accused of it that all National Health Service
(NHS) Trusts and universities in the United King-
dom have published clear policies on such matters.
49.5 What is being done about
handling research fraud?Given the growing concern over research miscon-
duct, a number of organizations have proposed that
universities and other research institutions should
safeguard public confidence in research by formu-
lating good research practice guidelines and laying
down clear and equitable procedures for investigat-
ing allegations of research misconduct. Increas-
ingly, funding agencies are making it a condition
of eligibility for research grants that institutions
have in place agreed procedures for governing
good research practice. Although the principles
involved are not new, the presence and use of a
published code of practice is widely regarded as the
best preventative measure against research mis-
conduct. Such policies have stepwise procedures
describing how to proceed, including clarifying
responsibilities at each stage and stressing the
need for full documentation.
The United States
The United States was the first to take a stand on the
detection and prosecution of research fraud. A
national body was established in 1972 to ensure
that research subjects had true protection. This
organization became the Office for Human
Research Protections (OHRP) in 2000. The
OHRP, which falls under the jurisdiction of the
Department of Health and Human Services
(HHS), provides guidance, education and clarifica-
tion on human research subject protection. It has
implemented a program to supervise compliance to
the Code of Federal Regulations, the legislation
surrounding clinical trials in human subjects in the
United States. Importantly, the OHRP reviews
investigations undertaken by institutions of cases
of alleged noncompliance with the regulations and
determines with those institutions the action to be
taken.
The United States has a second official body
overseeing research and ensuring its probity: the
Office of Research Integrity (ORI), which is part of
the Office ofPublic Health and Science (OPHS). Its
purpose is to promote integrity in biomedical and
behavioral research projects supported by the Pub-
lic Health Service (PHS) worldwide. It monitors
institutional investigations of research, helps to
develop policies and provides training and support
to researchers.
The FDA plays a major part in the prevention
and detection of research fraud and misconduct.
The FDA carries out two different types of reviews.
Study-orientated audits are conducted on clinical
trial data itself, in order to ensure patient eligibility,
and investigator-orientated inspections can be car-
ried out either routinely or because a sponsor has
concerns. If the inspectors have reason to believe
that a site has not complied with regulatory require-
ments or has engaged in fraudulent activity – for
which the definition in the Federal Code is very
similar to that of the Wellcome Trust – they have
the power to disqualify the investigator from taking
part in further research, or severely restrict his
activities. Such findings are widely publicized
both within and outside the United States on the
so-called ‘Black List’.Europe
Although European countries take research fraud
and misconduct seriously, most have no official
sanctions in research fraud. The first research mis-
conduct committees in the Nordic countries date
from the early 1990s. Their roles may be both
preventive and investigative, but they do not, for
the most part, allow sanctions to be taken; that
remains in the hands of the institutions.Finland
First was the National Research Ethics Council of
Finland, founded in 1991, under the auspices of the
Department of Education. It does not itself inves-
tigate research fraud, but produces guidelines for
the prevention, handling and investigation of636 CH49 FRAUD AND MISCONDUCT IN CLINICAL RESEARCH