Global health research approvals

Every study needs the right approvals before it can start. The approvals you need will depend on the nature of your research.

Research ethics

  • All global health research studies being led by a researcher or PhD student within the College of Medicine require a favourable opinion from the University of Edinburgh’s Medical School Research Ethics Committee (EMREC) and from a local ethics committee in the country where the study is being conducted (in-country ethics). EMREC approval should be obtained first, followed by in-country ethics approval.
  • BSc and MSc students should obtain ethics approval from the programme ethics committee in addition to the relevant local (in-country) ethics committee. Check with your supervisor or programme lead about any additional approval requirements.
  • Global health research studies being led by a researcher or PhD student within the Royal (Dick) School of Veterinary Studies require a favourable opinion from the Human Ethical Review Committee (HERC) and from a local ethics committee in the country where the study is being conducted.
  • Global Health research studies involving animals as well as humans also require ethics approval for the animal component from the Animal Welfare and Ethical Review Body (AWERB). 

What if there is no in-country ethics committee available?

  • Where no in-country ethics process is available, EMREC will work with global health researchers to engage with local academics, research partners, or networks to identify appropriate governance guidance.
  • For global health studies conducted entirely online (e.g. surveys open to participants worldwide), the current position is that EMREC review is sufficient. Your Global Health Sponsor Representative will check during the governance review that this position is acceptable. 

Regulatory approvals

You’ll need regulatory approval if your project is:

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

If you are unsure whether your global health study is regulated under local (in-country) guidance, you must contact the local regulatory authority. Provide them with your research proposal and request written confirmation.

  • If the study is regulated: ACCORD global health processes for regulated research will be followed, in line with local regulatory requirements.
  • If the study is not regulated: ACCORD global health processes for non-regulated research will apply.

A copy of the local authority’s written decision is required for Sponsor oversight and will be requested by your Global Health Sponsor Representative during the sponsorship review.

Regulated global health studies undergo risk assessment and need a Trial Manager and monitoring oversight.

Risk assessment

Risk assessment helps identify and manage potential risks to participant safety, data integrity, regulatory compliance, and overall study quality. The process considers factors such as study design, the investigational product (e.g. drug or device), pharmacovigilance, trial population, research environment, and the experience of the study team.

All regulated global health trials undergo risk assessment, as do some projects with complex designs, novel interventions, or vulnerable populations.

When a project is identified for risk assessment, a meeting is scheduled with ACCORD representatives, investigators, and trial managers. Together, they review the study, assess potential risks (low, moderate, or high), and agree on mitigation strategies. In some cases, trial methods may also be adapted to make the research more efficient while maintaining regulatory and ethical standards.

After the meeting, ACCORD provides written feedback and finalises a signed document outlining risks and agreed mitigations. This assessment supports monitoring decisions and authorises submission to regulatory bodies, ensuring proportionate safeguards are in place for both participants and the credibility of the research.

Trial Manager

For all regulated global health trials, appointing a Trial Manager (TM) is mandatory. The TM can be a University of Edinburgh employee or an external individual.

  • External TMs: ACCORD will conduct a vendor assessment* of their employing institution, carried out remotely by our QA team, and a contract must be established with their employer.
  • All TMs: Whether UoE-based or external, the TM must be familiar with ACCORD’s SOPs and clinical trial processes to ensure the study is conducted to the required standards.

*Vendor assessment ensures external partners, such as Clinical Trials Units, laboratories, and e-system providers, meet required regulatory, ethical and scientific standards. Depending on study design and risk, this may involve reviewing vendors’ QMS and SOPs, evaluating past performance, or conducting audits. Careful vendor oversight helps maintain compliance, safeguard participants, and protect data integrity.

Monitoring

The ACCORD Monitoring team provides Sponsor oversight for clinical research, ensuring participant safety, data integrity, and regulatory compliance. Using a risk-based approach, monitoring strategies are tailored to each study to support research teams from set-up to close-out.

Monitoring is required for all studies that undergo the ACCORD combined risk assessment process and are selected for oversight. In some cases, studies not subject to risk assessment may still require monitoring; the Global Health Research Facilitator will inform researchers if this applies.

Operational arrangements

The ACCORD Monitoring team is provided by NHS Lothian, a separate institution from the University of Edinburgh. The team does not perform local on-site monitoring directly. For on-site activities, the study team must source an independent Monitor, who will then work with ACCORD’s Monitoring team to support trial set-up and oversight.

ACCORD’s Monitoring team charges a fee for sponsor oversight activities. Regulated global health trials are sponsored by the University of Edinburgh and do not involve NHS as a sponsor, so the University contracts NHS Lothian to provide these essential monitoring services, typically via a Research Services Agreement.

Other approvals

Additional approvals may include:

  • Ministry of Health approval
  • Local Medical Research Council approval
  • Local hospital ethics approval
  • Community leader or village leader approval

If in doubt, ask us

The list of additional approvals is not exhaustive. Always speak to your Global Health Sponsor Representative for tailored advice.

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