FAQs

To ensure the success of your research study, it is essential to plan and cost it accurately. This guarantees that you request sufficient funding to support the study throughout its duration.

Contact ACCORD as early as possible, well ahead of your funding application deadline, to discuss your plans. We work closely with the Edinburgh Research Office and NHS Lothian Finance teams to provide coordinated support. This ensures accurate identification of NHS costs, appropriate allocation of funding, and clarity around which organisation will administer your grant.

Share your draft funding application with the Edinburgh Research Office, ACCORD and NHS Lothian Finance to allow for timely review and input.

The University of Edinburgh and NHS Lothian can take on the role of Sponsor. This can be a single organisation Sponsor arrangement, or more commonly, both organisations will Co-Sponsor research led by University of Edinburgh and NHS Lothian employees and students.

The Health Research Authority (HRA) decision tool and Defining Research table can provide guidance on this.

If you are still unsure, send your study outline or protocol to the Research Governance team for advice.

To understand what is needed, visit our Sponsorship and review page.  

To help you prepare, we have useful templates, including protocols, Participant Information Sheets, and Consent Forms, which should be used when drafting your study materials.

Once prepared, submit your draft study-specific documents, including a draft IRAS form, to the Research Governance team for review.

Our Clinical Research Facilitators can guide you through trial setup and work alongside Monitoring, QA, and Pharmacovigilance teams to ensure compliance.

Depending on your study, you'll likely need approval from a Research Ethics Committee, NHS R&D, and possibly the Medicines and Healthcare products Regulatory Agency (MHRA) if you are planning a regulated clinical trial or medical device study. Our team can advise you on these requirements and help with applications.

If your research study involves NHS patients, including their data and/or tissue, it will likely require a favourable opinion from an NHS Research Ethics Committee (REC).

If your participants are not NHS patients, and you are a University of Edinburgh employee or student, ethical approval from a University of Edinburgh REC will typically be required instead.

For locally sponsored studies (sponsored by the University of Edinburgh and/or NHS Lothian), your assigned Sponsor Representative will guide you through the sponsorship review process and advise on the necessary approvals.

Service evaluation and audit projects do not require a favourable opinion from an NHS Research Ethics Committee (REC), R&D management approval, or sponsorship.

However, these projects must be registered with the local NHS Quality Improvement Team (QIT) in each participating Board or Trust. You should also consult the relevant QIT to determine whether Information Governance and/or local Caldicott approval is necessary.

Under the UK Policy Framework for Health and Social Care Research, research databases do not need ethical review. However, organisations may voluntarily seek ethical approval for their governance arrangements, including data collection, storage, use, and sharing, particularly for releasing non-identifiable data to external researchers.

If a research project involves procedures beyond those outlined in the database’s ethical approval, additional ethical review is required, either as a substantial amendment or as a separate application.

Research databases do not require sponsorship. However, studies using data from a research database do require sponsorship and must have a favourable REC opinion. If the database already holds such an opinion, the study may proceed under its terms, provided it falls within the approved scope.

R&D management approval is not required to establish a research database. However, researchers accessing NHS patient data from a database for specific research purposes must obtain study-specific R&D approval.

Further guidance: Refer to the HRA guidance on research tissue banks and research databases.

R&D management approval is not required to establish a Research Tissue Bank (RTB). However, organisations managing RTBs across the UK may voluntarily apply for ethical review of their procedures for the collection, storage, use, and distribution of tissue.

An RTB does not require sponsorship. However, any study accessing tissue from an RTB does require sponsorship and must be conducted in line with a favourable opinion from a Research Ethics Committee (REC). If the RTB already holds a favourable opinion, a study may proceed under its terms, provided it falls within the approved scope.

For further guidance, please contact the NHS Lothian Tissue Governance Manager.

Further reading: HRA guidance on research tissue banks and research databases.

If your study is locally sponsored by the University of Edinburgh and/or NHS Lothian, your assigned Sponsor Representative will guide you through the sponsorship review process, including which approvals are required.

In NHS Lothian, the Caldicott Guardian oversees the use and sharing of patient-identifiable information for research, particularly where obtaining individual consent is not feasible. Approval is granted only if the study complies with the 8 Caldicott Principles.

Guidance on how to apply for Caldicott approval is outlined in ACCORD SOP GS008 Personal Identifiable Information: Caldicott Approval and Information Governance Review (v5.0).

Please note that NHS Lothian policies require Caldicott approval in certain situations, even when explicit consent has been obtained - for example, when using a mobile device that will store personal data.

When reviewing a research study prior to issuing R&D permission, a thorough check of the IT systems, software, or other methods used to process NHS Lothian personal data is required. This is particularly important in cases where personal data is transferred to a non-NHS organisation or where web-based systems are used to capture personal data. The decision to require this check is made by ACCORD during the study document review, in consultation with NHS Lothian Information Governance and IT Security teams as needed (see ACCORD SOP GS008 Personal Identifiable Information: Caldicott Approval and Information Governance Review v5.0). 

If you anticipate that your study will require an NHS Lothian Information Governance and IT review, we recommend engaging with the R&D IT Information Project Manager before your study undergoes the R&D review process, to initiate the necessary steps.

You can find detailed guidance on the Research Passport application system under the ‘HR Good Practice Resource Pack’ on the Integrated Research Application System (IRAS).

NHS Lothian R&D will issue honorary research contracts or letters of access to researchers where required in accordance with ACCORD SOP GS006 Research Passports v5.0.

Any changes must be submitted as modifications to your Sponsor Representative who will advise if further review or formal approval is required.

If required by your protocol, report events to ACCORD’s Pharmacovigilance team, who ensure timely reporting to the relevant authorities.

Notify your Sponsor Representative, the REC, and MHRA, and submit final reports including results and safety data. Share results publicly when required and archive essential documents.

Yes, we provide access to SOPs, templates, guidance leaflets, and a resource pack to support you through each phase of your research.

Public Involvement means conducting research with or by patients and the public - not just to, for, or about them. Contributors influence priorities, design, conduct, and dissemination.

It enhances relevance and clarity, improves study design, boosts participant engagement, enriches outcomes communication, and strengthens ethical integrity.

Use the UK Standards for Public Involvement and HRA’s best-practice guidance - these offer clear benchmarks and planning support.

Local support is available via the Edinburgh Clinical Research Facility.

Useful resources are also listed on the HRA website.

Research transparency means being open and clear about all aspects of your study, from design and methodology to data, analysis, and results. It allows others to understand, evaluate, and reproduce your work.

Transparent research improves credibility, reproducibility, and public trust. It helps prevent errors or bias and ensures that findings can be built upon by other researchers.

• Register your study protocol and analysis plan.
• Share data, code, and materials when possible.
• Clearly report methods, results, and any limitations.
• Publish negative or null results alongside positive findings.

Pre-registration is the process of documenting your study plan before collecting data. It helps prevent selective reporting and strengthens the credibility of your results.

Yes. Data can be anonymised, aggregated, or shared under controlled access agreements to maintain confidentiality while promoting transparency.

It ensures that research is accountable, ethical, and relevant. Transparent reporting allows patients, funders, and the public to see how studies were conducted and how decisions were made.

Many funders and journals now mandate registration, data sharing, and detailed reporting. Following these requirements not only meets compliance but also enhances the impact and credibility of your research.

Reach out to our key teams: 

• NHS Finance for funding application costs where the research involves NHS patients or resources. They work closely with the University Research Funding teams.
• Research Coordinators for non-regulated clinical research
• Clinical Research Facilitators (and associated QA, Monitoring, and Pharmacovigilance teams) for regulated research
• Global Health Research Facilitators
• The R&D team for NHS Lothian approvals (Edinburgh-led and hosted research)
• Contracts team for research agreements
• Monitoring and QA teams for clinical trial oversight and support with compliance
• Pharmacovigilance team for participant safety
• Information Governance team for compliance with data protection
• R&D Portfolio Performance team for recruitment support

Yes, our Global Health team assists researchers conducting studies in low‑ and middle‑income countries with both ethical review and logistics, while our Clinical Research Facilitators are experienced in supporting international and multi-site clinical trials.