If your research involves the National Health Service (NHS) or a Health and Social Care (HSC) organisation, you may need to apply for Health Research Authority (HRA) approval.
The Health Research Authority (HRA) is an organisation that works to regulate different aspects of NHS/HSC research in the UK. One of the HRA's core functions is the Research Ethics Service (RES), committed to enabling and supporting ethical NHS/HSC research.
The RES consists of Research Ethics Committees (RECs) in England that review NHS/HSC research. The Governance Arrangements for Research Ethics Committees (GAfREC) describe what is expected from RECs when reviewing research proposals.
HRA ApprovalHRA Approval
You will need to apply for HRA approval if your study:
- is research, and
- involves NHS/HSC facilities, staff or service users, and/or
- requires NHS/HSC REC approval
HRA approval involves two processes:
- Acquiring management permission: Assessment of the study's governance and legal compliance, undertaken by dedicated HRA staff.
- Acquiring ethical approval: Ethical review of the study (where applicable*), undertaken by an NHS/HSC REC.
*Most research studies that require HRA approval in order to attain management permission, will also require review by a REC, however there are some exceptions. For example, the following types of research project do not require NHS/HSC REC approval, but will still need to acquire management permission if they are undertaken in or through an NHS/HSC organisation:
Research involving the premises or facilities of care organisations (but not otherwise involving participants/activities/procedures that would require NHS/HSC REC review), such as research undertaken on NHS premises, involving healthy volunteers who are not recruited via use of UK health services.
Research involving NHS or social care staff as participants (but not otherwise involving participants/activities/procedures that would require NHS/HSC REC review).
Whilst these studies may not require NHS/HSC REC approval, they may require University REC approval. You will need to check whether, under Newcastle University's ethics policy, ethical review is required, by contacting firstname.lastname@example.org.
REC ApprovalREC Approval
The HRA and Medical Research Council (MRC) have provided a decision tool to help you determine if your study requires NHS/HSC REC approval. This can be found here: http://www.hra-decisiontools.org.uk/ethics/
As a guide*, in England, NHS/REC approval is required if your study is:
- Research (and therefore not service evaluation, clinical/non-financial audit, or usual practice in public health) as defined on the HRA Defining Research Table.
AND if your study involves any of the following:
- Research participants identified from, or because of their past/present use of services for which the UK health departments are responsible. (This includes services provided under contract with private or voluntary sectors).
- Research participants identified because of their status as relatives or carers of past/present users of services for which the UK health departments are responsible. (This includes services provided under contract with private or voluntary sectors).
- Prisoners and your research is health-related.
- Collecting/storing (or using previously collected) tissue (defined in this case as any human material, i.e. blood, biopsies, urine) or information from any users of these services (including users who have died within the last 100 years).
- Social care research funded by the Department of Health.
- A clinical trial of an investigational medicinal product (CTIMP).
- Using a non-CE marked medical device or a device being used outside of its CE mark intended purpose.
- Exposure to ionising radiation.
- The processing of disclosable protected information on the Register of the Human Fertilisation and Embryology Authority by researchers, without consent.
- A clinical trial and the participation of practising midwives.
- Storing relevant material (defined in this case as material other than gametes, which consists of, or includes, human cells) from the living/deceased without an appropriate licence from the Human Tissue Authority (HTA).
- Storing/using relevant material or analysing DNA from bodily material, collected since 1st September 2006, and where the study is not within the terms of consent from the donors.
*Please see the HRA website for the most up-to-date information: https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need/
Applying for ApprovalApplying for Approval
(1) Preparing the IRAS application form
To apply for HRA approval, you will need to complete a research application form on the Integrated Research Application System (IRAS).
In order to complete the application form, you will need to know:
- Research study details including: purpose and design, risks and ethical issues, procedures, data storage, publication and dissemination, scientific and statistical review
- Contact details for key investigators/collaborators
- Contact details for each research site
- Research sponsor details - see Research Sponsorship
- Insurance/indemnity arrangements (contact research sponsor for guidance)
- Details and reference number(s) for any research funding
- Lead NHS R&D contact details - if your study involves NHS/HSC facilities, patients or staff, you should contact the local R&D team as early as possible.
Additionally, you may need to provide the following supporting documentation for your study:
- Research Study Protocol
- Participant Information Sheet(s) (PIS)
- Statement of Activities & Schedule of Events
- Industry Costing Template
- Model Agreements
- Funding Letter
- Curriculum Vitae(s)
- Research Passports & Honorary Contracts or Letter(s) of Access
Note that all documents must be dated and version-controlled.
For further information about these, please see: https://www.hra.nhs.uk/planning-and-improving-research/research-planning/prepare-study-documentation/
(2) Booking the REC meeting
Once your application is complete and all electronic authorisations are in place, you will need to contact the Central Booking Service (CBS) on 020 7104 8000 (see: https://www.hra.nhs.uk/about-us/committees-and-services/central-booking-service/).
After the call, you should receive an email confirming your booking and REC reference number. You will need to enter the details of the REC and REC reference number at the start of your application form in IRAS, and then electronically submit your application. Unless your application is being processed under the Proportional Review Service, you should attend the REC meeting if possible.
(3) REC decision
You will be notified of the REC's decision usually within 10 working days of the REC meeting (and within 60 calendar days of the receipt of a valid application).
You will receive one of the following decisions:
- Favourable opinion with standard conditions*
- Favourable opinion with additional conditions*
- Provisional opinion with request for further information
- Provisional opinion pending consultation with referee
- Unfavourable opinion
*Where the REC specifies conditions, these must be met prior to the start of the study. Until these conditions are met, the study does not have favourable opinion and should not start. A standard condition of any favourable opinion is that NHS management permission at all applicable NHS sites is confirmed prior to the start of the study at that site, therefore you should contact the local R&D team(s) accordingly.
The Confidentiality Advisory Group & Data Protection Security ToolkitThe Confidentiality Advisory Group & Data Protection Security Toolkit
The Confidentiality Advisory Group (CAG)
If your study involves accessing identifiable patient information without consent in England and Wales you will need to apply to the Confidentiality Advisory Group (CAG). This applies whether your study is managed as research or non-research (e.g. service evaluation). First, you should contact Newcastle University’s Information Security Officer, Wendy Craig, about attaining a Data Protection Security Toolkit (see below).
All applications should be submitted using the Integrated Research Application System (IRAS), but before submitting, applications to CAG must be booked for review. You should only contact the team to book once an application is ready for submission as the application must be submitted within 24 hours of booking.
Before booking an application, please review the HRA guidance.
Data Protection Security Toolkit (DPST)
If your study involves the following, you will need to have a Data Protection Security Toolkit (DPST) in place:
- Accessing patient information without consent
- Obtaining data from NHS Digital (DARS)
- Obtaining data from an organisation that does not hold consent, or whose data originates from NHS Digital
A DPST ensures NHS data is handled safely and securely. It involves adhering to ten data security standards and completing data security training. In order to attain a DPST, you should contact Newcastle University’s Information Security Officer, Wendy Craig.
Contacting the Research & Development TeamContacting the Research & Development Team
If your study involves NHS/HSC facilities, patients or staff, then you should always contact the local Research and Development (R&D) team as early as possible, and before commencing your study. (This applies even if your study is not managed as research, for example, because it is a service evaluation study).
For studies taking place at Newcastle upon Tyne Hospitals NHS Foundation Trust, contact the R&D team at the Newcastle Joint Research Office (Trust.R&D@nuth.nhs.uk).
You can find contact details for R&D teams at other NHS organisations here: http://www.rdforum.nhs.uk/content/contact-details/
Applying for a Research PassportApplying for a Research Passport
If you are considering undertaking a study that involves having contact with patients/service users you may need to apply for a Research Passport, in which case you should apply for this as soon as possible to avoid delays to your research.
The NHS Research Passport system enables non-NHS staff working on a research project to obtain an Honorary Research Contract (HRC) or Letter of Access (LOA). For more information about these, see: https://microsites.ncl.ac.uk/njro/researchers/my-research-has-been-funded/research-passports/
You will not need a research passport or an honorary research contract if:
- You are employed by an NHS organisation.
- You are an independent contractor (e.g. GP) or employed by an independent contractor.
- You have an honorary clinical contract with the NHS (e.g. clinical academics).
- You are a student undertaking an education course for which there is a healthcare placement agreement already in place with the NHS organisation which is also hosting the student’s research activity.
- You are a student who will be supervised within clinical settings by an NHS employee or HE staff member with an honorary clinical or research contract.
Newcastle University staff/students wishing to apply for a research passport should contact email@example.com.
If you are employed by, or have an honorary clinical contract with an NHS organisation, you can obtain the necessary access to a different NHS organisation through the NHS-to-NHS Proforma scheme. You will need to complete an ‘NHS to NHS Confirmation of Pre-engagement Check’ form. For more information, contact the R&D team for the NHS organisation you wish to access.
Good Clinical Practice (GCP)Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted.
Everyone involved in the conduct of NHS research or clinical trial work must complete GCP training, to ensure:
- They are competent to perform the research tasks.
- They are qualified by education, training and experience.
This is a requirement of the UK Policy Framework for Health and Social Care Research and UK Clinical Trials Regulations.
If you are already employed by the NHS, it is likely that your employer will provide GCP training, and so you should contact them directly to access this.
If you are not employed by the NHS, or training is not provided by your employer, but you are a Newcastle member of staff or student, you can access (free) online training through the National Institute of Health Research, using your Newcastle University email address.
If you wish to recommend any changes to the information above, please contact firstname.lastname@example.org.