Intended for healthcare professionals

Rapid response to:

Editor's Choice

It’s time to change how Europe regulates research

BMJ 2008; 337 doi: (Published 11 December 2008) Cite this as: BMJ 2008;337:a2986

Rapid Response:

Future regulatory reform – the North American experience

Concern over the bureaucratization of research also resonates in
North America. But the issue differs from the justified concern over the
bureaucratic hurdles that UK researchers face and a regulatory process
that operates at the pace of a slow drip. (1) The regulatory process in
North America does seem faster than in the UK. But the speed at which it
operates has also raised a cautionary note. The concern is that the pace
at which protocols are reviewed and approved reflects a bureaucratic
climate that has transformed research oversight into administrative checks
in a box.

The concern was echoed in two national reports - one in Canada and
the other in the US.(2) It has been reinforced by profiled scandals at
leading research institutions. In one multicentred clinical trial
conducted in both countries protocols were approved that not only failed
to reflect the nature of what was being measured but withheld potential
life threatening risks from research participants.(3) Nor has concern
over the fast pace of research review and lax oversight abated. Last month
the US Office of Health and Research Protection (OHRP)halted recruitment
in 600 studies conducted at a Veteran Affairs (VA) Hospital and a
university due to audit results. OHRP found informed consent violations
and a failure of local oversight bodies to properly review the protocols
and "to make a formal judgment about risk levels." (4) OHRP does not take
halting trials lightly given the mayhem this causes for the research
community and public. The stoppage falls on the heels of an investigation
by the Office of Inspector General into research at another VA
facility.The investigation substantiated concerns which included not
reporting the death of 105 deaths during the study period. The
institutional review board failed to protect research subjects by not
addressing protocol deficiencies on numerous occasions and repeated non
compliance issues over informed consent practices and the timely reporting
of adverse events.(5)

It is against this backdrop that the North American regulatory pace
reflects an institutional culture that is widely seen to be in need of
reform. Clearly future regulatory reform on both sides of the Atlantic
should dismantle bureaucratic hurdles that unnecessarily impede the pace
of research. But improvement in speed should not result in cutting ethical
corners. Hopefully future reform will be sensitive to bureaucratic
experiences on both sides of the Atlantic and strike a better balance
between all stakeholders’interests.

1. Godlee F. It’s time to change how Europe regulates research, BMJ
2008 337: a2916 (13 Dec.)

2. McDonald M. Canadian governance of health research involving human
subjects: Is anybody minding the store? Health Law Journal 2001;

3. Wilson, M. Vulnerable subjects and Canadian research
governance.IRB: Ethics & Human Research, 2005 26(6), 9–11.

4 Song K M. Audit leads to enrollment halt in research at veterans
hospital. Seattle Times, Dec.10, 2008,

5. Human Subjects Protection Violations at the Central Arkansas
Veterans HealthCare System,August,2008,

Competing interests:
None declared

Competing interests: No competing interests

25 December 2008
Mark H Wilson
Director of Medical Ethics
Health Research Associates, Ottawa On. K2b 6j4