Bridging the gap between university and the National Health Service ethical scrutiny
| Date | 01 September 2012 |
| Published date | 01 September 2012 |
| DOI | 10.1177/0144739412458269 |
| Author | Steven J. Agius,Jeremy M. Brown |
| Subject Matter | Articles |
Article
Teaching Public Administration
Bridging the gap
30(2) 92–103
ª The Author(s) 2012
between university and
Reprints and permissions:
sagepub.co.uk/journalsPermissions.nav
DOI: 10.1177/0144739412458269
the National Health
tpa.sagepub.com
Service ethical scrutiny
Jeremy M. Brown and Steven J. Agius
Abstract
This paper attempts to identify the procedural gaps around research governance that can
create unnecessary barriers to health services, workforce and education research in
Universities and NHS. Difficulties lie with research governance process rather than the
guiding ethical principles to which different professionals adhere. University research
ethics review procedures should work more collaboratively with professional organi-
sations own research governance processes. Up-to-date training across organisations
for researchers working within the NHS to enable them to navigate these increasingly
labyrinthine arrangements.
Keywords
Research Ethics, Ethical scrutiny, Research Governance, National Health Service, Higher
Education, Researchers, Professionals
Introduction
This paper aims to identify the procedural gaps around research governance that can
create unnecessary barriers to health services, workforce and education research despite
the National Health Service (NHS) and higher education institution (HEI) sectors
wanting to encourage more research activity. The paper will then go on to suggest ways
of focusing research training in a way that brings together HEI research ethics scrutiny
and external and professional research ethics codes of conduct. Focus will then move on
to how academic supervisors can prepare their students for the ethics application process
both internally at university level and externally. An underlying theme throughout is the
importance the research community places on gaining ethical approval before data
collection takes places. On a legal level it is about managing risk; but ethical approval
upholds the principles of peer review, the protection and welfare of research participants
as well as the protection of the researcher themselves.
Corresponding author:
Jeremy M. Brown, Edge Hill University St Helen Road Ormskirk, L39 4QP United Kingdom. e-mail:
sadepauw@vub.ac.be
Brown and Agius
93
Background to NHS research governance changes
Over the last 12 years there has been a huge change in ethical review procedures in the
NHS. This can be traced back to controversies in the late 1990s surrounding research
studies such as the Alder Hey collection of organs scandal (Hall, 2001) and the Bristol
Infirmary Inquiry (Prasad and Butler, 2002). By 2001, a new Research Governance
Framework for Health and Social Care had been established by the Department of
Health (DoH) (2001). This was updated in 2005 (DoH, 2005a).
Since 2001, the length of time and the high levels of bureaucracy have, arguably,
discouraged rather than encouraged research that focuses on relatively low-risk topic
areas. An example of this is in medical education research, which investigates teaching
and learning issues in the clinical setting. There is a critical mass of evidence and com-
mentary that points to the impeding nature of NHS research governance procedures
(Brown et al., 2007; Pugsley and Dornan, 2007; Robinson et al., 2007). The concept
of introducing a proportional review system began to emerge as these barriers to research
activity were debated (DoH, 2005b; ESRC, 2005; Hunter, 2007). The term ‘proportion-
ality’ was finally adopted by the DoH in the autumn of 2011, underpinning the drive to
cut bureaucracy, especially for non-clinical studies, and therefore trying indirectly to
encourage more research activity.
Changes to NHS policy on proportional review were made through the Governance
Arrangements for Research Ethics Committees (GAfREC) by the DoH (National
Research Ethics Service (NRES), 2011). Up until then, studies that focused on NHS staff
had to follow the same ethical review processes as randomised clinical trials involving
patients. In this new proportional research review system, such low-risk studies will not
require ethical review within the NHS. There will be a reliance on universities to under-
take appropriate ethical reviews and evidence of this will be enough for individual NHS
Trust Research and Development (R&D) to register and allow data collection to take
place. Recent GAfREC guidance states:
Research does not require review by a [sic] REC within the UK Health Departments
Research Ethics Service if it is reviewed by another committee operating in accordance with
the Economic and Social Research Council’s Framework for Research Ethics, unless any of
the following apply:
(a)
The research involves withdrawing standard care;
(b)
The research involves NHS patients or service users as research participants;
(c)
The research is a social care research project funded by the Department of Health in
England;
(d)
There is a legal requirement for REC review of the research.
The effect of this exception is that some social care research does not require REC review,
provided that it is reviewed by a committee operating in accordance with the ESRC Frame-
work (for example, a university REC). (NRES, 2011: 2)
In addition, GAfRec outlines the changes regarding the review of projects involving
NHS staff:
93
94
Teaching Public Administration 30(2)
Under the 2001 edition, REC review was required for research involving NHS staff
recruited as research participants by virtue of their professional role. Such research, or
equivalent research involving the staff of social care providers, is excluded from the normal
remit of RECs under the harmonised edition of GAfREC. Alternative sources of review may
be available, e.g. from a university REC. (NRES, 2011: 3)
Revoking the requirement for specified categories of low-risk research to be scrutinised
by an NHS LREC, either at full committee or through proportionate review, while
widely perceived as removing an unhelpful layer of bureaucracy has had the side effect
of shifting responsibility for ethical scrutiny elsewhere. The authors have experience as
both research ethics applicants and also research ethics reviewers from both an NHS and
university perspective. These recent NHS changes could reduce barriers but there has to
be some recognition/coordination between universities and trusts regarding scrutiny and
research ethics training.
Health services, workforce and education research, for example, may no longer need
to be vetted by an NHS LREC but ethical scrutiny by an appropriately qualified body is
still required. For research undertaken by staff or students working under the aegis of a
higher education institution, such scrutiny may be provided by the relevant internal
ethics committee. The situation is less straightforward for research conducted inde-
pendently or by organisations without a standing ethics committee. Most NHS organi-
sations will have recourse to research governance protocols, as the requirement for
researchers to seek and obtain organisational approval for their work from the NHS
bodies concerned (e.g. trusts, strategic health authorities, etc.) is well established. Pro-
cedures for vetting research from an NHS organisational perspective should already be in
place, utilising an R&D variant of the standard integrated research application system
(IRAS) process used by LRECS.
The same NHS organisations are unlikely, however, to have systems in place
(including properly constituted and administered committees, working virtually or
otherwise) to vet research from an ethical standpoint, particularly so soon after the
changes to the LREC terms of reference. Such systems will almost certainly...
To continue reading
Request your trial