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Senate
Subject: Report of the Ethical Advisory Committee 2003/04
Origin: Secretary, Ethical Advisory Committee
1. Terms of Reference and Membership
Information regarding the Terms of Reference and Membership
of the Ethical Advisory Committee (EAC) is available on the EAC’s web-site at www.lboro.ac.uk/admin/committees/ethical/
2. Membership
Professor Clyde Williams (PE, SS & RMSchool of Sport and Exercise
Sciences) was re-appointed as Chair of the Committee. Chris Dunbobbin
replaced Miranda Whyte (both Academic Registry) as Secretary. Dr Sarabjit Mastana replaced Dr Paul Lucas,
representing the Faculty of Science, and Dr Greg Atkinson filled the remaining
vacancy from the Faculty of Social Sciences and Humanities. The position for a
second member representing the Faculty of Engineering remained vacant.
Professor Clyde Williams, Professor Peter Smith (Electronic and Electrical Engineering), and Dr Bruce Stafford (Social Sciences) were due to retire at the end of the session.
Dr Stephen Moore (co-opted member offering an independent
occupational health perspective) had resigned from
his position on the Committee in December 2003 as a co-opted
member offering an independent occupational health perspective,
following his appointment in December 2003 to a new post. The
Committee had not found a replacement, but this was being pursued with
assistance from the Heath, Safety and Environmental (HS&E) Office.
Following discussions with representatives of the HS&E Committee, and to
consolidate input from a health and safety perspective, the EAC had agreed that
steps should be taken to make the Health, Safety and Environmental Officer a
full member of the Committee.
2. Approval of Research Proposals and Generic Protocols
During
2003/04, the EAC met on three occasions and the Ethical Advisory Sub-Committee
(EASC) on nine occasions. Clearance to
proceed was given for 17 generic protocols and 105 research proposals (detailed
in Annex 1). This represented an
increase of 61% in the number of research proposals approved, following an
increase of 41% in 2002-03. (see table
below for the number of research proposals and generic protocols approved since
2000-01).
Academic Year |
Research Proposals |
Generic Protocols |
2000-01 |
37 |
13 |
2001-02 |
46 |
14 |
2002-03 |
65 |
6 |
2003-04 |
105 |
17 |
Dealing with this substantial increase in workload was only
made possible by the dedication and commitment of EAC members. The EAC continued to be encouraged by the
increased number of proposals submitted by departments other than Human
Sciences and the School of Sports and Exercise Science.
Over the course of the year, some research proposals were considered outside the routine meetings of the EAC and the EASC to facilitate urgent approval where needed. The EAC enjoyed a good relationship with investigators across the university, and representatives of the EAC continued to meet with individual researchers and groups of researchers to explain the Committee’s procedures and to discuss special arrangements in some areas.
3. Insurance Cover for Clinical Trials
The
EAC carried out numerous actions to comply with the Clinical Trial
Questionnaire (CTQ) scheme introduced by UMAL, the University’s insurers in
2002-03, including assuming responsibility for identifying those studies where
it was necessary to complete a CTQ, and alerting UMAL. Issues relating to
insurance cover were then followed up by the Research Office (in relation to
externally sponsored investigations) or the appropriate Head of Department /
Supervisor (for student projects / research). If the University undertook more
than 10 studies that were notified under the CTQ procedures within any 12 month
period from 1 August – 31 July, then an additional insurance premium of £100
per study would be imposed for every further notified study undertaken in the
same period. However, since 1 August 2003, just one study had been formally
notified under the CTQ procedures: R03-P27 Effects of melatonin on exercise
performance (extension to existing completion date).
Despite
efforts by the EAC to obtain clarification on the definitions used in the
application of the CTQ, and the issuing by UMAL of a new version of the CTQ
form, some uncertainty remained, specifically in relation to terms such as
‘food,’ ‘nutrient,’ ‘drug,’ and ‘food supplement.’ It was likely that it would
take time for a set of precedents to be established in this area, and the
Committee would continue to be watchful of studies that involved the variation
of diet. The Committee had amended the Ethical Clearance Checklist and the
Research Proposal forms to help flag more clearly those studies which might
require the submission of a CTQ, and where doubt existed, a CTQ was completed
and sent to UMAL for an opinion.
In conjunction with the Research Office, the Committee
continued to keep abreast of developments relating to the implementation of the
Department of Health’s Draft Research Governance Framework for Health and
Social Care, and the new EU
Directive on Good Practice in Clinical Trials. The EAC would react
appropriately according to the University’s response to this new legislation in
the next session.
4. Review
of Ethical Clearance Checklists
The
Committee conducted a review of Ethical Clearance Checklists lodged with Heads
of Department during the calendar year of 2003, where a full submission to the
Committee had not been triggered. There had been 20 such Checklists lodged
across the University, compared to a total of 113 research proposals considered
by the Committee, or Sub-Committee. Therefore, around 15% of proposals had been
filtered out by the Ethical Clearance Checklist process. While this figure was
relatively low, the criteria set in the Checklist for determining whether a
full proposal needed to be submitted to the Committee had been considered
carefully in the context of risk management, and it was important that projects
which involved features such as participants from vulnerable groups, or
invasive procedures, were subjected to comprehensive scrutiny.
5. Research Training
At the beginning of the 2004-05 academic year,
the EAC was expected to provide input on the University’s internal procedures
for ethical approval as part of a wider staff training programme on
methodological issues, co-ordinated by the Research and Professional
Development Offices. This seems unfinished????
6. Conclusion
2003/04
was a very busy year for the EAC with consideration and approval given to more
proposals than ever. The Committee
continued to involve new groups of staff from across the campus, and therefore
anticipated another productive year in 2004/05.
Author: Chris Dunbobbin
May 2004
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