Getting the best from IRAS

Authorisation is agreement from relevant individuals / organisations to support the delivery of your research. Authorisations may be required from investigators, sponsor representatives, radiation experts, educational supervisors etc. and are necessary on most forms before you can submit your application(s) for research approvals / permissions.

Authorisations can be obtained either in IRAS using the 'Authorisations' tab (also know as e-authorisation) or as hard copy/ink signatures (written authorisations). For further guidance please visit our Authorisations pages.

The Central Booking Service was a telephone booking service and has since been replaced by the online booking service. The Online Booking Service is used for all IRAS form applications for project-based research in the NHS (or HSC in Northern Ireland) and for Research Ethics Committee (REC) applications for tissue banks, databases and health research taking place outside of the NHS/HSC.

For guidance on how to make your booking, log in to IRAS and navigate to the ‘e-submission’ tab of the form you wish to submit. Here you will find a detailed step-by-step process, and a direct link to the booking portal.

Clinical Trial of an Investigational Medicinal Product (CTIMP)

A Clinical Trial of an Investigational Medicinal Product is an investigation in human subjects which is intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products, identify any adverse reactions or study the absorption, distribution, metabolism and excretion, with the object of ascertaining the safety and/or efficacy of those products. This definition includes pharmacokinetic studies.

Visit the MHRA pages on clinical trials for medicines.

You owe a duty of confidence, in common law, when information is given to you and:

• It is not in the public domain,
• It has a degree of sensitivity associated with it, and
• It has been communicated for a limited purpose and in circumstances where the individual is likely to assume an obligation of confidence; for example in the doctor patient relationship.

Please visit entry for Authorisation above.

Please visit entry for Submission below.

The Full Set of Project Data is the set of questions that IRAS generates for your particular project. The Full Set of Project Data is also referred to as the ‘integrated dataset’ and the ‘Full project dataset’ within IRAS. All three terms have been used interchangeably within this guide.

Health Research Authority

www.hra.nhs.uk

HRA Approval is the process for the NHS in England that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent Research Ethics Committee opinion provided through the UK Health Departments’ Research Ethics Service. It replaces the need for local checks of legal compliance and related matters by each participating organisation in England. This allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study.

Note: on 16 April 2018, HRA Approval became HRA and Health and Care Research Wales (HCRW) Approval and now applies to all project-based research taking place in the NHS in England and Wales.

IRAS will keep you up to date with progress on the implementation of changes relating to HRA and HCRW Approval both within the purple section of the IRAS home page and in updates on the IRAS help pages.

Human Tissue Authority

www.hta.gov.uk

Health and Social Care in Northern Ireland

www.hscni.net

Investigational Medicinal Product.

For further details please visit CTIMP above.

IRAS is the Integrated Research Application System which is a single system for applying for the permissions and approvals for health and social/community care research in the UK.

When we mention 'IRAS' or 'the system' within this guide, we are referring to the Integrated Research Application System.

www.myresearchproject.org.uk

All project-based research conducted in or through the NHS/HSC in England, Northern Ireland, Scotland and/or Wales use the ‘IRAS Form’ to seek: 

• HRA and Health and Care Research Wales (HCRW) Approval for research led from England or Wales.
• NHS/HSC R&D Permission and NHS REC review (where required) for research led from Northern Ireland or Scotland.

The IRAS Form should not be selected if your project is not conducted in or through the NHS/HSC.

Any instrument, apparatus, appliance material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used on human beings for the purpose of:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease,
• Diagnosis, monitoring, treatment, or alleviation of or compensation for an injury or handicap,
• Investigation, replacement or modification of the anatomy or of a physiological process,
• Control of conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

Medicines and Healthcare Products Regulatory Agency

www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

National Health Service (England, Wales and Scotland)

www.nhs.uk

The project owner is a term used in IRAS to describe the person who has overall control of the application for a research approval / permission (i.e. you will be the 'project owner' if you created the application or 'project' in your IRAS account or if someone else has permanently transferred a project to you). Further guidance on permanent transfer can be found within our Transfer and sharing pages.

The research protocol forms an essential part of a research project. It is a full description of the research study and will act as a ‘manual’ for members of the research team to ensure adherence to the methods outlined. As the study gets underway, it can then be used to monitor the study’s progress and evaluate its outcomes.

The primary aim of research is to derive generalisable new knowledge. A clear definition and clarification of how research differs from audit and service evaluation can be found in the HRA Defining Research table.

To help you decide if your study is defined as research, the HRA have a web-based decision making tool: Is my study research?

Research and Development (R&D)

This term is used generically to describe Research and Development offices or departments within either NHS organisations or universities.

A research ethics committee is a group of people appointed to review research proposals to assess formally if the research is ethical. This means the research must conform to recognised ethical standards, which includes respecting the dignity, rights, safety and well-being of the people who take part.

The Medicines for Human Use (Clinical Trials) Regulations define the sponsor of a clinical trial as "the person who takes responsibility for the initiation, management and financing (or arranging the financing) of that trial".

Note: The Clinical Trials Regulations allow for two or more persons to take responsibility for the functions of the sponsor. Where this applies, they require that one of the sponsors should take responsibility for each of the following functions:

(a) Communications relating to substantial amendments, modified amendments and the conclusion of the trial
(b) Communications relating to urgent safety measures
(c) Pharmacovigilance reporting.

Site Specific Information form. Note: From 5 June 2019 NHS/HSC site specific information (SSI) forms are no longer used or accepted.

This is the process by which you submit your application(s) to the relevant review bodies for research approvals / permissions.

In IRAS submissions are made in one of two ways, either using the 'e-submission' or 'Submission' tab. 'e-submission' allows you to send your application form and all supporting documentation directly from IRAS to the relevant review body. Whereas the 'Submission' tab requires you to send your application form and all supporting documentation either by email or post.

There are things that you should be aware of before you submit your application(s) for full guidance please visit our Submission pages.

A substantial amendment is any change to your research, which is likely to affect to a significant degree:

• the safety or physical or mental integrity of the subjects of the project;
• the scientific value of the project;
• the conduct or management of the project; or
• the quality or safety of any investigational medicinal product used in the trial.

For all research, it is the responsibility of the sponsor to determine whether an amendment is substantial.

For more guidance on the differences between substantial and non-substantial amendments please see the HRA website.

In this context it is any human material i.e. blood, biopsies, urine etc. This definition includes relevant and bodily material.