Research ethics, governance & integrity - Frequently Asked Questions

If your project is considered research, you will need ethics approval. To determine whether your project will require ethics approval, see Do I need NHS Ethics approval?. If NHS Ethics, or another external ethical approval (such as Ministry of Defence Research Ethics Committee approval) is not required, you will need University of Birmingham Ethics approval.

HRA and Health and Care Research Wales (HCRW) Approval applies to all project-based research taking place in the NHS in England and Wales. Please see What approvals and decisions do I need? - Health Research Authority for more information on whether your project will require HRA approval.

Depending on your research area, there may be additional approvals needed, including but not limited to the Medicines and Healthcare products Regulatory Agency (MHRA), HM Prison and Probation Service National Research Committee (HMPPS NRC), NHS Trust R&D departments, Confidentiality Advisory Group (CAG) and Local Authorities. You are responsible for identifying which approvals may be required in order to conduct your research. If you are unsure, please contact the REGI team at researchgovernance@contacts.bham.ac.uk.

All research initially needs to be registered on the Ethics Review Manager (ERM) (https://applicants-erm.bham.ac.uk/). See Research ethics - University of Birmingham for more information. If you require Sponsorship, you will then need to follow the steps found here: Applying for University of Birmingham Sponsorship - University of Birmingham

Contracts are initiated through WorkTribe. Staff members will need to create a project on WorkTribe prior to requesting the right contract type. Students do not have access to Worktribe. If your research requires a contract, your supervisor will need to create the project in Worktribe and submit the request on your behalf. We recommend discussing any contractual requirements with your supervisor as early as possible to avoid delays.

The REGI team cannot issue Research Passports and Letters of Access on behalf of NHS Trusts. You will need to get in touch with the Lead NHS R&D point of contact or the specific site you are planning to carry out your work at: see researchpassport.aspx for more information.

Retrospective ethics approval is rarely possible because ethics review considers whether the proposed research methods, participant protections and data handling arrangements are appropriate before the research takes place.

If you believe research activities have commenced without the necessary approvals, contact the REGI team on ethics-queries@contacts.bham.ac.uk for advice as early as possible.

Human tissue storage is subject to legal and governance requirements. Storage of relevant material for research can only happen under an NHS REC approval or through a licensed facility. For recognised licensing exemptions, please see: Code E: Research | Human Tissue Authority. You should seek advice before collecting samples. For information on the Human Tissue Act, please see: Research FAQs | Human Tissue Authority and Frequently Asked Questions (Scientific Access) - University of Birmingham.

Plans for long-term retention, future use, transfer to collaborators or eventual disposal should be considered before samples are collected – do not assume that samples can be stored indefinitely just because they have been collected for research purposes.

Possibly, but You should consider:

• Whether consent permits transfer
• Material Transfer Agreements (MTAs)
• Governance approvals
• Transport requirements
• International regulations (if samples are leaving the UK)

Appropriate agreements should be in place before samples are transferred.

Potentially, provided the necessary approvals, governance arrangements and permissions are in place.

You should establish:

• The consent status of the samples
• Whether the proposed use is compatible with the original permissions and consent
• Whether additional approvals are required
• Whether any transfer agreements are needed

Bespoke insurance arrangements should normally remain in place for the entire period during which the study is active and until all study-related activities covered by the policy have concluded.

When determining the required duration of cover, you should consider:

• Participant recruitment and follow-up periods
• Data collection activities
• Sample collection, storage and analysis (where applicable)
• Any ongoing interventions or study procedures
• Contractual requirements from funders, collaborators or host organisations
• Whether there may be potential claims arising after active study activities have ended

The required duration will vary depending on the nature of the study and the specific insurance arrangements in place. You are encouraged to discuss insurance requirements with the University's insurance team and the Research Governance and Integrity (REGI) team during study set-up.

Top tip: Insurance requirements should be considered early in study planning, as some external organisations may request evidence of cover before granting approval for research to proceed.

Not all studies require bespoke insurance arrangements. Many research activities are covered by the University's existing public liability/clinical trials policy. However, some studies may involve activities, locations, participants or risks that require additional review and potentially bespoke cover.

You should seek advice as early as possible if their study involves:

• investigating or participating in methods of contraception
• assisting with or altering the process of conception
• the use of drugs and/or nutrients
• the use of surgery (other than biopsy)
• genetic engineering
• subjects under 5 years of age
• subjects known to be pregnant
• pharmaceutical product/appliance designed or manufactured by the institution
• work outside of the United Kingdom
• E-cigarettes or vapes (electronic cigarettes)

The REGI team and University Insurance Office can advise on whether additional insurance arrangements may be required.

A Sponsor Representative is a member of University staff who has been formally authorised to act on behalf of the Sponsor and make decisions relating to the University's sponsorship responsibilities.

Because Sponsor approval carries institutional, regulatory and governance responsibilities, only staff with delegated authority can act as a Sponsor Representative. This role cannot be undertaken by a supervisor or member of the research team unless they have been formally authorised by the University to do so. This ensures that Sponsor decisions are made consistently and by individuals with responsibility for institutional oversight.

All ethics committees are made up of reviewers from different backgrounds, departments, specialties and experiences. Lay members, Chairs or Deputy Chairs may not be subject matter experts. It should be possible for an ethical assessment to be made of your proposal without the need for querying specialist/scientific language, and it is helpful to everyone if it is clear what you intend to study and why from the outset of the application process.

This varies considerably, but partly depends upon the quality of the application, the complexity of the study and which type of ethics approval you require. We strongly recommend you take great care and attention when preparing your application, take advantage of all of the training and guidance on offer and respond promptly and fully to questions raised by reviewers. While Ethics Committees aim to review applications as efficiently as possible, approval cannot be guaranteed within a specific timeframe. You should not make commitments to funders, sponsors, collaborators or participants that assume expedited review or a predetermined approval date, as committees must be given adequate time to undertake a thorough and independent assessment. The need to meet externally imposed deadlines does not, in itself, constitute grounds for expedited ethical review.

A good application is detailed, consistent, clear, provides context for each part of your study and also provides reviewers with sufficient information for an ethical assessment to be made. Please do not include acronyms throughout the application, and where relevant glossaries should be added to research protocols.

Consent is a key part of ethical research practice. It allows individuals to make an informed decision about whether they wish to take part in research.

Participants should be provided sufficient information to understand:

• What the research involves and its purpose
• Which data will be collected, how it will be stored and used
• Who will have access to the data and confidentiality arrangements
• Any potential risks or benefits
• Withdrawal options
• Who to contact with questions or concerns

Where Health Research Authority approval is required, the approved GDPR transparency wording should be included verbatim as required by the HRA.

For useful information about consent in research, see: Consent - UK Research Integrity Office. For useful templates for research taking place within the NHS: Content - Consent and Participant information sheet preparation guidance.

Usually, yes. The fact that participants are colleagues does not remove the need to consider informed consent, confidentiality and potential power dynamics.

You should consider whether participation is genuinely voluntary and whether individuals may feel pressured to take part because of professional relationships.

You should clearly explain:

• Whether participants can withdraw their participation
• How participants can withdraw
• Any deadlines for withdrawal
• What happens to data already collected

In some cases, there may be a point after which withdrawal is no longer feasible, for example after data have been anonymised or incorporated into aggregate analyses.

This should be explained transparently during the consent process, ie. in the participant information sheet.

Not necessarily. Written consent is often the preferred approach, but other methods may be appropriate depending on the study design and participant group.

Where verbal consent is proposed, You should be able to justify why written consent is not practical or appropriate and ensure appropriate records are retained to document that the participant has agreed to each statement on the consent form. For further information regarding methods for consent, please refer to Quality Management System (QMS) - University of Birmingham.

You are responsible for ensuring translated materials are correct, complete and suitable for the intended audience.

Not necessarily. The University expects all research to be conducted in accordance with its research integrity and ethics frameworks. Please ensure you are familiar with the University of Birmingham Code of Practice for Research and the University of Birmingham Code of Ethics.

Research ethics concerns a proactive commitment to protecting participants, maintaining integrity and managing risks appropriately. Ethical conduct is assessed against recognised standards and requirements, not solely by the absence of complaints.

Anonymous data cannot reasonably be linked back to an individual, and participants will be anonymous if you are not meeting them face-to-face or collecting any identifiable information.

Identifiable data can be linked directly or indirectly to an individual.

Examples may include:

• Names
• Email addresses
• Student or staff IDs
• Photographs
• Video recordings
• Audio recordings
• IP addresses

See Personal information - what is it? | ICO for more information about personal data.

Pseudonymised data have identifiers replaced with codes, but a link still exists somewhere that could re-identify individuals.

You should carefully consider whether data are truly anonymous before describing them as such. Research data can be anonymous or identifiable, but personal data is always identifiable. All members of staff should have completed mandatory data protection training: Enrol in Data Protection (GDPR) Training and data security training: Required Information Security Awareness Training – IT Security prior to commencing research.

Consent forms are a critical part of the study documentation, and should be stored in accordance with the University of Birmingham Quality Management System: Quality Management System (QMS) - University of Birmingham, unless there is a specific legal or ethical reason not to, which should be articulated in your protocol/ethics application. Original signed paper copies should be stored in a secure location during the course of the study and archiving period. If required, consent forms can be scanned to be stored in a secure location electronically, in accordance with IT Data Security procedures. A justification should be provided as to why paper consent forms cannot be retained, and a quality assurance process should be in place to ensure the scan is clear, complete and correct before any paper copies are destroyed. This should clearly be explained when describing the data management process for the study.

A DPIA may be required where research involves higher-risk processing of personal data. You should consider this early in the project planning process and seek advice where required. Further guidance is available through University Data Protection resources: Guidance on Storing Sensitive Data - University of Birmingham.

Yes, but there needs to be careful consideration in how this is done. Ensure there is sufficient detail in your application about how this will be managed, including whether forms/surveys will be shared via email or via a UoB approved survey tool (see Approved Software Applications) , when they will be shared and considerations around confidentiality and withdrawal.

To use an existing dataset (whether from within or outside of the UK) for your research, you will need to apply for ethics approval – as part of the application you will need to explain what data you intend to use, where it has come from and whether you require any permissions to use it. Where the dataset relates to human participants, it is your responsibility to demonstrate that consent was given for use of the dataset beyond its original purpose (especially if it was collected for a previous, specific research project), by evidencing that consent was in place from the participants in the original study to use their data for future research projects.

A Sponsor is the organisation or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project. In providing Sponsorship, the University of Birmingham takes legal responsibility for the oversight, governance, and compliance of your research, while supporting you in your responsibility for its conduct.

All health and social care research should have a sponsor. This includes all research that involves NHS patients, their tissue or information. When studies are submitted for Sponsorship review, the review process provides assurance that the study is feasible, appropriately designed, and can be conducted safely and in line with regulatory requirements before the University agrees to act as Sponsor.

Please see Applying for University of Birmingham Sponsorship for details on how to submit a Sponsorship application. Your study will not be ready for the Sponsorship review until you have submitted it in ERM, and sent the required document set to Research Governance at researchgovernance@contacts.bham.ac.uk.

The document set will need to include a completed protocol (see here for the UoB template) and a PDF of the completed IRAS form. Ensure you have the IRAS ID, version number and date in the header or footer of each document.

As Sponsor, the University is responsible for ensuring appropriate arrangements are in place to initiate, manage and oversee research throughout its lifecycle. Reviewing study documents is an important part of meeting these responsibilities. The University’s research governance framework and Code of Practice for Research set out these responsibilities and expectations.

The review is not just about compliance. We also aim to identify issues that may be raised by ethics committees, the HRA, participating organisations or other reviewers, helping you address them early and potentially avoid delays later in the approvals process. The process aims to help strengthen applications, improve clarity and consistency, and support you in developing high-quality, ethical and well-governed research.

A thorough Sponsorship review can save considerable time later by identifying issues before a study reaches ethics review, the HRA or other approval bodies. Taking the time to address these points early often helps applications move more smoothly through subsequent stages.

Review times vary depending on the complexity of the study, the quality and completeness of the submission, and the volume of applications under review. The Sponsorship team supports a large and diverse portfolio of research across the University, reviewing hundreds of studies each year, many of which have competing timelines.

If your documents are returned with extensive feedback, this usually reflects the level of detailed review they have received. Our comments are intended to help strengthen the application and reduce the likelihood of delays later in the process.

The review process works best as a collaborative effort between you and reviewers. Prompt responses to queries, engagement with feedback and clear communication can help applications move through review as efficiently as possible.

For more information and completing and submitting the modification tool, please see IRAS Help - Maintaining your approvals - Modification guidance -all review bodies. For each change, select the drop-down option which most closely fits the change type. The tool will need to be sent to REGI at researchgovernance@contacts.bham.ac.uk prior to submission. A member of the REGI team will confirm when this can be submitted via IRAS following the instructions available.

Yes. You should consider:

• Participant confidentiality
• Recording arrangements
• Secure storage of recordings
• Appropriate interview locations
• Whether participants may be identifiable from quotations
• Withdrawal arrangements
• Any potential power imbalance

For focus groups, you should also consider that confidentiality cannot be fully guaranteed because participants hear contributions from others. This should be addressed with/discussed with the group prior to the start of the focus group session.

You should consider:

• Whether responses are anonymous or identifiable
• How surveys will be distributed
• What platform will be used – see Approved Software Applications for more information
• How partially completed responses will be handled
• Whether participants can withdraw after submission

If using online surveys, you should ensure the platform meets University requirements.

Research involving sensitive subjects may require additional safeguards. You will need to show you have considered risk mitigation and management specific to your research.

You should consider:

• Participant welfare
• Researcher wellbeing
• Support mechanisms
• Appropriate expertise and training
• Risks arising from publication or dissemination
• Whether a distress protocol might be required as part of the study documents

You should ensure you understand:

• Local legal and regulatory requirements
• Ethical approval requirements
• Travel safety guidance
• Institutional requirements for overseas research activity

Even if you are familiar with the political or societal local context, you will need to reflect this understanding in the application. Useful resources include Foreign, Commonwealth and Development Office travel advice and relevant University travel policies: 

• Travel, Conferences & Working Abroad

• Research Risk Assessment & Mitigation Plans (RAMPs)

Yes. However, researchers remain responsible for the quality, integrity and ethical conduct of their research. AI should support, not replace, researcher judgement.

When using AI in research, you should:

• Use only University-approved AI platforms, such as BirminghamAI and Microsoft Copilot, for University work.
• Consider carefully what information you enter into an AI tool and comply with data protection, confidentiality and information security requirements.
• Critically review and verify all AI-generated outputs for accuracy, completeness, bias, copyright issues and suitability for their intended purpose.
• Be transparent about the use of AI where required by University policies, funders, publishers or journals.
• Follow the requirements of the University's Code of Practice for Research, as well as any discipline-specific or local guidance.
• Ensure that any decisions affecting people, research participants, funding, safety or regulatory compliance are not based solely on AI-generated outputs.
• Consider the environmental and financial impact of AI use and use these tools proportionately and responsibly.

Researchers should also be aware that AI outputs may be inaccurate, misleading, biased or out of date. Responsibility for the research always remains with the researcher, regardless of whether AI has been used.

Note that if you plan to use any personal data in a Generative AI tool and/or share the data with third parties via the tool or use it to train models this should be clearly explained in your ethics/sponsorship application, Participant Information Sheet and Consent Form, and you should also complete a Data Management Plan. For more information please refer to the University of Birmingham’s Framework for the use of AI for Research.

You remain responsible for your study after active data collection has finished.

This may include:

• Notifying relevant oversight bodies of study closure
• Ensuring documents are appropriately archived
• Managing data retention
• Reporting findings
• Meeting sponsor, funder and regulatory requirements: see uob-clo-sop-001-project-closure.docx for more information

It is imperative that you inform REGI when any study which has NHS REC and/or HRA approval is due to close. For more information please see: Ending your project - Health Research Authority.

You will need to check that the correct contractual arrangements and appropriate consent are place prior to sharing any data or samples. If you are unsure, please contact researchgovernance@contacts.bham.ac.uk.

Useful resources include:

• University Research Ethics, Governance and Integrity webpages: Research integrity - University of Birmingham
• University Quality Management System (QMS): Quality Management System (QMS) - University of Birmingham
• University of Birmingham IT services:
• Information Commissioner’s Office: UK GDPR guidance and resources | ICO
• HRA guidance and templates: Planning and improving research - Health Research Authority
• NIHR training resources for clinical research: Introductory courses and resources for health and care research | NIHR
• Trusted Research guidance: Trusted research and innovation – UKRI and Trusted Research
• Guidance and training on Research Integrity: Home - UK Research Integrity Office