Which ethics committee should I apply to?

There are currently the following different application routes for UCL staff and students whose projects require research ethics approval:

1. NHS Research Ethics Review – any research that involves NHS patients and carers, invasive research involving prisoners or adults lacking capacity, a Clinical Trial of an Investigational Medicinal Product or → human tissue. Please refer to → HRA checklist, → the HRA's decision tool.
2. Social Care Research Ethics Committee (SCREC) – ethical approval is required through SCREC for social care research projects funded by the → Department of Health.
3. Ministry of Defence Research Ethics Committee (MoDREC) – ethical approval is required through → MoDREC for research involving human participants either undertaken, funded or sponsored by MOD in order to meet nationally and internationally accepted ethical standards.
4. University Ethics Review – If your research does not fall into the above categories and it involves human participants, their tissue and/or data should apply to one of the following two ethics committees at UCL:
   EITHER
   UCL Research Ethics Committee – for all UCL staff and students
   OR
   UCL Institute of Education Research (IoE) Ethics Committee – for all IoE staff, students and visitors. The Institute maintains its own REC and policy separate from the UCL REC. For the Institute, all research projects which collect or use data from human participants including secondary data analysis and systematic reviews require ethical approval before the project starts. This includes preliminary and pilot studies. → Further details.

If you are unsure about the type of ethical review that is required please email: ethics@ucl.ac.uk for 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

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.
  OR
• involves → more than minimal risk

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 as defined in our guidelines.

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.

The UCL Committee is not responsible for considering the ethics of research which falls under the remit of Department of Health approved ethics committees who abide by Governance Arrangements for NHS Research Ethics Committee.

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.
• Use of Human Tissue
  • 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

Further details and information on how to apply is available from → NRES website but please also contact the → Joint Research Office 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).

Ethical clearance at UCL involves a two-stage process.

Completed applications are first submitted for departmental endorsement. Departmental endorsement can be via a departmental ethics/research committee or via the head of department. Departmental endorsement ensures:

1. Awareness by the department of proposals being put forward by departmental staff and students.
2. Compliance with the Data Protection Act.
3. Completion of a formal signed Risk Assessment Form.
4. An opportunity for modification of the ethics application before it reaches the UCL Ethics Committee if alterations are deemed necessary and desirable to expedite ethics approval.

Departmental endorsement also offers the department the opportunity to recommend to the UCL Ethics Committee that an application be considered by Chair's action. Such recommendations may be used as appropriate by the Ethics Committee to facilitate its role in making its decision in relation to ethical approval. A recommendation for Chair's action will be deemed appropriate for studies that do not involve:

1. Vulnerable Groups.
2. Intrusive interventions (including MRI)
3. Sensitive topics.
4. Deception.