Applications via the Integrated Research Application System (IRAS)

What is IRAS?

The Integrated Research Application System (IRAS) (https://www.myresearchproject.org.uk) is a single system through which you can apply for many of the approvals required to conduct Health and Social Care Research in the UK.

You will need to create an account if you are accessing IRAS for the first time. In larger research teams it is generally practical for one person to take primary responsibility for a given application, but it is possible to transfer a partially completed form between users if necessary.

Particularly for larger or more complex studies, completing the IRAS form can be a time-consuming process - it is recommended to allow time for it in your study plan. Exactly how much time will depend on the nature of your study, but certainly several hours - over a couple of sessions, to allow for Sponsor review and any required amendments.

IRAS homepage

Timelines

Sponsor Review

Sponsor review is required prior to IRAS submission. Review can be a time-consuming process and Research Governance staff may well have a queue of studies awaiting review. If you have a deadline for IRAS submission, you should contact Research Governance as early as possible and submit your documents to us as soon as you can. The time required for review will vary considerably depending upon the nature and complexity of the study, but you should allow for up to four weeks for review and revisions, once all relevant documents (IRAS, Protocol, PIS, Consent Forms, OID etc.) have been provided to Research Governance.

Sponsor review

Prior to submission, your draft IRAS form will need review and sign-off by your Sponsor. If you have requested Sponsorship from the University of Bristol, download a draft of your form and email it to research-governance@bristol.ac.uk, along with a copy of your study protocol and all other significant documents, for example: participant information sheets, consent forms etc.

Submission

Once reviewed and finalised, your IRAS form should be submitted in the system to research-governance@bristol.ac.uk for authorisation.

The document checklist lists a Sponsor covering letter as a required document. However, this is a hang-over from a previous, less automated, process and has been replaced by this sign-off in IRAS.

Note 1: This process does not include documents and does not allow for comments or editing. You should only submit after your form and documents have been reviewed and agreed by Research Governance.

Note 2: Any changes, however minor, made after authorisation will require the form to be re-authorised. Please ensure that you have run the form's verification checks and that all details are correct before submission.

Booking a REC Review

Once the form is submitted, the system will prompt you to book your REC review, this process also involves a brief series of questions.

Please note: the question "Has the application previously been deemed as not suitable for proportionate review?" is oddly phrased and potentially misleading. Proportionate review is an exception, only relevant to a small number of studies. Unless this has been specifically agreed during the application process, the correct answer is "Yes" (this study is not suitable for proportionate review).

 

UoB specific completion guidance

You can find general guidance on the completion of your IRAS application via IRAS help.

The following guidelines and standard text apply if you are requesting sponsorship by the University of Bristol:

Filter Question 2

CTIMPs and Medical Devices: if there is any possibility that your project fits into one of the first three categories, you will need greater input from Research Governance. If this wasn't identified in your Research Registration Checklist (Microsoft Forms) and you have not already had contact with Research Governance, e-mail research-governance@bristol.ac.uk to discuss.

Data-based research and Research Databases: there is an important distinction between categories 9 and 11. A Research Database (cat. 11) is a repository of data, either newly generated or gathered from existing sources, that will be made available to future researchers (with appropriate oversight).

If you are gathering data to answer a specific study question or meet a specific objective, you are conducting a "Study limited to working with data" (cat. 9). If it is possible that your study data will, in the future, form - or contribute to - a research database, that should be handled as a separate application in the future.

A2-2

For any educational project other than a PhD, the Chief Investigator must be your academic supervisor.

A4

Sponsor contact details are:

Mr Adam Taylor
Research Governance Team, Research & Enterprise Division
University of Bristol, Augustine's Courtyard, Orchard Lane,
Bristol
BS1 5DD
Email: research-governance@bristol.ac.uk
Telephone: +44 (0)1173940177

A5-1

Sponsor's/protocol number: this will be the number that Research Governance assigned to your case and will have used in correspondence, it will be in the format:

[Year RGT first contacted] - [Number (usually four digits)]

A17-1/2

Ensure that the eligibility criteria listed here are an exact match for those listed in your protocol.

A31

The standard expectation is that potential participants will have at least 24 hours to read and consider the participant information sheet, and to ask any questions.

This will not be proportionate or possible for all trial designs. If you are not intending to follow this standard, you should describe and justify your intended process here.

A36 - A45

In the context of these questions 'personal data' is any potentially identifiable participant data (including pseudonymised data), it will be subject to the Data Protection Act.

'Data' or 'research data' refers to fully anonymised data. It is best-practice to retain this long-term and, wherever possible, to make it available to other researchers. More information is available from the Research Data Service.

The handling and use of participant data, including the future use of anonymised data, should be described in the participant information sheet. Consent forms must include an indication that the participant has understood and agreed to this use.

You must use the HRA standard wording regarding data transparency and the General Data Protection Regulations (GDPR) in your patient information.

A42

Unless you have a dedicated data manager, the Custodian of your data will generally be the Chief Investigator for the study.

A64-1

Select 'Academic' - details as per A4, above.

A74

For studies requiring MHRA approval, Research Governance can advise you on how to answer this question. For all other research, please use the following text:

The University of Bristol has a Service Level Agreement with University Hospitals Bristol and Weston NHS Foundation Trust, whereby the Trust monitors 10% of the University's sponsored studies.

A76

You can find suggested answers to these questions on our IRAS Insurance Guidance page.

Please note that these answers may change as a result of routine policy updates and renewals. Please ensure that you are using the latest version and that the same information is reflected in your protocol.

For more information about about research insurance, please see our Research Insurance guidance.

A77

Unless this is a specific requirement of a funder or partner and it has been agreed with Research Governance and the Insurance Office, the answer to this question should be No.

A78

If you are unsure about the answer to this question, please speak to Research Innovation.

Part C

All research sites must have a Principal Investigator (PI): the individual responsible for the conduct of the study at that site. If the Chief Investigator, responsible for the conduct of the entire study, is based at one of these sites, they may also act as PI for that site. Ensure that you have the appropriate details from all sites before completing this section.

All non-UoB sites will need to have an appropriate form of collaboration agreement in place before study activity can begin.

Further information and advice

If you are unsure how to answer any part of the IRAS form or require any further advice, please contact research-governance@bristol.ac.uk.