Research Ethics Approval www.anglia.ac.uk about ethics and ethical procedures “isClarity important for Anglia Ruskin University because of our responsibility to participants in research. This guide provides a summary of the routes to ethical clearance for students its accompanying notes will be of help to undergraduate, taught postgraduate and undertaking research projects. As Chair of our Research Ethics Sub-Committee (RESC), I commend this summary to you. It is supported by a number of other documents which are listed on the following pages ” Professor Richard Andrews Deputy Vice-Chancellor, Research & Innovation It is important to remember that it is not just research which involves direct contact with human participants which requires ethical approval. Even if there is no direct contact with participants (e.g. sending questionnaires) the research needs ethical approval. Also, research which does not involve human participants, for example, research involving artefacts or which may have an impact on the environment may also require ethical approval. The checklist on the Research Ethics Application Form (Stage 1) covers the situations for which ethical approval is required. Notes about Research Ethics Review Procedure 1 All research conducted under the auspices of Anglia Ruskin University is subject to the same ethical review process . This includes research conducted by students on Undergraduate, taught Masters or Postgraduate research degree research on a consultancy basis. Research falls into green (low risk), amber (medium risk) or red (high risk) categories depending on the responses given on the Research Ethics Application Form (Stage 1). The red category can be either internal research or involving external bodies (NHS, Social Services, Ministry of Justice) whose approval we may accept as equivalent 2 to our own There are two types of ethics committee that approve research at Anglia Ruskin University. These are: • Faculty Research Ethics Panels (FREPs), which review higher risk research and • Departmental Research Ethics Panels (DREPs), which review lower risk research. All faculties have a FREP and DREPs, apart from Medical Science, which only has a FREP. Ethical approval by Research that falls into the green category does not require ethical review, but the Research Ethics Application 3 Form (Stage 1) must be submitted to the relevant DREP . Amber research requires light-touch ethical review only. Section 4 of the Research Ethics Application Form (Stage 1) must be completed and the form, participant information sheet and consent form (if applicable to the research) 3 submitted as a minimum requirement to the DREP . In some cases, further documents will be requested. Amber 3 research can be reviewed by two members of the DREP only as opposed to the entire committee, but these people must be independent of the research (e.g. the student’s supervisor cannot review the application). For research falling into the red (internal) category, Section 4 of the Research Ethics Application Form (Stage 1) does not need completing, but applicants need to submit this form, the Research Ethics Application Form (Stage 2) and all other documents they will be using in their research e.g. participant information sheet, consent form, questionnaire or interview schedule, poster advertising the research. The application must be reviewed by the application), these must be declared. For red (external) research the Research Ethics Application Form (Stage 1) and approval letters from the relevant external organisation(s) must be submitted as a minimum requirement. All applications must be sent by students to their Dissertation Supervisors/Supervisors, in order that they can check them. Supervisors then submit the applications to the FREP or DREP. Decisions of the FREP/DREP are: requested changes, which they then need to make to the application and resubmit. 1 apart from that involving animal subjects only when the animal checklist needs completing. See: http://www.anglia.ac.uk/ruskin/en/home/faculties/fst/research0/ethics.html 2 3 or FREP for Faculty of Medical Science. Research ethics review procedure for Anglia Ruskin University students Undergraduate and Masters students complete VLE-based ethics training and quiz https://vle.anglia.ac.uk/sites/non-mod/ethics1/Pages/Home3.aspx Research degree students complete training as per the Research Degrees Regulations http://web.anglia.ac.uk/anet/academic/ For Green applications, the student completes Research Ethics Application Form (Stage 1) and research ethics VLEbased training (undergraduates and masters students). For Amber research, the student also submits any additional documentation (participant information sheet, consent form etc). For Red (internal research) the student also submits the Research Ethics Application Form (Stage 2) and associated documentation. Student and supervisor discuss application. Supervisors submits application to FREP/DREP Risk category GREEN Risk category AMBER Risk category RED (Internal) Risk category RED (External) NHS/Social Care/Ministry of Justice Supervisor forwards application to DREP* Administrator Supervisor forwards application to DREP* Administrator Supervisor forwards application to DREP*@Administrator DREP Administrator logs application and informs DREP Chair DREP Administrator logs application and informs DREP Chair DREP Administrator logs application and forwards to FREP Administrator Referred to if higher risk DREP (Chair) checks a 2 Members DREP review sample of Green (must be independent Applications as a minimum e.g.not student’s supervisor) requirement DREP Administrator communicates outcome to student and supervisor FREP reviews be declared Supervisor forwards application to FREP Administrator to log, external approval letters to FREP when received & further documentation if Anglia Ruskin is acting as Sponsor OR both ethical approval from FREP/DREP and research governance review from the external organisation may be required –refer to Code of Practice for Applying for Ethical Approval. FREP Administrator communicates outcome to student and supervisor Feedback outcome to relevant DREP Logged by DREP Administrator KEY DREP = Departmental Research Ethics Panels FREP = Faculty Research Ethics Panel @ For FHSCE and LAIBS Red (Internal) applications are *Faculty of Medical Science does not have DREPs so all applications are sent directly to the FREP submitted directly to FREP Faculty Research Ethics Panel Chairs ALSS—Dr Sebastian Rasinger: sebastian.rasinger@anglia.ac.uk LAIBS—Dr Jonathan Wilson: jonathan.wilson@anglia.ac.uk FHSCE—Dr Sarah Burch: sarah.burch@anglia.ac.uk FMS—Dr Nigel Sansom: nigel.sansom@anglia.ac.uk FST—Dr Charlotte Nevison: charlotte.nevison@anglia.ac.uk Research Training and Ethics Manager—Julie Scott: julie.scott@anglia.ac.uk Beverley Pascoe on telephone number 0845 196 4211 or email address research.ethics@anglia.ac.uk Research Ethics Contacts Research Ethics Information Research Ethics Policy Code of Practice for Applying for Ethical Approval at Anglia Ruskin University Research Ethics Web-pages for Anglia Ruskin University ALSS—http://web.anglia.ac.uk/anet/faculties/alss/alss_research_ethics.phtml LAIBS—http://web.anglia.ac.uk/anet/faculties/laibs/Research/7_research_ethics.phtml FHSCE—http://web.anglia.ac.uk/anet/faculties/hsce/research-ethics.phtml FMS—http://ww2.anglia.ac.uk/ruskin/en/home/faculties/fms/research/ethics.html FST—http://ww2.anglia.ac.uk/ruskin/en/home/faculties/fst/research0/ethics.html Research, Development & Commercial Services (RDCS)—www.anglia.ac.uk/researchethics Other useful websites Association for Research Ethics—http://www.arec.org.uk/ Committee on Publication Ethics—http://publicationethics.org/ Information Commissioner (Data Protection Act, 1998)—https://ico.org.uk/ Human Tissue Authority—http://www.hta.gov.uk/ NHS Health Research Authority—http://www.hra.nhs.uk/ Social Care Research Ethics Committee—http://www.scie.org.uk/research/ethics-committee/ —http://www.ukrio.org/ Version 1.0 (March 2015)