Executive summary: A proposed communications plan to raise awareness and understanding of the Ethical Policy Framework and the work of the University’s Ethics Committee. Action required: The Ethics Committee is asked to APPROVE the communications plan. Origin: Hannah Baldwin, Head of PR It was agreed at the meeting of the Ethics Committee held on 24 October 2014 that there was a requirement to raise awareness and understanding of the University’s Ethical Policy Framework and the work of the Ethics Committee. The following communications plan is therefore proposed. 1. A link will be provided from the University’s externally-facing home page (http://www.lboro.ac.uk/) to the University’s ethical principles (Annex 1). The link would appear at the bottom of the home page, alongside the Accessibility, Freedom of Information, Privacy and Legal Information links. 2. The Frequently Asked Questions (Annexes 2 and 3) will be linked from the Ethics Committee homepage (http://www.lboro.ac.uk/committees/ethics/) under a new ‘Additional Information’ tab. 3. A new set of web pages will be developed to bring together all ethics-related information. The pages will include: An overview of the Ethics Committee and links to the Ethics Committee homepage (http://www.lboro.ac.uk/committees/ethics/) and any sub committees The Ethical Policy Framework (http://www.lboro.ac.uk/media/wwwlboroacuk/content/universitycommittees/ethics commitee/Ethical%20Framework%202014-15.pdf) The ethical principles (Annex 1) The Frequently Asked Questions (Annexes 2 and 3) The ethical quick test for student projects (Annex 4) These pages will be linked from the internally-facing home page (http://www.lboro.ac.uk/internal/), accessible from the dropdown menus for both staff and students. 4. Internal news articles will be posted to the internally-facing homepage (http://www.lboro.ac.uk/internal/) at appropriate times to raise awareness and understanding of the Ethical Policy Framework and the work of the University’s Ethics Committee, and to drive traffic to the appropriate policy and principles documents online. Annex 1: Loughborough University Ethical Principles As active members of an international academic community, we are fundamentally committed to: the creation, transmission and dissemination of knowledge for the social and economic enrichment of society, the Nolan principles of public life: selflessness, integrity, objectivity, accountability, openness, honesty and leadership, accepting our social, economic and environmental responsibilities and contributing to the wider goal of sustainable development. the protection of equity, human rights and civil liberties around the world, and supporting the academic freedom to further knowledge and debate, within UK law. As the representatives of a modern, progressive institution, we are also committed to: excellence in all our activities, good governance and collegiate, transparent leadership, safe working practices fair, rigorous and transparent processes and practice, encouraging social mobility and widening participation, and regarding legal compliance as a minimum expectation but not as a sufficient response to an ethical challenge, But we will not tolerate: initiation of or collusion in harmful acts, giving, offering, receiving or requesting improper inducements to influence decisions affecting the interests of the University, or retaliation or retribution against any person who in good faith challenges our ethical position. Furthermore, as members of the Loughborough University community, we are committed to: fostering a collegial community characterised by inclusivity, equality of opportunity, the valuing of diversity, mutual trust, respect for personal dignity and the promotion of unity across nations, respect for our diverse local community, listening to all members of the university community, past and present, the promotion of health and well-being, valuing participation, dedication and honest endeavour, and celebrating ever greater achievement and success fairly gained. Our ethical principles are manifest in our achievements including: a world-class research reputation, the ‘best’ student experience, enduring support to the professions, business, industry and public policy makers, unrivalled sporting achievement, outstanding staff satisfaction, financial stability and an award-winning, sustainable campus To enhance our position for the future, we must: demonstrate courage and consistency when facing challenging ethical dilemmas, choose partners who share our ethical commitments, and ensure that all members of the university community embrace and promote these ethical Annex 2: Frequently Asked Questions regarding Ethical Approval Policy and Procedure at Loughborough University The document outlines some of the frequently asked questions about how ethical approval is obtained at the University. This document has been approved by the Loughborough University Ethics Committee but is not a substitute for the full information available from the relevant SubCommittee websites. For more information on policies and procedures, please go to: LU Ethics Committee: http://www.lboro.ac.uk/committees/ethics/ Ethics Approvals (Human Participants) Sub-Committee: http://www.lboro.ac.uk/committees/ethics-approvals-human-participants/ Ethics Approvals (Human Tissue) Sub-Committee: http://www.lboro.ac.uk/committees/human-tissue-authority-licence/ How are projects ethically reviewed? How projects are ethically reviewed, and who reviews the projects, depends upon the nature of the work. The lead researcher (e.g. PI or supervisor) is responsible for deciding if ethical review is needed and which review procedure is applicable. At the very least, the Ethical Quick Test should be completed by the PI or supervisor. How does Loughborough University’s ethical review procedure work? The University Ethics Committee is responsible for overseeing all ethical review at Loughborough. It has ownership of the Ethical Policy Framework and the Quick Test. It delegates specific activity to two SubCommittees. The Ethics Approvals (Human Participants) Sub-Committee (HPSC) reviews all activity involving human participants. The Ethics Approvals (Human Tissue) Sub-Committee (HTSC) ensures all policy and procedure around the University’s Human Tissue Act Licence are maintained. How many people need to review projects under the University ethics review procedure? This depends upon the ‘risk’ of the project: Low risk projects will be assessed by the student and supervisor (in the case of student projects) and the member of staff (for staff projects). The appropriate forms may be signed by the Dean of School or their signatory, but they do not review the study in details. Potentially high risk projects will be assessed by the Ethics Committee or relevant SubCommittee. Depending on the nature of the risk, the project could be reviewed by up to seven people (in a full Ethics Approvals (Human Participants) Sub-Committee) What constitutes a ‘potentially high risk’ project? Work that is ‘potentially high risk’ will involve one of the following: Particularly vulnerable participants (e.g. who may not be able to exercise informed consent – such as children) Highly sensitive topics (e.g. religion, health, sexuality, violence) Potentially sensitive research funders (e.g. cigarette producers, arms manufacturers) Potentially sensitive donors to the University (e.g. persons who obtained their money unethically) Researchers should reflect on the risk-level presented rather than viewing the process as a boxticking exercise. The ethical approval process is to protect investigators as much as to protect any participants in research. The Ethics Committee and Sub-Committees provide the opportunity to prepare and manage the risks involved in a study more than preventing a higher-risk study from going forward. Does research which is undertaken abroad require ethical review? Yes. The researcher should determine if there is an appropriate ethics review procedure in the country where they wish to undertake the project. The researcher should then inform the Committee or SubCommittee of the ethical review process to be undertaken and, if sufficiently robust, this can go ahead. If the review is not sufficient, the researcher should apply for University ethical review. Does research which is undertaken with another UK university require approval via Loughborough University’s procedure? If the research is led by another UK university then the ethics procedure at that institution should apply, rather than Loughborough’s. It should be noted however, that Loughborough University reserves the right to ask investigators to provide evidence that the other university’s ethical procedure is sufficiently robust. This will depend on the nature of the research and the advice of the Research office should be sought. What documents are needed for ethical review? This will depend on the type of work the researcher is undertaking. All investigators should complete an Ethical Quick Test to ensure no further approvals are required. For approval for studies involving human participants, the investigators should look at the HPSC website to understand what application forms and supporting documentation are required. What level of detail should be included in the ethics application form? The application forms should include enough detail to enable a lay person unfamiliar with the work to understand the proposal. This then enables the Committee and Sub-Committee member to make an informed decision on whether or not the work should proceed, and provides sufficient information on the work if any complaints are made. How is the outcome of ethical review recorded? Ethical review decisions made by either the Ethics Committee or Sub-Committee are recorded within the Minutes of the meeting. Investigators are also informed separately of the ethical review decision. For how long should ethics documentation be kept? Where practical, ethics documentation should be kept for one year following the completion of undergraduate and postgraduate-taught student projects and for up to three years following the completion of staff and postgraduate research student projects. Documents can be kept in hard copy or electronically. If any student or staff has difficulty retaining documentation for this period of time, they should contact either the Ethics Committee Secretary or HPSC Secretary for advice. Where can I find out more about the University’s Ethical Approval Policy and Procedure? The Ethical Policy Framework can be found on the Loughborough University Ethics Committee website. Further information on ethical approval for work involving human participants can be found on the HPSC website. Annex 3: Frequently Asked Questions on Loughborough University’s Ethical Policy Framework The document outlines some of the frequently asked questions about the University’s Ethical Policy Framework. This document has been approved by the Loughborough University Ethics Committee but is not a substitute for the full Framework. For the Framework in full, please go to: http://www.lboro.ac.uk/media/wwwlboroacuk/content/universitycommittees/ethicscommitee/MAS TER%20Ethical%20Framework.pdf Why is the Ethical Policy Framework needed? The University is an independent academic institution that exists for the creation, transmission and dissemination of knowledge for the social and economic enrichment of society. We must be committed to fulfilling that purpose in ways that comply with broad obligations of social responsibility. Integral to this commitment are the adoption of high ethical standards across every aspect of University activity. The framework states the expectations of organisational and individual ethical behaviour. It also provides a structure for informed decision-making when ethical issues arise in the course of University business. What University activity should be ethically reviewed? The framework offers guidance to all members of our university community on how to act with integrity, good conscience and good judgement at all times. Whilst some specific types of project has a clear ethics review process, all staff and students should consider their work and the ethical issues that may arise from it. How are activities ethically reviewed? Any work at the University should be considered using the appropriate ethical quick test as a first step. Investigators should consider the work they wish to undertake and any ethical issues that may be associated with it. Work involving human participants should be reviewed by the Ethics Approvals (Human Participants) Sub-Committee (http://www.lboro.ac.uk/committees/ethics-approvals-humanparticipants/) How does the Loughborough University ethics review procedure work? If a member of the University feels that an aspect of their work is ethically questionable, it should be reported to the University Ethics Committee. The Committee will then consider the work and respond to the University member. The Ethics Committee may decide to delegate any investigation or review to the appropriate Sub-Committee or other relevant Committee of the University. Where can I find out more about the Ethical Policy Framework? The Loughborough University Ethics Committee website (http://www.lboro.ac.uk/committees/ethics/) provides further information, including a full copy of the Ethical Policy Framework (http://www.lboro.ac.uk/media/wwwlboroacuk/content/universitycommittees/ethicscommitee/MAS TER%20Ethical%20Framework.pdf Annex 4: The ethical quick test for student projects (draft) Schools must incorporate ethical approval into their processes for setting student projects. These approvals are not intended to be onerous and should be incorporated into the general procedures by which project proposals are approved. This quick-test is considered a sufficient first stage but Schools are at liberty to implement more comprehensive tests if they prefer. Schools should retain an audit trail for ethical approvals. Specific Ethical Approval Sub-committees will consider the following: Aspects of projects involving experiments with human participants Aspects of projects falling under the Human Tissues Act Aspects of projects funded by philanthropic gifts The Dean of School is responsible for ensuring that all necessary ethical approvals required from these sub-committees are obtained and that any further approvals are also obtained. This may often be achieved by delegation. For projects in which ethical aspects fall partially or wholly outside the remit of these sub-committees, the project supervisor should complete this quick test and provide a copy to the Dean of School (or a designated delegate such as an AD(T), programme director or projects coordinator) who is responsible for confirming that all necessary ethical approvals are in place before projects commence. To pass the test, all responses must be ‘yes’. Failing the quick test does not constitute a refusal by the University to undertake the project. If a project fails the quick test then this means that further ethical scrutiny is required. This process requires completion of the generic ethical checklist to be found in the Ethical Policy Framework which must then be forwarded together with the project proposal to the Dean of School (or their designated delegate). Where a decision cannot be made, the case passes to the PVC(T) but such cases are expected to be rare. Completion of the quick test requires familiarity with the University’s statement of ethical principles which can be found in the Ethical Policy Framework where extensive further details are also available. Question Are the action and its outcomes clearly legal? Does the action adhere without question to the ethical principles in section 2 of the Framework? Will I be proud of the action and its outcomes? Will I feel comfortable about the action and its outcomes? Will the action look acceptable to the media? Will the action look acceptable to my colleagues, friends and family? Yes No Not sure Comment