Study authorisation process

Study applications

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.

• IRAS

Study registration

Research studies must be registered with the Research and Development (R&D) Governance team by emailing Helen Langston or Lorna Dudley.

• Helen.Langston@uhb.nhs.uk
• Lorna.Dudley@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.

Required documents

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

Sponsorship

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
  • reporting

Ethical approval

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

Ethical 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.

• GOV.UK health research ethics committees: governance arrangements

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

• NHS Health Research Authority (HRA): do I need Research Ethics Committee (REC) review?

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.

• NHS Health Research Authority (HRA): online booking service

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

• NHS Health Research Authority (HRA): what approvals and decisions do I need?

Ministry of Defence (MOD) ethical approval

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.

• GOV.UK MODREC

Regulatory approval

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.

• GOV.UK clinical trials and investigations: detailed information
• GOV.UK clinical trials for medicines: apply for authorisation in the UK

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

Types of approval

UHB's R&D Governance authorisation procedures can be completed before, during or after being processed by a REC and regulatory body (if applicable).

UHB research study approval is only provisional until the R&D Governance team receives full REC and regulatory approvals.

Provisional approval

Provisional UHB research study approval can be given on:

• completion of a Trust assessment
• confirmation of funding arrangements
• finalising the clinical trial agreement ready for signature (commercial studies only)

Patients should not be recruited to a trial until full approval has been given.

Full approval

Full study approval will be confirmed once the R&D Governance team receives copies of:

• regulatory approval
• ethics favourable opinion
• protocol, patient information sheets and consent forms to match the approved REC and regulatory authority versions

No objection

There is a simplified process for studies likely to have little impact on the Trust. These studies are issued with "no objection" rather than full authorisation.

No objection rulings restrict the activities that can be undertaken as part of the study. Studies that may be considered no objection involve:

• identifying potential participants who contact external researchers directly if they are interested in taking part (referred to as participant identification centres in the IRAS)
• providing a service for patients of other trusts that would be carried out in standard clinical care (i.e. imaging or radiotherapy). If this service is not normally provided the full Trust authorisation process must be followed
• providing anonymised tissue samples from a licensed human tissue authority archive (i.e. pathology). Prospective collection of tissue samples is likely to require full Trust authorisation
• providing anonymised clinical patient data
• administering UHB staff questionnaires