Reprint
A question of intent
Guidelines on the practice of ethics committees in medical research involving human subjects, The Royal College of Physicians of London, August 1996.
Extracts.
“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.”
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