Ethics A - Z : How to apply for research ethics review : ... : Research : Staff : ��ܽ��Ƶ

Action research – Action research is a philosophy and methodology of research generally applied in the social sciences. It seeks transformative change through the simultaneous process of taking action and doing research, which are linked together by critical reflection. Often this process comes with its own ethical challenges which you should explore as part of your ethics application.

Animal Research - All research involving animals requires review by the Animal Welfare and Ethical Review Body (AWERB). Applications should be submitted to the AWERB direct – see How to apply for review from the AWERB.

Anonymity – see also Confidentiality and Anonymity

True anonymity refers to data collected from respondents who are completely unknown or unidentifiable to anyone associated with the data collection (such as in an anonymous survey where there are no possible identifiers so only the respondent knows that he or she participated in the survey, and the survey/researcher cannot identify the participants.) See also: Personal Data; Confidentiality and Anonymity; and Pseudonymisation.

Amendments - if your previously approved research protocol or the dates of your research require an extension then you will need to resubmit your application with these amendments. You can do this by logging into Sussex Direct, going to the 'research' tab and scrolling to 'ethical reviews'. Click on the application number of the application you want to amend:

Open the original application, and click on “copy”
Change the title "AMENDMENT TO ER/... [insert title]"
Ensure that the project description clearly outlines the proposed changes (you can delete the rest of the project description)
Ensure that all new or amended materials are attached

Approval - You should not start your research until you have been granted ethics apprval by the SREO or C-REC as it will not be covered under the university's insurance. Upon ethics approval you will receive a certificate of approval via Sussex Direct that will state the start date and end date of your research. If you require an extension to your research dates you will need to submit an amendment stating the new date of completion via Sussex Direct. (See also Conditional Approval)

Audio recording - When recording a participant interview you need to make sure this data is not held on a personal device such as your smartphone and is instead on a separate device such as a digital audio recorder that has a secure password. The resulting file/files should be removed and deleted from the device and kept securely in University approved research storage (One Drive or Box).

If you are recording an on-line interview meeting via Zoom or Teams you should store the recording in your One Drive or Box account. It is worth noting that Teams has a transcription function you can activate at the start of a meeting. For further details see ‘Transcription services’.

Consent: If you have not obtained consent (either in writing/or electronically) prior to the interview, you should seek verbal consent from the participant having first read out to them the information written in your Verbal Consent Form. This should be done in a separate recording to the interview to ensure that personal data and de-identified data can be stored separately.

Audits - The C-RECs review a small number of studies through light touch audits of previously approved studies. Further details can be found on http://www.sussex.ac.uk/staff/research/governance/erp_overview/ethicalreviewaudits

Autoethnography - Autoethnography is a form of qualitative research in which an author uses self-reflection and writing to explore anecdotal and personal experience and connect this autobiographical story to wider cultural, political, and social meanings and understandings. If you are considering this kind of research, you are advised to consider your own well-being during the research process as often this process can bring up difficult or complex emotions. You should make time to check in with your supervisor during the auto ethnographic research process and consider the support that is available from student services. More information on ethnograpy within anthropology can be found here https://ec.europa.eu/research/participants/data/ref/h2020/other/hi/ethics-guide-ethnog-anthrop_en.pdf

AWERB - The AWERB (Animal Welfare and Ethical Review Body) (see also Animal Research above) has oversight of research undertaken or involving animals. This ranges from work that comes under the legislation and regulations of the Home Office to observation in the field or activities involving domestic animals or insects both on or off campus. Please contact AWERB@sussex.ac.uk with any queries.

Blanket/Generic Module Approvals - Course/module convenors may apply for generic or 'blanket' ethical approval for modules where a number of UG or PGT students are going to be conducting research that involves either:

a cohort of students undertaking the same research exercise involving human participants, eg low risk training exercises as part of an educational programme, such as a research methods course; or
students undertaking slightly different research projects (within the umbrella of the module) that are low risk and of a sufficiently similar nature to be reviewed together.

The course/module convener submits a single application to apply for ‘blanket’ ethical approval for the students enrolled in the course. The process for this is outside the on-line Sussex Direct system by way of a manual Generic Research Ethics Application Form or the with review and approval required from the SREO and the C-REC Chair. Once the SREO has approved the form, the application is sent to the Chair for final authorisation (who may allocate the application for review by a C-REC member).

A certificate of approval will be provided to the applicant: approval is valid for one year only as all generic approvals require annual renewal. (C-REC Guides)

Box - is the University’s file sharing platform. Staff and PG research students can store an unlimited amount of files and data by logging onto box.com with a University account.

Children – see also: Children in school settings: Disclosure and Barring Service (DBS); and Safeguarding

Children are defined as those aged under 18. Children who have not yet attained their 16th birthday will require someone else (parent/carer, Headteacher in loco parentis) to consent to their participation in research: ie informed consent for research with children under 16 must also be obtained from those with parental responsibility for them in law. For children aged between 16 and 18, the ethical review process must take into account the context of each research project and whether the young people involved can be expected to have sufficient understanding to make an informed choice. Informed consent from children and young people should be actively and directly sought using communication methods that maximise their understanding of the research.

Research involving children will need particularly careful consideration regarding establishing and monitoring consent, the role of gatekeepers, the use and communication of findings and the potential disruption (emotionally or practically) caused by the research itself.

Researchers working with children also need to consider whether they need a safeguarding protocol for their application. This is unlikely to be necessary for whole class-based testing in schools for example, where a teacher will be present, but must be considered for any research entailing one-to-one testing or focus groups / interviews discussing issues that could lead to disclosures that might raise concerns. In such cases it is important to explain the limits of confidentiality as part of the consent procedure.

A safeguarding protocol is essential if researchers are visiting children in their own homes or anywhere else where there is not an institutional (such as a school, charity) policy in place. The University’s Safeguarding Policy can be found at Safeguarding Policy [DOCX 143.25KB].

Depending on where and how you are conducting your research you may need a Disclosure and Barring Service (DBS) check before you may collect data. DBS checks are to prevent unsuitable people from working with vulnerable groups, including children, and are managed by the government’s Disclosure and Barring Service. For further information see Disclosure and Barring Service (DBS).

For further guidance on research with children see the following resources produced by the School of Psychology and the School of Education and Social Work:

School of Psychology: Health, safety and ethics page Child Research Guidelines (on the list of the right hand side of the page)
School of Education and Social Work

For guidance on research involving children in schools see the University’s Guidance for obtaining consent for research with child participants in schools.

Children in school settings – see also: Children; Disclosure and Barring Service (DBS) and Safeguarding

If you are planning to conduct research with children in schools you must refer to the University’s Guidance for obtaining consent for research with child participants in schools and prepare your ethics application in line with this guidance.

It is important to remember that although you may approach schools for an ‘in principle’ agreement to take part in research, the formal acceptance by the head-teacher (or similar) that research can take place within a school can only occur after C-REC ethical approval has been granted and the relevant supporting documents provided.

The default position for research involving the primary data collection from participants aged under 16 years in schools should be ‘opt in’ and parent/carer permission procedures to be used unless you can justify using alternative procedures. This does not mean that research involving children and young people in formal educational settings is automatically treated as high risk research, rather that research and your ethics application must address procedures for obtaining permission from parents/carers and children and young people.

Situations in which ‘opt out’ parent/carer permission procedures may be permissible include group testing/data collection on topics included on the standard school curriculum or class observation (such as that undertaken in the course of teachers continuing professional development or similar). In such cases, Head Teachers must register their agreement to allow the application of ‘opt out’ parent/carer permission procedures.

'Opt-out' may be applied in cases where:

Head Teachers are made fully aware and give their explicit permission
All parents/legal guardians of children involved are informed directly and given a full explanation/justification of their decision
The continuous, informed consent from the child remains paramount in all conditions
The impact/benefit etc. of the research to the child, school, are made explicit.

If the demands of children's participation:

are likely to entail a risk of distress or discomfort (however moderate or transient);
are sufficiently burdensome and/or intrusive that children are likely to need assistance from parents/carers in deciding whether to take part; or
are likely to be a cause of concern to parents/carers

Then “opt in” parent/carer permission should be obtained in all but exceptional circumstances

In cases where any of these criteria apply, but where the researchers feel that “opt in” parent/carer consent is not ethically appropriate, a case must be made for alternative procedures in the application to the C-REC or SREO that approved the research in the first instance. If researchers are unsure as to whether “opt out” parent/carer permission procedures may be permissible, then they should contact the Chair of the relevant Cross-School Research Ethics Committee (C-REC) or the University’s Research Governance Officer prior to submitting their application for ethics approval.

Although the University is not in a position to direct individual schools’ policies and practices, if the C-REC or SREO that approved the research in the first instance concludes that “opt in” parent/carer permission should be obtained, then this approach should be used, even if schools express a preference for use of “opt out” procedures. Whilst some schools (such as boarding schools) may act in loco parentis, the researcher should ensure that they understand clearly the limits of such responsibilities.

In all cases, school-children must be aware that data collected for the purpose of research will in no way impact on their grades and (where possible) that those not participating in the research are able in some way to obtain or benefit from the research.

As a principle no child should miss out on an important aspect of their education as a result of taking part in the research. However, a further difficulty can arise when a research study stresses the possible benefits to be gained by taking part in the research. So, for example, if one class group take part in a research activity that brings about some benefit, it is unfair that class groups in the same year do not have equal access to these benefits. It is suggested therefore that if the research takes place in one group, at some point the same opportunity (or equivalent) is offered to others.

For further guidance on research with children see the following resources produced by the School of Psychology and the School of Education and Social Work:

School of Psychology: Health, safety and ethics page Ø Child Research Guidelines
School of Education and Social Work:

Clinical Trials/ CTIMP - Clinical trials are medical research studies involving people to test whether different treatments are safe and how well they work. They are also known as Clinical Trials of an Investigational or Medicinal Product (CTIMP). All CTIMPs require Sponsorship and the approval of a recognised Research Ethics Committee (REC) and the Medicine and Health Regulatory Agency (MHRA). For details on Sponsorship see the Research Sponsoship page.

Code of Practice for Research - The Code of Practice for Research sets out general rules and guidance for the conduct of research at the university and provides the framework for the University’s other research policies and guidance.

Coercion - Where a relationship exists between the researcher and participant (e.g. employees, patients, students) careful consideration as to the nature of consent is required. This relationship must not be allowed to exert pressure on people to take part in or remain in an investigation and the potential for a power relationship to bias the data should be considered. Willingness to volunteer may also be unduly influenced by the expectation of benefits or rewards.

When research is being conducted with detained persons (e.g. prisoners) particular care must be taken over informed consent, paying particular attention to the special circumstances that may affect the person’s ability to freely and voluntarily give informed consent.

People volunteering to participate in research may be paid for their inconvenience and time. Payments made to individuals must not be so large as to induce the individuals to risk harm beyond that which they would usually undertake. Financial payments might cover reimbursement for travel expenses and / or time. Risks resulting from participation must be acceptable to participants even in the absence of inducement.

(The promise of compensation and care for damage, injury or loss of income as a result of participating in research activities to participants should not be considered coercion by inducement.)

Complaints - In a Participant Information Sheet it is good practice to provide contact details should the participant wish to raise a complaint. Typically for student research this will be the supervisor. For all other research it will be the Research Governance Officer (rgoffice@sussex.ac.uk) or the Chair of the relevant C-REC: SS Arts Sci-Tec

Conditional Approval This means that the application is approved but that the applicant has certain conditions (such as minor corrections to supporting documents, or the obtaining of a DBS certificate for example) that need to be fulfilled as part of the approval. The application does not need to be resubmitted once the conditions are met as it has already been approved.

Confidentiality and anonymity – (see also: Personal Data and Pseudonymisation)

In most cases you should guarantee that data is confidential, this means that, although you know who participants are (unless you receive data anonymously e.g. through an anonymous online survey), your final report will not identify who they are (the data will be anonymised or pseudonyms are used in place of their names). Anonymising data does not simply mean removing names, it means ensuring that there is no way to trace individual This means that sometimes you will need to change detailed information to more generic information (e.g. date of birth changed to age range, job title changed to general occupational sector etc.). You will also need to be cautious about including actual names and locations that the participant may mention, if these could link back to the participant. In some studies, it is appropriate for participants’ data to remain identifiable. They may be an expert, a public figure or they may simply be eager that their opinions or experiences remain associated with them. In some disciplines, it is normal practice to identify participants, such as Oral History studies. In these cases, participants should be asked in the consent form whether they would like to be identified.

Protecting privacy also relates to the confidentiality and anonymity of organisations and institutions taking part. If you are recruiting participants through an organisation then the person who gives you permission to do this (the ‘gatekeeper’), will need to know how you are protecting the privacy of that organisation. Again there may be times when the organisation wishes to be named, in which case the participants should be told in their Information Sheet that you will be doing this (with a reassurance that individuals will not be identifiable).

Consent - Informed consent is one of the founding principles of research ethics so that human participants can enter research freely and voluntarily with full information about what it means for them to take part. A fundamental principle of ethical research is the expectation that participants are able to give consent after fully understanding possible risks, inconvenience or the possibility of any harm. Great care is needed in ensuring consent from a participant regarded as ‘vulnerable’ is clearly informed. In some instances, achieving this may need the assistance of a parent, guardian or carer.

Consent should be obtained before the participant enters the research. The minimum requirements for consent to be informed are that the participant understands what the research is and what they are consenting to.

You should ensure that you comply with the General Data Protection Regulation (GDPR) during and after the consent process, especially if collecting 'special category' (ie sensitive) data (also refer to the advice on consent in research involving children). As part of your ethics application you will need to provide details of how you intend to obtain consent from participants. Templates for Consent Forms are available to the right of this page.

Control of Substances Hazodous to Health (COSHH) - The law requires employers to control exposure to hazardous substances to prevent ill health. Researchers intending to conduct research involving chemicals or other hazardous substances will need to complete a form as part of their ethics application. For further information see the University’s A-Z of Health and Safety.

Creative practice (SS Arts Schools only)

Practice-based research. practice-led research and practice as research are all forms of research that involve some form of creative practice as part of the process and/or outputs. Often, this does not involve 'participants' in the 'collection of data' in the normal sense, which typically require ethics review. Below are some points which may help you decide if your practice would require ethics review. This list is by no means exhaustive, and you should always check with the Senior Ethics Officer if you are in any doubt.

Things which do not require ethical review include many activities that are a normal part of professional practice in your field, e.g.:

hiring musicians to play and record your music or actors to workshop your ideas.

running workshops with professional musicians and specialists in other art forms to explore ideas / create materials collaboratively.

taking photographs or shooting film to workshop an idea or develop your practice.

Regarding street photography and video and field recording in public spaces, including street protests:

people in public spaces don’t have the same rights to privacy as they would when they are at home and can be recorded or documented as part of general street ‘life’ provided they are not distinctly identifiable or incriminated (in the case of protests) from the output.

Please see audio recording and media release forms for more information

If your project involves observational research then ethics review and approval will be required.

Cross-School Research Ethics Committees (C-REC). The C-REC reviews the following categories of ethics review applications:

High risk UG and PGT students
Low and high risk Staff and PGRs

The University has two C-RECs: one for the Sciences and Technology Schools (SCI-TEC C-REC) and one for the Social Sciences and Arts Schools (SSARTS C-REC). Brighton and Sussex Medical Scholl (BSMS) has it's own Research Governance Ethics Commitee (RGEC). For further information see Contacts: SREOs and Committees.

Criminal Disclosures

The University of Birmingham has useful guidance on their intranet for staff and student researchers on when to escalate crimincla disclosures by participants which is publicly accessible here:

Data Protection - The Data Protection Act 2018 and the General Data Protection Regulation (GDPR) apply to any circumstances at the University where we are processing personal data. Processing includes things such as the collection, recording, analysis, storage, dissemination and even deletion of data, so any research involving personal data will amount to processing and the research will need to comply with the Regulation and Act.

Personal data is anything that enables a living person to be identified. It includes information that enables a person to be directly identified as well as information that enables them to be indirectly identified, such as a research participant number. In particular, personal data includes the physical, physiological, genetic, mental, economic, cultural or social identity of a living person.

Before starting your research you should refer to the university's 'Research and GDPR ' support and information pages

Data Management and Storage - See also Information Classification and Handling

Responsibility for research data management within any research project, programme or activity lies with the relevant Principal Investigator (PI) / supervisor. Data must be stored in accordance with the Information Classification and Handling Policy

Data should be stored on secure University-supported systems:

For staff: Box and OneDrive (and ‘G: drive’)

For students: OneDrive

You should store any research data collected during your research within your University system (Box or OneDrive) and state clearly on your application that this is where data will be stored. In the eventuality that data is not immediately stored to your University system at the point of data collection, you should state clearly within your ethics application how and where the data will be collected and that it will be transferred to a University system as soon as possible before being deleted from the other device or space.

You should explain the arrangements for storing collected data in your ethics application form and to participants: eg data will be stored in a de-identified way (e.g. using ID numbers not names) and kept separate from other personal details (e.g. from the consent form).

How long can I store data for?

Personal data: It is good practice to destroy participants personal data (eg consent forms, names) at the end of the project unless you have sought their explicit permission to retain their details for other purposes such as contacting them for future research projects.

Research data: Up to 10 years after the completion of the project (this is the University default.)

For more information see Research Data Management

Debrief – In certain studies it will be appropiate to provide participants with a debrief and remind them how they can withdraw their data. In cases of deception a debrief is always required to provide full disclosure of purpose of the study and justification of the necessity of deception/placebos (if used). Where appropiate the debrief should include signposting to support if there is any possibility of distress; and/or you may wish to provide participants with further information. The debrief text should be uploaded to the supporting document section of your ethics application.

Deception – (see also Debrief) - Some studies involve masking the truth or real intention for undertaking the study. or intentionally misleading participants about some key aspect of the experiment. This could include feedback to subjects that involves creating false beliefs about oneself, one’s relationship, or manipulation of one’s self-concept. ‘Incomplete Disclosure’ is a type of deception that involves withholding some information about the real purpose of the study, or the nature of the research procedures. If your research involves deception it is essential that you debrief participants and provide them with full disclosure as to the purpose of the study, an explanation of why deception was necessary, and the opportunity to withdraw (or re-consent if appropriate).

Deception in randomised control trials

The BPS Code of Human Research Ethics Section 7. Deception advises: “Deception or covert collection of data should only take place where it is essential to achieve the research results required, where there are no alternatives, where the research objective has strong scientific merit and where there is an appropriate risk management and harm alleviation strategy.” In the case of randomised control trials, deception in terms of which group a participant is in is necessary. However, it is usual protocol to fully inform a participant that they will be randomly assigned to one of two conditions so that they are informed about what the study entails, and that there are differing groups, and the deception is only which group they are in.

Digital Economy Act (DEA) 2017 – Chapter 5 of Part 5 of the Digital Economy Act 2017 facilitates the linking and sharing of datasets held by public authorities for research purposes. The aim is to broaden the capacity of research to deliver direct and indirect public benefits, including the production of valuable new research insights about UK society and the economy.

The ‘Research power’ set out in Chapter 5 of the DEA 2017 enables information held by one public authority to be disclosed to another person for the purposes of research. Projects and researchers must be accredited by the UK Statistics Agency in order to be able to access data under the act. For details on the DEA researcher accreditation and ethics process please contact the rgoffice@sussex.ac.uk.

Disclosure and Barring Service (DBS)

Depending on where and how you are conducting your research you may need a DBS check before you may collect data. DBS checks are to prevent unsuitable people from working with vulnerable groups, including children, and are managed by the government’s Disclosure and Barring Service. The checks look at whether a person has a criminal record and if they are on the barred list for certain activities.

Some projects that are integrated with current research and involve working under the direct supervision of a person who has clearance would normally not require a DBS check. If you are conducting research in a school where you will be alone with a child or children, you will need a DBS check before you may begin data collection. If you are conducting research in a laboratory you will not need a DBS check if the parent is with the child during the entire experiment. However, if you will be alone with the child in a room separate from the parent then you will need a DBS check.

It is essential that you discuss whether you require DBS clearance with your supervisor. If in doubt, get a DBS check. DBS checks are processed by individual Schools, so to find out how to apply check with your School.

Equality and Diversity

Our current Institutional Guidance on Equalities Monitoring is currently under review and the revised wording has not yet been confirmed. In the meantime, please use the categories recommended by Advance HE for Gender for surveys/questionairres etc

+ Man
+ Woman
+ Non-binary
+ In another way (specify, if you wish)
+ Prefer not to say.

If you also want to measure involvement of people who are Trans, the guidance recommends a separate question following the question on Gender.

For example:

Are you trans or do you have a trans history?
+ Yes
+ No
+ Prefer not to say

Or, alternatively,

Is the gender you identify with the same as your sex registered at birth?
+ Yes
+ No
+ Prefer not to say

The full guidance provided by Advance HE can be found here:

Ethics Drop in

On-line Ethics Drop-In Every Wednesday from 2-4 pm

For help with any aspect of your ethics application book an online meeting by contacting…

crecscitec@sussex.ac.uk for the following Schools: Engineering & Informatics, Life Sciences, Mathematical & Physical Sciences, Psychology

c-recss@sussex.ac.uk for the following Schools: Business (including SPRU), Education & Social Work, Global Studies, Law, Politics & Sociology, Media, Arts & Humanities and the Institute of Development Studies

Ethics approval from another institutions - If ethics approval has been previously granted from a UK institution or an institution that has comparable standards of ethical review process then the University ethics application process will not need to be followed. This is on the condition that a current certificate of ethical approval can be supplied to the C-REC and approved by the Chair of that committee, so you will still need to submit an ethics review application to the appropiate SREO/C-REC.

Experiments – see Laboratories

Extensions - If your research end date requires an extension then an amendment will need to be made to your ethics application in You are not permitted to continue your research past the end date of research stated in your certificate of approval without first having your new end date approved. To amend your original application log into Sussex Direct, go to the 'research' tab and scroll to 'ethical reviews'. Click on the application number of the application you want to amend:

Open the original application, and click on “copy”
Change the title "EXTENSION OF ER/... [insert title]"
Change the project end date
In the project description state that all materials and methods have been used without incident and no changes to these will be made.

External ethics review (other than NHS)

Undertaking research in some specific participant groups may require seeking ethics review and approval from external review bodies. Whilst the University prefers to avoid duplicate ethics review, as a minimum, some form of University research governance (whether via the C-REC, Sponsorship Sub-Committee or some other process) in the first instance will be needed before an application can be made. Please contact a member of the Research Ethics, Integrity and Governance team for guidance.

Examples of external review bodies:

(HMPPS)

(MODREC)

For NHS Research see Health Related Research

Far Right - Researching the Far-Right: Tips and Tricks for Maintaining Wellbeing
and Addressing Bias

If your research is based on the far right or associated groups/topics this document from UoS researchers provides guidance on how to look after your personal wellbeing online. You should detail this work (online or in the field) within an ethics application before starting your research.

Fieldwork - Fieldwork is regarded as any work or research carried out by staff or students in places not under the control of the University but where the University is responsible for the safety of staff and students and others who may be affected by their work.

If you intend to do any off-campus work, then you will need to explain in your ethics application how the safety of participants and researchers will be ensured. If you are doing data collection in public spaces, then you may wish to contact the insurance office for advice: insurance@sussex.ac.uk.

If you are working alone off-campus, you will need to explain procedures to ensure your safety. This is often done by ensuring that another member of the research team has a record of the time and location of off-campus work. You should also describe any check-in procedure to be used (e.g., a phone call or text message saying “I have now finished the interview, and I am heading back to work”), and what will be done if no check-in message is received.

Depending on the nature of your fieldwork you may need to complete a risk assessment form, or have a protocol in place, and should upload this with your ethics application. (See also Lone working and Overseas Travel)

*** Due to COVID-19 there may restrictions in place regarding fieldwork so you MUST check the University Health and Safety webpages for the current position.***

Focus Groups - If your research involves focus groups you will need to ensure that explicit participant consent is sought at the start of any focus group and that the limits of participant withdrawal of their data is discussed beforehand. For example, a participant should be informed that they may leave a focus group at any time but the data they have provided during their time in the group will not be able to be removed from the study. A useful form of words to explain this to participants is below:

You can exit the focus group at any point, without giving any reason. Because of the nature of focus groups, it is not possible for us to withdraw your data once it has been given - there are usually lots of people talking, and it can be hard to pick out who is saying what, and what one person says may have an effect on what another participant says. Therefore, if you do choose to withdraw from this study then the researchers will retain any data that you have provided up to that point and will include this data in any subsequent analyses.

Gatekeepers - A gatekeeper is any person or institution that acts as an intermediary between a researcher and potential participants. A gatekeeper may also have the power to grant or deny permission for access to potential research participants.

Use of a gatekeeper will be necessary where a researcher does not have legitimate access to personal data (names and contact details) of potential participants; in such cases a gatekeeper who does have such access will need to make first contact on behalf of the researcher. In other cases, it may be good etiquette (though not mandatory) to use a gatekeeper.

Gatekeepers may include:

health and social care professionals, such as those working with patients, children or elderly
headteachers and college principals
an employer, for research within a workplace/organisation
any adult whose permission is required to gain access to research participants within a community (in the UK or overseas), such as another family member (e.g. the parent or husband of the participant), clergy, community leaders or community elders.

You must describe your recruitment strategy in your ethics application and give full consideration as to whether there is a need for a gatekeeper, as well as addressing any potential consent issues arising. You should also upload to your supporting documents section the letter/e-mail you intend to use to approach the gatekeeper.

GCP/ Good Clinical Practice - Good clinical practice (GCP) is an international quality standard for conducting clinical trials that in some countries is provided by , an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects. These standards are widely understood to be a set of principles important for ethical research across many types of clinical research are considered essential for many types of human intervention studies with patients or users of health services. GCP training (via ) is available using a University email address.

GDPR - The General Data Protection Regulation (‘GDPR’) and the Data Protection Act 2018 apply to any circumstances at the University where we are processing personal data. Processing includes things such as the collection, recording, analysis, storage, dissemination and even deletion of data, so any research involving personal data will amount to processing and the research will need to comply with the Regulation and Act.

Before starting your research you should refer to consider the university's 'Research and GDPR ' support and information pages http://www.sussex.ac.uk/ogs/policies/information/dpa/research-and-gdpr.

Generic Module Approvals – see Blanket/Generic Module Approvals

Health and Safety - see also Risk Assessments, Fieldwork and Lone working

It is important that the University operates effectively and allows its staff, students and visitors to undertake their activities without detriment to their health, safety and wellbeing. Undertaking risk assessments covering possible dangers to both participants and researchers is a vital part of this and, also, good research practice. Research must be carried out in accordance with relevant regulations, policies, local rules and guidance documentation. Where a risk assessment is required, this must be uploaded to the supporting documents section of your ethics application. For more information see the University’s Health & Safety Home Page

Health related research - The (RGEC) is responsible for reviewing applications from BSMS staff and students conducting non-clinical health related research involving healthy volunteers. Clinical research involving NHS patients, their data or tissue, service users, or staff requires University Sponsorship and application to the Health Research Authority (HRA) for . Detailed advice and guidance on applying to the HRA can be found on the HRA website.

Human Tissue Act - The removal, storage, use and disposal of human bodies, organs and tissue for a number of Scheduled Purposes – such as research, transplantation, and education and training - is regulated under the Human Tissue Act 2004. The ��ܽ��Ƶ holds licences for the storage of human tissue for research purposes under the Act. Any researcher planning to work with Human Tissue must follow the Standard Operating Procedures for the licence that they will be working under and should consult the relevant contacts on the University’s Human Tissue Act webpage for further guidance.

For all ethics applications involving HTA-regulated procedures (that is, anything involving taking bloods, saliva, urine or any other samples which contain cells), applicants should incorporate into their applications: the Standard Operating Procedures for the collection of samples; risk assessments; and informed consent. This includes a SEPARATE consent form for the samples, which is compliant with the HTA regulations – these forms can all be seen on the HTA website: http://www.sussex.ac.uk/lifesci/internal/servicesandsupport/ethics/humantissue. Applicants will also need to complete an HTA training session – this is a requirement before sample collection begins.

Inclusive Language

The University’s Equality, Diversity and Inclusion Unit advise the following:

“Depending on what you are communicating, some charities and organisations provide advice on language. For example, if you needed advice on the language used in relation to topics about LGBT related issues, Stonewall provide a that may be helpful. Advance HE provides guidance on the use of language in relation to .

The use of language and terminology can change very quickly so advice on language is often updated regularly. In many areas there is a lively debate and/or disagreement on definitions of terms so there is no one source that provides a consensus on the use of language. We generally advise that any group starting work where language may be sensitive consults locally on the language and definitions they wish to use

Information Classification and Handling

The University’s Information Classification and Handling Policy provides a framework for safeguarding University information.

The policy applies to all information handled by the University, both internally and externally, and whether held electronically or physically.

Anyone who is responsible for information or handles information must ensure that it is classified correctly based on a risk assessment of its sensitivity. In general, examples of ‘Sensitive’ information include commercial information, research data, special categories of personal data, or information relating to contractual or legal obligations

If you have any queries about the Policy, or how it applies to the information you handle, then please contact the Information Management Team for guidance.

Insurance - In order to be covered under the University's insurance your research requires approval by an SREO or C-REC. More information on insurance, including the public liability insurance certificate can be found on the University’s Finance Division Insurance webpage.

Internet-Mediated Research including Social Media Research and On-line interviews and Questionnaires

The British Psychological Society (BPS) defines Internet-Mediated Research “any research involving the remote acquisition of data from or about human participants using the internet and its associated technologies.” (.) Such research may involve on-line surveys, interviews or experiments; or the collection of data from text found in blogs, forums or other online spaces; analyses of websites; or other online activity.

Platforms to use: Teams is recommended for on-line research interviews and Qualtrics is recommended for on-line questionnaires. For further information see On-line interviews and Questionnaires.

(It is important to note that services using personal accounts (such as Skype, Facebook Messenger, WhatsApp) should NOT be used as they have not been evaluated as appropriate and approved for University business that involves processing personal data.)

For further information see:

Guidance on the use of video conferencing platforms in research and ethics review

Interviews and Focus Groups

Ethics applications must include all participant facing materials including draft topic guides for interviews and focus groups. Reviewers understand that specific interview questions may develop as the interview unfolds however, they do need to see an outline of the anticipated topics to be covered and interview structure in order to conduct their review.

Social Media Research (including mass-data)

Social media research involves human participants and ethics approval must be secured for a project involving the collection of data from social media or on-line sources before the collection of any data. The following University guidance outlines the key ethical issues researchers must consider when conducting research via social media and explains how researchers should approach the ethics review application and process: Ethics guidance on research using human participant data from on-line sources/social media – Research Ethics Integrity and Governance Team

Can I recruit participants via my social media accounts?

Researchers should avoid using personal social media accounts and profiles for recruiting and interacting with participants due to the blurring of professional and personal boundaries (which can risk both participants’ and researchers’ privacy and personal safety). Where it is necessary to have a presence on a social media platform for research purposes, a separate profile should be created (using a university e-mail address or a dedicated study webpage, etc.). Please also review the University’s guidance on social media.

If you wish to advertise your study on social media with a separate profile, you should upload a standalone study advertisement to your ethics application. This advert should direct those interested in participating in the study information sheet/details, or to a dedicated study site created using your university account/email. Alternatively, this advertisement could invite potential participants to contact you via your ��ܽ��Ƶ e-mail address.

Once posts are created on social media using professional/University accounts, then it is possible to share those official posts via a personal account. We recommend that you share the social post without edits or comments.

We understand that researchers may want to share projects with potential participants using messaging apps (e.g., WhatsApp). To ensure safety and participant anonymity, please don't share study information within messaging groups where everyone can see each other's contact information (e.g., names and phone numbers). If the messaging app allows it, you can share links to a study via mechanisms that preserve recipient anonymity; for example, in WhatsApp, you can use the broadcast feature to send study links to a list of potential participants without recipients seeing one another during messaging.

Like many personal interactions, researchers who use social media and messaging may encounter harassment. Risks of harassment should be considered in the ethics application, and the researcher should detail how risks are minimised and what support mechanisms are available to address such issues should they arise. There are several online guides available, from organisations as well as social media and messaging apps, that may be useful for helping to ensure safety [make sure to check out help resources from different apps, as guidance links may change over time:

- .

Useful guidance on internet-mediated research:

Social Media Research: A Guide to Ethics Dr. Leanne Townsend and Prof. Claire Wallace, The University of Aberdeen:

Joint applications with other institutions - Where a joint research project with another institution is proposed, the lead principal investigator at the ��ܽ��Ƶ should submit an application to seek ethics approval. In cases where the co-applicant is at Sussex (and the lead principal investigator is at another institution), the ��ܽ��Ƶ co-applicant should submit an ethics application and provide confirmation of the ethics approval from the second institution. Approval will be granted on the condition that the second institution has a comparable standard of ethical review process to ours.

If Sussex is collaborating with another UK HEI or research organisation who is the lead partner, then the broad expectation is that the ethical review procedure in place within the other partner should apply to the research. Characteristics of being appropriate will include public statements of endorsement of the Concordat to Support Research Integrity or terms of reference that align to recognised standards such as the ESRC Framework for Research Ethics, the AFRE Framework of Policies and Procedures for University Research Ethics Committees or the HRA’s Governance Arrangements for Research Ethics Committees (GAfREC. As a general principle, as long as the project does go through the other research partner’s ethics review procedure, it will not need to be reviewed through ��ܽ��Ƶ ethics procedures. However there may be circumstances where a local review may be necessary, for example, if the recruitment of participants is largely or entirely based at Sussex. In either case, a copy of the lead institution’s ethics approval should be available as part of the project documentation and have been received before research activity at the ��ܽ��Ƶ can commence. Contact the Research Governance Officer (rgoffice@sussex.ac.uk) with any queries.

Laboratory work – individual laboratories will have their own Standard Operating Procedures (SOP). An SOP is a document that sets out the procedures and processes that anyone working in that lab must follow, and any training they must complete. Labs will have SOPs for proposed research methodology. Examples of this include studies involving:

Electrocardiogram (ECG)
Electroencephalogram (EEG)
Electroretinography (ERG)
Transcranial magnetic stimulation (TMS)

If your application involves lab work you should check the relevant SOP and upload this with your ethics application. In some instances, having an SOP in place may mean that an application which would automatically be categorised as high risk may be considered as low risk by the C-REC.

Where a health and safety risk assessment is required, this must also be uploaded to the supporting documents section of your ethics application. For more information on risk assessments see the University’s Health & Safety Home Page.

Due to the COVID-19 situation there may be restrictions in place regarding in-person research on campus, so you should check the University Health and Safety webpages for the current the position.

Local Authority Research Governance

If you are considering conducting research that involves a local authority. Please consult the before completing your ethics review. Each local authority may have different processes to assess research, and you should consult with them directly to understand what this involves as part of your research plans. Please see 'Researching Vulnerable Groups:Ethical Issues and the Effective Conduct of Research in Local Authorities' for more information on this process.

Lone working - (see also: Fieldwork)

The HSE defines lone workers as those who ‘work by themselves without close or direct supervision’. ‘Lone workers’ therefore means any person meeting the HSE’s definition who are working, studying or carrying out research on behalf of the University, whether they are working on or off Campus. Research that takes place on campus out of normal office hours (08:30-17:30) is also considered lone working. If your research involves lone working then you will need to complete the appropriate Lone Working Risk Assessment and upload this to the supporting documents section of your ethics application.

LGBTQ+ Terms (Glossary)

Stonewall UK maintains a glossary of LGBTQ+ terms and is recommeneded by the University's Equality and Diversity team.

Media Interview Survival Tips

If you find yourself requested to give an interview on your work to the media, these tips (provided by Professor Ivor Gaber from the School of Media Arts and Humanities) should get you started on the right foot.

1. Find out everything you can about the media request – what are they after, what’s the context, who else are they speaking to etc.

2. Tell them you’ll call back as soon as possible.

3. Seek advice from supervisor/press team.

If going ahead ..
4. Work out your key messages – three bullet points is good.

5. Don’t try and avoid questions but do try and get your points across

6. Avoid jargon – test out your messages on family/friends to see if they can understand.

7. If you don’t understand a question ask for it to be repeated

8. Always be polite and smile (when appropriate)

9. Think about how you’re going to look; it’s head and shoulders – anything distracting?

10. Try and record yourself in order to watch back and improve for the next time.

11. Telling the public about your research is a good thing to be doing.

12. Enjoy – media interviews are scary but fun.

Media release forms - Media Release Forms are consent forms signed by collaborators in creative practice projects, for example those involving photography, filming, sound recording, or digital media. By signing these forms, your collaborators consent for their creative contribution to be used as part of your project, and agree where the project can be exhibited / performed / distributed. Examples of creative collaborators who sign media release forms might be: a composer who works on the soundtrack to a film, a professional model who features in a photography shoot, an actor in a fiction film, etc. Media release forms should be used across all creative practice projects, regardless of whether they involve ethical considerations or not. However, if your creative project additionally involves human research subjects (for example the subject of a documentary film, photo shoot, or podcast etc.), then you need to seek ethical approval and, in addition to media release forms, provide a participant information sheet and consent form approved by the university ethics committee.

Misconduct - Collecting human participant data without ethics approval is a breach of the Code of Practice for Research and any breaches will be considered and investigated under the University’s Procedure for the Investigation of Allegations of Misconduct in Research (staff and PhD students) or the University’s Regulations for examinations and assessment (taught students).

Nagoya Protocol () - The Protocol applies to

Genetic Resources (GR): any material of plant, animal, microbial or other origin (excluding human) containing functional units of heredity (e.g. genes and DNA) which is of actual or potential value; or their derivatives, e.g. proteins, lipids, enzymes or RNA.
Traditional Knowledge: knowledge, know-how and practice of indigenous and local communities relevant for the utilisation of the genetic resource

Please visit http://www.sussex.ac.uk/staff/research/governance/erp_overview/nagoyaprotocol for further information.

Observational research - The term observational research is used to refer to several different types of non-experimental studies in which behaviour is systematically observed and recorded. The goal of observational research is to describe a variable or set of variables. More generally, the goal is to obtain a snapshot of specific characteristics of an individual, group,or setting

Off-campus work – see Fieldwork

Online application process - All ethics applications both high and low risk are submitted via the online ethics application system on To access the system, log into Sussex Direct then click on 'research' and then 'ethical reviews'. You can then start a new application by clicking on the tile on the left-hand side marked 'new'. ‘How to’ videos and a User Guide are available on the How to Apply for Ethics Review Page.

Online interviews

Platforms to use: Both staff and student researchers should use University video-conferencing service accounts when conducting interviews online. Researchers should log in to these services using their UoS log-in details (see also ITS pages).

The approved platforms are:

• UoS Microsoft Teams

• UoS Zoom

If your research involves the discussion of sensitive information the University recommends using UoS MS Teams - please see the Guidance on the use of video conferencing platforms in research and ethics review for more information.

Services using personal accounts (such as Skype, Facebook Messenger, WhatsApp, Telegram and Signal) should NOT be used as they have not been evaluated as appropriate and approved for University business that involves processing personal data.

Recording interviews:

Researchers should ensure that when recording interviews either a seperate audio recording device is used (such as a digital audio recorder and not a personal mobile phone) or the recording functionality on UoS MS Teams or UoS Zoom is used. When a recording on one of these platforms is completed the file must be securely uploaded to your UoS OneDrive or UoS Box accounts and not stored in a non-secure location.

See Guidance on the use of video conferencing platforms in research and ethics review for further information on conducting on-line interviews.

Overseas travel and OTSSRA Form - Research that involves travel overseas requires an Overseas Travel Safety and Security Risk Assessment form to be completed and signed by your Head of School. Due to the COVID-19 situation there may be restrictions in place regarding overseas travel and fieldwork overseas so you MUST check the University Health and Safety webpages for the current the position.

Students who return to their home countries to conduct online research are not required to complete an OTSSRA form as part of their application but should state clearly that this is the case in their ethics application.

You can find an example of a best practice OTSSRA form that was used for travel to a designated 'red' FCO area and guidance relating to 'when to complete an OTSSRA form' here

Participant Information Sheet - All research conducted at the University that involves human participants requires a Participant Information Sheet. Researchers should use the University template (available here) which they can edit to include their study details. A completed version of the Participant Information Sheet should be uploaded to the supporting documents section of the ethics application.

‘Payment’ to participants - Participants in research are usually not ‘paid’ (as in employed) but may be given financial compensation for their time.

It is essential that researchers do not offer disproportionate rewards for consenting, as this could be seen as coercing participantion. However, it is reasonable to offer proportionate recompense for attendance, travel, other incurred costs and the time and inconvenience of participation.

Payments to child participants: the British Psycholgical Society advises in their ‘Gifts, certificates, books, stickers or T-shirts with appropriate printed logos and text are especially appropriate for children.’

Some Schools have a set rate/scheme of compensation for participation so check this with your school.

Prize draw entry: you should aim to gather contact details in a way that does not link participants to responses. (It is possible within Qualtrics to have a custom 'end of survey' event (eg. after participants click the last forward button) such that it redirects to a new URL.) The Qualtrics website contains lots of useful FAQs including '

Prizes in prize draws should normally be no more than £50. If you want to retain people in a longitudinal study, then you may want to clarify at the start that only people who complete the follow-up will be able to enter the prize draw.

The University does not mandate any specific provider of rewards/vouchers for research participation: it is open to schools to select their own providers/make appropiate arrangements.

If using a prize-draw/providing a financial reward in an online questionairre. you should consider the prevention of fraud such as using attention checks, CAPTCHAs and quality control disclaimers to prevent ‘bots’ ‘participating’ in order to claim rewards.

Placement Scheme Years (undergraduate students)

Placement Scheme Years* (undergraduate students)

*This guidance does NOT refer to students undertaking professional practice placements within their course as an integral part of a professional training programme.

Placement scheme years occur outside the programme of study and typically take place between years 2 and 3 of an undergraduate (UG) course. Placement scheme years are focused on working as an employee of an organisation. Students on placement scheme years are contractually employed by the host organisation, and supervision and governance arrangements (including ethics) for work-related activities are the employer’s responsibility.

1.1 Research activities that may take place on a placement scheme year

Research commissioned specifically by the employer

This should be pre-agreed as part of a job description and set out in the University agreement with the placement provider, which is signed off by the central Placements Team and the Lead Academic Tutor in the student’s School department.

Research activities that are considered day-to-day work by the employer and are within the scope of the job-description

Examples include (but are not limited to) audits, service evaluations and quality improvement projects.

Opportunities identified during the placement which the host organisation and student would like to take forward as University research

The host organisation should confirm this in writing to the Lead Academic Tutor and the student should contact the Research Governance Office prior to the collection of any data for advice on the ethics review of the project.

1.2 Research activities that cannot take place on a placement scheme year

Individual academic research

Individual academic research cannot take place under the auspices of the University whilst students are employed on a placement scheme year. By extension, students cannot seek University ethics approval for individual projects whilst on their placement scheme year* and it will not be appropriate for staff to act as ‘remote’ research supervisors for placement scheme year students wishing to conduct individual projects outside a programme of study.

*unless the placement employer is the ��ܽ��Ƶ and they are applying as staff members for approval of a project which is part of the placement activity.

Data collection for individual academic research

In no circumstances may students collect data for their individual research whilst on a placement scheme year with the intention of applying for ethics approval upon their return to the University for their final year, as ethics approval cannot be granted retrospectively.

1.3 Students returning to their studies following placement scheme years

In some circumstances, it may be appropriate for students to use data for their dissertation research projects which has already been collected during their placement as part of the placement activity. An example of when this might apply would be where the data collection was conducted under the remit of the host organisation and the student then seeks permission post-placement to use the (typically, de-identified) data for their own research. The specific conditions under which this may occur must be agreed with the host organisation, and should include explicit governance and data management arrangements, as well as reference to the original terms of consent.

Where data includes personal information, appropriate data sharing arrangements must be in place. In all cases, i.e. for personal data and de-identified data, University ethics approval must be obtained before a student can process the data for an individual research project.

Students returning from placement scheme years who wish to conduct research involving their former employer’s resources, data, staff or service users, must first agree their proposal with their academic supervisor and then seek ethics approval from the University in the normal way. In doing so they should demonstrate that they will seek gatekeeper permission for the research and that issues around potential coercion, confidentiality, privacy and professional boundaries have been fully considered. Compliance with data governance requirements must also be evidenced.

Personal Data – (see also Confidentiality and Anonymity)

“Personal data is defined in the General Data Protection Regulation (GDPR) as: “‘personal data’ means any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier (eg IP address) or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person”.

This means personal data has to be information that relates to an individual. That individual must be identified or identifiable either directly or indirectly from one or more identifiers or from factors specific to the individual.”

The legal framework for processing personal data in the UK is set out in the Data Protection Act 2018. Personal data is defined as information that relates to and identifies a living individual. If information is properly anonymised, then it is no longer regarded as ‘personal’ because it does not identify any person individually. ‘Processing’ is defined as obtaining, using, maintaining or holding personal information. All research with human participants will process personal data at some stage and you are required to comply with the DPA. (See http://www.sussex.ac.uk/ogs/policies/information/dpa/research-and-gdpr for further information)

Prevent - The Prevent duty aims to safeguard people from becoming terrorists or supporting terrorism. The government created y one of which is specifically for higher education bodies. under the Counter Terrorism and Security Act 2015. The University's position on Prevent is set out at http://www.sussex.ac.uk/prevent/

In specific cases, researchers who may wish to acces sensitive materials that may come under the Prevent duty may apply to access Security Sensitive documents and data. Process for accessing specific University IT resources to enable security sensitive research . Accessing ITS resource for sensitive research - application form

Prize draws – see ‘Payment’ to participants

Pseudonymisation - See also: Confidentiality and Anonymity and Personal Data

Pseudonymisation is the method used for research methods where you know who the participants are. In order to ensure that participants’ data is confidential you assign each person a random identity number or a pseudonym which links the data you have received from them back to their name and/or address.

Pseudonymisation is defined within the GDPR as “the processing of personal data in such a way that the data can no longer be attributed to a specific data subject without the use of additional information, as long as such additional information is kept separately and subject to technical and organizational measures to ensure non-attribution to an identified or identifiable individual

Qualtrics - Qualtrics software enables users to do any kind of online data collection and analysis. Qualtrics is GDPR compliant and is recommended by the University for on-line surveys and questionnaires. All staff and students have access to Qualtrics through their University account.

Questionnaires/surveys – (see also: Qualtrics)

On-line questionnaires:

If you intend to use online questionnaires you should use a platform for which the University holds a licence, such as Qualtrics.
If you are conducting a truly anonymous survey then you will need to ensure that IP addresses are not collected and explain this in your ethics application and to participants. (The default setting on Qualtrics is to collect IP addresses – but you can turn this off in the settings.)
Active consent: recommend the inclusion of a 'designated consent page as part of an online questionnaire with check boxes (for example) in response to explicit consent statements'. It is also a requirement under GDPR that consent is always 'active'. You should therefore ensure within your consent procedure that participants have to explicitly agree with the consent statements (e.g. with yes/no options or at least a tick box/ click button) rather than simply by clicking ‘continue’).
If using a prize-draw/providing a financial reward you should consider the prevention of fraud such as using attention checks, CAPTCHAs and quality control disclaimers to prevent ‘bots’ ‘participating’ in order to claim rewards.

For both paper-based and on-line questionnaires you should include with your ethics application a draft list of questions or the actual questionnaire you intend to use.

Recruitment materials - If you will be advertising, a copy of the advert / poster / recruitment email / social media posts / SONA adverts etc should be uploaded as a PDF file at the end of your application. Recruitment literature (i.e. recruitment letter or web pages) should also be submitted. If you will be emailing information to participants, you must send this from an official email address (i.e. your ��ܽ��Ƶ account - not a personal account such as Hotmail or Google). If you need to approach a ‘gatekeeper’, such as the head of a company or school you wish to recruit from or a charity / organisation of which participants are members, you will need to submit the letter /recruitment email/other documentation you intend to use when approaching them.

Research Impact and Ethics and Knowledge Exchange and Participatory Research - Research impact is the effect, change or benefit to the non-academic world which occurs as a consequence of research. Researchers are increasingly expected to engage in impact activities, both to enhance the impact of their research ('pathways to impact'), and to evaluate the benefit that has occurred.

Ethical approval is required for all university research. The definition of research is the creation of new knowledge or understanding through a systematic process of enquiry, effectively shared. Impact activities do not generally fall under this definition. Instead impact would normally be classified as a form of service evaluation, with research being the 'service'. Therefore ethical approval for impact activities is not routinely required.

Potential impact activities should, though, be considered by researchers in their initial project design, and captured in the main ethics application for the project. The same high levels of rigour, respect and responsibility that are expected in the conduct of research must also be applied to impact activities. Impact activities should be undertaken ethically, and risks should be appropriately identified, managed and mitigated.

As well as general conduct expectations, there may also be occasions where discrete ethical approval should be sought for impact activities.

explores the issues surrounding Research Impact and Ethics

Research Governance and Ethics Commitee (RGEC)

RGEC is the C-REC for the Brighton & Sussex Medical School (BSMS). In addition to reviewing all applications requiring ethics review from BSMS, it also reviews MRI scanning studies and healthy volunteer studies that require medical supervision -

Risk Assessments – see also: Fieldwork, Lone-working and Overseas Travel

Research studies involving hazardous substances and/ or equipment required formal review and approval from individuals who have responsibilities for health and safety within university facilities. Health and Safety risk assessments (appropriately countersigned) will need to accompany ethical review applications. Applicants should undertake specific training and provide evidence of competence in order to comply with health and safety requirements. Visit the University’s Health & Safety Home Page for more information.

Safeguarding

The University’s Safeguarding Policy can be found at Safeguarding Policy [DOCX 143.25KB].

Secondary Data (Secondary analysis of qualitative and quantitative data)

The UK Data Service defines secondary data analysis as:

“… the reanalysis of either qualitative or quantitative data that has already been collected for a previous study, by a different researcher typically looking to address a new research question.”

Secondary data analyses tend to fall into the following categories:

Meta-analysis and systematic review
Publicly available anonymised data sets uploaded to open access repositories/data bases
Secondary datasets available from previous ��ܽ��Ƶ projects (that received ethics approval) which are shared internally
Secondary datasets which are not publicly available but may be accessed under certain conditions/agreements (e.g. University of Bristol’s Avon Longitudinal Study of Parents and Children (ALSPAC), UK Biobank, ONS, data sets accessed via the Digital Economy Act 2017 etc.)

When using secondary data, it is important to consider whether re-use of the data is in line with the original ethics approval and the consent given by participants. As a general principle, providing the data is truly anonymised it may be used for secondary research purposes even if consent was not explicitly sought for this purpose originally. However, if consent had been sought for the re-use of the data in future research but had NOT been granted by a participant, then their data could never be used, even if fully anonymised.

Typically, projects intending to use secondary data sets that are fully anonymised (i.e. do not contain any personal identifying data such as name, date of birth, participant ID number, pseudonym etc) do not require University ethics review and the researcher will not be required to complete the Sussex Direct on-line ethics review process unless special access permissions apply or the terms of the original consent restrict its re-use.

The following flowchart may help determine whether University ethics review is required for a project

Secondary Data Analysis and Ethics Review

Secondary Data Analysis and Ethics Review

If you/your supervisor are unsure whether the ethics review is required for your secondary data analysis, please contact the Senior Research Ethics and Integrity Officer for your School:

Sciences & Technology Schools

(Life Sciences, Psychology, Engineering & Informatics, Mathematical & Physical Sciences)

Alice Saryazdi - crecscitec@sussex.ac.uk

Social Sciences & Arts Schools

(Global Studies; Business; Education & Social Work; Law, Politics & Sociology; Media, Arts & Humanities)

Carol Cooley - c-recss@sussex.ac.uk

BSMS (Brighton and Sussex Medical School)

Alice Ashford - rgec@bsms.ac.uk

Please note that human participant data from on-line sources such as social media is primary data. Social media or other on-line research involving human participants requires ethics approval and this must be secured for a project before the collection of any data. The following University guidance outlines the key ethical issues researchers must consider when conducting research via social media and explains how researchers should approach the ethics review application and process:

Sensitive Technology Transfers

The University increasingly engages in international research collaboration and transnational education. While most of our activities are rightly free of constraints, nonetheless certain technology, equipment and partner organisations may be subject to legal restrictions to prevent
sensitive capabilities falling into the wrong hands. aims to prevent the proliferation of weapons of mass destruction (WMDs), the illicit transfer of military technology and prevent international threats such as terrorism by restricting the transfer of sensitive goods, technology, information and software to destinations outside of the UK. For more information, please visit the the General Counsel, Governance and Compliance Division’s managing risks in internationalisation webpage (Sussex login required). Any questions relating to export controls should be sent to the Export Controls Manager via: exportcontrols@sussex.ac.uk

Service Evaluation

Research and Service Evaluation

"The primary aim of research is to derive generalizable new knowledge, whereas the aim of audit and service evaluation projects is to measure standards of care. Research is to find out what you should be doing;audit is to find out if you are doing planned activity and assesses whether it is working.Some projects may have more than one intent, in which case a judgement* will need to be made on the primary aim of the project.”(as defined by the Health Regulation Authority, “Defining Research” April 2013). For further guidance please refer to the HRA decision making tool:

*When undertaking a study involving a service evaluation please refer to the appropriate Cross-Schools Research Ethics Committee for advice regarding the submission of an ethics application.

Terrorism’ and/or ‘Sensitive research’

Security sensitive research

Under the Terrorism Act 2000 and Counter-Terrorism and Border Security Act 2019 it is a criminal offence to:

collect or make a record of information of a kind likely to be useful to a person committing or preparing an act of terrorism
view or otherwise access via the internet documents or records containing information which is likely to be useful to a person committing or preparing an act of terrorism

Universities play a vital role in carrying out research on issues where security-sensitive material is relevant () but if security-sensitive research material is not registered, stored and circulated appropriately, researchers could run the risk of arrest and prosecution under counterterrorism legislation.

The University has therefore established a prresearcocess for researchers seeking permission to undertake security sensitive research using University ITS resources. This involves the completion of a proforma to permit access to sensitive material in a managed manner (which must be linked to an application for ethics review/ethics approval of the project.) Details of the process and the proforma to use are available here:

SREO – School Research Ethics Officer. SREOs are responsible for reviewing UG and PGT low-risk projects. Please see the SREO review page for more information. BSMS UG and PGT students should check thefor the criteria for SREO review.

Special category information

‘Special category data’ - Special category data are defined in the General Data Protection Regulations as information about an individual’s:

• race;

• ethnic origin;

• politics;

• religious or philosophical beliefs;

• trade union membership;

• genetics; • biometrics (where used for ID purposes);

• health;

• sex life; or

• sexual orientation.

Each of which are specifically protected and must be treated with the utmost care and sensitivity during research.

Researchers planning to use special category data or criminal convictions data are required to make sure that it is taken with explicit information provided to participants about how it will be used, stored and ultimately destroyed in compliance with the GDPR. This will include technical safeguards (such as encryption) to ensure its security.

Sponsorship - In the conduct of a clinical trial, a sponsor is an individual, institution, company or organization (for example, a contract research organisation) that takes the responsibility to initiate, manage or finance the clinical trial, but does not actually conduct the investigation. In the UK, all research that involves NHS patients, tissue, data or staff requires the granting of formal Sponsorship before research can commence.

The University can act as a Sponsor for its researchers. These projects receive their (HRA) ethical approval from a dedicated following local sponsorship acceptance by the University’s Sponsorship Sub-Committee. University oversight and granting of Sponsorship occurs at the University via the Sponsorship Sub-Committee (SSC).

New applications for university sponsorship are now made in writing to the (PSRP) for onward submission to the Sponsorship Sub-Committee.

The PSRP meets monthly according to a schedule with specific submission dates.

Queries about the operation of the should be directed to psrp@sussex.ac.uk

SREO – School Research Ethics Officer. SREOs are responsible for reviewing UG and PGT low-risk projects within SS-Arts or SCI-Tec.

Surveys – see Questionnaires and also Qualtrics

Sussex Direct - is the web-based platform that hosts the on-line ethical review application system. See Online application process for further information.

Transcription Services

The University subscribes to the following Microsoft audio transcription software which is available to staff and students via their UoS accounts:

MS Word Online
MS Teams

MS Word Online

Word Online’s audio transcription feature allows you to either:

Record directly in Word; or
Upload an audio file

See /its/help/faq?faqid=2943 for details. Documents containing identifying/personal information should be stored securely on a University managed system (eg One Drive or Box).

MS Teams

If you are recording a Teams meeting/interview, you can activate the transcription service at the start of the meeting. The text will appear alongside the meeting video or audio in real time, and can later be downloaded into a Word document for editing (ie removal of personal identifying information/pseudonymisation). Useful details of the service and how to start, stop, view, and download a transcript are available here:

It is worth noting that MS Teams can be used as a recording method for in-person interviews as well as those conducted on-line. It is permissible to use a laptop to record an interview in person using Teams because the audio recording is not saved to the device, but to the cloud (ie OneDrive); and can only be accessed via a University password protected account.

Non-University recommended platforms and apps should not be used.

Accessibility

Microsoft claim that Teams, and all their other related applications are built with inclusivity and accessibility in mind. Further information on Microsoft’s Accessibility Features is available here: .

Researchers should always check with their interviewee prior to the interview to ask if they have any specific accessibility requirements. For example, not everyone will have access to a device where they can access Zoom or Teams so alternatives (telephone, or in-person interviews) should be offered as alternatives if practicable.

Withdrawal from the research – It is important to think about the arrangements in place for participant withdrawal. You will need to explain how participants can withdraw from the research and what will happen to their data if they withdraw. You should confirm the specific date/timescale to be used as the deadline for participant withdrawal and ensure that this is consistently stated across all participant documentation. For example, the point beyond which it will not be possible to remove their data from the study might be when analysis has started, or the findings have been published, etc.

Think too about your research methods: if you are using a completely anonymous questionnaire then you cannot withdraw an individual’s response (unless you set up a process beforehand for doing so); and if you are running a focus group you would need to explain as follows:

You can exit the focus group at any point, without giving any reason. Because of the nature of focus groups, it is not possible for us to withdraw your data once it has been given - there are usually lots of people talking, and it can be hard to pick out who is saying what, and what one person says may have an effect on what another participant says. Therefore, if you do choose to withdraw from this study then the researchers will retain any data that you have provided up to that point and will include this data in any subsequent analyses.

Young people – Young people under the age of 18 years are children “regardless of housing, employment or any other status” [British Psychological Society Position Paper 'Safeguarding and Promoting the Welfare of Children' ]. If your participants are young people under the age of 18 see Children and Children in school settings

Course/module convenors may apply for generic or 'blanket' ethical approval for modules where a number of UG or PGT students are going to be conducting research that involves either:

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Research and knowledge exchange

Ethics A - Z

Templates

Useful Guidance

Ethics A - Z

Contacts

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Research and knowledge exchange

Ethics A - Z

Templates

Useful Guidance

Ethics A - Z

Contacts

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