QUESTION-SPECIFIC ADVICE FOR APPLYING FOR STAGE 2 ETHICAL APPROVAL
(Risk Category 3 or ‘Red’ research)
November2015
FifteenthEdition
Julie Scott & Dr Leslie Gelling
This guidance is aimed at Doctorate students and staff, but the process is the same for Undergraduate and Mastersstudent research, for students carrying out research at our Franchise Associate Colleges, our Research Institutes and for researchers on a Consultancy basis.
You also need to check the ethics page of your faculty website.
If you require this booklet or any of the research ethics documents in an alternative format (e.g. Braille, large print, audio, electronic), please contact Beverley Pascoe, Research Ethics Committee Secretary by telephone on 0845 196 4211 or emailat .
Table of Contents
Definitions / Page 5Faculties at Anglia Ruskin University / Page 5
Faculty Research Ethics Panels Chairs / Page 5
Faculty Research Ethics Panel Administrators
Research Ethics & Governance Manager / Page 6
Page 6
Applying For Stage 2 Research Ethics Approval / Page 7
Introduction / Page 7
Other Permissions / Page 8
FREP deadlines for applications / Page9
Question Specific Advice About Stage 2 Research Ethics Approval / Page 10
- Briefly describe the rationale for and state the value of the research you wish to undertake.
- Suitability/qualifications of researchers to undertake the research.
- What are the aims of the research?
- Briefly describe the overall design of the project.
- Briefly describe the methods of data collection and analysis.
- Describe the participants: give the age range, gender and any particular characteristics pertinent to the research project.
- If your participants are under 18 or vulnerable adults, please advise that you have obtained a Disclosure and Barring Service (DBS) check.
- How will the participants be selected and recruited?
- How many participants will be involved? For experimental studies, specify how the sample size was determined. In clinical trials, a power calculation must be included.
- What procedures will be carried out on the participants (if applicable)?
- What potential risks to the participants do you forsee?
- How do you propose to amerliorate/deal with potential risks to participants?
- What potential risks to the interests of the researchers do you foresee?
- How will you ameliorate/deal with potential risks to the interests of researchers?
- Has a risk assessment been completed?
- How will you brief and debrief participants?
- Will informed consent be sought from participants?
- If there are doubts about participants’ abilities to give informed consent, what steps have you taken to ensure they are willing to participate?
- If participants are aged 18 years or under please describe how you will seek informed consent?
- How will consent be recorded?
- Will participants be informed of the right to withdraw without penalty?
- How do you propose to ensure participants’ confidentiality and anonymity?
- Please describe which of the following will be involved in your arrangements for storing data?
- Will payments be made to participants?
- Modifications of proposal and extensions.
- (EXTERNALLY FUNDED PROJECTS ONLY). Has the funding body been informed of and agreed to abide by Anglia Ruskin University’s Ethics Procedures and standards?
- (EXTERNALLY FUNDED PROJECTS ONLY). Has the funder placed any restrictions on: a) the conduct of the research, and b) publication of results?
- Are there any further points you wish to make in justification of the proposed research?
Other points. / Page 27
Definitions
DBS checks Disclosure and Barring Service checks
DREP Departmental Research Ethics Panel
FREP Faculty Research Ethics Panel
RDCS Research, Development & Commercial Services
RESC Research Ethics Subcommittee
Faculties at Anglia Ruskin University
ALSS Faculty of Arts, Law & Social Sciences
FHSCE Faculty of Health, Social Care & Education
LAIBS Lord Ashcroft International Business School
FMS Faculty of Medical Science
FST Faculty of Science & Technology
Faculty Research Ethics Panel Chairs
ALSS Dr Oriola Sallavaci: email
FHSCEDr Sarah Burch: email
LAIBSDr John Salked: email
FMSDr Nigel Sansom: email
FSTDr Charlotte Nevison: email
Faculty Research Ethics Panel Administrators
ALSS Helen Jones: email
FHSCEClaire Mitchell: email
LAIBSKaren Smallwood: email
FMSJo Corney:
FSTSusan Short: email
Research Ethics & Governance Manager
RDCS Julie Scott: email
Applying for Stage 2 Research EthicsApproval
Introduction
Information and application formsrelating to the research ethics approval procedure are available on the Research, Development & Commercial Services (RDCS) website at:
These are aimed at research students and staff, but the same general process applies to undergraduate and masters students, students at our Associate Colleges, our Research Institutes and researchers employed on a Consultancy basis.
You should also consult the ethics page of your Faculty website.
If you are applying for Stage 2 ethical approval, you will have already completed the Research Ethics Application Form (Stage 1) and your research will have been classified as Risk Category 3or ‘Red’ according to the traffic-light system (which is Stage 2 Approval).
You will be applying for Stage 2 ethical approval from your Faculty Research Ethics Panel (FREP). Contact details for these can be found on the above website.
Your research project must comply with the ‘Research Ethics Policy’ for Anglia Ruskin University and ‘Code of Practice for Applying for Ethical Approval at Anglia Ruskin University’ (hereafter referred to as the Code of Practice) and any additional ethical requirements that apply in specific disciplines, organisations or countries with which you are collaborating, as well as professional codes of conduct and practice. It is also your responsibility to ensure that your research complies with the DataProtectionAct (1998)orequivalent and any other relevant legislation.
Research taking place in the UK must comply with the Data Protection Act (1998). If research is taking place in another country and personal data is NOT being transferred out of that country, it must comply with the data protection laws of that country. If research is taking place within the European Economic Area (EEA) it must comply with the laws of that country. Research data can be transferred back to the UK. If research is taking place outside of the EEA but personal data is being transferred back to the UK, it must comply with the laws of the country that the research is taking place in and also the UK Data Protection Act (1998). Please refer to Section 6.1 of the Code of Practice for Applying for Ethical Approval for more information about the Data Protection Act (1998).
A Risk Assessment must be completed for all Risk Category 3 or ‘Red’ research, unless advised otherwise by the Risk Management Department. Details regarding this can be found on the above website and also in the Code of Practice.
Failure to comply with our ethics procedures may be construed as misconduct or gross misconduct and dealt with by our Student Disciplinary Procedures or Staff Disciplinary and Dismissal Policy and Procedures, as appropriate.
This guidance provides some general information about applying for Stage 2 Research Ethics Approval and question-specific advice for completing the Research Ethics Application Form (Stage 2).
For Stage 2 approval, the documents you need to submit are as follows:
- Research Ethics Application Form (Stage 1)
- Research Ethics Application Form (Stage 2)
- A detailed projectproposal clearly outlining the research approach and methods to be used
- Participant Information Sheet
- Consent Form
- Any other documentation you will be using in the study e.g. questionnaire, interview schedule, recruitment posters etc.
- If applicable, the Questionnaire for Research involving Human Participants (Insurnace Questionnaire), which is on the RDCS ethics webisite and the response to this.
It is essential that you complete this questionnaire if your study falls into any of the categories defined in it. This is because your research may not be covered by Anglia Ruskin University’s existing insurance. Please note that the questionnaire must be completed for all research outside the UK involving human participants.
You must email the questionnaire, ethics application, proposal and other information about your study to Andy Chapman, Corporate Risk and Compliance Officer, at . This must be done prior to submitting your ethics application. You should submit a copy of the questionnaire and the response from Andy Chapman with your ethics application. If you are told additional insurance will be required for the research, please speak to your Supervisor/Line Manager/Faculty Director of Research (students) as a matter of urgency to establish whether your department/faculty will fund any additional costs that may be incurred.
Other Permissions
There are other permissions you need to consider whether you will require. Where there are standard documents for permissions, these can be accessed from the ethics section of the RDCS website –
Please note that this is only a general list. There may be further permissions or approvals required for your own field of research. These are:
- Risk assessment (must be completed for all Risk Category 3 or ‘Red’ research)
- Anglia Ruskin Travel and Insurance On-line Approval form
- Local ethical approval, e.g. if carrying out research in other organisations or outside of the UK (again, refer to the Code of Practice)
- Written permission from organisations you are carrying the research out in (this will always need submitting with your ethics application or to the ethics committee prior to starting your research. Please refer tothe Code of Practice)
- Equipment checks (please refer to the Code of Practice)
- Disclosure and Barring Service (DBS checks – formerly CRB checks). Students can access information about the processs for this via:
Staff will need to speak to HR Services.Please note that copies of DBS checks should NOT be included with your ethics application.
- Research visas, permits or other permissions if carrying out research overseas
- Intellectual property agreements (please see the Code of Practice)
- Other legal agreements.
FREP deadlines for applications
Applicants need to look at the relevant faculty web-page about committee meeting dates and deadlines or seek advice from their FREP Administrator.
Question Specific Advice for Stage 2 Research Ethics Approval
1. Briefly describe the rationale for and state the value of the research you wish to undertake.
- The rationale for your research should be grounded in existing research and the literature. Using this material, you should convince the ethics committee that the research is worth doing and that the methodological approach being used is the right one to answer the research question.
- Care should be taken to avoid statements such as ‘this very important research’.
- Clearly state any possible benefits, direct or indirect, to your research participants.
- If there are no clear benefits to your research participants you should also state this. In these circumstances, it is not uncommon to explain how others, including future patients/users, could benefit from the knowledge and understanding that might be gained through the research.
- You should not make claims that cannot be substantiated.
- If there is any potential intellectual property arising from your research, you should confirm that all agreements have been signed. For further information regarding intellectual property, please look on the RDCS website:
After consulting the website, please contact Julia Marsh (Strategic Initiatives and Commercial Projects Manager, Research, Development and Commercial Serviceson email address ) if you need any further clarification.
2.Suitability/qualifications of researchers to undertake the research. Please give details of any internal or external ethics training you have participated in.
- Please note that research ethics training is compulsory for all Doctoral candidates and their Supervisors, as stated in the Research Degrees Regulations. Please refer to the Research Degree Regulations, 15th Edition, September 2014, for further information. This is Section 3.8 to 3.10 for Doctorate candidates and Section 7.7 for Supervisors.
- There is also compulsory training for all undergraduates and masters students and their supervisors. There is a quiz at the end which must be succcessfully completed and the confirmation of completion submitted with your ethics application. To access the training, please go to:
- You should demonstrate that the researcher(s) has/have the research and practical/clinical experience required to complete the research. There are some restrictions on who can use psychological measures, for example. The researcher should also be experienced and have appropriate training in the use of any equipment used during the research. In addition, the researcher must ensure that any equipment has undergone any necessary safety or other checks.
- If working with any particular groups (for example, people with mental health problems or children), you must demonstrate that you have sufficient previous experience of working with this particular group of people. You must ensure that anyone 16 years of age or over does not fall under theMental Capacity Act(2005). Please note that people may fall under the Act as the result of short-term conditions, such as the effects of alcohol or shock, as well as enduring conditions such as learning disabilities or mental health problems. The emphasis of the Act is on capacity (supporting people to make decisions) rather than lack of capacity.
- If you, the lead applicant, do not possess the necessary qualifications and experience, you should demonstrate how you will be supported in your research and by whom. For student research, your Disseration Supervisor/Supervisor should be able to provide this support and must be appropriately experienced.
- You should include information about all members of the research team.
- Any other collaborators (for example, statisticians) should also be listed.
- You should demonstrate that the researchers are familiar with relevant legislation, including the Data ProtectionAct(1998),the Medical DevicesRegulations (2002) as amended,the Human Tissue Act (2004), the Human Tissue (Scotland) Act (2006), the Mental CapacityAct (2005)and the Medicines for Human Use (Clinical Trials) Regulations (2004) as amended. You should be aware that different legislation may apply in each of the countries which constitute the UK. If carrying out research outside the UK, it is your responsibility to be aware of and comply with any laws of that country relating to research.
- You should be aware that some forms of research will require that you seek an ethical opinion from an appropriate NHS REC or the Social Care Research Ethics Committee, even if the research does not involve the NHS or social care. The website for the Social Care Research Ethics Committee is:
- Research that falls under the Mental Capacity Act (2005)can only legally be reviewed by an NHS REC or the Social Care Research Ethics Committee.
- If research involves human tissue or samples and does not come under the conditions of Anglia Ruskin University’s research licence from the Human Tissue Authority, it can only be legally reviewed by an NHS REC. For further information regarding whether your study will fall under our licence please contact Matt Bristow on email address
- If your research falls under the Mental Capacity Act (2005), Human Tissue Act (2004) or any other legislation you need to be familiar with it, in order that you plan your research to comply with all parts of it.
- Should you be proposing research that involves a medical drug, device or intervention, please contact Michael Harrison, Director of the Anglia Ruskin Clinical Trials Unit on email address .uk in the first instance, with details of your study.
- If there are any conflicts of interest, you must state what these are. These should also be stated in the participant information sheet.
3. What are the aims of the research?
- You should clearly state the aims of your research. These should be kept to a reasonable number and you should be mindful of the time and resources available to you.
- You should state what the principal research question and objectives are and also include any hypotheses that will be tested, if applicable.
- Do not be too ambitious in setting aims and objectives for your research. It is important that these can be achieved in the time available to you, especially if you are undertaking a student project.
4. Briefly describe the overall design of the project.
- The ethics committee will need to be convinced that you have given due consideration to the design of your research. Based on the principle that ‘bad science is bad ethics’, it would be unethical to undertake any research that is not well-designed.
- The design should be realistic within the time and resources available to you.
- You should justify your choice of design. There may be reasons, including practical constraints, why you need to use a less robust design, but adequate justification for this must be provided.
- If you were required to obtain a power calculation for your research you must be reasonably confident that you can obtain the required number of participants.
- You should explain how you would deal with any problems that might arise during the course of your research. For example, what would you do if you found it difficult to recruit a sufficient number of participants?
- You should give careful consideration to whether a pilot study should be undertaken. If carrying out a pilot study, you must obtain ethical approval for this. Should you make any changes following the pilot study, these need to be submitted to the ethics committee for approval.
- If you are designing a questionnaire, it is advisable that you undertake a pilot study to ensure that the questions and instructions are clear.
- If you are seeking data through an anonymous questionnaire, you would still have a participant information sheet, but informed consent can be implied by the return of the completed questionnaire and an informed consent form will not be required. It is good practice, however, to include a box that participants can check to confirm that they have read the participant information sheet and understand the requirements of the study.
5. Briefly describe the methods of data collection and analysis.