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Studies requiring an NHS Research Ethics Committee (REC) review must apply for permission using the Integrated Research Application System (IRAS).

See the IRAS website for detailed guidance on application submission arrangements, site specific information (SSI) and research forms.

Integrated Research Application System (myresearchproject.org.uk)

Research studies must be registered with the Research and Development (R&D) Governance team by emailing the below address: randd@uhb.nhs.uk

The R&D Governance team will acknowledge registration of the study in writing and outline the documents and requirements needed to authorise the study.

Before submitting the IRAS SSI form to the R&D Governance team, researchers should ensure the following documents are included:

• Study protocol
• Participant information sheets that must correspond with the versions approved by the REC
• Consent forms that must correspond with the versions approved by the REC
• Written sponsor confirmation from the organisation acting as sponsor (a signature on the IRAS research form from an appropriate administrator at the sponsor may be sufficient)
• Draft clinical trial agreement for review. This is obligatory for industry sponsored clinical trials of investigational medicinal products (CTIMPS)
• Draft study costings of industry-sponsored studies for review
• Research team CVs (signed and dated)*
• Evidence of good clinical practice (GCP) training for the principal investigator*
• Signed principal investigator agreement
• Signed divisional director/clinical service lead approval form
• Local ionising radiation medical exposure regulations (IRMER) risk assessment form (if applicable)
• Data transfer form

* CVs and GCP evidence is not required if the R&D Governance team already have copies that are no more than two years old. GCP refresher training is recommended every three years and required every five years.

Documents do not need to be submitted as a single package. The R&D Governance team will routinely prompt researchers for missing documents.

Applications will only be processed when the minimum set of documents have been returned.

No objection studies only require the following documents:

• Study protocol
• IRAS research form (if applicable)
• Participant information sheets
• Consent forms

UHB may agree to act as the sole sponsor or a co-sponsor with another organisation. Generally, UHB will only act as a sponsor if the chief investigator is an employee.

The chief investigator must formally request UHB to act as a sponsor and submit a study protocol to the R&D Governance team. A sponsorship request form and chief investigator agreement must be completed by the chief investigator before UHB can confirm sponsorship.

Is a sponsor required?

Research that falls under the remit of the Secretary of State for Health must have a formal sponsor. This includes all health and social care research involving NHS patients, their tissue or information.

What does a sponsor do?

Study sponsors take ultimate responsibility for the initiation, management and financing (or arranging financing) of the research.

Sponsors must:

• be satisfied that appropriate checks have been taken
• ensure the study meets relevant standards
• make sure arrangements are put and kept in place for authorisation, management, monitoring and reporting.

Depending on the type of research and procedures involved, ethical or regulatory approval may be required in addition to R&D Governance approval.

The Research Ethics Service (RES) works closely with health departments to develop and maintain a UK-wide system for ethical review of health and social care research.

Ethical review REC requirements are outlined on the GOV.UK website.

[Withdrawn] Health research ethics committees: governance arrangements – GOV.UK (www.gov.uk)

The decision tool on the NHS Health Research Authority (HRA) website can be used to check if a study requires REC review.

Do I need NHS Ethics approval? (hra-decisiontools.org.uk)

Ethical review applications can be made via the HRA online booking service which also helps to identify the correct REC to submit an application to.

Online Booking Service – Health Research Authority (hra.nhs.uk)

Visit the HRA website for more information on the types of ethical approval.

What approvals and decisions do I need? – Health Research Authority (hra.nhs.uk)

The Ministry of Defence Research Ethics Committee (MODREC) undertakes ethical reviews of research:

• funded or sponsored by the MOD
• involving the British Armed Forces

The MODREC is recognised and works to the same standards as the RES.

The MODREC must review and approve research studies that involve predominantly military personnel or take place in a military establishment. A separate RES application is not required for studies involving the NHS unless they intend to recruit civilian patients.

Military patients can be included in civilian clinical research studies at Queen Elizabeth Hospital Birmingham (QEHB) due to the hospital treating military casualties. Military patients suitable for RES approved civilian studies do not require a separate MODREC application but the joint command medical director should be informed. If military patients form a significant part of the study or are specifically targeted for recruitment a MODREC application must be made.

Visit the GOV.UK website for more information on MODREC.

Ministry of Defence Research Ethics Committee – GOV.UK (www.gov.uk)

Depending on the type of research and procedures involved, regulatory approval may be required in addition to, or instead of, ethical approval.

Regulatory approval is in addition to R&D Governance approval and a summary of health research requirements can be found on the GOV.UK website.

Medicines: clinical trials – GOV.UK (www.gov.uk)

Clinical trials for medicines: apply for authorisation in the UK – GOV.UK (www.gov.uk)

Review body approval requirements and procedures are available on the IRAS. Further advice and guidance is available on the relevant review bodies website.

A substantial amendment is defined as a change that is likely to affect any of the following to a significant degree:

• Safety or physical or mental integrity of trial participants
• Scientific value of a trial
• Conduct or management of a trial
• Quality or safety of investigational medicinal products used in a trial

Substantial amendments include:

• a change of sponsor
• appointing a new chief investigator
• a new research site in a study requiring a site specific assessment consideration of local issues in a multi-centre study
• appointing a new research site principal investigator
• changing inclusion or exclusion criteria
• recruitment process changes
• extending a study that has the potential to generate significant cost implications

Researchers must not implement substantial amendments until receiving approval from the Medicines and Healthcare products Regulatory Agency (MHRA), Research Ethics Committee (REC) and the R&D team, unless patient safety would be compromised.

Minor amendments cover changes such as:

• correcting typographical errors in protocol or other study documentation
• appointing new support staff
• documentation changes for recording study data
• logistical arrangement changes for storing or transporting samples

Although R&D approval is not required for minor amendments, the principal investigator must notify R&D Governance of all study amendments.

The R&D Governance team should be notified of all amendments.

Study amendments can be reported by sending copies of the National Research Ethics Service (NRES) amendment form and new versions of the protocol or supporting documentation to the R&D Governance team.

Failure to notify the R&D Governance team of an amendment could result in the study being suspended, closed or investigated under the scientific misconduct procedure.

As well as notifying the R&D Governance team, the chief investigator or sponsor may also be required to report amendments to:

• REC – for all substantial amendments
• MHRA –  for substantial amendments to a clinical trial of an investigational medicinal product (CTIMP)
• the participating site principal investigator and R&D offices – for all amendments

Full R&D approval will be issued once REC and MHRA approvals have been provided to the R&D Governance team. Substantial amendments will be authorised by the head of R&D Governance.

See the NHS Health Research Authority (HRA) website for more information on reporting amendments. Amending an approval – Health Research Authority (hra.nhs.uk)

In the interest of study participants, urgent safety measures may be implemented without delay.

The REC, MHRA, study sponsor and R&D must be notified of any urgent safety measure amendments immediately. A substantial amendment should be reported within three days that documents the reasons for the measures taken.