Global health sponsorship and review

When to make contact

Get in touch at the early stages of study planning. Seeking sponsorship early helps ensure your research is on track from the start and avoids unexpected delays later on.

Sponsor approval is required before:

• Applying to the institutional ethics committee, usually the Edinburgh Medical Research Ethics Committee (EMREC), for review and approval
• Applying to local (in-country) ethics for review and approval
• Submitting to local (in-country) regulatory authorities for review and approval, where applicable for regulated clinical trials

The sponsorship review can take up to 10 working days, depending on the complexity of your study and how quickly you respond to feedback. If a Risk Assessment is needed, your global health Sponsor Representative will advise and explain this process.

What to send to Research Governance

Send the following documents, where applicable, to the Research Governance team for review:

• Draft global health protocol
• Draft EMREC ethics form - if you are a student, send your relevant programme institutional ethics committee form
• Global health Participant Information Sheet(s) for each participant group, e.g. adult participants, parents, children
• Written global health Consent Form(s) and/or Verbal Consent Form(s) for each participant group
• GP letter
• Any other documentation, e.g. poster, social media advert, approach script, invitation email/text, surveys, questionnaires, interview topic guide, website links, training documents, letter of support, e.g. from a community leader or hospital
• Brief CV for the Chief Investigator (and student if applicable)

What if my global health study is a regulated clinical trial?

Regulated global health studies can include:

• A Clinical Trial of an Investigational Medicinal Product (CTIMP)
• A Clinical Investigation of a Medical Device (CIMD)
• A combined drug and device trial

Regulated trials are typically more complex than other types of research. They require careful planning, close collaboration across teams and regulatory approval from the relevant local (in-country) regulatory authority.

To meet high ethical, legal, and safety standards, regulated trials follow detailed protocols and often involve specialised procedures and assessments. Planning and set up can be a more complex process than other types of research.

Our Global Health Clinical Research Facilitator will guide researchers through each stage of the process, offering expert support on study design, sponsorship, and approvals. Working alongside them, our Clinical Trial Monitors, Quality Assurance and Pharmacovigilance teams provide support with trial set-up and oversight - helping ensure your global health trial is well-designed, compliant, and ready to recruit.

• Once we receive your research study documents, a unique Sponsor number will be assigned - please include this in all future correspondence.
• A Global Health Sponsor Representative will be allocated to review your full document set. They may request additional documents if needed. After the initial review, you’ll receive a feedback document outlining comments, suggestions, and any required changes.
• To keep the process moving, please respond to the feedback promptly and return any revised documents for further review.

How long does the review take?

The review typically takes up to 10 working days, depending on the complexity of your study and the speed of your responses. If a Risk Assessment is required, your Global Health Sponsor Representative will let you know. Once all feedback has been addressed, the study will receive sponsorship approval.

Your Global Health Sponsor Representative will guide you through the research approval submission process, including how to obtain:

• EMREC favourable opinion
• Local (in-country) ethics committee favourable opinion
• Any other necessary research permissions, e.g. local Ministry of Health approval, local hospital ethics approvals
• Regulatory Approvals (in-country), where applicable for regulated clinical trials 

They will also provide insurance documentation if required. 

Please note: ACCORD does not issue separate Sponsor letters, as our authorisation on the ethics form confirms our agreement to act as Sponsor. If a formal letter is needed, speak to your Global Health Sponsor Representative.

⚠️ Important:

Please do not submit for research approvals before obtaining sponsorship. Failure to do so may delay your study. ACCORD cannot agree to sponsor global health research that has already started.

When can you start your study?

Unless advised otherwise by your Sponsor Representative, you may begin your study once:

• You have received a favourable EMREC and local (in-country) ethics committee opinion
• All ethics committee conditions have been addressed
• Any other necessary local research approvals are in place

Global health researchers are reminded that all University of Edinburgh sponsored studies must comply with ACCORD Standard Operating Procedures (SOPs). Researchers and study staff are expected to be familiar with these requirements. The current SOPs can be viewed and downloaded from the tab below. If any study-specific measures differ from ACCORD SOPs, these must be detailed in the study protocol and reviewed with the Global Health Sponsor Representative during sponsorship review.