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Joint Research Management Office

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Conducting research with human participants (outside the NHS)

Who are we?

Queen Mary Ethics of Research Committee

The Queen Mary Ethics of Research Committee (QMERC) provides ethical scrutiny of research projects conducted by Queen Mary researchers. It exists to provide approval and oversight of research and works to ensure that research at Queen Mary is always conducted with full awareness of the ethical issues, and necessary precautions are taken to preserve the highest ethical standards.

Any research involving human participants (including human data or human tissue) may give rise to ethical risks and researchers must take steps to manage these risks effectively. To ensure that high ethical standards are maintained policies and procedures must be followed. Our Standard Operating Procedure sits alongside the Queen Mary Policies on Research Integrity and Research with Human Participants.

The QMERC administration and management of projects sits within the Joint Research Management Office (JRMO).

What do we review?

Who should apply?

We invite applications from Queen Mary researchers, who are planning to conduct research using Queen Mary premises or facilities, or conducted at sites elsewhere but led by Queen Mary staff.  We review applications from all disciplines across all Schools and Institutes. 

We work closely with our colleagues in the JRMO Governance team, and in some circumstances, where the study procedures are classified as high risk and/or interventional, the proposal may also require formal sponsorship from Governance via a process known as ‘dual review’.

International Research: if all the research sites are international and/or the work is not funded by Queen Mary, researchers who are members of the staff or students of Queen Mary may be required, or may request a voluntary review, from the QMERC. 

If you are unclear whether ethical approval is required, from the QMERC or any other ethics committee, please contact us for advice.

Please note: If research is undertaken without appropriate ethical approval it puts all parties at risk; not only the research participants, but the researchers themselves, other Queen Mary staff, and Queen Mary’s institutional reputation.

Who need not apply?

Where there is a legal requirement for NHS REC review (see below for examples of such studies), there is no need for additional ethical review from the QMERC.

NHS Research Ethics Committee approval is a legal requirement for certain types of studies including (but not limited to) the following:

  • Any clinical trial that involves an investigational medicinal product, device or intervention that is regulated by the Medicines & Healthcare products Regulatory Agency (MHRA);
  • NHS Patients: potential research participants identified in the context of, or in connection with, their past or present use of NHS services, including participants recruited through the NHS services as healthy controls;
  • Carers and relatives of NHS patients: potential research participants identified because they are relatives or carers of patients or service users of the NHS;
  • Intrusive procedures with adults who lack the capacity to consent for themselves, including participants retained in a study following the loss of capacity;
  • Collection of tissue or information from past and present NHS patients, including those who have died within the last 100 years; and
  • Storage of relevant material human tissue from the living or deceased on UK premises (excluding Scotland), without an appropriate licence from the Human Tissue Authority (HTA).

The above is not an exhaustive list of all the types of study that the NHS REC needs to review.  For confirmation of whether or not your study requires an application to an NHS REC, complete a short questionnaire on the HRA website.

For full details of the NHS REC remit and review, see the information about Governance Arrangements for Research Ethics Committees (GAfREC) on the HRA website. and the document itself here (accessible only to Queen Mary staff and students). 

If your study requires NHS REC review, you should contact the JRMO Governance team on research.governance@qmul.ac.uk 

If you are unclear whether ethical approval is required, from the QMERC or any other ethics committee, please contact us.

Applications

For the majority of studies, the lead applicant will be required to complete a standard application form and it will be reviewed by a Panel of the Research Ethics Committee.  However, there will be some studies that are unusual or pose a higher risk to researchers, participants or the University, which will require review by the Main REC.  Furthermore, some low-risk studies are eligible for our fast track process.

Standard applications

To apply for ethical approval from the QMERC Committee:

  1. Download and complete the Application for obtaining ethical approval from the QMERC [DOC 109KB] which includes templates for Participant Information Sheets and Consent Forms
  2. Send a signed copy of this form (e-signatures acceptable) to the Facilitator of the QMERC: research-ethics@qmul.ac.uk 

For assistance with completing the application form, please refer to the QMERC Application Guidance Notes [PDF 148KB]

guidance here: QMERC Application guidance notes.

On receipt, your application will be validated and allocated to the next available panel meeting. To facilitate the review of your application, and to allow the Committee to understand your study better, the lead applicant will be invited to attend the meeting (for details see the Committee Meetings section below).

On receipt of your standard application, an assessment will be made about the risk and the nature of your study and if it deemed high risk, you will be notified and the application will be reviewed at a meeting of the full REC (as opposed to a Panel meeting).

Fast Track (Expedited) Review

Research that is classified as ‘extremely low risk’ (after being assessed as such via our ‘Fast Track’ application form) may be approved in an expedited fashion. Such work typically concerns non-vulnerable adults as participants, with non-contentious subjects being the focus of the research.

Applications can be made via an online application form (accessible only to Queen Mary staff and students with intranet access) or please complete the Word version of this Fast Track Application Form [DOC 69KB] and submit by e-mail. You will receive an acknowledgement within fifteen working days. Please note that the lead applicant is not invited to attend the REC meeting.

The Committee

Committee Membership

The Committee is comprised of a range of academic, research staff and student representatives from across the University representing all of the Schools; led by a lay independent Chair, supported by a Deputy Chair.

Committee Meetings

Panel meetings

These Committees review Standard Applications and are held approximately every three weeks; the deadline for receipt of applications is three weeks in advance of the meeting date. The lead applicant is invited to attend and if in attendance, will receive informal verbal feedback on the day, with written responses sent shortly after.

Click here for the dates of Queen Mary Ethics of Research Committee meetings.

Main meetings

This is a meeting of the entire REC membership and takes place once a semester.  The purpose of these meetings is high-level policy and procedural discussions and debate of the more complex applications that qualify for full REC review, either by their nature or as a referral from a REC Panel.

Decisions, responses and approvals

Following the Committee’s review, the lead applicant will receive a written response advising on the outcome.  The options available to the Committee are any one of the following:

  1. Approved
  2. Approved: with advisory points
  3. *Conditional Approval: with specific conditions
  4. Referred to Main Committee: upgrading the review from Panel to Main Committee to reflect the risk, significant ethical issues or sensitive nature of the study
  5. Referred to NHS or other external Ethics Committee
  6. *Deferred: in the case where the Committee considers the proposal to require significant further work or information
  7. Rejected

* Conditional Approval and Deferment opinions are valid for three months from the date of issue. The lead applicant has a maximum of three months to reply to the Committee’s outcome letter, and if this date is passed the application will be withdrawn.

Amendments and oversight

Amendments

Should your study require amendment after approval, please contact the Facilitator for guidance about the type of Amendment and the process to be followed for further approval. Amendments will be classified as Major or Minor.

Some examples of Major amendments:

  • Changes to the design or methodology of the study, or to background information likely to have a significant impact on its scientific value;
  • Changes likely to have a significant impact on the safety or physical or mental integrity of participants, or to the risk/benefit assessment for the study;
  • Significant changes to study documentation such as participant information sheets, consent forms, questionnaires, letters of invitation;
  • A change of sponsor or the insurance or indemnity arrangements for the study;
  • Appointment of a new lead applicant; or
  • Any other significant change to the original REC application.

Some examples of Minor amendments:

  • Minor changes to the protocol or other study documentation, e.g. correcting errors, updating contact points, minor clarifications;
  • Short time extensions; or
  • Additional named student researchers.

Researchers should be aware of the number of Amendments per application is, outside of exceptional circumstances, limited to one major and two minor amendments per study.

Unexpected Deviations

Please contact the Facilitator - research-ethics@qmul.ac.uk - in case of any unexpected events or deviations from the proposed protocol as per the original QMERC application.

Annual Progress Reporting

You should complete an Annual Progress Report [DOC 52KB] form on the 12-month anniversary of the QMERC’s approval letter and every year after that.  Please complete and submit it by email to the Facilitator: research-ethics@qmul.ac.uk 

End of Study notification

Should your study start and finish as planned within a year, please complete the End of Study Notification [DOC 52KB] and submit it by email to the Facilitator: research-ethics@qmul.ac.uk 

Guidance and useful links

Contact us

If you have any queries about the research ethics approval process, please contact the Research Ethics Facilitator in the first instance.

Research Ethics Facilitator, Hazel Covill
Email: h.covill@qmul.ac.uk / research-ethics@qmul.ac.uk
Tel: 020 7882 7915 (Monday and Wednesday) / 0207 882 6947 (Tuesday and Thursday)

Research Support & Development Manager, Katherine Ouseley
Email: k.ouseley@qmul.ac.uk
Tel: 020 7882 8002 (Tuesday, Wednesday and Thursday)

Postal Addresses:

The QMERC staff are based at the JRMO Whitechapel and Mile End offices:

Whitechapel Address
Joint Research Management Office (JRMO), Queen Mary University of London, QM Innovation Building, Lower Ground Floor, 5 Walden Street, London, E1 2EF

Mile End Address
Room W104, Queens' Building, Queen Mary University of London, Mile End Road, London, E1 4NS

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