A
question of intent: Royal College of Physicians
defines what is research,
and what is medical practice
"6.4. The
distinction between medical research and innovative
medical practice derives from the intent. In
medical practice the sole intention is to
benefit the individual patient consulting
the clinician, not to gain knowledge of general
benefit, though such knowledge may emerge from the
clinical experience gained. In medical research
the primary intention is to advance knowledge so that
patients in general may benefit: the
individual patient may or may not benefit
directly."
On the requirement
for ethical review:
"1.3. The
Department of Health (DoH) requires all projects
undertaken by NHS staff, carried out on NHS premises,
involving participants via the NHS or involving
access to past or present NHS records to be reviewed
by an LREC [Local research ethics committee]."
On money:
"10.1. Any
pecuniary relationship of an investigator to a
sponsoring company has ethical implications and
should be declared to the LREC giving details of both
the amount and nature (money, gifts, travel etc), of
payments to investigators. The same applies to
payments to departments and to institutions by a
pharmaceutical company or a contract research
company."
On who would know
that research was in progress:
"11.10. Nursing
and other staff should always be made aware that
research in progress with whom they are concerned has
been approved by an REC [Research ethics
committee]."
On the disregard for
ethics committees:
"5.17. RECs
have no direct sanctions, but if they discover that
their advice is unheeded or that clinical
investigations are being conducted without reference
to them, they should report the facts to the body
that set them up, eg an NHS health commission or
hospital or university board and, if appropriate, to
professional organisations such as Royal Colleges and
the GMC."
Guidelines
on the practice of ethics committees in medical
research involving human subjects, The Royal College
of Physicians of London, August 1996.