Ethics

Ethics System

 
The University, following review of proposals, agreed the development of a central Ethics system in 2011. The rationale for this development was essentially three fold. 1) To remove waiting times for ethics approval – in particular where it related to income generation and bids; 2) To align the Ethics SharePoint system with the e-Approve (bids) system to speed up commercial and research income generation/bidding; and 3) To increase consistency and equity of ethics approval systems and protocols across the University.

Ethics is dealt with via three committees (see details below), which as well as the University Ethics Committee (dealing with policy and governance matters), is administered by the Ethics and Integrity Unit within Research Services.

BAHSS (Business, Arts, Humanities and Social Science)
PSYSOC (Psychology and Social Work)
STEMH (Science, Technology, Engineering, Medicine and Health)

Administrators - Alison Naylor (ext 2728); Sinead Baldwin (ext 2397); Chris Riley (ext 4031)
University Officer for Ethics - Emma Sandon-Hesketh (ext 2735)

Please use EthicsInfo@uclan.ac.uk email address.

Click here to see which Committee has responsibility for your School.

The Generic Operating Procedures and Terms of Reference for the three Ethics Committees can be downloaded here.

The central Ethics system deals with applications in relation to staff research - both funded and non-funded, commercial projects and postgraduate research degree student projects.  Undergraduate 3rd Year Dissertation projects as well as Taught PG research proposals are not require to come through the central Ethics system. The University Ethics Committee are happy that Schools may have their own ethics processes, and that the central Ethics system should be used more as the exception, rather than the rule – and normally only where there is ground-breaking or innovative research considered unusual for that level.

HOW TO APPLY

To ascertain whether ethical approval is necessary for your activity, potential applicants should complete the UCLan Ethics Checklist to see whether your project can be exempted from the requirement to seek ethical approval.  

To apply to the relevant Ethics committee, you should complete the current version of the UCLan Ethics Application form (click on relevant link below to download). 

If you are a Research Degree Student (i.e. not taught), please note that ethical scrutiny is required on all postgraduate research student projects once RPA has been gained (e.g. either ethical clearance or ethical approval)- click here for further guidance.

Downloadable forms:

* N.B.  Office365 is now available for UCLan staff and students to download (on either PC or Mac), simply Login at http://portal.office.com and follow instructions.

Your ethics submission (completed application form and all appropriate supporting documentation) should be emailed to the Ethics and Integrity Unit at the EthicsInfo@uclan.ac.uk. Please prefix the subject line of your email with the acronym of the committee that needs to deal with your application.

External Ethical Approval - 

Where external ethical approval has already been gained, then submission for ethical approval at UCLan can use that documentation - click here for further guidance on the relevant submission documentation and process.  

If your project has been approved through the IRAS process (NHS Research Ethics Committee - NREC- application system), please submit all your IRAS paperwork (NREC 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 as opposed to completing the ethics application form.     Click here for further guidance regarding Health Research Authority approval and the requirement for UCLan sponsor sign off/approval on work involving the NHS. 

Please note that, depending on the nature of the project, UCLan Data Protection Checklist and/or Risk Assessment Form may also be required in addition to the external ethical approval documentation. 

REVIEW PROCESS

Applications are dealt with either by Full Review or Chairs Action, depending on the type of project (e.g. approval in principle for bid submission) or whether external ethical approval (e.g. NREC) has already been gained. The ethics committees can make five kinds of decisions on an application:-

1. Outline approval or approval in principle (may include exemption from full review)
2. Approved (either outright, or with recommendations)
3. List specific conditions that must be satisfactorily addressed before approval is granted (may also include recommendations)
4. Re-submission required
5. Reject

Please note that work (e.g. data collection, recruitment/contact with participants) cannot begin until your application has been approved. Additionally, you should seek the opinion of the relevant ethics committee when you are making any amendments to an on-going project previously granted approval. If appropriate, your project can be submitted for ethical approval in phases (with approval granted for each specific phase/stage).

At the end of the project, a closure report is required to be submitted to complete the ethics governance procedures.  Existing paperwork can be used for this purpose e.g. funder's end of grant report; abstract for student award or NRES final report.  If none of these are available please use Ethics Closure Report Proforma.

PRIVACY NOTICE

Personal data provided by researchers in an ethics application/checklist is required by the Ethics and Integrity Unit within Research Services, on behalf of the University, for the purpose of ethics review, and to evidence that the appropriate level of ethics review has been undertaken. Such data will be stored and managed in accordance with the principles established in the General Data Protection Regulations (GDPR) and the Data Protection Act 2018.

UCLan Guidance:
UCLan Ethical Principles for Teaching, Research, Consultancy, Knowledge Transfer & Related Activities
UCLan’s Code of Conduct for Research
UCLan Code of Practice for the Investigation of Allegations of Research Malpractice
UCLan's Concerns Procedure
UCLan's Ethics Committee Guidance on Self Experimentation
Data Protection Guidance (including DP Checklist

Health and Safety Forms
UCLan Insurance Certificates/Letters (for NRES / IRAS applications) - staff access only

National Guidance and Legislation:
Animals (Scientific Procedures) Act 1986
Data Protection Act (1988)
Disclosure and Barring Service (DBS) checks (previously CRB checks)
ERIC  - Ethical Research involving children
EU Clinical Trials Directive (2001/EC)
EU Directive on Medical Devices
Freedom of Information Act
The Human Tissue Authority (HTA)
Human Tissue Action 2004
HTA Code of Practice 9 - Research
Medicines and Health products Regulatory Authority
Mental Capacity Act (2005) - For further information guidance see also the Code of Practice and NRES guidance for applicants for research under the MCA
Medical Research Council (MRC) Data and Tissues Toolkit
MRC/Health Research Authority Consent and Participant Information Sheet Preparation Guidance
MRC Ethics Guide - Medical research involving children
NHS Code of Practice on Confidentiality
NHS Research Ethics Committee (REC) - Proportionate Review Service
National Research Ethics Service (NRES) and INVOLVE's Statement on Patient and public involvement in research and research ethics committee review
[INVOLVE is is a national advisory group that supports greater public involvement in NHS, public health and social care research. INVOLVE is funded by and part 
of the National Institute of Health Research (NIHR).]
RCUK Policy and Code of Conduct on the Governance of Good Research Conduct
UK Office for Research Integrity Code of Practice for Research

Research Ethics Guidance:
American Sociological Association
Association of Social Anthropologists of the UK and Commonwealth Ethical Guidelines
British Academy of Management (BAM) / Chartered Association of Business Schools (CABS) - Ethics Guide 2015
Biotechnology and Biological Sciences Research Council (BBSRC) Joint Code of Practice for Research
British Psychological Society (BPS)
BPS Code of Ethics and Conduct
BPS Guidelines on Internet-mediated Research
British Society of Criminology Code of Ethics
British Sociological Association Statement of Ethical Practice
Engineering and Physical Sciences Research Council (EPSRC): Guide to good practice in Science and Engineering Research
Economic and Social Research Council (ESRC) Research Ethics Framework
Natural Environment Research Council Ethics policy and guidance
Nuffield Council on Bioethics
Social Research Association Ethical Guidelines
World Health Organisation Guidance

Click HERE to access the Ethics SharePoint system (e-Ethics Committee Members only).