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.

• Research involving patients or service users of NHS healthcare (UK-wide), Adult social care (England, Wales and Northern Ireland) and Children's social care (Wales and Northern Ireland) including participants recruited through these services as healthy controls;
• Research involving participants identified because of their status as relatives or carers of past or present users of these services;
• Research involving the collection of information from any users of these services, or access to/processing of confidential information of patients/service users by researchers outside the normal care team without the person's consent;
• Research involving use of previously collected information from which a past or present user of these services could be identified;
• Research involving xenotransplantation;
• 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;
• Research involving 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);
• Research involving exposure to ionising radiation;
• Clinical investigations of (not simply using) 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;
• Clinical trials of investigational medicinal products;
• Clinical trials involving the participation of practising midwives;
• Research involving protected information from the Human Fertilisation and Embryology Authority register;
• Research involving participants from the UK Armed Forces, or research funded/sponsored by the Ministry of Defence (such studies will need to gain ethical approval through the Ministry of Defence Research Ethics Committees (MoDREC).
• Research involving any individual over the age of 16 who lacks (or loses) the → mental capacity to give informed consent to take part (or to keep taking part) in the research.

The Mental Capacity Act 2005 (MCA) provides a statutory framework for people who may not be able to make their own decisions, for example, because of learning difficulties, brain injury or mental health problems. It sets out who can take decisions, in which situations, and how they should go about this.

If you propose to conduct a research project that comes within the remit of the MCA:

• It applies to 16-17 year olds and adults (18 years and over) who lack capacity to make a particular decision or take a particular action for themselves at the time the decision or action needs to be taken.

• Guidance on the Act notes that lack of capacity may be permanent or temporary. It could be state-related (e.g. due to drug or alcohol use) or the person concerned could gain capacity for decision-making or action (within the legal definition) with appropriate support/training. The key point is whether they have capacity at the time.

then approval from a REC operating under the National Research Ethics Service will be required. You should note that research projects can be approved under the Mental Capacity Act only if the research cannot be carried out without the participation of individuals with the 'impairing condition' and the research is specifically connected to that impairing condition.

Please contact the UCLH/UCL Biomedical Research Unit or refer to the NRES webpages for guidance.

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• Research involving human tissue from the living or deceased. There are certain circumstances where ethical approval through the UK Health Departments Research Ethics Service is a legal or policy requirement for research involving the collection/use of human tissue. The requirements are complex, so it is recommended that you consult the NRES website for further guidance and also consult the following → flowchart which will influence whether your study can be reviewed by the UCL Research Ethics Committee.

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.

R&D Approval
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

All research proposals involving human participants and the collection and/or study of data derived from living human participants undertaken by UCL staff or students on UCL premises and/or by UCL staff or students elsewhere → requires ethical approval to ensure that the research conforms with general ethical principles and standards unless:

1. 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;
2. 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.

International Research
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 International Compilation of Human Research Standards
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.

 

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