Tempus Masters Programmes in Public health and Social ServicesTraining Week 8th – 14th May 2011Tamara Kudaibergenova, PhDThe Leverhulme FellowUniversity of CumbriaLancaster, UK
Research Ethics in the UK University Research Ethics Committees (UREC) University of Cumbria Research Ethics Committee (Ethics Panel): Student‟s Research projects
UK Research Integrity Office Code of Research Practice: “Organisations and researchers working with, for, or under the auspices of, any of the UK Departments of Health and/or the National Health Service must adhere to all relevant guidelines”. All reputable medical journals now require proof that research has been passed by an ethics committee. NHS claims that all research involving NHS staff and facilities must be passed by the Research Ethics Committee. All research involving the NHS is governed by the Governance Arrangements for Research Ethics Committees (GafREC) document.
A question to ponder: does research in non- medical research and social science need such a rigid approach to research scrutiny and governance?
The ESRC is the UKs largest organization for funding research on economic and social issues. It is a non-departmental public body established by Royal Charter in 1965 and receive most of funding through the Department for Business, Innovation and Skills. It supports independent, high quality research which has an impact on business, the public sector, and the third sector. It funds research and training in social and economic issues. It distributes funds to academics in universities and other institutes throughout the UK It supports over 4,000 researchers and postgraduate students in academic institutions and independent research institutes in the UK.
Social science is, in its broadest sense, the study of society and the manner in which people behave and influence the world around us. The main social sciences include:•anthropology•communication•criminology•cultural studies•economics•human geography•linguistics•law•political science•psychology•sociology•development studies
Launched July 2005, implemented January 2006, revised 2010; All grant applicants to ESRC must comply with the conditions set down in the REF; But the ESRC is trying not to force a single model on all institutions; And ESRC Framework aims to make the burden of research ethics oversight proportional to the dangers.
The principal aim of the ethics review is to protect all groups involved in research: participants, institutions, funders, researcher s throughout the lifetime of the research and into the dissemination process. Research integrity is closely linked. It sees as good practice for all social science research. Whilst it is mandatory for ESRC- funded research, it is also recommended for use by other funders.
The ESRC Framework for Research Ethics 2010 that core changes introduced The guidance in regards to research with participants who lack mental capacity, in light of the Mental Capacity act (2005) Clarity in ESRC requirements in regards to ethical review (all research ought to receive at least light touch” review) and student research (all student research should likewise receive at least “light touch” review)
Is this research? Professional codes of practice still apply? Does proposal address subject of ethics? Principal Investigator to write Ethics Discussion Does it involve more than minimal risk Review by „Light touch‟ Department REC Does the research involve NHS patients, records, equipment, premises or vulnerable people under the Mental Capacity Act 2005? Review by NHS NRES Review by UREC
To have dedicated research ethics committees: To delimit of activities of the ethics committees so that it has a clearly defined role and a realistic workload To meet requirements of external bodies, notably funding and professional bodies
Research is any form of disciplined inquiry that aims to contribute to a body of knowledge or theory (ESRC FRE 2010). Research requires the creation of new knowledge. It must advance the academic community‟s knowledge, not merely investigator‟s; Research presuppose formal and disciplined of inquiry (e.g. Caesar salad by Caesar Cardini 1924, FerranAdria head chief of El Bulli restaurants) Commitment to publication
Research Ethics refers to the moral principles guiding research, from its inception through to completion and publication of results and beyond – for example, the curation of data and physical samples after the research has been published.
1. Research should be designed, reviewed and undertaken to ensure integrity, quality and transparency. 2. Research staff and participants must normally be informed fully about the purpose, methods and intended possible uses of the research, what their participation in the research entails and what risks, if any, are involved. Some variation is allowed in very specific research context for which detailed guidance is provided in Section 2 of the ESRC FRE. 3. The confidentiality of information supplied by research participants and the anonymity of respondents must be respected. 4. Research participants must take part voluntarily, free from any coercion. 5. Harm to research participants must be avoided in all instances. 6. The independence of research must be clear, and any conflicts of interest or partiality must be explicit.
The responsibility to implement these principles rests with the principal investigator and the research/ employing organisation. Breaches of good ethics practice in ESRC funded research will be treated as a serious matter by the Council. Where these occur, the institution, researchers and Principal Investigator will be called to account by the Council and sanctions may apply depending on the severity of the breach. These could result in the immediate suspension of the individual project and other projects based at or under the co-ordination of the contracting institution, and a halt to the consideration of further applications from that institution.
A „Research Ethics Committee‟ (REC) is defined as a multidisciplinary, independent body charged with reviewing research involving human participants to ensure that their dignity, rights and welfare are protected. The independence of a REC is founded on its membership, on strict rules regarding conflict of interests, and on regular monitoring of and accountability for its decisions
Some RECs were set up before 1990 (Anthea Tinker, Vera Coomber, 2004); The Nuffield Council Report, University Research Ethics Committees: Their role, remit and conduct (2004) found that: 80% of universities had a UREC; half of them were set up since 2000; Most URECs covered only staff and graduate students but not undegraduate students;
The primary role of a REC is to protect the dignity, rights and welfare of research participants. RECs should also give due regard to the consequences of the proposed research for others directly affected by it and to the interests of those who do not take part in the research but who might benefit or suffer from its outcomes in the future. RECs also need to consider the safety of researchers, especially where they are working abroad, in covert situations and/or conducting lone fieldwork in settings that may pose risk to their safety.
Institutional RECs are responsible for reviewing all research involving human participants, personal data and sensitive personal data conducted under their auspices and undertaken by13 of 50individuals employed by the institution that does not come under the remit of the NHS NRES. RECs should review research proposals in a way that is independent, competent and timely. In some circumstances RECs may authorise other sub-committees or their chair to conduct reviews on research involving minimal risk on their behalf. These sub-committees and chair will be accountable to the REC and through it to the appropriate institutional authorities for the decisions they make.
RECs should be multidisciplinary and comprised of both men and women. They must include at least one lay member with no affiliation to the university or research institution in question. There must be members who have broad experience of and expertise in the areas of research regularly reviewed by the REC who have the confidence and esteem of the research community. At least one member must be knowledgeable in ethics. There must be a chairperson RECs would also benefit from including individuals who reflect ethnic diversity, users of specialist health, education or social services, where these are the focus of research activities, individuals with experience of professional care or counselling, and individuals with specific methodological expertise (for example, statistics or qualitative methods) relevant to the research they review RECs would normally need at least seven members.
Principal REC Secondary RECs (Faculty, School or Department based).
Light touch review: All ESRC-funded research should undergo it. Many student projects may fall under this category. Full REC review: The projects that involve more than minimal risk. Expedited review: In exceptional circumstances where research projects require a full review but have a short lead time and are commissioned in response to a demand of pressing importance.
Goal-based ethics Goals are outcomes that we are aiming to achieve Constrained-based ethics Constraints are restrictions or barriers to research which limit what it is permissible you do even in pursuit of valuable goals
Deontology is the view that some kind of action (e.g. killing, deceiving, causing serious harms) are wrong even the benefits they produce exceed the harms. Rights-based approaches are an example of deontological thinking, is that they place constraints on how we may treat individuals even in pursuit of worthwhile goals. Constraints need to be absolute, but they need more that a marginal balance of benefit over harm to be justifiably overridden
Consequentialism is the view that the right actions is always the one that produces the best overall consequences, so any action can be justified provided the benefits (to society as the whole) outweigh the harms. Consequentialism tells to maximize that extent to which morally important goals are satisfied even it this involves some significant trade-offs or sacrifices. Utilitarianism is an influential form of cinsequentialism, in which the relevant moral goal is identified as maximizing overall welfare or happiness (pleasure an the absence pain or satisfaction of individuals preferences)
Research that could damage the university‟s reputation: Research that is funded by “tainted” sources; Research that is funded by potentially embarrassing sources; Research that may offend people;
Universities and research institutions should establish procedures specifically for reviewing research projects undertaken by undergraduate students and students on taught postgraduate courses. The same principles should apply to postgraduate student research as to staff research. Student research poses particular challenges in relation to ethics review because of the large numbers, short timescales and limited scope of the projects involved. Nevertheless, the same high ethical standards should be expected in student research. Student projects involving more than minimal risk may need careful consideration and possibly a full ethics review.
However, in many cases student research may be managed at school/department level and overseen by a light touch Departmental Ethics Committee using an initial checklist. Established protocols for commonly occurring research can expedite the review process. It should be made clear to potential research participants that the study is a student project. Universities also need to ensure that students are not exposed to undue risk in conducting their research.
Process Chart and Guidance Notes:Developing Research and Completing a Request for Ethical Clearance Document E1: Checklist of Ethical Principles for Research Document E1A Checklist of Ethical Principles for Research involving Animals Document E2: Ethical Principles and Guidelines for Research involving Human Participants Document E3: Policy for Addressing Safeguarding Children and Young Persons (on the S-drive at S:Student And Staff PoliciesSafeguarding Children and Young PeoplePolicy documentsPolicy approved Oct07 amended Oct08) Document E4A: Application Form: Research involving Animals Document E4H: Application Form: Research involving Human Participants
Fully committed to inclusivity and accessibility, the University of Cumbria will reflect the Christian values and creative traditions on which it was founded, and will promote an environment where diversity is celebrated and inventiveness flourishes with a mission: To excel in the design and delivery of a range of accessible lifelong learning opportunities through a network of centres within Cumbria and North Lancashire To inspire all of our students to achieve their potential by providing progressive teaching and an innovative and flexible learning environment which encourages independent thinking, tolerance and social responsibility To support economic advancement and the development of diverse and sustainable communities by playing a prominent role in assisting the growth of the regional economy and enhancing its skills base To encourage research, scholarship and knowledge transfer activities of excellence, much of which will help shape and support sonstructuve social, cultural and economic change and development.
ACCOUNTABLE Researchers should consider, from the outset, the potential beneficiaries of their research. The research should be based on the informed consent of participants and/or their guardians. CONFIDENTIAL ANTI-DISCRIMINATORY RECIPROCAL Research should be based on mutual dialogue between researcher and participants and should seek to ensure that results can be used for the common good. EMPOWERING Research should be directed towards providing people, particularly those who are disadvantaged and discriminated against, with the means to improve their health and well-being in society. HONOURING OF PROFESSIONAL VALUES Professions have their own ethical codes of conduct. These ethics should not in any way be undermined or subverted by research. ACCESSIBLE All research should be capable of being disseminated in the public domain and be appropriate to the teaching and learning role of the university. CHALLENGING Research should seek to challenge received wisdom and embrace openness and creativity in order to further understanding.
RESPONSIBILITY TO THE RESEARCH PARTICIPANTS RESPONSIBILITY TO THE RESEARCH COMMUNITY RESPONSIBILITY TO THE FUNDING AGENCY RESPONSIBILITY TO THE PUBLIC RESPONSIBILITY TO THE UNIVERSITY OF CUMBRIA No research should be carried out which, once published, would demean the reputation of the University as an institution
Will it involve animals? yes - Submit to Ethics Committee; Will it involve Professional Body approval? Yes - Consult Tutor - Consult Professional Body - Submit to Professional Body Ethics Committee (eg BPS for work in the field of psychology, NHS Local Research Ethics Committees (RECs)) Will it involve Human Participants? Are the data in the Public Domain? Staff or Research Student? No - Submit to Supervisor Yes - Submit to Ethics CommitteeIf you are a student then seek advice of your Supervisor. If you are a member of staff you will probably already be aware of any requirements of your Professional Body, where applicable. If not then you should consult with a colleague.