Human Safety in Clinical Research

Recently, a great deal has been
written about clinical research
involving human subjects.
Unfortunately, much of the
news has been bad—fraudulent
investigators in academia
exposed, fined, and sent to
prison;1–2 institutional review
boards (watchdog groups for ethics
and safety in research) examined
and restrained or shut down by the
U.S. government because of inappropriate
practices;3–6 a physician
failing to follow regulatory
guidelines and
treating cancer subjects
with a vaccine
manufactured with a
“lack of control;”7 the
death of a young man
in a university clinical
trial testing a gene therapy.
8 The FDA reports
that the number of
complaints filed
against clinical investigators
by their own
staff members, pharmaceutical
or FDA investigators
markedly increased in 1999.9
Reports and recommendations
have issued from government
agencies. The Office of Inspector
General of the U.S. Department of
Health and Human Services published
a report on recruiting subjects
into clinical trials that pointed
to some possible reasons for problems
and suggested some
changes.10–11 Editorials have been
written.12 Academia, as represented
by a task force on research accountability
sponsored by the Association
of American Universities, has
also investigated and analyzed the
current state of clinical research
practices. Very clear “conclusions
and calls to action” are stated in
their report.13 Some private focus
groups, such as PRIM&R (Public
Responsibility in Medicine and
Research), are coming forth with
performance standards, self-assessment
tools, and peer-based accreditation
of institutional review boards
(IRBs) and institutions engaged in
human research.14 Education, testing,
and accreditation for clinical
research physicians and their staff
members are being considered,
and new regulations or guidelines
for oversight of clinical research
seem imminent.15
Speaking from the highest
level, former Health and...