Answers to popular questions relating to NHS research projects.
I'm planning to conduct my research in the
NHS. How do
I get ethical approval?
If your project is research, and involves
NHS patients, service users, organs, tissue, data or other bodily
material, the requirements of the Department of Health Governance
Arrangements for Research Ethics Committees (GAFREC) will apply.
For specific details of the scope of NHS REC
review, see the
governance arrangements for research ethics committees
Not all projects undertaken within the NHS are research. The
HRA has two
useful decision tools on its webpages to help you to determine
whether your project is research and whether it needs
See Is my
study research? and Do I need NHS REC
approval? You are advised to seek guidance from the
Research and Development Office if, having considered the published
guidance, you are unsure whether your project should be classified
How do I apply for NHS REC approval?
You will need to complete the IRAS
Research Application System) form. Before you begin your
application you must contact Leigh Taylor at firstname.lastname@example.org
Students requiring NHS REC
approval must discuss
this with their supervisor.
What is IRAS (Integrated Research
is the Integrated
Research Application System. It is a single system for applying for
the permissions and approvals for health and social care and
community care research in the UK.
Do I need NHS Trust Research and
If your research involves undertaking the
research on the premises of an NHS
then you should contact the local NHS
Trust Research and
Development office (see
NHS/HSC Research and Development review or permission
you will need permission from the relevant NHS
Trust Research and
Development office before access to these are
You will need to obtain
ethics approval for your research in addition to this
What is a Research Passport and how do I
apply for one?
is a mechanism for pre-engagement information about a
researcher to be shared with relevant NHS
organisations in which the
applicant intends to conduct research. It includes an occupational
health assessment, employment/student screening and DBS
Human Resources deal with Research Passport applications for all
members of staff, contact email@example.com. Student applications for
all faculties are handled by Leigh Taylor.
Please note: If you are a PhD student and also
a member of staff (i.e. you have a contract of employment with
UWE), your Research Passport application will be handled by Human
Resources. All other PhD students, e.g. those who are self
funded or bursary funded or sponsored by an employer, should
contact Leigh Taylor
who will deal with your Research Passport application.
My research participants include
vulnerable adults. What ethical approval do I need?
Under the Mental Capacity Act 2005, social
care research, i.e. involving people lacking capacity in England
and Wales, requires approval from the National Social Care
. For more
information see the National
Social Care Research Ethics Committee
Does the Mental Capacity Act apply only to
research ‘in or with’ the NHS?
The Act applies to any intrusive research
within England and Wales, wherever it takes place, except for
clinical trials of investigational medicinal products. This may
include research in health, social care, criminal justice and many
other settings. It is not limited to research undertaken within
organisations or other public bodies.
Do projects that are not classified as
research require approval under the Mental Capacity Act?
No. The provisions of Sections 30-34 of the
Act apply only to studies that are designed and presented as
research. It is the responsibility of the researchers’ employers or
sponsors/funders to determine whether a project should be presented