[SydPhil] Departmental Seminar at Macquarie - Wendy Rogers

[Jane Johnson]

The first Departmental Seminar at Macquarie this semester will be given by
Professor Wendy Rogers 1-3pm Friday 2nd August in W6A 127. All are welcome
to attend.

*Wendy Rogers *

*Addressing controversies in the ethical review of placebo-controlled
surgical trials*

Randomised controlled trials involving surgical placebos have been the
subject of heated debate. Proponents of placebo-controlled surgical trials
(PCSTs) argue that these trials are necessary to find out whether any
observed improvements are due to the intervention itself or due to the
placebo effect of surgery. Without an answer to this question, many
thousands of people are exposed to surgical interventions that may be
ineffective or harmful. Opponents of PCSTs claim that placebo surgery is
inherently risky and harmful and therefore breaches the ethical obligations
of researchers to minimise harm to participants, and that human research
ethics committees should protect potential participants by withholding
approval of such trials. Those in favour of PCSTs accept the necessity for
rigorous scientific, methodological and ethical review but argue that
decisions about whether the risks of participation are justified should be
up to potential participants. Despite their differences, the two groups
agree about the requirement for ethical review of PCSTs, and by extension,
about who the relevant stakeholders are in assessing the ethical
acceptability of such trials.



In this paper we suggest expanding the range of stakeholders whose views
should be taken into account when deciding about the ethical acceptability
of PCSTs. In particular, we argue for the inclusion of two groups who are
not usually explicitly included in the ethical deliberations: the relevant
patient community, and the clinical staff (other than the
surgeon/researcher) who must participate in the surgical intervention.
Inclusion of the views of these groups can inform ethical deliberations
about particular instances of PCSTs. Additionally, this approach may offer
a way of avoiding the paternalism that occurs when HRECs deem that the
risks of a PCST are too great to allow decisions about enrolling to rest
with potential participants.
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