ࡱ>  qbjbjT~T~ e66{i+$;;;Pt,;|1+A"ccc1!1!1!1!1!1!1&35!1jjj!1cc461&&&jcc1&j1&&V.@/c7fI;"l// 1L10|1;/xH6(H6//H6/DH&!1!1"|1jjjjH6 : UNIVERSITY OF STRATHCLYDE UNIVERSITY ETHICS COMMITTEE ANNUAL REPORT FOR 2009/10 INTRODUCTION The University Ethics Committee (UEC), together with its associated Departmental Ethics Committees (DEC), has been established to consider general ethical issues relating to the teaching and research of the University which involve investigations on human beings. It aims to provide impartial advice to participants and investigators and to protect the dignity, rights, safety and well-being of all actual and potential participants. The UEC is the body responsible for giving ethical approval for investigations. Ethical approval, together with insurance cover and sponsorship approval, must be in place before any such investigation can start. The paper represents the annual report from the University Ethics Committee for the period 2009/ 2010. Information on policy developments, approval of applications, monitoring of projects, training, internal and external challenges and risk management is provided in the paper and associated annexes. A summary of this paper will be sent to the Executive Committee for its meeting on 22nd May 2010. PROGRESS AGAINST TARGETS The UEC does not have specific targets, but there are a number of areas of activity which are essential to the effective and efficient operation of the UEC and which are closely monitored. These include: POLICY DEVELOPMENT Revised Code of Practice The Code of Practice on Investigations Involving Human Beings was significantly revised by a sub-group of the UEC comprising Professor J Blackie, Mrs E Condie, Miss S Currie, Dr J Edwards, Dr S Kelly, Mrs Anne Muir?, Mrs L McKean and Ms Z Wilson. The Code was revised in order to make it clearer, more user-friendly and accessible; and to reflect changes externally. It has also been updated to reflect current practice within the University in dealing with ethics applications. The revisions to the Code of Practice were approved by Senate in November 2009. In order for the Code of Practice to remain relevant and useful to researchers, it is essential that it is flexible enough to allow the guidance to reflect changes to the external environment. The UEC also comes across recurrent issues that researchers face when conducting their investigations that clearly require more focused guidance in the Code of Practice. Some of the main updates have included: the ethical issues around revealing information relating to illegal activities to the relevant authorities; guidelines for investigators dealing with cadaveric tissue; guidance on collaborative investigations. There are also now annexes in the Code of Practice on: Research in Relation to Deceased Persons; Consent to Participate in Research Children and Young Persons outside Scotland England and Wales; and, the Definition of Medical Devices. A substantial amount of the research involving human beings is governed by NHS ethical processes and the UEC pays close attention to any developments in this area. Over the past year, these have included clarification of the chief investigators in NHS ethics applications and model agreements to be used for non-commercial research. There have also been revisions to the NHS application process NHS investigators are now required to complete an online form through the Integrated Research Application System (IRAS). Members of the UEC have been involved in IRAS training sessions which have taken place within the University. The UEC remains content that the NHS Research Committees approval procedures are robust. There has also been further information put on the website regarding foreign travel and the health and safety of researchers undertaking research abroad. There is now a link to the Foreign and Commonwealth web page, a link to the Universitys Health and Safety Policy which provides guidance on those working away from University premises and there is now a contact name in the Finance Office for travel insurance advice. There is now a section on the application form which asks those undertaking research abroad to provide the UEC with the name of the local supervisor and to confirm that the supervisor has received a copy of the Universitys Code of Practice on Investigations Involving Human Beings. As part of this process the sub-committee also revised the ethics application form. The application form is now more interactive, making use of web links where possible, the guidance on how to complete the form is much clearer and the format of the form has improved making it easier for investigators to complete. We have also added a section for the contact details of overseas supervisors. We have asked that the methodology relating to medium and high risk projects be subject to external scrutiny and so have added a tick box and asked for the contact details of the independent reviewer. The Management Risk Assessment and Sponsorship Form was also revised however the Generic Framework From has still to be revised in line with the main application form. During the course of the year the UEC has also issued templates for Participant Information Sheets and Consent forms, which provide consistent guidance to researchers as to the right information that should be included in each form and also provides a format for researchers to follow. This has helped the UEC streamline the approval process as they get the relevant information first time from the researcher. The templates are on the ethics web page and are also referred to in the Code of Practice. A short summary paragraph explaining the revised Code of Practice and the templates was issued as part of the Weekly Digest, which goes to all University staff, in November 2009. A one page paper was also sent to Senate in November 2009 outlining the revisions to the Code of Practice, promoting the templates and highlighting the revised application form. An ethics email address has now been set up and this is now promoted as the best and easiest way for researchers to make contact regarding ethical issues relating to the UEC. The database that was set up in 2008/ 2009 is still used to monitor and record applications and track data trends over the past few years. Approval of Applications The UEC considered a total of 72 applications in 2008/ 2009, of which 65 were approved. The remaining 7 were either withdrawn or did not require University ethical approval. This total compares with 70 during the previous session (2007/ 2008). To date, during 2009/ 2010, a total of 32 applications have been considered, of which 10 have decisions outstanding, pending amendments. A number of the approvals during 2008/ 2009 and 2009/ 2010 have been related to NHS applications or have involved generic approvals or requests for devolvement of responsibility to DECs. Summaries of applications considered and approved by the UEC are available on request to the Secretary to UEC  HYPERLINK "mailto:ethics@strath.ac.uk" ethics@strath.ac.uk. Monitoring of Projects The UEC monitors the progress of each of the applications which is approved, either directly with the chief investigator of each project or via the relevant DEC (for generic or devolved applications). The monitoring takes place in July/ August each year. The UEC is currently monitoring 163 projects. Monitoring of Departmental Ethics Committees The UEC also monitors the activities of all the DECs, on an annual basis. The DEC are required to provide an annual report to the UEC each spring, summarising the progress with individual applications and providing a formal opportunity to raise relevant issues with the UEC. This allows the UEC to keep abreast of any concerns that DECs and staff within departments may have. To date, 15 DECs have provided information about the activity of their DEC, two departments do not have DECs and the reports are being followed up with the remaining 22 DECs. CHALLENGES AND FUTURE ISSUES Ethics Training and Education The UEC established a sub-committee in autumn 2008, to consider the provision of ethics training within the University, to develop a strategy for ethics training and to design and implement appropriate ethics training modules. The sub-committee was chaired by Dr Niamh NicDaeid, who is currently one of the Vice-Convenors to the UEC, and was comprised of the Convenor and members of the UEC together with representatives from Research and Knowledge Exchange Services (RKES), Corporate Services and CAPLE. The sub-committee had its last meeting in July 2009. There has been a number of discussions around the safety of researchers undertaking research abroad and the obligation of the Chief Investigator to ensure their students safety. The UEC is therefore in the process of organising a series of workshops to be delivered over a one year period. It is proposed that attendance be compulsory for the Convenor of each DEC to attend at least one workshop. This is currently being taken forward by the UEC. To date there have been a few training events held, however more work is required on promoting our training package to targeted audiences. One suggestion from a department was that we provide training at departmental induction events held at the start of term. We will also continue to review the training package to ensure it remains relevant and up to date. The ethics reading group continues to run, enabling staff to meet research colleagues from across the University and to discuss current ethics-related issues. External Environment It is essential that staff conducting investigations involving human participants keep abreast of developments in the external environment, whether they be legislative requirements, changes in NHS procedures or professional standards. Researchers also need to stay informed of issues in areas that they may be travelling to by keeping up to date with advice from the Foreign and Commonwealth Office. The Code of Practice clearly places responsibility on the Chief Investigator of each research project to ensure that the research is conducted in accordance with these external requirements (see Code of Practice, Annex 4). The UEC takes seriously its role to keep informed of external developments and takes steps to ensure that this is carried out. The University continues its membership of the Association of Research Ethics Committees (AREC) and its sub-committee, the University Research Ethics Committee (UREC). UEC members continue to participate in and receive regular information from these bodies. There has been discussion about AREC hosting a workshop in Scotland over the summer and the UEC is taking an active part in these discussions. Close links with the NHS continue to be maintained, through colleagues in RKES and through the West of Scotland Research Ethics Service. These external links are very important to the operation of the UEC and will form a key part of the development of the training package. Internal Developments The UEC is currently looking at the need to develop online application forms and indeed an online application process. During the course of the year, the training sub-committee was given a presentation on and demonstration of the Psychology Online Submission of Ethics (POSE). POSE allows researchers to complete their forms online and allows supervisors and Heads of Department to comment on and approve applications. This has been developed for the Psychology department, however there are ongoing discussions about this being widened out to the University. The UEC continues to seek ways to streamline its processes, ensuring that they remain user-friendly to researchers. As part of this commitment, a small sub-committee of the UEC has recently begun a user trial of Sharepoint, a system that is now widely used throughout the University for storing and sharing documents. The effectiveness of Sharepoint to the UEC will be monitored over the coming months. At the beginning of 2010 it was agreed the RKES would take over the administration of the UEC from Corporate Services. This ensures that sponsorship approval and ethics approval remain within the one directorate and that researchers have the one point of contact for sponsorship and ethics. UNIVERSITY ETHICS COMMITTEE MEMBERSHIP The UEC has confirmed that Mrs Condie will continue as Convenor for a further three years. This extension will enable the UEC to continue to benefit from the experience Mrs Condie has built up during her time in the UEC. It also ensures that researchers continue to receive a robust and prompt response to their research protocols. There are currently two Vice-Convenors supporting the work of the UEC. Our third Vice Convenor, Professor Effie Maclellan, retired at the beginning of the academic session 2009/ 2010. Andrew Hosie from the Faculty of Education came to the end of his period of membership in July 2009. Laura Steckley from the Glasgow School of Social has since replaced Mr Hosie on the UEC in August 2009. The current membership of the UEC is included as annex 1. RISK MANAGEMENT The UEC takes risk management very seriously and risk assessment is a constant part of its work, as members evaluate potential risks to human participants and the potential benefit of the research in their consideration of each application. Individual risk assessments for each ethics application are carried out by colleagues in RKES, who also confirm if the University will sponsor each project. Staff from RKES attend the UEC meetings for sponsorship purposes as well as to administer the UEC meeting. A representative from Finance is also in attendance at each UEC meeting and this representative liaises with the University insurers to establish sufficient cover for each application. Researchers must not commence their work until all aspects of this process are confirmed. This is confirmed in all email contact with researchers. A risk register is attached as annex 2. NEXT STEPS A summary of this report will go to the Executive Team at their meeting on 22nd May 2010. The UEC is asked to note this report and provide comments. Once this report has been approved by the UEC, it will be posted on the Ethics web page. ANNEX 1 UNIVERSITY ETHICS COMMITTEE MEMBERSHIP 2009/10 Name Category/Faculty Date Membership Appointed ends Convener Ms E Condie National Centre 01.09.03 31.07.12 Internal Members Professor J Blackie Law School 01.05.05 31.07.11 Dr C Burns HRM 01.08.08 31.07.11 Prof D Christie Childhood & Primary 01.09.05 31.07.11 Studies Ms L Steckley Social Work 01.09.09 31.07.12 Dr J Johnston SIPBS 01.03.08 31.07.10 Dr S Kelly Psychology 01.08.06 31.07.12 Dr N NicDaeid Forensic Science 01.09.03 31.07.12 Dr P Riches Bioengineering 01.08.07 31.07.10 External Members Dr J Bunney Chief Pharmacist 01.11.04 31.07.10 (Retired) Dr H Gray Student Health Service 01.10.00 31.07.09 Consultant, GRI (retired) Lay Members Mr D Blyth Lay 01.11.06 31.07.09 Mr C W Turner Lay 01.10.04 31.07.10 Mrs M Whitehead Lay 01.04.07 31.07.09 ANNEX 2Risk NbrDescription of riskSignificant consequencesKey controls and mitigating factorsEarly warning mechanismsLikelihood (L/M/H)Impact (L/M/H)Owner1Data issuesResearcher loses data; Data is corrupted; Anonymity of data is not preserved; University not compliant with Data Protection Act; Potential for litigation; Potential harm to participants; Potential damage to University reputation.University has clear Data Protection Policy; Guidelines within ethics application and the Code of Practice relating to data storage and security have recently been updated; Data is required to be stored in secure location on University premises, wherever possible, or be encrypted and password protected; UEC considers data issues as standard aspect of all applications.Feedback from researchers; Feedback from participants.MHUEC2Potential harm to participants in project approved by UECDamage to physical/ mental wellbeing of participants; Resulting damage to reputation of University; Potential for litigation.Ethical consideration of all medium-high risk projects by UEC focuses on well-being of participant above all other issues; Informed consent is one of guiding principles of UEC; Participants always encouraged to ask questions; Contact details of independent contact (usually secretary to UEC) provided on all information to participants; Regular monitoring of projects.Negative feedback; Monitoring.LHUEC3Negative outcome of project approved by UEC or a project carried out in unethical mannerExternal reputation of University affected - impact on staff and student recruitment and resulting impact on ability to attract funding and deliver strategic objectives; Possibility of legal ramifications.UEC considers all projects that meet clearly defined criteria; UEC considers all medium and high risk projects in detail, drawing on extensive knowledge and experience of members; Risk management analysis carried out by RKES for all projects; Management approval considered for all projects by Director of RKES and Deputy Principal; Regular monitoring of projects and DECs.Negative feedback; Responses to monitoring.LHUEC4Failure of staff and students to follow University proceduresProjects carried out without appropriate ethical approval, University sponsorship or insurance; Harm to participants; Risk of litigation/ legal ramifications; Risk to external reputation of University - impacts ability to recruit staff and students and to attract funding.Suitable training developed about relevant procedures - much greater focus on this since development of sub-committee; Code of Practice published on website; Updates to procedures are publicised widely; UEC web page is regularly updated; Regular reviews of suitability of all aspects of procedures; Any projects that require external funding are routed through RKES and staff can identify grant proposals that require ethical approval; Increased liaison with DECs to raise awareness; Applications are signed off by Chief Investigator and relevant Head of Department; Contact details for independent contact are included on all information to participants (usually the secretary to UEC); University sponsorship and insurance have to be in place before a project can start; Regular monitoring of all ongoing projects and of DECs; UEC has high-level administrative support, able to provide advice and guidance to researchers.Negative feedback about research projects; Projects being submitted for external funding through RKES can be identified; UEC members drawn from across the research community within the University; Incomplete applications; Monitoring of projects and DECs.LHUEC5Inadequate supervision for students undertaking projects within University or with external partnersQuality of application is not adequate - ie. methodology is not ethically sound, ethical issues are not adequately considered; Potential impact to participants; Potential damage to external reputation; Potential for litigation.Chief Investigator (ordinance 16 staff) required for each project (only exception is NHS projects); Close liaison with CI in terms of UEC decisions and requests for amendments; Regular project monitoring ensures continuing supervision; UEC requires notification about changes to supervision; Development of training for supervisors; CIs and HoDs required to sign applications.Incomplete/ unsigned applications; General quality of application; Monitoring.LHUEC6Failure of staff and students to follow external procedures and/ or meet external requirementsProjects carried out without appropriate ethical approval, sponsorship or insurance; Harm to participants; Risk of litigation/ legal ramifications; Risk to external reputation of University - impacts on ability to recruit staff and students and ability to attract funding; Research does not meet professional standards.UEC requires that projects undertaken in collaboration with other universities receive ethical approval from university sponsoring the research, and applications are submitted to RKES and Finance to ensure adequate risk management/ sponsorship and insurance cover is in place before the project begins; UEC member of external organisations and groups (AREC/ UREC/ Glasgow Research Governance Group) to ensure it is informed about external developments; Training provided to staff and students about expectations in relation to external requirements/ procedures; Close liaison with key contacts in NHS; Any projects that require external funding are routed through RKES, and staff can identify grant proposals that require ethical approval; Increased liaison with DECs to raise awareness. UEC convener reviews ethical status of all external projects; Negative feedback about research projects; RKES work in relation to funding/ sponsorship.LHUEC7Failure of UEC members to understand processes/ legislative requirementsProjects approved that are not ethically sound; Projects approved that do not meet legal requirements; Potential for legal ramifications and/ or litigation; Potential harm to participants; Damage to external reputation of University; Projects approved without appropriate insurance cover or sponsorship.UEC members have a breadth and depth of experience from across range of relevant fields; New members are drawn from relevant areas of University, to ensure this level of expertise continues; Development of training for UEC, DEC and researchers across University; Quorum of 7 members required for each meeting; Code of Practice sets out procedures in clear and accessible way; UEC able to seek further external advice if decision is not clear.UEC meetingsLHUEC8UEC unable to reach decision on applicationsFailure to reach a decision may impact on project, in terms of delayed start, opportunities for funding, etc; Ethical approval process undermined if UEC becomes known for inability to reach decision.All medium-high risk projects are considered by the UEC at their regular meetings; Breadth and depth of experience means that members have expertise to reach decisions on wide range of issues; UEC will seek further advice from external experts if required.All projects awaiting approval are reviewed at every meeting.LMUEC9UEC fails to adequately monitor external environmentDecisions do not reflect changes to legal and/ or professional requirements; NHS applications may not be approved if correct advice is not provided. Members with wide range of expertise ensures good awareness of legal and professional issues; UEC has membership of external bodies, including AREC, UREC and Glasgow Research Governance Group; Regular contact with NHS colleagues; UEC agenda has information sharing as standing item; Ethics Reading Group discusses current issues - information distributed to UEC; Training and awareness-raising sessions; Code of Practice outlines clear expectation for researchers to keep up to date with developments to professional standards and UEC will seek advice from researchers in field as required.Feedback from researchersLMUEC10Projects are not/ not adequately insuredPotential of legal ramifications/ litigationFinance representative responsible for insurance is in attendance at each UEC meeting and reviews all subsequent amendments to applications; All UEC applications scrutinised for adequate insurance cover.Insurer requires further details about applications.LMUEC11Failure of DEC members to understand processes/ legislative requirementsProjects approved that are not ethically sound; Projects approved that do not meet legal requirements; Potential for legal ramifications and/ or litigation; Potential harm to participants; Damage to external reputation of University; Projects approved without appropriate insurance cover or sponsorship.DEC members are experts in relevant field and external or lay member is required; DEC often includes member of UEC; Code of Practice made widely available on website to all staff within University; Development of training programme; UEC professional support is able to provide advice and guidance as necessary; Regular monitoring of DECs; DEC consider low risk projects only.Response to regular monitoring; Feedback from researchers/ participants; Applications coming to UEC that could be dealt with at DEC level.LLUEC12UEC lacks experienced staff/ suitably-wide membershipJudgements taken in relation to applications are not ethically sound; Judgements taken do not comply with legislative requirements; Decisions are inconsistent in relation to similar applications.Convener/ Vice Conveners/ Members appointed on fixed-term basis; Period of membership is known for all members; Membership regularly reviewed and discussed by whole UEC and new appointments are sought from relevant areas; Lay and external members have skills/ expertise in relevant areas; Wide pool of potential internal members - from across research community; Awareness-raising via sub-committee for training and education, ethics reading group and website to further widen pool of potential internal members; Networks/ contact with external environment builds pool of potential external/ lay members.Regular review of membershipLLUECResearch students based abroad do not ensure University ethical approval is in place.Potential for legal ramifications and/ or litigation; Potential harm to participants; Damage to external reputation of University; Projects approved without appropriate insurance cover or sponsorship.Suitable training developed about relevant procedures - much greater focus on this since development of sub-committee; Code of Practice published on website; Updates to procedures are publicised widely; UEC web page is regularly updated with information regarding foreign travel; Regular reviews of suitability of all aspects of procedures; Any projects that require external funding are routed through RKES and staff can identify grant proposals that require ethical approval; Increased liaison with DECs to raise awareness; Applications are signed off by Chief Investigator and relevant Head of Department; Contact details for independent contact are included on all information to participants (usually the secretary to UEC); University sponsorship and insurance have to be in place before a project can start; Regular monitoring of all ongoing projects and of DECs; UEC has high-level administrative support, able to provide advice and guidance to researchers; Code of Practice is sent to local supervisor to ensure adherence to University procedures.Negative feedback about research projects; Projects being submitted for external funding through RKES can be identified; 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