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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