
>
> I would just like to pick up on a point made by Ben about the ethical
> requirements for research versus audit. In England we find that some
> Research Ethics Committees automatically waive review of a
> project if it is
> deemed to be audit instead of research. I think this is
> unfortunate, as
> audit projects can have ethical issues too. Isn't this a case
> of throwing
> out the ethical issues with the bathwater?
>
> Janet Harris
> Academic Director, Health Sciences
> University of Oxford
> Centre for Professional Development
> 16/17 St Ebbes Street
> Oxford ENGLAND
> OX1 1PT
>
> 01865 286944/286942
>
> >In the US, at least, increasingly there are some new regulatory
> >requirements, which can help decide what is "audit" and what
> is "research".
> >If you plan to publish the study (and thus contribute to
> acquiring a new
> >knowledge) your activity may be called "research" and thus has to be
> >approved by the IRB (Institutional REview Boards, similar to Ethics
> >Committee elsewhere). If you activity is done for the
> purpose of improving
> >your own practice, etc but with no intention to publish,
> there is no such a
> >requirement in place, and hence it may be called "audit".
>
> ben djulbegovic
> > -----Original Message-----
> > From: David Birnbaum [mailto:[log in to unmask]]
> > Sent: 18 June 2002 21:49
> > To: [log in to unmask]
> > Subject: Re: audits as evidence
> >
> >
> > Janet Harris posted:
> >
> > > ... audit can be part of a service or programme evaluation.
> > Evaluation is
> > > a form of research. After doing evaluations in North
> > America for many
> > > years, it was confusing for me to experience the National
> > Health Service
> > > definition of audit as 'not research'.
> >
> > Whether called audit, formative (or summative) evaluation,
> or survey,
> > perhaps a key distinction emerging in this thread is one of
> > funding and
> > management responsibilities vs. a conceptual framework for
> > strength-of-evidence?
> >
> > Kev and Badri posted pertinent examples, and I offered Last's
> > definition of
> > research involving "generalizable knowledge." Under that
> > definition, I'd
> > vote with Badri to consider the Tropman et al. study applied
> > health service
> > research. I might even vote to fund such studies from public
> > sources since
> > they provide generalizable knowledge about the evaluation and
> > provision of
> > health services when they address unknown ground. On a
> > population-health
> > level, it might even be worth funding a series of regional
> or national
> > research studies to see how well programs are addressing
> > community health
> > needs over time. On the other hand, once a standard of care
> > is defined and
> > criteria for its evaluation set within a specific health service
> > organization, then one responsibility of sound organizational
> > management is
> > on-going evaluation (which could still be considered applied
> > research of
> > interest to fewer stakeholders but essential to inform
> > quality improvement
> > decisions) that should be supported by that organization's
> operational
> > budget rather than from external research funding
> > competitions. Audit as a
> > simple case-series or survey type research design provides an
> > approach to
> > gathering evidence that is relatively easy but susceptible to
> > bias. I agree
> > with Karen and Badri that its purpose defines whether a given
> > audit project
> > should be funded as research or as a normal management
> responsibility.
> >
> > David Birnbaum, PhD, MPH
> > Adjunct Professor
> > Dept. of Health Care & Epidemiology
> > University of British Columbia, Canada
> >
>
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