Getting a fix on good governance
Getting a fix on good governance
The Olivieri symposium offers an opportunity to reflect on
the Canadian regulatory climate and public governance.
Baylis’s paper raises a concern about the Canadian bioethics
community’s collective silence and stewardship
regarding the Olivieri case.1 A similar collective silence
greeted the recent McDonald report2 on research governance
in Canada. The McDonald report assessed the integrity and
effectiveness of research governance arrangements and
concluded that serious reform was required.
Curiously, although the McDonald report was recently
referred to in a Canadian Medical Association Journal (CMAJ)
editorial as an example of Canadian leadership,3 it has never
received an editorial commentary in the CMAJ. Nor has any
article in the CMAJ ever addressed the McDonald report. Yet
the CMAJ created an ethics editorship and a senior Canadian
bioethicist was chosen for the position in light of the growing
importance of ethics in public policy.4 A chapter of the
McDonald report also focused on the mandate of the
Canadian Medical Association and the provincial colleges of
physicians and surgeons and how research governance issues
are part of their ethics responsibilities (McDonald,2 section D-
3). Nor has the McDonald report been discussed in Canadian
law and health journals except by its principal investigator.5
One might expect a national study on research governance
that raises public concerns to warrant more than occasional
references. Unfortunately, the McDonald report is rapidly
approaching the status of a footnote. Its concerns included
token public representation in research governance; widespread
institutional conflict of interest; a regulatory system
and culture that favours the research community; a narrow
view of ethics that is funnelled through research interests;
and agendas that influence the thinking and practices of
researchers, research institutions, and research ethics boards
(REBs)—the ethics watchdogs.
The McDonald report noted that REBs tend to focus
narrowly on consent forms; REBs pay too little attention to
benefits and harms for research subjects; researchers
consider ethics to be a matter of navigating through the
REB; and institutions see ethics as little more than the
efficient processing of research proposals (McDonald,2 section
F). Revelations of REBs violating ethics guidelines at
academic centres and teaching hospitals heighten the
McDonald report’s accountability concerns.6 And although
federal granting agencies can withhold research funding
from academic centres that fail to comply with ethics
guidelines, this has not occurred to date.7
In light of this regulatory climate, the question should be
pressed whether it makes good governance sense to enhance
REBs’ powers along the self governing institutional lines
DuVal proposes in the Olivieri symposium.8 His proposal puts
more power in local REB hands by extending their watchdog
function to oversee contracts with sponsors. Clearly, it is
sensible for universities and hospitals to ensure that contracts
are in keeping with good ethics and the law. But for local
REBs to be the regulatory watchdog raises concerns about
conflict of interest. As Health Canada notes: ‘‘there may be
serious conflict of interest on many different levels: within
REBs; between researchers and sponsors; and within
research institutions’’.9 Research ethics boards are also
steeped in a tradition of secrecy. Transparency is a key
feature of good public governance and especially important
for watchdog bodies if public trust is to be ensured.10 An open
and independent watchdog that is at arm’s length from
research institutions would better serve the public good.