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School of Health Sciences

Frequently Asked Questions

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, University of London, 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).

In order to determine where you should present your project for approval please follow the guidance set out here. You may need NRES approval if your research is likely to cover the following:

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 will act as Sponsor for my research project?

NRES applications require sponsorship. The sponsor is usually the main funder of the research. However, where this is not appropriate the educational institute, will act as the sponsor. City, University of London is part of the Department of Health list of approved sponsors.

It is the researcher's responsibility to ensure that the sponsor is aware of their research proposal and accepts the responsibilities. In order to obtain sponsorship you should contact your Divisional Lead, or if they are involved in the research the Associate Dean for Research. They will be required to sign your NRES application form, please allow time for this.

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.

Process

There are two mandatory employment checks that must be undertaken before a research passport could be issued.

  1. 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.
  2. 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, University of London.

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.

National Research Ethics Service

Health Research Authority

NIHR Research Passports

Offender Research Network

Research governance framework for health and social care: Second edition