Ethics Guidance for Occupational Health Practice 9th Edition - Book - Page 92
5.05. The definition and classifications of research are, however, not always clear 67.
The distinction between research, audit (designed to inform delivery of best
care through assessment against a ‘gold’ standard) and service
development/evaluation (designed to define or judge current care) is important
to clarify. In practice these categories may not be mutually exclusive. The Health
Research Authority provides an online decision tool to help you decide whether
a project is classified as research 68 . It is possible that larger projects
may contain elements of both audit and research. For the occupational health
professional, the investigation of a disease cluster, health surveillance and
biological monitoring programmes may be added to the list of activities which
may be considered to fall into this ‘grey area’. There are also published
standards for epidemiology 69.
Independent ethics review
5.06. Although research, audit, and service evaluation have distinct purposes, the
same ethical principles apply to all. While research may require formal ethical
approval, all quality assurance activities must still be conducted within an ethical
framework. For the purposes of ethical practice in occupational health, these
distinctions are secondary, as the underlying principles and their proper
interpretation remain consistent.
5.07. Good practice is ethically informed and ‘decisions about the need for ethics
review should be based on the morality of all actions rather than arbitrary
distinctions between audit and research’ 70. The distinction becomes important,
however, in defining the need for an independent ethics review of the
work, generally by a research ethics committee, and here OH practitioners must
consider whether their proposed research falls into one of the following
classifications where independent ethics review is required:
Statutory requirement. In some cases, there is a specific statutory requirement
for independent ethics review. One example in occupational health practice
from the UK would be obtaining biological samples which are considered
‘relevant tissue’ under the Human Tissue Act (2004).
Page | 91