*IRAS Form
All submissions are made via the IRAS Form available at www.myresearchproject.org.uk. It is the researcher’s responsibility to complete all necessary forms according to their particular project. For CTIMPs, submissions are coordinated through CCTU.
The draft IRAS form should be submitted to the governance team for review along with other study documents*. When the documents are finalised and approved a governance coordinator will sign off the IRAS Sponsor Authorisation tab and the application will be submitted to the appropriate body for their review.
For sponsored studies the following are required to be in place before the IRAS form can be signed by the Governance Coordinator:
- Study Assessment Form to be provided by the governance team and signed off by the authorised signatory (Speciality Lead or Clinical Director)
- Confirmation of funding: funding letter or an agreement from a commercial funder whatever is applicable
- *Peer review
- *University insurance confirmation (for Jointly sponsored studies)
- Protocol
- PIS and other patient facing documents
For studies that are not single centre, ie at CUH/University of Cambridge only, the following additional documents are required to be submitted and form part of the Local Information Pack which will be emailed out to other sites:
- Contract Agreement template or Organisation information document (OID) – This lists clauses, responsibilities and expectations for participating sites, along with any financial details or consumables. Contact the R&D Office for the correct template to include with your submission.
- Schedule of Events Cost Attribution Tool (SoECAT) or Schedule of Events – This is to help to ensure that the appropriate resources are identified to support study delivery and that there is clarity for participating NHS/HSC organisations about how the costs associated with participating in a study are attributed.
All supporting documents should be uploaded directly to the IRAS Checklist tab. Documents uploaded in either Project Documents or My Documents areas are not automatically added to the form checklist.
Questions in IRAS all have an information button which will tell you what to enter, we recommend selecting this and also doing the e-learning module if you are new to the form. The Filter page questions are important as they will dictate what questions appear in relation to your type of study.
Step by step instructions are available here.
Research Ethics Committees (RECs)
Most studies will require review by an NHS Research Ethics Committee. RGCs/ Researchers can use this tool to assess whether REC review is required: http://www.hra-decisiontools.org.uk/ethics/
Some projects are eligible for proportionate review; this is for projects where clinical procedures are not in addition to standard care e.g. blood tests only taken at the same time as clinical bloods or where qualitative research involved validated questionnaires only.
The REC booking can take place online, over the phone or via email.
Please check for more details to book the review.
https://myresearchproject.org.uk/crirasguide/booking.html
Once the REC review has taken place, an opinion letter will be issued. Researchers may be asked to make changes to documents or provide further information before a favourable opinion can be given. The Governance Coordinator can provide guidance and input – including re-reviewing documents – at this stage.
Health Research Authority
The Health Research Authority (HRA) Approval brings together the assessment of governance and legal compliance for the NHS in England. This takes place in parallel with the REC. The HRA will issue an ‘Initial Assessment Letter’ in all cases except where the Sponsor is also the single site. Once all other regulatory approvals have been received and HRA assessment has been completed, HRA Approval will be issued.
It is the study team’s responsibility to provide further information if requested by the HRA Assessor. Up-to-date guidance on the HRA can be found at: www.hra.nhs.uk
Medicines and Healthcare products Regulatory Agency
Approval from the Medicines and Healthcare Regulatory Agency (MHRA) is required for studies that are investigating the efficacy or safety of medicines, research involving medical devices that are not CE (Conformité Européene) marked, or when devices are used outside their intended purpose.
Guidance can be found here, along with an algorithm to assess whether MHRA application is necessary: https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-authorisation-in-the-uk
It is best to consult the Cambridge Clinical Trials Unit if you are designing a study that involves a drug.
Receiving regulatory approvals
After regulatory approvals are received, the R&D governance team will then conduct the capacity and capability assessment. The C&C confirmation letter is necessary in order for your study to open and start recruitment.
Multi-Site study setup
If your study is multi-site then you are required to make up the UK Local Information Pack to email to your other research sites’ R&D office and study delivery teams (Principal Investigator or Local Collaborator, as applicable) at participating NHS organisation(s). If the study is an NIHR portfolio study, you should copy the Local Information Pack to the LCRN of participating organisations in England. You may send them after receiving the HRA Initial Assessment Letter or the HRA Approval Letter. Contact details for organisations can be found in Appendix 1. (QUESTION: Where is Appendix 1?)
