City, University of London, has an agreed Governance Framework for Good Practice in Research which applies to all staff and students who are engaged in or support research activity. It is designed to establish and promote a code of good practice in the conduct of research, to encourage members of this institution to maintain the highest achievable standards in their research conduct, to ensure that the ethical and scientific quality of research conducted by members of this institution is safeguarded and to document the procedure for investigating allegations of misconduct. Before commencement, all new research proposals involving human participation must undergo formal ethical peer review. 'Human participation' covers direct data collection from participants and it also includes retrieving personal data from individual records.
The School of Health Sciences Research Governance Policy reflects this framework and ensures the regulation, monitoring and quality assurance of all research projects which involve human participants or their data. This policy encompasses all research undertaken in the School, including:
- Funded projects
- Unfunded projects
- Research undertaken as part of an educational programme such as a BSc, MSc or Research Degree.
Secondary analysis of anonymised data that is published or otherwise disseminated does not require ethical approval. Analysis of routinely collected anonymised data which does not contain personal information does not need approval either as long as permission has been given by the data owner. Literature reviews or reviews of published or otherwise disseminated material does not require ethical approval. If in doubt you should discuss this with the chair of the School of Health Sciences Research Ethics Committee (SHS REC).
City's Senate Research Ethics Committee is responsible for considering the ethical implications of all research and staff conduct at City, University of London. The School of Health Sciences has its own Research Ethics Committee (REC) which reports to the Senate REC. The ethics approval process is designed to protect research participants and to ensure that the research conducted in the School meets the highest ethical standards.
Research involving human participants or their data can be approved at School level (SHS REC), Institutional level (Senate REC) or by an appropriate external ethics committee (such as NRES). There is also a proportionate review system for low risk projects within the Divisions of Language & Communication Science and Optometry. If this may apply to you, please follow download the Framework for delegated authority - Appendix 1. Low risk projects from other divisions must go through SHS REC. If there is sufficient demand, the proportionate review system can be extended to other divisions within the School.
The School's REC also provides assistance to staff and students through the provision of:
- Compliance and policy advice
- Approval of research protocols.
Please read the following guidance carefully and refer also to the FAQs before making an application for ethical approval.
In order to determine where you should present your project for approval please follow the guidance set out immediately below.
You must make a full application to Senate REC or The National Research Ethics Service (NRES) which encompasses the NHS, (unless otherwise directed below) if you answer "Yes" to any of the following questions. If you are in any doubt as to whether the answer is "Yes" or "No" you should speak to Dr Nick Drey, Chair of SHS REC.
If all the questions are answered "No" then the ethical approval can be managed by SHS REC.
- Will the study recruit patients and or their relatives or carers through the NHS, or access their medical records or personal details. (Such research will require NRES approval, please see the National Research Ethics Service website for further details.)
- Does the study involve participants who unable to give informed consent, for example, but not limited to, people who may have a degree of learning disability or mental health problem, that means they are unable to make an informed decision on their own behalf. (Such research needs to considered by a duly authorised NRES committee if participants fall under the Mental Capacity Act 2005 and not Senate REC, please see the National Research Ethics Service website for further details.)
- Will any participants be recruited who are currently under the auspices of the Criminal Justice System, for example, but not limited to, people on remand, prisoners and those on probation? (NB Such research needs to be authorised by the ethics approval system of the National Offender Management Service and not Senate REC, please see guidance from The Offender Health Research Network, further details.)
- Is there a risk that the highly sensitive nature of a research topic might lead to disclosures from participants concerning their own involvement in illegal activities? If Yes, Senate REC approval will be required.
- Is there a risk that obscene and or illegal material may need to be accessed for the research study? Including online content and other material? If Yes, Senate REC approval will be required.
- Does any part of the research involve the researcher travelling to another country outside of the UK, where the Foreign & Commonwealth Office has issued a travel warning? If Yes, Senate REC approval will be required.
- Are drugs, placebos or other substances, for example, but not limited to, foodstuffs or vitamins, to be administered to study participants or will the study involve invasive, intrusive or potentially harmful procedures of any kind. These may include for example, but not limited to, electrical stimulation, heat, cold or bruising. If Yes, Senate REC approval will be required.If you have answered No to all these questions then your application can be considered by the SHS REC.
Applications to Senate REC
You should follow the guidance set out on the Senate REC web pages.
Application to the School of Health Sciences REC
You will need to complete: Application for Approval of Research Involving Human Participants and a Research Registration Form (EC3). The University is in the process of rolling out a new low risk form for projects that involves human participants (guidance to be provided), (this still requires an EC3). These should be forwarded electronically to Alison Welton.
Applications to The National Research Ethics Service (NRES)
If you are applying for NRES approval you will need to follow their guidance. Additionally you will need to show that you have provisional indemnity to cover your application. In order to get this you will have to complete the Research Registration Form (EC3) and return it to Alison Welton. (For more details please see FAQs). You will also need to obtain sponsorship for your application (a signature from your Head of Division or the Associate Dean for Research)
Applications to the National Offender Management Service
Please discuss these with the Chair of the SHS REC.
Dr Nicholas Drey
Chair Research Ethics Committee
Research Governance Officer
- Why do I need to register my research project with the School?
- What needs ethical approval?
- Where should I go for my ethical approval?
- How do I obtain Indemnity Cover for my research project?
- Who should I contact in order to recruit School Staff or Students for my research project?
- What is a Project Audit?
- Should my research proposal be peer-reviewed?
- How do I obtain a Research Passport or an Honorary Contract in order to undertake research in the NHS?
- Can I undertake research abroad?
- Can I amend my project or extend the approval period?
- Links to useful information
Why do I need to register my research project with the School of Health Sciences?
For all research projects involving human participants or their personal data which start after 1st February 2003, a brief Research Registration Form must be completed and submitted through the School Research Ethics Office.
You will need to do this if you are an MSc or Research Degree student undertaking a course at the School, or if you are a member of staff.
The pro-forma will be used to register the project on the School Research Information System and may be used to make summary details publicly available. The pro-forma should be submitted to the School of Health Sciences Research Ethics Committee (SHS REC) which will review the Research Registration Form and undertake further action if necessary, you will be contacted by the chair to discuss any potential issues. City will provide provisional indemnity for NRES applications on the basis of this form.
What needs ethical approval?
This is a valued judgment. Literature reviews and the use of routinely available data with open access do not normally require ethical approval. Work-based project may require ethical approval as may research projects.
City, University of London, requires that all research projects involving people, human tissue, personal data or animals must have ethical approval. Similarly, the NHS requires ethical approval if research involves patients, their carers and families, their tissue or archived material relating to any of the above. Research undertaken in the criminal justice system may also need separate approval.
If you are in doubt you should consult Nick Drey, Chair, SHS REC.
Where should I go for my ethical approval?
Research involving human participants or their data can be approved at School level, Institutional level (Senate Research Ethics Committee (REC)) or by an appropriate external ethics committee such as National Research Ethics Service (NRES).
a. potential research participants identified from, or because of, their past or present use of the NHS services (including services provided under contract with the private or voluntary sectors), including participants recruited through these services as healthy controls;
b. potential research participants identified because of their status as relatives or carers of past or present users of these services;
c. collection of tissue (i.e. any material consisting of or including human cells) or information from users of these services; or
d. use of previously collected tissue or information from which individual past or present users of these services could be identified, either directly from that tissue or information, or from its combination with other tissue or information in, or likely to come into, the possession of someone to whom the tissue or information is made available.
The NHS makes a distinction between research, service evaluation and audit. Only research needs ethical approval from NRES. The NRES website explains the difference. If in doubt you should check with your local R&D department and NRES. There is also a useful algorithm for determining whether your project is audit, service evaluation or research and where in the NHS you need to get permissions from.
Projects defined as audit or service evaluation may still need City, University of London, approval, particularly if they involve interviewing anyone or administering a questionnaire. Please check with Nick Drey, Chair, SHS REC.
You should apply for NHS REC approval through NRES and liaise closely with the R&D department(s) in the NHS Trust(s) where you will undertake the work. You will need to obtain Provisional Indemnity & Sponsorship (Please see related FAQs). If you are applying for NRES approval you should read the Research governance framework for health and social care: Second edition. There is also a very useful resource for researchers in the NHS from the Health Research Authority, you are advised to follow the advice and guidance you find there.
If your research involves the criminal justice system, offenders, those in prison or on probation you should consult the Offender Research Network for guidance.
For research that is not covered above you should apply initially to the SHS REC at City, University of London. Exceptionally projects that are considered high risk will be seen by Senate Research Ethics Committee but you should approach the chair of the SHS REC Nick Drey in the first instance.
How do I obtain Indemnity Cover for my research project?
Once a completed Research Registration Form is received and approved, the School Research Office will provide the researcher with a provisional indemnity letter. This letter offers the provisional indemnity that is required for a NRES Research Ethics Committee application. Researchers will NOT be FULLY covered until they submit a letter of ethical approval from the NRES Research Ethics Committee. At this point the School Research Office will provide a full indemnity cover letter.
Indemnity cover is provided in the form of Employer's Liability, Public and Products Liability, Clinical Trials/ No Fault Compensation, and Professional Indemnity.
Projects going through Senate REC, do not require provisional indemnity. Full indemnity will be given to the applicants when they get final ethical approval from Senate REC or SHS REC.
Who should I contact in order to recruit School Staff or Students for my research project?
Projects which involve the recruitment of School staff or students require approval by the School. This ensures that the same group of staff or students are not repeatedly contacted to become involved in research projects. Principal investigators should not contact students or staff directly. Your application to the committee should include a brief summary outlining which students or staff you wish to recruit, the aims of the study, and the methodology. Initially you should contact Nick Drey, Chair, SHS REC to discuss this.
What is Project Audit?
City, University of London, may check active projects by requiring principal investigators to complete a brief progress report. These reports will be audited by the Senate REC may require further investigation of a project if a progress report is not submitted or problems are identified.
Should my research proposal be peer-reviewed?
The Research governance framework for health and social care: Second edition states that: All proposals for health and social care research must be subjected to review by experts in the relevant fields able to offer independent advice on its quality.
To meet the requirements of the NHS Research Governance Framework, all research projects must therefore undergo a peer review process before an NRES REC can assess them. A peer working in an appropriate field of research, preferably one external to this institution should complete a peer review form.
Applications to the Senate REC do not require peer review.
How do I obtain a Research Passport or an Honorary Contract in order to undertake research in the NHS?
The Department of Health Research Governance Framework makes the requirement for a research passport or honorary contracts explicit. It states that researchers who do not have a paid contract with a NHS body but whose research involves NHS patients, their organs, tissue or data must have a research passport or an honorary contract with a NHS body.
You can find details here of how to obtain a Research Passport. Staff requiring a Research Passport should contact Alana Graham in the HR department and have made themselves familiar with the requirements for a Research Passport from the link above.
Students who require a research passport should contact Tracy Rowson in the Research Office and have made themselves familiar with the requirements for a Research Passport from the link above
Background information on Research Passports
It is a requirement that anyone working with NHS patients, patient records or on NHS premises to perform a research related activity, has in place appropriate local access arrangements (i.e. a Letter of Access or an Honorary Contract for each NHS Trust).
If you are not an NHS employee then one way to start the process of securing access to several NHS sites is through the Research Passport scheme. That scheme allows appropriate checks and confirmations to be undertaken in conjunction with your substantive employer just once, up front - rather than at each Trust. It creates a form (the Research Passport) which can be shown to each NHS Trust so allowing them to grant appropriate access arrangements without undertaking further local checks.
Whether the outcome is a Letter of Access or an Honorary Research Contract depends on whether the research activity has a direct impact on the clinical care of the patients involved in that research. Most frequently it does not, and a Letter of Access is the usual outcome. However, the final decision as to which form of access is issued is a matter for each Trust's R&D office.
Research passport required
If you and/or your team require a research passport to secure access at an NHS Trust the Trust's R&D office will issue you with the relevant form (i.e. a research passport application). This is completed by the Principal Investigator, the researcher and the School Human Resources team, before being presented to the lead NHS Trust's R&D office for a counter-signature.
There are two mandatory employment checks that must be undertaken before a research passport could be issued.
- Occupational health (OH) clearance - a recent OH health check is usually required to support a Research Passport form. This check encompasses an up to date status on immunizations depending on the nature of the research undertaken. Where an applicant is unable to provide written proof that they already have these immunizations then it will need to taken again.
The applicant will also be required to give a detailed summary of the nature and extent of involvement with patients/human tissue based on the application made to the Trust. The HR department can provide you with the OH form should you need to make an application.
- DBS (Disclosure & Barring Service - formerly CRB) check - which must be less than 6 months old at the time it is presented to the lead NHS R&D office. That check will then remain valid for as long as the Research Passport (a maximum of 3 years).
The NIHR website has comprehensive information about this process.
Can I undertake research abroad?
Research undertaken abroad can pose many potential problems for researchers because of different legal and regulatory systems, and cultural mores. It is difficult to have concrete guidance as each country and research situation is likely to be different. Researchers must ensure they comply with local regulations and laws. In order to do this it is advisable to have a local investigator who is familiar with the laws and regulations of the host country, who will be in a position to guide and advise researchers from City, University of London. All regulatory procedures of the host country must be complied with, including any requirements for research ethics approval.
Projects should also have a local contact for complaints as well as the standard City contact for complaints. The reason for this is that participants may feel inhibited or unable to complain to City, University of London, for reasons of cost, language, literacy and culture; the local contact can pass written and verbal complaints onto City.
Projects will still need ethical approval from City, University of London. It is anticipated that the views of the local research ethics committee will be deferred to in most instances, and we will make an effort not to review the research twice. The reason for review at City is to ensure a consistent approach to the ethics of research across all research projects in the School of Health Sciences, and also to take account of the fact that some countries have advanced and comprehensive systems to review the ethics of research, whereas in others it may be rudimentary or non-existent.
When conducting research overseas it is important to carry out a Health & Safety Risk Assessment which should be signed off by the appropriate Divisional lead.
If you are undertaking research abroad it would be a good idea to seek some guidance before making the application from Nick Drey, Chair, SHS REC.
Can I amend my project or extend the approval period?
If you wish to amend a project which has ethical approval from NRES you can seek minor amendments from the Chair of the NHS REC that you submitted your application to. Major amendments are likely to require a resubmission. The Health Research Authority has guidance here.
The period of ethical approval can normally be extended in discussion with the REC that granted the original approval.
If you wish to amend a project that has approval from the SHS REC you should initially approach the Nick Drey. Minor amendments can usually be approved by Chair's Action; more substantial amendments may require a resubmission of your application. Extensions to the one year ethical approval can be sought from the Chair.
For projects with approval from Senate REC you should contact Anna Ramberg in the first instance.
For amendments or extensions to City, University of London approvals you should use this form.
Download the NRES application form
Links to useful information
|REC Meeting dates||Latest submission dates for paperwork|
Wednesday 21 September 2016
Tuesday 6 September 2016 - by 5.00pm
Thursday 24 November 2016
Wednesday 9 November 2016 - by 5.00pm
Wednesday 25 January 2017
Tuesday 10 January 2017 - by 5.00pm
Thursday 23 February 2017 (MRes applications)
Wednesday 8 February 2017 - by 5.00pm
Wednesday 22 March 2017
Tuesday 7 March 2017 - by 5.00pm
Thursday 18 May 2017
Wednesday 3 May 2017 - by 5.00pm
Wednesday 5 July 2017
Tuesday 20 June 2017 - by 5.00pm
The following documents provide further details of the School Governance System:
- Frequently Asked Questions
- SHS guidelines and procedures for authorising an IRAS form Feb 17
- Policy and Procedures School of Health Sciences Research Ethics Committee
- Senate Research Ethics Committee Guidance
- Application for Approval of Research Involving Human Participants
- Research Registration Form (EC3)
- Guidance on the data protection act for researchers - Research and the Data Protection Act 1998
- Researcher's checklist for compliance with the Data Protection Act, 1998
- Lone working procedure
- Procedures for study closure
Current SHS REC membership November 2013
|Name||Internal (I) / External (E)||Member from||Role|
|Nick Drey (Chair)||I||2008||SL Health Services Research|
|Ron Douglas (Deputy Chair)||I||2008||Prof of Visual Science|
|Julia Jones (Deputy Chair)||I||2008||Reader in Mental Health|
|Eamonn McKeown (Acting Deputy Chair)||I||2012||Lecturer, Health Services Research|
|Rachel-Anne Knight||I||2011||SL Phonetics|
|Kathryn Waddington||I||2009||SL Organisational Psychology|
|Paul Bland||I||2009||SL Diagnostic Radiography|
|Byki Hunttjens||I||2012||Lecturer Optometry and Visual Science|
|Jitka Jancova||I||2013||Lecturer in Adult Health|
|Kathleen Mulligan||I||2013||Senior Research Fellow|
|Rachel Holland||I||2013||Lecturer LCS|
|Gill Craig||I||2013||Senior Lecturer in Disabilities & Social Inclusion|
|Caroline Llewellyn||I/E||2011||Information Assurance Officer|
|Anna Ramberg||I/E||2008||Secretary to Senate REC|
|Deanna Gibbs (BLT)||E||2010||Research Consultant Barts Health NHS Trust|
|Kirti Patel (Sparks)||E||2011||Research manager Sparks (children's medical charity)|