Which ethics committee should I apply to?
There are currently the following different application routes for staff and students within UCL whose projects require research ethics approval:
- Research Ethics Committees falling within the UK Health Departments' Research Ethics Service (including NHS RECs and the Social Care Research Ethics Committee through the National Research Ethics Service (NRES) in England, and equivalent Research Ethics Services in Scotland, Wales and Northern Ireland).
- UCL Research Ethics Committee.
First check that your study does not require ethical approval from a Research Ethics Committee falling within the UK Health Departments' Research Ethics Service as detailed below. If it does not, and your study falls under the review requirements of the UCL Research Ethics Committee (REC), then you will need to apply to the UCL REC. The following guidance will help you to ascertain which committee you should apply to.
Research Ethics Committees falling within the UK Health Departments' Research Ethics Service
The UK Health Departments have revised their review requirements known as the harmonised Governance Arrangements for Research Ethics Committees (GAfREC) for the kinds of research activity which must be ethically approved by a Research Ethics Committee within the UK Health Departments' Research Ethics Service. The circumstances where a research project may need ethical approval through this route are summarised below.
- potential research participants identified from, or because of, their past or present use of NHS healthcare (UK-wide), Adult social care (England, Wales and Northern Ireland), Children’s social care (Wales and Northern Ireland) and services provided under contract with the private or voluntary sectors including participants recruited through these services as healthy controls.
- potential research participants identified because of their status as relatives or carers of past or present users of these services.
- Xenotransplantation (i.e. putting living cells, tissue or organs from animals into people).
- health-related research involving prisoners in the custody of the National Offender Management Service, Scottish Prison Service and Northern Ireland Prison Service.
- social care research projects funded by the Department of Health.
- patients (or information about patients) who are cared for in private and voluntary sector nursing homes (in England, Wales and Northern Ireland) and/or residents (or information about residents) of residential care homes (in Northern Ireland only).
- exposure to ionising radiation.
- medical devices that are not CE-marked (i.e. not compliant with European Directives) or CE-marked medical devices that have been modified or are being used for a new purpose;
- investigational medicinal products;
- practising midwives conducting a clinical trial; or
- protected information from the Human Fertilisation and Embryology Authority Register.
- people who lack (or lose) the capacity to give informed consent to take part (or to keep taking part) in the research.
- collection of tissue (i.e. any material consisting of or including human cells) or information from users of these services; or
- 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 without consent where this could breach confidentiality.→ Tissue Flowchart
Use of Human Tissue
Further details and information on how to apply through this route is available from the National Research Ethics Service (NRES): www.nres.nhs.uk but please also contact the Joint Research Office: http://www.ucl.ac.uk/jro who can give the appropriate advice.
It should be noted that some studies that fall outside of the review requirements of the UK Health Departments' Research Ethics Service will still also require approval/management permission from the host care organisations, often called R&D approval. For all UCLH, RFH and Institute of Neurology staff undertaking medical research the Joint Research Office provides all the information for i) R and D approval at UCLH; ii) Research contracts with UCLH both commercial and non-commercial; iii) for research governance and keeping your study legal; iv) training and education in research governance; v) collaborations with statisticians.
Please note that Multi Research Ethics Committee (MREC) approval may be necessary if it is a multi-centre study (i.e. involving more than one research site).
The UCL Research Ethics Committee
Ethical approval is required through the UCL REC if a specific research project is:
- a non-NHS study involving human participants and the collection and/or study of data derived from living human participants undertaken by UCL staff or students on the UCL premises and/or by UCL staff or students elsewhere;
- a study involving NHS staff recruited as research participants by virtue of their professional role;
- a study on NHS premises, involving healthy volunteers not recruited as NHS patients and not subject to any legal requirements;
- a clinical trial conducted overseas;
- a 'mechanistic' study in which a drug is used to investigate a physiological process in healthy volunteers;
- a study involving a CE-marked medical device that has not been modified or is not being used for a new purpose.
- involves more than minimal risk
to ensure that the research conforms with general ethical principles and standards unless:
- the only involvement of human participants in particular research activities will be one or more of the categories listed in our → exemptions in which case the research will be EXEMPT from ethics approval unless approval is specifically required by an external funding body or other external body in order to obtain research permission;
- UCL staff are involved as co-researchers in a project led by a Principal Researcher from another UK institution and ethics approval has been granted by that institution. Please note that for studies conducted overseas, ethical approval from both a UK and a local institution is required.
If research is exempt from formal approval under the following criteria, it is still expected that UCL researchers will abide by the appropriate ethical guidelines of their discipline.
Department Heads have final judgment as to whether a particular activity should be exempt from the requirement for approval by the UCL Ethics Committee. But note that the exemptions do not apply to research involving vulnerable participants (e.g. mental patients, prisoners), children, fetuses, pregnant women or human in vitro fertilization.
Exemption from approval by the UCL Ethics Committee DOES NOT IMPLY that the research is also exempt from registration with the UCL Data Protection Officer nor from UCL Risk Assessment procedures.
If your study is not exempt from ethical approval you will need to submit an application to the UCL Research Ethics Committee. Please follow the steps on our → Procedures for Applicants page.
When the researcher is based at UCL but conducting research outside Britain, or in the case of collaborative research with international institutions, the researcher should, where possible, refer to international guidelines for the country where research is being carried out in addition to applying for approval from the UCL Research Ethics Committee. In cases where ethical or legal permissions are required from local organisations or gatekeepers, it is the researchers responsibility to ensure that these have been obtained prior to commencing the study.
The → ICoHPS listing compiled by the Office for Human Research Protections, US Department of Health and Human Services provides details of Research Ethics Committees in over 100 countries. It is also recommended that researchers regularly check the → British Foreign Commonwealth Office website for further details and travel advice for the country they are planning to travel to.