Q – I want to make changes to my project – what is process for getting changes approved?
A – Send an email to EthicsInfo@uclan.ac.uk detailing the changes, and include any documentation which has been amended due to this change (e.g. revised advert, PIS, etc). Depending on the nature of the change this will likely be dealt with by Chairs Action, only where the change is significant or creates new ethical issues will a further review be required.
Q – I will not be taking participant’s names, addresses, age or gender - why do I need to complete a Data Protection (DP) checklist?
A – Personal data means any information by which a participant can be identified, such as a participant describing a set of circumstances or characteristics that clearly identifies them.
Q – What if a research participant wants to be named in any future publication of the research?
A – Where necessary to the research, this should be included on the consent form.
Q – I will be undertaking interviews off campus (e.g. NHS premises or individual participant homes) – how can I ensure the safety of my recorded data?
A – Use a device (iPad, laptop, etc) that allows immediate upload of the data / recordings, etc to the UCLan server via remote access. Additionally, ensure that you always use an encrypted device (e.g. encrypted recorder or data drive). TrueCrypt is available for download on the University server.
Q – Is the University registered under the Data Protection Act 1998? If so, what is our notification reference number?
A – Yes; it is a legal requirement to notify the Information Commissioner that we are processing personal data. This is carried out by the Information Governance Officer on an annual basis. The University’s notification reference number is Z5512420. Information about our notification is available to the public on the register of data controllers, maintained by the Information Commissioner and available on the ICO website at www.ico.org.uk.
Q – The data I will be processing is personal data, not sensitive personal data – how does this effect the four statements under ‘Consent’ (page 3) on the Data Protection checklist?
A – The consent section refers to both personal data and sensitive personal data. Only the 2nd statement in this section refers to purely sensitive personal data, the other 3 statements relate to personal data regardless of whether it is sensitive or not. Your answers therefore should be on the basis of personal data for statements 1, 3 and 4; and sensitive personal data for statement 2.
Q – Do I need ethical approval to conduct a pilot study?
A – Yes. Depending on the nature of the pilot study a separate application can be submitted for that part of the study and then a subsequent application submitted for the main or later stage, where findings from the pilot study will determine how the main study is managed. Alternatively one application can be submitted to cover both the pilot and main study.
Q – I will be doing semi-structured interviews – what supporting information does committee need to see?
A – Topics or illustrative/guide questions will need to be provided, normally in the form of an interview schedule.
Q – My research involves micro-organisms – which committee do I submit an ethics application to?
A – In the first instance, submit an application to the Biological Safety Committee (BSC), then submit the approved BSC application form to the relevant ethics committee where your application will be dealt with by Chairs Action. If you are unsure which committee to submit to, check our web site which details the appropriate committees for all Schools.
Q – How long can it take to gain ethical approval here at UCLan?
A – Initial outcome notification is normally provided within 10 working days. You are advised to allow 3-4 weeks to gain approval in case conditions are set that need meeting, or further clarification is needed by the ethics committee.
Health Research Authority (HRA) Approval including NHS REC & IRAS
Q – Who is the University Sponsor that needs to be inserted in the IRAS application form (Section A64-1 and Authorisation Section)
A – The UCLan IRAS sponsor has recently changed to six Sponsor representatives. IRAS applications requiring UCLan IRAS Sponsor sign off should, in the first instance, email the IRAS form and all supporting documentation to IRASSponsor@uclan.ac.uk in order for governance checks to be undertaken prior to submission to the IRAS system. The Ethics & Integrity team will then liaise with the appropriate sponsor designated for that time and support applicants through the process of gaining approval.
Q – Is HRA approval required on service evaluations?
A – HRA Queries response is that where a project is considered to be non-research, e.g., solely audit or service/therapy evaluation, it will not be managed as research within the NHS or social care. Such projects do not require ethical review by a NHS or Social Care Research Ethics Committee or management permission through the NHS R&D office. Under these circumstances, there is no need to submit applications to the NHS Research Ethics Committee (REC) or NHS/HSC R&D office or HRA Approval. However, researchers should contact the clinical governance office of the NHS organization or local R&D office at which the study will be conducted to discuss their project and check what other review arrangements or sources of advice apply. For example, there may be standard guidelines on the conduct of clinical audit. The Caldicott Guardian will be a source of advice on the use of patient data. Please refer to the HRA decision tool / table to help determine/confirm a project is not NHS research. N.B. Projects considered non-research by NHS/HRA may still require ethical review by UCLan (e.g. for research student degree, etc).
Q – Do I need to fill in an UCLan ethics application if I’ve already got NREC approval?
A – No, instead submit all your IRAS paperwork (NREC/HRA approval letters, IRAS application form, protocol and all supporting document for which ethical approval has been granted - i.e. information sheet, consent form, etc) to EthicsInfo@uclan.ac.uk to be reviewed by the Chair of the relevant ethics committee. Please note that depending on the nature of the project, relevant UCLan Health and Safety (Risk Assessment or COHSS forms) and/or Data Protection (DP Checklist) elements may also be required.
Click here for further guidance on HRA Approval process and University Sponsor requirements
Q - How do I answer Question A5-1 (Research reference numbers), if my project does not currently have a UCLan ref No?
A - It is permissible to respond 'Not applicable' for those project that require NREC approval as part of the IRAS submission and where submission to UCLan ethics will be undertaken after that approval is gained. For IRAS submission that are exempt from NREC, UCLan ethics review can be started as soon as IRAS form has been finalised and therefore the unique reference number (e.g. STEMH ###) assigned as part of the UCLan ethics review can be used.
Q – What documents do I need to submit if I have already received approval to use human tissue samples from Brain Tissue North West?
A – Simply submit the approved Brain Tissue North West application form along with your approved RDSC2 form to EthicsInfo@uclan.ac.uk where it will be dealt with by Chairs Action.
NOMS – National Offender Management Service
Q – How does NOMS research application fit in to the UCLan ethics process?
A – You should apply for NOMS approval first. Where appropriate, the following statement can be used to answer the questions on the NOMS form which asks whether ‘a relevant ethics committee has approved the research’:- “In line with UCLan’s procedures, an ethical review will be undertaken, by the [BAHSS, PSYSOC or STEMH] Ethics Committee, once NOMS approval has been granted.” Once NOMS approval has been granted, please submit all your NOMS paperwork (application form, final versions of supporting documents and approval notification) to EthicsInfo@uclan.ac.uk for review by the relevant e-Ethics Committee.
Q – Do I need any other clearances to undertake research work in prisons?
A – All directly and not directly employed people (including researchers) working within prisons will need a personnel security vetting check. You will need to contact the Governing Governor or Director of the specific establishment / prison to initiate this check.
If you would like further advice on how to complete a NOMS research application, including advice on the security vetting procedure, please contact Michelle Baybutt (firstname.lastname@example.org).
Participant Information / Consent
Q – What level of detail should I give to potential participants?
A – Any prospective participant needs to have sufficient information to enable them to make a decision as to whether to participate or not. Therefore, as well as what the research is about, you need to include details such as - what they will be asked to do, how long their involvement will last, who the research is for, the researchers/investigators involved, financial considerations, any potential harm/distress and any other pertinent information to allow anybody to make decision to be involved. You also need to ensure that you include details on withdrawal from the research, clearly specifying whether withdrawal can happen at any point, or should have happened by a certain point beyond which it is not allowable. Clarity is the key.
Click here to download a UCLan Participant Information Sheet template
Q – Is written consent always required?
A – There are instances where written consent may not be possible and/or appropriate (e.g. public observation; ethnographic research). If this applies to your project please provide full details explaining what the circumstances are that do not allow written consent; or where the research will be compromised if written consent is requested.
Click here to download a UCLan Consent Form template
Q – Why, and when, would I need to give participants a debrief sheet?
A – Some projects require that the participants are not told at the start what the actual research aim is for the activity that the participant is asked to do, as to do so would compromise and distort the results. E.g. someone researching violence or aggression may not tell his/her participants that is what is being done, as it would compromise their response. In these circumstances, a debrief sheet is required and should be provided to participants at the end of their involvement to ensure that they are aware of the real reasons for the research, and are still happy to have their data considered.
Q – I am a research student – who is responsible for submitting an ethics application for my research degree programme?
A – You and your Director of Studies are jointly responsible for submitting an ethics application and we would strongly recommend that all members of your supervisory team have reviewed and approved your ethics application. However, your first stop is to look at the Ethics Check List, to make sure that approval is required. Please visit the Document Library on our website where you will find it
Q – I am a research student and my work involves accessing and analysing records / data that are in the public domain – does this require ethical approval?
A – Ethical approval – no; Ethical Clearance – yes. Ethical Clearance is a straight forward process of submitting your approved RDSC2 form and a completed Ethics Checklist for process by Chairs Action
Q – I am a research degree student but my work does not involve human participants – do I still need to go through ethics process?
A – Yes, all research degree student projects need to be ethical reviewed. In the first instance, review the Ethics Checklist and if all answers are ‘No’ submit for Ethical Clearance (referee approved RDSC2 form and the completed Ethics Checklist). If any answers are ‘Yes’ then a full ethical approval application will need to be submitted.
Lack of detail - As a researcher you will know your project in minute detail – an ethics committee can only work with the information you provide, they cannot make assumptions, so always provide exact details
Missing documentation – If a document is referred to in your ethics form (e.g. information sheet, poster/advert, etc) please make sure that this is also submitted
On participant information sheets or recruitment communications, don’t use phrases that presume participation, i.e. Dear Participant!
When communicating with proposed participants restrict the use of technical jargon or professional acronym. Where these are necessary, provide an explanation and always use lay terms – get someone from outside your discipline to read and check that they understand everything!
Don’t make claims regarding the benefits of the work that cannot be demonstrated, far better to state that there are no direct benefits to participants
If the activity or subject matter is likely to be distressing – provide more detail on specifically what will be distressing, so that a participant can make a fully informed decision. Remember also to include details of help and support information (web links, contacts, etc) and where possible make sure expert help is on hand (don’t offer to provide support yourself if you are not qualified – and, even if you are, you will have conflict of interest so ensure that your participants are referred elsewhere)
Typing and grammatical errors – get colleagues, friends, family to proofread.