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Research Ethics - External Research Ethics Committees (RECs)

It may be the case that the proposed study involves certain ethical considerations that require review and approval from a REC which is recognised by the UK Health Departments. This REC will be part of the National Research Ethics Service (NRES), now part of the Health Research Authority (HRA), or equivalent bodies in Northern Ireland, Scotland and Wales. If you are conducting your proposed study overseas, there will likely be similar ethical approval processes which must be satisfied before the research may begin.

Why do I need to apply elsewhere?

With regard to any proposed research involving ethical parameters that relate to UK Health Department policy or UK law, University Research Ethics Committee (UREC) is not a recognised authority and approval must be sought through the Integrated Research Application System (IRAS).

What is IRAS?

IRAS is a single, unified applications process for ethical approval of research involving health, social care and community based research throughout the UK. Further help on completing the IRAS form is available here.

IRAS Electronic Authorisations

As part of the IRAS approval system, applicants will be required to obtain an electronic authorisation from the Chief Investigator and Sponsor Representative. It is important that the relevant party providing electronic authorisation has a registered account with IRAS, which can be obtained here.

The Chief Investigator may be either the principal investigator for the research or the Director of Studies, where the project is postgraduate student research. A postgraduate research student may not be registered as Chief Investigator for the purposes of authorisation.

In the case of Sponsor Representative, the request for authorisation should be sent to Merlin Harries at m.harries@uel.ac.uk.

I have approval from a UK Health Department REC

If you have pre-existing approval from a UK Health Department REC, you do not need to complete the standard UREC approval process. Please simply forward a copy of your REC approval letter to researchethics@uel.ac.uk and your study will be registered.

NHS Health Research Authority

The UK Health Departments have recently revised Governance arrangements for Research Ethics Committees (GAfREC) (Department of Health, May 2011), with the new requirements coming into effect from 1 September 2011. Under the revised framework, a combination of both UK Health Department policy and UK law, the various ethical considerations requiring review and approval by a UK Health Departments REC are detailed.

With regard to UK Health Department policy, should the proposed research involve the following UK Health Departments or ethical parameters, as indicated in GAfREC (2011), REC review is required. Please note, this list is not exhaustive:

UK Health Department Services

England - Department of Health NHS and adult Social Care
Wales - Department for Health and Social Services NHS and Social Care
Scotland - Scottish Government Health Directorates NHS
Northern Ireland - Department of Health, Social Services and Public Safety Health and Social Care

  • potential research participants identified from, or because of, their past or present use of the services listed above (including 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;
  • collection of tissue (i.e. any material consisting of or including human cells) or information from users of these services;
  • 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;
  • health-related research involving prisoners, for which the National Offender Management Service, Scottish Prison Service and Northern Ireland Prison Service require review by a REC as well as compliance with their own approval procedures;
  • social care research projects funded by the Department of Health, which must always be reviewed by a REC within the Research Ethics Service for England.

In the event that the proposed research does not involve the health or social care services for which the UK Health Departments are responsible, REC approval is required by UK law for studies that involve the following:

  • people who lack (or lose) the capacity to give informed consent to take part (or to keep taking part) in the research;
  • processing of confidential patient information without consent where this would otherwise breach confidentiality;
  • material consisting of or including human cells, which has been taken from the living or the deceased;
  • patients who are cared for in private and voluntary sector nursing homes (in England, Wales and Northern Ireland) and/or 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;
  • protected information from the Human Fertilisation and Embryology Authority register.

For further details on which committee the application should be submitted to please email NRES in the first instance or researchethics@uel.ac.uk. NRES provide the following guidance on establishing whether or not a project needs NHS REC‌ Approval

The Mental Capacity Act (MCA) 2005

As stipulated in the Mental Capacity Act (MCA) 2005, any intrusive research "...carried out on, or in relation to, a person who lacks capacity to consent to it is unlawful". In this instance, 'intrusive' research covers a wide variety of primary data-gathering where the data is not anonymised and there is no breach of the Data Protection Act (DPA) 1998. Intrusive research should not be interpreted as being restricted to medical or scientific research where the data collection is physically invasive.

Participants of the proposed research who may be deemed to lack mental capacity may include those with learning difficulties, a brain injury or mental health problems. If the proposed research involves the recruitment of participants over the age of 16 who may be deemed to lack mental capacity, the MCA requires approval of ethical parameters to be obtained from a research ethics committee that operates under the NRES.

The Department of Health have released a fact sheet for social science research that involves participants who lack capacity.

(NRES) have also released an on-line toolkit, which covers the provisions of the Act in research involving participants who lack capacity to provide informed consent.

For any proposed research involving participants who lack capacity, the Department of Health asks that researchers consider the following:

a) is the research related to the ‘impairing condition’ that causes the lack of capacity, or to the treatment of those with that condition?

If the answer to this question is ‘no’ then the study should proceed without involving those who do not have the capacity to consent to participation. If the answer is ‘yes’ the researchers need to answer a second question:

b) could the research be undertaken as effectively with people who do have the capacity to consent to participate?

If the answer to this question is ‘yes’ then the study should exclude those without the capacity to consent to participation. If the answer is ‘no’ then the inclusion of people without capacity in the study can be justified. The research team will still need to decide however - as it would have done prior to the legislation - if it has the time, resources and expertise to ensure the meaningful involvement of people without capacity.

It is also important to note that Department of Health guidance makes clear that studies may only be able to proceed under the MCA when those responsible for the proposed research are able to demonstrate:

i) that it will be likely to be of benefit to the person lacking capacity, either
directly (i.e. by improving her/his personal circumstances) or indirectly (by
improving the quality of treatment or care more generally), and that this
benefit is in proportion to any burden on that person caused by taking part;

OR

ii) that the research will serve to increase knowledge of the cause,
treatment or care of people with the same or similar condition and that the
risks to participants will be negligible, with no significant interference with
their privacy or freedom of action.

If the proposed research involves participants who lack capacity, it is a legal requirement that ethical approval is obtained from an appropriate body recognised by NRES. For confirmation of the relevant local REC please email National Research Ethics Service (NRES) in the first instance or researchethics@uel.ac.uk.

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