1 SALC Research Ethics training (2016/17) Dr Jenny Hughes, Chair – SALC Ethics Committee
2 Aims of today: To increase awareness of research ethics principlesTo encourage connections between your research projects and internationally recognised principles of research ethics To offer guidance on School and University research ethics procedures
3 University of Manchester Research Ethics Committee (UREC)‘Research ethics is a world-wide set of principles governing the way any research involving interaction between the researcher and other humans or human tissue or data relating to humans, is designed, managed and conducted. In preparing a research project, the dignity, rights, safety and well-being of human participants must at all times be considered, respected and safeguarded’ University of Manchester Research Ethics Committee (UREC)
4 All projects conducted by University staff or students that involve human participants in a way that might harm, disturb or upset them (however slight the possibility) or where they can be deemed to be in a vulnerable or disadvantageous situation, must receive approval from a recognised research ethics committee. UREC
5 An ethics committee will assess whether:the research is justified, i.e. is the research likely to add to the existing knowledge base; it is of sufficient standard - including whether the researchers are qualified to carry out the roles proposed; the risk it poses to participants is outweighed by the potential benefits of the research?; the research appears to comply with all statutory and other guidance; data management and handling appears to comply with the relevant legislation; financial arrangements appear sound. Research Ethics Committees are responsible for reviewing ethics applications in order to ensure that adequate consideration has been given to the ethical aspects of a research project thus reducing the potential for harm and upset to the participants.
6 Autonomy Beneficence Non-maleficence Confidentiality IntegrityThe principles of research ethics are grouped under these headings – what do they mean? Autonomy - the participant must be free to take part in the research without coercion or penalty for not taking part; the participant must be free to withdraw at any time without giving a reason and without a threat of any adverse effect. Beneficence - the research must be worthwhile in itself and have beneficial effects that outweigh any risks; the methodology must be sound so that positive results will be yielded. Non-maleficence - any possible harm must be avoided or mitigated by robust precautions Confidentiality – the right of the participant and his/her personal data to remain unknown to all but the research team must be respected (unless the participant agrees otherwise). Integrity - the researcher must be open about any gains he or she makes from the research.
7 In practice - What is the research and why is it important?Who is involved? What are you asking people to do? What are the ethical issues involved? How will you manage these? All research proposals are scrutinised to ensure that these principles are addressed. In practice, this means the researcher reporting on and the reviewer scrutinising responses to these questions … The processes can seem drawn out and complex, but thecore aspects of research ethics are essentially simple (slide) … What does this mean in practice? (a) We need to think about whether the research is necessary; (b) Identify the specific risks it poses for research participants (including ourselves); (c) Develop a plan for managing those risks; (d) Develop a considered approach to obtaining informed consent; (e) Be clear with participants about the level of confidentiality or anonymity on offer
8 Applying for ethical approvalNuts and bolts Applying for ethical approval The remainder of the session will be looking in detail at the process of applying for ethical approval.
9 Steps in the process … Develop research proposal (with supervisor, if appropriate) – research questions, rationale, significance, who is going to be involved and how? Ethical issues? Decide - what level of review do I need? Complete an application via the University’s online system, appropriate to the level of review required (‘Ethical Review Manager’ - ERM) Submit for review – to supervisor, School or UREC – depending on level of risk 4 steps in the process …
10 What level of review do I need?Low risk – reviewed by supervisor/tutor Medium risk – review by School Research Ethics Committee High risk – reviewed by University Research Ethics Committee NOTE – ALL STAFF APPLICATIONS ARE REVIEWED BY THE UNIVERSITY RESEARCH ETHICS COMMITTEE, REGARDLESS OF LEVEL OF RISK We work to the principle of proportionate review … less scrutiny required for low risk projects; more for high risk projects … The level of scrutiny applied must be proportional to the risks involved. Sometimes approval from supervisors is enough, sometimes an application for ‘ethical approval’ will need to be made to the University ethics committee (7 committees, 1 sitting each week in semester time), sometimes an application to the School research ethics committee will be needed (no deadlines – all year round for PGR and MA taught courses; one deadline for MA Dissertations – 14th March 2017). If there is no process of scrutiny evident, researchers are not protected by the University from any adverse consequences, financial or otherwise, that might arise. This is a set of obligations that fall on supervisors as much as students. Conducting research without ethical approval is seen as professional misconduct.
11 High risk High risk: The research focuses on groups within society in need of special support, is carried out in an unstable or volatile setting, involves non-standard methodologies or approaches, presents risks to the personal safety of the researcher or research participant beyond what is normal in the setting, or where there is a possibility the research may be distressing to the researcher or research participant in one or more ways. High risk applications are reviewed by the University Research Ethics Committee (UREC) after initial screening at School level.
12 Example 1: Why would this research project need to be assessed by UREC?Texts of 'refugee-ness' (MA Dissertation) The research explores how contemporary understandings of the ‘refugee experience’ are produced by a range of circulating discourses. It compares the construction of the refugee experience in government policy and procedural discourse (via the analysis of legislation and procedural texts produced by government agencies), fictional narratives (in literature and poetry), and first-hand narratives gained via interviews with refugees in Manchester. The researcher intends to carry out in-depth narrative interviews with up to 10 asylum seekers currently being supported by Refugee Action as part of the research. Be specific about the risks – legal status, traumatic experience, support needs – how might these be managed? Informed consent, partner agency support, debrief process, ongoing sources of support …
13 Example 2: Why would this research project need to be assessed by UREC?Performance in a place of war (PhD project) Youth music networks in the Palestinian Territories: the research explores a network of young musicians in the Palestinian Territories, documenting and understanding how musicians are using independent music to confront and counter narratives of war in communities. The researcher intends to carry out an ethnographic study of the network, spending up to 6 months in the Palestinian Territories and engaging in interviews and observations of their practice. What are the risks – specifically? Researcher safety, confidentiality and protection of data from authorities (confidentiality). How might they be managed? – risk assessment, informed consent, encryption and anonymisation … Note: international research taking place in sites that the UK Foreign and Commonwealth Office advise against travel to, or advise against ‘all but essential’ travel to, are automatically designated high risk, and need to go to UREC for review.
14 Medium risk applications are reviewed at School level.The research engages adults and children (in an accredited setting such as a cultural institution, school or youth club and accompanied by a carer or professional with a duty of care), follows standard procedures and established research methodologies, is carried out in a public setting that does not present risks to the researcher or research participants beyond what is normal in that setting, and does not require research participants to provide personal and sensitive information likely to lead to significant levels of distress (the research topics are either not contentious or sensitive, or a reasonable person would agree the topic is of legitimate interest and may result in distress in rare instances). Medium risk applications are reviewed at School level.
15 Example 3: Why would this research project need to be assessed by the SALC Ethics Committee?Women and liberation theology in India (PhD project) The research explores attitudes to women within liberation theology in India. 20 scholars in liberation theology working at reputable religious and educational sites across India, known for their work in this area, are invited to take part in recorded interviews exploring how contextual realities like caste, class, gender, and rights have influenced attitudes to women, and how new theoretical insights can help develop the recognition of women’s rights in India. Why medium risk? Controversial topic – but not about personal experience or personally distressing, necessarily … Researcher can manage the boundary … How? Informed consent …
16 Low risk The research engages healthy adults or children (in an accredited setting such as a cultural institution, school or youth club and accompanied by a carer or professional with a duty of care), who are able to give informed consent in a way that accords with accepted practice. The research follows standard procedures and established research methodologies, is carried out online or in a public setting that does not present risks to the researcher or research participants beyond what is normal in that setting, and does not require research participants to provide personal and sensitive information likely to compromise them, or to lead to distress (the research topics are not contentious or sensitive, such as asking about religious beliefs, sexual preferences, political views or illegal activities, or a reasonable person would agree the topic may only result in distress in extremely rare instances). Student projects deemed to be of low ethical risk require only the approval of the supervisor, but still need to be submitted via ERM.
17 Is my research low or medium risk?Low risk research, typically – Does not focus on contentious or sensitive topics Does not involve collection of personal or sensitive data Focuses on professional practice/professional roles Takes place within normal working hours and in a public setting Does not involve the collection of photographs or videos of participants
18 Example 4: How does this comply with the low ethics risk guidelines?Kinaesthetic learning in the museum (MA Dissertation) The research explores a new approach to kinaesthetic learning tested out in collaboration with education teams at three museums. The researcher observes 15 groups of parents and children taking part in a 20-minute creative object-handling session in 3 museums. The researcher carries out 10-minute interviews following the session with parents and children asking for their reflections on the experience. Children are also asked to draw a picture that shows what they were thinking about and feeling during the session.
19 Exercise: What risk level is your research?Discuss with your neighbour: Your research proposal whether the questions and topics you are exploring are contentious or sensitive whether you will need to involve human subjects who may be from vulnerable groups the settings and methods of your research the potential risks to you as researcher Is the category: HIGH, MEDIUM, LOW?
20 If you are in any doubt about the level of risk, please James Mawdesley at
21 The application process
22 (University log in required)ALL applications are now made via the ‘Ethical Review Manager’ (ERM) – the University’s new online system for processing applications https://submission-ethicalreview.manchester.ac.uk (University log in required) Log on – you are taken to a ‘work area’, where you can ‘create project’
23 You can then see the ‘Project tree’ page – click on ‘START HERE’ (this is a test project I invented for the purposes of creating the screen shot) Use the ‘Next’ button (top left) to go to the next set of questions
24 ERM asks you some general questions to help you establish the level of risk your project involves, and to check insurance arrangements (extra cover needed only when research activities carried out by a partner org or involve physical, invasive or psychological interventions – not normally applicable to SALC research). At question A5 are then asked to select the right form…. High risk applications go to UREC needs to use the UREC ethical approval form; medium risk applications go forward for ‘Division/School Review’.
25 Selecting ‘University Research Ethics Committee Review’ will take you to the UREC form (questions E1 – 53): Research question Academic justification Details of what you are going to do – interviews, focus groups, questionnaires, other Numbers of participants and recruitment processes Key questions (E11 and E12) – ‘What do you consider to be the main ethical issues which may arise with the proposed study?’ & ‘What steps will be taken to address the issues raised in the question above?’ Procedures for informed consent Risks and safeguards Data management Reporting and dissemination Conflict of interest/funding = Key sections of the form …
26 For low/medium risk projects, select ‘Division/School Review’ (at AFor low/medium risk projects, select ‘Division/School Review’ (at A.5) - this will take you to general and insurance questions. Under D5.2 – which asks for your School/Division – select ‘School of Arts, Languages and Cultures’
27 SALC ethics form (questions J1 – 87)J1 is a checking question that asks you to confirm risk level J2 directs you to the appropriate template form to fill in On both medium and low risk forms – most questions are tick boxes with pre-written answers – you are required to read and select which apply to you …
28 Low risk template Research question Academic justificationNumber of participants Fieldwork and risk assessment (see below) Tick box lists to confirm low risk nature of the research Fewer questions, quicker and easier to fill out = key sections of the form …
29 Medium risk template The key sections are the same as the UREC (high risk) form but with more pre-written answers and tick box lists. For example …
30 Key questions – J14 to 18 What do you consider to be the main ethical issues which may arise with the proposed study? Tick all that apply. ☐ Issues of informed consent - research participants’ awareness of the reasons why the research is taking place and what will happen to information they provide. ☐ Issues of confidentiality - research participants may feel that their views or identities will be exposed in undesired ways. ☐ Where researchers are engaged in projects in sites outside of the University, there are additional risks relating to personal safety of the researcher. ☐ Research participants may find research activities tiring or intrusive. ☐ Some topics explored - for example, explorations of religious beliefs and practices, the representation of specific communities in art and literature, questions of cultural difference, the production and reception of provocative exhibitions or performances - may provoke strong feelings in respondents. ☐ The research takes place across cultural boundaries, presenting specific challenges relating to communication and cultural awareness. ☐ The research will not carry risk of criminal or other disclosures requiring action (for example, involving safeguarding of children or vulnerable/dependent adults). The Template has a combination of questions – some ask for you to write your own answers, some are tick box checklists, others a mixture of both (UREC form just asks questions – fewer tick box lists …). The list intends to provide suggestions as to what you might need to consider … you are asked to briefly expand on your response immediately underneath this list
31 Key questions – J14-18 What steps will be taken to address the issues raised in question 13.1? ☐ A participant information sheet has been developed for the research project and is attached here ☐ Participants will give written or verbal consent to participate in the study after they have reviewed the participant information sheet. ☐ Where projects have multiple stages, informed consent will be obtained for each phase of the work. ☐ Where the research engages children and young people, a CRB check has been undertaken either via the University or the host institution. ☐ Where research participants cannot read English, the information sheet will be translated into a language understandable to them. ☐ Where the research takes place across cultural differences, researchers will develop awareness of cultural norms in the research site/community and act in ways that are respectful of these at all times. Researchers will manage encounters so as to minimise power imbalances that may occur, including making research participants aware of their right to withdraw from the research without giving an explanation. ☐ The research project takes place off-campus and a risk assessment is appended to this application. Again, the list provides of examples of good practice as regards managing research ethics issues – here, you tick those that are relevant to you, and add some brief details … (the list on the form is longer – these are examples only). These two tick box lists also highlight the key ethical issues we expect you to consider, and how we expect you to manage these …
32 Supporting documentation (not all documents are needed for all projects)Risk assessment Participant information sheet (PIS) Consent form for participants Consent letters from third parties Additional documents (e.g. questionnaires, interview questions, invitation letter to participants, advertisements)
33 Risk and risk assessments – key areasCausing offence (issues of access/inclusion; discussing topics that may provoke strong responses) Lone working Working in private residences Working in international sites Health and safety Please consider (with your supervisor, if appropriate) the risks involved in your research. These might be (see slide) You are also asked to complete and append a risk assessment form if you are working off-site. The School have developed two generic risk assessments for you to draw on here, available via the ‘quick links’ section of the research ethics website (one for low risk research taking place nationally, and one for low risk research taking place internationally). The two risk assessments, like the Template – describes commonly arising risks relevant to low risk research, and details how researchers will manage these. As with the Template they draw on good practice in managing risks. You are asked to confirm that you (and your supervisor) have read the risk assessment, and add details to the generic forms where appropriate. Commonly arising risks are listed here Risk of causing offence – through cultural insensitivity for example. ‘Measures to control risk’ here include accessing information about communities in advance, respecting difference, using professional translators, putting in place an action plan should strong feelings be invoked (via discussion with supervisors for example). Lone working, working in people’s homes and working in international sites all raise specific risks – these are detailed on the risk assessment forms, and measures to control risk outlined. For e.g. the University’s lone working guidance advises that researchers nominate a ‘buddy’ (normally a supervisor) to whom they regularly report when working off-site, that high crime areas are approached carefully (carrying a map and phone, scoping out areas in advance etc). Working in people’s homes places researchers in a vulnerable situation, potentially, and here reporting in with buddies needs to happen more regularly (before and after each visit) – we advise against MA researchers working in people’s homes on their own. Researchers going to international sites are asked to consult FCO advice in advance, and research that raises specific health and safety issues (physical activities in a drama workshop for example) needs to respond to the University’s health and safety guidance as well as good practice in the site of the research.
34 The risk assessment … Any research conducted off-campus requires a risk assessment, whether or not your research involves human subjects There are two LOW risk assessment templates available on the SALC ethics website – one for UK ‘Generic Risk Assessment Form A’), one for international projects (‘Generic Risk Assessment Form A=B’ . Please read these and highlight sections relevant to your research. Upload the risk assessment to your online application. IMPORTANT NOTE: You may need to add to the risk assessment any particular risks associated with the location or nature of your research that are not already covered by the form. If your research takes place in countries on the list that the FCO advises against ‘all or all but essential travel to’ you must apply through UREC. (log in required – scroll down for the risk assessments) The risk assessment templates have written a list of potential risks and risk management measures – read carefully and highlight those relevant to your research. Add any risks or risk management strategies not already covered by the template.
35 Participant information sheet and consent form …You will find a template for your PIS/consent form that you can tailor to your project’s specifications on the UREC website The document has been designed for you to communicate clearly to your participants the answers to key ethical issues that may concern them. No personal personal mobile numbers or s should be included, only university contact details. Not all categories are required (e.g. delete the subheading and text related to Criminal Record Checks if you will not be working with unsupervised children or vulnerable adults). The PIS takes a Q&A format – for e.g. ‘Who will conduct the research?”, ‘Why have I been chosen?’, ‘What happens to the data collected?’, ‘How is confidentiality maintained?’. Participants should have some time to review the form prior to giving their consent. Child friendly consent forms should be developed where appropriate. The PIS is perhaps the most important document as it is a key means of ensuring informed consent. The Template for this takes a Q&A format (‘why have I been asked to take part in the research?’; ‘what will happen to the information I give?’). The PIS is given to all research participants, is written succinctly and in layperson’s terms and will include: - The name and contact details of the researcher (University , address and phone numbers only) - An explanation of the research aims and what the research will achieve - The reasons why the research participant has been approached - The activities that the research participant will engage in, where these will take place and how long it will take, including brief details of the kinds of questions that might be asked (especially those questions that may provoke strong responses) - A description of what happens to the data collected - The likely outputs of the research - A statement clarifying the limits of anonymity and confidentiality offered - A statement emphasising that the participant is free to withdraw at any time without giving a reason - A statement of payment (where appropriate) - The name and contact details of the supervisor and the University of Manchester Research Governance office Consent letters from third parties – for e.g. letter/ s of support from educational or cultural institutions hosting your research, clarifying their willingness to host the research. Please append these to your applications and submit as a single pdf or word file. Application may be delayed if all relevant documents are not included. The consent form – asks participants to sign, giving their consent – it takes the form of a tick box list … Note – you do not need to ask for signed consent, although it is advised (provide a justification on the form if you are not asking for signed consent). You may also need to modify this to suit your project (e.g. Will you offer participants a choice of anonymity or being named? Or choice whether or not to be recorded?)
36 Letters from third parties and additional documentsIf you are conducting research within an external institution or a private company you will need to verify that you have their approval to do so. If you are conducting questionnaires or interviews, or if you are advertising for participants, these documents need to be approved by a committee (UREC or SALC) or by your supervisor. We realise that sometimes these will not be finalised at the time of application - near-complete drafts can be approved (although substantial changes will require further approval).
37 Final pointers …
38 Data Management (D3.3) All research projects now have to have a data management plan - outlining the storage and life cycle arrangements for any data collected New for this year – every researcher has to have a data management plan – under D3.3. of each form, there is guidance here. You send off for a data management plan number via the library, and submit a plan at a later date. For most SALC projects – this will be relatively simple description of what data is collected, how it will be stored, organised, shared …
39 When filling in the form:Be succinct – short, clear answers are more effective than long explanations. Don’t cut and paste wholesale from research proposals … Make sure your application makes sense to an interested layperson – avoid technical terms and jargon Be pragmatic – we need to know what you are going to do, why, with whom, when and where (we don’t need extended critical or theoretical explanation, however interesting this is!) PGR/PGT – you need supervisor approval prior to submission, and supervisors should help you draft the application
40 What happens after submission?Low risk – supervisor review and approval Medium risk – School ethics committee will review and respond within 21 working days. The applicant will receive an either confirming approval or asking for amendments High risk - UREC will invite the applicant to a committee meeting to discuss queries arising from the application (it takes up to 3 weeks to process a UREC application)
41 (PGR and staff applications reviewed/screened throughout the year)Deadlines (PGR and staff applications reviewed/screened throughout the year) Postgraduate students on MA programmes applying for ethical approval for Dissertation research must submit their applications by 14th March This deadline helps the School Ethics committee manage the high volume of MA applications. MA students applying for ethical approval for research activities taking place as part of a taught course can submit applications throughout the year
42 Useful links School Research Ethics webpages: University Research Ethics webpages: Training guides and videos are available on the ERM are available here -
43 Q&A Q&A Evaluation forms