This document is an informal guide, which does not override formal documentation. It is meant as a handbook for all eventual questions researchers might have about the process of review and aspects of consideration involved.
Throughout 2020, HAPP SREC in cooperation with SRECs representing other AHSS Schools, have been assessing the changing needs of researchers in the permanently changing social environment. The sets of documents produced by individual schools’ research committee, particularly SSESW and AEL, have been informing the details in this document.
All further documentation can be found on SharePoint, here. The SharePoint documentation is also linked from the School Home page, under individual disciplines, Research: Research Ethics.
Why ethical approval of Research?
All research involving human participants is subject to ethical scrutiny and requires ethical approval. The guidance notes below are designed to help you to consider ethics application in the context of the wider requirement affecting all researchers, that is integrity of research.
The SREC is guided by the University’s Research Governance policies and procedures which provide further detail regulations. Researchers must be familiar with the University Policy on the Ethical Approval of Research. They are also required to adhere to ethical guidelines for educational and social science research such as those of the British Educational Research Association and other professional bodies, such as the British Anthropological Association.
- What is the role and remit of the SREC?
The SREC’s role is to examine ethics applications. In order to give ethical approval, the Committee must be confident that
- Methods for data collection correspond to research aims;
- The participants are taking part willingly and knowingly, and
- Care and foresight will be applied when storing of the information collected.
Where necessary the SREC will request adjustment to research plans to ensure integrity of research and ensure it is ethically acceptable. Unless there is a clear implication of data collection methods for the integrity of your research process, and therefore on the ethical dimension of your research outputs, the SREC will not comment on the content or research methods-related details of a proposal.
- Are applications to the SREC required for ALL research projects?
Ethics applications must be submitted for all empirical research projects involving human participants, their material or data. You do not need to apply for ethical approval in the following circumstances.
- Your research does not involve human participants, their material or data.
- Your research only involves the secondary analysis of publicly available anonymised datasets (e.g. as administrative datasets). However, you (or your supervisor if you are a student) must inform the Ethics Committee via the SREC administrator, XXX if you plan such a research project.
- Your research targets patients (or their relatives or carers) or other users of health and social care services, or access to personal records. In these circumstances, ethical approval must be obtained from a National Health Service Research Ethics Committee (NHS REC) and/or Health Trust REC.
- When should I apply for ethical approval and how long does the process take?
You must apply for ethical approval in advance of beginning any research activity involving the collection of data from or about human subjects. The SREC cannot give retrospective approval. Please allow as much time as possible for the ethical review process – do not leave this until the last moment. Ideally you should apply at least six weeks before the date on which you intend to begin the research, to give some leeway (and further in advance if the timing of your application coincides with a holiday period or a particularly busy time in the academic calendar).
- What type of research is reviewed by the SREC?
The SREC can review projects in category A, “Those being conducted by staff (or students under their supervision) involving human participants (their tissue or data, including commercially purchased human material), but excluding NHS/HSC patients, patient records and NI Prison Healthcare Service. Any clinical trials of medicinal products or devices are also excluded from this category.” If your project does not fall into category A please check the information on the Research Governance webpage about the review routes for projects in categories B, C, and D. If in any doubt, please consult the Ethics Chair for guidance.
How does the process work?
I am a member of academic staff. How do I submit a project for ethical review? What exactly do I need to submit?
After completing the ethics application form as comprehensively as possible, please submit it by email to the together with any other relevant documents to be used in the project (recruitment letter, participant information sheet(s), consent form(s), draft research instrument(s) such as survey/questionnaire, focus group or interview schedule, etc., as relevant), and any other supporting material. The SREC needs to review all relevant documents as part of an application and review cannot commence until these have been submitted.
- I am a member of academic staff involved in supervising student research. What do I need to do to ensure university ethical procedures are followed?
Supervisors of student research (whether UG, PGT, or PGR) must ensure that their supervisees are aware of and design and conduct their research in line with university ethics policy. Supervisors should also, where necessary, inform their supervisees of the various opportunities for research ethics training both within and outside the School. Once your student’s project has been approved you are also responsible for uploading details to the University’s Insurance database – see below.
- I am a student. How do I apply for ethical approval for my research project?
You must discuss your ethics application with your supervisor and seek their guidance and review when completing the ethics application form. They will supply you with the required forms and need to approve and sign the forms prior to their submission. You should ensure your supervisor(s) is/are copied in on all correspondence relating to research ethics. For PGT students, your supervisor should be the one to submit the application to the Chair, copying you. Whilst PGR students may submit forms themselves, they must copy their supervisor(s) on all correspondence relating to ethics.
As in the case of staff applications, students must complete the ethics application form as comprehensively as possible and submit it along with any other supporting documentation (recruitment letter, participant information sheet(s), consent form(s), draft research instrument(s) such as survey/questionnaire, focus group or interview schedule, etc., as relevant). The SREC needs to review all relevant documents as part of an application and review cannot commence until these has been submitted. If you are a student, your supervisor has overall responsibility for your project.
- Where can I find details of University policy on research ethics?
The QUB Policy on the Ethical Approval of Research is available on the main QUB website at http://www.qub.ac.uk/Research/Governance-ethics-and-integrity/Ethics/. Some additional policy documents, including the QUB Regulations for Research Involving Human Participants, and the recently developed QUB Principles for Human Participant Research during COVID-19 Pandemic, are available at http://www.qub.ac.uk/Research/Governance-ethics-and-integrity/Policies-procedures-and-guidelines/. Please read and familiarise yourself with these policies prior to making an ethics application.
- Where can I access the ethics application form in use in AHSS? Are templates for participant information sheets and consent forms available?
The SREC ethics application form is available on Sharepoint under School of HAPP / Research Committee / Research Ethics Committee / Forms and Regulations, here.
In the folder, we have also included similar forms from SSESW and AEL which provide annotations to give advice on how to complete it – please do follow the advice as closely as possible. The same folder also contains guidance for participant information sheets and consent forms and a template for the latter. Please note these are templates only, and are in use across other AHSS schools.
The HAPP SREC adapted the policy of transferring the details from your submitted application document into the Participant Information Sheet. Please note that only academic staff have access to this folder. Students need to request the forms via their supervisor, who must also oversee their completion and submission.
What documents do I have to submit with my SREC application?
You must provide evidence that the prospective research participants have been fully informed about the purpose of the research and their role in it, how their data will be gathered, the purposes to which their data will be put and how their right to privacy (confidentiality and anonymity) will be respected. Throughout the application process, you will need to submit an application in a given format and (at least) three additional files
- Description of Research Procedures, including a sample of your research instruments (interview questions), or in case you have not prepared a final version of it, a sufficiently detailed draft;
- Participant Information Sheet;
- Consent Form.
- What constitutes Description of Research Procedures?
You have to annex a description of the research procedures for distinct methods of data collection involved in your research (e.g., a description of the interview procedure and description of your focus groups procedure). We are looking to see that your research procedure maps well onto the proposed methods of data collection, particularly those involving human participants, that these are legitimate in the light of your research aims, are appropriate in the context of the research design, and have been chosen after systematic exclusion of other methods of data collection (eg secondary data analysis).
Survey questionnaires, interview schedule, group discussion or observation schedules all constitute research instruments. You are required to attach a detailed description of each of the procedures of your research (e.g., if the research involves a questionnaire, explain the rational for the use of the sampling procedure in the form proper). If a mixed-methods design is used, the information sheets usually offer information on procedures of data collection on each of these separately.
You have to annex separate lists of questions you intend to ask of your research subjects. (e.g., a list of interview questions, if your research involves interviews). If at the time of submitting your application for ethical approval you do not have the final version of questions (e.g., you may not have the final version of the interview schedule, or phrasing of interview questions), you have to provide at least a good sketch of the procedure (e.g., of the types of questions that will be used in the interview).
There may be components of your methodology that don’t need ethical approval (e.g., interpretative analysis of publically available information, access to and referencing freely accessible sources, meetings with individuals to assess the background information for your research aims). You don’t need to annex a description of these components.
- What should be included on the Participant Information Sheet?
HAPP SREC discourages you from issuing your own participant information sheet; rather the information you provide to SREC will be used to populate your PIS. Many of the sections of this ethics review application form have separate items. When filling out the form, it is mandatory that you address each of the items separately. If you think an item is not applicable to your research, please state so in your own words, explaining why this is not the case, rather than writing "N/A". Since this information will be fed into the Participant Information Sheet verbatim, it is essential that you highlight in your own words to your research participants that you have considered each of the elements.
The information you will provide on the Research Ethics Application form will be both inward and forward looking: Inwardly, it will be used by the REC to assess the integrity of your proposed research methodology against your research aims, as well as your research design which you need to provide separately. Outwardly, the form collects information which will be automatically fed into the Participant Information Sheet (the relevant sections are marked as such). Hence, we ask you to use accessible language that can be understood by your research subjects.
- What should be included on the Consent form(s)?
If different levels of consent are required – e.g. parental/guardian; gate keeper/institutional (e.g. school) and child - information sheets and consent forms are required for each level. Written active (opt in) consent is regarded as good practice for all participants. However, applicants can make a case for verbal and/or passive consent (opt-out), if they feel this is required. For survey research with adults aged 16 years and over who are capable of informed consent, participation in the survey is implicitly regarded as informed consent, and separate consent forms are not required.
You will find the template for your Consent Form at the end of the Form document; you will need to amend the details of your project/names of investigators with the details inserted in the Research Ethics Application Form. Please collate all the documents into one file; also, please refrain from reformating the document or splitting it into separate files. REC will retain these documents for the record and accountability.
At the end of your submission, you will find the template of the approval form. Please pre-fill this form as well. This already contains information on the further steps you need to undertake to file the record of your work with the QUB Research Data base.
Both, Participant Information Sheet with the adjoined Consent Form will need to be supplied your research subjects before commencing the interview/fieldwork.
Can I submit any further relevant supporting documents?
We require all students submissions to have been reviewed by their supervisors. Both student and staff, should attach confirmation of institutional approval, if available, or evidence of peer review of your project methodology. Peer review is a critical review of methods and design-related issues of your study by your colleagues with the aim to improve the study design, where necessary. The university expects peer review to be undertaken for each research project involving humans and their data before it commences.
When you apply for ethical approval, you must therefore provide evidence that peer review has taken place. However, it is not the responsibility of the SREC to provide this peer review. Except for the three cases below, SREC applications must have completed Peer Review :
- If a competitive research funding application process (e.g. Research Council applications) has taken place which involves peer review.
- For Doctoral students, if a successful completion of the differentiation (or annual progress review (APR) where no differentiation is required) has taken place, at which the research design was discussed and approved. Please provide evidence for successful differentiation/APR.
- For undergraduate and Masters students peer review is completed through supervision arrangements. Student supervisors confirm with their submission of the SREC application that they are content with their student’s study design.
- What is the process for ethical approval for research undertaken abroad?
Queen’s University expects research undertaken abroad to adhere to the same ethical standards as in the UK. However, cultural sensitivities of the host jurisdiction must also be observed. Any additional regulations (e.g. for example police clearance, where this is required) must be adhered to.
- What do I have to do to be GDPR compliant in my research?
Any research which involves human participants or involves information relating to individuals will be subject to data protection legislation. It is essential that your research complies with data protection laws and you are advised to review the Guide to Handling Personal and Sensitive Data - Research and ensure that your research complies with the University’s Data Protection Policy. It may be necessary to conduct a data protection impact assessment where you answer yes to any of the screening questions. A DPIA can be competed .
The General Data Protection Regulation (GDPR) is an EU-wide law which came into force in May 2018 and regulates how personal data can and should be accessed and handled. There are six legal bases for accessing and processing personal data. One of these legal bases is that an individual has given clear consent that you can process their data. We normally expect that clear informed consent is in place before a data collection can commence.
It is essential to be clear what the consent is for and to include consent for all possible further uses of the data (e.g. secondary data analysis, if this is planned, data storage, passing on of personal identifiable information to research collaborators, etc.). Under certain circumstances, the ‘public task’ basis may also apply to your research. This means that if a research project is deemed to be in the public interest, then you may also process personal data. This may apply if a study is funded by government, for example. In these cases, evidence must be provided that prior informed consent from participants cannot be sought.
Note: GDPR only applies to personal identifiable data, so anonymised or de-identified data is NOT personal data and GDPR does NOT apply.
- What should I do if my project involves work with children or vulnerable adults?
Research involving children and/or vulnerable adults must be given particularly careful scrutiny and will therefore always undergo full, formal ethical review (for QUB’s classification of vulnerable groups, see the Glossary on page 12 of the Policy on the Ethical Approval of Research). If you are planning to work with children, please ensure you include an additional description outlining procedures of participant selection and reflecting on process of accessing parental consent.
Research involving children and/or vulnerable adults may also constitute a regulated activity, in which case additional steps need to be taken. Work of this kind falls under the University policy on Safeguarding Children and Vulnerable Adults (see information in the Ethics Forms folder on Sharepoint as well as on the main university website at https://www.qub.ac.uk/directorates/HumanResources/legal-services-and-employee-relations/, under Safeguarding Children and Vulnerable Adults). It is the School’s responsibility to identify regulated activity affecting children and vulnerable adults and to ensure appropriate checks are conducted prior to any such activities. Staff/students who require an Access NI check should contact the School Manager for information on how to proceed.
When making an ethics application for a project involving work with children or vulnerable groups you must include relevant information in your ethics application form and explicitly confirm that the necessary permissions are in place (these will vary according to your project but it is your responsibility to establish what is required and provide information about this in your ethics form). The SREC Chair will also refer any applications involving this type of participant to the School Manager for a check, prior to commencing the review process.
- What do I need to do after receiving positive decision from the SREC?
It is the responsibility of the principal investigator /the student supervisor to add any research projects involving human participants, their material or data to the University’s Insurance Database, which is accessible through QOL under ‘My Research’. If you fail to do this, you are not insured in case anything goes wrong during the fieldwork.
- What impact has the Coronavirus pandemic had on ethical approval processes?
- What are the ethical implications and requirements for research using online methods of data collection?
If you are thinking of alternative approaches for your research or that of your students, then it would be advisable to consider how you/they could adapt your/their plans to be able to proceed without the need to gather data from human subjects in person/undertake travel at this time. If data from human subjects is essential for your work or that of your students, and you wish to consider online rather than face-to-face methods of data collection from or about human subjects please be aware that these still require ethical approval to be in place before beginning the work. The only exception to this foreseen in the QUB Policy on the Ethical Approval of Research is if so-called “big data” is provided to the researcher in an anonymized format (see section 2.7 of the document, on “Big Data”, which is available at http://www.qub.ac.uk/Research/Governance-ethics-and-integrity/Ethics/).
The University does not yet have a more detailed ethics policy for research conducted online including data collection via/from social media, but this matter is currently under consideration. One general resource which is very useful as a starting point is the material produced by the Association of Internet Researchers’ Ethics Working Committee: http://aoir.org/ethics/. The Ethics Forms folder on Sharepoint also has a link to a crowdsourced resource on online research ethics which may be of interest. Please contact the Chair of the SREC if you have any queries about this type of research. You should always err on the side of caution.
- What advice is available on using digital platforms for interviews or focus groups?
If you are proposing to use an online platform for interviews or focus groups (via video or audio calling) then please ensure you provide some context in your application on the reasons for your informed choice of a given platform in your application, showing that you have thought this through and are aware of and have addressed any relevant issues in your project design. Please be as specific and detailed as possible.
You are advised to use an encrypted platform for any online research interaction if possible. The platform supported and advised by the University is Microsoft Teams, which can also be used to interact with people outside the University. Zoom is considered restricted and if you wish to use it, or a different platform, in your research project you should provide justification for why it is the most appropriate tool in the context of your proposed research interactions, and any precautions that will be put in place to protect your participants’ data. We have been advised that when using Zoom the meeting/researcher host must ensure that a unique meeting with access code is organised and that participants are ‘admitted’ to the meeting individually. Neither Teams or Zoom should be used for recording purposes unless this has been explicitly stated to those participating and it should be made clear to all participants they are not allowed to record the meeting. Further advice on this type of research context may be forthcoming from the University and will be made available if that is the case.
- What advice is there on using electronic surveys or questionnaires?
If using this method is important that there is a consent statement at the start of the survey and some mechanism to collect active consent e.g. a box that must be ticked before the survey itself can be completed. There is some brief information about surveys on the FAQ page for researchers (https://www.qub.ac.uk/home/coronavirus-faqs/researchers-and-funding/, under "how do I collect consent from my participants if I am using an online forum"): "For surveys, the consent process can be captured as part of the response. Build a consent statement into the preamble at the start of your survey and make sure that it is explained that the participant can withdraw and exit at any time, however, data already collected may well be retained and used." [N.B. We'd always ask people to state a concrete date for withdrawal rather than "at any time".]
We suggest the following information be provided at the start of any online survey: context and information on survey at start including who is undertaking it and in what context (if by a student state level of study, name of course, and give both student and supervisor names and contact details); what the survey’s aims are; a clear statement that participation is voluntary; clarity on how data will be stored and used (refer to anonymous use in dissertation, secure encrypted storage on QUB servers); and a tick box confirming participants are 18 or over and agree to take part. It should not be possible to proceed with the survey unless this box is ticked.
For surveys, consider what information can be given on withdrawal arrangements (if indeed this is possible once the survey has been completed and submitted given the anonymous completion); participants need to be clear on this before taking part. Consider if it is possible to make questions optional or provide a statement at the start stating that it is not obligatory to answer all questions. Alternatively consider if it would be relevant to include the option 'prefer not to say' for all relevant questions. In the ethics application, clarify if the survey platform to be used collects IP addresses.