Seeking Approvals: Ethical approval

Introduction

Ethical review of research projects involving human participants or their data or tissues is a requirement of good research practice (in some cases a legal requirement) to safeguard the rights, dignity and welfare of people participating in research. Research Ethics Committees (RECs) should be independent in membership of the researcher and the organisations funding and hosting the research.

NHS Research Ethics Committees
NHS RECs review research projects that involve NHS patients or access to data, organs or other bodily material of past or present patients. The full remit of NHS RECs is outlined in the 1st resource below. Where there is a legal requirement, NHS RECs will review projects that propose to use tissues from non-NHS patients, or imported material, for example to ensure that an exemption from the requirement for an HTA licence can be applied. For other projects that are not within the remit of NHS RECs and where there is no legal requirement for NHS REC review, the relevant local committee may voluntarily review the project (see 2nd resource below for contact details of NHS RECs). Alternatively, a university research ethics committee may review the project (see below).

Before making an application, it should be ascertained if the project falls within the remit of an NHS REC. If a project is audit or service evaluation then it would NOT be classified as research for the purposes of ethical review and therefore would not require ethical review by an NHS REC. There is information on the differences between research, audit and service evaluation in the National Research Ethics Service (NRES) leaflet, ‘Defining Research', which can be downloaded from the 3rd resource below. Projects not classified as research do not require NHS R&D permission for research but may require other NHS management arrangements. A consensus of opinion between RECs and R&D departments is, therefore, desirable so that projects are handled in the same way by different organisations.

Ethical approval from the National Research Ethics Service (NRES) should now be made using the Integrated Research Application System (IRAS).  This is a single system for applying for the permissions and approvals for health and social/community research in the UK.  It streamlines the process for seeking relevant approvals as you do not need to enter the details for a single project in separate application forms. You can find out more about IRAS on the UKCRC website (4th resource below) or visit the IRAS site (5th resource below).  A brochure on IRAS has also been produced (6th resource below).

Responsibility for Site-Specific Assessment (SSA) for NHS sites will be transferred from RECs to NHS R&D offices from 1 April 2009.  Further information and guidance for REC applicants is available in the joint bulletins issued by the National Research Ethics Service and the NHS R&D Forum (see the NRES latest news, 7th resource below).

The IRAS form makes provision, in the front-end filter, for Research Tissue Banks to voluntarily apply for ethical review of the bank. This focuses on the consent process for the collection of tissues for banked purposes. The application form includes the option for overarching review of all projects that will use the banked tissues, based on the reasoning that there are few ethical considerations if using anonymised samples already collected for research purposes.
A similar approach is being developed for ethical review of research databases, also referred to as data banks.

University research ethics committees
Some universities have research ethics committees to review research projects that cannot be reviewed by NHS RECs. The Economic and Social Research Council has produced a framework for these committees (8th resource below). The application process and form will differ for each committee. The relevant organisation should be contacted for further information.

Gene Therapy Advisory Committee
GTAC is the UK national research ethics committee (REC) for gene therapy clinical research. GTAC's definition of gene therapy is "The deliberate introduction of genetic material into human somatic cells for therapeutic, prophylactic or diagnostic purposes." This includes techniques for delivering synthetic or recombinant nucleic acids into humans. Further information on GTAC is available from their website, a link is provided in the 9th resource below.

International studies
Research studies that involve the collection of data or tissues from other countries will require research ethics committee review in the source country or local equivalent, and UK review depending on funder / sponsor policy (see 10th resource below for developing countries, and Collection and storage of tissues station for tissue import requirements).