Research Ethics Policy Alternative Formats If you require this policy document in an alternative format, please contact Beverley Pascoe, Research Ethics Subcommittee (RESC) Secretary on telephone number: 0845 196 4211 or email address: research.ethics@anglia.ac.uk Introduction All research – whatever the subject of investigation – has the potential to contribute to or challenge academic knowledge; however, it also has the potential to impact on society at large, for instance, through the development of new knowledge or informing the development of professional practice. Public confidence in research can be seriously harmed where there is doubt about researchers’ integrity or honesty. Anglia Ruskin University is therefore committed to ensuring that all research undertaken in its name is carried out to the highest level of ethical standards, is fully compliant with relevant legislation and policy requirements, and informed by overarching principles of integrity and honesty. This document sets out Anglia Ruskin’s general policy on the ethical conduct of research involving human participants, human tissue and organs and sensitive or personal data. It applies to all staff (both on substantive and honorary contracts) and students, including those at our Franchise Associate Colleges, and to all types and stages of research. It must be read in conjunction with Anglia Ruskin University’s Code of Practice for Applying for Ethical Approval, which is available at: www.anglia.ac.uk/researchethics Definitions For the purposes of this policy, research is defined as ‘the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods’1 and ‘a process of investigation leading to new insights, effectively shared.’2 The term ‘researcher’ is used to refer to all students and staff of Anglia Ruskin University who are undertaking research, and encompasses anyone involved in conducting research with Anglia Ruskin University, whether on or off our premises or in collaboration with our staff and/or students, including on a consultancy basis. The policy also relates to students at our Franchise Associate Colleges. Other types of Associate College need to adhere to agreed requirements. 1 Research Governance Framework for Health and Social Care (2nd edition), (DH, 2005) https://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-secondedition 2 REF2014 Assessment framework and guidance on submissions, (HEFCE, 2011) http://www.ref.ac.uk/media/ref/content/pub/assessmentframeworkandguidanceonsubmissions/GOS%20including %20addendum.pdf Please also note that we consulted the University of Oxford’s Policy Statement when putting together this policy. Oxford’s Policy Statement is available at: http://www.admin.ox.ac.uk/curec/policystatement/ Underpinning Principles When planning, undertaking and disseminating research, researchers should consider the following seven principles: Beneficence – all researchers should consider how their research might benefit individuals or groups through the generation of new knowledge or an additional contribution to existing knowledge. It is recognised, however, that educational benefits to students carrying out research is a valid benefit, but lower-level benefits (e.g. educational) should be matched by lower ethical-risk projects. Non-maleficence – researchers should undertake research with due regard to minimising the risks of physical, emotional, social and economic harm to all those involved in research. It is important to remember that it is not possible to eliminate all risks. There needs to be a balance between the potential benefits of a research project and the possible risks. Researchers should ensure that strategies are in place should anyone be harmed as a result of participating in a study. Fidelity – researchers should seek to build a trusting relationship with research participants. By agreeing to participate in a study, research participants are entrusting themselves to the researcher, who subsequently has an obligation to safeguard the welfare of participants in the research setting. Justice – researchers should always seek to be fair to research participants. It is this principle which dictates there are no individuals or groups in society who cannot be involved in research. Veracity – researchers should in general be truthful and not deceive research participants. As part of the process of giving informed consent, research participants should be fully informed about what the research is about (it is, however, accepted that this would not be possible for some types of research project, but justification needs to be provided for this and risks to participants carefully addressed). Autonomy – apart from when the nature of the research makes this impossible, researchers should ensure that participants freely give informed consent before and during their participation in the research. Special care should be taken in recruiting participants who might be considered vulnerable. Where appropriate, researchers must comply with the Mental Capacity Act (2005). Confidentiality – researchers should seek to maintain confidentiality within the limitations of research. It is recognised that there are some circumstances where confidentiality may need to be breached, for example disclosure of the risk of harm to a research participant or others. Research Ethics Policy Anglia Ruskin University expects its researchers to conduct their research in a way which: respects the autonomy, rights and welfare of participants minimises risk to participants and researchers respect participants’ rights to withdraw from the research at any time appropriately manages personal data. Research taking place outside the UK must uphold Anglia Ruskin University’s ethical standards, but also be cognisant of local expectations and practices and compliant with local laws. In order to ensure that research activities are conducted in line with the above principles, Anglia Ruskin University is committed to providing a robust and independent ethical review process that is proportionate to the potential risk of the research. Ethics applications are treated as confidential. 2 Research which involves human participants, their tissues or data will always require ethical approval. Anglia Ruskin University also requires other types of research to undergo ethical review, including the following: risk of damage to the environment risk of damage or disturbance to culturally, spiritually or historically significant artefacts or places or human remains political or social sensitivity. Researchers are required to engage with Anglia Ruskin’s commitment to conduct research to high ethical standards and fully participate in the ethical review process. This includes both university procedures and ethical review processes required by collaborating organisations such as the NHS, which may be accepted as equivalent to our own. It is researchers’ responsibility to familarise themselves with this Research Ethics Policy and Anglia Ruskin’s University Code of Practice for Applying for Ethical Approval. This includes requirements after ethical approval has been obtained, as set out in the Code. Researchers who are involved as research partners with other organisations should ensure that ethics approval has been given by a properly constituted ethics committee and that such approval fully covers their own involvement in the research. Whilst duplicacy of ethical review is avoided wherever possible, students and staff should also check with their Faculty Research Ethics Panel (FREP) Chair whether any approval from Anglia Ruskin University is also required. FREP Chairs’ contact details are available at: http://web.anglia.ac.uk/anet/rdcs/ethics/about/frep.phtml In addition to research ethics approval, researchers should seek additional research governance approval if required. For example, researchers undertaking studies in the NHS will also need to obtain R&D Management Approval from the relevant NHS Trust(s). Researchers are also responsible for seeking additional insurance for their research if required and complying with professional and other codes of practice and legislation relating to their research. All researchers are also required to undertake some form of recognised research ethics training. Information regarding this is available at: http://web.anglia.ac.uk/anet/rdcs/ethics/training.phtml Research Supervisors are in addition expected to assist students in becoming familiar with this policy, Anglia Ruskin’s University’s Code of Practice for Applying for Ethical Approval and the ethical review process. Details of compulsory ethics training for all Supervisors is available via the above link, and in the Research Degree Regulations at: http://web.anglia.ac.uk/anet/academic/acad_sec/research.phtml Supervisors should be aware that some Faculties have additional requirements. This requires clarification with the relevant FREP Chair. http://web.anglia.ac.uk/anet/rdcs/ethics/about/frep.phtml 3 Mandatory nature of ethics approval Undertaking research where ethics approval has not been obtained is a serious matter. Such behaviour may be construed as misconduct or gross misconduct, and may be dealt with under the Student Disciplinary Procedures, or the Staff Disciplinary and Dismissal Policy and Procedures, as appropriate. The underpinning principles apply to all kinds of research but this Research Ethics Policy does not cover all of the issues for research involving animals. For further information regarding this type of research, please see the Faculty of Science and Technology website: http://www.anglia.ac.uk/ruskin/en/home/faculties/fst/research0/ethics.html Governance Structure The Research Ethics Subcommittee (RESC) is a Subcommittee of the Research Committee, which in turn is a Standing Committee of the Senate. RESC sets policy and monitors the activities of the Faculty Research Ethics Panels (FREPs). RESC delegates responsibility for the ethical review of research to FREPs. FREPs, in turn, delegate the review of low risk research to Departmental Research Ethics Panels (DREPs), subject to their decisions being ratified by FREP. Terms of reference for RESC, FREPs and DREPs are set out in the Constution of Senate and its Standing Committees, available on the Academic Office’s website: http://web.anglia.ac.uk/anet/academic/ Complaints Complaints or expressions of concern about the research ethics processes at Anglia Ruskin University can either be made via the relevant FREP Chair, contact details available at: http://web.anglia.ac.uk/anet/rdcs/ethics/about/frep.phtml or through the Office of the Secretary and Clerk, email address: complaints@anglia.ac.uk 23.6.14 V1.0 4